子供も含め若い人は、細胞年齢も低く、身体が強いことから
癌の治療によって命を落とす人の割合は低いです。
しかし、闘病生活は決して楽なものではなく
厳しい苦しみ、痛みに耐える必要があります。
多くの事をまだ知らない子供が癌の治療を受けている姿を見ると
第三者であっても、心を痛めることがあります。
少しでも楽な治療、制限の少ない高い生活の質、
さらには良い予後などの実現に向けた
小児医療に対する思いは強いと言えます。
小児、新生児に対する医療に対して
ブログでのカテゴリーを特異的に用意しているというのは
一つとしてそういった背景があるということです。
---
子供も含めた若い人に対する癌の免役療法は
高い臨床効果につながることがありますが、
免疫治療特有、あるいは重篤な有害事象、副作用を伴うことがあり
それによって健康が脅かされることがあります。
最近では
CAR治療や免疫チェックポイント阻害薬などを使った
新しい治療もあります。
これら最新の治療も含めて
Dristhi Ragoonanan, Sajad J. Khazal, Hisham Abdel-Azim, David McCall, Branko Cuglievan, Francesco Paolo Tambaro, Ali Haider Ahmad, Courtney M. Rowan, Cristina Gutierrez, Keri Schadler, Shulin Li, Matteo Di Nardo, Linda Chi, Alison M. Gulbis, Basirat Shoberu, Maria E. Mireles, Jennifer McArthur, Neena Kapoor, Jeffrey Miller, Julie C. Fitzgerald, Priti Tewari, Demetrios Petropoulos, Jonathan B. Gill, Christine N. Duncan, Leslie E. Lehmann, Sangeeta Hingorani, Joseph R. Angelo, Rita D. Swinford, Marie E. Steiner, Fiorela N. Hernandez Tejada, Paul L. Martin, Jeffery Auletta, Sung Won Choi, Rajinder Bajwa, Natalie Dailey Garnes, Partow Kebriaei, Katayoun Rezvani, William G. Wierda, Sattva S. Neelapu, Elizabeth J. Shpall, Selim Corbacioglu & Kris M. Mahadeo
(敬称略)からなるイタリア、ドイツを含むアメリカ合衆国(全米)の
医療研究グループは
子供、若い人に対する癌免疫療法に対する
コンセンサスステートメント(合意声明)を発表しています(1)。
以下の団体のコラボレーションによって実現されています。
★★★
Members of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI)
Network Hematopoietic Cell Transplantation-Cancer Immunotherapy (HCT- CI) Subgroup,
Paediatric Diseases Working Party (PDWP) of the European Society of Blood and Marrow Transplantation (EBMT),
Supportive Care Committee of the Pediatric Transplantation and Cellular Therapy Consortium (PTCTC)
MD Anderson Cancer Center CAR T Cell Therapy- Associated Toxicity (CARTOX) Program
★★★
本日はその内容のうち、Box1に示されている
Key consensus recommendationsをベースにして
内容の一部について独自の視点を加えたうえで
読者の方と情報共有したいと思います。
子供や若い人の癌の事例は中年、高齢の方に比べて稀であるため
可能な限り早い段階で熟考された治験を行う必要があります。
若い癌の患者さんの治験参加を促すために
研究者、スポンサー、期間、規制機関、支払人など
人的、空間的、経済的リソースを確保する必要があります。
一方で、治験の参加を促すために
本人や親御さんの理解を促す必要があります。
治験のゴール、目的を明確に示す必要があります。
また年齢依存的な層化など安定期の大人に比べて
分類の難しさなどが存在する可能性もあります。
なぜなら子供の身体は年齢と共に発育し、
免疫機能、神経機能など変化していくからです。
---
免疫治療に伴う副作用であるサイトカインストームや神経毒性などは
American Society for Transplantation and Cellular Therapy (ASTCT)
が定める評価基準(2)に従ってグレード評価する必要があります。
ヘルスケア期間は現在のエビデンスと患者さん(宿主)と生体物質変化
に基づいて患者さんをマネイジメントするガイドラインを総括して、
総合的に判断する必要があります。
サイトカインストームなどの有害事象を抑制するために
特定のサイトカインを抑制する治療を早期に始めることは
検討される必要があります。
サイトカインストームや神経毒性は
参考文献(1) Fig.1/Fig.2にそれぞれ示されるように
臨床症状依存的にグレードが4段階に分類されています。
それぞれに対してどのようにケアする必要があるかが
明記されています。
---
ベースとなる臓器の機能の評価によって
免疫治療によって生じた有害事象をモニタリングする事に繋がります。
それによって長期的な治療や臨床症状のフォローアップに繋がる
コラボレーション研究を活性化させる事につながります。
---
最先端の免疫治療である免疫チェックポイント抑制剤の投与においては
副腎皮質刺激ホルモン、甲状腺刺激ホルモン
黄体形成ホルモン濃度、卵胞刺激ホルモン
これらのホルモンの一連の監視は必要になるかもしれません。
これらの測定結果において異常がみられた場合
X線画像測定、ホルモン代替療法、
ステロイド投与、ベータ遮断薬、
内分泌系の評価、入院などによる処置を検討します。
---
グレード3以上の有害事象、副作用が生じている場合には
できるだけ早く評価を行い、適切な治療を提供する必要があります。
---
(iPS細胞の使用を含む)CAR-TやCAR-NK療法など
同種異系の免疫エフェクター細胞の投与が行われた場合には
移植片対宿主病(拒絶反応)の評価を行い、
グレード分類、治療のガイドラインを明確化する必要があります。
---
免疫療法に対する年齢に適合した評価基準を参照する必要があります。
身体の大きさ(表面積)や腎機能、内分泌機能、便などによって
適切に評価する必要があります。
下垂体炎が生じた場合には精神に異常をきたすことがあります。
グレードは4段階に分かれて
グレード4では免疫治療を中断する必要があります。
---
不眠が生じている場合には
免疫療法による副作用が生じている早期の段階である可能性があります。
従って、患者さんが規則正しく、しっかり眠れているか
それを確認する事が治療中必要になります。
最新の電子機器などによって
睡眠の質を測ることも早期の適切な治療に貢献するかもしれません。
---
免疫治療を受けている場合には
免疫機能と高い関連性を持つ細菌やウィルス感染に注意する必要があります。
必要に応じて予防処置をとる必要があります。
インフルエンザなどの予防接種は
免疫治療を受ける子供に対して勧められます。
新型コロナウィルスも今後、追加される可能性があります。
その際、6か月間の継続的な抗体の評価を行う必要があります。
---
分野横断的かつ最前線のスタッフは必要な資格や
卓越した能力が求められます。
分野の垣根を超えたスタッフのトレーニングによって
このような最前線で高い医療の質を提供するスタッフの養成に貢献します。
//Discussion//---
In my impression from the clinical reports, when immune therapy well-functions for the patients, side effect tend to be severe. The simultaneous achievement of effective immune therapy and less-side effect may be fundamentally difficult. Spatial(lesion-specific) and time effective immune therapy is one of the ways for immunotherapy for the children and young adult. Furthermore, pain management and mental care including compassionate one during treatment are demanded simultaneously. We could pursue application possibility of the cell-specific delivery system against pediatric cancer.
(Reference)
(1)
Dristhi Ragoonanan, Sajad J. Khazal, Hisham Abdel-Azim, David McCall, Branko Cuglievan, Francesco Paolo Tambaro, Ali Haider Ahmad, Courtney M. Rowan, Cristina Gutierrez, Keri Schadler, Shulin Li, Matteo Di Nardo, Linda Chi, Alison M. Gulbis, Basirat Shoberu, Maria E. Mireles, Jennifer McArthur, Neena Kapoor, Jeffrey Miller, Julie C. Fitzgerald, Priti Tewari, Demetrios Petropoulos, Jonathan B. Gill, Christine N. Duncan, Leslie E. Lehmann, Sangeeta Hingorani, Joseph R. Angelo, Rita D. Swinford, Marie E. Steiner, Fiorela N. Hernandez Tejada, Paul L. Martin, Jeffery Auletta, Sung Won Choi, Rajinder Bajwa, Natalie Dailey Garnes, Partow Kebriaei, Katayoun Rezvani, William G. Wierda, Sattva S. Neelapu, Elizabeth J. Shpall, Selim Corbacioglu & Kris M. Mahadeo
Diagnosis, grading and management of toxicities from immunotherapies in children, adolescents and young adults with cancer
Nature Reviews Clinical Oncology volume 18, pages435–453 (2021)
---
Author information
Affiliations
Department of Pediatrics, CARTOX Program, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Dristhi Ragoonanan, Sajad J. Khazal, David McCall, Branko Cuglievan, Ali Haider Ahmad, Basirat Shoberu, Jeffrey Miller, Priti Tewari, Demetrios Petropoulos, Jonathan B. Gill, Fiorela N. Hernandez Tejada & Kris M. Mahadeo
Department of Pediatrics, Blood and Marrow Transplantation Program, Keck School of Medicine, University of Southern California, Children’s Hospital Los Angeles, Los Angeles, CA, USA
Hisham Abdel-Azim & Neena Kapoor
UOC SIT–TMO AORN Santobono–Pausilipon, Napoli, Italy
Francesco Paolo Tambaro
Department of Pediatrics, Division of Critical Care, Indiana University School of Medicine, Riley Hospital for Children, Indianapolis, IN, USA
Courtney M. Rowan
Department of Critical Care, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Cristina Gutierrez
Department of Pediatrics Research, Center for Energy Balance in Cancer Prevention and Survivorship, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Keri Schadler
Department of Pediatrics Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Shulin Li
Pediatric Intensive Care Unit, Bambino Gesù Children’s Hospital, IRCCS, Rome, Italy
Matteo Di Nardo
Division of Diagnostic Imaging, Neuroradiology Department, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Linda Chi
Division of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Alison M. Gulbis & Maria E. Mireles
Department of Pediatrics, Division of Critical Care, St Jude Children’s Research Hospital, Memphis, TN, USA
Jennifer McArthur
Department of Pediatrics, Division of Critical Care, Medical College of Wisconsin, Milwaukee, WI, USA
Jennifer McArthur
Department of Anesthesia and Critical Care, University of Pennsylvania Perelman School of Medicine, The Children’s Hospital of Philadelphia, Philadelphia, PA, USA
Julie C. Fitzgerald
Pediatric Hematology-Oncology, Dana-Farber Cancer Institute, Harvard University, Boston, MA, USA
Christine N. Duncan & Leslie E. Lehmann
Department of Pediatrics, University of Washington School of Medicine, Division of Nephrology, Seattle Childrens and the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
Sangeeta Hingorani
Renal Section, Baylor College of Medicine, Texas Children’s Hospital, Houston, TX, USA
Joseph R. Angelo
Department of Pediatrics, Division of Pediatric Nephrology, McGovern Medical School, The University of Texas Health Science Center, Houston, TX, USA
Rita D. Swinford
Department of Pediatrics, University of Minnesota, Minneapolis, MN, USA
Marie E. Steiner
Department of Pediatrics, Division of Transplant and Cellular Therapy, Duke Children’s Hospital, Duke University, Durham, NC, USA
Paul L. Martin
Division of Hematology, Oncology, Bone Marrow Transplant and Infectious Diseases, Nationwide Children’s Hospital, Ohio State University, Columbus, OH, USA
Jeffery Auletta
Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA
Sung Won Choi
Division of Pediatric Hematology/Oncology/Blood and Marrow Transplantation, Nationwide Children’s Hospital, The Ohio State University, Columbus, OH, USA
Rajinder Bajwa
Department of Infectious Disease, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Natalie Dailey Garnes
Department of Stem Cell Transplantation and Cellular Therapy, CARTOX Program, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Partow Kebriaei, Katayoun Rezvani & Elizabeth J. Shpall
Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
William G. Wierda
Department of Lymphoma and Myeloma, CARTOX Program, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Sattva S. Neelapu
Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University of Regensburg, Regensburg, Germany
Selim Corbacioglu
(2)
Lee, D. W. et al.
ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells.
Biol. Blood Marrow Transpl. 25, 625–638 (2019).
経皮冠動脈インターベンションは
1位箇所以上の冠動脈が狭窄している状態において
ステントなどを使って拡張することによって
心筋の虚血を防いだり、灌流を促すことを目的としています。
この経皮冠動脈インターベンションでは
カテーテル、ワイヤー、バルーン、ステントなど
材料依存的に血栓が生じる事があり、
処置と合わせて非経口の血液抗凝固薬が必要となっています。
---
虚血や血栓に対して高いリスクのある患者さんは
P2Y12抑制剤、リバーロキサバンなど
長い間の抗凝固剤による治療が利益があるかもしれませんが、
その場合、出血のリスクを考える必要があり、
そのリスクが少ない場合に当てはまります(3-5)。
一方で、1か月程度に短縮したほうが
全体的な評価から良いかもしれないという報告もあります(2)。
---
経皮冠動脈インターベンションにおいて
血管凝固による血栓、梗塞を防ぎつつ、
抗凝固剤を使ったときのリスクである出血を如何に防ぐか？
この両立が非常に重要になります。
---
Davide Capodanno, Deepak L. Bhatt, C. Michael Gibson, Stefan James, Takeshi Kimura, Roxana Mehran, Sunil V. Rao, Philippe Gabriel Steg, Philip Urban, Marco Valgimigli, Stephan Windecker & Dominick J. Angiolillo
(敬称略)からなる医療研究グループは
経皮冠動脈インターベンションの術前、術中、術後
それぞれにおいて出血をどう防ぐかについての戦略を詳しく包括しています。
本日は、その内容の一部を読者の方と情報共有したいと思います(1)。
Marco Valgimigli氏らの報告によれば
出血の頻度が血栓、閉栓が生じるよりも統計的に高くなっている(2)ため
どのように出血を防ぐかという観点は非常に重要になります。
//術前の出血の予防//---
(診断)
非侵襲の診断、例えば、冠動脈のCT血管造影法などが
好ましいとされています。
特に冠動脈疾患の罹患歴がない方において勧められます(1)。
血管再開通術においても、不必要な再開通術を防ぐような
評価基準にしっかり従ったうえで
血管造影法によるデータを活用できます。
---
(リスク段階の層化)
参考文献(1)Table 1にリスク層化のツールによってスコアをつけます。
その中で入院中、長期間など
出血が想定される期間と確率の差異を
おおよそ想定することができいます。
リスクに基づき、
抗凝固剤の投与の期間と投与量は患者さん事に
個別化されるのが重要であるとされています(6)。
---
他には日常的に抗凝固剤による治療が行われているのであれば
それを避ける必要があるとされています(1)。
//術中の出血防止の戦略//---
---
(1:血管のアクセスサイト)
ステントを挿入するためのアクセス部位において
大腿部より橈骨からアクセスしたほうが全体的な評価において
出血などを含む有害事象が少ないことが示されています(7)。
もし大腿部から入れる事が必要な場合、
安全な部位から穴をあけてアクセスする必要があります。
それは蛍光透視法や超音波検査でガイドすることが
進められています(8)。
---
(2:抗凝固薬の最適化)
*Class1 recommendaton
抗凝固剤として非分画ヘパリンの使用
※ヘパリン誘発性血小板減少症が生じた場合には
bivalirudinが推奨されます。
*Class2a reccomendatiohn
enoxaparin ヘパリンの代替の薬剤
--
*Class 1 recommendation
ST上昇型ではない急性冠症候群において
P2Y12拮抗薬である
prasugrelもしくはticagrelorは
2次予防のために勧められます。
---
(3:適切なステントの選択)
薬剤溶出性ステントが臨床症状に関わらず勧められます。
最近は
*Lower strut thickness,
*More biocompatible,
*Biodegradable
*Durable polymers,
*Polymer-free designs,
このような機能向上を実現した新しいタイプの
薬剤溶出性ステントが出ているため
従来のベアメタルステントからシフトしています。
--
(4:視覚化によるステント着床最適化)
ステント着床の後、
超音波検査、光干渉断層計などの血管内の視覚化によって
ステントの拡張を最適化します。
それによって標的部位の障害や
再度血管再開通術を行うリスクを低下する事ができます(9,10)。
//術後の出血防止//---
(1:2剤抗血小板療法の選択)
患者さんに合わせて2剤抗血小板療法を行う期間を
判断する必要があります。
出血のリスクが高い患者さんに対しては
2剤抗血小板療法の期間短縮化を検討する必要があります。
M. Valgimigli氏らの報告によれば
ステントを着床させた1か月後にすぐに投薬を中断しても
2か月以上続けた場合と比較して
出血のリスクを減らした状態で
血栓、閉塞などに関わるリスクにおいて
継続投与に比べて顕著に劣るという事はないと結論付けています(2)。
---
(2:2剤抗血小板療法の短縮化)
2剤抗血小板療法の短縮化の後に
アスピリンもしくはP2Y12拮抗薬が検討されます。
---
(3:2剤抗血小板療法の調節)
ステント着床後、血栓、閉塞などによって生じる
虚血性の有害事象を回避しつつ、出血を防ぐことが目的ですが
それを達成するために血小板の凝集を防ぐ
P2Y12拮抗薬の用量を調整する事が挙げられています(11-15)。
---
(4:プロトンポンプ阻害薬)
胃の出血リスクが高い場合には
胃の保護機能があるプロトンポンプ阻害薬の投与が検討されます。
これらはticagrelorやprasugrelなどP2Y12拮抗薬
と同時に投与された場合においてお互いの効果に干渉することは
ないとされています。
//細胞特異的輸送系統の観点//---
出血を防止しつつ、ステント着床後に生じる血栓、閉塞などに
起因した虚血性イベントを回避するためには
患者さんの臨床症状や血管の状態を良く分析する必要があります。
しかし、両方を防ぐことが難しい場合もあるかもしれません。
細胞特異的輸送系統では
狙ったところに特異的に薬剤を輸送できるため
血栓や閉塞などのリスクが高いところだけ
抗凝固剤や抗血小板凝集薬などを運ぶことが可能です。
また血液中であり、
固定組織ではなく流体中のアプローチなので
CAR-T治療の標的化成功などを考えると
適切な特異的結合部位を探すことができれば、
特異的な薬剤輸送に成功できる可能性があります。
従って、血栓が生じるときに特異的に発現する結合部位を
見つける事が重要になります。
この事により血栓のリスクと関連性の低い部位における
出血のリスクを避ける事ができる可能性があります。
一方、出血を特異的に止めるという考え方もあります。
血管の内皮や細胞連結などにおいて傷害を受けている部位において
マクロファージなど組織修復免疫機能を高めるような
機能を薬剤ナノ粒子に加えて特異的輸送系統を実現する事です。
//Special note from me//---
I provide additional value for the global society continously and step-by-step in my activity.
Currently, the financial support is urgently needed.
Thank you.
//Discussion//---
We need to make /state-of-the-art stent including Lower strut thickness, Biocompatible, Biodegradable, Durable polymers, Polymer-free designs/ implant for the patient with acute coronary syndromes to promote blood perfusion. However, stent induce thrombosis, so we need to administrate anticoagulant. On the other hand, anticoagulant increases risk of (fatal) bleeding. Therefore, balance between maintaining blood perfusion and reducing risk of bleeding is difficult. We need to tailor the drug administration for each patient in line with clinical symptom and blood vessel condition.
The cell-specific delivery system may become game-changer on treatment of acute coronary syndrome. We could deliver the drug with anticoagulant function and/or the function of bleeding protection specific to the target lesion. Current anticoagulant drug may affect off-target site including stomach, bowel, lung and so on. Therefore, lesion-specific function is demanded.
(Reference)
(1)
Davide Capodanno, Deepak L. Bhatt, C. Michael Gibson, Stefan James, Takeshi Kimura, Roxana Mehran, Sunil V. Rao, Philippe Gabriel Steg, Philip Urban, Marco Valgimigli, Stephan Windecker & Dominick J. Angiolillo
Bleeding avoidance strategies in percutaneous coronary intervention
Nature Reviews Cardiology (2021)
---
Author information
Affiliations
Division of Cardiology, Azienda Ospedaliero-Universitaria Policlinico “G. Rodolico-San Marco”, University of Catania, Catania, Italy
Davide Capodanno
Department of Medicine, Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA, USA
Deepak L. Bhatt
Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA
C. Michael Gibson
Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala, Sweden
Stefan James
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
Takeshi Kimura
Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA
Roxana Mehran
The Duke Clinical Research Institute, Durham, NC, USA
Sunil V. Rao
Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Paris, France
Philippe Gabriel Steg
Hôpital de la Tour, Geneva, Switzerland
Philip Urban
Cardiocentro Ticino Institute and Università della Svizzera italiana (USI), Lugano, Switzerland
Marco Valgimigli
Department of Cardiology, Bern University Hospital, Bern, Switzerland
Stephan Windecker
University of Florida College of Medicine, Jacksonville, FL, USA
Dominick J. Angiolillo
(2)
Marco Valgimigli, M.D., Ph.D., Enrico Frigoli, M.D., Dik Heg, Ph.D., Jan Tijssen, Ph.D., Peter Jüni, M.D., Pascal Vranckx, M.D., Ph.D., Yukio Ozaki, M.D., Ph.D., Marie-Claude Morice, M.D., Bernard Chevalier, M.D., Yoshinobu Onuma, M.D., Ph.D., Stephan Windecker, M.D., Pim A.L. Tonino, M.D., Marco Roffi, M.D., Maciej Lesiak, M.D., Felix Mahfoud, M.D., Jozef Bartunek, M.D., Ph.D., David Hildick-Smith, M.D., Antonio Colombo, M.D., Goran Stanković, M.D., Ph.D., Andrés Iñiguez, M.D., Ph.D., Carl Schultz, M.D., Ph.D., Ran Kornowski, M.D., Paul J.L. Ong, M.D., Ph.D., Mirvat Alasnag, M.D., Ph.D., Alfredo E. Rodriguez, M.D., Ph.D., Aris Moschovitis, M.D., Peep Laanmets, M.D., Michael Donahue, M.D., Sergio Leonardi, M.D., and Pieter C. Smits, M.D., Ph.D. for the MASTER DAPT Investigators*
Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk
The New England Journal of Medicine August 28, 2021
---
Author Affiliations
From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) — all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) — all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) — all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) — both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III–Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) — all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of Medicine, University of Belgrade, Belgrade, Serbia (G.S.); Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.); the Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia (C.S.); Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel (R.K.); Tan Tock Seng Hospital, Singapore, Singapore (P.J.L.O.); the Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia (M.A.); Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (A.E.R.); and North Estonia Medical Center Foundation, Tallinn, Estonia (P.L.).
(3)
Capodanno, D. et al.
Dual- pathway inhibition for secondary and tertiary antithrombotic prevention in cardiovascular disease.
Nat. Rev. Cardiol. 17, 242–257 (2020).
(4)
Knuuti, J. et al.
2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes.
Eur. Heart J. 41, 407–477 (2020).
(5)
Costa, F. et al.
Dual antiplatelet therapy duration based on ischemic and bleeding risks after coronary stenting.
J. Am. Coll. Cardiol. 73, 741–754 (2019).
(6)
Urban, P. et al.
Assessing the risks of bleeding vs thrombotic events in patients at high bleeding risk after coronary stent implantation: the ARC- high bleeding risk trade- off model.
JAMA Cardiol. 6, 410–419 (2021).
(7)
Valgimigli, M. et al.
Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial.
Lancet 392, 835–848 (2018).
(8)
Mignatti, A., Friedmann, P. & Slovut, D. P.
Targeting the safe zone: a quality improvement project to reduce vascular access complications.
Catheter. Cardiovasc. Interv. 91, 27–32 (2018).
(9)
Neumann, F.-J. et al.
2018 ESC/EACTS Guidelines on myocardial revascularization.
EuroIntervention 14, 1435–1534 (2019).
(10)
Buccheri, S. et al.
Clinical outcomes following intravascular imaging- guided versus coronary angiography- guided percutaneous coronary intervention with stent implantation: a systematic review and Bayesian network meta- analysis of 31 studies and 17,882 patients.
JACC Cardiovasc. Interv. 10, 2488–2498 (2017).
(11)
Cuisset, T. et al.
Benefit of switching dual antiplatelet therapy after acute coronary syndrome: the TOPIC (timing of platelet inhibition after acute coronary syndrome) randomized study.
Eur. Heart J. 38, 3070–3078 (2017).
(12)
Sibbing, D. et al.
Guided de- escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL- ACS): a randomised, open- label, multicentre trial.
Lancet 390, 1747–1757 (2017).
(13)
Claassens, D. M. F. et al.
A genotype- guided strategy for oral P2Y12 inhibitors in primary PCI.
N. Engl. J. Med. 381, 1621–1631 (2019).
(14)
Kim, H.-S. et al.
Prasugrel- based de- escalation of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (HOST- REDUCE-POLYTECH- ACS): an open- label, multicentre, non- inferiority randomised trial.
Lancet 396, 1079–1089 (2020).
(15)
Pereira, N. L. et al.
Effect of genotype- guided oral P2Y12 inhibitor selection vs conventional clopidogrel therapy on ischemic outcomes after percutaneous coronary intervention: the TAILOR- PCI randomized clinical trial.
JAMA 324, 761–771 (2020).
日本における死因の第二位が心臓疾患です。
その多くが心筋梗塞によって血流がとまり、
栄養供給が停止する事によって細胞が死んでしまいます。
その影響は全身に波及する場合もある事も考えられます。
病院内で心筋梗塞が生じれば、
すぐに医師、看護師が対応する事が可能ですが、
突発性のものも含めて、病院外で生じる心筋梗塞においては
蘇生や入院に成功したとしても、
65%の人は命を落とし、予後はよくないとされています(1,2)。
---
ST上昇の場合は心臓の心筋に原因があるということで
心筋梗塞の原因がはっきりしますが、
ST上昇がみられない場合においては、
考えられる原因が多岐にわたるため(3,4)、
即時の治療判断が難しくなると考えられます。
---
心筋梗塞の治療に当たる際に
血管造影法によって血流状態を連続的に撮影することによって
動脈、静脈の病変を診断する場合がありますが、
副作用もあります。
吐き気、発赤、じんましんなど軽いものから
ショック症状など重篤なものもあります。
それを即座に「標的を定めずに」する場合には
手順におけるリスクもあります。
造影する部分が増えるということもあるかもしれません。
一方で血管造影が遅れる事によって
急性冠不全症候群の他の心不全の原因になることがあります。
従って、ST上昇がみられない原因が掌握しにくい場合において、
病院外で心筋梗塞が生じた場合には
蘇生の後、即座に血管造影をするべきか
あるいは様々な診断の後、選択的に遅らせて血管造影をするべきか
その判断は医師にとって難しいものであると考えられます。
---
S. Desch, A. Freund(敬称略)ら
ヨーロッパを中心とする国際的な医療研究グループは
上述したST上昇がみられない心筋梗塞が
病院外で生じ、蘇生後の血管造影のタイミングに対する
臨床効果の比較について報告しています(1)。
即座にするのがいいか、
遅らせて選択的にするのがいいかという判断です。
その結果によると顕著な差はないものの
血管造影のタイミングを遅らせて
選択的にするほうが即座にする場合に比べて
やや30日以内の死亡例は少なくなっています。
また、出血、脳卒中、急性腎不全などのリスクにおいても
即座にするほうがリスクが高くなっています。
(参考文献(1) Table 3)
また65歳以上の高齢、
あるいは女性において
即座に血管造影をする場合にリスクが高くなっています。
(参考文献(1) Figure 2)
S. Desch, A. Freund, I. Akin, M. Behnes, M.R. Preusch, T.A. Zelniker, C. Skurk,
U. Landmesser, T. Graf, I. Eitel, G. Fuernau, H. Haake, P. Nordbeck, F. Hammer,
S.B. Felix, C. Hassager, T. Engstrøm, S. Fichtlscherer, J. Ledwoch, K. Lenk,
M. Joner, S. Steiner, C. Liebetrau, I. Voigt, U. Zeymer, M. Brand, R. Schmitz,
J. Horstkotte, C. Jacobshagen, J. Pöss, M. Abdel-Wahab, P. Lurz, A. Jobs,
S. de Waha-Thiele, D. Olbrich, F. Sandig, I.R. König, S. Brett, M. Vens, K. Klinge,
and H. Thiele(敬称略)の医療研究グループの報告では
即座に血管造影をすることは遅らせて、選択的にする場合に対して
利益はなかったと結論付けられています。
//Support for ref.(1)//---
Supported by the German Center for Cardiovascular Research.
//Acknowledgement in Ref.(1)//---
We thank the patients and their families for their participation in the trial and the investigators who recruited the trial patients.
//Special message from me//---
This brief letter is uploaded based on my philanthropy and/or charity.
However, financial support is urgently needed in my activity.
(Reference)
(1)
Steffen Desch, M.D., Anne Freund, M.D., Ibrahim Akin, M.D., Michael Behnes, M.D., Michael R. Preusch, M.D., Thomas A. Zelniker, M.D., Carsten Skurk, M.D., Ulf Landmesser, M.D., Tobias Graf, M.D., Ingo Eitel, M.D., Georg Fuernau, M.D., Hendrik Haake, M.D., et al., for the TOMAHAWK Investigators*
Angiography after Out-of-Hospital Cardiac Arrest without ST-Segment Elevation
The New England Journal of Medicine August 29, 2021
---
Author Affiliations
From Heart Center Leipzig at the University of Leipzig, Departments of Internal Medicine–Cardiology (S.D., A.F., J.P., M.A.-W., P.L., A.J., H.T.) and Cardiac Surgery (S.W.-T.), Leipzig Heart Institute (S.D., A.F., A.J., H.T.), and University Clinic Leipzig (K.L.), Leipzig, University Heart Center Lübeck (S.D., T.G., I.E., G.F., A.J.) and the Center for Clinical Trials (D.O., S.B., K.K.) and the Institute for Medical Biometry and Statistics (F.S., I.R.K., M.V.), University of Lübeck, Lübeck, the German Center for Cardiovascular Research (S.D., A.F., I.A., M. Behnes, M.R.P., T.A.Z., C.S., U.L., T.G., I.E., G.F., F.H., S.B.F., S.F., J.L., M.J., C.L., C.J., A.J., D.O., F.S., I.R.K., S.B., M.V., K.K.) and University Clinic Charité, Campus Benjamin Franklin (C.S., U.L.), Berlin, University Clinic Mannheim, Mannheim (I.A., M. Behnes), the Department of Cardiology, Angiology, and Pneumology, University Hospital of Heidelberg, Heidelberg (M.R.P., T.A.Z.), Kliniken Maria Hilf, Mönchengladbach (H.H.), University Clinic Würzburg, Würzburg (P.N.), University Clinic Greifswald, Greifswald (F.H., S.B.F.), University Clinic Frankfurt, Frankfurt (S.F.), Rechts der Isar Hospital, Technical University (J.L.), and the Department of Cardiology, German Heart Center (M.J.), Munich, the Department of Cardiology, Pneumology and Intensive Care, St. Vincenz Hospital, Limburg (S.S.), Kerckhoff Clinic, Bad Nauheim (C.L.), the Departments of Acute and Emergency Medicine and of Cardiology and Angiology, Elisabeth Hospital Essen, Essen (I.V.), Klinikum Ludwigshafen, Ludwigshafen (U.Z.), University Clinic Marien Hospital Herne, Klinikum der Ruhr–Universität Bochum, Herne (M. Brand), the University Heart Center, Bad Krozingen (R.S.), Diakonissenkrankenhaus Flensburg, Flensburg (J.H.), University Medicine Göttingen, Göttingen (C.J.), and Vincentius–Diakonissen Hospital, Karlsruhe (C.J.) — all in Germany; the Division of Cardiology, Medical University of Vienna, Vienna (T.A.Z.); and the Department of Cardiology, Rigshospitalet, and the Department of Clinical Medicine, University of Copenhagen — both in Copenhagen (C.H., T.E.).
(2)
Grunau B, Kime N, Leroux B, et al.
Association of intra-arrest transport vs continued on-scene resuscitation with survival to hospital discharge among patients with out-of-hospital cardiac arrest.
JAMA 2020; 324: 1058-67.
(3)
Dumas F, Cariou A, Manzo-Silberman S, et al.
Immediate percutaneous coronary intervention is associated with better survival after out-of-hospital cardiac arrest: insights from the PROCAT (Parisian Region Out of hospital Cardiac ArresT) Registry.
Circ Cardiovasc Interv 2010; 3: 200-7.
(4)
Zanuttini D, Armellini I, Nucifora G, et al.
Predictive value of electrocardiogram in diagnosing acute coronary artery lesions among patients with out-of-hospital-cardiac-arrest.
Resuscitation 2013; 84: 1250-4.
新型コロナウィルスの世界的な流行に伴って
自宅にいるケースが増えています。
仕事もテレワークなど通勤での歩行の機会も失われています。
従って、運動不足となっている人は
世界的に多いと推測されます。
また家にいる事によって食生活が乱れる事も考えられます。
長引くコロナ禍と活動制限から
ストレスも生じやすくなっています。
このような事は生活習慣病につながり、
2型糖尿病のリスクを高めると考えられます。
---
この2型糖尿病ではインスリン抵抗性が生まれる事により
血糖値の制御に不全が生じます。
高血糖の状態が長く続くと
腎臓の中のろ過の役割を果たす糸球体の機能が低下して
タンパク尿がでることがあります。
従って、糖尿病になると腎障害のリスクも高まるとされています。
また慢性腎臓病が2型糖尿病を悪化させる事もあります(2)。
---
慢性腎臓病には腎不全、心臓血管不全のリスクに対する
重症度の分類があります。
それらは糸球体のろ過機能(GFR)と
アルブミン/クレアチニン比の両方で行列的に分類されます。
今までステージ3,4など重症度の高い患者さんにおいて
鉱質コルチコイド受容体拮抗薬であるフィネレノンが
高カリウム血症や腎機能低下を増加させることなく、
用量依存的にアルブミン尿を減少させ
心臓血管のダメージ軽減にも効果があることが示されています(5-9)。
これは、鉱質コルチコイド受容体の過剰活性が
腎臓病や心臓血管病と関連がある事が示されているからです(3-5)。
従って、その活性を抑える拮抗薬フェネレノンが
臨床においても効果を発揮するということです。
---
B. Pitt, G. Filippatos(敬称略)ら
ヨーロッパを中心とする国際的な医療研究グループは
比較的軽症な腎障害の人も含めて
フェネレノンの心臓血管などに対する臨床効果を
プラセボと比較しています(1)。
7437人という大規模な調査において
腎障害の分類を見ると糸球体のろ過機能である
GFRが60ml/min/1.73m2以上ある人が62%であり
この指標からすれば軽度か、正常の範囲内、
一方、アルブミン/クレアチニン比
30以上が46.8%、300以上が50.2%と
A2,A3ランクで高くなっています。
この条件においてフェネレノンの臨床効果を評価しています(1)。
またグルコース低下治療を受けている人が
97.9%で糖尿病治療を受けている人がほとんどです。
---
特に心不全による入院のケースが
プラセボに対して低くなっています(ハザード比0.71)。
また腎臓障害の症状の悪化も防がれています。
従って、腎臓の機能の維持や
それに付随する心臓血管の悪化において
比較的軽度な腎障害の患者さんにおいても
効果がある事が示されました。
---
フェネレノンの副作用は
全体的な有害事象はプラセボに比べて
少なくとも高くはありません。
一方、高カリウム血症になる人は
治療を受けた人において高くなっています。
B. Pitt, G. Filippatos, R. Agarwal, S.D. Anker, G.L. Bakris, P. Rossing,
A. Joseph, P. Kolkhof, C. Nowack, P. Schloemer, and L.M. Ruilope,
(敬称略)からなる医療研究グループの結論では
従来より広い症状の程度においてフェネレノンは
心臓血管の臨床効果が偽薬に対してあったとされています。
//Support for Ref.(1)//---
Supported by Bayer.
//Special message from me//---
This brier letter is uploaded in line with my charity or/and philanthropy.
However, the financial support is urgently needed in my prosocial acitivity.
//Participating Countries and Investigators//---
Argentina: Diego Aizenberg, Inés Bartolacci, Diego Besada, Julio Bittar, Mariano Chahin,
Alicia Elbert, Elizabeth Gelersztein, Alberto Liberman, Laura Maffei, Federico Pérez Manghi,
Hugo Sanabria, Augusto Vallejos, Gloria Viñes, and Alfredo Wassermann.
Australia: Walter Abhayaratna, Peter Colman, David Colquhoun, Elif Ekinci, Chris Ellis,
Kim Joshua, Richard MacIsaac, Peak Mann, Craig Nelson, David Packham, Alexia Pape,
Eugenia Pedagogos, Paul Regal, Simon Roger, Hugo Stephenson, Michael Suranyi,
Duncan Topliss, James Vandeleur, Johan Verjans, Gary Wittert, and Katie-Jane Wynne.
Austria: Martin Clodi, Heinz Drexel, Christoph Ebenbichler, Evelyn Fliesser-Görzer,
Ursula Hanusch, Bernhard Ludvik, Gert Mayer, Peter Neudorfer, Rainer Oberbauer,
Bernhard Paulweber, Rudolf Prager, Friedrich Prischl, Gerit-Holger Schernthaner,
Hans‑Robert Schönherr, and Harald Sourij.
Belgium: Peter Doubel, Francis Duyck, Pieter Gillard, Jean-Michel Hougardy,
André Scheen, Marijn Speeckaert, Luc van Gaal, and Hilde Vanbelleghem.
Brazil: Daniela Antunes, Marcelo Bacci, Roberto Botelho, Claudia Brito, Luis Canani,
Maria Eugenia Canziani, Maria Cerqueira, Rogerio de Paula, Freddy Eliaschewitz,
Carlos Eduardo Figueiredo, Adriana Forti, Miguel Hissa, Maurilo Leite Jr, Lilia Maia,
Irene Noronha, Bruno Paolino, Roberto Pecoits Filho, Marcio Pereira, Evandro Portes,
Dalton Precoma, Rosangela Rea, Miguel Riella, Joao Eduardo Salles,
Eduardo Vasconcellos, Sergio Vencio, and Aline Villacorta.
Bulgaria: Radostina Boshnyashka, Ghassan Farah, Dimitar Georgiev,
Valentina Gushterova, Neli Klyuchkova, Mariya Lucheva, Petya Manova, Angel Marinchev,
Dotska Minkova, Mariya Miteva, Boyan Nonchev, Mariyana Pichmanova, Zhulieta Prakova,
Rangel Rangelov, Rosen Rashkov, Pavel Stanchev, Bilyana Stoyanovska-Elencheva,
Zhivko Tagarev, Theodora Temelkova-Kurktschieva, Svetla Vasileva, and
Mariana Yoncheva-Mihaylova.
Canada: Brian Carlson, James Conway, Serge Cournoyer, Richard Dumas, Fadia El Boreky,
Sameh Fikry, Richard Goluch, Pavel Hamet, Randolph Hart, Sam Henein, Alan Kelly,
Lawrence Leiter, Joanne Liutkus, Francois Madore, Valdemar Martinho, Giuseppe Mazza,
Philip McFarlane, Dennis O’Keefe, Sean Peterson, Daniel Schwartz, Daniel Shu,
Andrew Steele, Ivor Teitelbaum, Guy Tellier, Karthik Tennankore, Sheldon Tobe,
George Tsoukas, Richard Tytus, Louise Vitou, Michael Walsh, Stanley Weisnagel,
Igor Wilderman, and Jean-Francois Yale.
Chile: Jorge Cobos, Fernando González, Marcelo Medina, Juan Carlos Prieto Dominguez,
Eliana Reyes, Carmen Romero, Victor Saavedra, and Paola Varleta.
China: Ruifang Bu, Hanqing Cai, Nan Chen, Qinkai Chen, Dejun Chen, Jinluo Cheng,
Junwu Dong, Youping Dong, Yuming Du, Yi Fang, Tianjun Guan, Weiying Guo,
Chuanming Hao, Fangfang Jiang, Sheng Jiang, Jian Kuang, Minxiang Lei, Dongmei Li,
Hongmei Li, Jingmei Li, Ling Li, Yan Li, Yinan Li, Yuxiu Li, Zhonghe Li, Fang Liu, Jian Liu,
Yinghong Liu, Yu Liu, Zhihong Liu, Yuantao Liu, Gang Long, Guoyuan Lu, Weiping Lu,
Yibing Lu, Jianhua Ma, Heng Miao, Zhaohui Mo, Jianying Niu, Ai Peng, Wen Peng,
Feixia Shen, Jiansong Shen, Bingyin Shi, Qing Su, Zhuxing Sun, Shuifu Tang, Nanwei Tong,
Guixia Wang, Hao Wang, Jianqin Wang, Li Wang, Lihua Wang, Xinjun Wang, Jiali Wei,
Chaoqing Wu, Tianfeng Wu, Changying Xing, Fei Xiong, Mingtong Xu, Ning Xu, Xudong Xu,
Jinkui Yang, Aiping Yin, Longyi Zeng, Hao Zhang, Yanlin Zhang, Ying Zhang, Zhiquan Zhao,
Hongguang Zheng, Ling Zhong, Liyong Zhong, Dalong Zhu, and Jun Zhu.
Colombia: Clara Arango, Edgar Arcos, Gustavo Aroca, Sandra Barrera, Germán Barreto,
Nelly Beltrán López, Diego Benitez, Andres Bermudez, Guillermo Blanco, Rodrigo Botero,
Tatiana Cárdenas, Julian Coronel, Carlos Cure, Carlos Durán, Wilmer Figueroa, Luis García,
Gustavo Guzmán, Eric Hernández, Jaime Ibarra, Carlos Jaramillo, Mónica Jaramillo,
Nicolás Jaramillo, William Kattah, Manuel Liévano, Mónica López, Dora Molina,
Ricardo Rosero, Gregorio Sánchez, Mónica Terront, Pedro Trillos, Freddy Trujillo,
Miguel Urina, Iván Villegas, and Hernán Yupanqui.
Czech Republic: Dino Alferi, Michal Brada, Petr Bucek, Tomas Edelsberger,
Drahomira Gulakova, Jitka Hasalova Zapletalova, Olga Hola, Lucie Hornova, Jana Houdova,
Helena Hrmova, David Karasek, Sarka Kopecka, Richard Kovar, Eva Krcova, Jiri Kuchar,
Vlasta Kutejova, Hana Lubanda, Ivo Matyasek, Magdalena Mokrejsova, Libor Okenka,
Martin Prazny, Jiri Pumprla, and Pavel Tomanek.
Denmark: Ulla Andersen, Alin Andries, Jesper Bech, Jens Faber, Gunnar Gislason,
Jeppe Gram, Jørgen Hangaard, Claus Juhl, Thure Krarup, Thomas Lauridsen,
Morten Lindhardt, Sten Madsbad, Joan Nielsen, Torben Østergaard, Grzegorz Pacyk,
Erling Pedersen, Ulrik Pedersen-Bjergaard, Per Poulsen, Ole Rasmussen, Peter Rossing,
Karoline Schousboe, and Birger Thorsteinsson.
Finland: Päivi Flöjt, Mikko Honkasalo, Kari Humaloja, Kristiina Kananen, Ilkka Kantola, Arvo
Koistinen, Pirkko Korsoff, Jorma Lahtela, Sakari Nieminen, Karita Sadeharju, Jorma Strand,
and Sakari Sulosaari.
France: Bertrand Cariou, François Chantrel, Sylvaine Clavel, Jean-Pierre Fauvel,
Karim Gallouj, Bruno Guerci, Dominique Guerrot, Alexandre Klein, Yannick Le Meur,
Michel Marre, Rafik Mesbah, Arnaud Monier, Olivier Moranne, Ronan Roussel,
Pierre Serusclat, Bruno Verges, and Philippe Zaoui.
Germany: Christoph Axthelm, Andreas Bergmann, Andreas L. Birkenfeld, Hermann Braun,
Klaus Busch, Christel Contzen, Stefan Degenhardt, Karl Derwahl, Thomas Giebel,
Andreas Hagenow, Hermann Haller, Christoph Hasslacher, Thomas Horacek,
Wolfgang Jungmair, Christof Kloos, Thorsten Koch, Annemone Koechel, Thilo Krüger,
Joachim Müller, Andreas Pfützner, Andrea Rinke, Ludger Rose, Lars Rump,
Volker Schettler, Ingolf Schiefke, Heike Schlichthaar, Norbert Schöll, Kristin Schubert,
Thomas Schürholz, Helena Sigal, Lutz Stemler, Georg Strack, Heidrun Täschner,
Nicole Toursarkissian, Diethelm Tschöpe, Achim Ulmer, Markus van der Giet,
Christoph Wanner, and Bernhard R. Winkelmann.
Greece: Ioannis Boletis, George Dimitriadis, Erifili Hatziagelaki, Christos Iatrou,
Ioannis Ioannidis, Theodora Kounadi, Ioanna Makriniotou, Dorothea Papadopoulou,
Aikaterini Papagianni, Ploumis Passadakis, George Piaditis, and Ioannis Stefanidis.
Hong Kong: Paul Lee, Ronald Ma, Tai Pang Ip, Wing Sun Chow, and Vincent Yeung.
Hungary: Dora Bajcsi, Peter Danos, Eleonora Harcsa, Akos Kalina, Szilvia Kazup,
Katalin Keltai, Robert Kirschner, Julianna Kiss, Laszlo Kovacs, Beata Lamboy,
Botond Literati-Nagy, Laszlo Nagy, Ebrahim Noori, Gabor Nyirati, Gizella Petro,
Karoly Schneider, Judit Simon, Albert Szocs, Szilard Vasas, Krisztina Wudi, Zsolt Zilahi, and
Marianna Zsom.
Ireland: Joe Eustace, John Holian, and Donal Reddan.
Israel: Rosane Abramof Ness, Faiad Adawi, Zaher Armaly, Shaul Atar, Amir Bashkin,
Sydney Ben Chetrit, Gil Chernin, Mahmud Darawsha, Shai Efrati, Mazen Elias,
Evgeny Farber, Mariela Glandt, Ehud Grossman, Majdi Halabi, Ilana Harman-Boehm,
Idit Liberty, Oscar Minuchin, Ofri Mosenzon, Farid Nakhoul, Assy Nimer, Doron Schwartz,
Julio Wainstein, Yoram Yagil, and Robert Zukermann.
Italy: Carlo Antonio Bossi, Enzo Bonora, Paolo Calabrò, Davide Carlo, Roberto Cimino,
Salvatore David, Michele Emdin, Antonio Ettore Pontiroli, Enrico Fiaccadori, Paolo Fiorina,
Giovanni Giorgio, Maria Cristina Gregorini, Gaetano La Manna, Giorgio Luciano Viviani,
Franco Luigi, Roberta Manti, Anna Maria, Giancarla Meregalli, Antonello Pani,
Norberto Perico, PierMarco Piatti, Antonio Pisani, Paola Ponzani, Gennaro Santorelli,
Domenico Santoro, Renzo Scanziani, Ugo Teatini, Maurizio Tiziano Bevilacqua, Giancarlo
Tonolo, and Roberto Trevisan.
Japan: Hideo Araki, Yukihiro Bando, Osamu Ebisui, Naruhiro Fujita, Hirotaka Fukasawa,
Ryuichi Furuya, Yoshiyuki Hamamoto, Akihiro Hamasaki, Kotaro Hasegawa,
Masahiro Hatazaki, Terumasa Hayashi, Masayuki Hayashi, Nobuyoshi Higa, Takayuki
Higashi, Yoshihide Hirohata, Shuji Horinouchi, Ayumu Hoshi, Hirofumi Imoto, Akemi Inagaki,
Masayuki Inagaki, Daijo Inaguma, Toshihiko Inoue, Masao Ishii, Tamayo Ishiko,
Motohide Isono, Hideaki Jinnouchi, Hidetoshi Kanai, Daisuke Kanda, Hideo Kanehara,
Masayuki Kashima, Yuko Kataoka, Shigehiro Katayama, Kiyoe Kato, Takeshi Katsuki,
Katsunori Kawamitsu, Daiji Kawanami, Satsuki Kawasaki, Fumi Kikuchi, Hidetoshi Kikuchi,
Rui Kishimoto, Kunihisa Kobayashi, Junko Koide, Rieko Komi, Miyuki Kubota, Genpei
Kuriya, Takeshi Kurose, Yoshiro Kusano, Hajime Maeda, Sunao Matsubayashi,
Kazunari Matsumoto, Naoya Matsumura, Yasuto Matsuo, Naoki Matsuoka, Hiroaki Miyaoka,
Satoshi Miyata, Takeshi Morita, Isao Murakami, Satoshi Murao, Udai Nakamura,
Mikihiro Nakayama, Jun Nakazawa, Sakae Nohara, Takashi Nomiyama, Masayuki Noritake,
Yoshiaki Oda, Takayuki Ogiwara, Hiroshi Ohashi, Hideki Okamoto, Shinichi Okino,
Takeshi Osonoi, Nobuhiro Sasaki, Yoshitaka Sayo, Taiji Sekigami, Taro Shibasaki,
Hirotaka Shibata, Tatsushi Shimoyama, Junji Shinoda, Hiroshi Sobajima, Kazuya Sugitatsu,
Toshiyuki Sugiura, Toru Sugiyama, Daisuke Suzuki, Masaaki Suzuki, Asami Takeda,
Asami Tanaka, Seiichi Tanaka, Izumi Tsunematsu, Yasuo Ueda, Soichi Uekihara,
Makoto Ujihara, Ken Yajima, Daishiro Yamada, Masayo Yamada, Kazuo Yamagata,
Fumiko Yamakawa, Ken Yamakawa, Yoshimitsu Yamasaki, Yuko Yambe, Taihei Yanagida,
Hidekatsu Yanai, Toshihiko Yanase, and Tetsuyuki Yasuda.
Lithuania: Dovile Kriauciuniene, Jurate Lasiene, Antanas Navickas, Lina Radzeviciene,
Egle Urbanaviciene, Gediminas Urbonas, and Audrone Velaviciene.
Malaysia: Norhaliza Mohd Ali, Nor Azizah Aziz, Nik Nur Fatnoon Nik Ahmad, Wan Hasnul,
Rizmy Najme Khir, Li Yuan Lee, Chek Loong Loh, Masni Mohamad,
Jeyakantha Ratnasingam, Tong Boon Alexander Tan, and Wan Mohd Izani Wan Mohamed.
Mexico: Melchor Alpizar Salazar, Sandro Avila Pardo, Miriam Bastidas Adrian,
Alfredo Chew Wong, Jorge Escobedo de la Peña, Guillermo Fanghänel Salmón,
Pedro García Hernández, José González , Guillermo González Gálvez,
Ramiro Gutiérrez Ochoa, José Lazcano Soto, Magdalena Madero Rovalo,
Gustavo Méndez Machado, Luis Nevarez Ruiz, Gabriel Ramos López,
Arturo Saldaña Mendoza, Sergio Irizar Santana, Leobardo Sauque Reyna,
Gustavo Solache Ortiz, Rafael Valdez Ortiz, Elvira González Vilchis, and
Juan Villagordoa Mesa.
Netherlands: Rene Bakker, Jos Barendregt, Arnold Boonstra, Catherine Brouwer,
Ron Gansevoort, Adriaan Kooy, Marielle Krekels, Aloysius Lieverse, Peter Luik, Lars Penne,
Bert-Jan van den Born, Marjolijn van Buren, and Ruud van Leendert.
New Zealand: John Baker, Veronica Crawford, Rick Cutfield, Peter Dunn, Jeremy Krebs,
Kingsley Nirmalaraj, Russell Scott, Nine Smuts, and Janet Titchener.
Norway: Emil Asprusten, Erik Eriksen, Trine Finnes, Robert Hagemeier, Hans Høivik,
Kjetil Høye, Thomas Karlsson, Peter Scott Munk, Knut Risberg, Jan Rocke, Hilde Selsås,
Leidulv Solnør, Frode Thorup, and Cecilie Wium.
Philippines: Albert Bautista, Elizabeth Catindig, Carlo Manalo, Roberto Mirasol,
Glenda Pamugas, Maribel Tanque, and Louie Tirador.
Toshiyuki Sugiura, Toru Sugiyama, Daisuke Suzuki, Masaaki Suzuki, Asami Takeda,
Asami Tanaka, Seiichi Tanaka, Izumi Tsunematsu, Yasuo Ueda, Soichi Uekihara,
Makoto Ujihara, Ken Yajima, Daishiro Yamada, Masayo Yamada, Kazuo Yamagata,
Fumiko Yamakawa, Ken Yamakawa, Yoshimitsu Yamasaki, Yuko Yambe, Taihei Yanagida,
Hidekatsu Yanai, Toshihiko Yanase, and Tetsuyuki Yasuda.
Lithuania: Dovile Kriauciuniene, Jurate Lasiene, Antanas Navickas, Lina Radzeviciene,
Egle Urbanaviciene, Gediminas Urbonas, and Audrone Velaviciene.
Malaysia: Norhaliza Mohd Ali, Nor Azizah Aziz, Nik Nur Fatnoon Nik Ahmad, Wan Hasnul,
Rizmy Najme Khir, Li Yuan Lee, Chek Loong Loh, Masni Mohamad,
Jeyakantha Ratnasingam, Tong Boon Alexander Tan, and Wan Mohd Izani Wan Mohamed.
Mexico: Melchor Alpizar Salazar, Sandro Avila Pardo, Miriam Bastidas Adrian,
Alfredo Chew Wong, Jorge Escobedo de la Peña, Guillermo Fanghänel Salmón,
Pedro García Hernández, José González , Guillermo González Gálvez,
Ramiro Gutiérrez Ochoa, José Lazcano Soto, Magdalena Madero Rovalo,
Gustavo Méndez Machado, Luis Nevarez Ruiz, Gabriel Ramos López,
Arturo Saldaña Mendoza, Sergio Irizar Santana, Leobardo Sauque Reyna,
Gustavo Solache Ortiz, Rafael Valdez Ortiz, Elvira González Vilchis, and
Juan Villagordoa Mesa.
Netherlands: Rene Bakker, Jos Barendregt, Arnold Boonstra, Catherine Brouwer,
Ron Gansevoort, Adriaan Kooy, Marielle Krekels, Aloysius Lieverse, Peter Luik, Lars Penne,
Bert-Jan van den Born, Marjolijn van Buren, and Ruud van Leendert.
New Zealand: John Baker, Veronica Crawford, Rick Cutfield, Peter Dunn, Jeremy Krebs,
Kingsley Nirmalaraj, Russell Scott, Nine Smuts, and Janet Titchener.
Norway: Emil Asprusten, Erik Eriksen, Trine Finnes, Robert Hagemeier, Hans Høivik,
Kjetil Høye, Thomas Karlsson, Peter Scott Munk, Knut Risberg, Jan Rocke, Hilde Selsås,
Leidulv Solnør, Frode Thorup, and Cecilie Wium.
Philippines: Albert Bautista, Elizabeth Catindig, Carlo Manalo, Roberto Mirasol,
Glenda Pamugas, Maribel Tanque, and Louie Tirador.
Poland: Patrycja Butrymowicz, Kazimierz Ciechanowski, Grazyna Cieslik, Edward Franek,
Janusz Gumprecht, Michal Hoffmann, Krystyna Jedynasty, Jolanta Krzykowska,
Ilona Kurnatowska, Katarzyna Landa, Adam Madrzejewski, Katarzyna Madziarska,
Stanislaw Mazur, Piotr Napora, Michal Nowicki, Anna Ocicka-Kozakiewicz,
Barbara Rewerska, Teresa Rusicka, Jan Ruxer, Izabela Sein Anand, Ewa Skokowska,
Andrzej Stankiewicz, Agnieszka Tiuryn-Petrulewicz, Katarzyna Wasilewska,
Bogna Wierusz‑Wysocka, and Renata Wnetrzak-Michalska.
Portugal: Edgar Almeida, Ana Rita Alves, Rosa Ballesteros, Carlos Barreto, Ilidio Brandao,
Rui Carvalho, Joao Coelho, Cesar Esteves, Jose Guia, Susana Heitor, Ana Lourenco,
Pedro Matos, Pedro Melo, Fernando Nolasco, Amalia Pereira, Cristina Roque,
Vanisa Rosario, Francisco Rosario, Joao Sergio Neves, Gil Silva, Ana Silva,
Fernando Teixeira e Costa, and Ana Vila Lobos.
Puerto Rico: Yudit Brito-Peguero, Gildred Colon-Vega, Gregorio Cortes-Maisonet,
Gregorio Cortes-Maisonet, and Amaury Roman-Miranda.
Romania: Adrian Albota, Cornelia Bala, Hortensia Barbonta, Elena Caceaune,
Ciprian Constantin, Adriana Dumitrescu, Adriana Filimon, Nicoleta Mindrescu,
Cristina Mistodie, Gabriela Negrisanu, Adriana Onaca, Silvia Paveliu, Ella Pintilei,
Lavinia Pop, Amorin Popa, Alexandrina Popescu, Iosif Szilagyi, Liana Turcu,
Georgeta Vacaru, Ioan Veresiu, and Adrian Vlad
Russia: Mikhail Antsiferov, Yulia Argunova, Mikhail Arkhipov, Andrey Babkin,
Vitaliy Baranov, Olga Barbarash, Elena Chernyavskaya, Arkadiy Demko, Alexander Dreval,
Anton Edin, Polina Ermakova, Albert Galyavich, Leyla Gaysina, Ivan Gordeev, Irina Ipatko,
Marina Kalashnikova, Yuriy Khalimov, Vadim Klimontov, Zhanna Kobalava,
Elena Kosmacheva, Natalya Koziolova, Lyudmila Kvitkova, Sergey Levashov, Roman Libis,
Natalia Malykh, Sofya Malyutina, Vyacheslav Marasaev, Vyacheslav Mareev,
Vladimir Martynenko, Imad Meray, Ashot Mkrtumyan, Galina Nechaeva, Konstantin Nikolaev,
Shamil Palyutin, Nina Petunina, Leonid Pimenov, Elena Rechkova, Tatyana Rodionova,
Oksana Rymar, Ruslan Sardinov, Olga Semenova, Alexander Sherenkov,
Taiwan: Chiz-Tzung Chang, Lee-Ming Chuang, Cheng-Chieh Hung, Ju-Ying Jiang,
Chien‑Te Lee, Der-Cherng Tarng, Shih-Te Tu, Mai-Szu Wu, and Ming-Ju Wu.
Thailand: Chaicharn Deerochanawong, Natapong Kosachunhanan, Chatlert Pongchaiyakul,
Bancha Satirapoj, and Piyamitr Sritara.
Turkey: Ozer Badak, Murat Cayli, Necmi Eren, Ibrahim Gul, Ismail Kocyigit,
Abdulbaki Kumbasar, Aytekin Oguz, Oner Ozdogan, Idris Sahin, Ibrahim Sari,
Ramazan Sari, Talat Tavli, Ahmet Temizhan, Mustafa Tigen, Ugur Turk, Yavuz Yenicerioglu,
Huseyin Yilmaz, and Mehmet Yilmaz.
Ukraine: Iryna Bondarets, Volodymyr Botsyurko, Viktoriia Chernikova, Oleksandra Donets,
Ivan Fushtey, Mariia Grachova, Ganna Isayeva, Dmytro Kogut, Julia Komisarenko,
Nonna Kravchun, Oleksandr Larin, Kateryna Malyar, Borys Mankovsky, Liliya Martynyuk,
Vitaliy Maslyanko, Halyna Myshanych, Larysa Pererva, Nataliia Pertseva,
Oleksandr Serhiyenko, Ivan Smirnov, Liubov Sokolova, and Maryna Vlasenko.
United Kingdom: Rudy Bilous, Cuong Dang, Andrew Johnson, Hassan Kahal,
Dhanya Kalathil, Anne Kilvert, Christina Kyriakidou, Amit Mathew, Kieran McCafferty,
Rasha Mukhtar, Imrozia Munsoor, Sui Phi Kon, Anton Poterajlo, Sam Rice, Pauline Swift,
Arutchelvam Vijayaraman, and Yuk-ki Wong.
United States: Emaad Abdel-Rahman, Edel Abreu, Idalia Acosta, Atoya Adams,
Sharon Adler, Dilawar Ajani, Slamat Ali, Radica Alicic, Amer Al-Karadsheh, Sreedhara Alla,
Dale Allison, Nabil Andrawis, Ahmed Arif, Ahmed Awad, Alaa Awad, Masoud Azizad,
Nader Bahri, Shweta Bansal, Steven Barag, Mark Barney, Khalid Bashir, Jose Bautista,
Srinivasan Beddhu, Sabrina Benjamin, Ramin Berenji, John Bertsch, Anuj Bhargava,
Jose Birriel, David Bleich, Jonathan Bornfreund, Harjeet Brar, Susan Brian,
Stephen Brietzke, Cynthia Brinson, Humberto Bruschetta, Osvaldo Brusco, Anna Burgner,
Robert Busch, Rafael Canadas, Maria Caramori, Jose Cardona, Jose Carpio,
Christopher Case, Steven Cohen, John Cosby, Humberto Cruz, Ramprasad Dandillaya,
Dalia Dawoud, Soni Dhanireddy, Jorge Diaz, Zia Din, Bradley Dixon, Ankur Doshi,
Fredrick Dunn, Mahfouz El Shahawy, Mohammed El-Shahawy, Sabitha Eppanapally,
Damaris Vega, Peter Weissman, Adam Whaley-Connell, Don Williamson, Jonathan Winston,
Jonathan Wise, Catherine Womack, Hala Yamout, Michael Yuryev, and Steven Zeig.
Vietnam: Lam Van Hoang, Tran Khanh, Thuy Khuong Le, Boi Ngoc Nguyen,
Pham Nguyen Son, Thao Nguyen, Nguyen Minh Nui, Tran Quang Nam, Lan Phuong Tran,
and Kim Chi Tran.
(Reference)
(1)
Bruce Neal, M.B., Ch.B., Ph.D., Yangfeng Wu, M.D., Ph.D., Xiangxian Feng, Ph.D., Ruijuan Zhang, M.Sc., Yuhong Zhang, M.Med., Jingpu Shi, Ph.D., Jianxin Zhang, Ph.D., Maoyi Tian, Ph.D., Liping Huang, Ph.D., Zhifang Li, M.Sc., Yan Yu, Ph.D., Yi Zhao, Ph.D., Bo Zhou, Ph.D., Jixin Sun, M.Sc., Yishu Liu, M.Sc., Xuejun Yin, M.P.H., Zhixin Hao, M.D., Jie Yu, M.D., Ph.D., Ka-Chun Li, M.Sc., Xinyi Zhang, M.P.H., Peifen Duan, M.Sc., Faxuan Wang, Ph.D., Bing Ma, M.Sc., Weiwei Shi, Ph.D., Gian Luca Di Tanna, Ph.D., Sandrine Stepien, M.Sc., Sana Shan, M.Sc., Sallie-Anne Pearson, Ph.D., Nicole Li, M.D., Ph.D., Lijing L. Yan, Ph.D., Darwin Labarthe, Ph.D., and Paul Elliott, M.B., B.S., Ph.D.
Effect of Salt Substitution on Cardiovascular Events and Death
The New England Journal of Medicine August 29, 2021
---
Author Affiliations
From the George Institute for Global Health (B.N., M.T., L.H., Y.L., X.Y., J.Y., K.-C.L., G.L.D.T., S. Stepien, S. Shan) and the Centre for Big Data Research in Health (S.-A.P.), University of New South Wales, and George Clinical (N.L.) — all in Sydney; the School of Public Health (B.N., K.-C.L., P.E.), the U.K. Dementia Research Institute (P.E.), the British Heart Foundation Centre for Research Excellence (P.E.), and the NIHR Imperial Biomedical Research Centre (P.E.), Imperial College London, Health Data Research (P.E.), the NIHR Health Protection Research Unit in Chemical and Radiation Threats and Hazards (P.E.), and the Medical Research Council Centre for Environment and Health (P.E.) — all in London; Peking University Clinical Research Center, Peking University (Y.W.), the George Institute for Global Health at Peking University Health Science Center (Y.W., M.T., Z.H., X.Z., L.L.Y.), and the Department of Cardiology, Peking University Third Hospital (J.Y.), Beijing, the School of Public Health, Changzhi Medical College, Changzhi (X.F., Z.L., P.D.), the School of Public Health, Xi’an Jiaotong University, Xi’an (R.Z., Y.Y.), the School of Public Health and Management, Ningxia Medical University, Yinchuan (Y. Zhang, Y. Zhao, F.W.), the Department of Evidence-Based Medicine, First Hospital of China Medical University, Shenyang (J. Shi, B.Z., B.M.), the Department of Noncommunicable Disease Prevention and Control, Center for Disease Control of Hebei Province, Shijiazhuang (J.Z., J. Sun, W.S.), the School of Public Health, Harbin Medical University, Harbin (M.T.), the Global Health Research Center, Duke Kunshan University, Kunshan (L.L.Y.), and the School of Health Sciences, Wuhan University, Wuhan (L.L.Y.) — all in China; and the Feinberg School of Medicine, Northwestern University, Chicago (D.L.).
(2)
Gansevoort RT, Correa-Rotter R, Hemmelgarn BR, et al.
Chronic kidney disease and cardiovascular risk: epidemiology, mechanisms, and prevention.
Lancet 2013; 382: 339-52.
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Barrera-Chimal J, Girerd S, Jaisser F.
Mineralocorticoid receptor antagonists and kidney diseases: pathophysiological basis.
Kidney Int 2019; 96: 302-19.
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Lother A, Moser M, Bode C, Feldman RD, Hein L.
Mineralocorticoids in the heart and vasculature: new insights forold hormones.
Annu Rev Pharmacol Toxicol 2015; 55: 289-312.
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Agarwal R, Kolkhof P, Bakris G, et al.
Steroidal and non-steroidal mineralocorticoid receptor antagonists in cardiorenal medicine.
Eur Heart J 2021; 42: 152-61.
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Agarwal R, Anker SD, Bakris G, et al.
Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone.
Nephrol Dial Transplant 2020 December 6 (Epub ahead of print).
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Filippatos G, Anker SD, Böhm M, et al.
A randomized controlled study of fi-nerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease.
Eur Heart J 2016; 37: 2105-14.
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Pitt B, Kober L, Ponikowski P, et al.
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Eur Heart J 2013; 34: 2453-63.
(9)
Bakris GL, Agarwal R, Chan JC, et al.
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JAMA 2015; 314: 884-94.
日本の平均の食塩の摂取量は9.9gと
オーストラリアの6.2gよりも高い水準となっています。
韓国も同様に9.9gとなっています。
醤油、漬物、味噌など日本食において
食塩は欠かせないものとなっています。
1日の食塩接種量と高血圧有病率は高い相関関係にあります。
従って、高血圧の患者さんにおいて
減塩や食塩に変わる調味料の摂取は重要になります。
---
B. Neal, Y. Wu(敬称略)ら医療研究グループは
MEETING OF THE EUROPEAN SOCIETY OF CARDIOLOGYとして
The New England Journal of Medicine誌に8月29日付で
食塩の代替となる調味料の心臓血管に対する効果について
報告しています(1)。
中国の地方600の地域での20,995人、
平均年齢65,4歳の大規模な比較評価されています。
食塩の代替として25%塩化カリウムの混合塩を使用したところ、
介入から12カ月から60カ月までの間において
最大血圧は顕著な低下を示しています。
一方最低血圧は大きくは変わりません。
さらに、脳卒中の罹患率も通常の食塩摂取群と比べて
リスク比が0.86となっています。
また急性冠不全症候群は
1000人当たり3.76-5.12と低いですが
その比較の中でリスク比-0.70となっています。
---
この食塩の代替は
「ナト・カリ塩」と呼ばれる混合塩で
塩味は、普通の塩とほとんど同じです。
また塩化カリウムにはナトリウム排泄効果があるため
血圧低下の効果があります。
日本でも健康塩として知られており、注目されています。
//Support for Ref.(1)//---
Supported by research grants (APP1164206 and APP1049417) and an investigator grant (APP1197709, to Dr. Neal) from the National Health and Medical Research Council of Australia; the salt substitute used in the trial was purchased by the investigators from local manufacturers in each province for years 1, 2, and 5 but was donated by Jiangsu Sinokone Technology for years 3 to 4.
//Acknowledgement in Ref.(1)//---
We thank all the trial teams and the trial participants.
//Special message from me//---
This brief letter is uploaded based on my charity mind.
However, financial support is urgently needed in my prosocial activity.
(Reference)
(1)
Bruce Neal, M.B., Ch.B., Ph.D., Yangfeng Wu, M.D., Ph.D., Xiangxian Feng, Ph.D., Ruijuan Zhang, M.Sc., Yuhong Zhang, M.Med., Jingpu Shi, Ph.D., Jianxin Zhang, Ph.D., Maoyi Tian, Ph.D., Liping Huang, Ph.D., Zhifang Li, M.Sc., Yan Yu, Ph.D., Yi Zhao, Ph.D., Bo Zhou, Ph.D., Jixin Sun, M.Sc., Yishu Liu, M.Sc., Xuejun Yin, M.P.H., Zhixin Hao, M.D., Jie Yu, M.D., Ph.D., Ka-Chun Li, M.Sc., Xinyi Zhang, M.P.H., Peifen Duan, M.Sc., Faxuan Wang, Ph.D., Bing Ma, M.Sc., Weiwei Shi, Ph.D., Gian Luca Di Tanna, Ph.D., Sandrine Stepien, M.Sc., Sana Shan, M.Sc., Sallie-Anne Pearson, Ph.D., Nicole Li, M.D., Ph.D., Lijing L. Yan, Ph.D., Darwin Labarthe, Ph.D., and Paul Elliott, M.B., B.S., Ph.D.
Effect of Salt Substitution on Cardiovascular Events and Death
The New England Journal of Medicine August 29, 2021
---
Author Affiliations
From the George Institute for Global Health (B.N., M.T., L.H., Y.L., X.Y., J.Y., K.-C.L., G.L.D.T., S. Stepien, S. Shan) and the Centre for Big Data Research in Health (S.-A.P.), University of New South Wales, and George Clinical (N.L.) — all in Sydney; the School of Public Health (B.N., K.-C.L., P.E.), the U.K. Dementia Research Institute (P.E.), the British Heart Foundation Centre for Research Excellence (P.E.), and the NIHR Imperial Biomedical Research Centre (P.E.), Imperial College London, Health Data Research (P.E.), the NIHR Health Protection Research Unit in Chemical and Radiation Threats and Hazards (P.E.), and the Medical Research Council Centre for Environment and Health (P.E.) — all in London; Peking University Clinical Research Center, Peking University (Y.W.), the George Institute for Global Health at Peking University Health Science Center (Y.W., M.T., Z.H., X.Z., L.L.Y.), and the Department of Cardiology, Peking University Third Hospital (J.Y.), Beijing, the School of Public Health, Changzhi Medical College, Changzhi (X.F., Z.L., P.D.), the School of Public Health, Xi’an Jiaotong University, Xi’an (R.Z., Y.Y.), the School of Public Health and Management, Ningxia Medical University, Yinchuan (Y. Zhang, Y. Zhao, F.W.), the Department of Evidence-Based Medicine, First Hospital of China Medical University, Shenyang (J. Shi, B.Z., B.M.), the Department of Noncommunicable Disease Prevention and Control, Center for Disease Control of Hebei Province, Shijiazhuang (J.Z., J. Sun, W.S.), the School of Public Health, Harbin Medical University, Harbin (M.T.), the Global Health Research Center, Duke Kunshan University, Kunshan (L.L.Y.), and the School of Health Sciences, Wuhan University, Wuhan (L.L.Y.) — all in China; and the Feinberg School of Medicine, Northwestern University, Chicago (D.L.).
脚の付け根や腕、手首などの血管から、カテーテルとを差し込んで、
冠動脈の狭くなった部分を治療する方法である
経皮的冠動脈インターベンションは
狭心症や心筋梗塞などの虚血性心疾患などの患者さんに治療に
使われる方法です。
その際、ステントが血管内異物となるため
血小板凝集が惹起されて血栓が形成される恐れがあります。
血栓、閉塞予防のために抗血小板療法がおこなわれます。
しかしながら、抗血小板療法は出血のリスクが伴うため
経皮的冠動脈インターベンションの術後に
出血と血栓の両方を防ぐ必要があります。
その際、「どれくらいの期間」
抗血小板療法を行うことがいいか？
という治療期間の最適化があります。
---
M. Valgimigli, E. Frigoli, D. Heg, J. Tijssen(敬称略)らは
ステント(*)を血管内に着床させたのち1か月間の
抗血小板療法を行ったのち、すぐにそれを中断する治療
(Abbreviate therapy)と
そこから追加的に少なくとも2か月間続ける治療
(Standard therapy)の
両方の治療の臨床効果(関連有害事象、出血など)を比較しています(1)。
---
その結果によると
目的とする出血のハザード比は
抗血小板療法が1か月に短縮されたAbbreviate therapyにおいて
2か月以上継続された場合に対して
0.68と低く、目的とする出血が抑えられたことを示しています。
正味の全体としての臨床的な有害事象は変わりません。
しかし、結果には異種性があります。
Abbreviate therapyでは、
脳卒中、虚血性発作などは低く
一方で心筋梗塞やステントの血栓塞栓は高くなっています。
しかしながら血栓塞栓が生じた患者さんの割合は0.4-0.6%と低く
一方で出血は6.4%-9.2%と両群の間で高いことから
全体的な評価では出血を抑えられる
抗血小板療法を術後1か月に短縮するほうが好ましいのではないか
と考えます。
(参考文献(1) Table 2より)
ただし、年齢の中央値は76.1歳と高く、
若年層に同様の結果が当てはまるかどうかは注意が必要です。
抗血小板療法や抗凝固剤などの使用においては
患者さんの血管の状況(内皮などの損傷、硬化)などの状況をみながら
出血のリスクを考え、
逐次、調整されることが好ましいと考えられます。
//Support(1)//---
Supported by Terumo.
//Acknowledgement From (1)//---
We thank Sophie Rushton-Smith, of MedLink Healthcare Communications, funded by the European Cardiovascular Research Institute, for providing editorial assistance with an earlier version of the manuscript.
//Special message by me//---
This letter is uploaded based on my "気持ち" "charity".
However, I need financial support from any institution and persons in not only Japan, but also the other countries for this pro-social activity.
//MASTER DAPT TRIAL: COMMITTEES AND INVESTIGATORS//---
Executive Committee
Coprincipal Investigator M. Valgimigli
Coprincipal Investigator P.C. Smits
Sponsor Representative G.A. Van Es until June 1, 2018
Sponsor Representative From June, 1 2018, G.B.W.E. Vos
Sponsor Representative From October 16, 2020, E. Spitzer
Principal Investigators P. Vrancks; B. Chevalier; Y. Ozaki
Clinical Research Organization Representative M.C. Morice
Cardiologists S. Windecker, Y. Onuma; E. Frigoli
Bern University Hospital Representative A. Frenk
Biostatisticians P. Jüni; J. Tijssen
Terumo Representative (nonvoting member) D. Paunovic
Steering Committee
National Lead Investigators
Bangladesh, India M.S. Ajit
Kingdom of Bahrain, Saudi Arabia M. Alasnag
Belgium J. Bartunek
France B. Chevalier
Italy A. Colombo
United Kingdom D. Hildick-Smith
Portugal, Spain A. Iñiguez
Austria, Denmark, Estonia, Germany, Sweden F. Mahfoud
Israel R. Kornowski
Bulgaria, Czech Republic, Hungary, Poland M. Lesiak
Singapore, South Korea, Vietnam P.J. Ong
Japan Y. Ozaki
Argentina A.E. Rodriguez
Switzerland M. Roffi
Australia C. Schultz
Macedonia, Serbia G. Stankovic
The Netherlands P. Tonino
Top Enrollers
Inselspital, Bern, Switzerland Aris Moschovitis
North Estonia Medical Center, Tallinn, Estonia Peep Laanmets
Interventional Cardiology Unit, Policlinico Casilino, Rome,
Italy
Michael Donahue
Data Monitoring Committee
Chair M. Bertrand
Biostatistician S. Pocock
Cardiologist P. Urban
Clinical Events Committee
Chair S. Leonardi
Cardiologists C. Hanet; R. Lopes; E.P. McFadden; P. Radke; E. Spitzer
Safety reporting group (Cardialysis, Rotterdam, The Netherlands)
Boudijn Ladan (Safety Specialist), Laura van der Waal (Safety Assistant), Yvonne Engelbrecht (Safety
Assistant), Fred Paddenburg (Safety Manager), Ben Ren, M.D., Ph.D. (Medical Reviewer).
CEC management group (Cardialysis, Rotterdam, The Netherlands)
Ingrid de Zwart (Data Manager), Liliane Elshout (Data Manager), Judith Jonk (Data Manager), Tessa
Rademaker-Havinga (Statistician).
Project Management
Ria van Vliet (Project Manager, ECRI, Rotterdam, The Netherlands). Marie-Claude Morice (Medical
Director, CERC, France), Phani Krishna Kondamudi (Clinical Project Leader, CERC, France), Laure
Morsiani (Clinical Operations Manager, CERC, France), Ute Windhövel (Regulatory Affairs Manager,
CERC, France). Anita van der Wal (Project Manager, Cardialysis, Rotterdam, the Netherlands), Chantal
Bakker (Project Manager, Cardialysis, Rotterdam, The Netherlands). Kazuhiro Minagawa (Project
Manager, CVQuest, Tokyo, Japan).
//COUNTRIES, INVESTIGATORS, AND NUMBERS OF PATIENTS ENROLLED//---
Argentina
Buenos Aires, Otamendi Hospital Dr. Juan Mieres
Buenos Aires, Institutio
Cardiovascular de Buenos Aires Dr. Fernando Cura
Buenos Aires, Clinica IMA Dr. Carlos
Fernandez-Pereira
Australia
Perth, Royal Perth HospitalCardiology Research Prof. Carl Schultz
Wollongong, Wollongon Hospital Dr. Astin Lee
Sydney, Prince of Wales Hospital Dr. Nigel Jepson
Fitzroy, St Vincent Hospital Prof. Robert
Whitbourn
Chermside, The Prince Charles
Hospital
Dr. Owen
Christopher Raffel
Austria
Vienna, Wilhelminenspital Prof. Kurt Huber
Vienna, Rudolfstiftung Hospital Prof. Franz
Weidinger
Bangladesh Dhaka, National Heart Foundation
Hospital & Research Institute
Prof. Fazila-TunNesa Malik
Belgium
Hasselt, Jessa Ziekenhuis Prof. Pascal
Vranckx
Bonheiden, Imelda Ziekenhuis Dr. Willem Dewilde
Charleroi, CHU de Charleroi –
Hopital Civil Marie Curie Dr. Adel Aminian
Aalst, OLV Ziekenhuis
Prof. Emanuele
Barbato----from 6th
Sep 2018 Dr. Jozef
Bartunek
Liege, CHR La Citadelle Dr. Suzanne
Pourbaix
Brussels, CHU St. Pierre UMC St.
Pieter
Dr. Panagiotis
Xaplanteris
Bulgaria
Sofia, UMHAT St. Anna Dr. Vasil Velchev
Plovdiv, MHAT "Sveta Karidad"
Plovdiv
Dr. Dimitar
Karageorgiev
Sofia, National Heart Hospital Dr. Hristo Mateev
Sofia, Tokuda Hospital Prof. Valeri Gelev
Czech
Republic
Brno, University Hospital Brno Prof. Petr Kala
Praha, Na Homolce Hospital Dr. Martin Mates
Denmark Roskilde, Roskilde Hospital
Kogevej
Dr. Henning
Kelbæk
Estonia Tallinn, North-Estonia Medical
Centre Foundation Dr. Peep Laanmets
France
Massy, Hopital Prive Jacques
Cartier
Dr. Thomas
Hovasse
Montauban, Clinique du Pont de
Chaume
Dr. Laurent
Delorme
Marseille, CHU La Timone Prof. Thomas
Cuisset
Annecy, Centre Hospitalier
Annecy Genvois Dr. Loïc Belle
Caen, Centre hospitalier regional
universitaire de Caen Prof. Farzin Beygui
Nantes, Hopital Prive le Confluent Dr. Ashok
Tirouvanziam
Montpellier, Clinique du Millenaire Prof. Christophe
Piot
Caen, Hopital Prive Saint Martin Dr. Jean François
Morelle
Rouen, Clinique Saint-Hilaire Dr. Rene Koning
Metz, Hopital de Mercy Dr. Mathieu Valla
Dijon, GCIDB – Hopital Prive
Dijon Bourgogne Dr. Philippe Brunel
Nimes, CHU Caremeau Dr. Guillaume
Cayla
Creteil, Centre Hospitalier
Universitaire Henri-Mondor
Prof. Emmanuel
Teiger
Paris, Hopital Universitaire PitieSalpetriere
Prof. Gilles
Montalescot
Paris, Hopital Europeen GeorgesPompidou
Prof. Christian
Spaulding
Saint-Denis, Centre Cardiologique
du Nord Dr. Phillipe Guyon
Germany
Homburg, Saarland University Prof. Felix Mahfoud
Landshut, Landshut-Archdorf
Krankenhaus
Dr. Pyxaras,
Stylianos
Hungary
Budapest, Semmelweis University
Heart and Vascular Center Prof. Béla Merkely
Szeged, Invasive Cardiology Unit
University of Szeged Dr. Imre Ungi
India
Coimbatore, G Kuppuswamy
Naidu Memorial Hospital
Dr. Rajpal K
Abhaichand
Surat, Shri BD Mehta Mahavir
Heart Institute
Dr. Atul Damodar
Abhyankar 33
Chennai, Apollo Hospitals,
Chennai Dr. Sengottuvelu. G
Chennai, Madras Medical Mission Dr. Ajit Mullasari .S
Israel
Safed, Ziv Medical Center,
Cardiology Department Dr. Halabi Majdi
Petach Tikva, Rabin MC Prof. Ran
Kornowski
Haifa, Rambam Medical Center
Prof. Ariel Roguin---
-from 14th Oct
2018 Dr. Yair Feld
Jerusalem, Hadassah Ein Karem
Medical Center Prof. Chaim Lotan
Italy
Rome, Policlinico Casilino Dr. Michael
Donahue
Vimercate, Ospedale di Vimercate Dr. Stefano
Garducci
Rozzano, Humanitas Research
Hospital
Dr. Bernhard
Reimers
Rome, Policlinico Umberto I Dr. Gennaro
Sardella
Milan, San Raffaele Hospital
Dr. Antonio
Colombo---from
20th June 2019 Dr.
Alaide Chieffo
Catania, Ferrarotto Hospital Prof. Corrado
Tamburino
Messina, AOU Policlinico Martino Dr. Giuseppe Andò
Milan, Policlinico San Donato Dr. Luca Testa
Milan, Sacco Hospital Dr. Maurizio Di
Biasi
Rome, Ospedale Sandro Pertini Dr. Alessandro
Sciahbasi
Caserta, Azienda Ospedaliera di
Caserta Sant Anna e San
Sebastiano
Dr. Paolo Calabro
Andria, Ospedale Lorenzo
Bonomo
Dr. Gianluigi
Minervini
Cagliari, Azienda Ospedaliera
Brotzu Dr. Bruno Loi
Milan, Centro Cardiologico
Monzino IRCCS
Dr. Franco
Fabbiocchi
Milan, ASST Grande Ospedale
Metropolitano Niguarda Dr. Jacopo Oreglia
Treviglio, ASST Bergamo Ovest Dr. Paolo
Sganzerla
Japan
Toyoake, Fujita Health University
Hospital Prof. Yukio Ozaki
Kokura, Fukuoka Kokura
Memorial Hospital Dr. Kenji Ando
Osaka, Osaka Police Hospital Dr. Yoshiharu
Higuchi
Tokyo, Sakakibara Heart Institute Dr. Mamoru
Nanasato
Kanagawa, St. Marianna
University School of Medicine Dr. Yuki Ishibashi
Gifu, Gifu Heart Center Dr. Hitoshi Matsuo
Nagoya, Japanese Red Cross
Nagoya Daini Hospital Dr. Ruka Yoshida
Ichinomiya, Ichinomiya municipal
hospital
Dr. Kiyokazu
Shimizu
Nagoya, Japanese Red Cross
Nagoya Dr. Haruo Kamiya
634 – Japan, Tokyo, St. Lukes
International Hospital
Dr. Nobuyuki
Komiyama
Nagakuteshi, Aichi Medical
University Hospital Dr. Tetsuya Amano
Nagoya, Nagoya University
Hospital
Dr. Toyoaki
Murohara
Sapporo, Sapporo Higashi
Tokushukai Hospital Dr. Seiji Yamazaki
Kingdom of
Bahrain
Riffa, Bahrain Defence Force
Hospital Dr. Husam Noor
Macedonia Skopje, University Clinic of
Cardiology Dr. Sasko Kedev
Poland
Krakow, Institute Of Cardiology
Jagiellonian University Dr. Jakub Podolec
Poznan, Szpital Kliniczny
Przemienienia Panskiego Prof. Maciej Lesiak
Wroclaw, 4 Wojskowy Szpital
Kliniczny
Dr. Krzysztof
Reczuch
Lubin, Miedziowe Centrum
Zdrowia SA
Dr. Adrian
Wlodarczak
Krakow, University Hospital
Krakow Poland
Prof. Dariusz
Dudek
Portugal Lisbon, Hospital de Santa Maria Dr. Pedro Canas da
Silva 1
Saudi Arabia King Fahd Armed Forces Hospital Dr. Mirvat Alasnag
Serbia
Belgrade, Institute for
Cardiovascular Disease Dedinje
Dr. Ljupco
Mangovski − from
17 April 2019 Dr.
Dragan Topic
Belgrade, Clinical Center of
Serbia
Prof. Goran
Stankovic
Sremska Kamenica, Institute of
Cardiovascular Diseases
Dr. Dragan
Debeljacki
Singapore
Singapore, Tan Tock Seng
Hospital
Prof. Paul Ong Jau
Lueng
Singapore, KhooTeck Puat
Hospital
Dr. Syed Saqib
Imran
South Korea Seoul, Asan Medical Center Dr. Park SeungJung 15
Spain
Huelva, Juan Ramon Jimenez
Hospital
Dr. José Francisco
Diaz Fernandez
Vigo, Alvaro Cunqueiro Prof. Andrés
Iniguez
Barcelona, Hospital Vall Hebron Dr. Bruno Garcia
del Blanco
Alicante, Hospital General
Universitario de Alicante Dr. Vicente Mainar
Madrid, Hospital 12 de Octubre Dr. Ivan Gomez
Blazquez
El Palmar, Universitario Virgen de
la Arrixaca Dr. Eduardo Pinar
Madrid, Hospital Clinico San
Carlos
Prof. Javier
Escaned Barbosa
Barcelona, Bellvitge University
Hospital
Dr. Joan Antoni
Gomez Hospital
Santander, Hospital Universitario
Valdecilla Dr. Fermin Sainz
Majadahonda, Hospital
Universitario Puerta de Hierro Dr. Javier Goicolea 1
Sweden
Orebro, Orebro University
Hospital Dr. Ole Fröbert
Gavle, Gavle Hospital Dr. Robert
Kastberg
Switzerland
Bern, Inselspital
Dr. Aris
Moschovitis---from
20th Oct 2020 Prof.
Stephan Windecker
Liestal, Kantonsspital Baselland Dr. Gregor
Leibundgut
Lugano, Cardiocentro Ticino Dr. Giovanni
Pedrazzini
Geneva, University Hospital Prof. Marco Roffi
Bern, Lindenhofspital Dr. Ali
Garachemani
Zurich, University Hospital Zurich Dr. Patrick Siegrist
Fribourg, HFR Hopital cantonal Prof. Stéphane
Cook
Netherlands
Rotterdam, Maasstad Ziekenhuis Dr. Peter Smits
Terneuzen, Zorgsaam Dr. Al Mafragi
Emmen, Treant Zorggroep
PI Dr. Jessurun---
from 1st July 2020
Dr. Ruifrok
Eindhoven, Catharina Ziekenhuis Dr. Pim Tonino
Arnhem, Rijnstate Ziekenhuis Dr. Peter Danse
Hertogenbosch, Jeroen Bosch
Ziekenhuis Dr. J. Polad
Dordrecht, Albert Schweitzer
Ziekenhuis Dr. Floris Kauer
Enschede, Medisch Spectrum
Twente
Dr. Clemens von
Birgelen
Nieuwegein, Antonius Ziekenhuis
Nieuwegein Dr. Jurrien ten Berg
Breda, Amphia Ziekenhuis Dr. Sander
Ijsselmuiden
Den Haag, Hagahospital Dr. Samer Somi
United
Kingdom
Bristol, Bristol Heart Institute Dr. Tom Johnson
Worcester, Worcestershire Royal
Hospital
Dr. Helen
Routledge
Brighton, Brighton & Sussex
University Hospitals Trust
Dr. David HildickSmith
Bournemouth, Royal
Bournemouth Hospital Dr. Jehangir Din
Wolverhampton, Heart and Lung
Centre – New Cross Hospital Dr. Shahzad Munir
Blackburn, Royal Blackburn
Hospital Dr. John McDonald
Stevenage, Lee Haynes
Research Institute, Lister Hospital Dr. Neville Kukreja
Stoke on Trent, Royal Stoke
University Hospital
Prof. Mamas
Mamas
Newcastle upon Tyne, Freeman
Hospital Dr. Rajiv Das
Manchester, Wythenshawe
Hospital
Dr. Hussain
Contractor
Derry, Altnagelvin Hospital Dr. Aaron Peace
London, St. George’s Hospitals Dr. Rupert Williams
Vietnam Vietnam National Heart Institute –
Bach Mai Hospital Hanoi
Prof. Nguyen Ngoc
Quang
(Reference)
(1)
Marco Valgimigli, M.D., Ph.D., Enrico Frigoli, M.D., Dik Heg, Ph.D., Jan Tijssen, Ph.D., Peter Jüni, M.D., Pascal Vranckx, M.D., Ph.D., Yukio Ozaki, M.D., Ph.D., Marie-Claude Morice, M.D., Bernard Chevalier, M.D., Yoshinobu Onuma, M.D., Ph.D., Stephan Windecker, M.D., Pim A.L. Tonino, M.D., Marco Roffi, M.D., Maciej Lesiak, M.D., Felix Mahfoud, M.D., Jozef Bartunek, M.D., Ph.D., David Hildick-Smith, M.D., Antonio Colombo, M.D., Goran Stanković, M.D., Ph.D., Andrés Iñiguez, M.D., Ph.D., Carl Schultz, M.D., Ph.D., Ran Kornowski, M.D., Paul J.L. Ong, M.D., Ph.D., Mirvat Alasnag, M.D., Ph.D., Alfredo E. Rodriguez, M.D., Ph.D., Aris Moschovitis, M.D., Peep Laanmets, M.D., Michael Donahue, M.D., Sergio Leonardi, M.D., and Pieter C. Smits, M.D., Ph.D. for the MASTER DAPT Investigators*
Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk
The New England Journal of Medicine August 28, 2021
---
Author Affiliations
From the Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano (M.V.), CTU Bern, University of Bern (E.F., D.H.), and the Department of Cardiology, Bern University Hospital (S.W.), Bern, the Division of Cardiology, Geneva University Hospitals, Geneva (M.R.), and HerzZentrum Hirslanden Zürich, Zurich (A.M.) — all in Switzerland; the Department of Cardiology, Amsterdam University Medical Centers, Amsterdam (J.T.), European Cardiovascular Research Institute (J.T.), and the Department of Cardiology, Maasstad Hospital (P.C.S.), Rotterdam, and the Department of Cardiology, Catharina Hospital, Eindhoven (P.A.L.T.) — all in the Netherlands; the University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto (P.J.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, and the Faculty of Medicine and Life Sciences, Hasselt University, Hasselt (P.V.), and the Cardiovascular Center, OLV Hospital, Aalst (J.B.) — all in Belgium; the Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Japan (Y. Ozaki); the Cardiovascular European Research Center (M.-C.M.), and Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud (B.C.) — both in Massy, France; the National University of Ireland, Galway (Y. Onuma); the First Department of Cardiology, University of Medical Sciences, Poznan, Poland (M.L.); the Department of Internal Medicine III–Cardiology, Angiology, and Intensive Care Medicine, Saarland University, Homburg, Germany (F.M.); Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom (D.H.-S.); the Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan (A.C.), the Interventional Cardiology Unit, Policlinico Casilino, Rome (M.D.), and the University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia (S.L.) — all in Italy; the Department of Cardiology, Clinical Center of Serbia, and the Faculty of
心房細動患者数は、日本では80万人と推計されており、
実際には100万人を超すとも言われています。
高齢の方に多く、今後、高齢化に伴って患者数は増えると
考えられており、予防的な事も含めて適切な対策が重要になります。
---
大動脈弁が損傷を受けた場合、
それを人工弁に置き換える必要がある場合があります。
それに対して経カテーテル的大動脈弁置換術が選択される事があります。
高齢の方や、呼吸器疾患を持っている方など
開胸による外科的手術に対するリスクがある場合には
上述のカテーテルを使って大腿部の血管からアプローチします。
そのような施術後に心房細動が生じることがあります。
おおよそ33%の人に生じるとされています(2-8)。
それに対して血流を保つため抗凝固薬が使われる事があります。
その際、ビタミンKの働きを抑えて
血液の凝固を防ぐ薬が使われていましたが、
ビタミンK含有食品(納豆、野菜)の摂食制限、
用量調整のための頻繁な血液検査が問題とされていました。
---
そこでN.M. Van Mieghem, M. Unverdorben, C. Hengstenberg(敬称略)ら
ヨーロッパを中心とする国際的な医療研究グループは
経カテーテル的大動脈弁置換術後に心房細動が生じた患者さんに対する
心臓血管系のメンテナンスにおいて、
凝固に関わる第Xa因子阻害薬であるエドキサバンと
ビタミンK阻害薬の臨床効果の比較を行っています(1)。
本日は血管の凝固に関わる疾患や出血などの副作用についての
結果の概要を読者の方と情報共有いたします。
//結果//---
年齢;18歳以上
確率:それぞれ713人に対して
エドキサバン(左)/ビタミンK阻害薬(右)---ハザード比(左)/(右)
出血: 9.7%/7.0%---1.40
死亡: 7.8%/9.1%---0.86
虚血性脳卒中: 2.1%/2.8%---0.75
心筋梗塞: 1.1%/0.7%
全身性血栓塞栓: 0.2%/0.3%
弁血栓: 0%/0%
脳卒中: 2.7%/3.5%---0.78
心臓、心臓血管有害事象: 8.2%/8.1%---1.02
致命的な出血: 1.0%/1.0%
生命に関わる出血: 1.6%/1.9%
頭蓋内出血: 1.5%/2.1%---0.72%
Clinically relevant nonmajor bleeding:18.2%/16.4%---1.13
---
エドキサバン群の出血は多いが
多くのケースでは胃腸の出血です。
脳内出血や重篤な出血は少ないか、同程度であると評価されています。
その他、死亡、脳卒中、心筋梗塞、血管塞栓、心臓有害事象など
循環器系の異常に関連する有害事象においては
エドキサバンはビタミンK阻害薬に劣らないとされています。
しかしながら、
この結果は主に高齢の方であり
無症候性大動脈弁狭窄症の若い人には適用できない
とされています。
//Special message//
This article is updated based on my “気持ち”.
//Trial//---
Trial was conducted in accordance with the International Council for Harmonisation and the Declaration of Helsinki.
From April 2017 through January 2020
Successful TAVR at 173 centers in 14 countries
Asia
Japan South Korea
Europe
Austria Belgium France Germany Italy Netherlands Poland Spain Switzerland United Kingdom
North America
Canada United States
//Support//---
Supported by Daiichi Sankyo.
//ENVISAGE-TAVI AF STUDY ORGANIZATION//---
Executive Committee members: George Dangas, Nicolas van Mieghem (Global Lead
Investigators), Cathy Chen, Christian Hengstenberg, Roxana Mehran, Shigeru Saito, Martin
Unverdorben, Marco Valgimigli, Roland Veltkamp, Pascal Vranckx
Sponsor Leadership (Daiichi): Anil Duggal, James Jin, Petra Laeis, Martin Unverdorben
Data Monitoring Committee: Bernard Gersh (Chairperson), Deepak Bhatt, Jonathan
Halperin, Freek Verheugt, Timothy Collier
Clinical Events Committee: Steven Marx (Chairperson), Nicola Corvaja, Douglas DiStefano,
Newsha Ghodsi, Jose Meller, Jesse Weinberger, David Kaufman, Mark Milstein
National Leads: Austria: I. Lang; Belgium: P. Vranckx; Canada: J. Rodés-Cabau; France:
P. Ohlmann; Germany: H. Mӧllmann; Italy: C. Tamburino; Japan: K. Hayashida,
Y. Watanabe; Korea: H.-S. Kim; Netherlands: N. Van Mieghem; Poland: M. Grygier; Spain:
R. Moreno, L. Nombela-Franco; Switzerland: T. Pilgrim; United Kingdom: R. Anderson;
United States: G. Dangas
Site Principal and Co-Investigators (**number of patients randomized):
Austria (**62): I. Lang, J. Bergler-Klein, C. Gatterer, J. Kastner, M. Lenz, C. Nitsche, P.
Pichler, S. Stojkovic (MUW – Medizinische Universität Wien, AKH – Allgemeines Krankenhaus –
Universitätsklinik für Innere Medizin II, Vienna); F. Guy, N. Bonaros, L. Gutierrez-Roman, J. Kilo,
B. Metzler, F. Plank (Medizinische Universität Innsbruck – Universitätsklinik für Innere Medizin
III, Innsbruck); K. Huber, T. Andric, A. Geppert, E. Wessely, F. Egger (Wiener
Gesundheitsverbund – Klinik Ottakring, Vienna); R. Zweiker, S. Gharibeh, T. Glantschnig, D.
Zweiker (Medizinische Universität Graz – Klinische Abteilung für Kardiologie, Graz); R. Binder, K.
Danninger, E. Laβnig (Klinikum Wels-Grieskirchen GmbH, Wels); C. Adlbrecht, A. Schober, P.
Stratil, A. Strouhal (Krankenhaus Nord – Wien, Vienna); J. Egresits, C. Kaulfersch, H. Alber, K
Ferlic, K. Laubreiter, K. Leitner, M. Rybczynkski, P. Wimmer (Klinikum Klagenfurt am
Wörthersee, Wörthersee)
Belgium (**34): P. Vranckx, E. Benit (Jessa Ziekenhuis, Hasselt); J. Bosmans, T.
Vandendriessche, H. Heidbuchel (Antwerp University Hospital, Edegem); B. Ferdinande, D.
Cottens, S. Deferm (Ziekenhuis Oost-Limburg, Genk); F. Stammen, S. Van de Walle (AZ Delta –
Campus Rumbeke, Roeselare); I. Buysschaert, P. Vanduynhoven, M. Rosseel (Algemeen
Stedelijk Ziekenhuis, Aalst)
Canada (**14): J. Rodés-Cabau, L. Asmarats Serra, C. Chamandi, R. De Larochelliere, D.
Doyle, E. Dumont, L. Faroux, A. Ferrira Neto, A. Garcia, L. Guimaraes, F. Maes, S. Mohammadi,
J.-M. Paradis, T. Rodriguez Gabella (Institut Universitaire de Cardiologie et de Pneumologie de
Québec, Quebec City); R. Whitlock, A. Smith (Population Health Research Institute [PHRI],
Hamilton); M. Chu, R. Bagur, P. Diamantouros, B. Kiaii, P. Teefy (London Health Sciences
Centre – University Hospital, London)
France (**46): N. Dumonteil, D. Tchetche (Clinique Pasteur, Toulouse); D. Himbert, J. Abtan,
M. Urena-Alcazar (Hôpital Bichat – Claude-Bernard, Paris); L. Leroux, C. Alexandrino, M. Dijos,
N. Nasser, J. Peltan, B. Seguy (CHU Hopitaux de Bordeaux – Hôpital Haut-Lévêque, Pessac); S.
Delepine, F. Pinaud (Centre Hospitalier Universitaire d'Angers, Angers); C. Caussin, N. Amabile,
F. Rauox, C. Roig, A. Veugeois (Institut Mutualiste Montsouris, Paris); E. Teiger, R. Gallet,
Gauthier, Mouillet, V. Rubimbura (CHU Hôpital Henri Mondor, Créteil); P. Ohlmann, S. Hess, O.
Morel (Hôpitaux Universitaires de Strasbourg – Hôpital Civil, Strasbourg); E. Van Belle, N.
Debry, C. Delhaye, T. Denimal, F. Juthier, A. Mugnier, T. Pamart, N. Rousse, H. Spillemaeker, B.
Verdier, F. Vincent (Centre Hospitalier Régional Universitaire de Lille [CHRU] – Hôpital
Cardiologique, Lille)
Germany (**336): W. Koenig, C. Hengstenberg, S. Ates, M. Joner, A. Knyphausen, C.
Pellegrini, T. Rheude, T. Trenkwalder (Herzzentrum München, Munich); H. Möllmann, J.
Blumenstein, B. Dickmann, J. Froemke, L. Gaede, J.-E. Guelker, O. Guerocak, O. Husser, M.
Marks, N. Schulze-Waltrup, D. Soetemann (St.-Johannes-Hospital, Dortmund); R. Hambrecht, A.
Ammar, A. Fach, M. Kuehl, R. Osteresch, P. Pader, H. Wienbergen, E. Wolters, J. Hassfurther,
A. Martel-Coll (Klinikum Links der Weser gGmbH, Bremen); N. Gessler, F. Meincke, C. Freker, N.
Gosau, S. Hakmi, K.-H. Kuck, T. Ubben, S. Willems (Asklepios Klinik St. Georg, Hamburg); H.
Thiele, C. Binner, S. Desch, P. Hartung, D. Holzhey, P. Kiefer, S. Leontyev, P. Münch, M. Sandri
(Heart Center Leipzig at University of Leipzig – Department of Internal Medicine/Cardiology,
Leipzig); T. Zeus, S. Afzal, L. Dannenberg, L. Kleinebrecht, A. Mohring, K. Piayda, A. Polzin, D.
Stötemann, V. Veulemans (Universitätsklinikum Düsseldorf, Düsseldorf); K. Debl, M. Fischer, M.
Hilker, L. Maier, C. Strack, M. Tafelmeier (Universitätsklinikum Regensburg, Regensburg); W.
Rottbauer, J. Woehrle, B. Gonska, D. Scharnbeck, J. Seeger, O. Smirnova, J. Mörike, M. Kessler
(Universitätsklinikum Ulm, Ulm); P. Nordbeck, S. Herrmann, O. Maniuc, T. Salinger, L. K.
Seidlmayer (Universitätsklinikum Würzburg, Würzburg); T. Geisler, O. Borst, M. Droppa
(Universitätsklinikum Tübingen, Tübingen); E. Freiherr von Hodenberg, D. Federov (MediClin
Herzzentrum Lahr/Baden Klinik für Innere Medizin – Kardiologie, Lahr); W. Reents, G. Kucinoski,
M. Zacher (RHÖN-Klinikum Campus Bad Neustadt, Bad Neustadt an der Saale); R. Toelg, M.
Abdel-Wahab, M. Landt, A. Allali, D. Sulimov (Segeberger Kliniken GmbH [SKG], Bad Segeburg);
R. von Bardeleben, E. Schulz, M. Geyer, T. Jansen, F. Kreidel, T. Ruf, B. Schnorbus, A. Tamm
(Universitätsmedizin der Johannes Gutenberg – Universität Mainz, Mainz); M. Lutz, D. Frank, J.
Frank, J. Gänsbacher, C. Kuhn (Universitätsklinikum Schleswig-Holstein, Kiel); M. Licka, J.
Destani, M. Preusch (Medizinische Universitätsklinik Innere Medizin III, Heidelberg); A. Wolf, E.
Blank, R. Schueler, E. Vogel, T. Schmitz, C. Jensen (Elisabeth-Krankenhaus Essen GmbH, Klinik
Tarantini, A. Barioli, F. Cardaioli, C. Fraccaro (Azienda Ospedaliera di Padova, Padua); D.
Trabattoni, P. Olivares (Centro Cardiologico Monzino, Milano); A. S. Petronio, M. Angelillis, M.
De Carlo, C. Giannini, P. Spontoni (Azienda Ospedaliero Universitaria Pisana - Stabilimento di
Cisanello, Pisa); G. Bruschi, C. Marchetti, B. Merlanti (ASST Grande Ospedale Metropolitano
Niguarda, Milan); C. Di Mario, P. Demola, F. Meucci, F. Ristalli, M. Stolcova (Azienda
Ospedaliero – Universitaria Careggi, Florence); F. Ribichini, M. Bellamoli, G. Berton, L. Maritan,
A. Pepe, F. Zucchelli, G. Pesarini (Azienda Ospedaliera Universitaria Integrata Verona –
Ospedale Borgo Trento, Verona); S. Imme, M. Patanè, D. Tempio (Casa di Cura G.B. Morgagni,
Catania); A. Poli, E. Ferrara, P. Martina (Azienda Ospedaliera Ospedale Civile di Legnano,
Legnano); Tiziana Attisano, E. De Angelis, G. Galasso, A. G. Maione, C. Sellitto, F. Vigorito
(Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona, Salerno); G. P.
Perna, L. Angelini (Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona, Torrette); O.
Piro, M. Crisci, V. Monda, I. Monteforti (AORN – Ospedali dei Colli Ospedale V. Monaldi, Napoli);
C. Briguori, G. Ciccarelli, C. DAmore, A. Focaccio, M. Golino (Clinica Mediterranea SpA – Napoli,
Naples); A. Berni, F. Giovannelli, S. Rigattieri (Azienda Ospedaliera Sant'Andrea, Rome); G.
Tiberti, A. Farina (Ospedale “Alessandro Manzoni”, Lecco); R. Rossini, G. Musumeci , G. Baralis
(Azienda Sanitaria Ospedaliera S. Croce e Carle Cuneo, Cuneo); R. F. E. Pedretti, S. De Servi, A.
Antonelli, L. Alberti (Casa di Cura Multimedica, Sesto San Giovanni); D. Maffeo, O. Leonzi, L.
Bettari, C. Maiandi (Fondazione Poliambulanza Istituto Ospedaliero, Brescia); C. Trani, C.
Aurigemma, F. Burzotta, S. Cangemi (Fondazione Policlinico Universitario Agostino Gemelli,
Roma); P. Calabro, D. Di Maio, V. Diana, A. Cesaro, E. Moscarella (Azienda Ospedaliera di
Caserta "Sant'Anna e San Sebastiano", Caserta)
Japan (**159): K. Ando, M. Hayashi, A. Isotani, S. Ito, T. Kawaguchi, S. Mori, T. Morinaga, S.
Shirai, H. Takiguchi, T. Taniguchi, M. Yano (Kokura Memorial Hospital, Kitakyushu); K.
Hayashida, H. Hase, Y. Kobari, S. Myojin, T. Ryuzaki, T. Saito, N. Yoshijima (Keio University
Hospital, Tokyo); M. Izumo, Y. Akashi, K. Chatani, T. Kaihara, R. Kamijima, K. Okuyama, Y.
Sato, Y. Tanabe, M. Watanabe (St. Marianna University School of Medicine Hospital, Kawasaki);
K. Mizutani, A. Ito, S. Iwata, M. Ogawa, T. Okai, T. Yamaguchi, M. Yoshiyama (Osaka City
University Hospital, Osaka); N. Morioka, A. Higashimori, K. Fukuda, Y. Yokoi (Kishiwada
Tokushukai Hospital, Kishiwada); T. Naganuma, T. Amano, H. Kawamoto, S. Matsuoka, A.
Nakajima, K. Tani (New Tokyo Hospital, Matsudo); Y. Nakajima, T. Fusazaki, Y. Ishikawa, A.
Kumagai, Y. Morino, R. Ninomiya (Iwate Medical University Hospital, Yahaba); H. Nishina, A.
Sugano (Tsukuba Medical Center Hospital, Tsukuba); Y. Ohno, Y. Ikari, J. Miyamoto, T.
Murakami, G. Nakazawa, K. Sakai (Tokai University Hospital, Isehara); N. Tada, Y. Enta, A.
Inoue, K. Ishiii, Y. Mizutani (Sendai Kousei Hospital, Sendai); H. Ueno, H. Kuwahara, H. Onoda,
M. Sobajima, Y. Ueno (Toyama University Hospital, Toyama); N. Watanabe, K. Takagi (Ogaki
Municipal Hospital, Ogaki); Y. Watanabe, M. Arai, M. Hatsuno, H. Hioki, Y. Ikeda, Y. Iseki, R.
Ishibashi, M. Ito, A. Kataoka, T. Katayama, H. Kawashima, K. Konno, K. Kozuma, H. Kyono, M.
Mitsui, M. Miyanaga, F. Nagura, M. Nakashima, T. Nomura, R. Okabe, T. Ota, S. Otsuki, K.
Sasaki, S. Takahashi, S. Takamura, Y. Terada, Y. Watari, H. Yamamoto, N. Yokoyama, N.
Yukimitsu (Teikyo University Hospital, Tokyo); M. Yamamoto, Y. Adachi, S. Hosoba, S. Kano, T.
Shimura, R. Yamaguchi (Toyohashi Heart Center [Cardiovascular Center], Toyohashi); M.
Yamamoto, A. Kagase, Y. Koyama, S. Tsujimoto (Nagoya Heart Center, Nagoya); F. Yamanaka,
K. Shishido, S. Yokota (Shonan Kamakura General Hospital, Kamakura); K. Yamasaki, H. Bouta,
Y. Gohira, Y. Hosoi, K. Kayanuma, K. Kuroda, Y. Otomaru, G. Takenouchi, T. Tani, S. Yamazaki
(Sapporo Higashi Tokushukai Hospital, Sapporo); M. Yamawaki, M. Araki, S. Hayashi, Y. Honda,
Y. Ito, N. Kobayashi, K. Makino, M. Mori, S. Mori, Y. Sakamoto, S. Shirai, M. Tsutsumi (Saiseikai
Yokohamashi Tobu Hospital, Yokohama)
Netherlands (**55): N. van Mieghem, J. Daemen, N. El Faquir, H. Kroon, J. Ooms, Z.
Rahhab, M. van Wiemen, P. de Jaegere (Erasmus MC, Amsterdam); J. Piek, R. Delewi, W.
Vlastra (Universiteit Van Amsterdam – Academisch Medisch Centrum, Amsterdam); T.
Vossenberg, A. Van Boven (Medisch Centrum Leeuwarden, Leeuwarden); C. Schotborgh, A.
Haasdijk, V. van Driel (HagaZiekenhuis van den Haag, Den Haag); E. Lipsic, P. van der Harst,
R.A.J. Schurer, P. Vandorp, H.W. van der Werf (University Medical Center Groningen,
Groningen)
Poland (**20): M. Grygier, A. Komosa, A. Olasinska-Wisniewska, M. Wrotynski (Szpital
Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego,
Poznań); M. Fijalkowski, W. Bachorski, D. Jagielak, A. Mickiewicz, I. Pisowodzka (Uniwersyteckie
Centrum Kliniczne, Gdańsk); T. Hirnle, M. Frank, M. Mirtosz, R. Trzcinski (Uniwersytecki Szpital
Kliniczny w Białymstoku, Białystok); Z. Huczek, J. Kochman, B. Rymuza, K. Zbronski
(Samodzielny Publiczny Centralny Szpital Kliniczny – II Klinika Anestezjologii i Intensywnej
Terapii, Warsaw)
South Korea (**19): H.-S. Kim, M. Chang, J.-K. Han, J. Kang (Seoul National University
Hospital, Seoul); K. Chang, Y. Choi (The Catholic University of Korea, Seoul St. Mary’s Hospital,
Seoul); D.-W. Park, J.-M. Ahn, D.-Y. Kang, S.-J. Park (Asan Medical Center, Seoul); M.-K, Hong,
I.J. Cho, G.-R. Hong, Y.-G. Ko, C. Y. Yu (Yonsei University College of Medicine, Seoul); H. Kook,
C. W. Yu, H. Joo, H. Kook (Korea University Anam Hospital, Seoul)
Spain (**344): P. Jimenez-Quevedo, G. Armijo, A. Castro, M. Del Trigo Espinosa, J. Escaned,
C. Espejo, N. Gonzalo, R. Guerra, C. Macaya, L. Marroquin, A. McInerney, L. Nombela-Franco, I.
Nuñez, P. Salinas, G. Tirado-Conte, O. Vedia, A. Fernández-Ortiz, A. Arturo (Hospital Clínico San
Carlos, Madrid); J. R. Moreno-Gomez, G. Galeote, H. Hernandez, S. Jimenez, J. R. Rey, A.
Sanchez (Hospital Universitario La Paz, Madrid); J. J. Gomez Doblas, J. María Hernandez, A.
Domínguez, A. Muñoz (Hospital Universitario Virgen de la Victoria, Málaga); J. L. Zamorano
Gómez, L. M. Rincón Díaz, L. Salido, M. Sanmartin, D. del Val, V. Jiménez Franco (Hospital
Universitario Ramón y Cajal, Madrid); C. Morís, P. Avanzas, R. Díaz Méndez, R. Del Valle
(Hospital Universitario Central de Asturias, Oviedo); L. Tercedor, D. Castro, E. Molina, R. Rivera
(Hospital Virgen de las Nieves, Granada); V. A. Jimenez Diaz, J. A. Baz Alonso, R. Estevez
Loureiro, S. Fernandez Barbeira, G. Fernández Bastos, A. Iñiguez Romo, A. Ortiz Saez, T.
Torrado Chedas, A. A. de Miguel Castro (Hospital Xeral, Vigo); V. Mainar, P. Bordes, P. Llamas,
J. Meseguer, M. Sandin (Hospital General Universitario de Alicante, Alicante); E. Pinar
Bermudez, J. Garcia, F. Marin, A. Tello Montoliu (Hospital Universitario Virgen Arrixaca, El
Palmar); D. Lopez-Otero, B. Cid Álvarez, J. López País, X. C. San Martin Pena, R. Trillo Nouche
(Complexo Hospitalario Universitario de Santiago [CHUS] - Hospital Clínico Universitario,
Santiago); J. de la Torre Hernandez, T. Garcia Camerero, D.-H. Lee, F. Sainz Laso, G. Veiga
Fernández, J. Zueco (Hospital Universitario Marqués de Valdecilla, Santander); A. San Roman, I.
Amat, A. Aparisi-Sanz, H. Gutiérrez, B. Ramos, T. Rodríguez Cabella, S. Santos-Martinez, A.
Serrador, S. Vera (Hospital Clínico Universitario de Valladolid, Valladolid); E. Fernandez
Nofrerias, O. Abdul-Jawad, X. Carillo Suarez, J. Mauri, O. Rodriguez, V. Villalta del Olmo
(Hospital Universitari Germans Trias i Pujol, Barcelona); J. Nunez, R. De la Espriela, S. Garcia,
G. Minana, E. Valero, E. Santas Olmeda (Hospital Clinico Universitario de Valencia, Valencia); R.
Hidalgo Urbano, J. Ramón Benitez, R. Calvo, L. Madrona, B. Prado (Hospital Universitario Virgen
Macarena, Seville); G. Lasa Larraya, I. Elizondo, L. Ma (Koldo) Gaviria, F. J. Irazusta, S. Solana,
M. Tellería, A. Tramullas (Hospital Universitario Donostia, San Sebastián); F. Alfonso, T.
Alvarado, F. Rivero, F. J. de la Cuerda Llorente (Hospital Universitario de la Princesa, Madrid);
B. Garcia del Blanco, G. Marti Aquasca, V. Serra García (Hospital Universitario Vall d'Hebron,
Barcelona); R. Reyes, J. Benezet Mazuecos, D. Gemma, A. Lopez Ricardo, A. Lozano Rosada, J.
Curtis, K. Nollette (Providence Medical Research Center, Spokane); A. Nanjundappa, C. Adams,
S. Lewis (Charleston Area Medical Center Health Education and Research Institute, Charleston);
J. Schultz (Essentia Health – St. Mary’s Medical Center, Duluth); L. Wiley Nifong, H. DeAntonio,
B. Carabello, M. Patel, A. Siddiqui (East Carolina Hearth Institute, Inc, Greenville); M. Sanjay, N.
Adoni, U. Kanakadandi (Carle Foundation Hospital, Urbana); K. Harjai, B. Young (Geisinger
Medical Center, Danville); T. Noel (Tallahassee Research Institute, Inc., Tallahassee); N.
Kakouros, L. Rosenthal (University of Massachusetts Memorial Medical Center, Worcester); V.
Nkomo, M. Eleid, K. Greason, G. Sandhu (Mayo Clinic – Rochester Methodist Hospital,
Rochester); R. Makkar, T. Chakravarty, M. Nakamura (Cedars-Sinai Medical Center, Los
Angeles); D. Arab, D. Bamberger, D. Henderson, B. Sickinger, N. Valin (Cardiology Research
Associates, Daytona Beach); F. Shawl, D. Brill, L. Dobrovolay (Adventist HealthCare White Oak
Medical Center, Calverton); O. Aksoy, W. Suh (UCLA); H. Gada, G. Gustafson, A. Hancock, M.
Mumtaz (Pinnacle Health – CardioVascular Institute [PHCVI] – Wormleysburg, Wormleysburg);
R. Waksman, I. Bendor, L. Waksman (MedStar Washington Hospital Center, Washington); J.
Tuma, R. DeRaad, B. Purushottam (Monument Health Clinical Research, Rapid City); J. Depta,
F. Abtahian, A. Ahmed, T. Albro (Rochester General Hospital, Rochester); W. Crowder, J.
Bennett (Jackson Cardiology Associates, PA, Jackson); J. McClurken, J. Auteri, D. Boland, S. A.
Guidera, J. Harrar (Doylestown Hospital, Doylestown); D. Baldwin, W. Hwang, G. Velamoor
(Virginia Mason Hospital & Seattle Medical Center, Seattle); L. Tejada, P. Puleo, C. Sarnoski
(Saint Luke’s University Health Network, Bethlehem); A. Pineda Maldonado (University of Florida
[UF] Jacksonville, Jacksonville); M. Ahmed (HealthEast Medical Research Institute, St. Paul); A.
Goodman, S. Horr, J. Riddick (TriStar Centennial Medical Center, Nashville); P. Meraj, L. Boutis
(North Shore University Hospital, Manhasset); C. Rowan, A. Akinapelli (University of Nevada
School of Medicine Internal Medicine and Multispecialty Clinic, Reno)
(Reference)
(1)
Nicolas M. Van Mieghem, M.D., Ph.D., Martin Unverdorben, M.D., Ph.D., Christian Hengstenberg, M.D., Helge Möllmann, M.D., Roxana Mehran, M.D., Diego López-Otero, M.D., Ph.D., Luis Nombela-Franco, M.D., Ph.D., Raul Moreno, M.D., Ph.D., Peter Nordbeck, M.D., Holger Thiele, M.D., Irene Lang, M.D., José L. Zamorano, M.D., Fayaz Shawl, M.D., Masanori Yamamoto, M.D., Ph.D., Yusuke Watanabe, M.D., Ph.D., Kentaro Hayashida, M.D., Ph.D., Rainer Hambrecht, M.D., Felix Meincke, M.D., Pascal Vranckx, M.D., Ph.D., James Jin, Ph.D., Eric Boersma, Ph.D., Josep Rodés-Cabau, M.D., Patrick Ohlmann, M.D., Ph.D., Piera Capranzano, M.D., Ph.D., Hyo-Soo Kim, M.D., Ph.D., Thomas Pilgrim, M.D., Richard Anderson, M.D., Usman Baber, M.D., Anil Duggal, M.D., Petra Laeis, Ph.D., Hans Lanz, M.D., Cathy Chen, M.D., Marco Valgimigli, M.D., Ph.D., Roland Veltkamp, M.D., Shigeru Saito, M.D., and George D. Dangas, M.D., Ph.D. for the ENVISAGE-TAVI AF Investigators*
Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR
The New England Journal of Medicine August 28, 2021
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Author Affiliations
From the Department of Cardiology, Erasmus University Medical Center, Thoraxcenter, Rotterdam, the Netherlands (N.M.V.M., E.B.); Daiichi Sankyo, Basking Ridge, NJ (M.U., J.J., A.D., C.C.); the Department of Internal Medicine II, Division of Cardiology, Vienna General Hospital, Medical University, Vienna (C.H., I.L.); the Department of Internal Medicine, St. Johannes Hospital, Dortmund (H.M.), the Department of Internal Medicine I, University Hospital Würzburg, Würzburg (P.N.), the Department of Internal Medicine–Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig (H.T.), Bremer Institute for Heart and Circulation Research at Klinikum Links der Weser, Bremen (R.H.), the Department of Cardiology, Asklepios Klinik St. Georg, Hamburg (F.M.), Daiichi Sankyo Europe, Munich (P.L., H.L.), the Department of Neurology, Alfried Krupp Krankenhaus, Essen (R.V.), and the Department of Neurology, University Hospital Heidelberg, Heidelberg (R.V.) — all in Germany; Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, New York (R. Mehran, G.D.D.); the Department of Cardiology, Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela (D.L.-O.), the Cardiovascular Institute, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos (L.N.-F.), the Department of Cardiology, University Hospital La Paz (R. Moreno), and the Department of Cardiology, University Hospital Ramon y Cajal (J.L.Z.), Madrid — all in Spain; the Department of Cardiology, Washington Adventist Hospital, Takoma Park, MD (F.S.); the Department of Cardiology, Toyohashi Heart Center, Toyohashi (M.Y.), the Department of Cardiology, Teikyo University School of Medicine (Y.W.), and the Department of Cardiology, Keio University School of Medicine (K.H.), Tokyo, and the Division of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura (S.S.) — all in Japan; the Department of Cardiology, Jessa Hospital, Hasselt, Belgium (P.V.); Quebec Heart and Lung Institute, Laval University, Quebec, QC, Canada (J.R.-C.); the Division of Cardiovascular Medicine, University Hospital of Strasbourg, Strasbourg, France (P.O.); the Division of Cardiology, Policlinico Hospital, University of Catania, Catania, Italy (P.C.); the Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea (H.-S.K.); the Department of Cardiology, University of Bern, Bern (T.P.), and Cardiocentro Ticino Institute and Department of Biomedical Sciences, University of Italian Switzerland, Lugano (M.V.) — both in Switzerland; the Department of Cardiology, University Hospital of Wales, Cardiff (R.A.), and the Division of Brain Sciences, Imperial College London, London (R.V.) — both in the United Kingdom; the Cardiology Section, University of Oklahoma Health Sciences Center, Oklahoma City (U.B.); and National and Kapodistrian University of Athens, School of Medicine, Athens (G.D.D.).
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