経皮的冠動脈インターベンション後の血栓、出血防止の為の抗血小板療法期間の最適化

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