Author + information
- Received September 18, 2018
- Revision received November 13, 2018
- Accepted December 12, 2018
- Published online May 6, 2019.
- Ernest Spitzer, MDa,b,
- Eugene McFadden, MDc,
- Pascal Vranckx, MD, PhDd,
- Hector M. Garcia-Garcia, MD, PhDe,
- Jonathan H. Seltzer, MDf,
- Claes Held, MD, PhDg,
- Ton de Vries, MSca,
- Venu Menon, MDh,i,
- Kimberly J. Brown, RNi,
- Osama I.I. Soliman, MD, PhDa,b,
- Yoshinobu Onuma, MD, PhDa,b,
- Renato D. Lopes, MDj,
- Gregg W. Stone, MDk,l,
- Donald E. Cutlip, MDm,n and
- Patrick W. Serruys, MD, PhDo,∗ ()
- aCardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands
- bDepartment of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- cDepartment of Cardiology, Cork University Hospital, Cork, Ireland
- dDepartment of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Faculty of Medicine and Life Sciences Hasselt University, Hasselt, Belgium
- eDepartment of Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia
- fACI Clinical, Bala Cynwyd, Pennsylvania
- gDepartment of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden
- hCardiac Intensive Care Unit, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
- iC5Research, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
- jDivision of Cardiology, Duke University Medical Center/Duke Clinical Research Institute, Durham, North Carolina
- kClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- lDivision of Cardiology, Columbia University Medical Center, New York, New York
- mBaim Institute for Clinical Research, Boston, Massachusetts
- nBeth Israel Deaconess Medical Center, Boston, Massachusetts
- oNational Heart and Lung Institute, Imperial College London, London, United Kingdom
- ↵∗Address for correspondence:
Prof. Patrick W. Serruys, Erasmus University, P.O. Box 2125, 3000 CC Rotterdam, the Netherlands.
• Clinical trials utilize standardized clinical endpoint definitions for consistency, comparability, and poolability purposes.
• In 2018, the Academic Research Consortium and the Standardized Data Collection for Cardiovascular Trials Initiative published updated clinical and angiographic endpoint definitions for percutaneous coronary intervention trials.
• This article provides practical guidance to facilitate and harmonize implementation of these definitions in randomized trials or registries, as well as to foster consistency among independent adjudication committees, including standard, streamlined data-capture templates for reporting and adjudicating death, myocardial infarction, stroke, revascularization, stent/scaffold thrombosis, and bleeding.
• Continued collaborative efforts among academia, industry, regulatory agencies, and societies are critical to maintain and monitor consistency across ongoing and future clinical trials.
The Academic Research Consortium (ARC) and the Standardized Data Collection for Cardiovascular Trials Initiative have recently published updated clinical and angiographic endpoint definitions for percutaneous coronary intervention trials. The aim of this document is to provide practical guidance to facilitate and harmonize the implementation of those definitions in randomized trials or registries, as well as to foster consistency among independent adjudication committees. The authors compared the ARC-2 and Standardized Data Collection for Cardiovascular Trials Initiative definitions to identify areas of consistency, complex scenarios, and definitions in need of further standardization. Furthermore, the authors compared the fourth universal definition of myocardial infarction with the ARC-2 definition of myocardial infarction. The Society for Cardiovascular Angiography and Interventions definition of periprocedural myocardial infarction was also compared with the ARC-2 definition and the fourth universal definition of myocardial infarction. An in-depth assessment was done for each individual clinical endpoint to guide clinical investigators on reporting and classifying clinical adverse events. Finally, the authors propose standard streamlined data capture templates for reporting and adjudicating death, myocardial infarction, stroke, revascularization, stent or scaffold thrombosis, and bleeding.
- clinical endpoint adjudication
- clinical endpoint definition
- myocardial infarction
- scaffold thrombosis
- stent thrombosis
Prof. Serruys has served as consultant for Abbott, AstraZeneca, Biotronik, Cardialysis, GLG Research, Medtronic, Sinomedical, Europa Digital & Publishing, Stentys, Svelte, Phillips/Volcano, St. Jude Medical, Qualimed, and Xeltis. Dr. Garcia-Garcia has served as consultant for Tryton; has received speaking fees from Volcano/Philips; and has received institutional grants from Biotronik, Medtronic, InfraReDx, and Neovasc. Dr. Lopes has received personal fees from Bayer, Daiichi Sankyo, Merck, Portola Pharmaceutical, and Boehringer Ingelheim; and has received grants and personal fees from Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, and Pfizer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 18, 2018.
- Revision received November 13, 2018.
- Accepted December 12, 2018.
- 2019 American College of Cardiology Foundation
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