Author + information
- Received March 2, 2020
- Revision received March 24, 2020
- Accepted March 25, 2020
- Published online May 25, 2020.
- Davide Cao, MDa,b,
- Roxana Mehran, MDa,∗ (, )@Drroxmehran,
- George Dangas, MD, PhDa,
- Usman Baber, MD, MSa,
- Samantha Sartori, PhDa,
- Rishi Chandiramani, MDa,
- Giulio G. Stefanini, MD, PhDb,
- Dominick J. Angiolillo, MD, PhDc,
- Davide Capodanno, MD, PhDd,
- Philip Urban, MDe,
- Marie-Claude Morice, MDf,
- Mitchell Krucoff, MDg,
- Ridhima Goel, MDa,
- Anastasios Roumeliotis, MDa,
- Joseph Sweeny, MDa,
- Samin K. Sharma, MDa and
- Annapoorna Kini, MDa
- aThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- bDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
- cDivision of Cardiology, Department of Medicine, University of Florida College of Medicine, Jacksonville, Florida
- dDivision of Cardiology, Azienda Ospedaliero-Universitaria ’Policlinico-Vittorio Emanuele‘, University of Catania, Catania, Italy
- eCardiovascular Department, De la Tour Hospital, Geneva, Switzerland
- fCardiovascular European Research Center, Massy, France
- gDuke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
- ↵∗Address for correspondence:
Dr. Roxana Mehran, Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, New York 10029-6574.
Background Bleeding following percutaneous coronary intervention has important prognostic implications. The Academic Research Consortium (ARC) recently proposed a list of clinical criteria to define patients at high bleeding risk (HBR).
Objectives This study sought to validate the ARC definition for HBR patients in a contemporary real-world cohort.
Methods Patients undergoing coronary stenting between 2014 and 2017 at a tertiary-care center were defined as HBR if they met at least 1 major or 2 minor ARC-HBR criteria. To account for the presence of multiple criteria, patients were further stratified by the number of times they fulfilled the ARC-HBR definition. The primary endpoint was a composite of peri-procedural in-hospital or post-discharge bleeding at 1 year. Secondary endpoints included individual components of the primary bleeding endpoint, myocardial infarction, and all-cause mortality.
Results Among 9,623 patients, 4,278 (44.4%) qualified as HBR. Moderate or severe anemia was the most common major criterion (33.2%); age ≥75 years was the most frequent minor criterion and the most common overall (46.8%). The rate of the primary bleeding endpoint at 1 year was 9.1% in HBR patients compared with 3.2% in non-HBR patients (p < 0.001), with a stepwise increase in bleeding risk corresponding to the number of times the ARC-HBR definition was fulfilled. HBR patients also experienced significantly higher rates of all secondary endpoints.
Conclusions This study validates the ARC-HBR definition in a contemporary group of patients who underwent percutaneous coronary intervention. The ARC-HBR definition identified patients at increased risk not only for bleeding but also for thrombotic events, including all-cause mortality. Coexistence of multiple ARC-HBR criteria showed additive prognostic value.
Dr. Mehran has received consulting fees or honoraria from Abbott Laboratories, Boston Scientific, Medscape, Siemens Medical Solutions, Philips (Spectranetics), PLx Pharma, Roivant Sciences Inc., Volcano Corporation, Sanofi, Janssen, and Watermark Research Partners; has received research grants to her institution from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb, CSL Behring, Daiichi-Sankyo, Medtronic, Boston Scientific, Novartis, and OrbusNeich; has received institutional funding from and is on the Advisory Board of Spectranetics/Philips/Volcano Corporation; and has <1% equity in Claret Medical and Elixir Medical. Dr. Dangas has received consulting fees or honoraria from AstraZeneca, Biosensors, Boston Scientific, and Medtronic; is on the Advisory Board of Abbott Laboratories and Boston Scientific; has received research grants to the institution from Biotronik and Abbott Laboratories; and has equity (entirely divested) in Medtronic. Dr. Baber has received speaker honoraria from AstraZeneca and Boston Scientific; and has received honoraria from Amgen. Dr. Stefanini has received consulting fees or honoraria from B. Braun, Biosensors, Boston Scientific, and GADA; and the institution has received a research grant from Boston Scientific. Dr. Angiolillo has received consulting fees or honoraria from Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PhaseBio, PLx Pharma, Pfizer, Sanofi, and The Medicines Company; has received payments for participation in review activities from CeloNova and St. Jude Medical; and has received research grants to his institution from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, Osprey Medical, and Renal Guard Solutions. Dr. Capodanno has received consulting fees or honoraria from Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Daiichi-Sankyo, and Sanofi. Dr. Urban has received consulting fees or honoraria from Biosensors-Europe; has participated in paid review activities (Clinical End Point Committee, Data Safety Monitoring Board) for Edward Lifesciences, Terumo, and Abbott Vascular; is a shareholder in and medical codirector of the Cardiovascular European Research Center (CERC), a contract research organization based in Massy, France; and is a shareholder in MedAlliance. Dr. Morice is the chief executive officer of CERC. Dr. Krucoff has received consulting fees and research grants from Abbott Vascular, Biosensors, Boston Scientific, Cook Medical, Medtronic, and OrbusNeich. Dr. Sharma has received consulting fees or honoraria from Abbott Vascular, Boston Scientific, Abiomed, and Cardiovascular System, Inc; and is on the Speakers Bureau of Abbott Vascular, Boston Scientific, and Cardiovascular System, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. P. Gabriel Steg, M.D., served as Guest Associate Editor for this paper.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC author instructions page.
- Received March 2, 2020.
- Revision received March 24, 2020.
- Accepted March 25, 2020.
- 2020 American College of Cardiology Foundation
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