Author + information
- Received August 15, 2018
- Revision received November 7, 2018
- Accepted November 8, 2018
- Published online February 18, 2019.
- Francesco Costa, MD, PhDa,b,
- David Van Klaveren, MScc,d,
- Fausto Feres, MD, PhDe,
- Stefan James, MD, PhDf,
- Lorenz Räber, MD, PhDb,
- Thomas Pilgrim, MDb,
- Myeong-Ki Hong, MDg,
- Hyo-Soo Kim, MDh,
- Antonio Colombo, MDi,
- Philippe Gabriel Steg, MDj,k,
- Deepak L. Bhatt, MD, MPHl,
- Gregg W. Stone, MDm,n,
- Stephan Windecker, MDb,
- Ewout W. Steyerberg, PhDc,
- Marco Valgimigli, MD, PhDb,∗ (, )@vlgmrc,
- for the PRECISE-DAPT Study Investigators
- aDepartment of Clinical and Experimental Medicine, Policlinic “G. Martino,” University of Messina, Messina, Italy
- bSwiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland
- cDepartment of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands
- dInstitute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts
- eIstituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil
- fDepartment of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden
- gSeverance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea and Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Korea
- hDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea
- iInterventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy and Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy
- jFACT, Assistance Publique–Hôpitaux de Paris (AP-HP), Paris, France
- kUniversité Paris-Diderot, Bichat Hospital, Paris, France
- lBrigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts
- mColumbia University Medical Center/New York-Presbyterian Hospital, New York, New York
- nCardiovascular Research Foundation, New York, New York
- ↵∗Address for correspondence:
Dr. Marco Valgimigli, Swiss Cardiovascular Center Bern, Bern University Hospital, CH-3010, Bern, Switzerland.
Background Complex percutaneous coronary intervention (PCI) is associated with higher ischemic risk, which can be mitigated by long-term dual antiplatelet therapy (DAPT). However, concomitant high bleeding risk (HBR) may be present, making it unclear whether short- or long-term DAPT should be prioritized.
Objectives This study investigated the effects of ischemic (by PCI complexity) and bleeding (by PRECISE-DAPT [PREdicting bleeding Complications in patients undergoing stent Implantation and SubsequEnt Dual AntiPlatelet Therapy] score) risks on clinical outcomes and on the impact of DAPT duration after coronary stenting.
Methods Complex PCI was defined as ≥3 stents implanted and/or ≥3 lesions treated, bifurcation stenting and/or stent length >60 mm, and/or chronic total occlusion revascularization. Ischemic and bleeding outcomes in high (≥25) or non-high (<25) PRECISE-DAPT strata were evaluated based on randomly allocated duration of DAPT.
Results Among 14,963 patients from 8 randomized trials, 3,118 underwent complex PCI and experienced a higher rate of ischemic, but not bleeding, events. Long-term DAPT in non-HBR patients reduced ischemic events in both complex (absolute risk difference: −3.86%; 95% confidence interval: −7.71 to +0.06) and noncomplex PCI strata (absolute risk difference: −1.14%; 95% confidence interval: −2.26 to −0.02), but not among HBR patients, regardless of complex PCI features. The bleeding risk according to the Thrombolysis In Myocardial Infarction scale was increased by long-term DAPT only in HBR patients, regardless of PCI complexity.
Conclusions Patients who underwent complex PCI had a higher risk of ischemic events, but benefitted from long-term DAPT only if HBR features were not present. These data suggested that when concordant, bleeding, more than ischemic risk, should inform decision-making on the duration of DAPT.
Mr. Van Klaveren and Dr. Steyerberg were supported by the National Institutes of Health (grant U01NS086294). Dr. James has received intuitional research grants from The Medicines Company, AstraZeneca, Abbott Vascular, and Boston Scientific. Dr. Pilgrim has received personal fees from Biotronik, Medtronic, and Edwards; and has received speakers fees from Biotronik and Boston Scientific. Dr. Steg has received grants from Bayer, Merck, Servier, and Sanofi; and has received speaking or consulting fees from Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CSL-Behring, Daiichi-Sankyo, GlaxoSmithKline, Janssen, Lilly, Merck Novartis, Pfizer, Regeneron, Sanofi, Servier, and The Medicines Company. Dr. Bhatt has been a member of the advisory Board for Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, and Regado Biosciences; has been on the Board of Directors for Boston VA Research Institute and the Society of Cardiovascular Patient Care; has been the Chair for the American Heart Association Quality Oversight Committee; has been a member of the Data Monitoring Committees for Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Cleveland Clinic, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, and Population Health Research Institute; has received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; clinical trial steering committee), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), HMP Communications (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), and WebMD (CME steering committees); has received other fees from Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); has received research funding from Abbott, Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, Regeneron, Roche, Sanofi, and The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); has been a site co-Investigator for Biotronik, Boston Scientific, St. Jude Medical (now Abbott), Svelte; has been a trustee for the American College of Cardiology; and has received unfunded research from FlowCo, Merck, PLx Pharma, and Takeda. Dr. Stone has received personal fees from Velomedix, Toray, Vascular Dynamics, Miracor, TherOx, Reva, V-wave, Matrizyme, Ablative Solutions, Neovasc, Medical Development Technologies; has received other fees from MedFocus family of funds, Guided Delivery Systems, Micardia, Vascular Nonotransfer Technologies, Cagent, Qool Therapeutics, Caliber, Aria, and Biostar family of funds; and has been a consultant on prasugrel patent litigation paid for by Lupin Pharmaceuticals. Dr. Windecker has received research grants to his institution from Abbott, Amgen, Boston Scientific, Biotronik, Medtronic, St. Jude, and Terumo. Dr. Valgimigli has received research grants from The Medicines Company, Terumo, and AstraZaneca; and has received personal fees from The Medicines Company, Terumo, St. Jude Vascular, Alvimedica, Abbott Vascular, AstraZaneca, and Correvio outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received August 15, 2018.
- Revision received November 7, 2018.
- Accepted November 8, 2018.
- 2019 American College of Cardiology Foundation
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