Author + information
- Received January 5, 2016
- Revision received May 4, 2016
- Accepted May 19, 2016
- Published online August 22, 2016.
- Matthew W. Sherwood, MD, MHSa,∗ (, )
- Derek D. Cyr, PhDa,
- W. Schuyler Jones, MDa,b,
- Richard C. Becker, MDc,
- Scott D. Berkowitz, MDd,
- Jeffrey B. Washam, PharmDb,
- Günter Breithardt, MDe,
- Keith A.A. Fox, MB, ChBf,
- Jonathan L. Halperin, MDg,
- Graeme J. Hankey, MDh,
- Daniel E. Singer, MDi,
- Jonathan P. Piccini, MD, MHSa,b,
- Christopher C. Nessel, MDj,
- Kenneth W. Mahaffey, MDk and
- Manesh R. Patel, MDa,b
- aDuke Clinical Research Institute, Durham, North Carolina
- bDuke Heart Center, Duke University School of Medicine, Durham, North Carolina
- cUniversity of Cincinnati College of Medicine, Cincinnati, Ohio
- dBayer HealthCare Pharmaceuticals, Parsippany, New Jersey
- eHospital of the University of Münster, Münster, Germany
- fUniversity of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, UK
- gZena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Medical Center, New York, New York
- hSchool of Medicine and Pharmacology, University of Western Australia, Crawley, WA, Australia
- iMassachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts
- jJanssen Pharmaceutical Research and Development, Raritan, New Jersey
- kDepartment of Medicine, Stanford University, Stanford, California
- ↵∗Reprint requests and correspondence:
Dr. Matthew W. Sherwood, Duke Clinical Research Institute, 2400 Pratt Street, P.O. Box 17969, Durham, North Carolina 27715.
Objectives The authors assessed the use of dual antiplatelet therapy (DAPT) and outcomes in patients undergoing percutaneous coronary intervention (PCI) during the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation).
Background The frequency, patterns, and outcomes when adding DAPT to non-vitamin K antagonist oral anticoagulants in the setting of PCI in patients with AF are largely unknown.
Methods The study population included all patients in the treatment group of the ROCKET AF trial divided by the receipt of PCI during follow-up. Clinical characteristics, PCI frequency, and rates of DAPT were reported. Clinical outcomes were adjudicated independently as part of the trial.
Results Among 14,171 patients, 153 (1.1%) underwent PCI during a median 806 days of follow-up. Patients treated with rivaroxaban were significantly less likely to undergo PCI compared with warfarin-treated patients (61 vs. 92; p = 0.01). Study drug was continued during PCI in 81% of patients. Long-term DAPT (≥30 days) was used in 37% and single antiplatelet therapy in 34%. A small number switched from DAPT to monotherapy within 30 days of PCI (n = 19 [12.3%]) and 15% of patients received no antiplatelet therapy after PCI. Rates of stroke/systemic embolism and major bleeding events were high in post-PCI patients (4.5/100 patient-years and 10.2/100 patient-years) in both treatment groups.
Conclusions In patients with AF at moderate to high risk for stroke, PCI occurred in <1% per year. DAPT was used in a variable manner, with the majority of patients remaining on study drug after PCI. Rates of both thrombotic and bleeding events were high after PCI, highlighting the need for studies to determine the optimal antithrombotic therapy.
- coronary disease
- direct-acting oral anticoagulants
- percutaneous coronary intervention
The ROCKET AF trial was supported by Johnson & Johnson Pharmaceutical Research & Development (Raritan, New Jersey) and Bayer HealthCare AG (Leverkusen, Germany).
Dr. Sherwood was funded by NIH T-32 training grant #5 T32 HL 7101-37. Dr. Jones received research grants from the American Heart Association, AstraZeneca, Boston Scientific Corporation, and Daiichi-Sankyo. Dr. Becker is a consultant/advisory board member for Janssen Research & Development, Portola, Cook, and Boehringer Ingelheim. Dr. Berkowitz is an employee of Bayer HealthCare Pharmaceuticals. Dr. Breithardt has received consulting fees from Bayer HealthCare, Johnson & Johnson, Boehringer Ingelheim, Sanofi, Merck Sharp & Dohme, and 3M. Dr. Fox has received research funding from Bayer, Janssen, and AstraZeneca; honoraria from Bayer, AstraZeneca, GlaxoSmithKline, Janssen, and Sanofi; consulting fees from Bayer, Lilly, AstraZeneca, and Sanofi. Dr. Halperin has received consulting fees from Bayer AG HealthCare, Boehringer Ingelheim, Daiichi-Sankyo, Johnson & Johnson, Ortho-McNeil-Janssen Pharmaceuticals, Pfizer, and Sanofi-Aventis. Dr. Hankey has received consulting fees from Bayer and Sanofi. Dr. Inger has received research funding from Johnson & Johnson, Bristol-Myers Squibb, Boehringer Ingelheim, and Medtronic; consulting fees from Boehringer Ingelheim, Bristol-Myers Squibb, CVS Health, Johnson & Johnson, Merck, Pfizer, and St. Jude Medical. Dr. Piccini has received research grants from ARCA biopharma, Boston Scientific, Gilead, Janssen Pharmaceuticals, ResMed, and St Jude Medical; and consulting fees from GlaxoSmithKline, Johnson & Johnson, Laguna Pharmaceuticals, Medtronic, and Spectranetics. Dr. Nessel is an employee of Janssen Research and Development. Dr. Mahaffey has provided full disclosures prior to August 1, 2013, available at www.dcri.org. Disclosures after August 1, 2013 available at https://med.stanford.edu/profiles/47970?tab=research-and-scholarship. Dr. Patel has received research funding from Johnson & Johnson, AstraZeneca; advisory board fees from Bayer, Janssen, AstraZeneca, and Genzyme.
- Received January 5, 2016.
- Revision received May 4, 2016.
- Accepted May 19, 2016.
- American College of Cardiology Foundation