Matthew W Sherwood1, Derek D Cyr2, W Schuyler Jones3, Richard C Becker4, Scott D Berkowitz5, Jeffrey B Washam6, Günter Breithardt7, Keith A A Fox8, Jonathan L Halperin9, Graeme J Hankey10, Daniel E Singer11, Jonathan P Piccini3, Christopher C Nessel12, Kenneth W Mahaffey13, Manesh R Patel3. 1. Duke Clinical Research Institute, Durham, North Carolina. Electronic address: matthew.sherwood@dm.duke.edu. 2. Duke Clinical Research Institute, Durham, North Carolina. 3. Duke Clinical Research Institute, Durham, North Carolina; Duke Heart Center, Duke University School of Medicine, Durham, North Carolina. 4. University of Cincinnati College of Medicine, Cincinnati, Ohio. 5. Bayer HealthCare Pharmaceuticals, Parsippany, New Jersey. 6. Duke Heart Center, Duke University School of Medicine, Durham, North Carolina. 7. Hospital of the University of Münster, Münster, Germany. 8. University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, UK. 9. Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Medical Center, New York, New York. 10. School of Medicine and Pharmacology, University of Western Australia, Crawley, WA, Australia. 11. Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts. 12. Janssen Pharmaceutical Research and Development, Raritan, New Jersey. 13. Department of Medicine, Stanford University, Stanford, California.
Abstract
OBJECTIVES: The authors assessed the use of dual antiplatelet therapy (DAPT) and outcomes in patients undergoing percutaneous coronary intervention (PCI) during theROCKET 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%) underwentPCI 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.
RCT Entities:
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.
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