Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 - STOPDAPT-2
Contribution To Literature:
The STOPDAPT-2 trial showed that 1-month DAPT was superior to 12-month DAPT at preventing net adverse ischemic events.
The goal of the trial was to evaluate 1-month dual antiplatelet therapy (DAPT) compared with 12-month DAPT among patients undergoing percutaneous coronary intervention (PCI).
Patients undergoing PCI were randomized to 1 month of DAPT followed by clopidogrel monotherapy for 5 years (n = 1,523) versus 12 months of DAPT followed by aspirin monotherapy for 5 years (n = 1,522).
- Total number of enrollees: 3,045
- Duration of follow-up: 1 year
- Mean patient age: 68 years
- Percentage female: 21%
- Percentage with diabetes: 39%
- PCI with a cobalt chromium everolimus-eluting stent
- No plan for staged PCI
- Need for oral anticoagulation
- History of intracranial hemorrhage
Other salient features/characteristics:
- Stable coronary artery disease: 62%
The primary outcome, death, myocardial infarction (MI), stent thrombosis, stroke, TIMI major/minor bleeding at 1 year, occurred in 2.4% of the 1-month DAPT group compared with 3.7% of the 12-month DAPT group (p for superiority = 0.04). There was evidence of possible treatment interaction favoring 12 months of DAPT among those with chronic kidney disease.
- Death, MI, stent thrombosis, or stroke at 1 year: 2.0% of 1-month DAPT group compared with 2.5% of 12-month DAPT group (p for noninferiority = 0.005)
- TIMI major/minor bleeding at 1 year: 0.4% of 1-month DAPT group compared with 1.5% of 12-month DAPT group (p for superiority = 0.004)
- Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding at 1 year: 0.5% of 1-month DAPT group compared with 1.8% of 12-month DAPT group (p for superiority = 0.003)
- Definite or probable stent thrombosis: 0.3% of 1-month DAPT group compared with 0.07% of 12-month DAPT group (p for superiority = 0.21)
Among patients undergoing PCI for stable and unstable cardiovascular disease, 1-month DAPT followed by clopidogrel monotherapy was superior to 12-month DAPT followed by aspirin monotherapy at preventing net adverse clinical events. One-month DAPT was noninferior to 12-month DAPT at preventing major adverse ischemic events and superior to 12-months DAPT at preventing TIMI major/minor bleeding. BARC 3 or 5 bleeding was low, but 1-month DAPT was also associated with a reduction in this outcome compared with 12-month DAPT. The design of this trial is like the GLOBAL LEADERS trial.
Watanabe H, Domei T, Morimoto T, et al. Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial. JAMA 2019;321:2414-27.
Editorial: Ziada KM, Moliterno DJ. Dual Antiplatelet Therapy: Is It Time to Cut the Cord With Aspirin? JAMA 2019;321:2409-11.
Presented by Dr. Hirotoshi Watanabe at the American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA, March 18, 2019.
Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention, Prevention, Atherosclerotic Disease (CAD/PAD), Anticoagulation Management and ACS, Interventions and ACS, Interventions and Coronary Artery Disease
Keywords: ACC19, ACC Annual Scientific Session, Acute Coronary Syndrome, Anticoagulants, Aspirin, Chromium, Cobalt, Coronary Artery Disease, Drug-Eluting Stents, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Renal Insufficiency, Chronic, Secondary Prevention, Stents, Stroke, Thrombosis, Vascular Diseases
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