One-Month Dual Antiplatelet Therapy Followed by Clopidogrel Monotherapy vs. Standard 12-Month Dual Antiplatelet Therapy With Clopidogrel After Drug-Eluting Stent Implantation - 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)
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.
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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