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.

Description:

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).


Study Design

  • Randomized
  • Parallel

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%

Inclusion criteria:

  • PCI with a cobalt chromium everolimus-eluting stent
  • No plan for staged PCI

Exclusion criteria:

  • Need for oral anticoagulation
  • History of intracranial hemorrhage

Other salient features/characteristics:

  • Stable coronary artery disease: 62%

Principal Findings:

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.

Secondary outcomes:

  • 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)

Interpretation:

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.

References:

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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