Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 - STOPDAPT-2

Jan 04, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Abbott Vascular Japan
Date Presented:
11/05/2021
Date Published:
01/02/2024
Date Updated:
01/04/2024
Original Posted Date:
03/18/2019
References

Contribution To Literature:

Highlighted text has been updated as of January 4, 2024.

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)

Combination STOPDAPT-2 and STOPDAPT-2 ACS trials (n = 5,997):

  • Primary endpoint: 2.8% in the 1-month DAPT group compared with 3.0% in the 12-month DAPT group (p for superiority = 0.68, p for noninferiority = 0.001) (p for interaction between acute coronary syndrome [ACS] and stable coronary disease = 0.052, p for interaction between high-bleeding risk and non-high-bleeding risk = 0.95, p for interaction between complex and noncomplex PCI = 0.48)
  • TIMI major/minor bleeding: 0.5% in the 1-month DAPT group compared with 1.3% in the 12-month DAPT group (log rank p = 0.001) (p for interaction between ACS and stable coronary disease = 0.4, p for interaction between high-bleeding risk and non-high-bleeding risk = 0.36, p for interaction between complex and noncomplex PCI = 0.90)

Five-year results:

  • Primary endpoint: 11.8% for clopidogrel vs. 13.6% for aspirin (p for noninferiority < 0.001, p for superiority = 0.13)
  • Cardiovascular outcomes: 8.6% vs. 11.5% (p = 0.03)
  • Major bleeding: 4.4% vs. 4.9% (p = 0.51)

Interpretation:

Among the total cohort of patients undergoing PCI for stable and unstable cardiovascular disease, 1 month of DAPT followed by clopidogrel monotherapy was noninferior to 12 months of DAPT followed by aspirin monotherapy at preventing net adverse clinical events. There was possible treatment interaction whereby there was a slight excess of net adverse ischemic events among ACS patients treated with 1 month of DAPT compared with 12 months of DAPT.

Long-term outcomes also favored clopidogrel by reduction in cardiovascular outcomes without an increase in major bleeding. 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, Morimoto T, Natsuaki M, et al., on behalf of the STOPDAPT-2 Investigators. Clopidogrel vs Aspirin Monotherapy Beyond 1 Year After Percutaneous Coronary Intervention. J Am Coll Cardiol 2024;83:17-31.

Editorial Comment: Bellemain-Appaix A, Montalescot G. Clopidogrel for Long-Term Secondary Prevention After Coronary Artery Stenting. J Am Coll Cardiol 2024;83:32-4.

Presented by Drs. Yuki Obayashi and Ko Yamamoto at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, Orlando, FL, November 5, 2021.

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: Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention, Prevention

Keywords: ACC19, Anticoagulants, Aspirin, Drug-Eluting Stents, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Secondary Prevention, TCT21


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