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Clopidogrel vs Aspirin Monotherapy Beyond 1 Year After Percutaneous Coronary Intervention
Hirotoshi Watanabe1, Takeshi Morimoto2, Masahiro Natsuaki3
1Department of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan.
Insights
Clopidogrel monotherapy after one month of dual antiplatelet therapy (DAPT) was noninferior to aspirin for long-term antiplatelet treatment post-percutaneous coronary intervention (PCI). It showed a significant benefit in reducing cardiovascular outcomes.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Pharmacology
Background:
- The optimal long-term antiplatelet monotherapy after dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) remains debated.
- Comparing clopidogrel versus aspirin for extended monotherapy post-PCI requires further investigation.
Purpose of the Study:
- To compare the efficacy and safety of clopidogrel monotherapy versus aspirin monotherapy for long-term antiplatelet treatment after PCI.
- To evaluate cardiovascular outcomes and bleeding events in patients receiving different antiplatelet strategies post-PCI.
Main Methods:
- A multicenter, randomized clinical trial (STOPDAPT-2) involving 3,005 patients undergoing PCI with cobalt-chromium everolimus-eluting stents.
- Patients were randomized to either 1-month DAPT followed by clopidogrel monotherapy or 12-month DAPT followed by aspirin monotherapy.
- The primary endpoint was a composite of cardiovascular outcomes or major bleeding, assessed over 5 years.
Main Results:
- Clopidogrel monotherapy was noninferior but not superior to aspirin for the primary composite endpoint (11.75% vs. 13.57%).
- Clopidogrel demonstrated superiority in reducing cardiovascular outcomes (8.61% vs. 11.05%) compared to aspirin.
- No significant difference in major bleeding events was observed between the clopidogrel and aspirin groups (4.44% vs. 4.92%).
Conclusions:
- Clopidogrel monotherapy following a short DAPT duration is a viable alternative to aspirin for long-term antiplatelet treatment post-PCI.
- Clopidogrel offers a borderline ischemic benefit beyond one year, suggesting its potential as an attractive option for patients post-PCI.
Background:
It remains unclear whether clopidogrel is better suited than aspirin as the long-term antiplatelet monotherapy following dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI).
Objectives:
This study compared clopidogrel monotherapy following 1 month of DAPT (clopidogrel group) with aspirin monotherapy following 12 months of DAPT (aspirin group) after PCI for 5 years.
Methods:
STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy 2) is a multicenter, open-label, adjudicator-blinded, randomized clinical trial conducted in Japan. Patients who underwent PCI with cobalt-chromium everolimus-eluting stents were randomized in a 1-to-1 fashion either to clopidogrel or aspirin groups. The primary endpoint was a composite of cardiovascular outcomes (cardiovascular death, myocardial infarction, stroke, or definite stent thrombosis) or major bleeding (TIMI major or minor bleeding).
Results:
Among 3,005 study patients (age: 68.6 ± 10.7 years; women: 22.3%; acute coronary syndrome: 38.3%), 2,934 patients (97.6%) completed the 5-year follow-up (adherence to the study drugs at 395 days: 84.7% and 75.9%). The clopidogrel group compared with the aspirin group was noninferior but not superior for the primary endpoint (11.75% and 13.57%, respectively; HR: 0.85; 95% CI: 0.70-1.05; Pnoninferiority < 0.001; Psuperiority = 0.13), whereas it was superior for the cardiovascular outcomes (8.61% and 11.05%, respectively; HR: 0.77; 95% CI: 0.61-0.97; P = 0.03) and not superior for major bleeding (4.44% and 4.92%, respectively; HR: 0.89; 95% CI: 0.64-1.25; P = 0.51). By the 1-year landmark analysis, clopidogrel was numerically, but not significantly, superior to aspirin for cardiovascular events (6.79% and 8.68%, respectively; HR: 0.77; 95% CI: 0.59-1.01; P = 0.06) without difference in major bleeding (3.99% and 3.32%, respectively; HR: 1.23; 95% CI: 0.84-1.81; P = 0.31).
Conclusions:
Clopidogrel might be an attractive alternative to aspirin with a borderline ischemic benefit beyond 1 year after PCI.
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