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Aspirin vs. clopidogrel monotherapy after percutaneous coronary intervention: 1-year follow-up of the STOPDAPT-3
Hirotoshi Watanabe1, Masahiro Natsuaki2, Takeshi Morimoto3
1Division of Cardiology, Hirakata Kohsai Hospital, 1-2-1, Fujisaka-higashi-machi, Hirakata, Osaka 573-0153, Japan.
Insights
Aspirin monotherapy and clopidogrel monotherapy showed similar cardiovascular and bleeding outcomes after drug-eluting stent placement. This finding supports both strategies following short dual antiplatelet therapy in high-risk patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- No prior trials directly compared aspirin monotherapy with P2Y12 inhibitor monotherapy after short dual antiplatelet therapy (DAPT).
- Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) typically involves DAPT, but optimal duration and subsequent monotherapy remain areas of investigation.
Purpose of the Study:
- To compare the efficacy and safety of aspirin monotherapy versus clopidogrel monotherapy following a 1-month DAPT regimen in patients undergoing PCI with DES.
- To evaluate cardiovascular and bleeding events in patients treated with aspirin or clopidogrel monotherapy after an initial short DAPT course.
Main Methods:
- The STOPDAPT-3 trial randomized patients with acute coronary syndrome or high bleeding risk (HBR) to 1-month DAPT (aspirin/prasugrel) followed by aspirin or clopidogrel monotherapy.
- This secondary analysis used a 30-day landmark to compare aspirin monotherapy with clopidogrel monotherapy.
- Co-primary endpoints included a composite cardiovascular event and Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding events, assessed up to 1 year.
Main Results:
- In the 30-day landmark analysis of 5833 patients, the incidence of cardiovascular endpoints (cardiovascular death, myocardial infarction, stent thrombosis, ischemic stroke) was similar between the aspirin and clopidogrel groups (4.5 per 100 person-years for both; HR 1.00 [95% CI .77-1.30], P=.97).
- Bleeding events (BARC 3 or 5) were also comparable between the groups (2.0 vs 1.9 per 100 person-years; HR 1.02 [95% CI .69-1.52], P=.92).
- Monotherapy was maintained in over 87% of patients in both groups throughout the 1-year follow-up.
Conclusions:
- Aspirin monotherapy is a safe and effective alternative to clopidogrel monotherapy following a 1-month DAPT regimen in patients treated with DES.
- These findings suggest that post-PCI antiplatelet strategies can be individualized based on patient risk profiles without compromising outcomes.
- The study provides evidence for similar cardiovascular and bleeding profiles for aspirin versus clopidogrel monotherapy beyond the initial DAPT period.
Background And Aims:
There was no previous trial comparing aspirin monotherapy with a P2Y12 inhibitor monotherapy following short dual antiplatelet therapy after percutaneous coronary intervention with drug-eluting stents.
Methods:
In the STOPDAPT-3, patients with acute coronary syndrome or high bleeding risk (HBR) were randomly assigned to either 1-month dual antiplatelet therapy with aspirin and prasugrel followed by aspirin monotherapy (aspirin group) or 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). This secondary analysis compared aspirin monotherapy with clopidogrel monotherapy by the 30-day landmark analysis. The co-primary endpoints were the cardiovascular endpoint defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischaemic stroke and the bleeding endpoint defined as Bleeding Academic Research Consortium 3 or 5.
Results:
Of the 6002 assigned patients, 5833 patients (aspirin group: N = 2920 and clopidogrel group: N = 2913) were included in the 30-day landmark analysis. Median age was 73 (interquartile range 64-80) years, women 23.4%, acute coronary syndrome 74.6%, and high bleeding risk 54.1%. The assigned monotherapy was continued at 1 year in 87.5% and 87.2% in the aspirin and clopidogrel groups, respectively. The incidence rates beyond 30 days and up to 1 year were similar between the aspirin and clopidogrel groups for both cardiovascular endpoint [4.5 and 4.5 per 100 person-year, hazard ratio 1.00 (95% confidence interval .77-1.30), P = .97], and bleeding endpoint [2.0 and 1.9, hazard ratio 1.02 (95% confidence interval .69-1.52), P = .92].
Conclusions:
Aspirin monotherapy compared with clopidogrel monotherapy was associated with similar cardiovascular and bleeding outcomes beyond 1 month and up to 1 year after percutaneous coronary intervention with drug-eluting stents (STOPDAPT-3 ClinicalTrials.gov number, NCT04609111).
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