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Three vs 12-month DAPT after implantation of biodegradable-polymer sirolimus-eluting coronary stent: a randomised
Hongbo Yang1, Feng Zhang2, Xiwen Zhang3
1Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital of Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 110015, China.
Insights
Shortening dual antiplatelet therapy (DAPT) to 3 months after Firehawk stent implantation is as safe as the standard 12-month regimen. This approach reduces major bleeding events without increasing ischemic risks.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Early discontinuation of dual antiplatelet therapy (DAPT) after drug-eluting stent implantation may lower bleeding risk without compromising ischemic outcomes.
- Firehawk stents show high reendothelialization rates at 3 months, suggesting potential for shorter DAPT durations.
- Assessing 3-month DAPT safety and efficacy compared to 12-month DAPT in Firehawk stent recipients is crucial.
Purpose of the Study:
- To evaluate if a 3-month DAPT regimen is non-inferior to a 12-month regimen in patients receiving Firehawk stents.
- To compare the safety and efficacy of short-term versus conventional DAPT duration.
- To determine the composite endpoint of death, myocardial infarction, stroke, and major bleeding at 18 months.
Main Methods:
- A randomized, open-label, non-inferiority trial involving 2445 patients undergoing percutaneous coronary intervention with Firehawk stents.
- Patients were assigned to either a 3-month (n=1222) or 12-month (n=1223) DAPT regimen.
- The primary endpoint was a composite of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding (BARC 2, 3, or 5) at 18 months.
Main Results:
- Non-inferiority of 3-month DAPT was established, with comparable rates for the primary composite endpoint (10.1% vs 10.9%).
- No significant differences were observed in co-secondary endpoints, including major adverse cardiovascular events.
- Landmark analysis revealed a significantly lower rate of major bleeding in the 3-month DAPT group (2.7% vs 4.4%).
Conclusions:
- Three-month DAPT is non-inferior to 12-month DAPT in patients treated with Firehawk stents regarding the primary composite endpoint.
- Shorter DAPT duration demonstrated a significant reduction in major bleeding events.
- These findings support the use of a 3-month DAPT regimen in specific patient populations treated with Firehawk stents.
Background:
Early discontinuation of dual antiplatelet therapy (DAPT) within 3 months after implantation of drug-eluting stents may reduce bleeding risk without increasing ischaemic events. This study aimed to assess whether 3-month DAPT is as safe as the conventional 12-month regimen in patients treated with Firehawk stents, which have demonstrated 99.9% reendothelialisation at 3 months by optical coherence tomography.
Methods:
From January 1, 2019, to April 30, 2022, 2445 patients were randomly assigned to a 3-month (n = 1222) or 12-month DAPT regimen (n = 1223) in this randomised, open-label, non-inferiority trial, patients from 36 centres in China who underwent percutaneous coronary intervention with Firehawk stents. The primary endpoint was a composite of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) at 18 months. The co-equal secondary endpoints were major adverse cardiovascular events, defined as a composite of all-cause death, myocardial infarction and ischaemia-driven target lesion revascularisation, and major bleeding.
Results:
From January 1, 2019, to April 30, 2022, 2445 patients were randomly assigned to 3-month (N = 1222) or 12-month DAPT regimen (N = 1223). Adherence to the protocol-defined DAPT duration was 71.0% and 95.5%, respectively. Rates of the primary endpoint were comparable between both groups (10.1% vs 10.9%). Non-inferiority of 3-month DAPT was established (absolute rate difference, - 0.76%; upper limit of 1-sided 97.5% CI, 1.70%; p non-inferiority = 0.0003, with a predefined non-inferiority margin of 3.5%). Rates of co-secondary endpoints showed no significant difference (both p > 0.05). Landmark analysis (3-18 months) showed significant lower rate of major bleeding (2.7% vs 4.4%; p = 0.03) with 3-month DAPT.
Conclusions:
In patients treated with Firehawk stents, 3-month DAPT was non-inferior to 12-month DAPT for the primary composite endpoint of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding at 18 months.
Trial Registration:
NCT03008083 (clinicaltrials.gov).
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