Short-Course DAPT Non-Inferior After Firehawk Stent Implantation: Study
China: Researchers have found in a new study that three months of dual antiplatelet therapy in patients treated with Firehawk stents was found to be non-inferior to 12 months of therapy, with similar rates of the composite outcome of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding at 18 months.
The findings are from a randomised clinical trial published in BMC Medicine by Hongbo Yang from the Department of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital of Fudan University, and colleagues.
The study explored whether shortening the duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with biodegradable-polymer sirolimus-eluting Firehawk stents could maintain safety while potentially lowering bleeding risk.
Firehawk stents have previously demonstrated rapid vascular healing, with optical coherence tomography studies showing near-complete re-endothelialisation by three months. Building on this evidence, the investigators designed a multicentre, open-label, non-inferiority trial to compare a three-month DAPT strategy with the conventional 12-month regimen.
Between January 2019 and April 2022, a total of 2,445 patients from 36 centres across China who underwent PCI with Firehawk stent implantation were randomly assigned to either three months (1,222 patients) or 12 months (1,223 patients) of DAPT. The primary endpoint was a composite of all-cause death, myocardial infarction, cerebrovascular accident, and major bleeding defined as Bleeding Academic Research Consortium type 2, 3, or 5 events at 18 months. Key secondary outcomes included major adverse cardiovascular events and major bleeding.
The study led to the following findings:
- At 18 months, the primary composite outcome occurred in 10.1% of patients in the three-month DAPT group and 10.9% in the 12-month group, showing comparable event rates.
- The shorter three-month DAPT regimen met the criteria for non-inferiority compared with 12 months of therapy.
- Rates of major adverse cardiovascular events were similar between the two treatment strategies.
- Overall, major bleeding rates did not differ significantly between the groups.
- Landmark analysis from three to 18 months showed a significantly lower incidence of major bleeding in patients who stopped DAPT at three months.
- Shortening DAPT appeared to reduce bleeding risk without increasing ischaemic events.
The authors noted several limitations, including the open-label design, which may have affected adherence, particularly in the three-month group. Treatment deviations were linked to bleeding, recurrent ischaemia, and COVID-19–related disruptions. The study’s restriction to a Chinese population and exclusion of patients with ST-elevation myocardial infarction or complex lesions may also limit the generalisability of the findings.
Despite these limitations, the researchers concluded that among patients with acute or chronic coronary syndromes undergoing PCI with Firehawk stent implantation, a three-month DAPT strategy provides comparable overall clinical outcomes to a 12-month regimen. They noted that elderly patients and those with renal dysfunction, who are at higher risk of bleeding, may particularly benefit from a shorter duration of dual antiplatelet therapy.
Reference:
Yang, H., Zhang, F., Zhang, X. et al. Three vs 12-month DAPT after implantation of biodegradable-polymer sirolimus-eluting coronary stent: a randomised clinical trial. BMC Med 23, 690 (2025). https://doi.org/10.1186/s12916-025-04515-y
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