Abstract
Previously we briefly reported the effect of 1-month dual antiplatelet therapy (DAPT) for patients with high bleeding risk (HBR) receiving percutaneous coronary intervention (PCI) in the STOPDAPT-2 trial, but full analysis data have not been available. We conducted post hoc subgroup analysis regarding the effect of very short DAPT for HBR patients in STOPDAPT-2 trial. The primary endpoint was a 1-year composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) and bleeding (TIMI major/minor bleeding) outcomes. Major secondary endpoints were 1-year cardiovascular composite endpoint and bleeding endpoint. HBR was defined by the academic research consortium (ARC) HBR criteria. Among the 3009 study patients, 1054 (35.0%) were classified as HBR and 1955 (65.0%) were as non-HBR. There were no significant interactions between HBR/non-HBR subgroups and the assigned DAPT group on the primary endpoint (HBR; 3.48% vs. 5.98%, HR 0.57, 95% CI 0.32–1.03, and non-HBR; 1.81% vs. 2.36%, HR 0.78, 95% CI 0.42–1.45; P for interaction = 0.48), the major secondary cardiovascular endpoint (HBR; 3.07% vs. 4.03%, HR 0.77, 95% CI 0.40–1.48, and non-HBR; 1.41% vs. 1.61%, HR 0.89, 95% CI 0.43–1.84; P for interaction = 0.77), and the major secondary bleeding endpoint (HBR; 0.41% vs. 2.71%, HR 0.15, 95% CI 0.03–0.65, and non-HBR; 0.40% vs. 0.85%, HR 0.48, 95% CI 0.14–1.58; P for interaction = 0.22). In conclusion, the effects of 1-month DAPT for the primary and major secondary endpoints were consistent in HBR and non-HBR patients without any significant interactions. The benefit of 1-month DAPT in reducing major bleeding was numerically greater in HBR patients.
Clinical trial registration Short and optimal duration of dual antiplatelet therapy after everolimus-eluting cobalt–chromium stent-2 [STOPDAPT-2]; NCT02619760.
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Acknowledgements
We appreciate the members of Research Institute for Production Development handling a series of large clinical trials and the co-investigators for exaggeratedly enrolling patients, collecting follow-up data, or adjudicating clinical events.
Funding
STOPDAPT-2 was funded by Abbott Vascular Japan. The study sponsor is not involved in the implementation of the study, data collection, event fixation and statistical analysis. However, approval of the study sponsor should be obtained for presentation in scientific meetings and submission of papers.
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Koichi Nakao has received a speaker honorarium from Sanofi and Daiichi-Sankyo. Kenji Ando has received a speaker honorarium from Japan Lifeline, Medtronic Japan, Terumo, and Biotronik Japan. Kengo Tanabe has received a speaker honorarium from Kaneka Medix. Yuji Ikari received a research grant from Abbott Vascular Japan. Yoshihisa Nakagawa has received a speaker honorarium from Daiichi-Sankyo, Bayer Yakuhin, and Bristol-Myers Squibb. Takeshi Kimura acts in an advisory role in Abbott Vascular Japan and received a research grant from Daiichi-Sankyo. Others have no conflict of interest.
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Watanabe, H., Domei, T., Morimoto, T. et al. Details on the effect of very short dual antiplatelet therapy after drug-eluting stent implantation in patients with high bleeding risk: insight from the STOPDAPT-2 trial. Cardiovasc Interv and Ther 36, 91–103 (2021). https://doi.org/10.1007/s12928-020-00651-9
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DOI: https://doi.org/10.1007/s12928-020-00651-9