One-month DAPT after biodegradable-polymer everolimus-eluting stent implantation in patients at high-bleeding risk: an individual patient data pooled analysis of the SENIOR and POEM trials

Abstract

Abstract Background Dual antiplatelet therapy (DAPT) can be shortened up to one month in high-bleeding risk (HBR) patients receiving a contemporary biodegradable-polymer sirolimus-eluting stent. We aimed to summarize the evidence on a similar DAPT regimen after biodegradable-polymer everolimus-eluting stent (EES) implantation in patients at HBR. Methods and Results We pooled the individual participant data from the available trials evaluating this strategy, namely the SENIOR and the POEM trials. Inclusion criteria were ≥ one biodegradable-polymer EES implantation and ≤ one-month duration of DAPT. The primary endpoint was the 1-year composite of cardiovascular death, myocardial infarction, or stroke. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) type 3-5 bleeding. Landmark analyses were performed at one month, the time point for intended DAPT interruption. We included 766 participants (age 77.5±8.2 years, women 31.9%), 323 from the SENIOR and 443 from the POEM trial. The primary endpoint had occurred in 45 participants (6.0%; 95% confidence interval [CI], 4.3%-7.7%) through one year of follow-up, in 21 (2.8%; 95% CI, 1.6%-3.9%) during the first month and in 24 (3.4%; 95% CI, 2.0%-4.7%) thereafter. The incidence of cardiovascular death, myocardial infarction, and stroke was 2.2% (95% CI, 0.36%-2.50%), 3.1% (95% CI, 1.8%-4.3%), and 1.2% (95% CI, 0.4%-2.0%), respectively. BARC type 3-5 bleeding incidence was 1.1% (95% CI 0.3-1.8%) at one month and 2.9% (95% CI, 1.6-4.1%) at one year. Conclusion HBR patients receiving biodegradable-polymer EES had few ischemic and bleeding events when given one month of DAPT. One-month DAPT after biodegradable-polymer EES implantation seems safe in patients at HBR.