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 Aims Dual antiplatelet therapy (DAPT) can be shortened up to 1 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 ≥1 biodegradable-polymer EES implantation and ≤1-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 1 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 occurred in 45 participants (6.0%; 95% confidence interval [CI], 4.3–7.7%) through 1 year of follow-up, with 21 (2.8%; 95% CI, 1.6–3.9%) events during the first month and 24 (3.4%; 95% CI, 2.0–4.7%) thereafter. The incidences of cardiovascular death, myocardial infarction, and stroke were 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 ocuurred in 1.1% (95% CI, 0.3–1.8%) at 1 month and 2.9% (95% CI, 1.6–4.1%) at 1 year. Conclusion HBR patients receiving biodegradable-polymer EES had few ischemic and bleeding events when given 1 month of DAPT. One-month DAPT after biodegradable-polymer EES implantation seems safe in patients at HBR.