30‐Day DAPT in Patients at High Bleeding Risk Undergoing PCI With Biodegradable‐Polymer Sirolimus‐Eluting Ultra‐Thin Stent

ABSTRACT Background There is limited evidence on the safety and efficacy of biodegradable‐polymer sirolimus‐eluting ultra‐thin stent (BP‐SES) in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). Aims This study aims to evaluate the clinical outcomes of HBR patients treated with BP‐SES and ≤ 30‐day dual antiplatelet therapy (DAPT) regimen. Methods A systematic review was conducted to identify relevant studies involving HBR patients who underwent PCI with BP‐SES (Supraflex Cruz). Individual patient‐level data were extracted from the included studies. The primary endpoint was the composite of cardiovascular death, myocardial infarction, or clinically driven target lesion revascularization at 1‐year. The safety endpoint was the 1‐year occurrence of Bleeding Academic Research Consortium (BARC) type 3−5. Results The study population included 1691 patients. Of these, 928 patients (55%) received a ≤ 30‐day DAPT, while 763 patients (45%) received a longer DAPT regimen. In the ≤ 30‐day DAPT group, primary outcome events occurred in 89 patients (9.5%, 95% CI: 7.7%−11.6%). The upper limit of the one‐sided 95% CI of 11.6% was below the pre‐specified non‐inferiority margin of 14%. There was no significant difference in the primary endpoint between the ≤ 30‐day DAPT group and the >30‐day DAPT group (propensity score adjusted HR: 0.95, 95% CI: 0.67−3). Notably, the incidence of BARC 3−5 bleeding events was significantly lower in the ≤ 30‐day DAPT group. Conclusions In HBR patients treated with BP‐SES, a ≤ 30‐day DAPT regimen is associated with a low rate of ischemic events and a significant reduction in major bleeding events. Trial Registration: PROSPERO CRD42024524208.