Key result
≤30-day DAPT in high bleeding risk patients undergoing PCI with an ultra-thin stent was non-inferior to a 14% margin for ischemic events (9.5%, p<0.001) and reduced major bleeding versus longer DAPT.
Why the study?
Evidence on the safety and efficacy of biodegradable-polymer sirolimus-eluting ultra-thin stents in high bleeding risk patients undergoing PCI was limited.
Does a ≤ 30-day DAPT regimen reduce bleeding without increasing ischemic events compared to a > 30-day DAPT regimen in high bleeding risk patients undergoing PCI with a biodegradable-polymer sirolimus-eluting ultra-thin stent?
Meta-Analysis (n=1,691)
Yes
Does a ≤ 30-day DAPT regimen reduce bleeding without increasing ischemic events compared to a > 30-day DAPT regimen in high bleeding risk patients undergoing PCI with a biodegradable-polymer sirolimus-eluting ultra-thin stent?
Hazard Ratio: 0.95 (95% CI 0.67–1.33)
Absolute Event Rate: 9.5% vs 7.8%
In high bleeding risk patients undergoing PCI with a biodegradable-polymer sirolimus-eluting ultra-thin stent, a ≤30-day DAPT regimen significantly reduces major bleeding without increasing ischemic events compared to longer DAPT.
Supports feasibility of ≤30-day DAPT with BP-SES in HBR; hypothesis-generating and requires randomized confirmation.
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.
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Erriquez et al. (2025) conducted a meta-analysis in High bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI) (n=1,691). ≤30-day dual antiplatelet therapy (DAPT) vs. >30-day DAPT was evaluated on Composite of cardiovascular death, myocardial infarction, or clinically driven target lesion revascularization at 1-year (HR 0.95, 95% CI 0.67-1.33). ≤30-day DAPT in high bleeding risk patients undergoing PCI with an ultra-thin stent was non-inferior to a 14% margin for ischemic events (9.5%, p<0.001) and reduced major bleeding versus longer DAPT.
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