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30-Day DAPT in Patients at High Bleeding Risk Undergoing PCI With Biodegradable-Polymer Sirolimus-Eluting Ultra-Thin
Andrea Erriquez1, David M Leistner2, Valeria Paradies3
1Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara, Cona, Ferrara, Italy.
Insights
Short dual antiplatelet therapy (DAPT) is safe and effective for high bleeding risk patients receiving biodegradable-polymer sirolimus-eluting stents. This approach significantly reduces major bleeding events without increasing ischemic risks.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomaterials Science
Background:
- Limited evidence exists on biodegradable-polymer sirolimus-eluting stent (BP-SES) safety and efficacy in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI).
- Optimizing antiplatelet therapy duration is crucial for HBR patients to balance ischemic and bleeding risks.
Purpose of the Study:
- To evaluate the clinical outcomes of HBR patients treated with BP-SES and a short dual antiplatelet therapy (DAPT) regimen (≤30 days).
- To assess the safety and efficacy of a ≤30-day DAPT regimen in HBR patients undergoing PCI with BP-SES.
Main Methods:
- A systematic review and individual patient-level data extraction were performed.
- Included studies focused on HBR patients treated with BP-SES (Supraflex Cruz) via PCI.
- Primary endpoint: composite of cardiovascular death, myocardial infarction, or target lesion revascularization at 1 year. Safety endpoint: Bleeding Academic Research Consortium (BARC) type 3-5 bleeding at 1 year.
Main Results:
- 1691 HBR patients were analyzed; 928 (55%) received ≤30-day DAPT.
- The ≤30-day DAPT group showed a 1-year primary outcome event rate of 9.5% (95% CI: 7.7%-11.6%), below the non-inferiority margin of 14%.
- No significant difference in primary outcomes between ≤30-day and >30-day DAPT groups; notably, BARC 3-5 bleeding events were significantly lower in the ≤30-day DAPT group.
Conclusions:
- A ≤30-day DAPT regimen is associated with a low rate of ischemic events in HBR patients treated with BP-SES.
- This short DAPT duration significantly reduces major bleeding events in this patient population.
- The findings support the use of shorter DAPT durations in HBR patients undergoing PCI with BP-SES.
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.
