Effectiveness and Safety of Polymer-free Biolimus-eluting Stents (PF-BES): a 1-year Single-center Study
Keywords:
Polymer-free Biolimus-eluting stents, High bleeding risk, Dual antiplatelet therapyAbstract
Background: An estimated one-fifth of patients undergoing percutaneous coronary intervention are at high bleeding risk (HBR), which has a high mortality rate. Most of these HBR patients are excluded from stent trials. In response, many studies have used polymer-free Biolimus-eluting stents (PF-BESs), mainly for HBR patients. However, there is a lack of data on the clinical outcomes of the effectiveness and safety of PF-BESs in Thailand. Objectives: To evaluate the effectiveness and safety profile of PF-BES in real-world, all-comer patients with coronary artery disease undergoing percutaneous coronary intervention at the Central Chest Institute of Thailand. Methods: An observational, retrospective (chart review), single-arm study was conducted. All consecutive patients who were implanted with a PF-BES at the Central Chest Institute of Thailand were included in the analysis. Results: A total of 208 patients were enrolled. Half of these patients (54.3%) had an HBR according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria. Within 1 year following the indexing procedure, the primary endpoint (a composite of cardiac death, target-vessel myocardial infarction, and clinically driven target lesion revascularization) was reached by 3.8% of the patients. Notably, there was no occurrence of stent thrombosis. Bleeding per the Bleeding Academic Research Consortium 5 definition was not seen for any patient. Conclusion: The PF-BES is safe and effective for real-world patients, irrespective of HBR status.
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