An estimated 20% of patients undergoing percutaneous coronary intervention (PCI) are at high bleeding risk (HBR) with associated mortality hazards. Most of them are excluded from many stent trials. In a first-in-human evaluation, the Biolimus-eluting stent was non-inferior to a Paclitaxel-eluting stent for in-stent late lumen loss at 12 months. Since then, numerous publications have been reporting using the Polymer-free Biolimus-eluting stents (PF-BES), mainly on HBR patients. However, there is a lack of data on the clinical outcomes of effectiveness and safety of PF-BESs in Thailand.

An observational, retrospective utilizing chart review, single-arm study was conducted. All consecutive patients who underwent PCI and received PF-BES at CCIT from 1st August 2015 to 31st July 2020 were included in this analysis. 

        Baseline characteristics of 208 patients who received PF-BES were almost male (66.3%), with a mean age of 70.4±12.8 years. The patients’ risk factors were dyslipidemia (93.3%), hypertension (84.1%), and diabetes mellitus (41.8%). The patients who underwent PCI for indication of chronic coronary syndrome, STEMI, NSTEMI, and unstable angina were 59.6%, 24.7%, 14.6%, and 0.7%, respectively. The mean CRUSADE score was 36.1±14.9, and 30.3% of patients had score >40 points, categorized as having a high risk of bleeding. Half of the patients (54.3%) had high bleeding risk according to ARC-HBR criteria. Eighteen patients were on warfarin with a median time in therapeutic range (TTR) of 37.5±28.0%. The left anterior descending artery was the most frequently treated target vessel (40.1%). The mean SYNTAX score was 28.1±14.7. PF-BESs were used 21.4% in ostial lesions, 21.0% in bifurcations lesions, and 38.7% in calcified lesions. According to the ACC/AHA lesion classification system, most lesions were classified as type B (90.6%). Dual antiplatelet therapy (DAPT) was prescribed for 88.5% of patients at discharge and 69.2% at one year follow up, while triple therapy was used 11.5% at discharge and 7.2% at one year follow up. In our study, the mean DAPT duration was 365.5±87.3 days. The primary endpoint a composite of cardiac death, target vessel-myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) within 12 months from the index procedure was 3.8%. For secondary endpoint including death from any cause, MI, and ischemic stroke occurred in 0.9%, 3.6%, and 1.5% at one year, respectively. Notably, there was no stent thrombosis in our study. Only 4.4% of patients who presented with heart failure required admission. For the bleeding endpoints, no patient presented with BARC 5 bleeding. BARC 1, 2, and 3 bleedings rates were 1.5%, 0.5% and 2.4% respectively.

   In terms of device effectiveness, when we used Polymer-free Biolimus-eluting stent (PF-BESs) in a real-world situation, our study showed less unfavorable outcomes such as cardiac death, MI, TV-MI, and clinically driven TLR compared to the LEADERS FREE results. PF-BES is safe and effective in real-world patients irrespective of HBR status.