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Angiographic and clinical performance of polymer‐free biolimus‐eluting stent in patients with ST‐segment elevation acute myocardial infarction in a metropolitan public hospital: The BESAMI MUCHO study
Author(s) -
Sgueglia Gregory A.,
D'Errico Fabrizio,
Gioffrè Gaetano,
De Santis Antonella,
Summaria Francesco,
Piccioni Fabiana,
Gaspardone Achille
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27206
Subject(s) - medicine , mace , myocardial infarction , cardiology , stent , revascularization , clinical endpoint , stenosis , percutaneous coronary intervention , clinical trial
Abstract Objectives This study aimed at assessing the performance of a new generation polymer‐free biolimus‐eluting stent (BES) in real‐world patients with ST‐segment elevation myocardial infarction (STEMI). Background Polymers components of early‐generation drug‐eluting stents have been implicated in the pathogenesis of delayed arterial healing, vessel remodeling, and delayed stent thrombosis. Recently, a novel polymer‐free BES has shown excellent clinical performance in clinical trial setting. Methods Overall, 175 consecutive patients (64 ± 14 years, 141 men) treated with the BioFreedom (Biosensors Europe, Morges, Switzerland) polymer‐free BES because of STEMI were included in this study. The primary endpoint was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction, and ischemia‐driven target vessel revascularization at 1 year follow‐up. A subgroup of patients underwent 6‐month angiographic follow‐up. Dual antiplatelet therapy was prescribed for 12 months after STEMI. Results At 1 year, the cumulative rate of MACE was 4.6%. One patient (0.6%) had an arrhythmic cardiac death and five (2.9%) had ischemia‐driven target vessel revascularization, although only three (1.7%) had target lesion revascularization. Two (1.1%) patients had acute stent thrombosis yielding nonfatal myocardial infarction. In 70 patients (63 ± 14 years, 61 men), quantitative coronary angiography at 6‐month follow‐up revealed diameter stenosis of 24.1 ± 13.7% and minimal lumen diameter of 2.29 ± 0.56 mm, yielding a late lumen loss of 0.13 ± 0.14 mm. Conclusions In real‐world setting, implantation of a new‐generation polymer‐free BES during STEMI is associated with favorable clinical and angiographic results, pointing toward the overall efficacy and safety of the device in complex clinical scenarios.