6-month clinical outcomes following implantation of the bioresorbable everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5 mm
Roberto Diletti, Yoshinobu Onuma, Vasim Farooq, Josep Gomez-Lara, Salvatore Brugaletta, Robert Jan van Geuns, Evelyn Regar, Bernard de Bruyne, Dariusz Dudek, Leif Thuesen, Bernard Chevalier, Dougal McClean, Stephan Windecker, Robert Whitbourn, Pieter Smits, Jacques Koolen, Ian Meredith, Dong Li, Susan Veldhof, Richard Rapoza, Hector M Garcia-Garcia, John A Ormiston, Patrick W Serruys, Roberto Diletti, Yoshinobu Onuma, Vasim Farooq, Josep Gomez-Lara, Salvatore Brugaletta, Robert Jan van Geuns, Evelyn Regar, Bernard de Bruyne, Dariusz Dudek, Leif Thuesen, Bernard Chevalier, Dougal McClean, Stephan Windecker, Robert Whitbourn, Pieter Smits, Jacques Koolen, Ian Meredith, Dong Li, Susan Veldhof, Richard Rapoza, Hector M Garcia-Garcia, John A Ormiston, Patrick W Serruys
Abstract
Objectives: We investigated the 6-month clinical outcomes after implantation of second-generation 3.0-mm bioresorbable everolimus-eluting vascular scaffolds (BVS) in small coronary vessels (<2.5 mm).
Background: BVS are a novel approach to treating coronary lesions and are untested in small vessels.
Methods: The ABSORB Cohort B Trial is a multicenter, single-arm, prospective, open-label trial assessing the performance of the second-generation BVS, in which 101 patients were enrolled. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary angiography during post hoc analysis. The vessel size was overestimated, by visual assessment, in 41 patients before implantation of 3.0-mm BVS in vessels with a pre-procedural RVD <2.5 mm. The study population was divided into 2 groups, group I (n = 41) with RVD <2.5 mm and group II (n = 60) with RVD ≥2.5 mm. The composite endpoint of ischemia-driven major adverse cardiac events, defined as ischemia-driven target lesion revascularization, myocardial infarction, or cardiac death, was assessed. Of the 45 patients scheduled for 6-month coronary angiography, 42 patients had the procedure performed, with intravascular ultrasound undertaken in 40 of these patients.
Results: At 6 months, no significant differences in ischemia-driven major adverse cardiac events (3 of 41 [7.3%] cases vs. 2 of 60 [3.3%] cases; p = 0.3933) were observed in the small- and large-vessel groups, respectively. No cardiac deaths or episodes of in-scaffold thromboses were seen. Angiographic and intravascular ultrasound follow-up demonstrated no differences in late lumen loss (0.16 ± 0.18 mm vs. 0.21 ± 0.17 mm; p = 0.3525) or percentage lumen area stenosis (17.6 ± 6.0% vs. 19.8 ± 8.5%; p = 0.3643).
Conclusions: The second-generation 3.0-mm BVS appears to be safe in small vessels, with similar clinical and angiographic outcomes compared with those of large vessels.
Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed