6-Month Clinical Outcomes Following Implantation of the Bioresorbable Everolimus-Eluting Vascular Scaffold in Vessels Smaller or Larger Than 2.5 mm

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. (J Am Coll Cardiol 2011;58:258-64) (C) 2011 by the American College of Cardiology Foundation