Abstract
The newer generation of Bioresorbable Vascular Scaffold ABSORB (BVS 1.1) showed better outcome in regard to scaffold area reduction as a result of improved scaffold design and enhanced polymer processing.
To assess the safety and efficacy of treating significant native coronary artery stenosis using ABSORB BVS.
Ninety-nine patients with de novo native significant coronary artery stenosis were selected between September 2012 and September 2014 and were treated using ABSORB BVS. For each patient, the target and the peri-scaffold segments (5mm proximal and distal to the scaffold edge) were analyzed by Quantitative Coronary Angiography (QCA) and Intravascular Ultrasound (IVUS) immediately after the procedure and at one year of follow-up. The major clinical endpoint was ischemia-driven major adverse cardiac events (ID-MACE) defined as a composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization (ID-TLR).
At one year, the overall scaffold area did not demonstrate any significant change. The angiographic insegment late lumen loss was estimated to be 0.11±0.19mm, while the IVUS assessment revealed a non-significant decrease in the minimal lumen area by 0.5% (p=0.79), without significant change in the mean lumen area. There were no reported cardiac deaths. However, two cases of ID-TLR were recorded, one case with STEMI after two weeks due to thrombosis at the distal edge of the BVS and another case with restenosis after one year. Both were treated with metallic drug-eluting stents (Xience V). At one year the overall ID-MACE was found to be 2%.
The performance of ABSORB BVS in the treatment of significant de novo native coronary artery stenosis makes it an attractive option with favorable early and late outcome.