Beyond the early stages: insights from the ASSURE registry on bioresorbable vascular scaffolds.

Abstract

Bioresorbable vascular scaffolds (BVS) have been available on the European market since November 2011. The ASSURE registry aims to investigate the safety and efficacy of the Absorb everolimus-eluting bioresorbable vascular scaffold in a real-world setting. Patients with de novo coronary artery disease were consecutively enrolled at six German centres in this prospective registry. Outcomes were procedural success, cardiovascular death, myocardial infarction, and ischaemia-driven target lesion revascularisation (TLR). Angiographic parameters were assessed quantitatively and visual estimates of lesion dimensions were studied. One hundred and eighty-three patients were treated. In 128 (64.7%) lesions a complex ACC/AHA morphology was present. Procedural success was achieved in all patients. Acute gain was 1.54±0.51 mm, resulting in a final minimal lumen diameter (MLD), which met the baseline reference vessel diameter (RVD), although visual estimates overrated the RVD by 0.5±0.5 mm. Up to 12 months, one patient (0.5%) had died from gastrointestinal bleeding, three (1.7%) non-target vessel myocardial infarctions occurred, and five (2.8%) TLR had become necessary because of restenosis. One-year results suggest that bioresorbable vascular scaffolds for de novo coronary artery disease are associated with favourable clinical and functional outcomes in routine clinical practice despite a visually overestimated RVD.