Thirty-Day Outcomes After Unrestricted Implantation of Bioresorbable Vascular Scaffold (From the Prospective RAI Registry)

Abstract The Absorb biovascular-scaffold (BVS) is a bioresorbable, everolimus-eluting scaffold whose data on real world patients with complex lesions are limited. Short-term follow-up from recent studies point to a higher rate of 30-day thrombosis than observed with drug-eluting stents. We aimed to understand the short-term safety and efficacy of BVS. RAI (ClinicalTrials.gov:NCT02298413) is an Italian, prospective, multicentre registry not funded, whose aim is to investigate BVS performance through a 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more BVS in different clinical/lesion subsets. Co-primary end-points were target lesion revascularization (TLR) and definite/probable thrombosis. Secondary endpoint was the occurrence of device-oriented cardiac events (DOCE). The registry involved 23 centers, with patient enrolment from October 2012 through December 2015. We here report the 30-day outcomes of the whole population of the registry.We enrolled 1505 consecutive patients, of which 82% were male and 22.4% diabetic. At presentation, 59.6% of the patients had an acute coronary syndrome, including 21% ST-elevation myocardial infarction. All lesions were pre-dilated and in 96.8% of the cases BVS was post-dilated. At 30 days, the co-primary study endpoint TLR occurred in 0.6% of patients and definite/probable BVS thrombosis in 0.8%. There were 2 cases of cardiac and overall death (0.13%). DOCE occurred in 1% of the patients. In conclusion, our data of consecutive patients suggests that current use of BVS in a wide spectrum of coronary narrowings and clinical settings is associated with good outcome at 30 days.