One-Year Clinical Outcomes After Unrestricted Implantation of Absorb Bioresorbable Scaffold (RAI Registry)

AIMS: to assess the outcomes following Absorb bioresorbable scaffold (BVS) implantation in an unrestricted clinical practice according to an "on-label" versus "off-label" indication. METHODS AND RESULTS: RAI is a prospective registry, investigating the BVS performance in different lesions subsets. No specific exclusion criteria were applied. Co-primary end-points were target lesion revascularization (TLR) and definite/probable scaffold thrombosis (ScT) at one-year. A total of 1,505 patients (1,969 lesions) were enrolled. In 58% of patients BVS was implanted in at least one off-label subset according to the manufacturer's instruction for use. Pre-dilatation was performed in 98.5% of the cases while post-dilatation in 96.8%. At one-year follow-up TLR and ScT rates were 3.3% and 1.3%. TLR was significantly higher in the off-label group (4.0% vs. 2.2%; HR:1.8; 95% CI:1.0-3.4; p=0.05) while a trend toward a higher ScT rate was observed in the off-label group (1.7% vs. 0.6%; HR:2.7; 95% CI:0.9-8.2; p=0.06). At multivariate analysis treatment of in-stent restenosis (ISR), chronic total occlusion (CTO) and BVS diameter were independent predictors of TLR. CONCLUSIONS: our data from a real-world population suggest that BVS could be associated with acceptable one-year clinical outcome when meticulously implanted. However a higher rate of adverse events was observed when this device is used in off-label lesions. (ClinicalTrials.gov: NCT02298413).