Long-Term Clinical Outcomes of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Stents: Final 5-Year Results of the AIDA Randomized Clinical Trial.

BACKGROUND Absorb bioresorbable vascular scaffold (BVS) related events have been reported between 1 and 3 years - the period of active scaffold bioresorption. Data on the performance of Absorb BVS in daily clinical practice beyond this time point is scarce. AIMS This report provides the final five-year clinical follow-up of the Absorb BVS in comparison with Xience everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual-antiplatelet therapy (DAPT) administration on events in the scaffold group. METHODS AIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either Absorb BVS (n=924) or Xience EES (n=921). Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction or target vessel revascularisation, was the primary endpoint. Scaffold thrombosis cases were matched with controls and tested for effect of prolonged DAPT. RESULTS Through 5 years follow-up, there was no difference in TVF between Absorb BVS (17.7%) and Xience EES (16.1%) (hazard ratio 1.31, 95% CI 0.90-1.41, p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) of the scaffold group compared to 13 patients (1.5%) of the stent group (hazard ratio 3.32; 95% CI 1.78-6.17; p<0.001). DT between 3- and 4-years occurred six times in Absorb-arm versus three in Xience-arm. Between 4- and 5-years the incidence was 3 versus 2, respectively. Of those three DT in scaffold group, two occurred in Xience EES treated lesions. The odds ratio of scaffold thrombosis in patients on DAPT compared to off DAPT throughout 5-year follow-up was 0.36 (95% CI 0.15-0.86). CONCLUSIONS The excess risk of Absorb BVS on late adverse events, in particular device thrombosis, in routine PCI continues up to 4-years and seems to plateau afterwards.