Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final five-year results of the AIDA randomised clinical trial.

backgroundAbsorb 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 the Absorb BVS in daily clinical practice beyond this time point are scarce.

aimsThis report aimed to provide the final five-year clinical follow-up of the Absorb BVS in comparison with the XIENCE everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual antiplatelet therapy (DAPT) administration on events in the scaffold group.

methodsAIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either the Absorb BVS (n=924) or the XIENCE EES (n=921). Target vessel failure (TVF), a 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 the effect of prolonged DAPT.

resultsUp to five-year follow-up, there was no difference in TVF between the Absorb BVS (17.7%) and the XIENCE EES (16.1%) (hazard ratio [HR] 1.31, 95% confidence interval [CI]: 0.90-1.41; p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) in the scaffold group compared to 13 patients (1.5%) in the stent group (HR 3.32, 95% CI: 1.78-6.17; p<0.001). DT between 3 and 4 years occurred six times in the Absorb arm versus three times in the XIENCE arm. Between 4 and 5 years, the incidence was three versus two, respectively. Of those three DT in the scaffold group, two occurred in XIENCE EES-treated lesions. The odds ratio of scaffold thrombosis in patients on DAPT compared to off DAPT throughout five-year follow-up was 0.36 (95% CI: 0.15-0.86).

conclusionsThe excess risk of the Absorb BVS on late adverse events, in particular device thrombosis, in routine PCI continues up to 4 years and seems to plateau afterwards. Clinical Trial Registration ClinicalTrials.gov: NCT01858077.