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

Abstract

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

Aims: This 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.

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 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.

Results: Up 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).

Conclusions: The 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.

Conflict of interest statement

H.M. Garcia-Garcia was a member of the clinical events committee of the trial. J. Piek is a member of the Medical Advisory Board of Abbott Vascular. MedStar Washington Hospital Center receives research grants for clinical research from Abbott Vascular. J. Tijssen has served on the DSMB of the early ABSORB trials, including ABSORB II. J. Henriques has received research grants from Abbott Vascular. J. Wykrzykowska had received consultancy fees and research grants from Abbott Vascular. The other authors have no conflicts of interest to declare.

Figures

Central illustration. Kaplan-Meier curves for target vessel failure up to five-year follow-up per study arm.

Figure 1. Kaplan-Meier curves for definite/probable device thrombosis up to five-year follow-up per study arm.

Figure 2. Temporal patterns of device failure in BVS treated lesions.

The upper panel depicts a pattern of early scaffold thrombosis, procedure-related edge dissection (A). Malapposition and DAPT cessation patterns are not visualised. The lower panel depicts patterns observed in very late scaffold thrombosis in the same patient, scaffold discontinuation (B) and acquired malapposition (C).

Figure 3. Relationship between definite device thrombosis and dual antiplatelet therapy (DAPT) status at the time of the event during five-year follow-up.

Figure 4. Effect of DAPT on occurrence of scaffold thrombosis.