The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Long-Term Clinical Outcomes of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Stents: Final 5-Year Results of the AIDA Randomized Clinical Trial
Laura Kerkmeijer1.; Mick P.L. Renkens2; Ruben Y.G. Tijssen2; Sjoerd H. Hofma3; Rene J. van der Schaaf4; E.Karin Arkenbout5; Auke P.J.D. Weevers6; Hector M. Garcia-Garcia7; Robin Kraak8; Jan J. Piek2; Jan G.P. Tijssen2; Jose P.S. Henriques2; Robbert J. de Winter2; Joanna J. Wykrzykowska9;
1. Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, the Netherlands, Netherlands 2. Amsterdam UMC, Heart Center, University of Amsterdam, Amsterdam, The Netherlands 3. Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, The Netherlands 4. Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands 5. Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands 6. Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, The Netherlands 7. Cardiology, MedStar Washington Hospital Center, Washington, DC, USA 8. Department of Cardiology, Onze lieve vrouwe gasthuis, Amsterdam, The Netherlands 9. UMC Groningen, Thorax Center, University of Groningen, Groningen, The Netherlands
As a public service to our readership, this article - peer reviewed by the Editors of EuroIntervention and external reviewers - has been published immediately upon acceptance as it was received in the last round of revision. The content of this article is the responsibility of the authors.
Please note that supplementary movies are not available online at this stage. Once a paper is published in its edited and formatted form, it will be accompanied online by any supplementary movies.
To read the full content of this article, please log in to download the PDF.
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).
Conclusion 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.