MedStar Authors catalog › Details for: Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final five-year results of the AIDA randomised clinical trial.
Citation: Eurointervention. 17(16):1340-1347, 2022 Mar 18..Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.Published: ; ; 2022ISSN: 1774-024X.Full author list: Kerkmeijer LSM; Renkens MPL; Tijssen RYG; Hofma SH; van der Schaaf RJ; Arkenbout EK; Weevers APJD; Garcia-Garcia HM; Kraak R; Piek JJ; Tijssen JGP; Henriques JPS; de Winter RJ; Wykrzykowska JJ.UI/PMID: 34483094.Subject(s): Absorbable Implants | Coronary Artery Disease/su [Surgery] | *Coronary Artery Disease | *Drug-Eluting Stents | Everolimus | Humans | Percutaneous Coronary Intervention/ae [Adverse Effects] | *Percutaneous Coronary Intervention | Prosthesis Design | Stents | Treatment OutcomeInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Comparative Study | Journal Article | Multicenter Study | Randomized Controlled TrialDigital Object Identifier: https://dx.doi.org/10.4244/EIJ-D-21-00419 (Click here)Abbreviated citation: EuroIntervention. 17(16):1340-1347, 2022 Mar 18.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.Abstract: 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.Abstract: 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.Abstract: 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).Abstract: 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.