1. Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final five-year results of the AIDA randomised clinical trial
- Author
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Jan J. Piek, Karin Arkenbout, Jan G.P. Tijssen, Ruben Tijssen, Robin P. Kraak, José P.S. Henriques, Hector M. Garcia-Garcia, Sjoerd H. Hofma, Mick P.L. Renkens, Robbert J. de Winter, Laura S.M. Kerkmeijer, René J. van der Schaaf, Joanna J. Wykrzykowska, Auke P.J.D. Weevers, ACS - Heart failure & arrhythmias, Cardiology, Graduate School, ACS - Atherosclerosis & ischemic syndromes, and ACS - Microcirculation
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Coronary Artery Disease ,Prosthesis Design ,Coronary artery disease ,Percutaneous Coronary Intervention ,Clinical Research ,Internal medicine ,Absorbable Implants ,drug-eluting stent ,medicine ,Clinical endpoint ,Humans ,Everolimus ,Myocardial infarction ,stent thrombosis ,business.industry ,Hazard ratio ,Stent ,Drug-Eluting Stents ,bioresorbable scaffold ,medicine.disease ,Thrombosis ,Treatment Outcome ,Editorial ,Conventional PCI ,Cardiology ,Stents ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - 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
- Published
- 2022
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