TY - JOUR
T1 - Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents
T2 - final five-year results of the AIDA randomised clinical trial
AU - Kerkmeijer, Laura S.M.
AU - Renkens, Mick P.L.
AU - Tijssen, Ruben Y.G.
AU - Hofma, Sjoerd H.
AU - van der Schaaf, Rene J.
AU - Arkenbout, E. Karin
AU - Weevers, Auke P.J.D.
AU - Garcia-Garcia, Hector M.
AU - Kraak, Robin
AU - Piek, Jan J.
AU - Tijssen, Jan G.P.
AU - Henriques, Jose P.S.
AU - de Winter, Robbert J.
AU - Wykrzykowska, Joanna J.
N1 - Funding Information:
The AIDA trial was supported by an unrestricted educational grant from Abbott Vascular. The Amsterdam UMC Heart Center received an unrestricted educational research grant from Abbott Vascular for the AIDA trial. The Research Department of the Cardiology Division of the Medical Center Leeuwarden received non-study-related unrestricted educational research grants from Abbott Vascular.
Publisher Copyright:
© Europa Digital & Publishing 2022. All rights reserved.
PY - 2022/3
Y1 - 2022/3
N2 - 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.
AB - 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.
KW - bioresorbable scaffold
KW - drug-eluting stent
KW - stent thrombosis
U2 - 10.4244/EIJ-D-21-00419
DO - 10.4244/EIJ-D-21-00419
M3 - Article
C2 - 34483094
AN - SCOPUS:85122984819
SN - 1774-024X
VL - 17
SP - 1340
EP - 1347
JO - Eurointervention
JF - Eurointervention
IS - 16
ER -