Four-year follow-up of the randomised comparison between an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II trial).
Publisher DOI
PubMed ID
29094677
Abstract
AIMS
No randomised comparison data are available beyond the resorption of the everolimus-eluting bioresorbable scaffold. Absorb is expected to be completely resorbed by 3 years. The purpose of this report is to provide the 4 year results of a randomised, single blind, multicentre evaluation of Absorb versus the metallic stent Xience (Abbott Vascular, Santa Clara, CA, USA).
METHODS AND RESULTS
Three-year follow-up has been previously published. Patients re-consented for additional follow-up up through to 5 years; 86% (N=289) and 84% (N=139) of whom underwent a 4 year follow-up visit. TLF was noted in 11.5% in the Absorb arm and 6.0% in the Xience arm (p=0.063) at 4 years, with 1.0% and 0.7% absolute difference respectively between 3 and 4 years. No new very late definite/probable scaffold/stent thrombosis was reported between 3 and 4 years, with a 4-year rate of 3.0% versus 0.0% (p=0.035) and a slight decrease in DAPT prescription in both arms at 4 years (25.9% versus 21.1%, p=NS).
CONCLUSIONS
A downturn of events was recorded beyond the expected resorption time. Further long-term evaluation in larger randomised studies is necessary to confirm this observation.
No randomised comparison data are available beyond the resorption of the everolimus-eluting bioresorbable scaffold. Absorb is expected to be completely resorbed by 3 years. The purpose of this report is to provide the 4 year results of a randomised, single blind, multicentre evaluation of Absorb versus the metallic stent Xience (Abbott Vascular, Santa Clara, CA, USA).
METHODS AND RESULTS
Three-year follow-up has been previously published. Patients re-consented for additional follow-up up through to 5 years; 86% (N=289) and 84% (N=139) of whom underwent a 4 year follow-up visit. TLF was noted in 11.5% in the Absorb arm and 6.0% in the Xience arm (p=0.063) at 4 years, with 1.0% and 0.7% absolute difference respectively between 3 and 4 years. No new very late definite/probable scaffold/stent thrombosis was reported between 3 and 4 years, with a 4-year rate of 3.0% versus 0.0% (p=0.035) and a slight decrease in DAPT prescription in both arms at 4 years (25.9% versus 21.1%, p=NS).
CONCLUSIONS
A downturn of events was recorded beyond the expected resorption time. Further long-term evaluation in larger randomised studies is necessary to confirm this observation.
Date Issued
2018-01-20
Publication Type
Article
Subject(s)
Language(s)
en
Author(s)
Chevalier, Bernard | |
Cequier, Angel | |
Dudek, Dariusz | |
Haude, Michael | |
Carrie, Didier | |
Sabaté, Manel | |
Reith, Sebastian | |
de Sousa Almeida, Manuel | |
Campo, Gianluca | |
Iñiguez, Andres | |
Onuma, Yoshi | |
Serruys, Patrick W |
Additional Credits
Journal
EuroIntervention
Publisher
Europa Digital & Publishing
ISSN
1774-024X
Access(Rights)
restricted