Key result
Absorb bioresorbable scaffold linked to ~104% higher target lesion failure vs XIENCE at four years.
Why the study?
No randomised comparison data are available beyond the resorption of the everolimus-eluting bioresorbable scaffold, which is expected to be completely resorbed by 3 years.
Does an everolimus-eluting bioresorbable scaffold reduce target lesion failure compared to an everolimus-eluting metallic stent in patients with coronary artery stenosis?
RCT (n=501)
Single-blind
Randomized
Yes
Does an everolimus-eluting bioresorbable scaffold reduce target lesion failure compared to an everolimus-eluting metallic stent in patients with coronary artery stenosis?
At 4-year follow-up, the everolimus-eluting bioresorbable scaffold showed a trend toward higher target lesion failure and significantly higher scaffold thrombosis compared to a metallic stent, though no new thrombosis events occurred between 3 and 4 years.
Answers are grounded in this paper and cite their sources.
Bioresorbable scaffold increases 4-year target lesion failure risk versus metallic stent; challenges its adoption over XIENCE in coronary stenosis.
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.
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Chevalier et al. (2018) conducted an RCT in Coronary artery stenosis (n=501). Absorb everolimus-eluting bioresorbable scaffold vs. XIENCE everolimus-eluting metallic stent was evaluated on Target lesion failure up to 4 years (HR 2.04, 95% CI 0.98, 4.24, p=0.050). At four years, target lesion failure occurred in 11.1% of patients treated with the Absorb bioresorbable scaffold compared to 5.6% with the XIENCE metallic stent.
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