AIMS: Absorb bioresorbable vascular scaffolds (BVS) and XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES) had comparable angiographic and clinical outcomes up to one year in patients enrolled in the ABSORB China randomised trial. Whether these favourable results with BVS continue beyond one year up to three years is unknown. In this study we sought to analyse the outcomes from the trial up to three-year follow-up. METHODS AND RESULTS: ABSORB China was a prospective, open-label, multicentre trial in which 480 patients with one or two native coronary artery lesions were randomised 1:1 to BVS (N=241) vs. CoCr-EES (N=239). Clinical endpoints included target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction or ischaemia-driven target lesion revascularisation), its components, and definite/probable stent/scaffold thrombosis (ST). There were no significant differences in clinical outcomes in patients treated with BVS and CoCr-EES up to three years, including TLF (5.5% vs. 4.7%, p=0.68) and definite/probable ST (0.9% vs. 0.0%, p=0.50). STs in the BVS arm consisted of one probable subacute event at 15 days and one definite very late event at 622 days. Among 32 BVS patients with a reference vessel diameter between 2.25 and 3.75 mm byquantitative coronary angiography and in whom post-dilatation was performed at >16 atm with a balloon:scaffold diameter >1:1 and balloon ≤scaffold diameter 0.5 mm, no TLF or ST events occurred within three years. CONCLUSIONS: In the ABSORB China trial, BVS and CoCr-EES had similar results up to three-year follow-up, the time at which the scaffold has completely resorbed. BVS outcomes may be further optimised by appropriate lesion selection and implantation technique.
RCT Entities:
AIMS: Absorb bioresorbable vascular scaffolds (BVS) and XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES) had comparable angiographic and clinical outcomes up to one year in patients enrolled in the ABSORB China randomised trial. Whether these favourable results with BVS continue beyond one year up to three years is unknown. In this study we sought to analyse the outcomes from the trial up to three-year follow-up. METHODS AND RESULTS: ABSORB China was a prospective, open-label, multicentre trial in which 480 patients with one or two native coronary artery lesions were randomised 1:1 to BVS (N=241) vs. CoCr-EES (N=239). Clinical endpoints included target lesion failure (TLF; cardiac death, target vessel-related myocardial infarction or ischaemia-driven target lesion revascularisation), its components, and definite/probable stent/scaffold thrombosis (ST). There were no significant differences in clinical outcomes in patients treated with BVS and CoCr-EES up to three years, including TLF (5.5% vs. 4.7%, p=0.68) and definite/probable ST (0.9% vs. 0.0%, p=0.50). STs in the BVS arm consisted of one probable subacute event at 15 days and one definite very late event at 622 days. Among 32 BVS patients with a reference vessel diameter between 2.25 and 3.75 mm by quantitative coronary angiography and in whom post-dilatation was performed at >16 atm with a balloon:scaffold diameter >1:1 and balloon ≤scaffold diameter 0.5 mm, no TLF or ST events occurred within three years. CONCLUSIONS: In the ABSORB China trial, BVS and CoCr-EES had similar results up to three-year follow-up, the time at which the scaffold has completely resorbed. BVS outcomes may be further optimised by appropriate lesion selection and implantation technique.
Authors: Mateusz P Jeżewski; Michał J Kubisa; Ceren Eyileten; Salvatore De Rosa; Günter Christ; Maciej Lesiak; Ciro Indolfi; Aurel Toma; Jolanta M Siller-Matula; Marek Postuła Journal: J Clin Med Date: 2019-12-07 Impact factor: 4.241