Why the study?
Early studies of the Absorb bioresorbable scaffold for in-stent restenosis showed promising short- to mid-term outcomes, but long-term outcomes up to 5 years remained to be evaluated.
Does the Absorb everolimus-eluting bioresorbable scaffold prevent device-oriented composite endpoints in patients with in-stent restenosis?
Does the Absorb everolimus-eluting bioresorbable scaffold prevent device-oriented composite endpoints in patients with in-stent restenosis?
Treatment of in-stent restenosis with the Absorb bioresorbable scaffold is associated with unacceptably high long-term rates of device-oriented composite endpoints and scaffold thrombosis, suggesting it should be used very restrictively.
High 5-year DOCE rates after Absorb BRS for ISR warrant clinical caution; leaves open BRS utility in restenosis pending randomized trials.
BACKGROUND: Early studies evaluating the performance of bioresorbable scaffold (BRS) Absorb in in-stent restenosis (ISR) lesions indicated promising short-term to mid-term outcomes. AIMS: To evaluate long-term outcomes (up to 5 years) of patients with ISR treated with the Absorb BRS. METHODS: We did an observational analysis of long-term outcomes of patients treated for ISR using the Absorb BRS (Abbott Vascular, Santa Clara, California, USA) between 2013 and 2016 at the Heart Centre Luzern. The main outcomes included a device-oriented composite endpoint (DOCE), defined as composite of cardiac death, target vessel (TV) myocardial infarction and TV revascularisation, target lesion revascularisation and scaffold thrombosis (ScT). RESULTS: Overall, 118 ISR lesions were treated using totally 131 BRS among 89 patients and 31 (35%) presented with an acute coronary syndrome. The median follow-up time was 66.3 (IQR 52.3-77) months. A DOCE had occurred in 17% at 1 year, 27% at 2 years and 40% at 5 years of all patients treated for ISR using Absorb. ScTs were observed in six (8.4%) of the cohort at 5 years. CONCLUSIONS: Treatment of ISR using the everolimus-eluting BRS Absorb resulted in high rates of DOCE at 5 years. Interestingly, while event rates were low in the first year, there was a massive increase of DOCE between 1 and 5 years after scaffold implantation. With respect to its complexity, involving also a more unpredictable vascular healing process, current and future BRS should be used very restrictively for the treatment of ISR.
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Madanchi et al. (2021) studied this question.
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