Bioresorbable scaffold versus drug coated balloon for treatment of in-stent-restenosis – long-term outcomes of the randomized ABSORB-ISR trial

Abstract

Abstract Background Observational studies showed promising results after treatment of coronary instent-restenosis (ISR) using the everolimus-eluting bioresorbable vascular scaffold (BVS) Absorb®. Purpose We compared long-term outcomes after treatment of ISR with BVS versus the paclitaxel-eluting drug coated balloon (PE-DCB) SeQuent® Please, which is commonly used for treatment of ISR. Methods This was randomized-controlled trial of Absorb® BVS versus SeQuent® Please PE-DCB in an all-comers population with clinically relevant ISR. The patients were randomized in a 1:1 fashion. The angiographic primary endpoint was late lumen loss (LLL) at 9 months. Clinical follow-ups (FU) up to 48 months were conducted. Results Totally, 53 patients and lesions were enrolled. The mean age was 66.7±9.8 years, 23 (43.4%) had an acute coronary syndrome (ACS) and 16 (30.2%) were diabetic. PCI was successful in all patients. After 9 months, the mean LLL did not significantly differ between patients treated with BVS versus PE-DCB (median 0.41 (interquartile range (IQR) 0.15; 1.23)mm versus 0.27 (IQR 0.13; 0.66)mm, p=0.86). Moreover, mean lumen area on optical coherence tomography (OCT) did not significantly differ (median 5.47 (IQR 4.44; 7.69)mm2 versus 6.70 (IQR 5.00; 7.82)mm2, p=0.24). Rates of significant ISR (angiographic stenosis >70%) were similar with BVS versus PE-DCB (7 (30.4%) versus 6 (27.3%), p=0.81). The target vessel revascularization rates were 9 (33.3%) versus 9 (34.6%) using the BVS versus PE-DCB (p=0.72), also highlighted in the Figure below). No stent/ scaffold thrombosis occurred during FU. The study was prematurely stopped due to withdrawal of the Absorb® BVS in September 2017. Conclusions In this randomized pilot study, we found no significant difference in angiographic, OCT and clinical endpoints after treatment of ISR lesions using the Absorb BVS versus SeQuent® Please PE-DCB during long-term follow-up (≥48months). However, rates of target vessel revascularization were very high in both groups (>30%). TVR and TLF with BVS or PE-DCB for ISR Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Abbott Vascular