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

Abstract

Background: Observational studies showed promising results after treatment of coronary instent-restenosis (ISR) using the everolimus-eluting bioresorbable vascular scaffold (BVS) AbsorbR. Purpose: We compared long-term outcomes after treatment of ISR with BVS versus the paclitaxel-eluting drug coated balloon (PE-DCB) SeQuentR Please, which is commonly used for treatment of ISR. Methods: This was randomized-controlled trial of AbsorbR BVS versus SeQuentR 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)2 versus 6.70 (IQR 5.00; 7.82)2, 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 AbsorbR 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 SeQuentR Please PE-DCB during long-term follow-up (≥48months). However, rates of target vessel revascularization were very high in both groups (>30%). (Figure Presnted).