Aims: Although the proof of concept of the bioresorbable vascular scaffold (BRS) is well documented, device-related adverse outcomes with first-generation BRS indicate longer-term surveillance. The current study provides insights into the safety and performance of the MeRes100, a novel second-generation sirolimus-eluting BRS, beyond one-year up to three-year follow-up (FU). Methods and results: A total of 108 enrolled patients with de novo coronary artery lesions who underwent implantation of MeRes100 as part of the first-in-human MeRes-1 trial were followed up clinically beyond one year at two and three years and with multiple modality imaging at six months and two years. At three-year FU, the cumulative major adverse cardiac events rate was 1.87%, in the form of two ischaemia-driven target lesion revascularisations. No scaffold thrombosis was reported. Between six months and two years at quantitative coronary angiography, in-segment late lumen loss (LLL) (0.15±0.22 mm vs 0.23±0.32 mm; p=0.18) and in-scaffold LLL (0.13±0.22 mm vs 0.24±0.34 mm; p=0.10) changed insignificantly. IVUS subset analysis revealed a non-significant reduction in mean lumen area (6.17±1.28 mm2 vs 5.47±1.50 mm2 ; p=0.21) and minimum lumen area (5.14±1.19 mm2 vs 4.05±1.42 mm2 ; p=0.10) at two years compared to post-procedural measurements. OCT subset analysis demonstrated 99.24±2.27% neointimal strut coverage. Conclusions: The extended outcomes of the MeRes-1 trial demonstrated sustained efficacy and safety of the MeRes100 BRS with maintained lumen patency up to two years by multimodality imaging and no very late scaffold thrombosis up to three-year clinical FU. The MeRes-1 trial is registered at the Clinical Trials Registry-India. CTRI Number: CTRI/2015/04/005706

Additional Metadata
Keywords • bioresorbable scaffolds • clinical research • clinical trials
Persistent URL dx.doi.org/10.4244/eij-d-19-00324, hdl.handle.net/1765/120532
Journal EuroIntervention
Citation
Seth, A, Onuma, Y, Chandra, P, Bahl, V.K., Manjunath, C.N., Mahajan, A.U., … Serruys, P.W.J.C. (2019). Three-year clinical and two-year multimodality imaging outcomes of a thin-strut sirolimus-eluting bioresorbable vascular scaffold: MeRes-1 trial. EuroIntervention, 15(7), 607–614. doi:10.4244/eij-d-19-00324