TY - JOUR JO - EuroIntervention TI - Three-year clinical and two-year multimodality imaging outcomes of a thin-strut sirolimus-eluting bioresorbable vascular scaffold: MeRes-1 trial AB - <p><strong>Aims:</strong> 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).</p> <p><strong>Methods and results</strong>: 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&plusmn;0.22 mm vs. 0.23&plusmn;0.32 mm; p=0.18) and in-scaffold LLL (0.13&plusmn;0.22 mm vs. 0.24&plusmn;0.34 mm; p=0.10) changed insignificantly. IVUS subset analysis revealed a non-significant reduction in mean lumen area (6.17&plusmn;1.28 mm2 vs. 5.47&plusmn;1.50 mm2; p=0.21) and minimum lumen area (5.14&plusmn;1.19 mm2 vs. 4.05&plusmn;1.42 mm2; p=0.10) at two years compared to post-procedural measurements. OCT subset analysis demonstrated 99.24&plusmn;2.27% neointimal strut coverage.</p> <p><strong>Conclusions:</strong> 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</p> AU - Seth Ashok AU - Onuma Yoshinobu AU - Chandra Praveen AU - Bahl K. Vinay AU - Manjunath N. Cholenahally AU - Mahajan U. Ajaykumar AU - Kumar Viveka AU - Goel K. Praveen AU - Wander S. Gurpreet AU - Kaul Upendra AU - Ajit Kumar K. V. AU - Abizaid A. Alexandre AU - Serruys Patrick W. VL - 15 IS - 7 Y1 - 20/09/2019 Y1 - 2019 DOI - 10.4244/EIJ-D-19-00324 SP - 607 EP - 614 KW - bioresorbable scaffolds KW - clinical research KW - clinical trials PB - Europa Digital & Publishing SE - Coronary interventions UR - https://eurointervention.pcronline.com/article/three-year-clinical-and-two-year-multimodality-imaging-outcomes-of-a-thin-strut-sirolimus-eluting-bioresorbable-vascular-scaffold-meres-1-trial SN - 1774-024X ER -