CLINICAL RESEARCH CORONARY INTERVENTIONS 607 EuroIntervention 2019;15:607-614 published online ahead of print May 2019 DOI: 10.4244/EIJ-D-19-00324 © Europa Digital & Publishing 2019. All rights reserved. *Corresponding author: Fortis Escorts Heart Institute, Okhla Road, Sukhdev Vihar Metro Station, New Delhi – 110025, Delhi, India. E-mail: ashok.seth@fortishealthcare.com Three-year clinical and two-year multimodality imaging outcomes of a thin-strut sirolimus-eluting bioresorbable vascular scaffold: MeRes-1 trial Ashok Seth 1 *, FRCP, FESC, D.Sc; Yoshinobu Onuma 2,3 , MD, PhD; Praveen Chandra 4 , MD, DM; Vinay K. Bahl 5 , MD, DM; Cholenahally N. Manjunath 6 , MD, DM; Ajaykumar U. Mahajan 7 , MD, DM; Viveka Kumar 8 , MD, DM; Parvin K. Goel 9 , MD, DM; Gurpreet S. Wander 10 , MD, DM; Upendra Kaul 11 , MD, DM; V.K. Ajit Kumar 12 , MD, DM; Alexandre Abizaid 13 , MD, PhD; Patrick W. Serruys 14 , MD, PhD 1. Fortis Escorts Heart Institute, New Delhi, India; 2. Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; 3. Cardialysis B.V., Rotterdam, the Netherlands; 4. Medanta, Gurgaon, India; 5. All India Institute of Medical Science, New Delhi, India; 6. Sri Jayadeva Institute of Cardiovascular Sciences & Research, Bengaluru, India; 7. Lokmanya Tilak Municipal General Hospital, Mumbai, India; 8. Max Super Speciality Hospital, New Delhi, India; 9. Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India; 10. Dayanand Medical College & Hospital, Ludhiana, India; 11. Batra Heart Centre and Dean Academics and Research of BHMRC, New Delhi, India; 12. Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, India; 13. Instituto Dante Pazzanese de Cardiologia and Hospital Albert Einstein, Sao Paulo, Brazil; 14. Imperial College London, London, United Kingdom GUEST EDITOR: Alec Vahanian, MD, PhD; Department of Cardiology, Hôpital Bichat-Claude Bernard, and University Paris VII, Paris, France. Abstract 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 siroli- mus-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 quan- titative 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 analy- sis revealed a non-significant reduction in mean lumen area (6.17±1.28 mm 2 vs 5.47±1.50 mm 2 ; p=0.21) and minimum lumen area (5.14±1.19 mm 2 vs 4.05±1.42 mm 2 ; 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 KEYWORDS • bioresorbable scaffolds • clinical research • clinical trials 2019 SUBMITTED ON 31/03/2019 - REVISION RECEIVED ON 10/04/2019 - ACCEPTED ON 18/04/2019