The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Three-year clinical and two-year multimodality imaging outcomes of a thin-strut sirolimus-eluting bioresorbable vascular scaffold: MeRes-1 trial

1. Fortis Escorts Heart Institute, New Delhi, India; 2. Department of Interventional Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; 3. Medanta, Gurgaon, India; 4. All India Institute of Medical Science, New Delhi, India; 5. Sri Jayadeva Institute of Cardiovascular Sciences & Research, Bengaluru, India; 6. Lokmanya Tilak Municipal General Hospital, Mumbai, India; 7. Max Super Speciality Hospital, New Delhi, India; 8. Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India; 9. Dayanand Medical College & Hospital, Ludhiana, India; 10. Batra Heart Centre and Dean Academics and Research of BHMRC, New Delhi, India; 11. Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram, India; 12. Instituto Dante Pazzanese de Cardiologia and Hospital Albert Einstein, Sao Paulo, Brazil; 13. Imperial College London, London, United Kingdom

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 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

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