First-in-human evaluation of a novel poly-L-lactide based sirolimus-eluting bioresorbable vascular scaffold for the treatment of de novo native coronary artery lesions: MeRes-1 trial

EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Ashok SethPatrick W Serruys

Abstract

The MeRes-1 trial sought to study the safety and effectiveness of a novel sirolimus-eluting bioresorbable vascular scaffold (MeRes100 BRS) in treating de novo native coronary artery lesions by clinical evaluation and using multiple imaging modalities. The MeRes-1 first-in-human trial was a single-arm, prospective, multicentre study, which enrolled 108 patients with de novo coronary artery lesions (116 scaffolds were deployed to treat 116 lesions in 108 patients). At six months, quantitative coronary angiography revealed in-scaffold late lumen loss of 0.15±0.23 mm with 0% binary restenosis. Optical coherence tomography demonstrated minimum scaffold area (6.86±1.73 mm2) and percentage neointimal strut coverage (99.30%). Quantitative intravascular ultrasound analysis confirmed a 0.14±0.16 mm2 neointimal hyperplasia area. At one year, major adverse cardiac events, a composite of cardiac death, any myocardial infarction and ischaemia-driven target lesion revascularisation, occurred in only one patient (0.93%) and there was no scaffold thrombosis reported. At one year, computed tomography angiography demonstrated that all scaffolds were patent and in-scaffold mean percentage area stenosis was 11.33±26.57%. The MeRes-1 trial demonstra...Continue Reading

References

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Citations

Sep 20, 2018·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Ashok Seth, Dhananjay Kumar
Mar 10, 2018·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Gentil BarreiraAlexandre Abizaid
Nov 28, 2018·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Ashok Seth, Vishal Rastogi
Mar 22, 2019·Minerva cardioangiologica·Dhruv Mahtta, Islam Y Elgendy
May 31, 2019·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Ashok SethPatrick W Serruys
Jan 13, 2018·Korean Circulation Journal·Davide Capodanno
Aug 28, 2017·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Yuki KatagiriPatrick W Serruys
Dec 14, 2018·Nature Reviews. Cardiology·Hiroyuki JinnouchiAloke V Finn
Jul 10, 2020·Minerva cardioangiologica·Andrea BuonoAntonio Colombo
Dec 4, 2020·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Alexandre AbizaidSripal Bangalore
Oct 27, 2020·Bioactive Materials·Wenjiao LinJiandong Ding

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