Data from the MeRes-1 and MeRes-1 Extend clinical trials, released at EuroPCR 2019 (20–24 May, Paris, France), demonstrate sustained efficacy and safety for the recently CE-approved MeRes100 (Meril) bioresorbable scaffold (BRS).
A press release from Meril describes it as a next generation, thin strut sirolimus-eluting bioresorbable vascular scaffold for the treatment of de novo coronary artery lesions. Both trials demonstrated zero scaffold thrombosis and a very low major adverse cardiac event (MACE) rate of 1.87% at three years as shown in MeRes-1, and 1.61% in MeRes-1 Extend at two years.
Ashok Seth (New Dehli, India), principal investigator for the MeRes-1 trial presented the data at EuroPCR. In the press release, he states: “First generation bioresorbable scaffolds have not shown the most favourable results at long term. MeRes100, a next-generation bioresorbable scaffold, has been developed with reduced strut thickness, an improved profile for better deliverability, faster degradation and possibly lower scaffold thrombosis.”
From multimodality imaging at two years MeREs 1 demonstrated low late lumen loss (0.24±0.34mm) with quantitative coronary angiography (QCA), 99.24% strut coverage with optical coherence tomography (OCT), and a sustained mean flow area with 7.5% volume obstruction on intravascular ultrasound (IVUS).
MeRes-1 Extend is a global study which enrolled patients from Brazil, Europe and Asia. It found a low late lumen loss (0.18±0.31mm) with serial QCA analysis at six-month follow-up, and a sustained mean flow area and 97.9±3.7% strut coverage in an OCT subset analysis at six months.