Serial Multimodality Imaging and 2-Year Clinical Outcomes of the Novel DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold System for the Treatment of Single De Novo Coronary Lesions

摘要: Abstract Objectives This study sought to report the late multimodality imaging and clinical outcomes of novel poly- l -lactic-acid–based DESolve novolimus-eluting bioresorbable coronary scaffold for treatment de novo lesions. Background Bioresorbable scaffolds are an alternative drug-eluting metallic stents provide temporary vascular scaffolding, which potentially may allow vessel restoration reduce risk future adverse events. Methods Overall, 126 patients were enrolled at 13 international sites between November 2011 June 2012. The primary endpoint was in-scaffold lumen loss 6 months. Major cardiac events, main safety endpoint, defined as composite death, target myocardial infarction, or clinically indicated lesion revascularization. All underwent angiography Serial intravascular ultrasound optical coherence tomography performed in a subset patients. Results device success rate 97% (n = 122 126), procedural 100% 122). major event 3.3% 4 122) months 7.4% 9 24 months, including 1 probable stent thrombosis within first month. At 6-month angiographic follow-up, 0.20 ± 0.32 mm. Paired analysis demonstrated significant increase vessel, dimensions post-procedure strut-level showed full strut coverage 99 1.7%. Conclusions Our results favorable performance scaffold, effective inhibition neointimal hyperplasia, time, early luminal growth with sustained efficacy through 2 years. (Elixir Medical Clinical Evaluation Novolimus Eluting Coronary Scaffold System—The Nx Trial; NCT02086045 )