First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study

摘要: Abstract Objectives This study sought to assess the safety and effectiveness of drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in treatment patients with coronary artery disease. Background Polymer-free drug-eluting stents have potential improve clinical outcomes facilitate shorter durations dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire an outer cobalt chromium layer, middle tantalum inner lumen coated sirolimus. Small laser-drilled holes on abluminal surface control drug elution. Methods RevElution trial enrolled 100 de novo lesions 2.25 3.50 mm diameter length ≤27 2 cohorts 50 for angiographic, intravascular ultrasound, assessment at 9 or 24 months, optical coherence tomography performed subset 30 each time period. primary endpoint was angiographic in-stent late loss months compared Resolute zotarolimus-eluting (Medtronic) historical data. Results Fifty 56 were treated 9-month cohort. In-stent 0.26 ± 0.28 0.36 ± 0.52 (pnoninferiority  Conclusions At safe effective high rates early strut coverage and noninferior Resolute. (Medtronic Trial [RevElution]; NCT02480348)