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

• Published in: JACC. Cardiovascular interventions 2017-01, Vol.10 (2), p.147
• Main Authors: Worthley, Stephen G, Abizaid, Alexandre, Kirtane, Ajay J, Simon, Daniel I, Windecker, Stephan, Brar, Sandeep, Meredith, Ian T, Shetty, Sharad, Sinhal, Ajay, Almonacid, Alexandra Popma, Chamié, Daniel, Maehara, Akiko, Stone, Gregg W
• Format: Article
• Language: English
• Subjects: Australia; Chromium Alloys; Coronary Angiography; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - therapy; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - etiology; Coronary Thrombosis - diagnostic imaging; Coronary Thrombosis - etiology; Coronary Vessels - diagnostic imaging; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Latin America; Male; Middle Aged; Myocardial Infarction - diagnostic imaging; Myocardial Infarction - etiology; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Platelet Aggregation Inhibitors - administration & dosage; Predictive Value of Tests; Prosthesis Design; Risk Factors; Singapore; Sirolimus - administration & dosage; Sirolimus - analogs & derivatives; Tantalum; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional
• ISSN: 1876-7605
• DOI: 10.1016/j.jcin.2016.10.020

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