First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study
Stephen G Worthley, Alexandre Abizaid, Ajay J Kirtane, Daniel I Simon, Stephan Windecker, Sandeep Brar, Ian T Meredith, Sharad Shetty, Ajay Sinhal, Alexandra Popma Almonacid, Daniel Chamié, Akiko Maehara, Gregg W Stone, RevElution Investigators, Stephen Worthley, Sharad Shetty, Ajay Sinhal, Ian Meredith, Alexandre Abizaid, Nigel Jepson, Ravinay Bhindi, Soo Teik Lim, Peter Stewart, Peter Barlis, Darren Walters, David Muller, Stephen Cox, Rohan Bhagwandeen, Stephen G Worthley, Alexandre Abizaid, Ajay J Kirtane, Daniel I Simon, Stephan Windecker, Sandeep Brar, Ian T Meredith, Sharad Shetty, Ajay Sinhal, Alexandra Popma Almonacid, Daniel Chamié, Akiko Maehara, Gregg W Stone, RevElution Investigators, Stephen Worthley, Sharad Shetty, Ajay Sinhal, Ian Meredith, Alexandre Abizaid, Nigel Jepson, Ravinay Bhindi, Soo Teik Lim, Peter Stewart, Peter Barlis, Darren Walters, David Muller, Stephen Cox, Rohan Bhagwandeen
Abstract
Objectives: 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.
Background: 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.
Methods: 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.
Results: 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 (pnoninferiority <0.001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by optical coherence tomography was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non-Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred.
Conclusions: At 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348).
Keywords: drug-eluting stent(s); drug-filled stent(s); percutaneous coronary intervention; polymer-free stent.
Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed