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First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study.
- Source :
-
JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2017 Jan 23; Vol. 10 (2), pp. 147-156. - Publication Year :
- 2017
-
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.<br />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.<br />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.<br />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 (p <subscript>noninferiority</subscript>  <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.<br />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).<br /> (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Australia
Chromium Alloys
Coronary Artery Disease diagnostic imaging
Coronary Restenosis etiology
Coronary Thrombosis diagnostic imaging
Coronary Thrombosis etiology
Drug Therapy, Combination
Female
Humans
Latin America
Male
Middle Aged
Myocardial Infarction diagnostic imaging
Myocardial Infarction etiology
Percutaneous Coronary Intervention adverse effects
Platelet Aggregation Inhibitors administration & dosage
Predictive Value of Tests
Prosthesis Design
Risk Factors
Singapore
Sirolimus administration & dosage
Sirolimus analogs & derivatives
Tantalum
Time Factors
Treatment Outcome
Coronary Angiography
Coronary Artery Disease therapy
Coronary Restenosis diagnostic imaging
Coronary Vessels diagnostic imaging
Drug-Eluting Stents
Percutaneous Coronary Intervention instrumentation
Tomography, Optical Coherence
Ultrasonography, Interventional
Subjects
Details
- Language :
- English
- ISSN :
- 1876-7605
- Volume :
- 10
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- JACC. Cardiovascular interventions
- Publication Type :
- Academic Journal
- Accession number :
- 28104208
- Full Text :
- https://doi.org/10.1016/j.jcin.2016.10.020