First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent
| Autor: | 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, Stephen Worthley, Ian Meredith, Nigel Jepson, Ravinay Bhindi, Soo Teik Lim, Peter Stewart, Peter Barlis, Darren Walters, David Muller, Stephen Cox, Rohan Bhagwandeen |
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| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
medicine.diagnostic_test business.industry medicine.medical_treatment Lumen (anatomy) Stent Polymer free First in human 030204 cardiovascular system & hematology medicine.disease Coronary artery disease 03 medical and health sciences 0302 clinical medicine Sirolimus Intravascular ultrasound Clinical endpoint medicine 030212 general & internal medicine Radiology Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | JACC: Cardiovascular Interventions. 10:147-156 |
| ISSN: | 1936-8798 |
| DOI: | 10.1016/j.jcin.2016.10.020 |
| Popis: | 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 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) |
| Databáze: | OpenAIRE |
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