We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
RAPSTROM™ first-in-man study long-term results of a biodegradable polymer sustained-release sirolimus-eluting stent in de novo coronary stenoses.
- Authors
Kumar, Prathap; Pillai, Ramakrishna; Sreedharan, Madhu; Davidson, Deepak; Manjunath, C N; Fischer, Louie; Balakrishnan, K P; D'Ascenzo, Fabrizio; Sheiban, Imad
- Abstract
<bold>Background: </bold>Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. We report the first real-life human experience with the rapamycin-eluting biodegradable polymer-coated Rapstrom stent.<bold>Methods: </bold>All consecutive patients with single de novo native coronary stenosis (<30 mm and between 2.5 and 4.0 mm) were enrolled. Major adverse cardiac events (MACE) at 1 year (cardiac death, myocardial infarction [Q and non-Q], or ischemia-driven target lesion revascularization) were the primary end-point.<bold>Results: </bold>A total of 123 patients were enrolled. The stent was implanted without complications in all patients, and no MACE were recorded at 30 days. At 12-month follow-up 9 patients (7.3%) experienced a MACE and 4 (3.2%) required a target lesion revascularization, while 1 (1%) stent thrombosis was recorded. A planned angiographic follow-up (FU) was performed in 73 patients (59%) at 9.4 ± 2.6 months following the index procedure. In-stent late loss was 0.16 ± 0.09 mm, and in-segment late loss was 0.18 ± 0.8 mm.<bold>Conclusion: </bold>The Rapstrom biodegradable polymer rapamycin-eluting stent appeared safe and efficacious in this first real-life human experience, due to a low late lumen loss. Larger randomized studies are required to confirm these preliminary results.
- Publication
Journal of Interventional Cardiology, 2014, Vol 27, Issue 4, p373
- ISSN
0896-4327
- Publication type
journal article
- DOI
10.1111/joic.12132