1. RAPSTROM™ First-in-Man Study Long-Term Results of a Biodegradable Polymer Sustained-Release Sirolimus-Eluting Stent in De Novo Coronary Stenoses.
- Author
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KUMAR, PRATHAP, PILLAI, RAMAKRISHNA, SREEDHARAN, MADHU, DAVIDSON, DEEPAK, MANJUNATH, C.N., FISCHER, LOUIE, BALAKRISHNAN, K.P., D'ASCENZO, FABRIZIO, and SHEIBAN, IMAD
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DRUG-eluting stents ,POLYMER research ,MYOCARDIAL infarction ,CARDIAC arrest ,ANGIOGRAPHY ,KIDNEY diseases ,PATIENTS - Abstract
Background 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. Methods 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. Results 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. Conclusion 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. (J Interven Cardiol 2014;27:373-380) [ABSTRACT FROM AUTHOR]
- Published
- 2014
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