RAPSTROMTM First-in-Man Study Long-Term Results of a Biodegradable Polymer Sustained-Release Sirolimus-Eluting Stent in De Novo Coronary Stenoses

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 rapamycineluting 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.