Seven Years Follow-Up of Biodegradable Polymer Coated Paclitaxel-Eluting Infinnium Coronary Stent in Saudi Arabia

摘要

Aim: In the present study, we analyzed 7-year clinical outcomes of patients included in the BIO degradable Polymer coated drug-eluting stent REgistry of Sahajanand Medical Technologies Pvt. Ltd. stents in Saudi Arabia (BIOPRESS)-Infinnium? registry. Methods: This was multicentre, observational, non-randomized, post-marketing surveillance registry, which included 276 consecutive patients treated with Infinnium? paclitaxel-eluting stent between July-2004 and June-2006. All patients underwent single-vessel or multiple-vessel percutaneous coronary intervention with high atherosclerotic risk factors and the patients were followed up to 7 years. Baseline and post-procedure angiographic follow-up were pre-specified in 231 patients. Results: The registry included 276 consecutive patients (81.5% male) with a mean age of 56.0 ± 11.1 years. Among 276 patients, diabetes and hypertension were present in 142 (51.4%) and 172 (62.3%) of patients respectively. Of all patients studied, 186 (67.4%) had single-vessel disease, 75 (27.2%) had double-vessel disease, and 15 (5.4%) had triple-vessel disease. Total 476 Infinnium? stents were implanted with an average stent length of 21.8 ± 7.5 mm. The incidence of major adverse cardiac events (MACE) up to 1 year was 26 (9.4%). Clinical follow-up was completed in 235 patients at seven-year follow-up. The data of seven-year clinical outcomes were as follow: cumulative MACE rate of 18.1% with 7.6% of total mortality and 3.6% of restenosis. Conclusion: These 7-year results of BIOPRESS-Infinnium? registry clearly provide evidence for safety and long-term effectiveness of the Infinnium? paclitaxel-eluting stent with the biodegradable polymer in real-life patients.