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

Layth Mimish, Abdullateef Khoja, Mohammad Anwar, Vitek Rizniceck, Taher Hasan, Ashok Thakkar

Bugshan Hospital, Jeddah, KSA.
King Abdulaziz University, Jeddah, KSA.
King Fahad Hospital, Jeddah, KSA.
Sahajanand Medical Technologies Pvt. Ltd., Surat, India.
Soliman Fakeeh Hospital, Jeddah, KSA.

DOI: 10.4236/ijcm.2014.55035                

Abstract

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.

Keywords

Coronary Artery Disease; Paclitaxel Eluting Stent; Stent Thrombosis

Conflicts of Interest

The authors declare no conflicts of interest.

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