TITLE:
Seven Years Follow-Up of Biodegradable Polymer Coated Paclitaxel-Eluting Infinnium Coronary Stent in Saudi Arabia
AUTHORS:
Layth Mimish, Abdullateef Khoja, Mohammad Anwar, Vitek Rizniceck, Taher Hasan, Ashok Thakkar
KEYWORDS:
Coronary Artery Disease; Paclitaxel Eluting Stent; Stent Thrombosis
JOURNAL NAME:
International Journal of Clinical Medicine,
Vol.5 No.5,
March
18,
2014
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.