Biodegradable-polymer-based, paclitaxel-elutingInfinnium™ stent: 9-Month clinical and angiographic follow-up results from the SIMPLE II prospectivemulti-centre registry study

ABSTRACT

Background: SIMPLE II was a multi-centre, prospective registry study aimed at investigating the safety andefficacy of the Infinnium™ (Sahajanand Medical Technologies Pvt. Ltd, India) paclitaxel-eluting stent forthe treatment of single de novo lesions in the native coronary arteries.Methods: One hundred and three patients with symptomatic coronary artery disease were treated for singlede novo native coronary artery lesions using the Infinnium™ stent (paclitaxel concentration1.4 mcg/mm2 released over 48 days) in a multi-centre, prospective study performed on 3 continents (Asia,Europe and South America). The primary safety endpoint was major adverse cardiac events at 30 days(MACE 30d) and efficacy was assessed by in-stent binary restenosis as measured by quantitative coronaryangiography (QCA) at six-month follow-up. A clinical follow-up was scheduled at nine months.Results: The mean patient age was 58.5 years; 70.9% were males; 43.7% had unstable angina and 38.8%previous myocardial infarction. Risk factors included hypertension in 62.1%, hypercholesterolemia in52.4%, current smoking in 32.0% and diabetes in 28.2%. Stent implantation was successful in all patients,with more than one stent being implanted in 9 patients (8.7%). Hierarchical MACE 30d was 2.9%. At ninemonths, 101 patients had clinical follow-up (1 patient had died and 1 refused). There was one death(1.0%), one Q-wave myocardial infarction (Q MI) (1.0%), three non-Q MIs (2.9%), one clinically-driven targetlesion Coronary Artery Bypass Grafting (CABG) (1.0%), and one clinically-driven target lesion repeatpercutaneous coronary intervention (re-PCI) (1.0%). The overall event-free rate at nine months was 93.2%.QCA revealed in-stent and in-segment late loss of 0.38±0.49 mm and 0.18±0.46 mm, resulting in binaryrestenosis rates of 7.3% and 8.3%, respectively. There was one case of late stent thrombosis in the patientexperiencing the Q MI and subsequent re-PCI...