Aims: To demonstrate the safety, performance and efficacy of the Conor CoStar(R) cobalt chromium paclitaxel-eluting Stent System in the treatment of de novo coronary lesions in up to two native coronary arteries.
Methods and results: Two groups of patients were treated with the CoStar(R) stent in a prospective multicentre two arm registry; 145 patients received 194 stents releasing 10 microgm of paclitaxel over 30 days (Arm 1), and 137 patients were treated with 158 stents releasing 30 microgm of paclitaxel over 30 days (Arm 2). Baseline demographics were well matched. Overall device success was 98.2%. Intention-to-treat in-segment late loss at six months was 0.09+/-0.40 mm in Arm 1, and 0.22+/-0.46 mm in Arm 2 (p=0.015), with an in-stent late loss of 0.28+/-0.42 mm and 0.40+/-0.48 mm in Arm 1 and Arm 2 respectively (p=0.028), with no deleterious edge effect in either group. Cumulative MACE at 12 months in Arm 1 was 8.3%, with a stent thrombosis rate of 0.7%, and in Arm 2, 10.2% and 1.4% respectively (MACE: p=0.682). Hierarchical target lesion revascularisation (TLR) at 12 months was 2.8% in Arm 1 and 3.4% in Arm 2 respectively (p=0.759).
Conclusions: The Conor CoStar(R) cobalt chromium stent system is highly deliverable and when loaded with low dose slow release paclitaxel (10 microgm released over 30 days), the stent appears safe and efficacious as judged by angiographic and clinical variables assessed at six and 12 months respectively.