Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: The PLUS-ONE first-in-man study

Abstract Background The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol–gel matrix coating that elutes low dose paclitaxel within 6months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES. Methods A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7μg/18mm, n=30) or group B (8μg/18mm, n=30). The primary endpoint was MACE at 4months defined as cardiac death, myocardial infarction, and target lesion revascularization. Results Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4months was 3.3% and 0% respectively ( P =1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4months was similar in both groups (0.36±0.30mm and 0.34±0.20mm P =.773). Conclusions In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol–gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1year.