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

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• 作者：Carlos Calderas ; Jose Francisco Condado ; Jose Antonio Condado ; Alej ; ra Flores ; Amy Mueller ; Jack Thomas ; Daisaku Nakatani ; Yasuhiro Honda ; Katsuhisa Waseda ; Peter Fitzgerald
• 关键词：Drug eluting stent ; Paclitaxel eluting stent ; Coronary artery disease
• 刊名：Cardiovascular Revascularization Medicine
• 出版年：January, 2014
• 年：2014
• 卷：15
• 期：1
• 页码：18-22
• 全文大小：506 K

文摘

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 6 months. 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 (3.7 渭g/18 mm, n = 30) or group B (8 渭g/18 mm, n = 30). The primary endpoint was MACE at 4 months 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 4 months was 3.3% and 0% respectively (P = 1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 卤 0.30 mm and 0.34 卤 0.20 mm 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 1 year.