Randomized Comparison Between Polymer-Free Versus Polymer-Based Paclitaxel-Eluting Stent: Two-Year Final Clinical Results

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Abstract

Background—

Most drug-eluting stents currently in use are coated with a polymer carrying the drug that is released for several weeks. However, a durable polymer may provoke hypersensitive reaction, delayed artery healing, and eventually stent thrombosis. The aim of this study was to investigate the safety and efficacy of a polymer-free paclitaxel-eluting stent (PF-PES) versus a polymer-based PES (PB-PES).

Methods and Results—

Eligible patients undergoing percutaneous coronary intervention were randomized 1:1 to receive either PF-PES or PB-PES. The primary end point was late loss at 9 months. Intravascular ultrasound analysis at 9 months and final 2-year clinical follow-up were also performed. From October 2007 to April 2009, 164 patients were enrolled and randomized into 2 groups (PF-PES: n=84; PB-PES: n=80). Mean in-stent lumen loss was 0.90±0.59 mm for PF-PES and 0.49±0.52 mm for PB-PES (P<0.001). Mean neointimal area by intravascular ultrasound was higher in PF-PES than in PB-PES (1.42±1.09 versus 0.51±0.61 mm2; P<0.001). At 2 years, a composite end point of all-cause death, any myocardial infarction, and target vessel revascularization occurred in 36.9% for PF-PES and 16.3% for PB-PES (P=0.004), mainly driven by a higher rate of target vessel revascularization (PF-PES: 35.7%; PB-PES: 13.8%; P=0.001). One late stent thrombosis was observed in PF-PES.

Conclusions—

Compared with PB-PES, PF-PES was associated with increased neointimal proliferation and subsequent clinical restenosis. Polymer plays an essential role in the performance of drug-eluting stents.

Clinical Trial Registration—

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01375855.

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