Randomized Comparison Between Polymer-Free Versus Polymer-Based Paclitaxel-Eluting Stent

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 mm 2 ; 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.

Polymer‐free versus permanent polymer‐coated drug eluting stents for the treatment of coronary artery disease: A meta‐analysis of randomized trials

“…Twelve RCTs met the predefined inclusion criteria and were included in the final quantitative analysis . All twelve trials contributing to clinical outcomes, while nine contributed to angiographic outcomes.…”

Vascular response profiles following a nano polymer-free sirolimus-eluting stent implantation assessed by optical coherence tomography in a porcine model

“…However, there is evidence that the durable polymers may lead to delayed vascular healing and reendothelialization, and localized hypersensitivity reactions and inflammation, resulting in a high frequency of in-stent restenosis and/or late stent thrombosis (4,18–20). The most effective solution appears to be the application of drugs to the stent surface without polymers to eliminate the adverse effects associated with the polymer (21). Previously, the polymer-free DES as an emerging technology has been proved to be a feasible and valuable method to inhibit neointimal proliferation without the potential of late polymer-related adverse effects (7,8).…”

Edge Vascular Response After Polymer-Free vs. Polymer-Based Paclitaxel-Eluting Stent Implantation

“…19 Briefly, this trial was a prospective, randomized, single-blinded, multicenter trial comparing PF-PES with the PB-PES. All the patients who met all the inclusion/exclusion criteria were randomized 1:1 to receive either the PF-PES (AXXION TM ; Biosensors International, Kampong, Singapore) or the PB-PES (TAXUS Express TM ; Boston Scientific, Natick, MA, USA) for the treatment of coronary lesions.…”

“…19 The LISA trial was prematurely stopped due to the higher rate of TLR in the PF-PES as compared to PB-PES. Only 76 patients with 84 lesions (46%) had paired IVUS, due to premature discontinuation of the trial and were therefore enrolled into this substudy.…”