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Results of the REMEDEE trial reported at TCT 2011
Date:11/11/2011

SAN FRANCISCO, CA NOVEMBER 11, 2011 A randomized comparison of a dual therapy stent which combines low-dose sirolimus delivery from an abluminal biodegradable polymer matrix with a covalently bound anti-CD34 antibody layer with a paclitaxel-eluting stent showed that the dual therapy stent effectively controls neointimal proliferation and was shown to be safe and effective. Results of the REMEDEE trial were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The REMEDEE trial was designed to demonstrate the safety and effectiveness of the new dual therapy stent compared to a clinically proven paclitaxel-eluting stent. The new stent is designed for control of neointimal proliferation as well as accelerated vessel healing. The trial was conducted among patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a single native coronary artery.

In the study, 183 patients were randomized at 17 sites in Australia (4), Belgium (2), Brazil (2), Germany (2), Hong Kong (1), Malaysia (2), Netherlands (2), and Singapore (2). Of all subjects enrolled, 124 subjects were placed in the dual therapy group and 59 in the paclitaxel-eluting group.

Major inclusion criteria included single de-novo lesions in native coronary arteries, lesion length ≤ 20 mm and a diameter of 2.5 mm to 3.5. Major exclusion criteria were acute myocardial infarction, ostial lesions and unprotected left main with ≥ 50% stenosis. Baseline patient characteristics included a mean age of 64.2 in the dual therapy group and 64.0 in the paclitaxel-eluting group; 71.8% male in the dual therapy group and 71.2% in the paclitaxel-eluting group. The mean number of lesions treated per patients was 1.1 in both groups.

The primary endpoint was angiographic in-stent late lumen loss at nine months post-procedure.

Secondary endpoints i
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Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

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