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

SAN FRANCISCO, CA NOVEMBER 11, 2011 A clinical trial of patients with diabetes has demonstrated that cryoplasty post-dilitation compared to conventional balloon angioplasty in the superficial femoral artery (SFA) decreased the risk of in-stent restenosis (ISR). Results from the COBRA clinical trial were presented today at the 23rd Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).

Diabetes is associated with increased risk of in-stent restenosis after superficial femoral artery (SFA) stenting with nitinol self-expanding stents (nSES). The objective of the COBRA trial (Cryoplasty Or Conventional Balloon Post-dilation of Nitinol Stents For Revascularization of Peripheral Arterial Segments) was to determine whether cryoplasty post-dilation, when compared to conventional balloon angioplasty, decreases the risk of SFA nSES in-stent restenosis.

Researchers used a cryoplasty dilatation system that simultaneously dilates and cools the vessel wall. Cooling to -10oC was achieved by inflating the balloon with nitrous oxide instead of saline and contrast. The system induces smooth muscle cell (SMC) apoptosis, minimizes SMC necrosis (-5 to -15oC) and reduces ISR.

In this prospective, multi-center, randomized clinical trial, 121 patients with diabetes mellitus were enrolled between August 2008 and December 2010 in four clinical sites within the United States. Inclusion criteria included insulin or non-insulin dependent diabetic patients, severe lifestyle limiting claudication (Rutherford category ≥3), chronic critical limb ischemia with rest pain (RB stage 4) or ischemic ulcers (RB stage 5), and SFA lesions requiring nSES ≥5 mm in diameter and ≥60mm in length.

Seventy-four patients with 90 SFA lesions were randomized to cryoplasty (n=45 lesions) or conventional balloon angioplasty (CBA) (n=45 lesions). Mean age was 6411.4 years, and 88%
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Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

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