Navigation Links
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% were men. Mean hemoglobin A1C was 7.41.6 g/dL. The baseline ankle-brachial index (ABI) was 0.590.21 and 0.620.19 in the cryoplasty and CBA groups, respectively.

The primary endpoint was 12 month SFA nSES binary in-segment restenosis, defined as a ≥2.5 times increase in peak systolic velocity by duplex ultrasound. The rate of occurrence was 55.8% for the conventional balloon group and 29.3% for the cryoplasty group.

"In patients with diabetes mellitus presenting with life-style limiting claudication, post-dilation of nitinol self-expanding stents in the superficial femoral artery using cryoplasty significantly reduced 12-month in-stent restenosis compared to conventional balloon post-dilation," said Subhash Banerjee MD. Dr. Banerjee is Chief of Division of Cardiology at VA North Texas Health Care and Associate Professor of Medicine at The University of Texas Southwestern Medical Center in Dallas, Texas.

"These results indicate the potential impact of stent post-dilation strategies on endovascular treatment of symptomatic peripheral arterial disease," Dr. Banerjee said.


'/>"/>

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

Related medicine news :

1. Results of the PROFI study reported at TCT 2011
2. Results of the EVOLVE trial reported at TCT 2011
3. Results of the REMEDEE trial reported at TCT 2011
4. Results of the NEXT clinical trial Reported at TCT 2011
5. Results of the PEPCAD-DES trial reported at TCT 2011
6. Results of the STACCATO Trial reported at TCT 2011
7. Results of the DEB-AMI Trial reported at TCT 2011
8. Results of the RIFLE STEACS clinical trial reported at TCT 2011
9. Results of the PARTNER Trial Cohort B 2-year follow up presented at TCT 2011
10. Results of the PARTNER Trial Cohort A cost effectiveness analysis reported
11. Combination epigenetic therapy clinical trial results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... (PRWEB) , ... December 09, 2016 , ... ... planning assistance from offices in Pasco and Richland, is initiating a charity drive ... serious injuries resulting from a recent automobile collision. , On October 29th ...
(Date:12/9/2016)... ... December 09, 2016 , ... "I have gout, and ... this old family recipe, which is meant to relieve gout and pain caused by ... a 12-hour energy boost every time. It relieved what VA doctors called the worst ...
(Date:12/9/2016)... ... December 09, 2016 , ... An inventor from Cana, Va., wanted ... all types of amusement park rides. , The patent-pending SAFETY STRAP FOR AMPUTEES improves ... use and could be set up in a matter of minutes, or even seconds. ...
(Date:12/9/2016)... ... December 09, 2016 , ... ... proudly announced today that a new solution for Emergency Departments (ED) has been ... tight space in Emergency Department examination rooms, and with a simplified pallet of ...
(Date:12/8/2016)... ... December 08, 2016 , ... The West Virginia Medical ... 2017. The name change aligns the entire company with its existing Quality ... quality. , “We are very proud of the achievements associated with the West ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... , Dec. 8, 2016 Australia Glaucoma ... GlobalData,s new report, "Australia Glaucoma Surgery Devices ... on the Australia Glaucoma Surgery Devices market. The ... volume (in units) and average prices (USD) within ... report also provides company shares and distribution shares ...
(Date:12/8/2016)... , Dec. 8, 2016 KEY FINDINGS ... poised to grow in 2017-2023. Various reasons for growth ... obese population, higher incidences of chronic diseases, high recovery ... mobility aid services. Medical lifting sling refers to ... with limited mobility. These slings connect to the lift ...
(Date:12/8/2016)... INDIANAPOLIS , Dec. 8, 2016  Eli Lilly ... detailed results of its phase 3 EXPEDITION3 trial at ... (CTAD) meeting. As previously disclosed, solanezumab did not meet ... study of solanezumab initiated in people with mild dementia ... pursue regulatory submissions for solanezumab for the treatment of ...
Breaking Medicine Technology: