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:9/1/2020)... (PRWEB) , ... September 01, 2020 , ... ... a new practice in Glendale. While the office will be the first ... breast augmentation, tummy tucks, buttock augmentation (Brazilian butt lift), as well as rhinoplasty, ...
(Date:9/1/2020)... ... 01, 2020 , ... Dr. Kiran Gill is a Board ... the face, breast, and body. In 2018, she founded Aesthetics in Plastic Surgery ... aesthetic practice in Southwest Florida. Dr. Gill and her team offer surgical and ...
(Date:8/31/2020)... ... 31, 2020 , ... Ocean Springs, Mississippi-based pharmaceutical distributor Gulf ... responders across the United States. Since the start of the global COVID-19 pandemic, ... medical centers , hospitals , firefighters , and public schools ...
(Date:8/31/2020)... ... August 31, 2020 , ... ... services to dental groups in the United States, today announced the grand opening ... Beaumont, CA. , Patients will enjoy convenient hours, a comfortable office, and ...
(Date:8/31/2020)... ... August 31, 2020 , ... Dr. Chang ... persons with autism and other developmental disabilities, as well as supporting staff in ... adolescents with autism, school consultation, and staff development. She joined the company in ...
Breaking Medicine News(10 mins):
(Date:9/2/2020)... , ... September 02, 2020 ... ... Fight Against Covid-19 , Advanced Penetration Technology, LLC, (APT) a Texas- and ... patients utilizing non-prescription, Over The Counter (OTC) products, was today provided results ...
(Date:9/1/2020)... (PRWEB) , ... September 01, 2020 , ... ... laboratory technologies, will host the Agilent Science and Technology Virtual Symposium 2020 ... two-day symposium, Agilent will open a suite of Live webinars and Networking sessions, ...
(Date:9/1/2020)... ... September 01, 2020 , ... Neil Oberfeld of global law ... the Board of Trustees and committee chair of the Governance Committee for Mile ... nonprofit organization that fights for the education, health, and financial stability of residents ...
Breaking Medicine Technology: