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:4/30/2016)... , ... April 30, 2016 , ... ... Carol Francis Talk Radio with Hypnotherapist, Mary O'Maley. What is hypnosis and ... habit control (substances, smoking, weight control), pain relief (chronic and acute), birthing processes ...
(Date:4/30/2016)... CA (PRWEB) , ... April 30, 2016 , ... “Aging well is a challenge for all of us, but there ... NCMA’s Dr. Parul T. Kohli . “Research is showing more and more that there are ... of disease and disability as we age.” Top priorities Dr. Kohli’s recommends for her patients include;, ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... Footwear Foundation, the national charitable foundation serving the footwear industry, has broken all ... representing more than 130 companies across 23 states during the months of April ...
(Date:4/29/2016)... ... April 29, 2016 , ... The American workforce ... stability, even security. Most importantly, employees are the single most important asset in ... workers so unhappy? , Just under half of American workers are emotionally checked ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... infants born with severe congenital diaphragmatic hernia have better survival rates if surgery ... diaphragmatic hernia (CDH)—a condition where the diaphragm fails to form completely, letting abdominal ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... 2016   Click here for supplemental information ... DPLO), the nation,s largest independent specialty pharmacy, announced ... to acquire Valley Campus Pharmacy, Inc., doing business ... specialty pharmacy that provides individualized patient care, based ... In 2015, TNH generated approximately $400 million in ...
(Date:4/28/2016)... April 28, 2016  Marking its one year ... and ovarian cancer risk test, Color Genomics ... genes that highly impact the most common hereditary ... the Color Test analyzes hereditary cancer risks for ... uterine cancers. The Color Test is physician ordered ...
(Date:4/28/2016)... , April 28, 2016 ... insights on healthcare, announced today that it has been ... Cool Vendor in Life Sciences, 2016, ... 2016.  The report focuses on life-science- oriented analytics, algorithms ... from patients and doctors, confirm medication ingestion, and analyze ...
Breaking Medicine Technology: