2012 Issues   /   November 2012

Balloon Cryoplasty Effective for PAD in Diabetics

USM By U.S. Medicine
November 11, 2012

NEW YORK — The COBRA trial suggests that cryoplasty for post-dilation of nitinol stents in the superficial femoral artery is an effective adjunctive treatment for peripheral arterial disease (PAD) in diabetics.

“Post-dilation of SFA stents with cryoplasty can significantly reduce the risk of restenosis in patients with diabetes mellitus,” the study concludes. The authors note that post-dilation using cryoplasty significantly reduced the in-stent restenosis rates at one year, compared with post-dilation using a conventional balloon.

Results from the COBRA (Polar Cath Cryoplasty Versus Conventional Balloon Postdilation of Nitinol Stents for Peripheral Vascular Interventions) trial, led by Subhash Banerjee, MD, FACC, FSCAI, chief of cardiology at the VA North Texas Health Care System in Bonham, appeared recently in the Journal of the American College of Cardiology.1

The authors explain that cryoplasty is performed with a U.S. FDA-approved angioplasty balloon positioned at the arterial lesion and inflated with nitrous oxide, which cools the surface of the balloon and freezes the plaque in the artery.

“This action has three potential beneficial effects: 1) weakens plaque, thereby promoting uniform dilation resulting in less vessel trauma; 2) reduces vessel wall recoil; and 3) induces smooth muscle cell apoptosis, limiting neointima formation,” they write.

In the multicenter randomized trial comparing cryoplasty with conventional balloon post-dilation of nitinol self-expanding stents implanted in the SFA of 74 diabetic patients with symptomatic PAD, 90 lesions were stented, half of them total occlusions.

Post-dilation balloon diameters were 5.23 mm with conventional balloon angioplasty, placed in half of the trial participants, compared with 5.51 mm with cryoplasty, performed in the other half.

Although five patients died during the 12-month follow-up period, none of the deaths was related to the index procedure, and the mortality rate was not significantly different between study arms (p=0.31).

Binary restenosis — the primary outcome, defined as at least a 2.5-fold increase in peak systolic velocity within the stented segment — was significantly lower in the cryoplasty group (29.3% vs 55.8%, p=0.01; odds ratio 0.36).

There also was a sustained improvement at 12 months in the ankle-brachial index in the cryoplasty group as opposed to the conventional balloon angioplasty group.

1. Banerjee S, Das TS, Abu-Fadel MS, Dippel EJ, et. al. “Pilot Trial of Cryoplasty or Conventional Balloon Post-Dilation of Nitinol Stents for Revascularization of Peripheral Arterial Segments: The COBRA Trial.” J Am Coll Cardiol. 2012 Sep 5. [Epub ahead of print] PubMed PMID: 22981558.


Related Articles

How Veterans Feel About Remote Management of Their Care

While implantable devices have shown promise in reducing rehospitalization for heart failure (HF), VA researchers sought to determine if options that are less expensive and non-invasive would have comparable results.

Legislation: Clinicians Must Be Involved in Formulary Design, Purchasing

Legislation to prevent VA from outsourcing creation of its drug formulary and to require more input from medical professions is being considered in Congress.


U.S. Medicine Recommends


More From department of veterans affairs

Department of Veterans Affairs (VA)

How Veterans Feel About Remote Management of Their Care

While implantable devices have shown promise in reducing rehospitalization for heart failure (HF), VA researchers sought to determine if options that are less expensive and non-invasive would have comparable results.

Department of Veterans Affairs (VA)

Legislation: Clinicians Must Be Involved in Formulary Design, Purchasing

Legislation to prevent VA from outsourcing creation of its drug formulary and to require more input from medical professions is being considered in Congress.

Department of Veterans Affairs (VA)

GAO: VA Needs Better Planning for ‘Complex’ Appeals System Overhaul

VA’s Consolidated Mail Outpatient Pharmacy (CMOP) in Charleston, SC. New legislation is seeking to increase clinician input into formulary decisionmaking. WASHINGTON — Legislation to prevent VA from outsourcing creation of its drug formulary and to... View Article

Department of Veterans Affairs (VA)

Community Providers Unprepared to Serve Veterans Under Choice Program

As the debate about increasing access for veterans to community-based provider heats up, a serious problem has emerged: Few providers outside the VA health system appear to be prepared to meet the unique challenges of the veteran population.

Department of Veterans Affairs (VA)

Former VA Secretary Nominee Claims Allegations Against Him Are False

Veterans’ groups expressed concern last month regarding a “lack of permanent leadership at the department,” after Rear Adm. Ronny L. Jackson, MD, withdrew his name from consideration as VA secretary amid anonymous allegations of misconduct.

Facebook Comment

Subscribe to U.S. Medicine Print Magazine

U.S. Medicine is mailed free each month to physicians, pharmacists, nurse practitioners, physician assistants and administrators working for Veterans Affairs, Department of Defense and U.S. Public Health Service.

Subscribe Now

Receive Our Email Newsletter

Stay informed about federal medical news, clinical updates and reports on government topics for the federal healthcare professional.

Sign Up