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COBRA results published: Cryoplasty reduced restenosis rates in patients with diabetes
Results from the COBRA trial have indicated that cryoplasty using nitinol self-expanding stents significantly reduced 12-month in-stent restenosis rates compared with a conventional balloon among patients with diabetes who underwent superficial femoral artery stenting, confirming what was presented at Transcatheter Cardiovascular Therapeutics 2011.
Subhash Banerjee, MD, and fellow trial investigators randomly assigned 74 patients with 90 stented superficial femoral artery lesions to post-dilation using cryoplasty (n=45 lesions) or conventional balloon angioplasty (n=45 lesions).
Patients had a mean lesion length of 148 mm, mean stented length of 190 mm and mean stent diameter of 6.1 mm, and 50% of the lesions were total occlusions. Post-dilation balloon diameters were 5.23 mm in the cryoplasty arm vs. 5.51 mm in the angioplasty group (P=.02).
Twelve-month follow-up data revealed that among patients in the cryoplasty group, binary restenosis — defined as 2.5-fold increase in peak systolic velocity within the stented segment and within 10 mm of its proximal and distal edges — was significantly lower compared with angioplasty (29.3% vs. 55.8%; OR=0.36; 95% CI, 0.15-0.89).
Subhash Banerjee
“The complexity of [superficial femoral artery] lesions treated in the COBRA trial is greater than those in prior randomized studies performed in this area,” Banerjee, a Cardiology Today Intervention Editorial Board member, and colleagues wrote. “A comparison of outcomes in the total occlusion and bilateral treatment groups provides the opportunity to analyze the effect of cryoplasty for stent post-dilation in complex and unbiased subsets unique to this trial. The strategy of affecting outcomes with a post-dilation balloon may also be relevant to drug-coated stents.”
Disclosure: Banerjee receives research grants from Boston Scientific and The Medicines Company; consultant/speaker honoraria from Boehringer Ingelheim, Cordis, Gilead, Medtronic, Sanofi-Aventis and St. Jude Medical; is a consultant to Covidien; and has ownership in MDCare Global (spouse) and intellectual property in HygeiaTel.