Pilot Trial of Cryoplasty or Conventional Balloon Post-Dilation of Nitinol Stents for Revascularization of Peripheral Arterial Segments: The COBRA Trial

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• 作者：Subhash Banerjee ; Tony S. Das ; Mazen S. Abu-Fadel ; Eric J. Dippel ; Nicolas W. Shammas ; Daniel L. Tran ; Ahmad Zankar ; Cyril Varghese ; Kevin C. Kelly ; Rick A. Weideman ; Bertis B. Little ; Robert F. Reilly ; Tayo Addo ; Emmanouil S. Brilakis
• 关键词：cryoplasty ; diabetes mellitus ; peripheral arterial disease ; superficial femoral artery
• 刊名：Journal of the American College of Cardiology
• 出版年：2012
• 出版时间：9 October, 2012
• 年：2012
• 卷：60
• 期：15
• 页码：1352-1359
• 全文大小：733 K

文摘

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ss=""h4"">Objectives

The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease.

ss=""h4"">Background

Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus.

ss=""h4"">Methods

We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon. Inclusion criteria included diabetes mellitus, symptomatic peripheral arterial disease, and superficial femoral artery lesions requiring implantation of stents >5 mm in diameter and >60 mm in length. Primary endpoint was binary restenosis at 12 months, defined as ¡Ý2.5-fold increase in peak systolic velocity by duplex ultrasonography.

ss=""h4"">Results

Seventy-four patients, with 90 stented superficial femoral artery lesions, were randomly assigned to post-dilation using cryoplasty (n = 45 lesions) or conventional balloons (n = 45 lesions). Mean lesion length was 148 ¡À 98 mm, mean stented length was 190 ¡À 116 mm, mean stent diameter was 6.1 ¡À 0.4 mm, and 50 % of the lesions were total occlusions. Post-dilation balloon diameters were 5.23 ¡À 0.51 mm versus 5.51 ¡À 0.72 mm in the cryoplasty and conventional balloon angioplasty groups, respectively (p = 0.02). At 12 months, binary restenosis was significantly lower in the cryoplasty group (29.3 % vs. 55.8 % , p = 0.01; odds ratio: 0.36, 95 % confidence interval: 0.15 to 0.89).

ss=""h4"">Conclusions

Among diabetic patients undergoing implantation of nitinol self-expanding stents in the superficial femoral artery, post-dilation with cryoplasty balloon reduced binary restenosis compared to conventional balloon angioplasty. (Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease [COBRA]; )