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

Banerjee S, Das TS, Abu-Fadel MS, et al (Univ of Texas Southwestern Med Ctr, Dallas; Presbyterian Hosp of Dallas, TX; Univ of Oklahoma Health Sciences Ctr, Oklahoma City; et al) J Am Coll Cardiol 60:1352-1359, 2012^§

Abstract

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.

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.

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 ≥2.5-fold increase in peak systolic velocity by duplex ultrasonography.

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