Clinical studyPercutaneous Lower-extremity Arterial Interventions with Primary Balloon Angioplasty Versus SilverHawk Atherectomy and Adjunctive Balloon Angioplasty: Randomized Trial
Section snippets
Materials and Methods
A two-center, randomized trial was performed to compare the treatment of infrainguinal de novo lesions with PTA versus atherectomy with adjunctive balloon angioplasty. Adjunctive balloon angioplasty in the atherectomy arm was used to record the pressure needed for full balloon expansion after debulking. Patients were included if they were at least 18 years of age and referred for claudication (ie, Rutherford–Becker class I–III) or critical limb ischemia (ie, Rutherford–Becker class IV–V). They
Results
Fifty-eight patients were included in the study. Of these, 29 (36 vessels) were randomized to the atherectomy arm and 29 (48 vessels) to the PTA arm. Baseline clinical and demographic variables were all similar between the two groups (Table 1). Patients were elderly in general, with a high incidence of diabetes and hypertension and high baseline high-sensitivity C-reactive protein levels. Approximately 20% of patients had critical limb ischemia and 80% had claudication. Baseline procedural
Discussion
In the present study, TLR and TVR rates at 1 year were statistically similar in the atherectomy arm with adjunctive PTA and the primary PTA arm. However, atherectomy with adjunctive PTA significantly reduced stent use compared with PTA alone. In addition, optimal balloon inflation after atherectomy with adjunctive PTA was achieved at lower pressures than with primary PTA, which may have been related to improved compliance of the pretreated lesion with atherectomy. Published studies suggest that
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This study was supported in part by FoxHollow (ev3, Plymouth, Minnesota), Edwards Lifesciences (Irvine, California), and the Nicolas and Gail Shammas Research Fund at the Midwest Cardiovascular Research Foundation.