Clinical study
Percutaneous Lower-extremity Arterial Interventions with Primary Balloon Angioplasty Versus SilverHawk Atherectomy and Adjunctive Balloon Angioplasty: Randomized Trial

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Abstract

Purpose

Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus SilverHawk atherectomy and adjunctive PTA of de novo infrainguinal disease has not been well defined. This study was conducted to compare the two approaches.

Materials and Methods

In this prospective, two-center randomized trial of PTA versus atherectomy of infrainguinal vessels, the primary endpoint of TLR was evaluated at 1 year. Secondary endpoints included the rate of “bailout” stent placement for suboptimal acute angiographic results and the rate of target vessel revascularization (TVR).

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. Final acute angiographic success rates were 100% in the PTA arm and 97.2% in the atherectomy arm (P value not significant). There was no statistical difference in TLR (16.7% vs 11.1%) or TVR (21.4% vs 11.1%) between the PTA and atherectomy groups, respectively. Bailout stent placement was performed in 18 of 29 patients (62.1%) in the PTA arm and eight of 29 patients (27.6%) in the atherectomy arm (P = .017). Major adverse events were similar between the PTA and atherectomy arms. Finally, when embolic filter protection was used, distal macroembolization occurred in 11 of 17 patients (64.7%) treated with atherectomy versus none of 10 in the PTA group (P < .001).

Conclusions

TLR and TVR at 1 year were statistically similar in atherectomy and primary PTA. Atherectomy reduced the need for bailout stent placement compared with primary PTA.

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.

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