Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial

J Vasc Interv Radiol. 2011 Sep;22(9):1223-8. doi: 10.1016/j.jvir.2011.05.013. Epub 2011 Jul 14.


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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Webcast

MeSH terms

  • Aged
  • Aged, 80 and over
  • Amputation, Surgical
  • Angioplasty, Balloon* / adverse effects
  • Angioplasty, Balloon* / instrumentation
  • Angioplasty, Balloon* / mortality
  • Ankle Brachial Index
  • Atherectomy / adverse effects
  • Atherectomy / instrumentation*
  • Atherectomy / mortality
  • Chi-Square Distribution
  • Combined Modality Therapy
  • Embolic Protection Devices
  • Equipment Design
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Limb Salvage
  • Lower Extremity / blood supply*
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / diagnosis
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / mortality
  • Peripheral Arterial Disease / therapy*
  • Prospective Studies
  • Radiography
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Stents
  • Time Factors
  • Treatment Outcome
  • United States