title: Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Midwest Cardiovascular Research Foundation, Davenport, IA 52803, USA. shammas@mchsi.com
authors.forename: Nicolas W
authors.initials: NW
authors.lastname: Shammas
authors.forename: Denise
authors.initials: D
authors.lastname: Coiner
authors.forename: Gail A
authors.initials: GA
authors.lastname: Shammas
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Dippel
authors.forename: Lori
authors.initials: L
authors.lastname: Christensen
authors.forename: Michael
authors.initials: M
authors.lastname: Jerin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D055109:Ankle Brachial Index; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D003131:Combined Modality Therapy; D057505:Embolic Protection Devices; D004867:Equipment Design; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D011859:Radiography; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States