title: The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease.
abstract: OBJECTIVE
  This study compares treatment results of orbital atherectomy (OA) vs balloon angioplasty (BA) for calcified femoropopliteal (FP) disease. BA for calcified FP disease is associated with increased dissection rates and suboptimal results. OA is hypothesized to decrease these acute complications via lesion compliance change.
  
  
  METHODS
  Fifty patients (65 lesions) with calcified FP disease were randomized to OA plus BA vs. BA alone and followed for 12 months. The primary endpoint was freedom from target lesion revascularization (TLR), including adjunctive stenting, or restenosis as evidenced by duplex ultrasound at 6 months.
  
  
  RESULTS
  Mean maximum balloon pressure was 4.0 atm in the OA arm vs. 9.1 atm in the BA arm (P<.001). In subjects with residual stenosis >30%, the operator chose to stent 2/38 lesions (5.3%) in the OA arm vs 21/27 lesions (77.8%) in the BA arm (P<.001). Freedom from TLR (including adjunctive stenting) or restenosis was achieved in 77.1% of lesions in the OA group vs. 11.5% in the BA group (P<.001) at 6 months, and 81.2% vs. 78.3% at 12 months, excluding adjunctive stenting (P>.99).
  
  
  CONCLUSIONS
  Compared to BA alone, OA plus BA yields better luminal gain by improving lesion compliance and decreases adjunctive stenting in the treatment of calcified FP disease. At 12 months, the occurrence of TLR or restenosis was similar in both groups despite the large disparity in stent usage at the time of initial treatment.
authors.affiliation: Flint Hills Heart, Vascular and Vein Clinic, 3905 Vanesta Drive, Manhattan, KS 66503 USA. icardmd@aol.com.
authors.forename: Raymond
authors.initials: R
authors.lastname: Dattilo
authors.forename: Stevan I
authors.initials: SI
authors.lastname: Himmelstein
authors.forename: Robert F
authors.initials: RF
authors.lastname: Cuff
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D017073:Atherectomy / Q000009:adverse effects / Q000379:methods; D002114:Calcinosis / Q000209:etiology / Q000473:pathology; D005260:Female; D005263:Femoral Artery / Q000473:pathology / Q000601:surgery; D006801:Humans; D007431:Intraoperative Complications / Q000175:diagnosis / Q000209:etiology; D000069451:Long Term Adverse Effects; D035002:Lower Extremity / Q000098:blood supply; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery; D010865:Pilot Projects; D011150:Popliteal Artery / Q000473:pathology / Q000601:surgery; D015607:Stents; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex / Q000379:methods