title: Endovascular management of patients with critical limb ischemia.
abstract: BACKGROUND
  Although percutaneous intervention (PTA) is considered first-line therapy for peripheral vascular disease in many scenarios, its role in critical limb ischemia (CLI), wherein anatomic disease is more extensive, remains unclear. In the present study, late (5-year) clinical and patency data for PTA in CLI are defined.
  
  
  METHODS
  From January 2002 to December 2007, 409 patients underwent infrainguinal PTA ± stent for CLI (Rutherford IV-VI) of 447 limbs. Primary patency, assisted patency, limb salvage, and survival were assessed using Kaplan-Meier. Predictors of patency, limb salvage, and death were determined using multivariate models.
  
  
  RESULTS
  Demographics included age (70 ± 12 years old), diabetes (65.8%), and dialysis dependence (13%). The superficial femoral artery was treated in 58% of the patients, 16% were limited to the crural vessels, 38% had multilevel treatment, and stents were placed in 26%. Eighty percent of patients received postprocedure clopidogrel. Mean follow-up was 28 months (0-83). Five-year primary and assisted patency were 31% ± 0.04 and 75% ± 0.04, respectively. Limb salvage at 5 years was 74% ± 0.038. Sixty-three patients had major amputations. Survival at 5 years was 39% ± 0.03. Multivariate analysis identified dialysis dependence (P = .0005; 2.7 [1.6-4.8]), ≤1 vessel runoff (P = .02; 1.5 [1.1-2.0]), and warfarin use (P = .001; 1.7 [1.25-2.3]) as negative predictors of primary patency, but none of these were negative predictors of assisted patency. Dialysis dependence (P = .006; 2.5 [1.3-4.8]), female gender (P = .02; 2.0 [1.1-3.7]), and ≤1 vessel run-off (P = .04; 1.8 [1.0-3.2]) predicted limb loss. Dialysis dependence (P = .0003; 2.3 [1.5-3.5]), diabetes (P = .04; 1.5 [0.5-2.1]), and poor run-off (P = .04; 1.6 [1.2-2.1]) were predictors of mortality.
  
  
  CONCLUSIONS
  Although primary patency is low, excellent limb salvage rates can be achieved in patients with CLI through close follow-up and secondary interventions. These data, and the 12% annual death rate, validate PTA as first-line therapy in patients with CLI.
authors.affiliation: Massachusetts General Hospital, Vascular and Endovascular Surgery, 15 Parkman Street, WAC 440, Boston, MA 02114, USA. mconrad@partners.org
authors.forename: Mark F
authors.initials: MF
authors.lastname: Conrad
authors.forename: Robert S
authors.initials: RS
authors.lastname: Crawford
authors.forename: Lauren A
authors.initials: LA
authors.lastname: Hackney
authors.forename: Vikram
authors.initials: V
authors.lastname: Paruchuri
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Abularrage
authors.forename: Virendra I
authors.initials: VI
authors.lastname: Patel
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Lamuraglia
authors.forename: Richard P
authors.initials: RP
authors.lastname: Cambria
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D001900:Boston; D000077144:Clopidogrel; D016638:Critical Illness; D005260:Female; D006801:Humans; D007511:Ischemia / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine