Abstract 11141: Long-term Clinical Outcomes after Endovascular Therapy for Patients with Critical Limb Ischemia due to Isolated Below the Knee Lesions
Background: Long-term clinical outcomes after endovascular therapy (EVT) for patients with critical limb ischemia (CLI) due to isolated below the knee (BTK) lesions have not yet been systematically studied. The objective of this study was to examine long-term clinical outcomes after EVT to determine the risk stratification for patient overall survival (OS), freedom from major amputation (FFMA), and reintervention.
Method: Between March 2004 and October 2010, 465 limbs (Rutherford 5 and 6: 79%) from 406 patients with CLI due to isolated BTK lesions were treated by angioplasty alone. Endpoints out to 5 years (Kaplan-Meier analysis), differences (log-rank test), and independent predictors and risk stratification (Cox proportional hazards model) were assessed. Likely reintervention time period after angioplasty was estimated (receiver operating characteristic [ROC] analysis).
Results: Notable baseline characteristics included patient age (71±11yrs), diabetes mellitus (69%, 280/406), and end stage renal disease (ESRD) on dialysis (60%, 242/406). Mean follow-up was 18±15 mo. OS was 76±2, 57±4 and 41±6% at 1, 3, and 5 years, respectively. Predictors of overall survival were body mass index <18 (hazard ratio [HR], 2.7; 95% confidence interval [CI], 1.3-5.5, P=0.009), non-ambulatory status (HR, 1.9; 95% CI, 1.1-3.2, P= 0.02) and ejection fraction <45% (HR, 3.7; 95% CI, 1.8-7.4, P= 0.0003). FFMA was 79±2% at 5 years. Factors associated with major amputation were ulcers defined as Rutherford 6 (HR, 2.3; 95% CI, 1.2-4.4, P= 0.0095), presence of diabetes mellitus (HR, 2.3: 95% CI, 1.1-4.8, P= 0.0269), CRP>5 (HR, 2.6: 95% CI, 1.3-5.3, P= 0.0103), and age < 60 (HR, 2.8: 95% CI, 1.4-5.3, P= 0.0025). Five year freedom from reintervention was 53±5%; and age (HR, 0.97; 95% CI, 0.95-0.99, P=0.0007) and number of BTK run-off after angioplasty (HR, 0.67; 95% CI, 0.51-0.85, P=0.0015) were both negatively associated with reintervention. The ROC analysis showed that maximum sensitivity and specificity was observed at 5.5 months following angioplasty.
Conclusions: Despite relatively high mortality and reintervention rates, FFMA was acceptable after EVT for patients with CLI presenting with isolated BTK lesions
- © 2011 by American Heart Association, Inc.