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Background: Optimal medical management is an integral part of the treatment of patients with peripheral arterial disease according to the Trans-Atlantic Intersocietal Conference (TASC) II guidelines. The aim of this study was to determine the proportion of patients with chronic critical limb ischemia (CLI) who failed to adhere to current guidelines of medical therapy and to quantify the effect of sub-optimal medical management on amputation free survival (AFS).
METHODS: The patient cohort was identified from a prospectively maintained database of consecutive patients presenting with CLI to the Vascular Surgery service at a single hospital. The primary outcome variable was amputation-free survival (AFS). The effects of baseline demographics, comorbid medical conditions, ambulatory status, optimal medical management, and Rutherford classification were assessed. Optimal medical management was defined as adherence to Trans-Atlantic Conference II recommendations for the management of atherosclerotic risk factors. Significant univariate predictors (p < 0.10) of AFS were entered into a multivariate Cox proportional hazards model.
RESULTS: From August 1, 2010 through January 1, 2012, 98 patients (mean age 59.9 +/- 10.1 (SD) years; 58 men; 40 women) were evaluated with rest pain (n=38) or tissue loss (n=60). The mean follow-up for the cohort was 333.3 +/- 196.1 days. Optimal medical management was identified in 32% of patients at initial presentation, including compliance rates of 63% for statin use, 71% on antiplatelet therapy, 51% for angiotensin-converting enzyme inhibitor use, and 49% for a beta-blocker use. Significant univariate predictors of major amputation or death included: non-ambulatory status (p<0.01, hazard ratio [HR] 2.17, 95% confidence interval [CI], 1.68-2.81); un-revascularized patients (p<0.01, HR, 2.77, 95% CI, 1.32, 5.85); a history of tobacco abuse (p=0.09, HR, 1.49, 95% CI 0.57, 3.86); a history of end-stage-renal disease (p<0.01, HR, 7.97, 95% CI, 3.10, 20.52), sub-optimal medical management (p=0.02, HR, 4.25, 95% CI, 1.28, 14.07), and an absence of anti-platelet agents (p=0.08, HR, 1.94, 95% CI, 0.92, 4.11). Independent predictors of major amputation or death included: initial non-ambulatory status (p<0.01, hazard ratio HR, 2.43; 95% CI, 1.03,2.05); un-revascularized status (p=0.01, HR, 2.43; 95% CI, 1.76, 3.34); and sub-optimal medical management at presentation (p<0.01, HR, 8.54; 95% CI, 2.05, 35.65.)
CONCLUSIONS: Despite guidelines advocating the optimization of atherosclerotic risk factors in peripheral arterial disease, less than one-third of patients with CLI present with their risk factors appropriately managed. Patients who are sub-optimally medically managed have greater than a four-fold risk of major amputation and/or death. Of the risk factors affecting amputation-free survival, medical therapy optimization is the variable that can be most significantly improved by vascular surgeons and the medical community. Population based efforts to improve outcomes in CLI require attention to improving the medical management.