Abstract
INTRODUCTION: Despite improvements in endovascular interventions and multidisciplinary approaches, improving clinical outcomes and increasing limb salvage have become increasingly challenging. This prospective study investigated the associations of cilostazol treatment with clinical outcomes and predictive factors in patients with diabetes mellitus (DM) and critical limb ischemia (CLI) after endovascular revascularization of the affected angiosome. METHODS: In this study, 172 consecutive patients with CLI (Fontaine levels III-IV) received cilostazol treatment after successful endovascular intervention according to the angiosome concept, and their primary patency rates and cardiovascular and amputation events during a 24-month follow-up period were assessed. RESULT: The 24-month primary patency rate, mortality rate, and amputation rate were better in the patients under long-term cilostazol treatment (P < 0.001, P = 0.029, and P = 0.014). Weighted multivariate Cox analyses with a propensity scoring-based method showed that long-term cilostazol treatment [hazard ratio (HR) 0.2, 95% confidence interval (CI) 0.11-0.36, P < 0.001], direct revascularization (DR) (HR 0.46, 95% CI 0.28-0.74, P = 0.002), and supervised exercise (HR 0.4, 95% CI 0.24-0.66, P < 0.001) were independently associated with primary patency. Patients with lower-extremity amputation (LEA) had a higher risk of coronary artery disease (CAD) and mortality. Cellulitis and neuropathy were independently associated with LEA events (cellulitis: HR 2.89, 95% CI 1.66-5.05, P < 0.001; neuropathy: HR 2.2, 95% CI 1.31-3.7, P = 0.003). CONCLUSION: Our results showed that patients with DM who received cilostazol treatment for more than 3 months had significantly better outcomes and decreased amputation and mortality rates after DR, and cellulitis and neuropathy were highly associated with the risk of limb loss. A large-scale randomized trial should be conducted in the future to confirm these results. TRIAL REGISTRATION: Taipei Veterans General Hospital (TVGH) IRB no. 2013-08-020B. Registered 30 August 2013.