Peripheral Arterial Disease Clinical Predictors of Long-Term Outcomes in Patients With Critical Limb Ischemia Who have Undergone Endovascular Therapy Shang-Hung Chang, MD, PhD 1 , Yueh-Ju Tsai, MD 2 , Hsin-Hua Chou, MD 3 , Tien-Yu Wu, MD 3 , Chien-An Hsieh, MD 3 , Shih-Tsung Cheng, MD 3 , and Hsuan-Li Huang, MD 3 Abstract Clinical predictors of long-term outcomes in patients with critical limb ischemia (CLI) treated with endovascular therapy (EVT) remain unclear. In this study, clinical predictors of long-term outcomes in EVT-treated patients with CLI were investigated. In this prospective, observational study, we analyzed a total of 253 Taiwanese patients with CLI with 314 limbs who underwent EVT between 2005 and 2012. Cox models were used to estimate hazard ratios of death, limb loss, and sustained clinical success (SCS). Multivariate analysis showed that age, atrial fibrillation (AF), end-stage renal disease (ESRD), and albumin were significant predic- tors of mortality. Patients with coronary artery disease and low albumin levels had a significant risk of major limb amputation, while AF, ESRD, and albumin were significant, independent predictors of SCS. In addition to previously reported predictors, we showed that AF and malnutrition can be used to predict long-term outcome in EVT-treated patients with CLI. Keywords critical limb ischemia, endovascular therapy, prognosis, predictors, nutrition Introduction Critical limb ischemia (CLI) is an end-stage presentation of peripheral arterial disease (PAD), with a prevalence of 15% to 20% in persons older than 70 years. 1-3 The heavy economic burden imposed by CLI is reflected by the high primary ampu- tation rates in these patients (10%-40% increasing to about 50% in untreated patients). 2,4-6 The major risk factors for CLI are thought to be old age, smoking, and diabetes mellitus (DM). 7 A recent meta-analysis, which analyzed a total of 50 studies, showed that presence of ischemic heart disease, tissue loss, and older age were all correlated with a higher probability of death at 3 years. 8 The prognosis of patients with CLI is bleak and without timely revascularization. Patients with CLI: (1) are at higher risk of limb loss, extremely slow wound healing, pro- gression of gangrene, and development of sepsis, 9,10 and (2) have a higher risk of mortality. 2,11 The goal of CLI therapy is to restore pulsatile flow to help wound healing, limb salvage, and to improve quality of life. This revascularization can be achieved by (1) bypass surgery or (2) endovascular therapy (EVT) with strategies such as percutaneous transluminal angioplasty, subintimal angioplasty, drug-eluting stents, and cutting balloon angioplasty. 10,12,13 A dual vascular access technique using a combination of antegrade femoral and retrograde tibial approaches was also recently used to successfully treat complex popliteal and infrapopliteal occlusions. 14 The complications and mortality associated with bypass surgery have led to a recent shift to endovascular procedures. Endovascular therapy has been recently recommended as first-line treatment for patients expected to live <2 years, while bypass surgery is recom- mended for patients expected to live >2 years. 15 A comparison between bypass surgery and EVT in patients with CLI showed no significant difference between amputation-free survival (AFS), overall survival, and limb salvage rates, although the EVT group showed significantly lower rate of major adverse limb events. 16 Although long-term data are not available, 1 meta-analysis reported 3-year outcomes of 68% survival, 1 Section of Cardiology, Chang Gung Memorial Hospital, Taoyuan, Taiwan 2 Department of Ophthalmology, Chang Gung Memorial Hospital, Taoyuan, Taiwan 3 Department of Internal Medicine, Section of Cardiology, Taipei Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation, Taiwan Corresponding Author: Hsuan-Li Huang, Taipei Tzuchi Hospital, The Buddhist Tzuchi Medical Founda- tion, Taiwan: 289 Jiang Kuo Road, Xindian District, New Taipei City 231, Taiwan. Email: huang304@gmail.com Angiology 2014, Vol. 65(4) 315-322 ª The Author(s) 2013 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0003319713515544 ang.sagepub.com