The Natural History and Outcomes of Endovascular Therapy for Claudication.

BACKGROUND: The natural history of claudication is well-characterized and traditional therapy includes risk factor modification and exercise protocols with revascularization reserved for patients who are severely impaired. However, the reduced periprocedural morbidity with endovascular therapy has led physicians to broaden the indications for intervention for peripheral artery disease, and more claudicants are undergoing procedures for disease that is moderately limiting to their lifestyle. This study sought to assess the natural history of patients who have undergone peripheral vascular intervention for claudication.

METHODS: All patients who underwent at least 1 peripheral vascular intervention (PVI) for claudication at a single institution from January 2007 to December 2013 were identified. Patient demographics were assessed using the hospital record. Outcomes included secondary endovascular intervention, secondary bypass intervention, amputation, and survival. Cox proportional hazards models were created to assess risk factors for further intervention.

RESULTS: Five hundred fifteen patients were identified as having undergone PVI for claudication during the study period. Forty-three percent were female, 37% had diabetes, 31% had coronary artery disease, 26% were current smokers, 6.6% had congestive heart failure, 8.2% had a tibial lesion that was intervened upon, and 35% had a Trans-Atlantic Inter-Society Consensus Document (TASC) II C/D lesion. Actuarial survival at 5 years was 79.9% and 62.5% of patients had primary patency. The limb salvage rate was 97.2%. Over the follow-up period, 21.8% required some type of further intervention: either endovascular (17.7%) or open bypass (7.2%). A Cox proportional hazards model adjusting for age, sex, and other comorbidities showed that the two largest risk factors for requiring reintervention were angioplasty only (no stent; hazard ratio [HR] 1.36, P = 0.02) and TASC C/D lesion (HR 1.52, P = 0.03).

CONCLUSIONS: With 5-year follow-up, patients have a primary patency that is comparable to an open prosthetic bypass to an above knee target. In addition, the secondary patency rate was over 90% and the major amputation rate as less than 3%. The presence of a TASC C/D lesion was predictive of failure of endovascular therapy, and surgical bypass should be considered in these patients.