Introduction:
Critical limb ischemia (CLI) is the most severe stage of peripheral vascular disease (PVD), affecting 3-10% of the population [1]. Clinically, patients present with rest pain and/or tissue loss (ulcers or gangrene). Revascularization has been considered the gold standard treatment for CLI, based on the guidelines of the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) [2]. However, the short term risk of amputation and/or death after revascularization remains high [3]. A multicentre clinical trial reported only 35% amputation-free survival rate at 5 years after either surgical bypass or endovascular angioplasty [4]. There is also a considerable morbidity after revascularization related to wound infection or grafts occlusion requiring re-intervention. Therefore, careful patient assessment is crucial to determine the risk/benefit ratio prior to intervention.
Revascularization cannot be achieved in 25 – 40% of patients [2], due to medical comorbidities or anatomically diffuse disease. These “no-option” CLI patients are at high risk for major amputation and/or death. Nevertheless, some of these patients improve significantly on conservative management with best medical therapy and optimal wound care. A retrospective cohort study of 144 patients reported no significant improvement in amputation-free survival (AFS) of invasively treated patients, concluding that “not all CLI patients require revascularization” [5]. A systematic review including 11 clinical trials revealed significant improvement in AFS for no-option CLI patients [6], indicating the important role of conservative management as a definite treatment for CLI.
In this study, we compare the overall survival (OS) and AFS rates for patients treated with revascularization versus conservative management, to determine suitability of the latter as a main first line treatment for CLI even when revascularization is technically feasible.