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.