Abstract
Background: Revascularization has been considered the gold standard
treatment for critical limb ischemia (CLI). Due to the high morbidity
and mortality associated with intervention, evidence has emerged
recently supporting the suitability of conservative management as a
primary option to achieve amputation-free survival (AFS) in CLI patients
even when revascularization is technically feasible. Methods: A
prospective database of CLI patients was developed during pre-screening
of patients for a phase 1 stem cell therapy clinical trial. The overall
survival (OS) and AFS rates for patients treated with revascularization
were compared to those treated conservatively. Statistical significance
was set as p value < 0.05. OS and AFS for the two groups were
estimated by Kaplan-Meier survival curves. Results: Patients in the
conservative group were more likely to have Rutherford Class 5 and be
diabetic while they were less likely to be active smokers or have
hyperlipidemia (Table 1). There were no significant differences between
the two groups in mortality, amputation, overall AFS or one-year AFS
rates. Kaplan-Meier cumulative OS and AFS over the 3 years follow-up
period of the study demonstrated significant differences between the
conservative and revascularization groups (Log Rank: 0.031 & 0.045;
respectively). This statistical significance was not detected when
one-year AFS was evaluated (Log Rank 0.096). Conclusion: Conservative
management can be a suitable management option to achieve one-year AFS
for some CLI patients. Further studies are needed to identify robust
clinical criteria for identifying patients who will benefit from
conservative management.