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.