Results:
A total of 280 CLI patients were included in the study with 128 (44.6%) of patients treated conservatively. The majority of patients were males (70.7%), with mean age of 71.6 years. At baseline, 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 conservative and the revascularization groups in mortality, amputation (major and minor), overall AFS and one-year AFS rates (Table 2).
Kaplan-Meier cumulative overall survival 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) (Figure 1 & 2). This statistical significance was not detected when one-year AFS was evaluated (Log Rank 0.096) (Figure 3).
Further evaluation of the clinical outcome of the conservatively treated group was performed by comparing the baseline characteristics of patients who recovered to those who had amputation or died during the follow up period. Recovery was defined as complete resolution of rest pain for patients with Rutherford class 4 CLI or complete ulcer healing for Rutherford class 5 patients. In univariate analysis, diabetes and chronic kidney disease were associated with higher rates of amputation and/or mortality in CLI patients treated conservatively (Table 3).