Therapeutic approach to CLI with tissue loss--a comparative prospective cohort study in Finland and Japan.

Background: To compare the demographics, chosen treatment options, and 1-year outcome of patients with severe critical limb ischemia (Fontaine IV) in 2 different patient cohorts.

Methods: A total of 118 consecutive patients with an ischemic tissue lesion in a lower extremity referred for the first time to the vascular surgery outpatient clinic of Helsinki University Hospital and 96 patients referred to the Division of Vascular Surgery of the Tokyo Medical and Dental University Hospital were included in this comparative analysis. Kaplan-Meier estimates were used to assess survival, leg salvage, and amputation-free survival (AFS). Propensity score analysis was used to adjust for differences between the study groups.

Results: The median age of the study cohorts was greater in Finland than in Japan (80 vs. 69 years, P < 0.001). The prevalence of coronary artery disease and hypertension were greater in the Finnish cohort (72% vs. 41%, P < 0.001 and 86% vs. 51%, P < 0.001, respectively). The prevalence of male gender (77% vs. 42%, P < 0.001), cerebrovascular disease (35% vs. 20%, P = 0.015), end-stage renal disease (35% vs. 5%, P < 0.001), and current smoking (64% vs. 21%, P < 0.001) was greater in the Japanese cohort. The prevalence of diabetes did not differ between the cohorts (52% vs. 47%, P = 0.286). The proportion of independently ambulant patients at referral was greater in Finland (80% vs. 54%, P < 0.001). In Helsinki and Tokyo, the initial treatment was bypass, an endovascular procedure, conservative treatment, and amputation in 42% vs. 41%, 24% vs. 14%, 24% vs. 41%, and 10% vs. 5% of the cases, respectively. One-year survival, leg salvage, and AFS were 65% vs. 71% (P = 0.326), 82% vs. 74% (P = 0.216), and 59% vs. 55% (P = 0.573) in the Finnish and Japanese cohorts, respectively. AFS was significantly better in ambulant than in nonambulant patients in the combined data (68% vs. 36%, P < 0.001). Adjusted propensity score analysis showed no statistical difference in survival between the study cohorts.

Conclusions: The pattern of comorbid conditions in these 2 patient cohorts is significantly different, but the outcome did not differ significantly between cohorts.