Background: Peripheral arterial disease are a widespread pathology  associated with atherosclerosis, giving place only to coronary artery disease. Although current recommendations provide  a conservative strategy for patients with intermittent claudication (IC),  number of operations performed in connection with this disease remains high.  The aim оf investigation  to conduct  meta-analysis of clinical trials to assess  risk of adverse events  in groups of patients with intermittent claudication, who underwent early revascularization (open or endovascular) and  conservative treatment group over a long follow-up period (5 years or more). 

Materials and methods: Аnalysis included 6 clinical trials comparing conservative and operative treatment strategies  оf IC.  Following endpoints were evaluated:  frequency of unplanned revascularization procedures, progression to critical lower limb ischemia (СLI), high limb amputation, and overall mortality. The results of dichotomous outcomes are presented in the form of indicators of risk difference (PP) and confidence interval (CI). The model of fixed effects and the model of random variables were used to calculate PP. The heterogeneity coefficient (I2) was also determined. 

Study results: After 5 years of follow–up,  frequency of unplanned revascularization was significantly higher in  revascularization group compared with  conservative treatment group (PP 0.131; 95% CI: 0.0701-0.191, p < 0.001). Also, in  early revascularization group, frequency of limb amputation and progression to  CLI  was higher, but the research data were heterogeneous (I2 – 83.87%, I2 - 87.67%), and when using a randomized model, the differences between the groups turned out to be unreliable. Mortality is slightly higher in  conservative treatment group, but  differences between the groups are unreliable given the high heterogeneity of  data (I2 – 79.91%). 

Conclusion: A meta-analysis of clinical trial data comparing conservative and operative treatment strategies for  IC with a follow-up period  5 years  and  more shows the advantage of conservative tactics in relation to the risk of unplanned revascularization. There is a trend towards an increase in  frequency of amputations and progression to  CLI  in the early revascularization group compared with  conservative treatment group in clinical trials with a long follow-up period, however, this trend requires additional evidence given  high heterogeneity of data.