OBJECTIVES:

Given the significant burden of critical limb ischemia (CLI), endovascular interventions with stent use remains challenging. Recognizing methodological and practical limitations which exist in conventional clinical trials, real-world evidence (RWE) is increasingly adopted in research for CLI management. This study assessed the quality and the comprehensiveness of RWE on the clinical and economic outcomes associated with below-the-knee (BTK) drug-eluting stents (DES) and bare-metal stents (BMS) in CLI patients.

METHODS:

A systematic literature review was conducted to identify RWE studies on DES and BMS published in the United States between January 2011 and September 2021. A critical appraisal of studies was performed using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist and the Critical Appraisal Skills Programme (CASP) assessment tool for cohort studies.

RESULTS:

Of the 42 RWE studies identified, 8 (6 clinical and 2 economic) were critically analyzed: 67% (4) met the STROBE criteria for addressing confounders. The CASP tool highlighted: 1) study design issues (external validity), 2) limited information on the strategies to minimize selection, and 3) low external validity of the study findings. The STROBE checklist showed: 1) study design issues, 2) missing data not addressed, 3) limited information to minimize systematic bias and confounders, 4) missing flow chart of included and excluded participants, and 5) threats to external validity due to the choice of database.

CONCLUSIONS:

This appraisal demonstrates that eligible RWE studies are well-designed, powered, and offer reliable evidence to discern a statistical difference to clinicians and payers on the clinical and economic outcomes of BTK DES and BMS in CLI patients. However, the evidence supporting the economic outcomes of BTK stents is limited. Since payers rely on economic studies to enhance resource decision-making, there is a need for more healthcare economic data on the value of endovascular interventions for the treatment of CLI.