Covered Stents Versus Bare Metal Stents in the Treatment of Aorto-iliac Disease: A Systematic Review and Individual Participant Data Meta-analysis.

ABSTRACT

OBJECTIVE: To assess the comparative safety and efficacy of covered stents (CS) and bare metal stents (BMS) in the endovascular treatment of aorto-iliac disease in patients with peripheral arterial disease. DATA SOURCES A systematic review was conducted adhering to the PRISMA 2020 and PRISMA for Individual Participant Data 2015 guidelines. REVIEW METHODS: A search of PubMed, Scopus, and Web of Science for articles published by December 2023 was performed. The primary endpoint was primary patency. Certainty of evidence was assessed via the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. RESULTS: Eleven studies, comprising 1 896 patients and 2 092 lesions, were included. Of these, nine studies reported on patients' clinical status, with 35.5% classified as Rutherford 4 - 6. Overall primary patency for CS and BMS at 48 months was 91.2% (95% confidence interval [CI] 84.1 - 99.0%) (GRADE, moderate) and 83.5% (95% CI 70.9 - 98.3%) (GRADE, low). The one stage individual participant data meta-analyses indicated a significant risk reduction for primary patency loss favouring CS (hazard ratio [HR] 0.58, 95% CI 0.35 - 0.95) (GRADE, very low). The 48 month primary patency for CS and BMS when treating TransAtlantic Inter-Society Consensus (TASC) C and D lesions was 92.4% (95% CI 84.7 - 100%) (GRADE, moderate) and 80.8% (95% CI 64.5 - 100%) (GRADE, low), with CS displaying a decreased risk of patency loss (HR 0.39, 95% CI 0.27 - 0.57) (GRADE, moderate). While statistically non-significant differences were identified between CS and BMS regarding technical success, 30 day mortality rate, intra-operative and immediate post-operative procedure related complications, and major amputation, CS displayed a decreased re-intervention risk (risk ratio 0.59, 95% CI 0.40 - 0.87) (GRADE, low). CONCLUSION: This review has illustrated the improved patency of CS compared with BMS in the treatment of TASC C and D lesions. Caution is advised in interpreting overall primary patency outcomes given the substantial inclusion of TASC C and D lesions in the analysis. Ultimately, both stent types have demonstrated comparable safety profiles.