Systematic Review, Meta-analysis, and Trial Sequential Analysis of Randomised Controlled Trials Comparing Balloon...

This review aimed to investigate the efficacy and safety of balloon expandable vs. self expanding stents in the treatment of iliac artery occlusive disease.

A systematic review of randomised controlled trials (RCTs) comparing balloon expandable with self expanding stents for the treatment of iliac artery occlusive disease was conducted following PRISMA guidelines. MEDLINE and Embase were searched using the Ovid interface. Meta-analysis and trial sequential analysis were performed. Dichotomous data were pooled using fixed effects models (Mantel-Haenszel method). Trial sequential analysis assumed alpha = 5% and power = 80%. The revised Cochrane tool and GRADE framework were used to assess risk of bias (RoB) and certainty of evidence, respectively.

Three RCTs reporting 891 patients were included. Meta-analysis found no statistically significant difference in target vessel revascularisation (TVR) (odds ratio [OR] 1.55, 95% confidence interval [CI] 0.43-5.58; p = .50), primary patency (OR 1.24, 95% CI 0.34-4.48; p = .74), amputation (risk difference 0.00, 95% CI -0.02 - 0.02; p = .99), and major adverse vascular events (OR 1.89, 95% CI 0.90-3.97; p = .090) when balloon expandable stents were compared with self expanding stents. For target lesion revascularisation (TLR), the results favoured self expanding stents (OR 2.26, 95% CI 1.00-5.11; p = .050) with borderline statistical significance. Odds of death were lower for self expanding stents (OR 3.25, 95% CI 1.16-9.05; p = .020). Trial sequential analysis confirmed that further trials are required to demonstrate a significant effect. There were "some concerns" in RoB for TLR and TVR, and high RoB in one study for primary patency. Certainty of evidence was low.

Meta-analysis of highest level data showed no significant difference in certain clinical outcomes between balloon expandable and self expanding stents in the treatment of iliac artery occlusive disease. Overall, there are insufficient data in the current literature to ascertain the superiority of one stent strategy over another, and trial sequential analysis confirmed that further trials are required.