High- Versus Low-Dose Paclitaxel-Coated Balloons for Femoropopliteal Disease: A systematic review and meta-analysis.

To evaluate the comparative effectiveness of high- and low doses of paclitaxel in endovascular revascularization procedures for patients with femoropopliteal disease. The databases (Embase, PubMed, Scopus, and Web of Science) were searched for studies that had compared outcomes of high-dose and low-dose paclitaxel-coated balloons (PCBs) in the treatment of patients with femoropopliteal disease. Randomized controlled trials and nonrandomized comparative studies (eg, cohort studies and case-control studies) were eligible for inclusion. The primary outcomes of interest were patency rates, risk of restenosis, and clinically-driven target lesion revascularization (CD-TLR). Pooled effect sizes were reported as relative risk (RR) with 95% confidence intervals (CI). The analysis included 7 studies. High-dose PCB use was associated with higher patency (RR, 1.10; 95% CI, 1.00-1.21), reduced risk of restenosis (RR, 0.60; 95% CI, 0.46-0.79), and reduced need for CT-TLR (RR, 0.57; 95% CI, 0.41-0.79) compared to low-dose PCB. Rates of limb salvage (RR, 1.01; 95% CI, 0.99-1.04), freedom from major adverse limb events (RR, 1.39; 95% CI, 0.79-2.42), and overall survival (RR, 1.02; 95% CI, 0.99-1.05) were comparable in the 2 groups. There was no evidence of publication bias. High-dose PCB correlates with superior outcomes in patients with femoropopliteal disease, particularly in terms of better vascular patency, reduced restenosis risk, and lower need for target lesion revascularization, compared to low-dose PCB.