Comparison of safety and efficacy of femoropopliteal arterial disease using different dose drug-coated balloons: Systematic review and meta-analysis.

Background: Endovascular therapy with balloon percutaneous angioplasty (PTA) in the femoro-popliteal segment is frequently performed, however, long-term favorable outcomes and patency remain challenging, with restenosis rates reaching 60% post-standard balloon angioplasty. Drug-coated balloons (DCBs) have shown promise in improving these outcomes; Paclitaxel, used in DCBs, inhibits hyperplasia and smooth muscle cell proliferation, reducing restenosis; however, the optimal dose of Paclitaxel remains unclear, with high-dose (HD-DCB [>3 mg/mm]) and low-dose (LD-DCB [<2.0 mg/mm]) options available. This meta-analysis aims to compare the efficacy and safety of HD-DCB and LD-DCB in treating femoropopliteal arterial disease.

Methods: We followed PRISMA guidelines and conducted a comprehensive search of PubMed, EMBASE, Cochrane, Scopus, and Mendeley up to May 27, 2024. We included randomized controlled trials and cohort studies comparing HD-DCB and LD-DCB in patients with femoropopliteal arterial disease. Data were extracted on baseline characteristics, outcomes, and study quality. The Newcastle-Ottawa Scale and ROB2 tool were used for bias assessment. Outcomes included overall survival (OS), limb salvage (LS), freedom from clinically driven target lesion revascularization (CD-TLR), and major amputation.

Results: Six studies comprising 2563 patients were included. HD-DCB showed a significant benefit in limb salvage at 6 months (RR = 0.38, 95% CI = 0.18-0.78, = .009) but not at 12 months (RR = 3.08, 95% CI = 0.14-67.13, = .47). No significant difference was observed in overall survival between HD-DCB and LD-DCB at either 6 months (RR = 1.53, 95% CI = 0.25-9.57, = .65) or 12 months (RR = 1.21, 95% CI = 0.17-8.84, = .85). HD-DCB was associated with an increased risk of perioperative complications (RR = 1.90, 95% CI = 1.14-3.17, = .01) and a higher, though not statistically significant, risk of major amputation (RR = 4.73, 95% CI = 0.54-41.52, = .16).

Conclusion: HD-DCB may offer advantages in limb salvage over LD-DCB in the short term, but this comes with an increased risk of perioperative complications. These findings underscore the need for careful patient selection when considering HD-DCB for femoropopliteal artery disease.