Abstract Body (Do not enter title and authors here): Background and Aims: Peripheral arterial disease (PAD) is a prevalent condition caused by the narrowing or blockage of peripheral arteries, primarily affecting the lower extremities. This disease significantly increases the risk of adverse cardiovascular events and worsens long-term prognosis. Drug-coated balloons (DCBs) have recently gained attention as an effective endovascular therapy for PAD by combining vessel dilation with localized delivery of antiproliferative medication—usually paclitaxel—aimed at improving vessel patency and clinical outcomes.
Methods: We conducted a systematic review and Bayesian network meta-analysis of randomized controlled trials and cohort studies comparing DCBs to non-DCB interventions in PAD patients. Interventions included DCB, plain old balloon angioplasty (POBA), bare-metal stents (BMS), drug-eluting stents (DES), uncoated balloons (UB), percutaneous transluminal angioplasty (PTA), and plain balloon angioplasty (PBA). Outcomes were major adverse cardiovascular events (MACE), MI, target vessel revascularization (TVR), target lesion revascularization (TLR), target vessel thrombosis (TVT), cardiovascular death (CVD), and all-cause death (ACD). Odds ratios (ORs) with 95% credible intervals (CrIs) were estimated using Bayesian random-effects models. Comparisons were made versus the intervention with the lowest SUCRA.
Results: We included 33 studies with 9,060 PAD patients. DCB was associated with lower MACE compared to POBA (OR: 0.39; 95% CrI: 0.12–1.20). POBA had a lower MI rate than DES (OR: 0.17; 95% CrI: 0.00–3.40). PTA had higher TVR (OR: 2.60; CrI: 0.75–9.80) and TLR (OR: 3.20; CrI: 0.63–17.00) versus DA + DCB. DCB reduced TVT compared to UB (OR: 0.13; CrI: 0.02–0.87). DES showed numerically lower CVD vs. UB (OR: 0.24; CrI: 0.00–4.70). ACD was lower with DA + DCB vs. UB (OR: 0.18; CrI: 0.02–1.10).
Conclusions: DCB demonstrates promising benefits for patients with PAD. Although most pairwise comparisons did not achieve statistical significance, DCB consistently showed the highest likelihood of improving major cardiovascular outcomes in this population. In particular, DCB combined with directional atherectomy exhibited superior efficacy and safety compared to other interventions. Conversely, conventional balloon angioplasty and uncoated balloons appeared less effective and may be best reserved for selected cases.