Comparative efficacy and safety of drug-coated balloons versus drug-eluting stents in small vessel coronary artery disease: an updated systematic review and meta-analysis of randomized controlled trials.

Background: Small vessel coronary artery disease presents challenges in percutaneous coronary intervention due to higher restenosis rates with traditional treatments. Drug-coated balloons (DCBs) offer a potential alternative, but their efficacy compared to drug-eluting stents (DES) remains debated. This meta-analysis aims to provide updated insights into the comparative outcomes of DCBs versus DES in small coronary artery disease.

Main Text: Following PRISMA guidelines, a systematic review identified seven randomized controlled trials (RCTs) comparing DCBs with DES for small vessel CAD. Data were extracted and pooled for analysis, assessing outcomes including target lesion revascularization (TLR), target vessel revascularization (TVR), mortality, myocardial infarction (MI), stent/vessel thrombosis, and major adverse cardiovascular events (MACE). Statistical analysis was performed using RevMan version 5.4, employing random-effects models and forest plots with odds ratios (OR) and 95% confidence intervals (CI). Among 1,808 patients across seven RCTs, no significant difference was found in TVR between DCB and DES over 3 years (OR = 0.95, 95% CI [0.58, 1.54], p = 0.82). While initial analyses favoured higher TLR incidence in DES, the trend shifted towards DCB over time, with a non-significant association favouring DCB at 3 years (OR = 0.51, 95% CI [0.26, 1.00], p = 0.05). DCB use was associated with significantly higher rates of MACE and MI at the 3-year mark (MACE: OR = 0.55, 95% CI [0.38, 0.79], p = 0.001; MI: OR = 0.35, 95% CI [0.17, 0.7], p = 0.003), while mortality rates converged between the two interventions over time. Vessel thrombosis rates were similar between DCB and DES.

Conclusions: While DCBs may offer comparable efficacy to DES in terms of TVR and TLR over shorter durations, there is a concerning trend towards higher rates of MACE and MI associated with DCB use at the 3-year mark. Further research with larger sample sizes, longer follow-up durations, and consistent inclusion criteria is needed to elucidate the optimal treatment strategy for small vessel CAD. Until then, DES may be considered a safer option for managing small vessel CAD.