Regional Differences Between Drug-Coated Balloons and Drug-Eluting Stents in

Background: Randomized trials of drug-coated balloons (DCBs) versus drug-eluting stents (DESs) for Methods: PubMed, Embase, and Cochrane Central were searched for randomized trials comparing DCB with DES in dnCAD. Incidence rate ratios (IRRs) were pooled with a random-effects model (DerSimonian-Laird; Hartung-Knapp confidence intervals (CIs)). The pre-specified primary question was regional (Europe vs Asia) subgroup comparison of a harmonized device-oriented composite outcome (DOCO). To determine whether any regional signal reflected geography itself or trial-level confounding, we performed subgroup-aware leave-one-out analysis and examined two alternative explanations Results: Thirteen trials (4,673 randomized patients) were included; the primary DOCO analysis comprised 12 trials (4,396 patients). DOCO did not differ overall (IRR = 1.00; 95% CI, 0.70-1.44; I Conclusions: The apparent regional difference appears largely attributable to trial-level confounding (vessel size, comparator generation, single-trial dominance) rather than to geography itself. Because the randomized evidence comes only from Europe and Asia, these findings show that the Europe-Asia difference is not robust, but do not rule out geographic effects in other regions. Because all current randomized evidence is paclitaxel-specific and confined to Europe and Asia, globally representative trials of limus-coated balloons against contemporary DES are required.