Drug-coated balloon versus drug-eluting stent for de novo culprit lesion in acute coronary syndromes: a report from nationwide registry in japan

Abstract Background Randomized trials have demonstrated the non-inferiority of DCB strategy compared to DES strategy for ACS [1-3]. However, generalizability in clinical settings remains unclear. Purpose This study aims to compare the outcomes between drug-coated balloon (DCB) and drug-eluting stent (DES) strategies in percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) within a nationwide procedure-based registry. Methods This is a retrospective analysis of a cohort study from a prospective, nationwide registry from January 2017 to December 2020 in Japan, focusing on ACS patients who underwent DCB or DES strategy for a single de novo lesion. One-year incidence of all-cause death, cardiovascular death, non-cardiovascular death, non-fatal ACS, stroke, and major bleeding events were compared. Subgroup analysis included lesion-based and ST-elevation myocardial infarction/non-ST-elevation ACS stratification. Results Among 5,212 propensity-matched ACS patients, DCB and DES strategies showed no significant differences in one-year incidence of all-cause death (4.5% vs. 4.6%, hazard ratio [HR]: 0.92, 95% confidence interval [CI]: 0.72-1.19), cardiovascular death (2.5% vs. 2.5%, HR: 0.90, 95% CI: 0.64-1.26), non-cardiovascular death (2.0% vs. 2.1%, HR: 0.96, 95% CI: 0.65-1.42), and non-fatal ACS (1.7% vs. 2.0%, HR: 1.04, 95% CI: 0.70-1.54). DCB showed higher stroke occurrence (0.8% vs. 0.3%, HR: 2.33, 95% CI: 1.06-5.08) but lower major bleeding events (1.4% vs. 2.3%, HR: 0.65, 95% CI: 0.43-0.99) (Figure 1). Subgroup analyses did not reproduce these findings (Figure 2). Conclusions ACS patients using the DCB strategy demonstrated clinical outcomes equivalent to those undergoing the DES strategy at one year. Further investigation with an extended follow-up is necessary to confirm these findings.