Successful or Uncomplicated Use of Drug‐Coated Balloon Versus Drug‐Eluting Stent Strategies for De Novo Culprit Lesions in Acute Coronary Syndromes: Insights from a Nationwide Registry in Japan

Background Randomized trials demonstrated that drug‐coated balloon (DCB) was not inferior to drug‐eluting stent (DES) for acute coronary syndrome (ACS). However, generalizability in clinical settings remains unclear. The present study compared the outcomes of DCB and DES strategies in percutaneous coronary intervention for ACS within a nationwide procedure‐based registry. Methods and Results This was a retrospective analysis of a cohort study from a prospective, nationwide registry between January 2017 and December 2020 in Japan, focusing on patients with ACS who underwent DCB or DES for a single de novo lesion. Patients who required bailout stenting after treatment with DCB were excluded from the analysis. The 1‐year incidence of all‐cause mortality, cardiovascular death, noncardiovascular death, nonfatal ACS, stroke, and major bleeding events was compared. A subgroup analysis included lesion‐based and ST‐elevation myocardial infarction/non‐ST‐elevation ACS stratifications. Among 5212 propensity score–matched patients with ACS, no significant differences were observed in the 1‐year incidence of all‐cause mortality (4.5% versus 4.6%, hazard ratio [HR], 0.92 [95% CI, 0.72–1.19]); cardiovascular death (2.5% versus 2.5%, HR, 0.90 [95% CI, 0.64–1.26]); noncardiovascular death (2.0% versus 2.1%, HR, 0.96 [95% CI, 0.65–1.42]); or nonfatal ACS (1.7% versus 2.0%, HR, 1.04 [95% CI, 0.70–1.54]) between DCB and DES. DCB was associated with a higher incidence of stroke (0.8% versus 0.3%, HR, 2.33 [95% CI, 1.06–5.08]) and lower incidence of major bleeding events (1.4% versus 2.3%, HR, 0.65 [95% CI, 0.43–0.99]); however, these results were not reproduced in the subgroup analysis. Conclusions The DCB strategy for successfully treated ACS cases achieved similar clinical outcomes to DES after 1 year. Further studies with an extended follow‐up are needed to confirm these results.