Key result
A drug-coated balloon strategy for acute coronary syndrome was associated with a similar 1-year incidence of all-cause mortality compared to drug-eluting stents (4.5% vs 4.6%; HR 0.92, 95% CI 0.72-1.19).
Why the study?
Randomized trials showed DCB was not inferior to DES for ACS, but generalizability in clinical settings remains unclear.
Does a drug-coated balloon strategy improve clinical outcomes compared to a drug-eluting stent strategy in patients with acute coronary syndrome undergoing PCI for a single de novo lesion?
Cohort (n=5,212)
Yes
Does a drug-coated balloon strategy improve clinical outcomes compared to a drug-eluting stent strategy in patients with acute coronary syndrome undergoing PCI for a single de novo lesion?
Hazard Ratio: 0.92 (95% CI 0.72–1.19)
Absolute Event Rate: 4.5% vs 4.6%
In patients with acute coronary syndrome, a drug-coated balloon strategy for de novo lesions yielded similar 1-year mortality and cardiovascular outcomes compared to drug-eluting stents.
Similar mortality with drug-coated balloons in ACS; leaves open efficacy versus stents pending randomized trials.
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.
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Takahashi et al. (2025) conducted a cohort in Acute coronary syndrome (n=5,212). Drug-coated balloon (DCB) vs. Drug-eluting stent (DES) was evaluated on All-cause mortality (HR 0.92, 95% CI 0.72-1.19). A drug-coated balloon strategy for acute coronary syndrome was associated with a similar 1-year incidence of all-cause mortality compared to drug-eluting stents (4.5% vs 4.6%; HR 0.92, 95% CI 0.72-1.19).
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