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Drug-Coated Balloon versus Drug-Eluting Stent for DeNovo Culprit Lesion in Acute

Coronary Syndromes: A Report from Nationwide Registry in Japan

Brief title: Comparing Drug-Coated Balloon to Drug-Eluting Stent in Acute Coronary

Syndrome: Propensity-Matched Analysis from Nationwide Registry in Japan

Running title: DCB vs. DES strategies in ACS patients

Tomonori Takahashi, MD, PhD1, Kyohei Yamaji, MD, PhD2, Shun Kohsaka, MD, PhD3,

Hideki Ishii, MD, PhD4, Yuichiro Mori, MD, MPH5, Tetuszo Wakatsuki, MD, PhD1, Koji

Yamaguchi, MD, PhD1, Daisuke Nisioka, MD, PhD6, Kenya Kusunose, MD, PhD7, Tetsuya

Amano, MD, PhD8, Masataka Sata, MD, PhD1, Ken Kozuma, MD, PhD9, The J-PCI Registry

Investigators

1Department of Cardiovascular Medicine, Tokushima University Hospital, Tokushima, Japan

2Department of Cardiovascular Medicine, Kyoto University, Kyoto, Japan

3Department of Cardiology, Keio University School of Medicine, Tokyo, Japan

4Department of Cardiovascular Medicine, Gunma University Graduate School of Medicine,

Maebashi, Japan

5Department of Human Health Sciences, Graduate School of Medicine, Kyoto University,

Kyoto, Japan

6Department of Medical Statistics, Research & Development Center, Osaka Medical and

Pharmaceutical University, Osaka, Japan

7Department of Cardiovascular Medicine, Nephrology, and Neurology, Graduate School of

Medicine, University of the Ryukyus, Okinawa, Japan.

8Department of Cardiology, Aichi Medical University, Nagakute, Japan

9Division of Cardiology, Teikyo University Hospital, Tokyo, Japan

Address for Correspondence:

Tomonori Takahashi, MD, PhD

Department of Cardiovascular Medicine, Tokushima University Hospital, Tokushima, Japan

2-50-1 Kuramoto, Tokushima, Japan

TEL: 81-88-633-7851, FAX: 81-88-633-7894

E-mail: t.tomonori.0918@gmail.com

Abstract

Objectives: This study aim 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.

Background: Randomized trials have demonstrated the non-inferiority of DCB strategy

compared to DES strategy for ACS. However, generalizability in clinical settings remains

unclear.

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). Subgroup analyses did not

reproduce these findings.

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.