Takahashi Tomonori, Yamaji Kyohei, Kohsaka Shun, Ishii Hideki, Mori Yuichiro, Kikuta Yuetsu, Wakatsuki Tetsuzo, Yamaguchi Koji, Nishioka Daisuke, Kusunose Kenya, Amano Tetsuya, Sata Masataka, Kozuma Ken
Department of Cardiovascular Medicine Tokushima University Hospital Tokushima Japan.
Department of Cardiovascular Medicine Kyoto University Kyoto Japan.
J Am Heart Assoc. 2025 Jun 3;14(11):e038071. doi: 10.1161/JAHA.124.038071. Epub 2025 May 29.
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.
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.
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.
随机试验表明，在急性冠状动脉综合征（ACS）治疗中，药物涂层球囊（DCB）并不逊色于药物洗脱支架（DES）。然而，其在临床环境中的普遍性仍不明确。本研究在一个全国性的基于手术的登记系统中，比较了DCB和DES策略在经皮冠状动脉介入治疗ACS中的效果。
这是一项对2017年1月至2020年12月间日本一项前瞻性全国登记系统队列研究的回顾性分析，重点关注因单一新发病变接受DCB或DES治疗的ACS患者。分析排除了DCB治疗后需要补救性置入支架的患者。比较了全因死亡率、心血管死亡、非心血管死亡、非致命性ACS、中风和大出血事件的1年发生率。亚组分析包括基于病变和ST段抬高型心肌梗死/非ST段抬高型ACS分层。在5212例倾向评分匹配的ACS患者中，DCB和DES在全因死亡率（4.5%对4.6%，风险比[HR]，0.92[95%CI，0.72 - 1.19]）、心血管死亡（2.5%对2.5%，HR，0.90[95%CI，0.64 - 1.26]）、非心血管死亡（2.0%对2.1%，HR，0.96[95%CI，0.65 - 1.42]）或非致命性ACS（1.7%对
