Baumer Ulrike, Steinacher Eva, Hammer Andreas, Kazem Niema, Hofer Felix, Frey Bernhard, Lang Irene, Hengstenberg Christian, Hemetsberger Rayyan, Sulzgruber Patrick, Niessner Alexander, Koller Lorenz
Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Vienna Healthcare Group, 2nd Department of Medicine with Cardiology and Intensive Care Medicine, Clinic Landstrasse, Medical University of Vienna, Juchgasse 25, 1030, Vienna, Austria.
Clin Res Cardiol. 2025 Jun 23. doi: 10.1007/s00392-025-02700-w.
The use of drug-coated balloons (DCB) in percutaneous coronary interventions (PCI) is increasing due to potential benefits mainly by avoiding foreign material although a widespread application area beyond in-stent restenosis lacks robust clinical data to date. As such, we aimed to assess the safety and efficacy of DCBs in treating de novo lesions.
For this analysis, we included all patients treated with DCB in a de novo lesions from 2010 to 2019 at our institution. We performed a 1:1 propensity score matching to pair each DCB intervention with a comparable DES intervention. Follow-up continued until 09/2022 to assess clinical outcomes.
A total of 303 patients with de novo lesion were matched to 303 patients with comparable baseline characteristics. The median follow-up time was 5.7 years (IQR 2.7-9.3). There were no significant differences in cardiovascular (CV) mortality (HR 1.01 [95% CI 0.87-1.19], p value 0.874), all-cause mortality (HR 1.05 [95% CI 0.91-1.22], p value 0.491), MACE (HR 1.10 [95% CI 0.96-1.26], p value 0.170), acute myocardial infarction (HR 1.08 [95% CI 0.90-1.19], p value 0.308), or any revascularization (HR 1.03 [95% CI 0.90-1.19], p value 0.671) between both groups. However, we observed a trend toward lower rates of target lesion revascularization in patients with small vessel disease (HR 0.84 [95% CI 0.68-1.02], p value 0.072), and in side branch lesions (HR 0.79 [95% CI 0.58-1.04], p value 0.096).
DCBs demonstrated long-term safety and efficacy in de novo lesions, with promising trends in reducing target lesion revascularization in small vessel disease and side branches.
药物涂层球囊（DCB）在经皮冠状动脉介入治疗（PCI）中的应用日益增加，这主要是因为其潜在益处，尤其是避免了异物植入，尽管目前除支架内再狭窄外，广泛应用领域缺乏有力的临床数据。因此，我们旨在评估DCB治疗初发病变的安全性和有效性。
在本次分析中，我们纳入了2010年至2019年在我们机构接受DCB治疗初发病变的所有患者。我们进行了1:1倾向评分匹配，将每个DCB干预与一个可比的药物洗脱支架（DES）干预进行配对。随访持续至2022年9月以评估临床结局。
共有303例初发病变患者与303例具有可比基线特征的患者相匹配。中位随访时间为5.7年（四分位间距2.7 - 9.3年）。两组在心血管（CV）死亡率（风险比[HR] 1.01 [95%置信区间（CI）0.87 - 1.19]，p值0.874）、全因死亡率（HR 1.05 [95% CI 0.91 - 1.22]，p值0.491）、主要不良心血管事件（MACE）（HR 1.10 [95% CI 0.96 - 1.26]，p值0.170）、急性心肌梗死（HR 1.08 [95% CI 0.90 - 1.19]，p值0.308）或任何血管再通（HR 1.03 [95% CI 0.90 - 1.19]，p值0.671）方面均无显著差异。然而，我们观察到在小血管疾病患者（HR 0.84 [95% CI 0.68 - 1.02]，p值0.072）和分支病变患者（HR 0.79 [95% CI 0.58 - 1.04]，p值0.096）中，靶病变血管再通率有降低的趋势。
DCB在初发病变中显示出长期安全性和有效性，在降低小血管疾病和分支病变的靶病变血管再通方面有令人期待的趋势。
