Drug-coated balloon vs drug-eluting stent in de novo coronary lesions: a propensity score matched cohort study.

Abstract

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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.