Clinical value of drug-coated balloon versus second-generation drug-eluting stent for de novo lesions in large coronary arteries: insights from the real world.

Background: This study aims to evaluate the long-term outcomes of patients with large coronary arteries (LCA, reference vessel diameter more than 3.0 mm) de novo lesions treated by drug-coated balloon (DCB) versus second-generation drug-eluting stent (sDES) in real-world clinical practice.
Methods: Between January 2020 and June 2021, 2857 consecutive patients with equal number of LCA de novo lesions, including 708 lesions treated with paclitaxel DCB-only (DCB-only cohort) and 2149 lesions with sDES-only (sDES-only cohort), were enrolled in this retrospective study. The primary outcome was the clinically driven target lesion revascularization (CD-TLR) rate at two years. After propensity score matching, 708 patients treated with DCB-only and another 704 patients with sDES-only were successfully matched to study adjusted associations between treatment strategy and outcomes.
Results: CD-TLR rate was higher in the DCB-only group than sDES-only group (DCB: 5.5%, sDES: 3.1%, P = 0.028). However, lower major bleeding rate was observed in the DCB-only group compared to sDES-only group (0.8% vs. 3.0%, P = 0.003), which benefited from its short duration of antiplatelet therapy. Multivariate logistic regression analysis revealed that hypercholesteremia [odds ratio (OR), 2.516], diabetes (OR, 2.773), severe calcified lesions (OR, 5.184) and residual stenosis>30% (OR, 8.676) were risk predictors (P<0.01) of CD-TLR for DCB-only strategy; meanwhile, diabetes (OR, 3.255) and severe calcified lesions (OR, 2.152) were risk predictors (P<0.01) of CD-TLR for sDES strategy.
Conclusions: DCB-only strategy is feasible for LCA de novo lesions in patients with high bleeding risk, but not suitable in other patients, who should first choose intended stenting strategy especially with unmanageable hypercholesteremia, severe calcified lesions or non-ideal residual stenosis after preprocessing.
Competing Interests: Declarations. Ethics approval and consent to participate: This study was approved by the institutional ethics committee of Fuwai Central China Cardiovascular Hospital, Zhengzhou University (Zhengzhou, China) (No. 2021 [13]). All participants confirmed informed consent forms and follow-up agreements before enrolling. Consent for publication: Not applicable. Clinical trial number: Not applicable. Competing interests: The authors declare no competing interests.
(© 2024. The Author(s).)