Key result
Paclitaxel DCB shows no difference in MACCE compared to DES in large de novo lesions.
Why the study?
Although drug-coated balloons outperform drug-eluting stents in de novo small-vessel coronary lesions, comparable studies for de novo large-vessel coronary lesions were lacking.
Does paclitaxel drug-coated balloon angioplasty reduce major adverse cardiac and cerebrovascular events compared to drug-eluting stent implantation in patients with de novo large-vessel coronary lesions (reference diameter ≥3.0 mm)?
Cohort (n=960)
No
Does paclitaxel drug-coated balloon angioplasty reduce major adverse cardiac and cerebrovascular events compared to drug-eluting stent implantation in patients with de novo large-vessel coronary lesions (reference diameter ≥3.0 mm)?
In patients with de novo large-vessel coronary lesions (≥3.0 mm), paclitaxel drug-coated balloon angioplasty demonstrated comparable rates of death, myocardial infarction, and stroke compared to drug-eluting stents over 31.6 months, but was associated with a significantly higher rate of target vessel revascularization.
Answers are grounded in this paper and cite their sources.
Comparable MACCE with DCB versus DES in large de novo lesions despite higher TVR; hypothesis-generating and should not yet change practice.
Background: Although drug-coated balloons (DCBs) outperform drug-eluting stents (DESs) in the treatment of de novo small-vessel coronary lesions, no comparable studies are available for de novo large-vessel coronary lesions. Methods: This retrospective study examined 960 patients with de novo large-vessel coronary lesions (reference vessel diameter ≥3.0 mm) who underwent paclitaxel DCB angioplasty or DES implantation at Beijing Anzhen Hospital. The study endpoints included all-cause death, myocardial infarction (MI), stroke, and target vessel revascularization (TVR). Kaplan–Meier (KM) curves and Cox regression analysis were used to investigate the clinical outcomes of patients in the DCB and DES groups. Results: The overall incidence rates of major adverse cardiac and cerebrovascular events (MACCEs), all-cause death, MI, stroke, and TVR were 9.27% (89/960), 1.5% (14 patients), 0.9% (9 patients), 0.6% (6 patients), and 6.8% (65 patients), respectively. No significant differences were observed between the DCB and DES groups in MACCEs (13.2% vs. 5.6%; p = 0.511), all-cause death (1.9% vs. 1.0%; p = 0.763), MI (0.6% vs. 1.2%; p = 0.239), or stroke (0.6% vs. 0.6%; p = 0.361). However, the TVR rate was significantly higher in the DCB group than in the DES group (10.1% vs. 3.6%; p = 0.028), and this difference persisted after multivariate adjustment. Conclusions: For patients with de novo lesions in target vessels with diameters ≥3.0 mm, the safety and efficacy of DCB therapy were comparable to those of DES therapy, except for target vessel revascularization.
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Wang et al. (2026) conducted a cohort in De novo large-vessel coronary artery disease (n=960). Paclitaxel drug-coated balloon (SeQuent Please) angioplasty vs. Drug-eluting stent (DES) implantation was evaluated on Major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, stroke, myocardial infarction, or target vessel revascularization) (HR 0.842 (DES vs DCB), 95% CI 0.505-1.404, p=0.511). Paclitaxel DCB yielded comparable overall MACCE to DES (13.2% vs 5.6%, adjusted HR 0.842, p=0.511) in large de novo coronary lesions, despite higher target vessel revascularization (10.1% vs 3.6%).
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