- Question
- Can drug-coated balloon angioplasty (with rescue stenting for an unsatisfactory result) be non-inferior to intended drug-eluting stent implantation in de novo, non-complex coronary lesions?
- Design
- Open-label, randomised (1:1), non-inferiority trial conducted at 43 sites in China, enrolling 2272 patients, with a median follow-up of 734 days.
- Population
- Adults aged 18 years or older with de novo, non-complex coronary artery disease and an indication for percutaneous coronary intervention, irrespective of target vessel diameter, after successful lesion pre-dilatation.
- Intervention
- Paclitaxel-coated balloon angioplasty, with the option of rescue stenting if the result was unsatisfactory.
- Control
- Intended deployment of second-generation thin-strut sirolimus-eluting stents.
- Primary outcome
- Device-oriented composite endpoint (DoCE) at 24 months: cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation. Non-inferiority required the upper limit of the one-sided 95% CI for the risk difference to be below 2.68%.
- Results
- DoCE at 24 months occurred in 72 patients (6.4%) with the balloon and 38 (3.4%) with the stent, a risk difference of 3.04% (upper boundary of one-sided 95% CI 4.52; non-inferiority p=0.65; two-sided 95% CI 1.27-4.81; p=0.0008), so the non-inferiority criterion was not met. In the balloon group, 106 patients (9.4%) received a rescue stent.
- Safety
- No acute vessel closures occurred in the balloon group versus one (0.1%) in the stent group. Periprocedural myocardial infarction occurred in ten patients (0.9%) with the balloon and nine (0.8%) with the stent.
- Conclusion
- In de novo, non-complex lesions, a drug-coated balloon strategy with rescue stenting did not achieve non-inferiority to intended drug-eluting stent implantation at 2 years.
- Why it matters
- The trial indicated that, in this population, the drug-eluting stent should remain the preferred treatment over a balloon-based strategy.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026