Coronary disease & ACSRandomised controlled trial
Percutaneous Coronary Treatment With Bioadaptor Implant vs Drug-Eluting Stent
- Randomised controlled trial
- multicentre
- single-blind
- 34 hospitals in Japan, Europe and New Zealand
Authors' conclusion
At 2-year follow-up, fewer TLF events were observed in patients treated with the bioadaptor.
Study context
- Population
- Patients with de novo coronary lesions in up to 2 vessels440 per-protocol
- Participants
- 445 patients
- Comparison
- DynamX bioadaptor vs Resolute Onyx drug-eluting stent
- Primary endpoint
- TLF (Kaplan-Meier estimate)
- Follow-up
- 2 years
Primary result
As reported in the abstract
Risk difference
−3.6%
95% CI −7.8% to −0.0%
P = 0.044
Events by treatment group
Bioadaptor vs Drug-eluting stent
risk difference −3.6% (95% CI −7.8% to −0.0%); P = 0.044
Further findings
| Outcome | risk difference (95% CI) | P value | |
|---|---|---|---|
| Target vessel failure (Kaplan-Meier estimate) · 2 years · 1.8% [4 of 219] vs 5.9% (13 of 221) | −4.1% (−7.2% to −1.0%) | P = 0.027 | |
| −10−505Difference (linear scale) |
- Target vessel failure (Kaplan-Meier estimate): per-protocol population (n = 440)
Events between 6 months and 2 years
- Clinically driven target lesion revascularization, bioadaptor
- 1
- CV deaths, drug-eluting stent
- 2
- Clinically driven target lesion revascularizations, drug-eluting stent
- 4
Safety
Definite or probable device thrombosis · 2 years
P = 0.32
Original publication
Percutaneous Coronary Treatment With Bioadaptor Implant vs Drug-Eluting Stent. JACC Cardiovasc Interv. Published 26 February 2025. doi:10.1016/j.jcin.2025.01.426
Summarised from the published abstract; every number is checked against it