Biodegradable or durable polymer drug-eluting stents in patients with coronary artery disease: ten-year outcomes of the randomised NEXT Trial
Primary result · Death or MIResult — go to the resultHazard ratio 1.04 95% CI 0.90–1.20Authors' conclusion
The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1 year and up to 10 years after stent implantation.
Study context
- Population
- Patients with CAD undergoing stent implantation, 66 centres in Japanof 3,241 enrolled in NEXT
- Participants
- 2,417 patients
- Comparison
- Biodegradable polymer biolimus-eluting stents (BP-BES) vs durable polymer everolimus-eluting stents (DP-EES)
- BP-BESn = 1,204
- DP-EESn = 1,213reference
- Primary endpoint
- Death or MI (original primary safety endpoint at 3 years; here compared up to 10 years)
- Follow-up
- Up to 10 years
Methodological detailsmulticentre, originally non-inferiority design, Complete 10-year follow-up in 87.5%
- Multicentre
- Originally non-inferiority design
- Complete 10-year follow-up in 87.5%
Primary result
Death or MI
Hazard ratio
1.04
95% CI 0.90–1.20
P = 0.58
By group
BP-BES vs DP-EES
HR 1.04 (95% CI 0.90–1.20); P = 0.58
As reported in the abstract
Further findings
| Outcome | BP-BES | DP-EES | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| TLR · up to 10 years | 15.9% | 14.1% | 1.12 (0.90–1.40) | P = 0.32 | |
| 0.512Hazard ratio (log scale) |
Death or myocardial infarction (MI) and target lesion revascularisation (TLR), landmark analysis at 1 year
- Not significantly different between the 2 groups
Original publication
Biodegradable or durable polymer drug-eluting stents in patients with coronary artery disease: ten-year outcomes of the randomised NEXT Trial. EuroIntervention. Published 7 August 2023. doi:10.
Summarised from the published abstract; every number is checked against it