Polymer-free versus biodegradable-polymer drug-eluting stent in patients undergoing percutaneous coronary intervention: an assessor-blind, non-inferiority, randomised controlled trial
Primary result · Device-oriented composite endpoint (cardiovascular death, target vessel myocardial infarction, or target lesion revascularisation)Result — go to the resultRisk difference 1% 1-sided 95% CI upper limit 2.9%Authors' conclusion
In all-comer patients undergoing PCI, polymer-free AES were non-inferior to biodegradable-polymer EES at 1-year follow-up in terms of a device-oriented composite endpoint despite being associated with an increased risk of early stent thrombosis.
Study context
- Population
- All-comer patients undergoing percutaneous coronary intervention (PCI)patients with 3,042 coronary lesions randomised
- Participants
- 2,107 patients
- Comparison
- Polymer-free amphilimus-eluting stent (AES) vs biodegradable-polymer everolimus-eluting stent (EES)
- Polymer-free AESn = 1,051
- Biodegradable-polymer EESn = 1,056reference
- Primary endpoint
- Device-oriented composite endpoint:
- Cardiovascular death
- Target vessel myocardial infarction
- Target lesion revascularisation
- Follow-up
- 1-year follow-up
Methodological details14 hospitals in Italy
- 14 hospitals in Italy
Primary result
As reported in the abstract
Risk difference
1%
1-sided 95% CI upper limit 2.9%
P = 0.041 for non-inferiority
Events by treatment group
Polymer-free AESvs biodegradable-polymer EES
risk difference 1% (1-sided 95% CI upper limit 2.9%); P for non-inferiority = 0.041
Further findings
- There were no significant differences in the incidence of the components of the primary endpoint between groups
Safety
| Outcome | Polymer-free AES | Biodegradable-polymer EES | Hazard ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Definite or probable stent thrombosis | 1.0% | 0.3% | 3.72 (1.04–13.33) | P = 0.044 | |
| 0.050.21520Hazard ratio (log scale) |
- Definite or probable stent thrombosis: due to an increased risk of early stent thrombosis within 30 day
Original publication
Polymer-free versus biodegradable-polymer drug-eluting stent in patients undergoing percutaneous coronary intervention: an assessor-blind, non-inferiority, randomised controlled trial. EuroIntervention. Published 6 January 2025. doi:10.
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