Amphilimus-eluting versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: extended follow-up of the SUGAR randomised controlled trial
Primary result · TLFResult — go to the resultHazard ratio 0.84 95% CI 0.60–1.19Authors' conclusion
The SUGAR trial demonstrates that AES and O-ZES provide comparable long-term efficacy in preventing TLF in patients with DM undergoing PCI.
Study context
- Population
- Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI)
- Participants
- 1,175 patients
- Comparison
- Amphilimus-eluting stents vs onyx-zotarolimus-eluting stents
- Primary endpoint
- TLF (cardiac death, target vessel MI or ischaemia-driven target lesion revascularisation)
- Follow-up
- 2 years
Methodological detailsassessor-blinded, multicentre (23 centres), extended follow-up
- Assessor-blinded
- Multicentre (23 centres)
- Extended follow-up
Primary result
TLF
Hazard ratio
0.84
95% CI 0.60–1.19
P = 0.331
Events by treatment group
AESvs O-ZES
HR 0.84 (95% CI 0.60–1.19); P = 0.331
As reported in the abstract
Secondary outcomes
| Outcome | AES | O-ZES | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| TLF (extended follow-up) · 3 years | 11.4% | 14.9% | 0.77 (0.56–1.06) | P = 0.106 | |
| 0.512Hazard ratio (log scale) |
Target lesion failure (TLF), landmark analysis 1–3 years · between 1 and 3 years
- No significant differences in TLF rates between 1 and 3 years (HR 1.07; 95% CI 0.62 to 1.87)
- P = 0.801
Individual components of TLF
- Rates comparable between groups
Secondary endpoints (all-cause mortality, stent thrombosis, MACE)
- No significant differences
Original publication
Amphilimus-eluting versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: extended follow-up of the SUGAR randomised controlled trial. Heart. Published 25 June 2025. doi:10. 1136/ heartjnl-2025-325773
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