Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry
Primary result · TLRResult — go to the resultHazard ratio 1.38 95% CI 0.91–2.08Authors' conclusion
In the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.
Study context
- Population
- All-comer patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) with sirolimus-coated balloon MagicTouch41.5% diabetic
- Participants
- 2,083 patients
- Comparison
- Diabetes vs no diabetes in patients undergoing PCI with MagicTouch sirolimus-coated balloon (SCB)
- Diabetesn = 864
- Primary endpoint
- Target lesion revascularization (TLR)
- Follow-up
- 12-month follow-up
Methodological detailsmulticenter, investigator-initiated
- Multicenter
- Investigator-initiated
Primary result
TLR · 12 months
Hazard ratio
1.38
95% CI 0.91–2.08
By group
Diabetesvs No diabetes
HR 1.38 (95% CI 0.91–2.08)
As reported in the abstract
Further findings
All-cause death
- Numerically higher all-cause death with diabetes
- HR 1.81, 95%CI 0.95-3.46
Major adverse clinical events (MACE)
- Numerically higher MACE with diabetes
- HR 1.26 95%CI 0.92-1.74
Spontaneous myocardial infarction (MI)
- Incidence of spontaneous MI significantly higher among diabetic patients
- HR 2.15 95%CI 1.09-4.25
BARC 2-5 bleeding
- Bleeding events did not significantly differ
Target lesion revascularization (TLR) by lesion type
- Overall TLR higher in in-stent restenosis (ISR) vs de-novo coronary lesions, irrespective of diabetes status
Safety
BARC 2-5 bleeding
- Bleeding events did not significantly differ
Original publication
Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES prospective registry. Cardiovasc Diabetol. Published 3 February 2024. doi:10.
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