Sirolimus-coated balloon in all-comer population of coronary artery disease patients: the EASTBOURNE DIABETES...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Diabetes Mellitus Research

Background:

• Percutaneous coronary intervention (PCI) outcomes in diabetic patients remain suboptimal.
• The efficacy of drug-coated balloons (DCB) in diabetic patients undergoing PCI is not well-established.

Purpose of the Study:

• To assess the impact of diabetes mellitus on PCI outcomes using the MagicTouch sirolimus-coated balloon (SCB).
• To evaluate the performance of SCB in diabetic versus non-diabetic patients.

Main Methods:

• Subgroup analysis from the prospective, multicenter EASTBOURNE registry.
• Comparison of MagicTouch SCB performance in diabetic and non-diabetic patients.
• Primary endpoint: target lesion revascularization (TLR) at 12 months. Secondary endpoints: major adverse clinical events (MACE), death, myocardial infarction (MI), and bleeding.

Main Results:

• Diabetes was present in 41.5% of 2,083 patients.
• Diabetic patients showed numerically higher rates of TLR, death, and MACE.
• Significantly higher incidence of spontaneous myocardial infarction (MI) in diabetic patients (3.4% vs. 1.5%).
• No significant difference in bleeding events between groups.
• In-stent restenosis (ISR) had higher TLR than de-novo lesions, irrespective of diabetes.

Conclusions:

• Diabetic patients treated with MagicTouch SCB did not experience a significant increase in TLR compared to non-diabetic patients.
• Diabetic status did not affect SCB device performance regarding TLR in both de-novo and ISR lesions.