Key result
Sirolimus-coated balloons linked to ~300% higher 12-month TLR risk in Caucasians versus East Asians.
Why the study?
Ethnicity can influence procedural approaches and clinical outcomes in CAD, but data on drug-coated balloon performance across different ethnic groups, particularly Caucasian and East Asian patients, remain limited.
Does the clinical outcome of sirolimus-coated balloons differ between Caucasian and East Asian patients with coronary artery disease?
Observational (n=2,084)
Yes
Does the clinical outcome of sirolimus-coated balloons differ between Caucasian and East Asian patients with coronary artery disease?
Absolute Event Rate: 6% vs 1.5%
p-value: p=<0.001
Caucasian patients treated with sirolimus-coated balloons for coronary artery disease have higher rates of target lesion revascularization but lower bleeding risk compared to East Asian patients.
May indicate ethnic variation in sirolimus-coated balloon efficacy; prospective randomized trials needed before practice change.
Background: The treatment of coronary artery disease (CAD) has evolved significantly over the years with the emergence of drug-coated balloons (DCBs). Research has shown that ethnicity can influence procedural approaches and clinical outcomes. Despite this, there are still limited data on DCB performance in different ethnic groups - particularly Caucasian and East Asian patients. Aims: analysis of the EASTBOURNE Registry, we aimed to assess differences in clinical outcomes between Caucasian and East Asian patients. Methods: EASTBOURNE was a prospective, investigator-driven, multicentre, international study investigating the safety and efficacy of a sirolimus-coated balloon (SCB). A propensity-matching analysis was performed to mitigate differences in variables. The primary endpoint was target lesion revascularisation (TLR) at 12 months. Results: From September 2016 to December 2020, EASTBOURNE enrolled 2,123 patients from 38 centres. This analysis includes 2,084 patients: 1,657 in the Caucasian group and 427 in the East Asian group. After propensity matching, we analysed 602 patients with no significant differences in clinical characteristics. In procedural terms, the Caucasian population had higher baseline percentage diameter stenosis and contrast media usage, but they had lower predilatation rates and used shorter SCBs at higher pressures; the rate of bailout stenting was also higher. Twelve-month follow-up showed higher rates of TLR (6.0% vs 1.5%; p<0.001), whereas major adverse cardiovascular events, all-cause death, and spontaneous myocardial infarction did not differ significantly. Bleeding Academic Research Consortium Type 2-5 bleedings were lower (0.0 vs 5.0%; p<0.001). Conclusions: In this subgroup analysis of the EASTBOURNE Registry comparing patients of Caucasian versus East Asian origin treated with SCBs, there were higher incidences of TLR but less bleeding in the Caucasian population compared to East Asian patients.
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Khoury et al. (2025) conducted an observational in Coronary artery disease (n=2,084). Sirolimus-coated balloon (Caucasian patients) vs. Sirolimus-coated balloon (East Asian patients) was evaluated on Target lesion revascularisation (TLR) at 12 months (p=<0.001). Caucasian patients treated with sirolimus-coated balloons had a significantly higher rate of target lesion revascularisation at 12 months compared to East Asian patients (6.0% vs 1.5%).
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