Ethnic minorities treated with new-generation drug-eluting coronary stents in two European randomised clinical trials

Abstract

Background: Several ethnic minorities have an increased risk of cardiovascular events, but previous European trials that investigated clinical outcome after coronary stenting did not assess the patients' ethnic background.

Aims: To compare ethnic minority and Western European trial participants in terms of both cardiovascular risk profile and 1‑year clinical outcome after percutaneous coronary intervention.

Methods: In the BIO-RESORT and BIONYX randomised trials, which assessed new-generation drug-eluting stents, information on patients' self-reported ethnic background was prospectively collected. Pooled patient-level data of 5803 patients, enrolled in the Netherlands and Belgium, were analysed in this prespecified analysis. The main endpoint was target vessel failure after 1 year.

Results: Patients were classified as belonging to an ethnic minority (n = 293, 5%) or of Western European origin (n = 5510, 95%). Follow-up data were available in 5772 of 5803 (99.5%) patients. Ethnic minority patients were younger, less often female, more often current smokers, more often medically treated for diabetes, and more often had a positive family history of coronary artery disease. The main endpoint target vessel failure did not differ between ethnic minority and Western European patients (3.5% vs 4.9%, hazard ratio 0.71, 95% confidence interval 0.38-1.33; p = 0.28). There was also no difference in mortality, myocardial infarction, and repeat revascularisation rates.

Conclusions: Despite the unfavourable cardiovascular risk profile of ethnic minority patients, short-term clinical outcome after treatment with contemporary drug-eluting stents was highly similar to that in Western European patients. Further efforts should be made to ensure the enrolment of more ethnic minority patients in future coronary stent trials.

Keywords: Coronary artery disease; Drug-eluting stent; Ethnic minority; Percutaneous coronary intervention; Race; Randomised clinical trial.

Fig. 1

Infographic: Ethnic minority patients were younger, less often female, and more often current smokers. They also more often had medically treated diabetes. Despite their unfavourable cardiovascular risk profile, their short-term outcome was highly similar to that of Western European patients. CI confidence interval, HR hazard ratio, PCI percutaneous coronary intervention

Fig. 2

The study flow diagram displays patient enrolled in the two clinical trials and how many patients were included in the current analysis

Fig. 3

Kaplan-Meier event curves showing the 1‑year clinical outcome of Ethnic Minority and Western European patients. There was no difference in target vessel failure (a), cardiac death (b), target vessel myocardial infarction (c), and target vessel revascularisation (d). CI confidence interval, HR hazard ratio, MI myocardial infarction