BACKGROUND: Drug-eluting stent trials have predominantly examined male populations of European descent. SPIRIT Women single-arm study evaluates the XIENCE TM V everolimus-eluting stent in complex de novo lesions in a real world female population, including Latin American patients. This analysis provides an insight into how this population responds to stenting when compared to non-Latin American patients. METHODS: Of the 1,572 patients enrolled from 73 non-US sites, 138 (9%) were recruited from Argentina, Brazil and Venezuela. RESULTS: Target lesions had reference vessel diameter ranging between 2.25 mm and 4 mm and lesion length ≤ 28 mm. Baseline characteristics were similar between the groups, with exception to a higher prevalence of hypertension, anterior myocardial infarction (MI) and family history of coronary artery disease in the Latin American cohort. Lesions tended to be more complex in Latin American women with a smaller reference vessel diameter, longer lesion length, increased eccentricity and angulation, and more type B2/C lesions. Events were adjudicated according to the guidelines of the Academic Research Consortium. At 1 year, the composite endpoint of death, MI and target vessel revascularization (TVR) was 12.1% in the non-Latin American population and 10.1% in the Latin American population (P = 0.58). CONCLUSIONS: At 1 year, the low rates of adverse cardiac events, including stent thrombosis, target lesion failure, cardiac death, MI and TVR in Latin American women were comparable to those of the non-Latin American women, despite the higher complexity of lesions. These results demonstrate the safety and efficacy of the XIENCE TM V stent in this small cohort of Latin American patients, in line with what is observed in larger and more varied populations.
Coronary artery disease; Drug-eluting stents; Women; Latin America
