Gender-based analysis of randomized comparison of bioactive versus everolimus-eluting stents in acute coronary
Jussi Sia1, Wail Nammas, Matti Niemelä
1aDepartment of Cardiology, Kokkola Central Hospital, Kokkola, Finland bHeart Center, Satakunta Central Hospital, Pori, Finland cDepartment of Internal Medicine, Division of Cardiology, University of Oulu, Oulu, Finland dDepartment of Medicine, Turku University Hospital, Turku, Finland eDepartment of Cardiology, CHU de Charleroi, Charleroi, Belgium fHelsinki University Hospital, Helsinki, Finland gDepartment of Cardiology and Vascular Medicine, Dr. Hasan Sadikin Hospital, Bandung, Indonesia hDepartment of Cardiology, Jyväskylä Central Hospital, Jyväskylä, Finland iDivision of Cardiothoracic and Vascular Surgery, Department of Surgery, University of Oulu, Oulu, Finland.
Aims:
The randomized comparison of titanium-nitride-oxide-coated bioactive stent with everolimus-eluting stent in acute coronary syndrome (BASE-ACS) trial demonstrated an outcome of the titanium-nitride-oxide coated bioactive stents (BASs) that was statistically noninferior to that of the everolimus-eluting stents (EESs) at 12-month follow-up, in patients presenting with acute coronary syndrome (ACS) who underwent early percutaneous coronary intervention. We performed a post-hoc gender-based analysis of the BASE-ACS trial at 24-month follow-up.
Methods:
A total of 827 patients (198 women) with ACS were randomly assigned to receive either BAS or EES. The primary endpoint was a composite of cardiac death, nonfatal myocardial infarction (MI), or ischemia-driven target lesion revascularization.
Results:
Women were older, and more likely to have diabetes and hypertension compared with men (P < 0.05 for all). Moreover, women had significantly smaller reference vessel diameter and stent diameter (P < 0.05 for all). At 24-month follow-up, the cumulative incidence of the primary endpoint was similar between the two sex subgroups (15.2 versus 11.0%, for women versus men, respectively, P = 0.13). However, the rate of nonfatal MI was significantly higher in women compared with men (8.6 versus 3.8%, respectively, P = 0.007). After propensity score-adjusted analysis, there was a trend toward more nonfatal MI among women (8.6 versus 4.0%, respectively, P = 0.08). Moreover, among male patients, those assigned to BAS had significantly lower nonfatal MI compared with those assigned to EES (P = 0.027). However, among patients assigned to EES, female patients had a significantly higher rate of nonfatal MI compared with men (P = 0.02).
Conclusion:
In the current post-hoc gender-based analysis of the BASE-ACS trial, the 24-month outcome of patients undergoing percutaneous coronary intervention for ACS was slightly worse in women, compared with men, as reflected by a trend toward more nonfatal MI events after propensity score-adjusted analysis.
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