Abstract

Introduction: Interleukin-1 blockade with anakinra reduces C-reactive protein (CRP) levels and prevents heart failure (HF) events after ST-segment myocardial infarction (STEMI). Sex-based differences in STEMI patients have been reported, but no data are available regarding response to anakinra in this setting. Methods: We analyzed sex-based differences in the systemic inflammation (CRP levels) and composite end-point of new-onset HF or death in patients with STEMI from three different Virginia Commonwealth University Anakinra Response Trial (VCU-ART) randomized clinical trials. Data are reported as median and interquartile range [IQR] or number and percentage (%). Kaplan-Meier curves for event-free survival were constructed for the time-dependent composite endpoint and compared using the log-rank analysis. Results: We analyzed 139 patients from three VCU-ART trials, 29 (21%) were women while 110 (79%) were men. Baseline CRP was higher in women compared to men (8.9 [5.2-13.5] vs 4.2 [2.1-7.7] mg/L, P<0.001). Twenty-two (75%) women and 62 (56%) men were treated with anakinra. Area under the curve (AUC)-CRP at 14 days was numerically lower in patients receiving anakinra versus placebo both in men (86 [37-130] vs 223 [119-374] mg day/L) and in women (73 [46-313] vs 242 [102-988] mg day/L) (P<0.001 at ANOVA for multiple groups, P for interaction 0.22) Figure A . The incidence of the composite endpoint was also numerically lower in the anakinra group compared to placebo, both in men (4 [6.4%] vs 14 [29.1%]) and in women (3 [13.6%] vs 2 [28.5%]) (P=0.019 at ANOVA, P for interaction 0.44) Figure B . There were no statistically significant differences between women and men in AUC-CRP and HF events when comparing separately the anakinra and placebo groups (all P>0.05). Conclusions: Women were underrepresented in the VCU-ART trials, they appeared to have higher CRP levels at time of presentation, yet to benefit similar to men by treatment with anakinra in STEMI.

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