Alirocumab in Acute Myocardial Infarction: Results From the Virginia Commonwealth University Alirocumab Response Trial (VCU-AlirocRT).

Alirocumab improves outcomes in patients with a history of recent acute coronary syndrome, but treatment acutely at the time of myocardial infarction is untested. We present the results of a randomized, placebo-controlled, double-blinded pilot study of alirocumab treatment at the time of non-ST elevation MI (NSTEMI). Twenty patients with type 1 NSTEMI and low-density lipoprotein cholesterol (LDL-C) >70 mg/dL despite high intensity statin therapy were randomized 1:1 to one dose of alirocumab 150 mg subcutaneously or placebo within 24 hours of presentation. LDL-C and inflammatory biomarkers-including C-reactive protein-were obtained at baseline, 72 hours, and 14 days. Median (interquartile range) and number (%) were: age 59 (49, 65) years, 7 (35%) men, 16 (80%) black; baseline characteristics were similar between groups. Alirocumab significantly reduced LDL-C from baseline to 14 days by 64 mg/dL (-96, -47) compared with placebo [+1 mg/dL (-25, +16)] (primary endpoint). There were no significant between-group differences in C-reactive protein changes at any time point (all P > 0.2) or serious adverse events attributable to the study treatment. In conclusion, alirocumab administration at the time of NSTEMI significantly reduced LDL-C levels at 14 days, was safe, and had neutral effects on inflammatory biomarkers. Further studies are warranted to explore the effects on clinical outcomes.

Comparison of Cardiorespiratory Fitness in Black or African American Versus Caucasian Patients With Heart Failure.

PURPOSE: Cardiopulmonary exercise testing (CPX) is a well-established assessment with important insight into prognosis and therapeutic efficacy in patients with heart failure (HF). Prior studies have identified several clinical differences between Black or African American (B-AA) and Caucasian patients with HF. Differences in key CPX responses between these two groups require further investigation. METHODS: Using a database consisting of subjects with symptomatic HF who had undergone CPX for inclusion in various prospective randomized clinical trials, we identified 198 (n = 94 [47%] B-AA; n = 105 [53%] Caucasian) patients with a qualifying baseline CPX. Significant univariate predictors of peak oxygen uptake (V˙o2peak) were included in a multivariate linear regression model. RESULTS: When compared with Caucasian patients, B-AA were younger (mean ± SD = 54.8 ± 10.0 vs 57.9 ± 9.6 yr, P = .03), had higher C-reactive protein (CRP) (median [IQR] = 4.9 [2.3, 8.8] vs 1.9 [0.6, 5.5] mg/L, P < .0001), lower hemoglobin (13.0 ± 1.8 vs 13.8 ± 1.6 g/dL, P = .003), and lower left ventricular ejection fraction (LVEF) (40 [32, 51] vs 53 [43, 59]%, P < .00010). During CPX, B-AA patients also had lower V˙o2peak (14.6 ± 3.9 vs 17.6 ± 4.8 mL·kg-1·min-1, P < .0001). No differences were observed between B-AA and Caucasian in the minute ventilation/carbon dioxide production (V˙e/V˙co2) slope (P = .14). The difference in V˙o2peak between B-AA and Caucasian was largely attenuated after adjusting for age, body mass index, CRP, N-terminal pro-brain natriuretic peptide, hemoglobin, LVEF, and peak HR (14.1: 95% CI, 13.2-14.9 vs 15.6: 95% CI, 14.4-16.8 mL·kg-1·min-1, P = .053). CONCLUSIONS: Directly measured V˙o2peak was significantly lower in B-AA than in Caucasians with HF. This is largely explained by differences in clinical characteristics, whereas no significant differences were observed in the V˙e/V˙co2 slope.