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Studies Offer Insight on New Lipid Therapies Several Late-Breaking Clinical Trials presented at AHA 2016 provide new insights on lipid therapies. In the AEGIS-I Trial, C. Michael Gibson, MS, MD, et al., evaluated the safety profile of CSL112, an infusible formulation of human apolipoprotein A-I (apoA-I), and characterized its pharmacokinetic/ pharmacodynamic properties among patients with recent acute myocardial infarction. 1,258 patients were randomized to either 2 grams of CSL112, 6 grams of CSL112 or placebo via weekly infusion for four consecutive doses. The results of the study, simultaneously published in Circulation, show that the four weekly infusions of CSL112 are feasible, well-tolerated and not associated with any significant changes in liver or kidney function. Meanwhile, the MILANO-PILOT Trial, led by Stephen Nicholls, MD, et al., examined the effect of five 20 mg/kg weekly infusions of MDCO216 (apoA-I Milano) or placebo on patients with recent acute coronary syndrome. The results of the study show that the infusions of apoA-I Milano were well-tolerated and reduced HDL-C levels in patients receiving the treatment. However, the authors note that “MDCO-216 did not produce a significant effect on coronary disease progression, [and] … the findings from this pilot study do not provide the evidence required to proceed with further development.” In a third trial evaluating the effectiveness of a unique drug in reducing atherogenic lipoproteins, Sotirios Tsimikas, MD, et al., found that ionis-angptl3-lRx may show promise for treating elevated triglycerides and LDL-C in patients with elevated cholesterol. In this phase 1/2a study, researchers examined the effects of suppressing ANGPTL3 in 44 healthy volunteers with elevated triglycerides. Results showed that IONIS-ANGPLT3-LRx reduced plasma levels of ANGPTL3 levels up to mean 85%. Gibson CM, Korjian S, Tricoci P, et al. Circulation. 2016;doi:CIRCULATIONA HA.116.025687 ACC.org/CSWN GLAGOV: Does Evolucumab Affect the Progression of CHD? The addition of PCSK9 inhibitors in the treatment of coronary heart disease (CHD) patients already taking statins showed incremental benefits on the progression of coronary atherosclerosis, according to the results of the GLAGOV Trial presented during AHA 2016 and simultaneously published in the Journal of the American Medical Association. Steven E. Nissen, MD, et al., led the first intravascular outcome trial testing the effects of a PCSK9 inhibitor on the regression or progression of coronary atherosclerosis as measured The addition of PCSK9 inhibitors in the treatment of coronary heart disease patients already taking statins showed incremental health benefits on the progression of coronary atherosclerosis. by intravascular ultrasound. The study was a double-blind, placebo-controlled trial of 968 statin-treated patients with established CHD at 226 sites in 32 countries. The patients’ average age was 60, 72% were male, 24% were smokers and 21% were diabetic. Statin-treated patients were randomly assigned to take either the PCSK9 inhibitor, evolocumab, (420 mg) monthly or placebo for 78 weeks. Patients underwent an intravascular ultrasound examination of a single coronary artery during a clinicallyindicated angiogram at baseline and then repeated at end of the study. The results of the study show that the % atheroma volume decreased in patients treated with evolocu mab compared to those treated with the placebo after 76 weeks of treatment. Further, the patients treated with evolocumab achieved lower mean, time-weighted LDL-C levels, and evolocumab induced plaque regression in a greater percentage of patients than the placebo. Nicholls SJ, Puri R, Anderson T, et al. JAMA. 2016;doi:10.1001/jama.2016.16951 MOMENTUM 3: HeartMate 3 vs. HeartMate II in Advanced HF The HeartMate 3 left ventricular assist system may be safe and effective, according to the results of the MOMENTUM 3 Trial presented during AHA 2016 and simultaneously published in the New England Journal of Medicine. Mandeep R. Mehra, MD, et al., evaluated the safety and comparative effectiveness of the HeartMate 3 left ventricular assist system to the HeartMate II system in a prospective randomized, controlled trial of advanced heart failure (HF) patients. Patients were randomized to receive HeartMate 3 or the HeartMate II irrespective of the intended use as either bridge to transplantation or destination therapy for those ineligible for a transplant. The primary endpoint of the analysis evaluated if HeartMate 3 worked as well as or better than (non-inferior) HeartMate II in terms of survival free of debilitating stroke or reoperation to HeartMate3 provided incremental improvement in clinical outcomes due to the reduction in the rate of reoperation for pump malfunction without an apparent difference in other adverse events. replace or remove the pump. According to the results, HeartMate 3 provided incremental improvement in clinical outcomes due to reduction in the rate of reoperation for pump malfunction without an apparent difference in other adverse events. The researchers also found no significant between-group differences in the rates of death or disabling stroke but reoperation for pump malfunction was less frequent in the Heartmate 3 group than the HeartMate II group. ■ Mehra MR, Naka Y, Uriel N, et al. N Engl J Med. 2016;doi:10.1056/NEJMoa1610426 CardioSource WorldNews 13