Lumere Pharmacy Researcher Shirley Dehn recently attended the 2018 annual meeting of the American College of Cardiology (ACC). Below she highlights the newest research in medications and devices.
Of all the recently completed clinical trials highlighted at ACC, what most stood out to you?
Many physicians were eager to hear results from the ODYSSEY trial, which investigated the effects of the PCSK9 inhibitor, alirocumab, on long-term cardiovascular outcomes. Not only did alirocumab decrease the risk of major adverse cardiac events by 15%, it also significantly reduced the risk of all-cause mortality in patients with higher-than-optimal LDL levels. No new safety issues were reported (aside from injection site reactions).
These findings will certainly be compared to the FOURIER trial of alirocumab’s competitor evolocumab, including differences in follow-up period, patient populations and outcome measurements.
Takeaway: Costs and patient eligibility requirements are still barriers to wider adoption of either drug.
Which clinical trials were most interesting in the device arena?
The MOMENTUM 3 trial reported long-term outcomes in patients with advanced heart failure who received either HeartMate 3, a magnetically levitated left ventricular assist device (LVAD), or HeartMate II, an older mechanical-bearing LVAD. Significantly more patients with the newer device achieved two-year survival free of disabling stroke or reoperation. The overall rate of stroke was lower in the HeartMate 3 group.
These results are promising. Pump thrombosis is a major issue with older-generation LVADs, and it appears that the HeartMate 3 device may aid in avoiding these complications, especially during longer periods of use.
Takeaway: Data from the MOMENTUM 3 trial will most likely be used as part of an application for FDA approval as a long-term destination therapy in advanced heart failure patients.
You also mentioned some interesting results related to wearable cardioverter defibrillators (WCDs).
Yes, the VEST trial studied the efficacy of a WCD to reduce sudden death due to ventricular arrhythmia in post-myocardial infarction (MI) patients. Unlike implantable cardioverter defibrillators, which can’t be implanted until 40 days post-MI, patients in the VEST trial were enrolled in the hospital or within 7 days after discharge from acute MI. While the trial did not meet its primary outcome (sudden death rates were low in both the WCD group and control group), VEST did demonstrate a reduction in 90-day all-cause mortality with a WCD. However, the mechanisms behind these findings will require further analysis.
Given the decrease in all-cause mortality, investigators of the VEST trial, which was sponsored by the manufacturer Zoll, posit that it is reasonable to prescribe WCDs for monitoring immediately after myocardial infarction. However, critics point out that many patients in the WCD arm did not wear the device due to issues with discomfort, and some of those who did wear it received inappropriate shocks.
Takeaway: The inconvenience, cost and underwhelming efficacy of the vest may impact adoption.
The Lumere research team will keep these and similar topics on our watch list as we continue to review indications and outcomes.
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