Can’t-miss studies from ACC 2019


  • International Clinical Digest
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This is a transcript of a presentation by Christopher P. Cannon, MD, on the most important clinical trials discussed at the American College of Cardiology’s 68th Annual Scientific Session & Expo in New Orleans, Louisiana, on March 16-18, 2019.

Watch the streaming version on Univadis.

 

Christopher P. Cannon, MD: Hello. Welcome to this brief overview of the can’t-miss late-breaking clinical trials that were presented at the ACC meeting in New Orleans.

REDUCE-IT trial

Headlining, for me, were several of the trials, but first off was the REDUCE-IT trial where we saw additional data on the benefit of the high-dose EPA omega-3 preparation in patients with known disease or diabetes and risk factors. Initial results released last November showed a 25% cardiovascular event reduction in patients who had elevated triglycerides. The total events analysis was presented here at ACC, which didn’t look at just the first event that was prevented, but included other outcomes, i.e., if someone had an MI [myocardial infarction] and then later went on to die or had a stroke. Essentially, we saw an increased reduction in those events with continued EPA at the high dose—very exciting findings.

AUGUSTUS trial

The second large trial that caught lots of attention was the AUGUSTUS trial. This looked at a patient population who largely had atrial fibrillation, and a few ACS [acute coronary syndrome] patients, who then had to undergo PCI. The goal of the trial was to evaluate the role of dual therapy in these patients compared with triple therapy. AUGUSTUS used apixaban at a full dose and did a 2 by 2 randomization against warfarin and then also with or without aspirin. The benefit of the novel agent—in this case, apixaban—over warfarin was seen with lower rates of bleeding and similar thrombotic events; but then, dropping aspirin also led to a big reduction in bleeding without any significant increase in thrombotic events. And so, using full-dose apixaban with a P2Y12 inhibitor but no aspirin had the best outcomes of all. That’s in line with a trial I was involved with, RE-DUAL PCI and the PIONEER study. The concept of a novel oral anticoagulant and P2Y12 inhibitor as dual therapy for this group of patients with Afib undergoing PCI has really emerged.

STOPDAPT-2 trial

Another interesting late-breaking trial was the STOPDAPT-2 trial in patients with drug-eluting stents where typically a year of dual antiplatelet therapy (DAPT) is recommended. All patients in the study received DAPT for 1 month (clopidogrel or prasugrel and aspirin) and were then randomized to either clopidogrel monotherapy (dropping the aspirin) or to DAPT with clopidogrel + aspirin through 1 year. They found a significant reduction in bleeding and no increase in events with 1 month of DAPT + clopidogrel monotherapy. And so, dropping aspirin seemed to emerge as a theme in some of these settings. Dropping aspirin from primary prevention is now in the current guidelines as well.

Alcohol-AF trial

Another late-breaking trial talked about atrial fibrillation and dropping alcohol. That is, they studied patients with moderate alcohol intake who had paroxysmal or persistent Afib and randomized them to abstinence (which was largely achieved) vs continued alcohol consumption. There was a significant reduction in the burden of Afib with abstinence from alcohol.

EVOLUT and PARTNER 3 trials

Finally, there were 2 trials on the use of TAVR [transcatheter aortic valve replacement] in lower-risk patients with aortic stenosis; both showed outstanding results with markedly lower event rates. And so, TAVR may be a new standard of care for even lower-risk patients with aortic stenosis. Our heart teams largely make the decision, but I think that really opens the door to many more patients having the catheter-based TAVR, as opposed to aortic valve surgery replacement.

Watch the streaming version on Univadis.