ACC.21's Late-Breaking Science: A Preview From the ACC.org Team

We're both very excited about #ACC21 Virtual and it's top-notch science. The entire ACC.org team is ready to provide our daily trial and news coverage – and making the experience as engaging and informative as the live experience, and perhaps even better.

Here are some of the late-breaking clinical trials (LBCTs) and major studies scheduled for #ACC21 that we think will be particularly interesting, provocative, and/or potentially practice changing. Just so everyone is clear, we don't know the results of any of the trials (but we're happy to speculate!).

Hopefully, the ADAPTABLE trial will provide a definitive answer about what should be the right dose of aspirin in the cardiovascular setting. This has been a longstanding controversy with observational data and some randomized data suggesting lower gastrointestinal bleeding risk with 81 mg a day, but comparable efficacy compared with 325 mg a day of aspirin.

PARADISE-MI will tell us whether sacubitril/valsartan can reduce heart failure-related events compared with good old ACE inhibition when given within a week of an acute myocardial infarction. Either way, the results should be interesting.

The large LAAOS III trial should finally settle whether patients with documented atrial fibrillation (AFib)/flutter undergoing cardiac surgery should or should not have left atrial appendage occlusion. Seems like a logical thing to do, but so far, this approach has not been adequately validated in randomized trials. Again, positive or negative, this trial should change practice.

The ATLANTIS trial has a great acronym and is also testing a great hypothesis – post TAVR, does apixaban beat the current standard of care? Whether routine anticoagulation after TAVR is worthwhile, even in the absence of AFib, remains such an unresolved question. ATLANTIS will add meaningfully to this debate. As well, the ATLANTIS-CT substudy is the largest post-TAVR CT imaging study and should be highly informative.

DARE-19 has evaluated an SGLT2 inhibitor in hospitalized COVID-19 patients to determine if there is any impact on complications. If positive, this would of course be huge. A press release has indicated this was not the case. Still, the trial should provide further important data on the use and safety of SGLT2 inhibitors in these sick patients.

Patients with STEMI should undergo prompt PCI of their culprit lesion, as everyone knows. But in those with multivessel disease, what should happen next? The data show that complete revascularization is optimal, though whether angiography or fractional flow reserve should guide the treatment of the nonculprit lesions has been a big unknown. FLOWER-MI has stepped up to answer this question. Regardless of which arm of the trial wins, the trial may provide clarity on this common clinical conundrum.

AFib remains the most common arrythmia that cardiologists must address. The role of catheter ablation remains a topic of much debate. RAFT-AF seeks to determine whether catheter ablation reduces heart failure events compared with rate control in patients with AFib and heart failure with either reduced or preserved ejection fraction.

Several key secondary analyses, such as from ISCHEMIA, TAILOR-PCI, REALITY and others, will be presented and will be of great interest. An analysis from FIDELIO-DKD will assess the impact of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, on the occurrence of AFib in patients with diabetes and chronic kidney disease.

A really clever mechanistic study is examining the association between acute alcohol intake and AFib episodes in patients with paroxysmal AFib. The observational data are quite clear that alcohol consumption is associated with higher risks of AFib, but oenophiles (such as KAE) remain unconvinced. So, this study should prove who is right (DLB or KAE). Stay tuned for our video coverage – it could get ugly.

Results of several Phase II trials of novel therapeutics, including for hypertriglyceridemia and inflammation, will also be presented during ACC.21. Trials spanning the heart failure, interventional, electrophysiology, prevention, imaging and COVID-19 domains will be highlighted. There will be something for everyone attending #ACC21.

This list is by no means comprehensive. There are several other trials, observational studies and presentations that promise to be educational and clinically informative.

Deepak L. Bhatt, MD, MPH, FACC
Kim A. Eagle, MD, MACC

This article was authored by Deepak L. Bhatt, MD, MPH, FACC, senior associate editor, Clinical Trials and News, and Kim A. Eagle, MD, MACC, editor-in-chief, of ACC.org.

Keywords: ACC Publications, Cardiology Magazine, ACC21


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