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Dr. Steve Nissen talks about three trials presented at the 2020 American Heart Association Scientific Sessions: the STRENGTH trial, which looked at omega 3 fatty acid’s impact on cardiovascular events, the  STOP AF trial that studied medication vs. ablation in treating patients with new onset atrial fibrillation; and the RHAPSODY trial, which looked at the drug rilonacept in the treatment of recurrent pericarditis. He also provides his take on a couple additional trials looking at statin intolerance and a polypill for heart disease.

Learn more about these studies

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What's New in Heart Research?

Podcast Transcript

Announcer:
Welcome to Love Your Heart, brought to you by Cleveland Clinic's Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute. These podcasts will help you learn more about your heart, thoracic, and vascular systems, ways to stay healthy, and information about diseases and treatment options. Enjoy.

Dr. Steve Nissen:
I'm Dr. Steve Nissen, and I'm the chief academic officer of the Heart, Vascular & Thoracic Institute. And I'd like to share with you some of the results from the American Heart Association meeting which was held just a few days ago. This meeting was held virtually rather than in-person, but it was still very, very interesting. Cleveland Clinic physicians presented the results of three really landmark trials. The largest was the STRENGTH trial, one that I chaired, which studied a very potent form of omega-3 fish oil product, four grams a day, compared with placebo in 13,000 patients at over 600 sites in 22 countries. And these were people that have high triglycerides and low HDL levels. When the study was completed, there was absolutely no effect of the omega-3 fatty acids on any cardiovascular outcome, including cardiovascular death. The hazard ratio was 0.99. This is about as neutral as you can get.

Dr. Steve Nissen:
Now, everybody was talking about this trial because it's a completely different result from the REDUCE-IT trial, which studied a purified form of EPA. And the authors, including myself, in this article published as the lead article in JAMA, concluded that it had nothing to do with the fish oil. That these two studies, STRENGTH, the study we reported, and REDUCE-IT, the earlier study, used different placebos. The placebo in REDUCE-IT was mineral oil. The placebo in our study, STRENGTH, was corn oil. And we deliberately chose corn oil because we thought it had no effects on any lipid measures or inflammation, and it didn't. It was completely neutral, no effect on LDL, or CRP, or triglycerides. However, in REDUCE-IT, mineral oil raised LDL more than 10% and raised C-reactive protein 32%. And so we concluded that STRENGTH demonstrates that REDUCE-IT is almost certainly a false positive study that led to a misinterpretation of the benefits of fish oil.

Dr. Steve Nissen:
Now, there were a couple of other really terrific studies. Dr. Wazni published in The New England Journal of Medicine, the STOP-AF trial. And in STOP-AF, it was a strategy trial for patients with a new atrial fibrillation. Traditionally, these patients have been treated with drug therapy, and then if drug therapy fails, they go on and have a ablation. What Dr. Wazni showed is that a strategy of using cryoballoon ablation, it's a little bit newer form of ablation that uses a balloon to freeze the tissue, it's very easy to do, very safe, had a much higher success rate than using drug therapy. It was about 75% of people were free of atrial fibrillation at the end of a year compared with 45% who received drug therapy.

Dr. Steve Nissen:
There was a second trial showing virtually the same thing performed primarily in Europe. You have two trials, both in The New England Journal of Medicine that say that ablation is probably the most effective approach with new onset of atrial fibrillation to preserve normal sinus rhythm. And then the third Cleveland Clinic trial, known as RHAPSODY, was also a breakthrough study presented and authored by Dr. Allen Klein, also in The New England Journal of Medicine, and it took patients that had really severe recurrent pericarditis refractory and randomized them to either placebo or a drug known as Rilonacept, which is an IL-1 antagonist. And there was just a remarkable reduction in symptoms in the Rilonacept treated patients. It virtually wiped out the symptoms in these patients, these very miserable patients with lots of chest pain from recurrent pericarditis. And so it really is a breakthrough therapy and obviously will potentially lead to regulatory action to approve the drug for that indication. So very, very exciting.

Dr. Steve Nissen:
A couple more quick notes. A trial known as SAMSON was a really interesting study that gave patients that were statin intolerant three bottles, one contained nothing, one contained a placebo, and one contained Atorvastatin 20 milligrams, and the patients didn't know which drug they were taking. And remarkably, the rate of symptoms of statin intolerance, muscle pain, et cetera, was 90% as great, that it was nearly 100%, so it was almost exactly the same for placebo as it was for Atorvastatin. This study suggests that many people that have symptoms on statins actually can tolerate these drugs. Really a remarkable and very interesting study also in The New England Journal of Medicine.

Dr. Steve Nissen:
And then finally, there was a lot of buzz about a polypill study in The New England Journal. This suggested that a pill containing something like five different components, a statin, a beta-blocker, aspirin, I think an ACE inhibitor was included, modestly reduced cardiovascular outcome with a p-value that was just barely statistically significant. And it did work. The problem is it's like throwing the kitchen sink at every single patient, a single pill containing everything. And I was very vocal in opposition to the trial and its conclusions. These drugs all have adverse effects, beta-blockers causing erectile dysfunction in men, statins can cause some side effects, ACE inhibitors can cause angioedema. And not everybody needs every therapy.

Dr. Steve Nissen:
And what I said about this trial to the media is, "Look, modern medicine is about individualizing therapy, giving the right drug to the right patient for the right reasons." And so, I don't think the polypill makes sense for developed countries. Maybe it makes sense in the third world, but I don't know that this is really a great strategy. And a lot of people lining up to back the polypill, I don't think it's good medicine. That's a quick summary. Thank you very much for watching.

Announcer:
Thank you for listening. We hope you enjoyed the podcast. We welcome your comments and feedback. Please contact us at [email protected] Like what you heard? Subscribe wherever you get your podcasts or listen at clevelandclinic.org/loveyourheartpodcast.
Love Your Heart
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Love Your Heart

A Cleveland Clinic podcast to help you learn more about heart and vascular disease and conditions affecting your chest. We explore prevention, diagnostic tests, medical and surgical treatments, new innovations and more. 

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