November 13, 2020

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Albert CM et al. LBS.01: Heart Failure and Atrial Fibrillation: Vitamins, Minerals, Nutrients, and More. Presented at: American Heart Association Scientific Sessions; 13-17 November 2020 (virtual meeting).

Disclosure:
VITAL Rhythm was supported by a grant from the NHLBI. Parasite and Pronova BioPharma / BASF donated the study materials, placebos and packaging. Albert reports that she has received support from Abbott, Roche Diagnostics, and St. Jude Medical. Schnabel reports that she has received honoraria from Bristol-Myers Squibb and Pfizer.

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The intake of omega-3 fatty acids and vitamin D3 supplements did not increase or decrease the risk of atrial fibrillation for a period of 5 years, according to the results of the VITAL Rhythm study.

Christine M. Albert

“Our results also do not support the use of [eicosapentaenoic acid/docosahexaenoic acid] or vitamin D3 for primary prevention of AF incidents ” Christine M. Albert, MD, MPH, President of the Heart Rhythm Society and founding chairman of the Department of Cardiology at the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles, said during a press conference. The results “also show no increased risk of AF for patients using these supplements for other indications.”

Omega 3

Source: Adobe Stock.

VITAL Rhythm is an add-on study to VITAL, a primary prevention study against CVD and cancer that was conducted in more than 25,000 adults in the United States. The study assessed whether a daily supplement with 2,000 IU vitamin D3 and / or 840 mg omega-3 fatty acids (Omacor, Pronova BioPharma / BASF; 1 g per day), consisting of 460 mg eicosapentaenoic acid (EPA) and 380 mg Docosahexaenoic acid, composed of acid (DHA) would reduce the risk of AF incidents compared to placebo.

No reduction, AF increase

Over a median of 5.3 years of treatment, 900 participants – 3.6% of the population – had a confirmed AF event. AF events were determined through participant self-reports and CMS damage data, and events were then confirmed through medical record review, Albert said. Seventy-three percent of the AF events observed during follow-up were confirmed by EKG and 27 percent by medical records.

Most of the events were paroxysmal AF (58.4%) and 62% of patients had symptoms at diagnosis, but a “good portion” of participants had no symptoms prior to diagnosis, Albert said.

The trial had a 92% performance to determine a 20% decrease or increase in the observed HR for incident AF. The incidence of AF in the omega-3 fatty acid group was slightly higher compared to the placebo arm, but not significant (HR = 1.09; 95% CI, 0.96-1.24; P = 0.19), said Albert. Similarly, the vitamin D group showed no decrease or increase in AF incidence compared to placebo (HR = 1.09; 95% CI, 0.96-1.25; P = 0.19).

VITAL Rhythm was a randomized, double-blind, placebo-controlled study with a 2×2 factor design. The researchers included 25,119 participants who had no history of CVD cancer or AF at baseline. The median age was 67 years, 51% were women and 20% were black.

“Roadmap” for AF primary prevention studies

“The use of nutritional supplements, including fish oil and vitamin D, is very popular in the community. However, the health benefits have not been demonstrated with CVD. ” Renate B. Schnabel, MD, MSc, interventional cardiologist, professor of cardiology at the University Heart Center Hamburg, Germany, said during a press conference discussing the VITAL Rhythm results. (See Healio’s previous coverage of the main VITAL study here.)

According to Albert, there is a lack of randomized controlled trials on primary AF prevention, mainly due to feasibility concerns. Low levels of marine omega-3s and vitamin D have been linked to an increased risk of AF incidents, but there has been a lack of extensive and long-term randomized data, she said.

VITAL Rhythm is the “first large-scale, randomized, placebo-controlled, long-term study prospectively testing the effects of an intervention on the AF incident,” said Albert.

“Future research testing of other strategies for preventing AF is needed. There are various other strategies that include lifestyle, weight loss and lowering blood pressure, ”she said. “I hope this study can provide a roadmap for conducting these primary prevention AF studies.”

VITAL Rhythm “paved the way for primary prevention studies in AF,” said Schnabel. “In the future, AF detection will be improved through wearables and other devices, but it definitely shows us the increasing relevance of more pragmatic studies that are plausible and potentially valid.”

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Annabelle Santos Volgman, MD, FACC, FAHA)

Annabelle Santos Volgman, MD, FACC, FAHA

This was one of several AF studies presented at the AHA that showed that preventing AF is more difficult than administering fish oil and vitamin D. These studies give us more clarity on how AF works in stroke and major patients -Risk can be prevented, treated and detected adverse CV events.

The VITAL Rhythm Study is an adjunct study to the VITAL Study, a primary prevention study against CVD and cancer in 25,871 American men and women. The study examined whether a daily supplement with 2,000 IU vitamin D3 and / or 840 mg omega-3 fatty acids (Omacor 1 g per day), consisting of 460 mg EPA and 380 mg DHA, would prevent AF. After a follow-up period of 5.3 years, the incidence of AF could neither be reduced nor increased. To prevent AF, we recommend that patients control risk factors such as high blood pressure, obesity, and sleep apnea, and avoid or limit alcohol.

Annabelle Santos Volgman, MD, FACC, FAHA

Cardiology Today member of the editorial board

Rush University School of Medicine

Elected Governor of the American College of Cardiology in Illinois

Chair of the American Heart Association Women in Cardiology

Disclosure: Volgman reports that she owns shares in Apple.

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American Heart Association

American Heart Association

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