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Our November 2023 month in review for cardiology features highlights from AHA 2023, new atrial fibrillation guidelines, a pair of historic approvals from the FDA, and more!
The cardiology community was the recipient of an onslaught of clinically impact news during the month of November. So much so, the month will likely be remembered as historic not just for the field of cardiology, but the medical community and public health as a whole.
Although news of the SELECT trial dominated headlines early in the month, along with other news from the AHA Scientific Sessions 2023, the field also saw the FDA usher in a new era of hypertension management, learned a decades-long practice may provide no significant benefit, welcomed new atrial fibrillation guidelines, and were informed Bayer would be halting a trial of their factor XI inhibitor, asundexian, over a lack of efficacy.
On November 19, 2023, Bayer announced the Independent Data Monitoring Committee for the OCEANIC-AF trial recommended the trial be stopped due to inferior efficacy of asundexian compared to apixaban in patients with atrial fibrillation at risk for stroke. The move came less than a month after Bayer announced it would be expanding its phase III OCEANIC program to include a third clinical study—OCEANIC-AFINA. Bayer also noted the Independent Data Monitoring Committee recommended the continuation of the OCEANIC-STROKE trial as planned.
on November 30, 2023, American College of Cardiology and the American Heart Association released new guidance for prevention and management of atrial fibrillation. Although a focused update was released in 2019, the new guidance represents the first major guideline update released on the topic from the ACC and AHA since 2014. The 171-page guideline, which is endorsed by both the American College of Clinical Pharmacy and the Heart Rhythm Society, is broken down into 11 chapters and based on a comprehensive literature search performed from May 12, 2022, to November 3, 2022.
Key highlights of the guidance include a new staging classification for atrial fibrillation, a Class 1 recommendation for early rhythm control, a Class 1 recommendation for catheter ablation in select patients, and a Class 2a recommendation for left atrial appendage occlusion devices.
A trial in the New England Journal of Medicine randomizing brain-dead donor hearts to levothyroxine administration or saline has returned results challenging conventional wisdom on the topic, with data indicating thyroid hormone administration may provide no significant benefit.
A joint effort coordinated by 15 organ-procurement organizations in the US, results of the trial, which included 838 brain-dead donors, concluded intravenous levothyroxine infusion did not result in significantly more hearts being transplanted, with investigators suggesting this approach may even place recipients at greater risk of severe hypertension and tachycardia.
During the month of November, the FDA granted a pair of approvals to renal denervation systems for the management of hypertension. The first was awarded to ReCor Medical for their Paradise Ultrasound renal denervation system on November 7, 2023. The second was awarded to Medtronic for their Symplicity Spyral renal denervation system on November 23, 2023. Both devices were the subject of August 2023 meetings convened by the FDA’s Circulatory System Devices Panel.
The final annual meeting among the flagship organizations in cardiology each year, the AHA Scientific Sessions serve as a showcase for groundbreaking advances in the field. This year’s meeting was no different, with the landmark SELECT trial debuting during the first late-breaking session. In addition to the SELECT trial, which offered new insight into the 20% relative risk reduction in 3-point MACE observed in the trial, the editorial staff of HCPLive Cardiology are highlighting our top news in cardiology feature, which captures the perspective of 13 key opinion leaders on the news that defined the field during the last year.