Abridged AHA Scientific Sessions to Feature New Lipid Guidelines

Patrice Wendling

November 02, 2018

CHICAGO — The upcoming American Heart Association (AHA) Scientific Sessions 2018 will move to a leaner 3-day format but will have a full line-up, featuring new physical activity guidelines for Americans and a major overhaul of the cholesterol clinical practice guidelines.

The 2013 AHA/American College of Cardiology (ACC) cholesterol guidelines caused considerable confusion after they abandoned traditional targets in favor of treating four major primary and secondary prevention groups on the basis of calculated risk. The 2018 guidelines will update the atherosclerotic cardiovascular disease (CVD) risk calculator and go into much greater detail on how risk might be modified by a variety of different conditions or tests, said Eric Peterson, MD, Duke University Medical Center, Durham, North Carolina, who co-chairs the sessions' program committee.

The guidelines will also include recommendations on when and for whom to use the new proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors evolocumab (Repatha, Amgen) and alirocumab (Praluent, Sanofi/Regeneron).

"The positive thing is they incorporate a lot more science. The challenge will be that there's a lot that's different here, and then there's just a lot in them," he told theheart.org | Medscape Cardiology. "Like everything, it doesn't get easier with the function of time. And these are complex."

That said, the "premise of the 2013 guidelines remains important," guideline coauthor and co-chair of the sessions' program committee Donald Lloyd-Jones, MD, Northwestern University Feinberg School of Medicine, Chicago, said during a press conference in advance of the meeting. The document itself is substantially shorter, and the modular design allows physicians to find a specific recommendation with a brief text explaining its rationale.

The 2018 cholesterol clinical practice guidelines will be presented on Saturday, November 10, beginning at 10:45 AM CT. It will be followed by a deep dive session at 5:30 PM that will cover risk assessment, cost effectiveness of drug treatment, and select illustrative case presentations, he said.

The guidelines are bookended by a keynote session at 9:00 AM Monday, November 12, detailing the first update to the 2008 US Department of Health and Human Services' Physical Activity Guidelines for Americans. Roughly half of Americans fall short of meeting its recommended target of 150 to 130 minutes per week of moderate-intensity physical exercise. But since 2008, there is a greater understanding of both the quantity and the types of activities that carry specific benefits. There is particular interest in the intensity of exercise and whether, for example, a 10-minute burst of exercise can be potentially as beneficial as a more moderate 30-minute walk, Lloyd-Jones said.

The guideline committee's 2018 scientific report, which underpins the update and has been available for public comment, notes that the list of diseases and conditions for which exercise can reduce risk has continued to expand over the past decade and that for the first time research has shown that regular physical exercise provides health benefits to children as young as 3 to 5 years.

Late-Breaking Science

Sandwiched between the two guidelines presentations are no less than six late-breaking science sessions, the first of which, LBS.01, starts at 2:00 PM Saturday and is devoted to CV prevention, one of two major themes of the meeting.

The session kicks off with the National Institutes of Health–sponsored Vitamin D and Omega-3 Trial (VITAL), which examines the role for vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 g) supplements in preventing heart disease, cancer, and stroke.

The report from the long-running, roughly 25,000-patient trial is followed by REDUCE-IT, in which 8179 patients with elevated CV risk and persistent increased triglyceride levels were randomly assigned to receive high doses (4 g daily) of omega-3 oil eicosapentaenoic acid (EPA) or placebo. As recently reported by theheart.org | Medscape Cardiology, topline results show a 25% relative risk reduction in the primary endpoint of first occurrence of a major adverse CV event with EPA at 4.9 years' follow-up.

Peterson pointed out that REDUCE-IT was conducted on top of statin treatment in a broad primary- and secondary-prevention patient population with relatively low triglyceride levels (>150 mg/dL and <500 mg/dL).

"If you take the average population of patients with cardiovascular disease, half would meet this criteria," he told reporters. "So if it really works in all those populations and has a relatively large reduction, it has the potential to be a drug in up to half the patients we currently treat with statins."

Rounding out the session is the Japanese EWTOPIA 75 trial, investigating whether ezetimibe (multiple brands) can prevent CV events in middle- to high-risk elderly patients aged 75 years or older with elevated LDL-cholesterol, and an economic review of ODYSSEY Outcomes, examining the cost-effectiveness of alirocumab (Praluent, Sanofi).

Novel approaches to CV prevention are featured in LBS.02 at 3:45 PM Saturday and include DECLARE TIMI 58, investigating the sodium-glucose cotransporter type 2 (SGLT2) inhibitor dapagliflozin (Farxiga/Forxiga, AstraZeneca) in adults with type 2 diabetes and multiple CV risk factors or established CVD.

Topline results suggesting a beneficial effect on CV outcomes have already been reported, but Peterson said the details will be important in the wake of positive CV benefits with the SGLT2 drug empagliflozin (Jardiance, Boehringer Ingelheim/Lilly) in the EMPA-REG OUTCOME trial as well as an increased risk for amputations with the SGLT2 inhibitor canagliflozin (Invokana, Janssen).

"Also, we really need to understand a bit better which types of cardiovascular events they're reducing. Is it really just related to heart failure death, or can they actually reduce atherosclerotic events, which would another part of the Holy Grail?" added Lloyd-Jones. "This trial is big enough and well-powered enough to really give us some insights on that as a drug class."

The Cardiovascular Inflammation Reduction Trial (CIRT) will also be closely watched because of the great interest in inflammation as a new and potentially modifiable pathway to CVD, they noted. The anti-inflammatory drug canakinumab (Ilaris, Novartis) cut the overall risk for major CV events by 15% in CANTOS. CIRT is testing whether or not low doses of the generic arthritis drug methotrexate will reduce CV event rates in stable coronary artery disease patients with type 2 diabetes or metabolic syndrome.

Eschewing pharma entirely, the multicenter, randomized Yoga CaRe trial from India will close out the session by examining the effectiveness of a yoga-based cardiac rehabilitation program in more than 4000 patients after an acute MI.

Saturday's LBS.03 session at 5:30 PM is devoted entirely to harnessing technology and improving systems for global health. It features the Brazilian BRIDGE CV and BRIDGE-Stroke trials, which focus on adherence to evidence-based therapies in high-risk patients; two trials using computerized decision support in the management of atrial fibrillation, AF-ALERT and IMPACT-AF; and the mWELLCARE trial, which examined the use of a mobile health–based software application in community health centers in India.

The LBS.04 session kicks off at 9:00 AM Sunday, November 11, and focuses on preserving the brain and heart in acute care cardiology. On tap is the PRINCESS trial, which examined prehospital intranasal cooling during resuscitation; the Neuroprotect trial in comatose survivors after out-of-hospital cardiac arrest; and the T-TIME trial of low-dose adjunctive alteplase (Activase, Genentech; Actilyse, Boehringer-Ingelheim) during primary percutaneous coronary intervention (PCI).

Also scheduled are the EARLY trial, which examined early vs delayed PCI for intermediate- and high-risk non-ST-elevation acute coronary syndromes, and the Door to Unload pilot trial of the Impella system in acute MI.

The LBS.05 session at 10:45 AM promises to deliver "Hot News in HF" and features the PIONEER HF trial, which follows on the success of sacubitril/valsartan (Entresto, Novartis) in patients with chronic heart failure (HV) by comparing it against enalapril (multiple brands) in an acute HF population.

The novel randomized TRED HF trial looks at withdrawing HF treatment in patients with recovered dilated cardiomyopathy. "We've never known really do we have to just continue their meds for the rest of their days or are we able to safely withdraw them, so a nice and very interesting question for clinicians and patients alike," remarked Peterson.

The session also includes an analysis on the effects of rivaroxaban (Xarelto, Bayer/Janssen) on thrombotic events in HF patients in the recently reported COMMANDER HF trial; the EMPA-HEART study, which examined the effects of empagliflozin on cardiac structure in type 2 diabetes; and the Australian AV-Fistula study of cardiac remodeling following ligation of arteriovenous fistula in kidney transplant recipients.

Finally, running from 5:30 to 6:45 PM on Sunday, is the LBS.06 session on coronary revascularization starts with long-term follow-up from the REGROUP trial of endoscopic vein harvest for coronary artery bypass grafting (CABG).

The FREEDOM Follow-On study will provide long-term survival results from the pivotal FREEDOM trial of CABG vs PCI in multivessel disease in patients with diabetes.

Attendees will also hear data from the TiCAB trial of ticagrelor (Brilinta,AstraZeneca) vs aspirin in patients undergoing CABG and 10-year data from the ISAR-TEST-4 study of absorbable vs permanent polymer stents in an all-comers population.

In the final spot will be results from a sham-controlled trial, terminated by the National Heart Lung, and Blood Institute after only 10 patients has been enrolled, which evaluated the safety of injecting mesenchymal precursor cells into the heart during left ventricular assist device implantation.

The report comes amid close scrutiny of stem-cell therapy after Harvard University and Brigham and Women's Hospital called for the retraction of 31 journal articles by former staffer Piero Anversa, MD, over concerns the articles contained falsified and/or fabricated data.

New Ways of Doing Things

Although 2 days crammed with late-breaking science may be challenging, physicians are simply unable and/or unwilling to be away for more than 3 days, Peterson told theheart.org | Medscape Cardiology. In the 5 years they've been fighting for the shorter format, pharmaceutical support for overseas physician attendance has dried up, and practices, health systems, and academia are clamping down on longer absences to attend meetings.

"There's a lot of forces that have made it more expensive, either direct out-of-pocket costs or missing opportunities to actually earn revenue, and there's less leeway in the system now," he said. "And in part, we wanted to increase the excitement and offer higher quality, lower numbers of things."

Also reflecting the sessions' second major theme of "finding new ways of doing things," the typically very long Opening Session Address has been revamped to feature a series of TED-like talks on cutting-edge science, such as how your microbiome may affect disease risk, or vaccines for coronary disease, he said.

AHA President Ivor Benjamin, MD, will still deliver the Conner President's Address, but it will begin mid-meeting at 1:00 PM Sunday, November 11.

In recognition of the outdated "man-panel," the organizers also set a goal of 50% women and minority participation on session panels.

At upwards of 40%, "We didn't quite make it, but it will be much higher certainly than the percentage of women and minorities in cardiology as a whole," Peterson said.

In addition to the traditional "Go Red for Women" sessions, there is also a 7:15 AM session Sunday highlighting top women contributors in cardiovascular disease.

"So there's a lot of emphasis on fixing what has been imperfect in our field in terms of male majority and generally white panels," he said. "You won't see an all-white male panel in blue blazers up there this year."

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology , follow us on Twitter and Facebook.


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