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CHICAGO -- Big guideline updates will bookend the American Heart Association's annual Scientific Sessions here.
The meeting will kick off Saturday with release of AHA/American College of Cardiology lipid guidelines that revise the 2013 recommendations for both primary and secondary prevention as well as management of familial hypercholesterolemia.
One notable change will be specific recommendations on when and for whom to use the two PCSK9 inhibitors approved in 2015, said Donald Lloyd-Jones, MD, of Northwestern University in Chicago and co-chair of the meeting program committee as well as an author on the guidelines, in speaking at a media telebriefing preview of the program.
"We spent a lot of time thinking of what is the appropriate use of those medications," given the significant cost, Lloyd-Jones noted. "I think the clear recommendations will be helpful to clinicians."
Another key facet to the update will be how to better select primary prevention patients for cholesterol-lowering therapy -- which risk scores to use and when to focus on strategies beyond risk scores, he added. Even with these changes, he said the document is substantially shorter than in the past and is modular.
However, the guidelines will not be returning to a threshold number for starting lipid-lowering therapy, Lloyd-Jones noted. "It will never be as simple as a single cholesterol number because that has to be interpreted in the context of the patient's other risk factors, the likelihood that they will benefit from drug therapy and not just lifestyle therapy, and a number of other things."
Another set of important guidelines come out Monday, the last day of the now 3-day meeting: national physical activity recommendations from the Department of Health and Human Services.
The first such guidelines were published in 2008, "so this is really only the second time we've had national guidelines for physical activity in 10 years," Lloyd-Jones noted. "In addition to our long standing understanding that doing something is better than doing nothing, and doing more is better than doing something, I think we've in the past 10 years seen some really interesting data on the intensity of exercise, duration of bouts of exercise, and how those can potentially affect health outcomes."
A draft of the document has not been released, but a was published in February.
Among the important slated for presentation at the meeting, Eric Peterson, MD, of the Duke Clinical Research Institute in Durham, North Carolina, and chairman of AHA's Committee on Scientific Sessions Programming, highlighted the following:
- VITAL: A huge, NIH-funded, two-by-two trial of vitamin D and omega-3 fatty acid supplements for primary prevention of cardiovascular disease and cancer.
- REDUCE-IT: Prescription fish oil (Vascepa) worked for primary prevention in this large trial, based on top-line results, but just how big a win remains to be seen. The good news is it was done on top of statins and in a broad population with relatively low triglycerides, Peterson said. "It has the potential to be a drug we would think about in using in up to half of the patients we treat currently with statins."
- EWTOPIA75: A trial of ezetimibe (Zetia) for cerebro- and cardiovascular event prevention in people 75 and older -- a population in which there has been less evidence from clinical trials, Peterson noted.
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DECLARE: The cardiovascular outcomes trial for diabetes drug dapagliflozin (Farxiga) was recently to have met one primary endpoint for heart failure hospitalization or cardiovascular death but not the other primary composite of major adverse cardiovascular events. Full results will be presented.
- PIONEER-HF: Sacubitril/valsartan (Entresto) has been shown effective in chronic heart failure; this trial is testing it in the acute setting.
- TRED-HF: This trial looks at what Peterson called a seldom-addressed but important issue for clinicians and patients: the safety of withdrawing heart failure medication after heart function recovers in dilated cardiomyopathy.
- REGROUP: A long-term outcomes trial of endoscopic harvesting of vein grafts for coronary bypass.
Another notable trial is CIRT, which tested low-dose methotrexate for prevention of atherosclerotic events as a conceptual follow-on to the CANTOS trial's demonstration that cutting inflammation with immunotherapy reduced cardiovascular events.
However, the high cost of canakinumab (Ilaris) used in CANTOS and the counterbalancing risk of infections made it impractical for prevention in clinical practice, Peterson suggested, even if the FDA hadn't rejected a cardiovascular prevention label last month. Methotrexate, in contrast, is a relatively inexpensive drug with a well-known safety profile.
Generic low-dose methotrexate, too, is known to reduce inflammatory marker C-reactive protein, he pointed out. "Given its low cost and its potentially relative safety from other prior studies, this has the potential to think about a new therapeutic paradigm."