Novel approaches, secondary analyses at forefront of upcoming AHA Scientific Sessions
PHILADELPHIA — The American Heart Association Scientific Sessions, being held Saturday to Monday in Philadelphia, will include the presentation of important science focused on CVD risk reduction with novel approaches and the management of several conditions including aortic stenosis, ACS and HF.
Some major themes in late-breaking science that will be presented at this meeting include findings from phase 2 and 3 clinical trials on novel therapeutics and novel pathways and secondary analyses or subgroup analyses of recent clinical trials such as DAPA-HF, PARAGON-HF and COMPLETE.
“We all are aware of some of the high-profile trials that have come out in the last year, but it’s often the follow-up studies that really put the meat on the bones and help us understand in which types of patients in which settings these therapies may work best or where they may actually be a little bit more risky,” Donald M. Lloyd-Jones, MD, ScM, senior associate dean for clinical and translational research, chair of the department of preventive medicine, director of Northwestern University Clinical and Translational Sciences Institute, the Eileen M. Foell Professor of Preventive Medicine (Epidemiology) and professor of medicine (cardiology) and of pediatrics at Northwestern University Feinberg School of Medicine and chair of the AHA Committee on Scientific Sessions Programming, said during a telebriefing.
The ISCHEMIA trials will potentially generate the most buzz during this meeting, Lloyd-Jones said during the telebriefing. The trial, which compares health effectiveness of medical and invasive approaches with regard to clinical outcomes and quality of life in more than 5,000 patients, consists of two studies: one with and one without patients with chronic kidney disease. Patients in both trials have stable ischemic heart disease and documented moderate or severe ischemia on a stress test.
“This trial is very intelligently designed to address not only that hard outcome question, but really take the patient’s perspective and help us understand the quality of life outcomes that are associated with either that initial invasive or initial medical therapy approach,” Lloyd-Jones said during the telebriefing.
Several late-breaking clinical trials focus on novel approaches for medical therapy and intervention, including:
- COLCOT, which is evaluating the use of colchicine in patients after MI to reduce rates of CV events;
- Another trial will assess colchicine in patients after PCI;
- EVAPORATE, in which researchers assessed the effect of icosapent ethyl (Vascepa, Amarin) on coronary atherosclerosis progression in patients with elevated triglycerides;
- BETonMACE, a trial evaluating bromodomain and extraterminal domain protein inhibition with apabetalone in patients with ACS and diabetes; and
- ORION-9 and ORION-10, two phase 3 trials analyzing the efficacy and safety of inclisiran (The Medicines Company) in patients with heterozygous familial hypercholesterolemia and with atherosclerotic CVD and elevated LDL, respectively.
Other trials of interest include one that compared ticagrelor with and without aspirin in patients who were high risk after a coronary intervention for ACS. Impella (Abiomed) will be compared with an intra-aortic balloon pump in two separate studies: mortality and bleeding in patients with acute MI and cardiogenic shock, and a comparison of costs and effectiveness with both approaches.
One late-breaking science session will spotlight controversies in the contemporary management of patients with aortic stenosis and will include the GALILEO trial, which compares a rivaroxaban (Xarelto, Janssen/Bayer) strategy with an antiplatelet strategy in patients after transcatheter aortic valve replacement; a comparison of balloon-expandable TAVR with self-expandable TAVR from the FRANCE-TAVI registry, and a study comparing early surgery with conventional management of patients with asymptomatic severe aortic stenosis.
Cardiology Today and Healio will report live from the AHA Scientific Sessions. Stay tuned to Healio.com/Cardiology for breaking news, expert perspectives and more, and follow us on Twitter at @CardiologyToday. – by Darlene Dobkowski