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MUNICH -- Primary prevention of cardiovascular disease is in the spotlight here.
Top of the list for many cardiologists interviewed ahead of the meeting were the aiming to prevent first vascular events, and the in a 2×2 factorial design for primary cardiovascular prevention in type 2 diabetes. Both trials enrolled well over 10,000 participants.
"The two I am most excited to see results of are ARRIVE and ASCEND related to aspirin's effect and its role in prevention," said Martha Gulati, MD, of the University of Arizona College of Medicine in Phoenix, who noted that the data will be important and broadly applicable. "We need this data."
Omega-3 and aspirin are "both very important potential therapies that are inexpensive and low toxicity, said Carl "Chip" Lavie, MD, of the John Ochsner Heart and Vascular Institute in New Orleans.
The importance of ARRIVE will be dependent on the patient population, but ASCEND's diabetes population would potentially put millions in line for generalizability of the findings, noted Raymond Gibbons, MD, of the Mayo Clinic in Rochester, Minnesota. "Should they all be on aspirin? Best published evidence says NO. Official recommendation in state of Minnesota says YES."
With regard to the fish oil portion of ASCEND, Jennifer Robinson, MD, MPH, of the University of Iowa in Iowa City, noted: "Although early trials suggested omega-3 supplements reduced cardiovascular events in patients with cardiovascular disease, the more recent trials in the statin era have found no such benefits. ASCEND should provide an answer for primary prevention diabetic patients."
Also, ASCEND will be an "interesting exploration of lowering triglycerides (if they were lowered enough)," added Marc Sabatine, MD, MPH, of Brigham and Women's Hospital in Boston.
Another key primary prevention trial, likewise slated for presentation on Sunday, is , top line results of which were already released as showing for cardiovascular and metabolic effects in overweight and obese people.
"There is a huge market for an effective, well-tolerated weight loss drug with a good safety profile over a period of years," commented Robinson, who was an investigator in the trial. "Previous classes of weight loss drugs have had adverse effects on the heart. Whether longer term follow-up will be needed to establish the safety of lorcaserin remains to be determined."
While a reduction in cardiovascular events would have been big news, the drug has "very modest effects on weight loss," noted Christie Ballantyne, MD, of the Baylor College of Medicine in Houston.
are also out for the ATTR-ACT (Efficacy and Safety of Tafamidis in Transthyretin Amyloid Cardiomyopathy) trial, showing a significant reduction in combined all-cause mortality and cardiovascular-related hospitalizations with the drug versus placebo at 30 months. Still, it "will get a lot of attention because we have no therapy for amyloid and, if this drug changes it, [that] will be exciting," Gulati noted.
In heart failure, the trial of rivaroxaban (Xarelto) for patients with comorbid significant coronary artery disease after an episode of decompensated heart failure, was highlighted by Christopher Cannon, MD, of Brigham and Women's Hospital, as a potential driver for a new indication.
For interventionalists, the trial will be of particular interest as the first large randomized comparison of medical therapy against a device treatment for ischemic functional mitral regurgitation (MR), noted Ted Feldman, MD, of Evanston Hospital in Evanston, Illinois.
"This comparison has yet to be made with surgery for MR," he said, "and this first randomized trial will help to define the role of MitraClip -- and possibly other devices -- in this population."
Another randomized controlled trial of mitral regurgitation reduction using percutaneous edge-to-edge repair in patients with secondary (functional) MR and heart failure -- the -- is slated for presentation at the Transcatheter Cardiovascular Therapeutics meeting, added William Abraham, MD, of the Ohio State University in Columbus, who is a primary investigator on it.
"There has never been an RCT (percutaneous or surgical) of MR reduction in heart failure before, so these two trials will be landmark trials addressing this question," he pointed out.