For SGLT2 inhibitors and a fish oil capsule, there was plenty of good news; for aspirin, not so much. A recap of the American College of Cardiology's 68th Annual Scientific Session, held March 16-18, 2019, in New Orleans, Louisiana.
The American College of Cardiology's 68th Annual Scientific Session, held in New Orleans, Louisiana, March 16-18, 2019, offered a few departures from recent years and some controversy. Unlike recent years, there wasn’t a single giant randomized clinical trial to dominate the opening day, but there was still plenty of news that will shift clinical practice. Here are 5 takeaways:
1. Cardiologists are poised to prescribe novel diabetes drugs for primary prevention
An updated primary prevention guideline unveiled Sunday calls for using sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists to prevent long-term cardiovascular complications, such as heart failure or renal decline. Sessions during the meeting explored the relationship between diabetes and heart failure and offered case studies for choosing from these 2 drug classes. The shift comes as ACC and the American Diabetes Association (ADA) are collaborating more than ever on clinical guidelines.
2. The next wave of headlines will come from trials exploring SGLT2 inhibitors in heart failure and kidney care
On Monday, new results from DECLARE showed dapagliflozin offers benefits for diabetes patients with heart failure and may reduce the death risk for patients with reduce ejection fraction. While the results are exciting, commenters cautioned that the overall numbers were small and should be confirmed in larger studies. Those studies are in the pipeline now, and upcoming results will show the effects of SGLT2 inhibitors on heart failure and chronic kidney disease, including in patients without diabetes.
Results from the CREDENCE trial, which examines renal results from canagliflozin, are expected to make big news in June at the ADA 79th Scientific Sessions in San Francisco, California.
3. The Apple Heart Study was controversial, but more virtual trials are coming
Had it not occupied the entire Saturday morning late-breaking session—including a guest panel on the future of digital health—the Apple Heart Study might not have provoked such discontent. The study authors were clear that theirs was not a randomized clinical trial (RCT) and the watch is not a diagnostic device, but that didn’t stop grumbling that more important trials at ACC got less of a rollout. After results showed the watch was able to detect atrial fibrillation that matched up with an electrocardiogram patch with a predictive value of 84% for notification, Johnson & Johnson—maker of the anticoagulant rivaroxaban—announced it will conduct an RCT with the watch. The Apple Heart Study’s virtual enrollment method, which reached more than 400,000 patients in just 8 months, won praise as cost-saving design whose time has come.
4. Amarin’s fish oil pill gets more good news, but the mystery remains
Study authors still don’t know exactly how a high dose of a purified fish oil component, icosapent ethyl, does what it does. But after headlines at the American Heart Association, when the capsule sold as Vascepa was shown to reduce initial cardiovascular events by 25%, new results presented at ACC showed it cut the risk of second events by 32%, third events by 31%; and fourth events by 48%. Icosapent ethyl was first approved to treat triglycerides, and those familiar with the omega-3 fatty acid capsule say the new results bolster the case for triglycerides as a cardiovascular marker.
Lead study author Deepak Bhatt, MD, MPH, likened the situation to the early days of statins. He is looking ahead to cost-effectiveness studies, which he predicts will convince providers and payers alike that avoiding stents and bypass surgeries makes the capsule a winner. Amarin is expected to file with FDA for new indication any day now.
5. Poor aspirin. This meeting was a headache.
Sunday’s primary prevention guideline update called for more limited use of aspirin for those who have not had a cardiovascular event, based on new evidence about bleeding risk. And the AUGUSTUS trial featuring apixaban (Eliquis) showed that combining the anticoagulant with a P2Y12 inhibitor, an antiplatelet therapy, presented less bleeding risk for complex heart patients than a combination with aspirin. The primary prevention guideline shift caused a reaction from aspirin fans, who issued statements reminding everyone that this medicine cabinet mainstay is still recommended for many patients who have had a heart attack.