The coronavirus disease 2019 (COVID-19) pandemic forced the European Society of Cardiology to present its 2020 Congress (August 28-September 1) in a virtual format; by some accounts, this was a rousing success—the ESC did not charge for participation and reported online attendance of 116,000, with its largest female audience ever. More than half the participants were under age 40, the Congress reported in a press release. That’s not to say there weren’t a few snags. But the science was top notch, with many implications for clinical practice and regulatory approvals. Here are 5 takeaways from the 2020 Congress:
- SGLT2 inhibitors were the star of the show. Findings for EMPEROR-Reduced in Jardiance (empagliflozin) and DAPA-CKD in Farxiga (dapagliflozin) were the top draws; topline results announced ahead of the meeting indicated these trials would be home runs, and they did not disappoint. EMPEROR-Reduced (for heart failure with reduced ejection fraction) showed the sodium glucose co-transporter 2 (SGLT2) inhibitor cut the risk of cardiovascular death or hospitalization for heart failure by 25% and first or future heart failure hospitalizations by 30%. DAPA-CKD showed a 39% drop in the risk of renal decline or kidney failure death. As discussed in the August issue of Managed Healthcare Executive®, experts spoke of the results together as proof that the drug class has moved well beyond its roots in diabetes care; one commentator called it an “organ protection “ class.
- Will a combination for HFpEF come in 2021? After the PARAGON-HF trial for Entresto (sacubitril/valsartan, Novartis) just missed its end point for heart failure with preserved ejection fraction (HFpEF) in 2019, cardiologists wondered if this hard-to-treat condition would ever have an approved therapy. This weekend, the PARALLAX trial hit its mark on a key biomarker end point but missed on the 6-minute walk test. (FDA is reviewing Entresto in HFpEF.) But there’s more to the story. Patients in EMPEROR-Reduced taking both Entresto and Jardiance showed this combination can work well together, and the lead investigator for PARALLAX said in an interview that when trial results for EMPEROR-Preserved appear next year, a four-drug combination including Entresto and an SGLT2 inhibitor may finally offer a HFpEF solution.
- At long last, a therapy for HCM. One of the weekend’s true bright spots was the presentation from Italy’s Iacopo Olivotto, MD, who told listeners that after 60 years of trying, it was hard to describe the feeling among the scientific community about mavacamten, a drug that appears to be working for patients with hypertrophic cardiopmyopathy (HCM). This genetic condition causes too many heart contractions, which leads to thickening, shortness of breath, fatigue, and sometimes sudden death. Phase 3 results in EXPLORER-HCM showed that twice as many patients taking the drug hit clinical and functional benchmarks as those taking placebo. It’s expected that MyoKardia, the maker of mavacamten, make seek FDA approval in early 2021.
- New guidelines, including a first for sports. The annual ESC Congress is well-known for its release of guideline updates, and 2020 was no exception. This year’s updates came in management of acute coronary syndrome in patients presenting without ST-segment elevation, management of atrial fibrillation, and management of adult congenital heart disease. For the first time, ESC released guidelines in sports cardiology and exercise for patients with cardiovascular disease. Unlike prior position statements that focused on avoiding sudden cardiac death in athletes, these new guidelines are designed to integrate sports and physical activity into a health plan for patients with cardiovascular disease, thus addressing epidemics of obesity, diabetes, and heart disease.
- COVID-19 doesn’t just affect meetings—it’s affecting results. The ESC organizers did their best to give the original host city of Amsterdam attention in pre-taped travelogues, and the studio that hosted the “hot line” presentations set the bar for production values. But there were glitches here and there, and results like the breakthrough EXPLORER-HCM data missed the thunderous applause they deserved. More troubling was the notation in the EMPEROR-Reduced findings that 42 patients were lost to follow-up due to COVID-19 chaos, and one must wonder what will happen to key heart failure trials now in the pipeline. And on the heels of ESC came word that another major heart event—the American College of Cardiology—will move its annual meeting slot of mid-March to May 15-17, 2021, with the hope of boosting in-person attendance.