Results from the ODYSSEY Outcomes trial for the PCSK9 inhibitor alirocumab were the top news at the meeting.
The American College of Cardiology (ACC) held its 67th Scientific Session March 10-12, 2018, in Orlando, Florida, where approximately 18,000 people gathered for scientific updates and to see the latest technology in the field. Here are 5 takeaways from ACC:
1. Alirocumab cuts the death risk, but mostly for patients with the highest cholesterol. The big news everyone was waiting for came early March 10: Results from the ODYSSEY Outcomes trial showed the PCSK9 inhibitor alirocumab (Praluent), from Sanofi and Regeneron, produced a 15% reduction in the risk of cardiac events, which rose to 24% for patients with low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL. The study showed a 29% drop in the risk of all-cause death for patients with LDL-C ≥100 mg/dL, but this benefit was not seen for patients at LDL-C levels. While ODYSSEY had a difficult population and a longer follow-up period than FOURIER, the study for rival PCSK9 inhibitor evolocumab (Repatha, Amgen), the results seem to give alirocumab an edge in a class that has fallen well short of early sales expectations.
2. With results in hand, Sanofi and Regeneron offered payers a deal: be nice, and we’ll cut prices. For the second year, results from a big cardiovascular outcomes trial came with an overture to payers, who have been cool to the $14,000 price tag for these injectable antibodies despite studies showing 60% drops in LDL-C. Sanofi-Regeneron said a revised benchmark range from the Institute of Clinical and Economic Research (ICER) of $4450 to $8000 for patients with the highest LDL-C (above 100 mg/dL) would be a starting point for price talks if payers are willing to end the barriers that have bedeviled physicians since approval in 2015.
3. CVD-REAL data continue to mirror the randomized clinical trials. At ACC 2017, AstraZeneca’s CVD-REAL study was the surprise of the meeting: a mega-analysis that compared the performance of sodium glucose co-transporter 2 (SGLT2) inhibitors with other glucose-lowering agents, using claims and registry data the United States and Europeans countries. Not only did CVD-REAL get results for patients with existing cardiovascular disease (CVD) that mirrored what had been seen in the only outcomes trial to that point (EMPA-REG), but found results that suggested SGLT2 inhibitors might have potential for primary prevention. And the results presented this weekend only bolster that case: findings from South Korea, Japan, Singapore, Australia, Israel, and Canada showed a 49% lower risk of all-cause death and reductions in heart attacks and strokes in regions of the world where stroke is more common. In CVD-REAL 2, 75% of the patients took dapagliflozin (Farxiga), AstraZeneca’s SGLT2 inhibitor; the outcomes trial DECLARE, which has a larger primary prevention component than others seen thus far, is expected in November 2018.
4. A controversy in payment reform: is the readmissions focus creating unintended consequences? Cardiologists have an intense interest in CMS' penalties for exceeding benchmarks for the 30-day readmission rate because so many of the targeted conditions are in their field. First and foremost is heart failure, which affects some of the most complicated patients. At separate sessions this weekend, cardiologists discussed controversial findings in the January issue of JAMA Cardiology, which suggest a link between readmission penalties and increased mortality among these patients. Not everyone agrees that the data are conclusive, but as one physician put it: even if the Hospital Readmission Reduction Program isn’t the culprit, if mortality is rising, shouldn’t we be asking why?
5. Tech, tech, and more tech. The exhibit hall was bursting with software and gadgets of every kind, from life-saving instruments that save precious minutes in the emergency department, to wearables that feed data to the electronic health record, to solutions that create better images, crunch data, and promise to improve workflow. Cardiologists are embracing technology that will transition care from individual episodes to a continuous process, as discussed in this AJMC® podcast with Jagmeet P. Singh, MD, PhD, FACC, deputy editor of JACC: Clinical Electrophysiology, and Fred Bove, MD, MACC, editor-in-chief of Cardiology magazine.