Global biotherapeutics leader CSL Behring today announced the results of a new meta-analysis of seven interventional Phase 3 clinical trials that included more than 82,000 high-risk patients with recent acute coronary syndrome (ACS). The findings show that 49 percent of the recurrent major adverse cardiovascular events (MACE) experienced in the first year following an ACS event occurred within the first 90 days. The results were presented at the American College of Cardiology’s 70th Annual Scientific Session & Expo (ACC.21).
ACS describes a range of conditions with clinically obstructive coronary disease, where unstable or vulnerable plaque erosion or rupture may block an artery and restrict blood flow to the heart.1,2 While it is largely understood that, despite optimal clinical therapy, patients with ACS are at a high risk of experiencing a recurrent cardiovascular (CV) event within one year, recent research suggests the first 90 days may be the most critical time period.3
“While we know that patients with ACS are always going to be vulnerable for future cardiovascular complications, what is striking is that when we look at all of the recurrent events that occur within one year after ACS, about half are happening within just the first 90 days,” stated C. Michael Gibson, M.D., M.S., an interventional cardiologist at Beth Israel Deaconess Medical Center and principal study investigator. “These data tell us that we need to look beyond our traditional 30-day window in clinical studies and address the underlying cause of these early recurrent events to help provide our patients with more protection.”
Researchers performed a comprehensive search to collect data from Phase 3 interventional trials on high-risk ACS patients. A total of 82,727 high-risk patients with recent ACS from the seven trials were analyzed. Pooled rates of recurrent MACE were 4.1 percent (95% CI: 3.0%-5.7%) at 90 days and 8.3 percent (95% CI: 7.1%-9.8%) at 360 days. Approximately 49 percent of events occurred within the first 90 days.
“This meta-analysis reaffirms that the first 90 days after an ACS event are when patients are particularly vulnerable for recurrent MACE,” said Larry Deckelbaum, Vice President, Research and Development, Cardiovascular and Metabolic Therapeutic Area at CSL Behring. “Despite the treatment options available today, it is clear that more needs to be done to protect patients during this critical time period. That’s why we’re looking towards our novel Phase 3 research program to better understand this risk period and how we can deliver on our promise to patients and reduce the risk of these recurrent events.”
The AEGIS-II study is a Phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study, which will enroll approximately 17,400 patients from 49 countries. It will evaluate the efficacy and safety of CSL112 compared to placebo in reducing the risk of MACE in patients following a heart attack. The primary efficacy outcome is time to the first occurrence of the MACE composite, which includes cardiovascular death, heart attack or stroke, from randomization through 90 days.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, the company develops and delivers innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 27,000 people worldwide, and delivers its life-saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit Vita at CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.
Natalie de Vane
SOURCE CSL Behring
1 Rader DJ, et al. Translating molecular discoveries into new therapies for atherosclerosis. Nature. 2008; 451:904-913.
2 Bentzon, J., Otsuka, F., Virmani, R. and Falk, E., 2014. Mechanisms of Plaque Formation and Rupture. Circulation Research, 114(12), pp.1852-1866.
3 Wallentin L, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009; 361:1045-1057.