New Meta-Analysis of Patients with Acute Coronary Syndrome Shows Nearly Half of Recurrent Major Adverse Cardiovascular Events at One Year Occur Within the First 90 Days

Rhea-AI Summary

CSL Behring announced findings from a meta-analysis of seven Phase 3 trials involving over 82,000 patients with recent acute coronary syndrome (ACS). The analysis revealed that 49% of recurrent major adverse cardiovascular events (MACE) occurred within the first 90 days after an ACS event. The results highlight the criticality of this early period for high-risk patients. CSL Behring is advancing its Phase 3 AEGIS-II study to assess the efficacy of CSL112 in reducing MACE risk following heart attacks, aiming to enhance patient protection during this vulnerable timeframe.

Positive

• The meta-analysis involved over 82,000 patients, providing robust data on MACE occurrence.
• 49% of recurrent MACE events occurred within the first 90 days, highlighting the need for better patient care.
• CSL Behring is initiating the AEGIS-II Phase 3 study to further investigate MACE risk and treatment efficacy.

Negative

• None.

KING OF PRUSSIA, Pa., May 16, 2021 /PRNewswire/ -- 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."

About AEGIS-II

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.

Media Contact:

Natalie de Vane

Mobile: 610-999-8756

Office: 610-878-4468

Natalie.deVane@CSLBehring.com

SOURCE CSL Behring

References

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.

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SOURCE CSL Behring

FAQ

What were the findings of the CSL Behring meta-analysis regarding acute coronary syndrome?

The meta-analysis revealed that 49% of recurrent major adverse cardiovascular events (MACE) occurred within the first 90 days after an acute coronary syndrome event.

What is the AEGIS-II study by CSL Behring?

The AEGIS-II study is a Phase 3 trial evaluating the efficacy of CSL112 in reducing MACE risk in approximately 17,400 patients after a heart attack.

How many patients were included in the CSL Behring meta-analysis?

The meta-analysis included over 82,000 high-risk patients with recent acute coronary syndrome.

What does ACS stand for in the context of CSL Behring's research?

ACS stands for acute coronary syndrome, a condition involving obstructive coronary disease.

When were the results of the CSL Behring meta-analysis presented?

The results were presented on May 16, 2021, at the American College of Cardiology's 70th Annual Scientific Session & Expo.