ACUITY one-year findings meet all primary endpoints in favour of Angiox® (bivalirudin) alone treatment group

27.03.2007Major bleeding in patients treated for Acute Coronary Syndromes (ACS) nearly triples the risk of death at one year.

One-year findings from the landmark ACUITY trial show that acute coronary syndrome (ACS) patients in the “Angiox® (bivalirudin) alone” treatment group had similar rates of ischemic clinical outcomes compared with more complicated standard therapy, confirming previous findings, which showed similar ischemia at 30 days, and nearly 50% fewer episodes of major bleeding.
At one year, the mortality rate of patients treated in the Angiox® alone treatment group was 3.8%, compared to 4.4% in the control treatment group. A separate analysis found that, in patients with ACS, having a major bleeding episode within 30 days following treatment nearly triples the risk of death up to one year later, making major bleeding a more powerful predictor of mortality than even a heart attack.
The ACUITY one-year results were presented as late-breaking findings by investigators for the first time at the i2 Summit at the 56th Annual Scientific Session of the American College of Cardiology. Collectively, the data showed that ACUITY met all primary one-year endpoints and confirmed previously published 30-day findings.
"Our findings are important because compared with current standard therapy they  demonstrate that in moderate and high risk patients with ACS, Angiox® regimen, results in the overall best clinical outcomes,” said ACUITY's principal investigator, Gregg W. Stone, MD, professor of medicine and director of cardiovascular research and education at Columbia University Medical Center's Center for Interventional Vascular Therapy, and chairman of the Cardiovascular Research Foundation.

Study findings

The one-year ACUITY analysis showed that treatment in the Angiox® (bivalirudin) alone group resulted in comparable clinical outcomes compared to standard therapy. Specifically, in patients treated in the Angiox® alone group, the Angiox® plus GPI group (GPIIb/IIIa inhibitors, which are intravenous anti-platelet agents) and the heparin plus GPI group, respectively:

- Death occurred in 3.8%, 4.2% and 4.4% of patients. There was an observed numerical reduction (p=NS) in late mortality (after one month to one year) in the Angiox® alone treatment group, and

- Composite ischemia events occurred in 16.4%, 16.5% and 16.3% of patients. Composite ischemia was defined as death, heart attack or unplanned revascularization for ischemia.

“We have known for some time that bleeding is an important prognostic factor for patient outcomes including survival. Added to the data from the PCI (Percutaneuos Coronary Intervention) REPLACE-2 study in low and moderate risk patients, the ACUITY one year data in moderate and high risk ACS patients again shows that Angiox® offers protection from ischaemic events whilst significantly reduces bleeding. This is important data and will further support physicians in being able to make informed treatment decisions and tailor therapy to the benefit of their patients/protect their patients from bleeding events” said Dick Söderberg, Executive Vice President, Marketing, Nycomed.

Additionally, the study found that major bleeding within 30 days following treatment increased the risk of death within one year even more than did a heart attack. The death rate among patients who suffered major bleeding compared to those who had a heart attack or neither was 12.5% vs. 8.6% vs. 3.4%, respectively. After adjusting for other variables, the risk of death for patients who had a major bleed or heart attack within 30 days following treatment was 2.89 and 2.47 times greater, respectively, than the risk for patients who did not experience either (p < 0.0001 for both comparisons).

“While heart attacks tend to happen in the hospital, we found the risk of death associated with major bleeding continues long-term,” said Dr. Stone. “This makes major bleeding an even more powerful predictor of death than having a heart attack.”

About ACS

ACS includes a range of conditions, such as chest pain and heart attack, which are caused by insufficient blood supply to the heart due to blockages in coronary arteries, usually caused by blood clots. Patients with ACS symptoms are at significant risk for heart attack or death. Each year in the United States, 5 million people go to the emergency department with chest pain, of which about 1.4 million are identified with ACS.

The European Society of Cardiology as well as the American Heart Association and the American College of Cardiology recommend that moderate- and high-risk ACS patients undergo angiography and, based on the results, be treated through medical management (e.g., various anti-clotting drugs), bypass surgery, or PCI. Heparin plus a GPI is often used as part of these treatments to reduce the risk of blood clotting and further ischemia. However, while heparin plus GPI can reduce the risk of ischemia, heart attack and death in ACS patients, it also increases the risk of major bleeding, which ACUITY showed increases the risk of death.

About ACUITY

Enrolling 13,819 ACS patients in 17 countries, ACUITY is one of the largest ACS clinical trials ever conducted to evaluate anti-clotting therapies administered in the hospital. ACUITY (Acute Catheterisation and Urgent Intervention Triage strategY) was designed to show that, when compared with heparins (unfractionated or enoxaparin) and routine GPIs, Angiox®, with or without GP IIb/IIIa inhibition, reduces clinically significant bleeding and is equally effective for ischemic complications.

ACUITY evaluated the use of Angiox®, replacing heparins, starting in the emergency department or critical care unit and continued through the cardiac catheterisation laboratory. The control arm of ACUITY comprised  patients treated with the heparins combined with GPIs In the other two arms of the trial, Angiox® is evaluated both as mono-therapy and in combination with GPIs

About Angiox®

Angiox® (bivalirudin) - US trade name Angiomax® - is a thrombin-specific anti-coagulant currently indicated for use in patients undergoing PCI. In clinical trials, Angiox® has demonstrated reductions in both ischaemic events and bleeding complications. Reductions that remain evident even in high-risk patients.

Developed and owned by US-based The Medicines Company, bivalirudin was in-licensed by Nycomed with the exclusive right to market the product in 33 countries in Europe and Russia-CIS. Following the approval by the European Medicines Agency (EMEA) in September 2004, bivalirudin is now marketed in Europe by Nycomed under the trade name Angiox®.

About Nycomed

Nycomed provides products for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets. The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from own research and from external partners.

Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region Nycomed has a presence in about 50 markets worldwide.

Privately owned, the combined group employs about 12,000 and had non-audited estimated annual sales of approximately € 3.4 billion and an EBITDA of approximately € 927 million (2006 results). In connection with the acquisition of ALTANA Pharma AG, effective 1 January 2007, Nycomed is relocating its group headquarters from Roskilde (Denmark) to Zurich (Switzerland).

For more information visit http://www.nycomed.com


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