MATRIX Trial Results Presented at Hot Line Session of ESC Congress 2015 and Simultaneously Published in The New England Journal of Medicine
The Medicines Company (NASDAQ:MDCO) today announced that The New England Journal of Medicine (NEJM) has published results from the antithrombin program of the MATRIX trial, a large international, open label, multicenter clinical trial comparing the Company’s anti-thrombotic agent Angiomax®/ Angiox® (bivalirudin) against heparin in 7,213 acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). The results were presented today at a Hot Line Session of ESC Congress 2015 held in London. MATRIX – or Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX – showed that Angiomax®/Angiox was associated with similar rates of the primary outcome of composite major ischemic and net adverse events compared with heparin, but with significantly lower rates of the secondary outcomes of death and major bleeding. The results of the MATRIX access site program comparing femoral to radial access in 8404 ACS patients were published earlier this year in The Lancet.
“The MATRIX investigators addressed two critical questions in interventional ACS management, namely choice of anti-thrombotic treatment and vascular access site selection,” said Efthymios N. Deliargyris, MD, Vice President, Global Medical Director, Interventional Cardiology for The Medicines Company. “The reductions in mortality and major bleeding associated with Angiox/Angiomax in this high risk ACS population are consistent with the extensive body of evidence from multiple, large multicenter clinical trials over the past two decades.”
“The MATRIX program demonstrated that radial access outperformed femoral access and that bivalirudin even in patients undergoing transradial intervention lowers bleeding and has potential to decrease mortality over heparin,” said principal investigator Marco Valgimigli, MD, PhD, of the university hospital of Bern (Inselspital), Switzerland.
New MATRIX insights from ESC
MATRIX did not show a statistical difference between Angiomax/Angiox and heparin on the primary outcome measures of MACE (Major Adverse Cardiovascular Events) and NACE (Net Adverse Clinical Events) due to high rates of myocardial infarction that were not different between the two treatment groups. However, the trial demonstrated a 29% reduction in the secondary endpoints of all-cause mortality and a 45% to 50% reduction in major bleeding according to the established BARC and TIMI bleeding scales respectively. There were no differences noted on stroke rates between the two study treatments. Consistent with the observations from previous multicenter trials (EUROMAX, BRIGHT), MATRIX reported that prolonged infusions at the full PCI dose may mitigate the risk for acute stent thrombosis without any excess in bleeding, while low dose prolonged infusions were not protective against stent thrombosis.
“Our continued analysis of the MATRIX data is providing further clarity on how to best maximize the advantages of both radial access and bivalirudin in these high risk patients” said Dr. Valgimigli. “The post-procedural infusion data presented for the first time today suggest that a prolonged full dose bivalirudin infusion has an acceptable safety profile. While no significant difference in overall outcome was noted in patients receiving the post-PCI bivalirudin infusion as compared to those who did not, subsequent analysis based on the post-PCI bivalirudin regimen suggested that the full PCI dose regimen has potential to mitigate any excess risk for early stent thrombosis without increasing bleeding”
MATRIX was sponsored by the Societa Italiana di Cardiologia Invasiva (GISE) with funding from The Medicines Company and Terumo.
About ANGIOX®/ANGIOMAX® (bivalirudin)
In Europe, bivalirudin is marketed under the trade name Angiox® and is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation MI planned for urgent or early intervention.
In the United States, The Medicines Company markets bivalirudin under the trade name Angiomax®. Angiomax® is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
Please see full prescribing information for Angiomax, available at http://www.angiomax.com.
About The Medicines Company
The Medicines Company’s purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" "expects" and “potential” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the physicians, patients and other key decision makers will accept clinical trial results, whether the Company can protect its intellectual property and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed with the SEC on August 7, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
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