Independent Research Confirms Reduction in Mortality and Bleeding Associated with Bivalirudin in High-Risk Acute Coronary Syndrome Patients Undergoing PCI
Researchers today presented data from the Minimizing Adverse haemorrhagic events by TRansradial access site and systemic Implementation of angioX (MATRIX) trial, confirming the consistency of reduction in mortality and bleeding associated with bivalirudin in high-risk Acute Coronary Syndrome (ACS) patients undergoing Percutaneous Coronary Intervention (PCI). The late-breaking clinical trial results were presented by principal investigator Marco Valgimigli, MD, PhD, of Erasmus in Rotterdam, The Netherlands, during the American College of Cardiology 64th Annual Scientific Session.
MATRIX is a randomized, international, multicenter trial with a design that included direct comparisons of access site (radial vs. femoral) and anti-thrombotic strategies (bivalirudin vs. heparin) in more than 7,200 randomized patients. The primary comparison of bivalirudin vs. heparin consisting of MACE (Major Adverse Cardiovascular Events) and NACE (Net Adverse Clinical Events) did not achieve statistical difference based on equal rates of myocardial infarction and stroke observed between the two agents, a consistent observation with all previous trials. Importantly, the trial did show significant differences between bivalirudin and heparin in individual outcomes.
Specifically, the trial showed bivalirudin was associated with:
- Lower mortality, driven by a significant 32% reduction in cardiac mortality
- Highly significant 45-50% reductions in major bleeding according to the established BARC and TIMI bleeding scales
- No excess events in the composite of MACE
“In MATRIX, both radial access and bivalirudin outperformed femoral access and heparin by reducing major bleeding and mortality,” said Dr. Valgimigli. “These results, especially the mortality reduction, affirm radial access and bivalirudin as the standards of care for ACS patients undergoing PCI.”
“The MATRIX trial is a large, international, adequately-powered, multicenter study that has incorporated all important aspects relevant to the debate around the optimal anti-thrombotic therapy for PCI in ACS, and STEMI patients in particular,” said Gregg W. Stone, MD, Director, Cardiovascular Research and Education, Columbia University Medical Center/New York Presbyterian Hospital, and co-Director, Cardiovascular Research Foundation, Medical Research and Education Divisions. “The results are consistent with previous multicenter randomized trials and almost identical to the results of HORIZONS-AMI from 2008. After MATRIX, the debate can be settled; bivalirudin should be the preferred treatment for high risk ACS patients treated with PCI.”
“We congratulate Dr. Valgimigli and his co-investigators on completion of this landmark trial, and we are impressed by the consistency of the MATRIX results with data from both clinical trial and large outcomes data sets from around the world,” said Efthymios N. Deliargyris, MD, Vice President, Global Medical Director, Interventional Cardiology, The Medicines Company. “We will continue to support this important research and believe that the reduced mortality and bleeding demonstrated in trials to date uphold bivalirudin as a foundational treatment for high-risk PCI, whether vascular access is by radial or femoral route.”
“The MATRIX trial validates nearly everything we have known about bivalirudin for the past 18 years,” said Clive A. Meanwell, MD, PhD, Chairman and Chief Executive Officer, The Medicines Company. “During those years, we have conducted or financially supported 13 multicenter, randomized trials of bivalirudin reporting data from more than 35,000 patients. We have also seen multiple registries and outcome studies of this drug, adding up to more than half a million additional reported patients. The MATRIX data are remarkably consistent with prior research reinforcing bivalirudin’s value proposition, including the cost-effective and clinical benefits of treating high-risk PCI patients in the contemporary setting.”
MATRIX was sponsored by the Societa Italiana di Cardiologia Invasiva (GISE), with funding from The Medicines Company.
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, bivalirudin is marketed under the trade name Angiomax® and 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 Company's products will advance in the clinical trials process on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, 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 Annual Report on Form 10-K filed with the SEC on March 2, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Vice President, Communications
Neera Dahiya Ravindran, MD
Vice President, Investor Relations and Strategic Planning