New Analysis From HORIZONS-AMI Shows Major Bleeding Has a Significant Impact and Contributes to 30-Day Mortality Following Angioplasty in Severe Heart Attack Patients
PARSIPPANY, N.J.--(BUSINESS WIRE)--Sep 3, 2008 - The Medicines Company (NASDAQ:MDCO) today announced the presentation of a new analysis of data from the HORIZONS-AMI trial demonstrating that major bleeding contributes to more deaths at 30 days than repeat heart attack, or re-infarction, in severe heart attack patients treated with angioplasty. This analysis of ST-elevation myocardial infarction (STEMI) patients was presented at the European Society of Cardiology meeting in Munich, Germany.
"The new analysis from HORIZONS-AMI reveals that major bleeding is an important factor in predicting patient death shortly after a severe heart attack," said Steven Steinhubl M.D, Global Vice President, Thrombosis, The Medicines Company. "The reduction in bleeding shown by bivalirudin compared to standard therapy (heparin plus routine glycoprotein IIb/IIIa receptor inhibitor (GPI)) in STEMI patients following PCI (percutaneous coronary intervention) may explain in part why patients on bivalirudin showed improved 30-day survival in the HORIZONS-AMI study. While re-infarction resulted in a higher risk of mortality than major bleeding, major bleeding was associated with more deaths than re-infarction due to the fact that it occurred more frequently."
The objective of the analysis was to assess the relative impact of major adverse cardiac events and major bleeding events on overall mortality in STEMI patients undergoing primary PCI in the HORIZONS-AMI trial, which enrolled 3,603 patients. The investigators concluded:
-- Major bleeding and re-infarction are both significantly associated with 30-day mortality, the attributable risk scores with major bleeding were linked to more deaths than re-infarction (20.3 versus 9.0 attributable deaths, respectively).
-- The hazard ratio (HR) with re-infarction was higher than that associated with major bleeding (re-infarction HR = 9.75 vs. major bleeding HR = 4.66).
-- Definite stent thrombosis showed a strong association with the risk of death, while acute definite stent thrombosis (within 24 hours) was observed in the trial it was not a significant predictor of 30-day mortality.
-- Ischemic target vessel revascularization (TVR) and stroke were not significantly associated with mortality within the first 30 days after PCI.
"The data from the new analysis further strengthen the link between mortality and reduced bleeding in STEMI patients undergoing PCI, and they are consistent with overall results from HORIZONS-AMI that demonstrate treatment with Angiomax results in significantly reduced net adverse clinical events, decreased bleeding and fewer cardiac deaths, which ultimately leads to improved outcomes," said Dr. Steinhubl.
HORIZONS-AMI builds on a wealth of clinical experience that shows Angiomax results in potent efficacy with significantly reduced rates of major bleeding compared to heparin plus glycoprotein IIb/IIIa receptor inhibitor (GPI) across the entire spectrum of risk in patients undergoing PCI. These data and previous data demonstrate the efficacy of Angiomax in suppressing ischemic events and reducing major bleeding, which results in improved clinical outcomes.
About the HORIZONS-AMI Trial
HORIZONS-AMI, co-funded by a grant from The Medicines Company, is the largest study to focus on the appropriate use of anticoagulation medications in patients experiencing STEMI and undergoing primary percutaneous coronary intervention (PCI). The trial was a prospective, single-blind, randomized, multi-center study conducted in 11 countries. Patients undergoing angioplasty were randomly assigned to receive either Angiomax(R) (bivalirudin) with provisional use of GPI or heparin plus GPI.
The two primary endpoints of the trial were major bleeding and net adverse clinical events, a composite of major adverse cardiovascular events (death, reinfarction, stroke or ischemic target vessel revascularization) and major bleeding at 30 days. The major secondary endpoint was major adverse cardiovascular events at 30 days.
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and 25 minute half-life. In clinical trials, treatment with Angiomax resulted in improved clinical outcomes with significantly reduced rates of major bleeding compared to heparin plus GPI across the entire spectrum of risk in patients undergoing PCI and numerically lower rates of 1-year mortality in patients undergoing PCI.
In the United States, Angiomax with provisional GPI is indicated in patients undergoing angioplasty, also called PCI, and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. 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 is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information available at http://www.angiomax.com.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax(R)(bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty and Cleviprex(TM)(clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Company also has an investigational antiplatelet agent, cangrelor, in late-stage development and a serine protease inhibitor, CU-2010, in early-stage development. The Company's website is www.themedicinescompany.com.
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" and "expects" 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 clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers will accept clinical trial results, 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 on August 11, 2008, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Posted: September 2008