LONDON--(BUSINESS WIRE)--Researchers at ESC Congress 2015 presented data from secondary analyses of the CHAMPION PHOENIX trial comparing cangrelor, The Medicines Company’s fast-acting, rapid offset, intravenous antiplatelet agent, to oral clopidogrel in 11,145 patients undergoing percutaneous coronary intervention (PCI). Data demonstrate consistent reductions by more than 20% in the risk of primary endpoint ischemic events, which included a composite of death, myocardial infarction, stent thrombosis and repeat revascularization with cangrelor in patients treated by either the femoral or radial approach. The full report of this subgroup analysis will be published in the European Heart Journal.
“The CHAMPION Program including PHOENIX demonstrated the benefits associated with the use of a potent, fast-acting intravenous P2Y12 inhibitor over slower-acting clopidogrel in patients undergoing PCI,” said Efthymios N. Deliargyris, MD, Vice President, Global Medical Director, Interventional Cardiology for The Medicines Company. “This presentation at ESC affirms the efficacy of cangrelor in patients treated by the radial approach and highlights the clinical synergy that can be achieved when optimal vascular access technique is combined with modern pharmacology.”
Cangrelor was associated with a 21% reduction in the primary outcome of death, myocardial infarction, repeat revascularization and stent thrombosis in patients treated by the femoral approach and with a 24% reduction in patients treated by the radial approach compared with clopidogrel. Importantly, rates of GUSTO severe or moderate bleeding were low overall, without significant differences between cangrelor and clopidogrel (0.7% cangrelor vs. 0.4% clopidogrel with femoral access; 0.3% cangrelor vs. 0.2% clopidogrel with radial access).
“Cangrelor showed similar effectiveness and safety in PCI patients regardless of the vascular access site,” stated Deepak L. Bhatt, MD, MPH, Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital Heart & Vascular Center and Professor of Medicine at Harvard Medical School. “These results are particularly relevant as worldwide use of the radial artery approach to PCI increases.”
New European Society of Cardiology Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation have included cangrelor as an option in P2Y12 inhibitor–naive patients undergoing PCI. Additionally, the Guidelines strengthen the recommendation for the use of the radial approach for coronary angiography and PCI.
About KENGREXAL™ (cangrelor)
In the European Union, cangrelor is marketed under the trade name KENGREXAL. KENGREXAL, a synthetic, small molecule, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.
Important Safety Information
KENGREXAL™ is contraindicated in patients with active bleeding; increased risk of bleeding because of impaired hemostasis and/or irreversible coagulation disorders; or any history of stroke or intracranial hemorrhage. KENGREXAL™ is also contraindicated in patients with known hypersensitivity to cangrelor or any component of the product. KENGREXAL™ can increase the risk of bleeding. In clinical trials, the most common adverse reaction in patients treated with KENGREXAL™ was bleeding (17.5%) and dyspnoea (1.3%).
About KENGREAL™ (cangrelor)
In the United States, cangrelor is marketed under the trade name KENGREAL.
KENGREAL, a synthetic, small molecule, is indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.
Important Safety Information
KENGREAL™ is contraindicated in patients with significant active bleeding.
KENGREAL™ is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor or any component of the product.
Drugs that inhibit platelet P2Y12 function, including KENGREAL™, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL™ than with clopidogrel. Bleeding complications with KENGREAL™ were consistent across a variety of clinically important subgroups. Once KENGREAL™ is discontinued, there is no antiplatelet effect after an hour.
The most common adverse reaction is bleeding.
Please see full prescribing information for KENGREAL, available at http://www.kengreal.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.
Forward-Looking Statements
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, including the Company's preliminary financial results, are intended to identify forward-looking statements. These forward-looking statements involve important 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 the extent of the commercial success of our products, the Company's ability to develop its global operations and penetrate foreign markets, whether 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 on August 7, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
