The Medicines Company (MDCO) Resports Results from ISAR-REACT-4 Clinical Trial at American Heart Association Scientific Sessions 2011
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The ISAR group today simultaneously presented and published results of the 1,721-patient randomized, double-blind, active-controlled, multicenter ISAR-REACT-4 clinical trial in patients with evidence of evolving infarction (heart attack) undergoing percutaneous coronary interventions (PCI). The Medicines Company announced that the late breaking results were presented at the American Heart Association Scientific Sessions 2011 here today and published in The New England Journal of Medicine.
The study's purpose was to determine whether the combination of unfractionated heparin and abciximab (ReoPro) is more effective than bivalirudin (Angiox in Europe, Angiomax in the United States) in preventing thrombotic and bleeding complications in patients suffering from a heart attack known as non-ST segment elevation myocardial infarctions (NSTEMI) and undergoing PCI.
Principal Investigator Adnan Kastrati, MD of Deutsches Herzzentrum Muenchen presented the results of ISAR-REACT-4, which tested how many patients in each group within 30 days of treatment died, had another major heart attack, required another procedure to unblock the same artery or suffered major bleeding.
They found:
95 patients (11 percent) taking bivalirudin had at least one of those outcomes compared to 94 (10.9 percent) of those taking abciximab and heparin.
22 patients (2.6 percent) on bivalirudin experienced major bleeding compared to 40 patients (4.7 percent) taking abciximab and heparin.
In 2006, the ISAR group reported results of the ISAR-REACT-2 trial that included NSTEMI patients undergoing PCI. In that trial, abciximab plus unfractionated heparin was associated with a significant reduction of ischemic events versus unfractionated heparin in patients with elevated troponin, a cardiac marker of infarction.
Dr. Kastrati stated, "Based on the ISAR-REACT-4 results, a bivalirudin-based strategy should be the standard of care in these high risk patients."
Efthymios Deliargyris, MD, Global Medical Director for The Medicines Company, commented, "The ISAR group has a history of independently minded trials that have driven changes in guidelines and practice across Europe and around the world. We expect that the results from this large trial in PCI patients with evidence of evolving infarction will once again impact the pharmacologic management of these patients."
The study's purpose was to determine whether the combination of unfractionated heparin and abciximab (ReoPro) is more effective than bivalirudin (Angiox in Europe, Angiomax in the United States) in preventing thrombotic and bleeding complications in patients suffering from a heart attack known as non-ST segment elevation myocardial infarctions (NSTEMI) and undergoing PCI.
Principal Investigator Adnan Kastrati, MD of Deutsches Herzzentrum Muenchen presented the results of ISAR-REACT-4, which tested how many patients in each group within 30 days of treatment died, had another major heart attack, required another procedure to unblock the same artery or suffered major bleeding.
They found:
95 patients (11 percent) taking bivalirudin had at least one of those outcomes compared to 94 (10.9 percent) of those taking abciximab and heparin.
22 patients (2.6 percent) on bivalirudin experienced major bleeding compared to 40 patients (4.7 percent) taking abciximab and heparin.
In 2006, the ISAR group reported results of the ISAR-REACT-2 trial that included NSTEMI patients undergoing PCI. In that trial, abciximab plus unfractionated heparin was associated with a significant reduction of ischemic events versus unfractionated heparin in patients with elevated troponin, a cardiac marker of infarction.
Dr. Kastrati stated, "Based on the ISAR-REACT-4 results, a bivalirudin-based strategy should be the standard of care in these high risk patients."
Efthymios Deliargyris, MD, Global Medical Director for The Medicines Company, commented, "The ISAR group has a history of independently minded trials that have driven changes in guidelines and practice across Europe and around the world. We expect that the results from this large trial in PCI patients with evidence of evolving infarction will once again impact the pharmacologic management of these patients."
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