Cath Lab Digest - January 2008 - (Page 52)

CLINICAL AND INDUSTRY NEWS JANUARY ACUITY cont. “Long-term findings from ACUITY confirm the durable efficacy of bivalirudin supporting a simpler, more cost-effective option than the heparin plus GP IIb/IIIa combination.” John Kelley, President and Chief Operating Officer of The Medicines Company, which markets Angiomax, said “ACUITY also adds important new information on the value of starting Angiomax treatment earlier, in the emergency department, before the patient enters the cath lab.” Based on results of the ACUITY trial, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) recently recommended extending the indication for bivalirudin (Angiox®, the trade name for bivalirudin in Europe) to adult patients with ACS planned for urgent or early intervention. Bivalirudin should be administered with aspirin and clopidogrel. In the United States, The Medicines Company expects the Food and Drug Administration (FDA) to act in the second quarter of 2008 on an application to expand the use of Angiomax to include the emergency use of the drug in ACS patients. ACUITY (Acute Catheterization and Urgent Intervention Triage StrategY) was one of the largest ACS clinical trials ever conducted to evaluate anti-thrombotic therapies and enrolled 13,819 high-risk patients in 450 centers worldwide. The open label trial design employed an early invasive strategy (angiography within 72 hours), starting anti-clotting therapy when ACS patients arrived at the emergency department and randomly assigning them to treatment with standard of heparin (unfractionated or enoxaparin) plus GP IIb/IIIa, bivalirudin plus GP IIb/IIIa, or bivalirudin monotherapy. In the bivalirudin monotherapy group, selective use of GP IIb/IIIa was permitted in limited circumstances and occurred in less than 10% of patients. Then, based on an evaluation in the cardiac catheterization laboratory, patients were treated for ACS through medical management (e.g., various anticlotting drugs), bypass surgery or percutaneous coronary intervention (PCI). The one-year ACUITY analysis showed that, in patients undergoing treatment in the bivalirudin alone group, the bivalirudin plus GP IIb/IIIa group and the heparin plus GP IIb/IIIa group, respectively: Death occurred in 3.8%, 3.9% and 3.9% of patients (differences not significant). Composite ischemia events occurred in 16.2%, 16.0% and 15.4% of patients (differences not significant). Composite ischemia was defined as death, heart attack or unplanned revascularization for ischemia. Previously reported findings from ACUITY showed that bivalirudin was associated with significantly less bleeding at 30 days than heparin plus GP IIb/IIIa: 3.0% vs. 5.7% (p < 0.001).2 The one-year results from ACUITY were initially presented at the American College of Cardiology annual meeting in March 2007.2 The American Heart Association and the American College of Cardiology recommend that moderate- and high-risk ACS patients undergo angiography and, based on the results, be treated through medical management, bypass surgery, or PCI. Heparin plus GP IIb/IIIa is often used as part of these treatments to reduce the risk of blood clotting and further ischemia. However, while heparin plus GP IIb/IIIa can reduce the risk of ischemia, heart attack and death in ACS patients, it also increases the risk of major bleeding, which ACUITY showed, increases the risk of death. ■ References 1. 2. Stone GW, Ware JH, Bertrand ME, et al. Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management: One-year results from the ACUITY trial. JAMA 2007 Dec 5; 298(21): 2497–2506. Stone GW, Bertrand ME, Lincoff AM, et al. A prospective, randomized trial of bivalirudin in acute coronary syndromes: one year results from the ACUITY trial. Presented at: 56th Annual Scientific Session of the American College of Cardiology, New Orleans, March 24-27, 2007. BioImage Study Seeks to Identify Individuals at High Risk of Heart Attack or Stroke 2-3 Years before Occurrence Next phase of the High-Risk Plaque Initiative will leverage advances in diagnostic imaging and blood biomarker science to reduce morbidity, mortality and cost associated with cardiovascular disease G Medicine, on behalf of the High-Risk Plaque Initiative, announced the launch of the BioImage Study, designed to discover new blood tests and to optimize noninvasive imaging of atherosclerosis in order to identify and characterize individuals that are at high-risk for coronary heart disease or stroke. The BioImage Study is the next phase of the High-Risk Plaque Initiative, an industry-funded joint research and development effort to advance the understanding, recognition and management of high-risk plaque (HRP), the primary underlying cause of heart attacks and the leading cause of death in the Western world. The current method of reducing cardiovascular disease relies on minimizing risk factors, an effective strategy to some degree, but insufficient for treating established but asymptomatic disease such as HRP. Although the pharmaceutical industry has discovered promising treatment options to reduce the risk of heart attack or stroke associated with HRP, the therapeutic potential of these drugs is compromised by a general inability to identify the people who would benefit most from them. The BioImage Study is designed to identify those individuals with undetected but high-risk atherosclerosis in the months or years before a heart attack or stroke occurs, by taking advantage of the latest technologies in biomedical imaging and molecular medicine. This approach integrates a set of clinical measurements that may reliably and reproducibly predict those who are most at risk of heart attack or stroke associated with HRP and would benefit from innovative therapies. “The BioImage Study is expected to answer many important questions that would help us devise strategies to markedly reduce the burden of cardiovascular disease,” said Valentin Fuster, MD, PhD, a leading international cardiologis, chairman of the Scientific Advisory Board for the HRP Initiative and principal investigator of the BioImage Study. “The collaboration between academia, diagnostic and therapeutic industry participants and a leading health benefit provider creates an unprecedented opportunity to do a different kind of study to search for these answers in a way that would otherwise not be possible.” In addition to his work with the HRP Initiative, Dr. Fuster serves as director of the Zena and Michael A. Wiener Cardiovascular Institute and the Marie-Josée and Henry R. Kravis Center for Cardiovascular Health and Director of Mount Sinai Heart. Participants in the BioImage Study will have physical measurements taken (e.g., height, weight, blood pressure and waist/hip circumferences) and blood samples drawn for a number of advanced molecular analyses. Many of these participants will also undergo procedures to capture images of their hearts and cardiovascular systems. Based on this information, the HRP Initiative will work to discover and validate blood biomarkers that correlate with the imaging data, and that are predictive of future heart attack and stroke associated with HRP. The BioImage Study is novel not only in its design, but also in the collection of collaborative partners who have joined the HRP Initiative to address this critical medical need. Together with BG Medicine, these partners include Merck, AstraZeneca, Philips, and several distinguished members of academia. The current group of HRP Partners is seeking additional companies to collaborate in the HRP Initiative. Humana, one of the largest publicly traded health benefits companies in the U.S., will offer to selected members in Illinois, Kentucky and Southern Florida the opportunity to participate in the BioImage Study. The study uses mobile diagnostic imaging units equipped with Philips magnetic

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Cath Lab Digest - January 2008 Central Baptist Hospital Contrast Media Use in High-Risk Patients An Ergonomic Survey of Cath Lab Repetitive Stress Injuries Contents Clinical Editor’s Corner Takotsubo Cardiomyopathy, a.k.a., Transient Left Ventricular Apical Ballooning Syndrome: An Acute Coronary Syndrome Imposter Searching for the Key to D2B STEMI Intervention News STEMI Interventions: Commentary The Massachusetts Stent Study The Value of Educating Staff Ask the Clinical Instructor: A Q&A Column for Those New to the Cath Lab SICP* Chapter Updates The Society of Invasive Cardiovascular Professionals Holds an RCIS Review Course at New Cardiovascular Horizons 18:20 To Denver — One Student’s First Clinical Experience CEU Education Center Meetings Calendar What Do You Think? Clinical & Industry News Classifieds The Ten-Minute Interview with…Heather Vardon, RN Advertisers Index

Cath Lab Digest - January 2008

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