AstraZeneca – Call For Grants (CGA CV 1103) Therapeutic Area: Cardiovascular Disease State: Acute Coronary Syndrome Call for Grants Application Title: “CGA CV 1103 – Program Title…” • Your title must begin with Call for Grants Application (CGA) ID number. • Refer to Grant Submission Instructions for further information on submitting your formal grant application. Submission Timeframe: 6/24/11 – 7/22/11 Proposal: 2011 AHA - CME/CE-Certified Independent Satellite Symposia Educational Audience: Program Format: Multi-initiative educational platform. Two or more of the following formats: 1. Live satellite symposia 2. Web-based enduring 3. Live regional meetings Program Cost: < $400,000.00 Interventional Cardiologists Clinical Cardiologists Other health care professionals involved in the management of patients with acute coronary syndromes AstraZeneca is interested in providing grant support for independent education activities in the area of Acute Coronary Syndrome that address the comparative safety and efficacy of treatment options, increase awareness and adherence to treatment guidelines, and provide evidence-based solutions to meeting the unmet medical need with existing therapies. Needs Assessment: For Acute Coronary Syndrome Cardiovascular diseases are the most common cause of mortality & morbidity in the U.S., accounting for 40% of total mortality, the majority of which is related to ACS (Bonvini RF, 2009). ACS including unstable angina, non-ST-elevation myocardial infarction (NSTEMI), and the most serious form of ACS, ST-segment elevation myocardial infarction (STEMI), accounted for an estimated 1,365,000 hospital discharges in 2006. These cardiovascular diagnosis contribute to a large economic burden to the health care system: more than $75 billion in direct medical costs alone (Lloyd-Jones, D., 2010) Evidence exists that the antiplatelet therapy provided to ACS patients in many hospitals / practices is suboptimal. The data that supports this comes from a number of registries, including the Global Registry of Acute Coronary Events (GRACE), (Banihashemi B, 2009). Registry data exhibits widespread underuse of antiplatelet therapy in ACS patients, a practice which results in many patients being potentially exposed to unnecessarily high thrombotic risk. The need for improvement is so great that the American College of Cardiology (ACC) and the American Heart Association (AHA) regularly releases and updates ACS related “performance measures” for acute care hospitals that imitates measures required by the Joint Commission (JCAHO), and the Centers for Medicare and Medicaid (CMS) (Joint Commission, 2009). In addition, the ACCF/AHA Task Force on Practice Guidelines has created a “focused update” process to revise the existing guideline recommendations that are affected by the evolving data (2011 Writing Group Members: Wright, R.S. et al, 2011). Due to the continuous updates, education is required to keep practitioners aware of current guidelines and best practices as demonstrated by evidence based-medicine. Awareness and implementation of the ACCF/AHA STEMI guidelines is also an area requiring further education. In a survey conducted by the Texas Heart Institute, approximately one-fourth of respondents were “not at all familiar” or were “only somewhat familiar” with the STEMI guidelines (Peacock, W.F., 2008). Despite guideline recommendations for long-term antiplatelet therapy to prevent recurrent ischemic events in patients with ACS, evidence from clinical practice suggests that antiplatelet agents are being substantially underutilized. Analysis of the CRUSADE registry demonstrated that when given the opportunity to provide guidelines-recommended care in patients with NSTEMI ACS, 25% of therapy appropriate patients were missed in clinical practice. Antiplatelet therapy was not prescribed in 46% of eligible patients at hospital discharge (Peterson, E., 2006) With the recent explosion of data around both approved and novel agents, the optimal management of patients with ACS requiring antiplatelet therapy continues to be an educational gap for physicians. The literature confirms that correct dosing of antiplatelet therapies and concomitant use of aspirin in patients who have undergone percutaneous cardiac intervention (PCI) varies widely depending on the practitioner (Ridker, P., 2005) and (Baigent, C., 2009). A recognized gap revolves around genetics, comorbidities, and other individual patient factors that may impact efficacy and safety of any drug therapy used in the treatment of ACS. Many novel adenosine diphosphate (ADP) P2Y12 antagonists, including prasugrel, ticagrelor, cangrelor, and elinogrel, have data available. These ADP P2Y12 antagonists have different advantages over each other related to differences in metabolism, faster onset/offset of action, and / or greater antithrombotic effects, without an unacceptable increase in bleeding or other side effects (Mousa, S.A., 2010). Determining the optimal treatment plan for ACS patients, the physician must take into account the pharmacodynamics and pharmacokinetic profiles for each therapy (Geisler, T., 2010) in order to improve patient outcomes. References: American Academy of Family Physicians, American College of Emergency Physicians, Society for Cardiovascular Angiography & Interventions, and Society of thoracic Surgeons, Wright, R.S., Anderson, J.L., Adams, C.D., et al. 2011 ACCF/AHA Focused Update of the Guidelines for the Management of Patients with Unstable Angina / Non ST-Elevation Myocardial Infarction (Updating the 2007 Guideline): A Report of the American College of Cardiology Foundation / American Heart Association Task Force on Practice Guidelines. JACC vol. 57, No. 18, 2011. May 3, 2011. Pg 2-40. Baigent C, (2009). Aspirin in the Primary & Secondary Prevention of Vascular Disease: Collaborative meta-analysis of Individual Participant Data from Randomized Trials. Lancet, 1849-1860. Banihashemi B, (2009). Global Registry of Acute Coronary Events (GRACE) Investigators: Underutilization of Clopidogrel and glycoprotein llb/llla inhibitors in nonST-elevation ACS. American Heart Journal, 917-924. Bonvini RF, (2009). Acute Coronary Syndrome and its Antithrombotic Treatment: Focus on Aspirin and Clopidogrel Resistance. Cleveland Clinic Journal of Medicine, 198-208. Geisler T, (2010). Current Strategies in Antiplatelet Therapy: does Identification of Risk and Adjustment of Therapy Contribute to More Effective, Personalized Medicine in Cardiovascular Disease? Pharmacology & Therapeutics, 95-107. Joint Commission, Centers for Medicare & Medicaid. (2009). Specifications manual for national hospital quality measures. Version 2.6b. Joint Commission, Centers for Medicare & Medicaid: http://www.jointcommission.org/PerformanceMeasurement/PerformanceMeasureme nt/Current+NHQM+Manual.htm 4 September 2010 Lloyd-Jones D, (2010). Heart disease and stroke statistics-2010 update: A Report from the American Heart Association. Circulation, e46-e215. Mousa SA, (2010). Antiplatelet Therapy Prasugrel: A Novel Platelet ADP P2Y12 Receptor Antagonist. Clinical Applied Thrombotics & Hemostasis, 170-176. Peacock, W.F., Bhatt, D.L., Diercks, D., et al. (2008). Cardiologists’ and Emergency Physicians’ Perspectives on and Knowledge of Reperfusion Guidelines Pertaining to ST-Segment-Elevation Myocardial Infarction. Texas Heart Institute Journal. 2008; 35 (2): 152-161. Peterson E, (2006). Association between Hospital Process Performance and Outcomes among Patients with Acute Coronary Syndromes. JAMA, 1912-1920 Ridker P, (2005). A Randomized trial of low-dose Aspirin in the Primary Prevention of Cardiovascular Disease in Women. New England Journal of Medicine, 1293-1304. Program Requirements: The Program must be accredited and fully compliant with the criteria and/or standards of commercial support for ACCME, AAFP, AOA, ACPE, ANCC, AANP, or NCCPA. Furthermore, the program will be educational and non-promotional in nature and will be planned, designed and implemented in accordance with the U.S. Food and Drug Administration’s Guidance on Industry-Supported Scientific and Educational Activities ("Policy Statement"). The Policy Statement and the ACCME Standards require, among other things, that (i) Institution conduct the Program independently and without control or influence by AstraZeneca over the Program's planning, content (including the selection of speakers or moderators), or execution; (ii) the Program be free of commercial bias for or against any product; (iii) Institution make meaningful disclosure of AstraZeneca support of the Program and any prior relationship between Institution and AstraZeneca, and the relationship, if any, between AstraZeneca and the speakers selected by Institution; and (iv) AstraZeneca not engage in, and Institution not permit any other sponsor to engage in, promotional activities in or near the Program room or advertise its products in any materials disseminated as part of the Program. In addition, Institution is required by the Policy Statement and the ACCME Standards to ensure that any product discussions at the Program be accurate, objective, balanced and scientifically rigorous. This includes a balanced discussion of each product and of treatment alternatives, that limitations on data be disclosed, that unapproved uses be identified as such, and that for live presentations there be opportunities for questioning or debate. REMINDER - Submission Instructions: Call for Grants Application Title: “CGA CV 1103 – Program Title…” Submission Instructions: • Your title must begin with Call for Grants Application (CGA) ID number. • Refer to Grant Submission Instructions for further information on submitting your formal grant application.