AstraZeneca – Call For Grants (CGA CV 1103)

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
2011 AHA - CME/CE-Certified Independent Satellite
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
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.
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,
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:
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,
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.