PCORI Submitted Comments on National Priorities for Research and Research Agenda

March 15, 2012

Joe V. Selby, M.D., M.P.H.
Executive Director
Patient Centered Outcomes Research Institute
1701 Pennsylvania Ave, NW Suite 300
Washington, D.C. 20006

RE: Comments on PCORI National Priorities for Research and Research Agenda

Dear Dr. Selby:

The groups below comprise a task force of leading organizations in the thrombosis space that are exploring issues related to optimal stroke prevention in atrial fibrillation. Participants in this task force represent various audiences—from patients to health care providers—that are unified by the desire to improve the way in which stroke and bleeding risk are assessed in atrial fibrillation patients and ensure proper treatment of these patients. In our capacity as health care stakeholders, we support the Patient Centered Outcomes Research Institute’s (PCORI) mission to improve health care delivery and outcomes by producing and promoting high integrity, evidence-based information that comes from research guided by patients, caregivers and the health care community. As such we appreciate the opportunity to comment on PCORI’s national research priorities and research agenda.

Of Medicare beneficiaries who receive an atrial fibrillation diagnosis, 1 in 4 will die within a year.ⁱ Atrial fibrillation is associated with an approximate doubling of mortality risk, in large part due to the increased risk of stroke. Stroke in Medicare patients with atrial fibrillation who were not treated with anticoagulants cost Medicare $4.8 billion each year in direct costs. Those who had strokes despite prophylactic treatment cost an additional $3.1 billion.ⁱⁱ People over the age of 40 have a 1 in 4 risk of developing atrial fibrillation in their lifetime.ⁱⁱⁱ With as many as 1 in 10 Americans afflicted with atrial fibrillation by age 80, it is an increasingly pressing problem for our health care system as the Silver Tsunami of older Americans and chronic disease begins to impact Medicare.

Atrial fibrillation can be treated and the risk of thrombosis reduced with appropriate medication and monitoring. However, effective tools to assess stroke and bleeding risk and their proper utilization is critical to appropriately treating patients and reducing the human and economic burdens associated with the condition. In nonvalvular atrial fibrillation patients, successful use of antithrombotic therapy depends on patient-tailored assessments that evaluate both stroke and bleeding risks. However, current tools for assessing risks have substantial limitations including inadequate recognition of individual patient characteristics, poor practical value or ease of use, and areas of subjectivity. These problems are further amplified by conflicting guidelines and endorsements which lead to confusion about what tools to use and how best to use them. The result is commonly the underutilization of antithrombotics in patients of perceived high risk of bleeding (e.g. patients between the ages of 65 and 74).

This task force convened a panel of world-renowned experts in January of 2012 to identify the gaps in the current stroke and bleeding risk assessment tools and to attempt consensus on what needs to be done to ensure that these tools properly assess both risks. This expert panel considered the strengths and weaknesses of these tools—from the perspective of both existing treatments and treatments in the pipeline. These experts recommended that both stroke and bleeding risk be assessed annually in all patients with atrial fibrillation in an effort to improve physician and patient decision making about treatment, however they did call for additional research that is essential to improve bleeding risk assessment so that risk factors for serious intracranial bleeding could be better identified.

While the national research priorities and research agenda under review are broadly drafted, PCORI was designed to address specific questions of national importance. The Affordable Care Act that established PCORI states that “The Institute shall identify national priorities for research, taking into account factors of disease incidence, prevalence, and burden in the United States (with emphasis on chronic conditions), gaps in evidence in terms of clinical outcomes, practice variations and health disparities in terms of delivery and outcomes of care, the potential for new evidence to improve patient health, well-being, and the quality of care, the effect on national expenditures associated with a health care treatment, strategy, or health conditions, as well as patient needs, outcomes, and preferences, the relevance to patients and clinicians in making informed health decisions, and priorities…”^iv

We hope that the work of the task force will be considered when PCORI issues specific priorities that examine individual interventions and research questions. We contend that atrial fibrillation in older patients meets the statutory criteria for an important national priority; that research leading to more consistent application of current tools to assess stroke and bleeding risk can improve treatment for some; and that additional research into how physicians can better assess the risk of serious bleeds in patients can help mitigate improper treatment in challenging situations.

Thank you for the opportunity to comment on research priorities that have the potential to provide more information about a complex condition that affects more than 5 million Americans. Please contact Cynthia Bens at the Alliance for Aging Research should you have any questions- [email protected] or 202-293-2856.

Sincerely,

Alliance for Aging Research
Anticoagulation Forum
Atrial Fibrillation Society
ClotCare
The Heart Rhythm Society
Mended Hearts
Men’s Health Network
The National Forum for Heart Disease and Stroke Prevention
National Stroke Association
Preventive Cardiovascular Nurses Association
Society for Women’s Health Research
StopAfib.org

i Piccini, JP, BG Hammill, MF Sinner, PN Jensen, AF Hernandez, SR Heckbert, E Benjamin, and LH Curtis. “Incidence of Atrial Fibrillation and Associated Mortality Among Medicare Beneficiaries from 1993 to 2007”. Circ. Vol. 122, pp. A191718

ii Caro, JJ. “An Economic Model of Stroke in Atrial Fibrillation: The cost of suboptimal oral anticoagulation”. Am J Managed Care. Vol. 10, No. 14, pp. S451-61.

iii Lloyd-Jones et al. Circulation, 2012.

iv Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research. PUBLIC LAW 111–148—MAR. 23, 2010.