Date: July 19th, 2012
Expert Consensus Statement Recommends Process for Assessing Stroke and Bleeding Risk for Appropriate Anticoagulant Use
WASHINGTON, DC (July 19, 2012) – The Alliance for Aging Research (Alliance) announced the release of a new consensus statement written by leading experts in the area of stroke prevention in atrial fibrillation (AFib). The consensus development was spearheaded by the Atrial Fibrillation Optimal Treatment Task Force, led by the Alliance. The resulting statement provides a standardized approach to assessing moderate- to high-risk patients and determining who should be on an anticoagulant medication. Additionally, the document presents the leading stroke and bleeding risk tools all in one place – making them easy for health care professionals to access and compare.
Approximately 2.6 million Americans currently have AFib; which is associated with an approximate doubling of mortality risk – primarily because of the heightened risk of stroke. The irregular heart rhythm in AFib allows blood to pool in the heart’s chambers and oftentimes clot. That clot, or thrombus, can make its way to arteries in the brain and cause a stroke. AFib is a contributory cause of death for around 99,000 Americans each year. For those that survive, the disabilities can be extreme and consequently, the cost of treating the disease is high – around $6.65 billion in direct costs each year.
Yet despite the high risk of stroke in patients with atrial fibrillation – which is around 2 to 7 times greater than in those without the disease – anticoagulation therapy is still underused. According to a recent survey conducted by Edge Research on behalf of the Alliance and the AFib Optimal Treatment Task Force, 66% of physicians surveyed report that the number of clinical guidelines and tools in this area cause confusion, and 48% report that there are too many ambiguities in those guidelines. Additionally, only half of physicians reported being familiar with those guidelines that provide recommendations for assessing and treating the condition.
The primary objective of the AFib Optimal Treatment Task Force was to reduce the burden of stroke in AFib by creating consensus on the best practices for assessing stroke and bleeding risk in anticoagulation decision-making. The Task Force convened a roundtable of leading experts in cardiology, neurology, anticoagulants, and more to address this challenge and develop a consensus statement.
The consensus statement provides guidance on: (1) The process for assessing risk and making anticoagulant decisions in AFib; (2) Making decisions on anticoagulants in a landscape with increasing options; and (3) Promising areas of research requiring additional investigation.
“The Alliance for Aging Research Consensus Statement on Appropriate Anticoagulant Use addresses a very important and unmet need in the elderly population, namely, the inadequate use of antithrombotic prophylaxis in patients at risk for stroke with atrial fibrillation,” said Dr. Albert L. Waldo, one of the authors of the consensus statement. “Study after study has shown that despite the absence of contraindications to oral anticoagulant therapy, only 40-60% of patients with a significant risk for stroke in the presence of atrial fibrillation receives anticoagulation therapy, and the patients least likely to receive it are the most elderly.” He added that, “This whitepaper should go a long way towards helping healthcare professionals provide patients with the care needed to prevent stroke in this growing, at-risk population.”
Although anticoagulation is very effective at reducing AFib-related strokes, studies show that it is underused. AFib is more common in older adults, who are often regarded by their physicians as frail or at risk of falls. The Edge Research team revealed that when considering bleeding risk, fall risk tops the list of factors that physicians feel should be considered. This underuse of anticoagulants in older patients – those at heightened risk of stroke from AFib – is a major obstacle to effective care that reduces morbidity and mortality.
In the consensus statement, the experts recommend a three-step approach to anticoagulation decision-making in patients with AFib:
- First, a patient’s stroke risk should be assessed and recorded no less than annually using an established scoring tool. Those identified as intermediate or high risk should be put on an anticoagulant – warfarin or a direct thrombin inhibitor or a factor Xa inhibitor. Aspirin is not recommended for stroke prophylaxis in AFib.
- Second, if the patient is at high enough risk to require anticoagulation therapy, the patient’s bleeding risk should then be evaluated to estimate the net clinical benefit of an anticoagulant, again using an available tool as a starting point. Risk factors for intracranial hemorrhage should be considered although routine screening for these risk factors is not currently indicated.
- o For the majority of patients, the net benefit of stroke prophylaxis supersedes the “net harm” of serious bleeding events – even in older patients. The experts also emphasized that assessment of bleeding risk is not an opportunity to look for reasons not to anticoagulate, but an opportunity to address correctable risk factors for bleeding.
- Third, the decision to undergo anticoagulation therapy must reflect patient preferences and values. The patient must also understand the relative benefits and risks and be involved in the discussion and ultimate decision surrounding the clinical net benefit of anticoagulation therapy.
The consensus experts also recommended that education programs and tools be enhanced and disseminated at the primary care and family practitioner levels. For example, establishing stroke risk assessment tools for use in EMR systems, conducting public awareness activities and events at medical centers, educational initiatives by payers, pocket guides, and on-line resources.
Finally, the consensus experts called for enhanced patient education materials, tools, and outreach. Many patients are not aware that AFib confers a five-fold increase in stroke risk and participants recommended initiatives that prompt conversations about stroke risk between patients and medical providers. The task force also suggested that organizations join forces to promote accurate and objective healthcare information with a consistent message and voice.
“The Alliance for Aging Research is committed to working closely with scientific leaders and health organizations to ensure that older Americans are getting the best care, regardless of their age,” said Daniel P. Perry, president and CEO of the Alliance. “The survey results and recommendations outlined in the consensus statement highlight the need for increased awareness and consensus surrounding risk assessment and the appropriate use of anticoagulants,” Perry said. “Having this consensus will help reduce confusion and help us make real progress in identifying at-risk individuals and improving the quality and effectiveness of AFib treatment.”
“The consensus paper also addresses the emerging treatment options for anticoagulation – and the survey results support the notion that there is a lot of hope and excitement with these new drugs,” said Perry. “However the consensus experts did caution that while the expanding variety of therapies offer patients more personalized medicine options, at the same time it further complicates treatment decisions and makes the need for clear guidelines even more important.”
For more information about Atrial Fibrillation, please visit the Alliance for Aging Research AFib home page.
About the Alliance for Aging Research
Founded in 1986, the Alliance for Aging Research (Alliance) is a nonprofit, independent organization dedicated to improving the health and independence of aging Americans through public and private funding of medical research and geriatric education. The Alliance combines the interest of top scientists, public officials, business executives, and foundation leaders to promote a greater national investment in research and new technologies that will prepare our nation for the coming senior boom, and improve the quality of life for today's older generation. For more information, visit: http://www.agingresearch.org.