Dr. Christian Ruff discusses the North American Thrombosis Forum’s (NATF) Atrial Fibrillation Action Initiative, created to identify multidisciplinary best practices for stroke prevention in atrial fibrillation (AF). Dr. Ruff is the AF Action Initiative Co-Chair, Investigator at the TIMI Study Group, Associate Physician in the Cardiovascular Medicine Division at Brigham and Women’s Hospital, and Instructor in Medicine at Harvard Medical School.
What prompted the creation of the NATF Atrial Fibrillation Action Initiative? When was it formed?
Many of us involved in the North American Thrombosis Forum and interested in the field of stroke prevention in atrial fibrillation, realized that since the publication of landmark trials investigating novel oral anticoagulants and their subsequent approval, there has been a dramatic transformation in the landscape of anticoagulation for stroke prevention as warfarin was the only available anticoagulant. The availability of alternatives to warfarin that are at least as effective if not more effective than warfarin, as well as considerably safer and more convenient, has challenged us to rethink our old paradigm of how we determine which patients with AF have a high enough stroke risk to warrant anticoagulation. National and international guidelines have recommended enhanced risk stratification with the use of improved stroke (i.e., CHA2DS2-VASc) and bleeding (i.e., HAS-BLED) risk scores. This whole field has undergone a real paradigm shift — we probably should be anticoagulating more patients, and we’re doing a poor job overall (even with warfarin) in adequately protecting patients with AF from the devastating complications of stroke. We also found that the medical community is really struggling to figure out how to incorporate these new agents into clinical use — how they differ from warfarin, if there are important differences between the agents, and practical issues regarding the real-world implementation of these agents in their practice that were not addressed in the landmark phase 3 trials. Physicians, nurses, and patients are having difficulties wondering how the published trial information applies to the common scenarios that routinely occur in practice (e.g., what to do in patients with coronary disease who require antiplatelet therapy, recommendations regarding stopping and restarting these drugs before and after procedures). The amount of information that someone in the healthcare industry or a patient would have to synthesize in order to have a full grasp of this rapidly changing landscape is enormous — even for me as a clinical trialist in cardiology who specializes in this area. It can be very difficult to keep up and interpret this explosion of data.
Therefore, in the last two years we began to develop the Atrial Fibrillation Action Initiative. We envisioned a three-year project that incorporated a multidisciplinary approach to stroke prevention and atrial fibrillation. One of the primary things that we wanted to do was bring together a group of experts — from cardiology, neurology, hematology, primary care, emergency medicine, gastroenterology, pharmacology, etc. — to discuss the new landscape of stroke prevention and atrial fibrillation. AF is incredibly common, and patients with this condition interact with healthcare providers across the spectrum of subspecialties, so it was important to get a consensus of opinion among the various specialties since they are interacting with patients on different aspects. For example, a gastroenterology doctor or emergency department physician may see a patient with life-threatening bleeding — potentially on one of these new agents — and wonder how to manage them. We realized that the guidelines, whether from the American Heart Association, American College of Cardiology, or European Society of Cardiology, were restricted on what they could say since they’re often limited to providing recommendations based on trial data. So we wanted to bring together a group of experts who could digest all of the published information and expert opinion, with the goal of formulating a concise and practical consensus document that would be a valuable resource to any healthcare provider who encounters patients with AF. This cohesive yet very practical document would be made available through the NATF to the entire medical community, and the hope is that it will provide real-world guidance on how to evaluate a patient’s risk of stroke and bleeding with atrial fibrillation, how to choose an anticoagulant, how to monitor patients, and how to handle very common clinical scenarios that frequently occur in everyday practice.
Describe your role and involvement in this initiative. Who else is involved with the AF Action Initiative Consensus Group?
As a member of the NATF, I work very closely with its President and Founding Director, Dr. Samuel Goldhaber, and my other co-chair, Dr. Gregory Piazza. We are colleagues at Brigham and Women’s Hospital and Harvard Medical School. They asked if I would take a leadership role and chair the AF Action Initiative, and I was delighted to help spearhead this important effort. We’ve invited 29 national and international experts from various specialties to form our AF Action Initiative consensus group. The group represents thought leaders in the field who have pioneered risk stratification for stroke prevention, leaders of the clinical trials of warfarin and the novel oral anticoagulants.
Currently all of the members who are participating in this initiative are drafting different sections of the consensus document. In May 2014, the consensus group will convene in Boston to collate and finalize a consensus document that will include contributions from all of the participants in the AF Action Initiative. If you go to our website you can see the list of participants in the consensus document, including my co-chairs Dr. Goldhaber and Dr. Piazza.
Tell us more about the live consensus meeting that will be taking place on May 12th.
We’ve put together an extensive list of topics that we think should be included in the consensus document, and we’ve asked the individual consensus group members to provide a draft summary paragraph with the evidence supporting their recommendation on individual topics. Each member will be asked to participate in one or two topics, depending on their area of expertise, and that will generate a concise consensus document that we will ratify in person. The consensus group members are asked to provide us with their contributions in advance, so we can review and certify the consensus document soon after the meeting. In addition to the short and concise document that will be generated from their summary recommendations, which we think is essential for the readability of the general medical community, we’ll also have an in-depth supplement that will go through the exhaustive detail and evidence for these recommendations. This will be in a compendium supplementary document. We thought this was critical because some of the guidelines are hundreds of pages long and very difficult for people to navigate. Therefore, we’ll have two documents available: a very concise, brief summary paragraph for clinicians and healthcare providers, as well as a much more in-depth supplement.
Where will the final consensus document be available?
It will be freely available on our website, which I think is absolutely critical so people can access it. We intend to publish it as well, but have not yet determined which venue and journal we’ll submit for publication.
What are the long-term plans for the AF Action Initiative?
Although this is a three-year initiative that has already been planned and funded, we think this field is an evolving one. We hope this document provides a valuable resource to the medical community and will serve as a continuing dialogue among our expert consensus group. We hope to continue to update and address new issues that evolve — this is only the beginning of the story.
What opportunities are available for others to get involved with the AF Action Initiative and/or the NATF?
We welcome widespread collaboration — we’re taking outreach at different local, regional, national, and international meetings to invite a dialogue among people. Although the initial consensus group is finalized, we absolutely would love for people across the spectrum to be involved in this effort, whether it’s through local meetings and chapters, outreach, or patient advocacy. We think there is unlimited opportunity to collaborate.
What other information can clinicians and patients get from the website?
This microsite is continually populating content, and there are many different features on it. In addition to a description of the AF Action Initiative, there is an overview of the epidemiology of atrial fibrillation that is very accessible to both patients and clinicians, and provides a lot of evidence as far as who should be on anticoagulants and what to look for as far as your risk of bleeding and complications. We’re also building a stroke assessment tool, so that both clinicians and patients can go to the website and figure out their stroke risk and what type of therapy is recommended. We’re also in the process of building a section where we specifically address anticoagulation and talk about all of the different options and some of the common clinical pitfalls to look out for. We will have a special resource for patient advocacy, in which patients can interact with the NATF and the consensus guideline committee, and have their question addressed in a timely matter. We will also continually update the website based on the content that the viewers want to see. In addition, we’re recording videos from experts throughout the world who are participating in this initiative as well as from others who are unable to participate but have valuable contributions; clinicians and patients can access these brief videos on very specific topics, ranging from the risk for stroke or managing bleeding, to how to know which anticoagulant you should be on. The videos will be available in a searchable library that people can view at their convenience. We think that this will be something that people will find very useful.
Why was it important to form an initiative that covered all of the areas of expertise concerning AF?
There are several reasons. We realized that the current guidelines were potentially an inadequate resource for many — they were difficult to read and didn’t necessarily address real-world clinical scenarios. The guidelines generally avoid giving recommendations about things that don’t have a lot of evidence base, so there are clear holes in the guidelines. They’re also updated very infrequently because it’s an enormous effort to get those committees together. We thought there was a need for a much more streamlined guideline that was not hindered by these national or international societies that are very restricted in the recommendations that they can give. So the focus on this guideline was to be very practical and incorporate the evidence, but also give recommendations based on expert opinion in common clinical scenarios that people come across when they are using anticoagulants for stroke prevention. This type of practical information is not found in the guidelines, and it’s not updated frequently enough to include the rapid pace of publication and presentation of data in this field. The other issue is that often these guidelines are written mainly by cardiologists, and what we realized is that a patient with atrial fibrillation on an anticoagulant does not only interact with the healthcare sector in the cardiology department. Every subspecialty has their own committee and guideline, but there is not a lot of cross talk, and we think that can lead to significant problems because an emergency department physician may not be reading the ACC/AHA guidelines on anticoagulants in AF. Therefore, having all the major stakeholders at the table agreeing on a rational course of action is only possible in this kind of organic setting.
For more information, please visit: http://www.natfonline.org/afib-action/