MEDIA BRIEFING: Friday, June 12, 11 a.m. " 12 p.m. CT; Reporters planning to join the phone briefing, please contact Emily Blahnik at 507-266-3203 or [email protected] for call-in instructions. A listing of frequently asked questions on the CABANA Trial may be found at the end of this release.
We are holding this briefing to maximize the opportunity for reporters to talk with Dr. Douglas Packer, Mayo Clinic cardiologist and principal investigator.
EMBARGOED: Hold for release until Friday, June 12, 2009, 12 p.m. CT; Media Briefing
Newswise — Mayo Clinic received $48 million in grants from the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH), and from industry to study the treatment of atrial fibrillation in 3,000 patients and 140 centers around the world. Mayo Clinic is leading the study.
The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial is designed to determine whether catheter ablation is more effective than drug therapy for the treatment of atrial fibrillation, says Douglas Packer, M.D., the trial's principal investigator and a cardiologist at Mayo Clinic. The study, which will take six years from beginning to releasing results, is a collaborative effort among Dr. Packer and Richard Robb, Ph.D., at Mayo Clinic, Kerry Lee, Ph.D., and Daniel Mark, M.D., at Duke Clinical Research Institute in Durham, N.C., and the NHLBI.
Funding for the trial consists of $18 million from NHLBI/NIH, $20 million from St. Jude Medical and $10 million from Biosense Webster.
Atrial fibrillation is the most common cardiac arrhythmia seen by physicians and affects more than 2 million Americans. Most individuals with atrial fibrillation have identifiable risk factors, such as high blood pressure or structural heart disease, and tend to be elderly. Long-term complications resulting from atrial fibrillation and its treatment can include death, disabling stroke, serious bleeding and/or cardiac arrest.
The trial will determine whether left atrial catheter ablation - which involves inserting long, narrow tubes to reach and apply energy (hot or cold) to destroy abnormal heart tissue - to eliminate atrial fibrillation is better than current state-of-the-art drug therapy, Dr. Packer says.
The trial also will examine atrial fibrillation recurrence, stroke risk, quality of life and cost-effectiveness.
The study will randomize patients over three years, with half undergoing catheter ablation and half receiving rate control or rhythm control drug therapy (used to keep the heart in normal rhythm). Further information about this trial (NCT00911508) can be found at www.clinicaltrials.gov.
According to Dr. Packer, the trial is needed because:
* Atrial fibrillation is on a rapid rise and particularly increasing in individuals over 60 years of age.* Multiple recent trials have shown the inadequacy of drug therapy to maintain normal heart rhythm and reduce death.* The use of catheter ablation is rapidly increasing, but a large clinical trial such as CABANA is necessary to answer important questions about effectiveness and safety.* Atrial fibrillation has a large impact on a patient's quality of life and on health care costs.
"While prior trials have investigated the effectiveness of ablation in treating AF, their value in guiding the treatment of patients is limited by the small size of the studies, relatively short follow-up periods, and the exclusion of older patients with more long-standing AF as well as underlying disease. CABANA will include these patients and follow them for a much longer time period to more clearly define optimal therapy for AF," Dr. Packer says. "We believe that CABANA will be a landmark trial that will guide therapy in the atrial fibrillation arena for years to come."
In atrial fibrillation, the heart's two upper chambers beat irregularly and out of coordination with the two lower chambers. The resulting irregular and often rapid heart rate can lead to poor blood flow to the body. A person can experience symptoms such as heart palpitations, shortness of breath and fatigue, and may be at an increased risk of stroke. Treatment focuses on preventing stroke through the use of blood thinners or aspirin and controlling symptoms with medications or invasive procedures.
Before these grants were awarded, Mayo Clinic led a 10-center, 60-patient pilot study. Those results will be announced later this summer.
The CABANA Trial will be conducted as a collaboration between the Heart Rhythm Service and Biomedical Imaging Resource Center at Mayo Clinic, Duke Clinical Research Institute, and CABANA investigators from the 140 centers around the world.
Mayo Clinic and Drs. Packer and Robb have a financial interest in a mapping technology that may or may not be used in this research. In accordance with the Bayh-Dole Act, this technology has been licensed to St. Jude Medical and Mayo Clinic, and Drs. Packer and Robb have received annual royalties greater than $10,000, the federal threshold for significant financial interest.
Mayo Clinic and Dr. Robb have a financial interest in Analyze-AVW technology that will be used to analyze some of the heart images in this research. In accordance with the Bayh-Dole Act, this technology has been licensed to commercial entities, and both Mayo Clinic and Dr. Robb have received royalties greater than $10,000, the federal threshold for significant financial interest. In addition, Mayo Clinic holds an equity position in the company to which the AVW technology has been licensed.
About Mayo ClinicMayo Clinic is the first and largest integrated, not-for-profit group practice in the world. Doctors from every medical specialty work together to care for patients, joined by common systems and a philosophy that "the needs of the patient come first." More than 3,300 physicians, scientists and researchers and 46,000 allied health staff work at Mayo Clinic, which has sites in Rochester, Minn., Jacksonville, Fla., and Scottsdale/Phoenix, Ariz. Collectively, the three locations treat more than half a million people each year. To obtain the latest news releases from Mayo Clinic, go to www.mayoclinic.org/news. MayoClinic.com (www.mayoclinic.com) is available as a resource for your health stories. For more on Mayo Clinic research, go to www.mayo.edu.
CABANA Frequently Asked Questions
The following information is to provide a response to frequently asked questions arising about the CABANA trial. For more information, please see contact information at the end of the document.
All answers by Dr. Douglas Packer, Mayo Clinic cardiologist and CABANA principal investigator.
Q. What does CABANA stand for?A. Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation
Q. What will this trial examine?A. The CABANA Trial will test the hypothesis that primary catheter ablation is superior to state-of-the-art rate or rhythm control therapy in reducing mortality in patients with atrial fibrillation (AF). In so doing, the study will determine which treatment for atrial fibrillation works best.
Q. What are the endpoints being studied?A. Total mortality, the composite of cardiac mortality, disabling stroke, cardiac arrest, and serious bleeding, the composite of cardiovascular hospitalization and total mortality, and cardiac mortality and disabling stroke.
Q. What is atrial fibrillation?A. Atrial fibrillation is the most common abnormal cardiac arrhythmia, which occurs because of rapid and disorganized activation of the upper chambers (left and right atrium) of the heart.
Q. What kind of atrial fibrillation will these patients have?A. The trial will enroll patients with paroxysmal, or periodic, atrial fibrillation, as well as those with more persistent or even chronic atrial fibrillation.
Q. Which AF patients are being enrolled?A. Patients who have been previously untreated or under treated for their atrial fibrillation. Q. Other than AF, what underlying heart disease will these patients have?A. CABANA patients are not required to have other abnormal heart disease other than AF. Nevertheless, patients with underlying ventricular dysfunction, coronary artery disease, cardiomyopathies, or hypertensive heart disease will be enrolled.
Q. What age group of patients will the study examine?A. It is intended that the CABANA Trial examine the outcome of AF in patients regardless of age. Elderly patients who were typically excluded by other clinical trials may be enrolled.
Q. Where will the trial be conducted?A. Three thousand patients will be enrolled in 140 centers in the United States and Canada, the United Kingdom and Europe, as well as in Australia, New Zealand, and in several countries in Asia.
Q. Why is the trial needed?A. Several other studies have examined the impact of catheter ablation versus drug therapy in patients without other heart disease who have only episodic atrial fibrillation. In most trials, the data do not apply to patients over the age of 70. The CABANA Trial is needed to determine whether catheter ablation has any effect on mortality or other complications that may occur with AF. It also will determine the effect these two established treatment strategies have in patients with underlying disease and advancing age.
Q. What about other previously conducted studies?A. Recent trials have provided a substantial amount of support for treating AF with catheter ablation. Since these studies have only been conducted in several centers, the results are not more broadly applicable. They also do not address the long-term outcome of ablation and drug therapy. Since the CABANA Trial will run for a total of six years, substantially more long-term information in a more diseased population will be available.
Q. What is the significance of this trial?A. This trial is of substantial importance at multiple levels. Clinically, the trial will establish whether the emerging role of aggressive catheter ablation in the treatment of AF is justified by patient outcomes. The impact of age, AF type, and underlying disease on the outcome of ablation and drug therapy remain unclear. This study will answer these questions, will document the effect of ablation on AF recurrence and specifically examine health care costs, cost effectiveness, and quality of life outcomes. From a health care policy standpoint, this trial will help establish the place for medical and non-pharmacologic therapies for this escalating national healthcare dilemma.
Q. Who is funding the trial?A. The trial will be funded as a cooperative venture between the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH), with additional industry funding from St. Jude Medical, and Biosense Webster.
Q. Why the collaboration between the NHLBI and industry for funding the trial?A. A large mortality trial like CABANA is very expensive to conduct. While NIH funding is extremely important, the trial could not be conducted without additional funding from industry partners. Nevertheless, the trial will be conducted under the auspices of the principle investigator, Mayo Clinic, and the NIH, without industry interference in the design of the trial or how it is conducted.
Q. As a member of the news media, whom do I contact for more information?A. Traci KleinPublic AffairsMayo ClinicRochester, MN 55905507-284-5005, work507-990-1182, cell[email protected]
Q. Whom do patients contact for more information about the study?A. Kristi Monahan, RN, CABANA AdministrationPhone: 507-255-6676, fax: 507-255-9608CABANA web site: www.CABANAAF.comEmail: [email protected]
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