Seek Answers in International Multicenter Clinical Trial
NEW YORK (April 1, 2009) — Individuals diagnosed with a brain arteriovenous malformation (BAVM) — an abnormal tangle of arteries and veins — are at increased risk of vessel rupture and bleeding that can cause permanent brain damage. Traditionally, doctors have prescribed preventive interventions like surgery, but there is suggestive evidence that this invasive approach may actually increase risk of a rupture, at least in some patients.
Now, physician-scientists at Columbia University Medical Center and NewYork-Presbyterian Hospital are the principal investigators of an ongoing international, multicenter, NIH-funded study examining whether intervention or a hands-off approach is best for the two-thirds of individuals with a BAVM that has not bled.
“Before modern imaging was widely available, most BAVMs were discovered only after they had bled. At that time it was generally assumed that the few patients discovered with the condition that had not bled would require prophylactic intervention, but there was no conclusive evidence. This study will help answer this question,” says Dr. Timothy A. Pedley, neurologist-in-chief at NewYork-Presbyterian Hospital/Columbia University Medical Center and the Henry and Lucy Moses Professor and chairman of the Department of Neurology at Columbia University College of Physicians and Surgeons.
The clinical trial, called “A Randomized Unruptured Brain Arteriovenous Malformation (ARUBA),” is comparing the best possible invasive treatment strategy (any combination of endovascular, neurosurgical or radiation therapy) for unbled BAVM randomized against noninvasive medical management. The trial will recruit 800 patients to see whether invasive treatment or noninvasive management reduces the risk of death or symptomatic stroke over five years. There are more than 100 participating sites in the U.S. and around the world.
Previous research, including studies conducted by NewYork-Presbyterian/Columbia, has suggested that the annual risk of spontaneous hemorrhage may be as low as 1 percent for many non-ruptured BAVMs, especially among those for whom intervention appears feasible. But those with large and more complex BAVMs have higher hemorrhage rates and pose greater technical problems for intervention, and as a result treatment is deferred for many, given the risks. Age, deep brain location, associated aneurysms, and deep venous drainage add to hemorrhage risk factors.
“All told, it has been difficult for neurovascular teams to determine how to balance the possible risk of intervention against the potentially low hemorrhage risk in patients whose BAVMs have not bled. ARUBA has been undertaken to obtain information that will improve clinical decision-making,” says study principal investigator Dr. J.P. Mohr, neurologist at NewYork-Presbyterian Hospital/Columbia University Medical Center and the Daniel Sciarra Professor of Neurology at Columbia University College of Physicians and Surgeons.
Dr. Kiwon Lee is the site principal investigator and neurologist at NewYork-Presbyterian/Columbia and assistant professor of clinical neurology at Columbia University College of Physicians and Surgeons.
To enroll, participating patients must have been diagnosed with a BAVM that has not bled, as documented by any of several imaging techniques, and their lesion must appear treatable. For more information about the study, individuals may call (866) NYP-NEWS.
The ARUBA study is organized by the Doris and Stanley Tannenbaum Stroke Center, the Neurological Institute at Columbia University Medical Center and NewYork-Presbyterian Hospital, and the InCHOIR Clinical Trial Center at Mt. Sinai School of Medicine.
Brain Arteriovenous Malformations
Arteriovenous malformations of the brain, or BAVMs, are abnormal tangles of arteries and veins which usually date back to birth but can also result from head injury. Normally, blood from the heart moves from arteries to veins through a fine network of small blood vessels called a capillary bed. In an individual with BAVM, the arteries and veins are connected directly without a capillary bed, exposing the thin-walled veins to high pressures that increase risk for rupturing and bleeding into the brain.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The Medical Center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia’s College of Physicians and Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit www.cumc.columbia.edu.
NewYork-Presbyterian Hospital, based in New York City, is the nation’s largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments — more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Morgan Stanley Children’s Hospital, NewYork-Presbyterian Hospital/Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. It ranks sixth in U.S.News & World Report’s guide to “America’s Best Hospitals,” ranks first on New York magazine’s “Best Hospitals” survey, has the greatest number of physicians listed in New York magazine’s “Best Doctors” issue, and is included among Solucient’s top 15 major teaching hospitals. The Hospital’s mortality rates are among the lowest for heart attack and heart failure in the country, according to a 2007 U.S. Department of Health and Human Services (HHS) report card. The Hospital has academic affiliations with two of the nation’s leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. For more information, visit www.nyp.org.
# # #