Invasive therapies may do more harm than good in the prevention of strokes caused by arteriovenous malformation. Instead, medical management was preferable, according to the National Institutes of Health.
The National Institute of Neurological Disorders and Stroke (NINDS) halted an ongoing stroke prevention study after discovering that the study used invasive drugs resulting in increased number of deaths from stroke, paradoxically. According to the Centers of Disease Control and Prevention, 800,000 people die in the U.S. each year from cardiovascular disease and strokes out of which 130,000 cases are hemorrhagic strokes.
Arteriovenous malformation of brain (AMB) that causes these strokes results from tangled veins and arteries in the brain as they burst and bleed resulting in a stroke. Half of patients with AMB present with haemorrhage, and the other half either present with symptoms, such as headache, seizure, or focal neurological deficit, or have no symptoms. It is an interdisciplinary challenge to manage the condition.
Researchers from Columbia University conducted a study to investigate a method for stroke prevention, wondering if detecting this condition through brain scans and providing treatment for them could prevent a stroke.
The trial, called ARUBA (A Randomized Trial of Unruptured Brain Arteriovenous Malformations), was being conducted under the clinical leadership of J. P. Mohr, MD (Columbia University) and Christian Stapf, MD (Hôpital Lariboisière, Paris), and the data analytical and biostatistical leadership of Alan Moskowitz, MD and Michael Parides, PhD (Icahn School of Medicine at Mount Sinai). It was expected to enroll a total of 400 participants worldwide to be followed for 5 to 10 years. The interim analysis involved the first 224 patients, enrolled at 39 international centers, randomized to medical management or invasive treatments.
Invasive therapies include endovascular interventions, radiation treatment, or open surgery, either alone or in combination. Medical therapies were used for management of symptoms such as headache or seizures. In both groups, the specific treatments were tailored for each patient according to the treating physician's judgment.
"The data showed that, after a mean follow-up of 33 months, the event rate in the intervention group was more than three times higher than in the medical management group," the NINDS said in a statement..
"From what we can see, our current methods of intervention may pose a greater hazard for health than letting the natural history run itself out," Mohr said in a media interview.
The National Institutes of Health has stopped enrolling clinical trial participants but continues to monitor people that have already undergone treatment.
