Clot-retrieval devices failed to improve stroke-related disability
A stroke survivor's chances of living independently after 90 days are not improved by the use of devices inserted into the artery to dissolve or remove a stroke-causing clot shortly after the onset of symptoms, according to a randomized controlled trial involving 656 patients.
The study, funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health, compared the intra-arterial device-based approach plus the current standard of intravenous (IV) tissue plasminogen activator (t-PA), a clot-busting drug with IV t-PA therapy alone. The research will be presented at the International Stroke Conference 2013 in Honolulu, Hawaii and simultaneously published online Feb. 7 in the New England Journal of Medicine.
"This is the largest trial of an intra-arterial intervention for acute ischemic stroke, and is important because it shows that the addition of devices to treat clots within the brain artery was no more effective than treatment with IV t-PA alone," said Walter J. Koroshetz, M.D., deputy director, NINDS. "Such devices are already widely used in clinical practice based on dramatic improvements seen in individuals, but without evidence supporting their overall clinical effectiveness in a large group."
Intra-arterial treatment is known to be associated with significant risk; 16 percent of the patients in the study had complications from the minimally invasive surgical procedure. The Interventional Management of Stroke, or IMS-III, is the only trial designed to assess the overall balance between risk and benefit of intra-arterial treatment in acute stroke patients.
Eliminating a clot from within a vessel involves threading a catheter through an artery in the groin up to the site of a clot in the brain, and then administering t-PA directly on the clot, which dissolves it, or removing it via coiled wires or a stent system. Based on earlier studies, researchers anticipated that adding an intra-arterial approach to standard IV t-PA would reduce stroke-related disability by providing a means to eliminate very large clots that would otherwise persist despite IV t-PA, according to the researchers led by Joseph Broderick, M.D., of the University of Cincinnati Academic Health Center.
Participants, ages 18-82 years, were enrolled in the study starting in 2006. By April 2012, after 656 of the 900 planned participants had been treated, the study's Data and Safety Monitoring Board advised that the investigation should be stopped early because 90-day outcomes showed that the benefit was not substantially different between the groups. Patients in the IV t-PA alone group (39 percent) were just as likely as those in the combination therapy group (41 percent) to be functionally independent.
All patients in the study received IV t-PA therapy within three hours of their stroke symptoms. Within 40 minutes of that therapy, 434 patients who were randomized to the device-treatment group underwent angiography to identify arterial blockages. Those patients found to have a treatable blockage received intra-arterial therapy with one of five types of devices. The remaining 222 patients were randomized to receive IV t-PA alone.
Intra-arterial therapy was 40 percent more effective at removing clots and re-establishing blood flow but it did not improve disability due to stroke. "Our study highlights that improved reopening of arteries and delivery of blood flow to the brain is not a guarantee of improved clinical efficacy," concluded Dr. Broderick, who led the team of researchers at 58 U.S. and international clinical centers.
The time to intra-arterial treatment was 32 minutes longer in IMS III compared with the two pilot studies that preceded it. This may be an important reason for the lack of clinical benefit despite substantially better revascularization with intra-arterial therapy as compared to IV t-PA. "We probably did not open the arteries quickly enough," said Dr. Broderick.
Cutting the time to intra-arterial therapy poses significant challenges, given the logistics of assembling the treatment team and room and conducting the procedure, Dr. Broderick noted. In addition, most patients do not have immediate access to the level of care required to perform intra-arterial procedures. Instead, they are often treated with IV t-PA at a local hospital then transferred to another hospital, all of which further delays the time to treatment.
IMS III sheds light on research gaps that need to be addressed in trials to develop evidence-based recommendations on the use of intra-arterial devices, said Scott Janis, Ph.D., program director, NINDS.
"These devices still may play a critical role in improving outcomes among people with serious strokes involving clots that cannot be cleared or are cleared very slowly by standard IV t-PA" Dr. Janis said.
"Future research may show that newer generations of Food and Drug Administration-cleared devices and improved patient care may change the balance of the risk/benefit ratio of intra-arterial treatment for acute stroke. In addition, neuroimaging might be useful in selecting patients who can benefit from intra-arterial therapy," said Dr. Koroshetz.
Additional information from subset analyses of the IMS III data will be presented at the International Stroke Conference in Honolulu, February 6-8, 2013.
More information: Broderick, JP et al. "Endovascular Therapy after Intravenous t-PA versus t-PA Alone for Stroke," New England Journal of Medicine published online February 7, 2013, DOI:10.1056/ NEJMoa1214300.
Journal reference: New England Journal of Medicine
Provided by National Institutes of Health
- Intracranial stenting, injecting clot-busting drugs directly to brain Feb 25, 2010 | not rated yet | 0
- Near-complete blood flow restoration critical for best outcomes in stroke Oct 31, 2012 | not rated yet | 0
- Improvements within 1 hour of stroke treatment associated with better outcomes Nov 08, 2010 | not rated yet | 0
- How well does clot-busting drug work in stroke patients? Nov 09, 2010 | not rated yet | 0
- Safety results of intra-arterial stem cell clinical trial for stroke presented Oct 11, 2012 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Dipole term in multipole expansion
2 hours ago Hi. I'm having some difficult in understanding something about the dipole term in a multipole expansion. Griffiths writes the expansion as a sum of...
Bubbles in a Pre-Boiling/Boiling pot of water
4 hours ago How is it that bubbles form on the bottom of a surface of a pot of boiling water? I think that there is probably an elementary answer to this...
Assumptions of Griffith's fracture theory
14 hours ago Any experts on Griffith's fracture theory? I am studying the subject and I am having hard time finding out if the theory is valid for all possible...
Current leading voltage or vice versa concept
16 hours ago Hello, I was wondering if there is a conceptual explanation for when current leads voltage or vice versa for capacitors or inductors with AC...
Angular Frequency of AC voltage
19 hours ago Hello, I am wondering, what is the physical interpretation of the angular frequency of AC voltage? I don't see the physicality of what the angle...
Modeling Rigid Body - Unsure about Euler angles and angular velocity
19 hours ago I'm modeling a single 3D rigid body in preparation for some more complicated modeling in order to gain a better understanding of Euler angles, the...
- More from Physics Forums - Classical Physics
More news stories
A drug commonly used to treat depression and anxiety may improve a stress-related heart condition in people with stable coronary heart disease, according to researchers at Duke Medicine.
Cardiology 1 hour ago | not rated yet | 0 |
(Medical Xpress)—In a recent subgroup analysis of the largest blood pressure treatment trial in history, University of Alabama at Birmingham (UAB) researchers found that women and men react the same to ...
Cardiology 9 hours ago | 5 / 5 (1) | 0
Over the past few decades, scientists have developed many devices that can reopen clogged arteries, including angioplasty balloons and metallic stents. While generally effective, each of these treatments ...
Cardiology 9 hours ago | 4.8 / 5 (4) | 0 |
(Medical Xpress)—Cardiologists have identified a trio of biomarkers that may predict which patients with heart disease have a high risk of heart attack or death in the next two years.
Cardiology 10 hours ago | 4 / 5 (1) | 0 |
Hospitals with the highest rates of cardiac arrests tend to have the poorest survival rates for those cases, new University of Michigan Health System research shows.
Cardiology May 20, 2013 | not rated yet | 0
Activating an enzyme known to play a role in the anti-aging benefits of calorie restriction delays the loss of brain cells and preserves cognitive function in mice, according to a study published in the May ...
7 minutes ago | not rated yet | 0 |
(HealthDay)—Factors such as increased case finding may explain why Michigan had half of the total spinal infections associated with contaminated methylprednisolone acetate in the recent fungal meningitis ...
57 minutes ago | not rated yet | 0
(HealthDay)—Three-quarters of public schools in the metro Atlanta area contain microbes, including bacteria indicating the presence of fecal matter, according to research published in the May 17 issue of ...
47 minutes ago | not rated yet | 0
Transparent information on the evidence supporting global recommendations on paediatric medicines should be easily accessible in order to help policy makers decides on what drugs to include in their national drug lists, according ...
7 minutes ago | not rated yet | 0
A novel transcriptome-based classification of colon cancer that improves the current disease stratification based on clinicopathological variables and common DNA markers is presented in a study published in PLOS Medicine this w ...
7 minutes ago | not rated yet | 0
Trends in Helicobacter pylori (H. pylori) and smoking explain a significant proportion of the decline of intestinal-type noncardia gastric adenocarcinoma (NCGA) incidence in US men between 1978 and 2008, and are estimated ...
7 minutes ago | not rated yet | 0