KALAMAZOO, Michigan, USA, May 10, 2016 /PRNewswire/ -- Today, Stryker announced enrollment of the 1,000th patient into its Trevo® Retriever Registry. Data from the first 500 patients with 90-day follow-up completed showed that 9 out of 10 patients had complete or near complete removal of the clot and over half were functionally independent. These real-world results validate the benefit of clot retrieval with the Trevo® Retriever.
"The enrollment of the 1,000th patient into the Trevo Retriever Registry is a significant accomplishment for stroke researchers and a demonstration of our commitment to growing the body of evidence for ischemic stroke," says Mark H. Paul, President of Stryker's Neurovascular division. "Results from the first 500 patients are extraordinary and truly demonstrate the benefit of the Trevo Retriever in a real-world setting of patients with large vessel occlusions."
Data from the first 500 patients was presented at the European Stroke Organization Conference (ESOC) in Barcelona, Spain, by Professor Antonin Krajina (University Hospital, CZ). In a subset of these 500 patients, over 58 percent were functionally independent at 90 days. This closely matches the population of the interventional arm in a meta-analysis of randomized clinical trials for ischemic stroke.1
The same cohort saw a lower mortality rate (10.5 percent in the Trevo Retriever Registry vs. 15.3 percent in the interventional arm of the meta-analysis1) and a very low rate of symptomatic intracranial hemorrhage (0.6 percent in the Trevo Retriever Registry vs. 4.4 percent in the interventional arm of the meta-analysis1). This dataset will continue to grow and expand, with the next analysis planned after the first 1,000 patients have completed follow-up.
The Registry is intended to examine stroke therapy in a real-world setting. While the Registry includes patients with conditions such as carotid disease or uncontrolled diabetes or those with posterior anatomy occlusions, these patients have typically been excluded from randomized, controlled trials. With hundreds of patients included in the Registry, as compared to the much smaller number of patients enrolled in most stroke trials, investigators will have a robust dataset they can use to examine these less-studied patient populations and endovascular techniques.
Upon enrollment of the 1,000th patient into the Registry, Dr. Joey English, site Principal Investigator for the Trevo Retriever Registry and Medical Director of Neurointerventional Services at the California Pacific Medical Center in San Francisco, California, commented, "The Trevo Retriever Registry will provide physicians who treat stroke with important information on the benefits of mechanical thrombectomy as well as insights into how to best care for a wide range of patients suffering from this devastating disease. This data will not only be a rich source of knowledge that can be explored for years to come, but will also serve as a platform for generating new studies to further research and improve patient outcomes."
This is Stryker's second 1,000+ patient real-world registry for acute ischemic stroke. The first, the MERCI Registry, was completed in 2010. Enrollment for the Trevo Retriever Registry will continue up to 2,000 patients, making it the largest mechanical thrombectomy registry with a stent retriever in the world.
An animation of Stryker's Trevo Retriever is available here: https://youtu.be/PxcERzyI67I
- Goyal, et. Al. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Published Online February 18, 2016. http://dx.doi.org/10.1016/S0140-6736(16)00163-X.
About the Trevo Retriever Registry
The Trevo Retriever Registry initiated enrollment in 2013. It currently includes more than 65 sites worldwide. The only criteria for enrollment is that the patient have a confirmed large vessel occlusion and that the first mechanical thrombectomy device be the Trevo Retriever.
About the Trevo Retriever
The Trevo Retriever is a tiny stent-shaped medical device that is attached to a thin wire. In a minimally invasive procedure that utilizes X-ray, the physician navigates the retriever from the femoral artery (located in the upper leg) to the blocked blood artery in the brain. The retriever is designed to ensnare the blood clot and remove it from the body. Originally cleared by the FDA in 2012 for the revascularization of patients experiencing ischemic stroke, the Trevo Retriever has been used in thousands of patients worldwide.
About Ischemic Stroke
An ischemic stroke occurs when an artery in the brain becomes blocked by a blood clot or other substance such as plaque, a fatty material. Blood vessels carry blood, oxygen and nutrients throughout the body and to the brain. When the brain is deprived of blood and oxygen, it fails to work properly. Depending on the severity of the stroke and the area of the brain affected, loss of brain function or death may occur. According to the World Heart Federation, ischemic stroke is the 5th leading cause of death worldwide and contributes to nearly six million deaths around the globe.
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Potomac Communications Group
Kelly Cousineau, Sr. Program Director
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