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.
Data from the first 500 patients was presented at the European Stroke Organization Conference in Barcelona, Spain, by Professor Antonin Krajina from University Hospital, CZ. In a subset of these 500 patients, over 58% 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.
The same cohort saw a lower mortality rate (10.5% in the Trevo Retriever Registry versus 15.3% in the interventional arm of the meta-analysis) and a low rate of symptomatic intracranial hemorrhage (0.6% in the Trevo Retriever Registry versus 4.4% in the interventional arm of the meta-analysis). 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 consists of 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.
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.