Results from the TREVO 2 clinical trial were presented by Raul Nogueira, Atlanta, USA, at the European Stroke Conference (Lisbon, Portugal, 22–25 May 2012). The study met the primary effectiveness endpoint, with the Trevo Retriever (Stryker) achieving significantly better post-device revascularisation than the Merci Retriever (Stryker) (86.4% in the Trevo Retriever arm compared to 60% in the Merci Retriever arm).
The rates of functional independence at 90 days for patients treated with the Trevo Retriever were also better than for the Merci Retriever (40% mRS ≤2 compared to 21.8%). Other measures of performance also strongly favored the Trevo Retriever, including improvement in the National Institutes of HealthStroke Scale (NIHSS) and shorter hospital stays.
“This new generation of mechanical thrombectomy device provides us with a highly effective tool for revascularising large vessel strokes,” said Nogueira, director of the Neuroendovascular Division, Marcus Stroke &Neuroscience Center, Atlanta, USA. “We now have a fast and very reliable way to remove blood clots in patients with severe and potentially debilitating strokes.”
“This trial shows a significant evolution in stroke care,” said Helmi Lutsep, professor and vice chair of Neurology at Oregon Health & Science University, Portland, USA. “We have traditionally seen poor outcomes for patients with large vessel occlusion strokes, and new devices like the Trevo Retriever represent a much improved treatment option. Now we need to find additional ways to quickly get patients having a severe stroke to a hospital that can provide comprehensive stroke care.”
The results of the TREVO 2 trial are consistent with the earlier TREVO trial, which was conducted in Europe and presented at the International Stroke Congress in February.
About the TREVO 2 clinical trial
The TREVO 2 trial was a pivotal, randomised, core lab adjudicated clinical trial investigating the safety and efficacy of Stryker’s Trevo Retriever for removing clots from ischaemic stroke patients as compared to Stryker’s current retriever, the Merci Retriever. The Trevo Retriever is the first device utilising Stentriever technology, a novel method for retrieving clot from the neurovasculature of ischaemic stroke patients. The TREVO 2 trial enrolled 178 patients in 27 institutions in the United States and Europe. Stryker obtained investigational device exemption approval for the trial in December 2010 and began enrolment in the TREVO 2 trial in February 2011. The TREVO 2 data are being used in 510(k) submission to the FDA to seek clearance of the Trevo Pro Retriever.