The Solitaire With the Intention for Thrombectomy (SWIFT) trial1 and the TREVO II trial,2 published online in Lancet in August 2012, are important trials in the history of endovascular therapy for acute ischemic stroke for several reasons. First, both randomized trials compared a new technology, 2 versions of a stent-retriever, with a previously Food and Drug Administration-cleared technology, the Merci Retriever. The latest iteration of the Merci Retriever, which had been cleared for use since 2005, is a flexible nitinol wire with distal corkscrew-shaped coil loops with attached filaments. Stent-retriever technology is based on self-expanding stents that can be fully deployed and then retrieved about 5 minutes later, after migration of the thrombus through the stent struts.3 Retrievable stents were introduced in 2010 in experienced, high-volume comprehensive European stroke centers with increased rates of recanalization in a shorter time compared with intra-arterial thrombolysis.4 The Merci Retriever and retrievable stents are distal thrombectomy devices that require navigation of the device through and beyond the site of occlusion without image-guidance of a high-resolution biplane or 3D roadmap. In contrast, proximal thrombectomy devices allow a safe, image-guided approach to the site of occlusion and aspiration of the thrombus. These 2 randomized trials broke the trend of single-arm trials comparing a new technology with the intravenous heparin arm of the randomized PROACT II trial study, which was completed in 1998.5 The goal of past single-arm trials, used for both the Merci Retriever6,7 and Penumbra Aspiration System,8 was to obtain 510k clearance by the FDA, or regulatory approval in other countries, for thrombectomy in acute ischemic stroke. However, no randomized trial of these devices has demonstrated improved clinical outcome by a thrombectomy device compared with standard therapy, whether intravenous tissue-type plasminogen activator (tPA) within 3 and …
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