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WSC 2022 | The challenges of non-inferiority trials in stroke

At the World Stroke Congress 2022, Urs Fischer, MD, Basel University Hospital, Basel, Switzerland, and Yvo B. Roos, MD, PhD, Amsterdam University Medical Center, Amsterdam, The Netherlands, presented the findings of the IRIS collaboration pooled analysis, which investigated the use of direct mechanical thrombectomy (MT) versus bridging intravenous thrombolysis (IVT) with alteplase followed by MT for the treatment of acute ischemic stroke due to large vessel occlusion. The individual patient data meta-analysis included more than 2500 patients from six major randomized trials and was unable to show non-inferiority of direct MT, compared to bridging therapy. Prof. Roos and Prof. Fischer comment on future plans to further address this question. For example, subgroup analyses in the IRIS study are ongoing, to see if there is a patient population that shows a significant treatment benefit from one approach or the other. Prof. Roos also comments on the challenges that come with interpreting non-inferiority study findings. While this analysis demonstrated there was no significant difference in outcomes between those receiving direct MT and those receiving prior IVT, removing an established treatment from the standard of care approach is much more difficult than proving a certain therapy should not be introduced. This interview took place at the World Stroke Congress 2022 in Singapore.

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Prof. Fischer reports the following disclosures:
-research grants from Medtronic (BEYOND SWIFT, SWIFT DIRECT) and from Stryker, Rapid medical, Penumbra and Phenox (DISTAL).
-consultancies for Medtronic, Stryker, and CSL Behring (fees paid to institution).
-participation in an advisory board for Alexion/Portola and Boehringer Ingelheim (fees paid to institution).