Background Given the relative strength of prior mechanical thrombectomy (MT) data in face of the perceived poor natural history of emergent large vessel occlusion strokes, randomization to medical therapy during the recent clinical MT trials raised ethical challenges at individual and institutional levels despite overall clinical equipoise.
Methods In a thrombectomy stroke registry, we compared treatment rates preceding and following the SWIFT-PRIME and DAWN trials. Based on effect sizes of treatment in both trials, we estimated missed opportunities due to randomization to medical therapy and estimated the societal benefit resulting from additional patients who benefited as a result of these studies.
Results The average monthly thrombectomy rate in the SWIFT-PRIME time window increased from 14.1±4 patients-per-month (ppm) to 23.8±6 ppm (p<0·001). Twelve subjects were enrolled in SWIFT-PRIME and we estimated a missed opportunity of benefiting 2.3 of six subjects randomized to medical therapy. This was offset by providing treatment to an additional 9.7 ppm, resulting in an additional functional benefit to 3.7 ppm. Similarly, the thrombectomy rate in the DAWN window increased from 8.6±4 ppm pre-DAWN to 11.9±3.6 ppm post-DAWN (p<0.01). 38 subjects were enrolled in the DAWN trial with a missed opportunity to benefit eight of 16 subjects randomized to medical therapy. This was offset by the ability to offer MT to an additional 3.3 ppm, bringing definite benefit to an additional 1.65 ppm.
Conclusion Completion of recent trials resulted in observable increases in rates of thrombectomy, translating to functional benefits that rapidly offset any missed opportunities due to randomization to medical therapy arms.
- endovascular procedures
- social value
- randomized controlled trial
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Contributors GMR: conception and design of the study, acquisition and analysis of data, drafting a significant portion of the manuscript and all figures and tables. DCH: conception and design of the study, acquisition and analysis of data, drafting a significant portion of the manuscript. MB: drafting a significant portion of the manuscript. SR: drafting a significant portion of the manuscript. MRF: drafting a significant portion of the manuscript. RGN: Conception and design of the study, acquisition and analysis of data, drafting a significant portion of the manuscript.
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests GMR, DCH, MB, SR, and MRF have no competing interests to report. RGN was the Global PI in the DAWN trial (waived any consulting fees from Stryker Neurovascular) and part of the steering committee for the SWIFT-PRIME trial (waived any consulting fees from Medtronic).
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement The unpublished data from this dataset is held by Grady Memorial Hospital/Emory University and GMR/RGN. Requests for data sharing would be required to be discussed with them directly.