AUTHOR=Lin Chun-Jen , Saver Jeffrey L.
TITLE=The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment
JOURNAL=Frontiers in Neurology
VOLUME=11
YEAR=2020
URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2020.524220
DOI=10.3389/fneur.2020.524220
ISSN=1664-2295
ABSTRACT=Background and Purpose: Recent noninferiority clinical trials of novel endovascular thrombectomy devices for acute ischemic stroke have used substantial reperfusion as the primary outcome of achievement. Determining the minimal clinically important difference (MCID) is an essential step for the design of noninferiority clinical trials.
Materials and Methods: We surveyed international neuro-interventionalist and noninterventional vascular neurologist investigators. The questionnaire included demographic characteristics, level of clinical experience, and their MCID clinical scenario-based judgment regarding the MCID for the outcome substantial reperfusion (thrombolysis in cerebral infarction score 2b-3) within 3 passes.
Results: Survey responses were received from 58 of 200 experts. Among responders, 75.9% were neuro-interventionalists (most commonly interventional neuroradiologists and interventional neurologists, followed by endovascular neurosurgeons), and 24.1% were noninterventional vascular neurologists; 87.9% had been in practice for more than 5 years, and 67.3% devoted more than half of their practice to stroke care. Responder–nonresponder and continuum of resistance analysis indicated responders were representative of the full expert population. Among experts, the median MCID for substantial reperfusion was 3.1–5% (interquartile range 1.1–3% to 5.1–10%). MCID distributions did not differ among neuro-interventionalists and noninterventional vascular neurologists.
Conclusions: Neuro-interventionl and noninterventional stroke experts judged that the minimal clinically important difference in comparing thrombectomy devices for achieving substantial reperfusion is 3.1–5%. This MCID, lower than noninferiority margins used in several recent clinical trials, can inform trial designs and clinical development.