The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion with Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment

THIS IS WHAT IS SO FUCKING WRONG WITH STROKE. Thinking that substantial reperfusion is the goal. NO, IT ISN'T, 100% RECOVERY IS THE ONLY GOAL IN STROKE!  GET THERE! Not this lazy crapola.

The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion with Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment

 

Chun-Jen Lin^1* and Jeffrey L. Saver²

• ¹Taipei Veterans General Hospital, Taiwan
• ²UCLA Stroke Center, United States

Background and Purpose: 

Recent non-inferiority clinical trials of novel endovascular thrombectomy devices for acute ischemic stroke have used the primary outcome of achievement of substantial reperfusion.(Wrong goal, 100% recovery is the only goal!) Determining the minimal clinically important difference (MCID) is an essential step for the design of non-inferiority clinical trials.
Methods: 

We surveyed international neuro-interventionalist and non-interventional 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% non-interventional 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-non-responder 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% (IQR 1.1-3% to 5.1-10%). MCID distributions did not differ among neuro-interventionalists and non-interventional vascular neurologists.
Conclusions: 

Neuro-interventionl and non-interventional 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 non-inferiority margins used in several recent clinical trials, can inform trial designs and clinical development.

Keywords: Thrombectomy, MCID (minimal clinically important differences), ischemic stroke, device, Technical efficacy

Received: 08 Jan 2020; Accepted: 17 Aug 2020.

Copyright: © 2020 Lin and Saver. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Dr. Chun-Jen Lin, Taipei Veterans General Hospital, Taipei, Taiwan, zenlin1981@hotmail.com