Daniel Hanley, MD, BIOS division director, and Issam Awad, MD, director of neurovascular surgery at UChicago Medicine, joined the November 2019 episode of the Neurocritical Care Society Podcast to discuss the MISTIE III trial with podcast host Fawaz Al-Mufti, MD. The trial results were recently published in the article, “Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial,” in The Lancet.
Hanley and Awad have collaborated on numerous research projects over the years, including the MISTIE III trial. The investigators shared these three main goals of the MISTIE III trial.
MISTIE III Goals:
| 1. To re-establish that the MISTIE procedure could be performed safely on patients with acute intracerebral hemorrhage |
| 2. To establish that the procedure had a benefit in functional outcome and mortality |
| 3. To study the delivery of the surgical procedure and determine whether the quality of the delivery had any influence on patient outcomes |
“We broke the surgery into discrete tasks with measurable endpoints that allowed [us] to precisely quantify the surgical performance,” said Hanley regarding the trial’s third goal. He added that they correlated the surgical performance with long-term clinical goals.
Though the surgical performance was not as good as the investigators had hoped for, it was better than in the previous MISTIE II trial. Hanley specified that in MISTIE III, 58% of patients reached the planned goal of reducing the hematoma to 15ml.
The study found a strong relationship between the amount of clot removed and a good outcome for the patients, Hanley explained. The trial defined a good outcome as the proportion of participants who reached a modified Rankin Scale score of 0-3 at one year after their intracerebral hemorrhage. Additionally, while the full group randomized to the MISTIE procedure did not show improvement in good outcomes compared to the standard medical care group, Hanley shared that the subgroup of surgical patients who met the target of hematoma reduction to 15ml did statistically significantly better than the patients who did not see a hematoma reduction to 15ml.
For further details, listen to the full November 2019 episode of the Neurocritical Care Society Podcast.