An experimental procedure that combines minimally invasive surgery and recombinant tissue plasminogen activator (t-PA) to treat patients with intracerebral hemorrhages (ICH) saves more than $44,000 in medical care costs, researchers reported Feb. 7 at the American Stroke Association’s International Stroke Conference 2013 in Honolulu.
Daniel Hanley, MD, director of the Brain Injuries Outcomes Division at Johns Hopkins School of Medicine in Baltimore, and colleagues presented one-year results of the MISTIE (Minimally Invasive Surgery plus t-PA for Intracerebral Hemorrhage Evacuation) trial, a Phase II study that evaluated the use of a catheter-based clot removal technique and t-PA in patients with hemorrhagic stroke. The overall study enrolled 96 patients from 26 hospitals who had ICH.
The Hanley research group presented outcomes of 40 Stage I patients at 180 days, 56 Stage II patients at 180 and 365 days and results from a cost-benefit analysis. Patients were randomized to either the minimally invasive surgery and t-PA treatment (25 patients) or medical therapy (31 patients). Seventy-five percent of the patients were men, with an average age of 60 years old. Clot size, location, mortality and withdrawal of care were similar in both groups.
An assessment of functional performance measured on the modified Rankin Scale favored surgery plus t-PA at both 180 and 365 days. At 180 days, the surgery plus t-PA group had 11 percent better function, which increased to 14 percent better function at 365 days.
Median intensive care unit stay was nine days in the surgery plus t-PA group vs. eight days in the standard medical care group. Total median hospital time was 38 days less in the surgery plus t-PA group, though.
At 180 days, 17 percent of the surgery plus t-PA patients received long-term care vs. 24 percent of the standard care patients; at 365 days, the proportion was 8 percent vs. 21 percent, respectively, although the researchers added the long-term finding was not statistically significant.
In a cost-benefit analysis, they calculated that surgery plus t-PA saved $44,329 in medical care costs per patient. The researchers concluded that surgery plus t-PA appears to be safe compared with medical therapy, with shorter hospital time and lower costs.
In a release, Hanley described the minimally invasive procedure as “a practical treatment that can easily be done by all trained neurosurgeons.” They are planning to conduct a Phase III study that enrolls 500 patients at 75 sites. If the Phase II findings are confirmed, Hanley said, “It could make a substantial difference in this disease.”
Genentech provided the t-PA drug used in the study.