MISTIE: Minimally invasive surgery plus tPA safe, cost effective at 1 year

One-year results from the phase 2 MISTIE trial demonstrate that minimally invasive surgery plus tissue plasminogen activator was safe and reduced long-term disability following an intracerebral hemorrhage, according to research presented at the International Stroke Conference 2013.

The overall MISTIE trial involved 96 patients (mean age, 60 years; 75% men) with intracerebral hemorrhage. The phase 2 arm focused on 25 surgical patients compared with 31 assigned standard medical care. Surgery patients had minimally invasive surgery to deliver recombinant tissue plasminogen activator (tPA) directly to the clot, which was administered every 8 hours for 3 days, when the clot was removed via catheter.

Daniel F. Hanley

The procedure removed 57% of clots, on average, while clots dissolved naturally in only about 5% of the standard medical care group, according to a press release.

At 180 days, researchers reported that the surgical group had 11% better functional performance than the standard medical care group. At 1 year, the difference in functional capacity increased to 14% favoring the surgical group, and included a differential shift of 14% to higher levels of independence, according to the abstract.

Total median hospital stay was 38 days shorter for patients assigned surgery, and ICU stay data suggest that costs were about the same as for standard medical care (median, 9 days vs. 8 days, respectively).

The proportion of patients in long-term facilities at both 180 days and 1 year was lower for the surgical group. “The actual numbers are 21% of patients in a nursing home in the [standard medical care] group at 365 days and 8% in a nursing home in the surgery group, for a net difference of 13%,” Daniel F. Hanley, MD, from the department of neurology at the Johns Hopkins School of Medicine, said at a press conference.

The between-group difference in any level of hospital or rehabilitation care could represent a medical care cost savings of $44,000 per patient or more, according to data presented.

For more information:

Hanley DF. LB1. Presented at: International Stroke Conference 2013; Feb. 5-8, 2013; Honolulu.

Disclosure: Hanley reports receiving research grants from the National Institute of Neurological Disorders and Stroke; research support from Genentech, which donated the study drug; and ownership interest in Johns Hopkins, which holds a use patent for intraventricular tPA.