LONDON – Approximately 2%-3% of patients with spontaneous intracerebral hemorrhage may benefit from early surgical removal of hematoma, according to the results of the second Surgical Trial in Lobar Intracerebral Hemorrhage.
As reported at the annual European Stroke Conference and published simultaneously in the Lancet, patients with superficial lesions and an unfavorable prognostic score appeared to benefit from early surgical intervention, compared with those given conservative medical treatment (odds ratio [OR] = 0.49, P =.02). Conversely, those with a good prognostic score did not seem to benefit (OR = 1.12, P = .57).
The primary analysis showed no significant benefit of early surgery overall, with 41.4% of 297 patients in the early surgery group and 37.7% of 286 patients in the conservative treatment group having a favorable outcome at 6 months, as determined by the 8-point extended Glasgow Outcome Scale (GOS-E) (P = .367).
"That’s a 3.7% absolute benefit, which is not enough to change surgical practice on its own," said Dr. A. David Mendelow, professor of neurosurgery at Newcastle University in Newcastle upon Tyne, England. "We were looking for a 12% benefit when we set out to do this trial," he added during a press conference.
A 6% decrease in mortality at 6 months was seen favoring surgery (18% vs. 24% for conservative therapy), but this was not statistically significant (P = .095).
"Intracerebral hemorrhage is not a homogenous condition," Dr. Mendelow said, adding that it can be a difficult decision to operate. Clinical manifestations can range from no apparent effects to severe disability and rapid death. "STICH [Surgical Trial in Lobar Intracerebral Hemorrhage] focused on patients that we are not quite sure about whether to operate or not," he said.
The hypothesis for the trial was based on the findings of the first STICH trial (Acta Neurochir. Suppl. 2006;96:65-8). The results of the trial were again neutral overall, but subgroup analyses showed that some groups of patients did worse with surgery, such as those with deep-seated bleeds, and some may fare better, such as those with superficial lobar hematomas.
STICH II therefore specifically recruited this latter group of patients to see if the effect was real or an artifact of the scientific analysis. In total, 601 conscious ICH patients with a median age of 65 years were recruited at 78 centers in 27 countries. Patients had to have a superficial lesion (1 cm or less from the cortical surface of the brain) that was between 10 mL and 100 mL in volume, and with no sign of intraventricular hemorrhage on CT scanning. Patients had to be recruited within 48 hours of the stroke and surgical intervention had to be performed within 12 hours (Lancet 2013 May 29 [doi:10.1016/S0140-6736(13)60986-1]). (A total of 6 patients were excluded or withdrew from the study before intervention, and after intervention another 12 withdrew, were lost to follow-up, or were alive but had an unknown status.)
The GOS-E was calculated from the answers to a questionnaire sent out to patients and their relatives 6 months following their stroke. A cutoff score of approximately 27 was used to categorize patients as having a good or bad prognosis. At baseline, about two-thirds of patients had a good prognosis, and the remainder had a poor prognosis.
"The notion that early surgery might be beneficial in this subgroup of patients is supported by the results of the investigator’s updated meta-analysis of 15 trials,"
"One of the reasons, perhaps, for a lack of significance was the [number of] crossovers from initial conservative therapy to surgery," Dr. Mendelow said. Indeed, 21% of patients who were originally randomized to conservative treatment crossed over to the surgical arm. These patients had "clearly deteriorated" prior to having surgery, he said when presenting the findings. Furthermore, only 37% of these crossovers received surgery within the specified 12-hour time limit.
STICH provides the best, albeit insufficient, evidence to date on the role of surgery in ICH, Dr. Oliver Gautschi and Dr. Karl Schaller, both of the University of Geneva, commented in an editorial about the trial (Lancet 2013 May 29 [doi:10.1016/S0140-6736(13)61087-9]) .
"The notion that early surgery might be beneficial in this subgroup of patients is supported by the results of the investigator’s updated meta-analysis of 15 trials," they wrote. "The overall result of this meta-analysis of patients with different types of intracerebral hemorrhage favors surgery."
The results of two other surgical studies, CLEAR III and MISTIE III, "are eagerly awaited," Dr. Gautschi and Dr. Schaller said, noting that, "decompressive hemicraniectomy might be a[nother] promising surgical procedure."