Net improvement of 1 grade or more on Extended Glasgow Outcome Scale was observed in 30.4% of the surgical group compared with 14.5% of those on standard medical care.
Results from a secondary analysis of the RESCUEicp randomized clinical trial (ISRCTN66202560) showed better sustained reductions in mortality and higher rates of vegetative state, severe disability, and moderate disability at 24 months in those with traumatic intracranial hypertension treated with decompressive craniectomy over standard medical care.1
For every 100 patients treated with surgical rather than medical intent, 21 additional patients survived at 24 months (4 were in vegetative state, 2 had lower and 7 had upper severe disability, and 5 had lower and 3 had upper moderate disability). The study investigators concluded that these findings support the use and potential benefit of long-term follow-up for traumatic brain injury (TBI) clinical trials.
Lead investigator Angelos G. Kolias, MD, PhD, clinical senior lecturer and consultant neurosurgeon, Addenbrooke’s Hospital, United Kingdom, and colleagues randomly assigned 408 patients with traumatic intracranial hypertension (>25 mm Hg) to either decompressive craniectomy with standard care or to ongoing medical treatment with the option to add barbiturate infusion. At 6 and 24 months, investigators assessed patients using the 8-point Extended Glasgow Outcome Scale (GOS-E), with 1 indicating death and 8 denoting upper good recovery.
Previously published data showed distinct between-group differences in GOS-E score distribution at 6 months (X27 = 30.69; P <.001) and 12 months (X27 = 29.16; P <.001), which was further sustained at 24 months (X27 = 24.20; P = .001) in this analysis. Rates of lower and upper good recovery were similar between the two groups, with 11.0% of those in the surgical group and 10.9% of those in the medical group demonstrating recovery.
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"Additional analyses of GOS-E changes over time showed that patients in the surgical group were more likely to improve over time than patients in the medical group, as demonstrated by the paired time-point analyses,” Kolias et al wrote. "However, it is important to note that GOS-E scores for the majority of patients in both groups remained unchanged over the period from 6 to 24 months. Improvement by at least 1 grade was seen for 30.4% of the surgical group vs 14.5% of the medical group."
In comparison, 45.1% of those in the surgical group vs 31.0% of those in the medical group had a GOS-E outcome of upper severe disability or better (X2 = 7.41; P = .006), according to sensitivity analyses. Using Dunn-Bonferroni post-hoc testing, investigators found significant differences between the 6- and 24-month GOS-E outcomes in the surgical group (P = .004), but no other between-group significant differences at any other time points.
Between 6 and 24 months, there were significant differences of net change in improvement or worsening by 1 GOS-E grade or more or unchanged GOS-E scores, with 30.4% of those in the surgical group achieving an improvement of 1 grade or more vs 14.5% of those in the medical group (X22 = 13.27; P = .001). The net percentage of worsening of both treatment groups was equal, at 8.2%. In total, 61.3% and 77.5% of those in the surgical and medical groups had no change in GOS-E score, respectively.
"There is a wide spectrum of outcomes among patients undergoing decompressive craniectomy for intractable intracranial hypertension," the study investigators wrote. "These findings support the notion that careful patient selection, following the principles of multidisciplinary consensus and shared decision-making with the closest relatives, is required."
The original 6-month results of RESCUEicp, published in the New England Journal of Medicine in 2016, showed hat decompressive craniectomy leads to lower mortality and higher rates of vegetative state, lower severe disability, and upper severe disability, similar to what was observed in the new 24-month results. At 6 months, the GOS-E distributions were as follows: death, 26.9% in the surgical group vs 48.9% in the medical group; vegetative state, 8.5% vs 2.1%; lower severe disability, 21.9% vs 14.4; upper severe disability, 15.4% vs 8.0%; moderate disability, 23.4% vs 19.7%; and good recovery, 4.0% vs 6.9%.