早期微创清除脑出血的试验。
Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage.
机构信息
From the Departments of Neurosurgery (G. Pradilla, J.A.G., D.L.B.), Emergency Medicine (J.J.R., A.J.H., D.W.W.), Neurology (J.J.R., J.W.A., M. Frankel), and Radiology (J.W.A., X.T.L.), Emory University School of Medicine, and the Marcus Stroke and Neuroscience Center, Grady Memorial Hospital (G. Pradilla, J.J.R., A.J.H., J.A.G., M. Frankel, D.W.W.) - both in Atlanta; Berry Consultants, Austin, TX (B.R.S., G. Paulon, A.M., R.J.L., M. Fitzgerald); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (B.R.S.); the Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, CA (R.J.L.); the Department of Psychiatry, University of Michigan, Ann Arbor (A.F.C.); the Cerebrovascular Center, Cleveland Clinic, Cleveland (M.B., J.G.); the Department of Neurosurgery, University of Pennsylvania, Philadelphia (B.J.); the Department of Neurological Surgery, University of Pittsburgh, Pittsburgh (G.Z.); the Department of Neurology, Brigham and Women's Hospital, Boston (B.J.M.); the Department of Neurosurgery, State University of New York at Buffalo, Buffalo (J.D., A.S.); the Department of Neurosurgery, University of Missouri, Columbia (M.R.C.), and the Department of Neurology, Washington University, St. Louis (S.G.K.); and the Departments of Neurosurgery (M.V.S., B.N.B.) and Pulmonary and Critical Care Medicine (R.S.), Indiana University, Indianapolis.
出版信息
N Engl J Med. 2024 Apr 11;390(14):1277-1289. doi: 10.1056/NEJMoa2308440.
BACKGROUND
Trials of surgical evacuation of supratentorial intracerebral hemorrhages have generally shown no functional benefit. Whether early minimally invasive surgical removal would result in better outcomes than medical management is not known.
METHODS
In this multicenter, randomized trial involving patients with an acute intracerebral hemorrhage, we assessed surgical removal of the hematoma as compared with medical management. Patients who had a lobar or anterior basal ganglia hemorrhage with a hematoma volume of 30 to 80 ml were assigned, in a 1:1 ratio, within 24 hours after the time that they were last known to be well, to minimally invasive surgical removal of the hematoma plus guideline-based medical management (surgery group) or to guideline-based medical management alone (control group). The primary efficacy end point was the mean score on the utility-weighted modified Rankin scale (range, 0 to 1, with higher scores indicating better outcomes, according to patients' assessment) at 180 days, with a prespecified threshold for posterior probability of superiority of 0.975 or higher. The trial included rules for adaptation of enrollment criteria on the basis of hemorrhage location. A primary safety end point was death within 30 days after enrollment.
RESULTS
A total of 300 patients were enrolled, of whom 30.7% had anterior basal ganglia hemorrhages and 69.3% had lobar hemorrhages. After 175 patients had been enrolled, an adaptation rule was triggered, and only persons with lobar hemorrhages were enrolled. The mean score on the utility-weighted modified Rankin scale at 180 days was 0.458 in the surgery group and 0.374 in the control group (difference, 0.084; 95% Bayesian credible interval, 0.005 to 0.163; posterior probability of superiority of surgery, 0.981). The mean between-group difference was 0.127 (95% Bayesian credible interval, 0.035 to 0.219) among patients with lobar hemorrhages and -0.013 (95% Bayesian credible interval, -0.147 to 0.116) among those with anterior basal ganglia hemorrhages. The percentage of patients who had died by 30 days was 9.3% in the surgery group and 18.0% in the control group. Five patients (3.3%) in the surgery group had postoperative rebleeding and neurologic deterioration.
CONCLUSIONS
Among patients in whom surgery could be performed within 24 hours after an acute intracerebral hemorrhage, minimally invasive hematoma evacuation resulted in better functional outcomes at 180 days than those with guideline-based medical management. The effect of surgery appeared to be attributable to intervention for lobar hemorrhages. (Funded by Nico; ENRICH ClinicalTrials.gov number, NCT02880878.).
背景
针对幕上脑出血的手术清除试验通常并未显示出功能获益。早期微创外科清除是否会导致比药物治疗更好的结局尚不清楚。
方法
在这项涉及急性脑出血患者的多中心、随机试验中，我们评估了血肿清除术与药物治疗相比的效果。将血肿量为 30 至 80 毫升的叶性或前基底节区脑出血患者，按照 1:1 的比例，在发病后最后一次被认为健康时的 24 小时内，随机分配至微创血肿清除术加基于指南的药物治疗（手术组）或单纯基于指南的药物治疗（对照组）。主要疗效终点为 180 天时基于效用加权改良 Rankin 量表的平均评分（范围为 0 至 1，分数越高表示结局越好，由患者评估），预先设定的优势后验概率阈值为 0.975 或更高。该试验包括基于出血部位调整纳入标准的规则。主要安全性终点为入组后 30 天内的死亡。
结果
共纳入 300 例患者，其中 30.7%为前基底节区脑出血，69.3%为叶性脑出血。在纳入 175 例患者后，触发了一项调整规则，仅纳入叶性脑出血患者。手术组 180 天时的效用加权改良 Rankin 量表评分均值为 0.458，对照组为 0.374（差值为 0.084；95%贝叶斯可信区间为 0.005 至 0.163；手术的优势后验概率为 0.981）。叶性脑出血患者的组间平均差异为 0.127（95%贝叶斯可信区间为 0.035 至 0.219），前基底节区脑出血患者的差异为 -0.013（95%贝叶斯可信区间为 -0.147 至 0.116）。手术组 30 天内死亡的患者比例为 9.3%，对照组为 18.0%。手术组有 5 例（3.3%）患者术后再次出血和神经功能恶化。
结论
在发病后 24 小时内可进行手术的急性脑出血患者中，微创血肿清除术在 180 天时的功能结局优于基于指南的药物治疗。手术的效果似乎归因于对叶性脑出血的干预。（由 Nico 资助；ENRICH ClinicalTrials.gov 编号，NCT02880878）。
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