Background - Decompressive surgery (hemicraniectomy) for large hemispheric stroke reduces the risk of death and increases the chance of a favorable outcome. We aim to evaluate the outcome in patients up to 80 years of age with space-occupying hemispheric infarction treated with surgical decompression compared to medical therapy alone.

Methods - This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. The primary end point was survival with slight or moderate disability 12 months after randomization (defined by a score of 0 to 3 on the modified Rankin scale (mRS), which ranges from 0 [no symptoms] to 6 [death]). Secondary outcomes included death, Barthel Index, National Institute of Health Stroke Scale, and Stroke Impact Scale 2.0 (SIS) at 6 months and 1-year after randomization. The variables for subgroup analysis were age, sex, presence of aphasia and neglect.

Results - We randomly allocated 151 patients aged 41 years or older (median, 65 years; range, 41 to 79) with large hemispheric stroke to either conservative medical treatment or hemicraniectomy; the assignment was made within 12 to 38 hours after the onset of symptoms. A statistically significant reduction in mortality was achieved after 30 days in the surgery group compared to the medical treatment group. Fifty-five of 70 (79%) patients randomized to surgery versus 26 of 81 (32%) patients randomized to medical treatment survived (P=0.001). Of 151 patients randomized, the proportion of patients with a mRS score ≤3 at the 6-months and 1-year follow-up was 48% and 64%, respectively, in the surgery group compared to medical treatment group, 14% and 20%, respectively (P=0.001 and P=0.001, respectively). There was a 47% absolute risk reduction of death after surgery compared to medical treatment at 1-year after stroke (P=0.001). Activities of daily living (58.8+16.1 vs 50.9+15.2; P=0.04), strength (20.2+9.2 vs 15.3+7.2; P=0.020), hand function (1.2+0.7 vs 0.8+0.6; P=0.022), memory (71.9+14.9 vs 59.2+18.5; P=0.001), and communication (62+17.7 vs 51.9+17.6; P=0.019) assessed by the SIS, were better in the surgical group than in the medical treatment group 1-year after stroke.

Conclusions - This study showed that surgery in 48 hours increased survival and reduced mortality in life-threatening massive cerebral infarction. Early hemicraniectomy is a beneficial procedure in patients with large hemispheric infarction up to 80 years of age regardless of hemisphere dominance and improves daily life/ instrumental activities compared to medical therapy.

背景-大半球卒中的减压手术（半颅切除术）减少了死亡风险，并增加了取得有利结果的机会。我们的目标是评估与单纯药物治疗相比，接受手术减压治疗的占位性半球性脑梗塞的80岁以下患者的结局。

方法-该试验是一项基于卒中中心的前瞻性，随机，对照临床试验。主要终点是随机分组后12个月的轻度或中度残障生存率（由改良的Rankin量表（mRS）的0到3评分定义，范围从0 [无症状]到6 [死亡]）。次要结果包括随机分组后6个月和1年的死亡，Barthel指数，美国国立卫生研究院卒中量表和卒中影响量表2.0（SIS）。用于亚组分析的变量是年龄，性别，失语症的存在和忽视。

结果-我们将151名年龄在41岁或以上（中位年龄为65岁；范围为41至79岁）的大半球性卒中患者随机分配至保守药物治疗或半颅切除术；在症状发作后的12至38个小时内进行分配。与药物治疗组相比，手术组在30天后实现了统计学上显着的死亡率降低。随机接受手术的70名患者中有55名（79％）幸存，而随机接受药物治疗的81名患者中有26名（32％）存活了（P = 0.001）。在随机分组的151例患者中，与治疗组相比，在手术组的6个月和1年随访中，mRS评分≥3的患者比例分别为48％和64％，14分别为％和20％（分别为P = 0.001和P = 0.001）。与卒中后1年的药物治疗相比，手术后绝对死亡风险降低了47％（P = 0.001）。日常生活活动（58.8 + 16.1 vs 50.9 + 15.2; P = 0.04），力量（20.2 + 9.2 vs 15.3 + 7.2; P = 0.020），手功能（1.2 + 0.7 vs 0.8 + 0.6; P = 0.022），记忆术后1年，手术组比药物治疗组（71.9 + 14.9 vs 59.2 + 18.5; P = 0.001）和SIS评估的沟通能力（62 + 17.7 vs 51.9 + 17.6; P = 0.019）更好。中风。

结论-该研究表明，在威胁生命的大规模脑梗死中进行48小时手术可提高生存率并降低死亡率。早期半颅脑切除术对80岁以下的大半球性脑梗塞患者是有益的手术，无论其在半球占主导地位，并且与药物治疗相比，均能改善日常生活/器械活动。