From the Department of Cerebrovascular Medicine (K. Toyoda, M.K., S.Y., K. Tanaka, K.M.), Center for Advancing Clinical and Translational Sciences (H.Y., M.F.-D., S.O.), and Department of Neurology (M.I.), National Cerebral and Cardiovascular Center, Suita, Japan; Department of Public Health Sciences (Y.Y.P., L.F.), Medical University of South Carolina, Charleston; Department of Neurology (Y.H.), St. Marianna University School of Medicine, Kawasaki; Department of Neurosurgery and Stroke Center (Y.S.), Kyorin University School of Medicine, Mitaka; Department of Neurosurgery (T.I.), Gifu University Graduate School of Medicine; Department of Neurosurgery (K.K.), Nakamura Memorial Hospital, Sapporo; Department of Neurology (H.H.), Tokyo Saiseikai Central Hospital, Japan; Department of Neurology (T.S.), Klinikum Frankfurt Höchst, Germany; Department of Neurology (B.-W.Y.), Seoul National University Hospital, South Korea; Beijing Tiantan Hospital (Y.W.), China; China Medical University (C.Y.H.), Taichung, Taiwan; and Zeenat Qureshi Stroke Research Center (A.I.Q.), University of Minnesota, Minneapolis.
Neurology. 2021 Feb 2;96(5):e740-e751. doi: 10.1212/WNL.0000000000011229. Epub 2020 Nov 20.
To compare the impact of intensive blood pressure (BP) lowering right after intracerebral hemorrhage (ICH) on clinical and hematoma outcomes among patients from different geographic locations, we performed a prespecified subanalysis of a randomized, multinational, 2-group, open-label trial to determine the efficacy of rapidly lowering BP in hyperacute ICH (Antihypertensive Treatment of Acute Cerebral Hemorrhage [ATACH]-2), involving 537 patients from East Asia and 463 recruited outside of Asia.
Eligible patients were randomly assigned to a systolic BP target of 110 to 139 mm Hg (intensive treatment) or 140 to 179 mm Hg (standard treatment). Predefined outcomes were poor functional outcome (modified Rankin Scale score 4-6 at 90 days), death within 90 days, hematoma expansion at 24 hours, and cardiorenal adverse events within 7 days.
Poor functional outcomes (32.0% vs 45.9%), death (1.9% vs 13.3%), and cardiorenal adverse events (3.9% vs 11.2%) occurred significantly less frequently in patients from Asia than those outside of Asia. The treatment-by-cohort interaction was not significant for any outcomes. Only patients from Asia showed a lower incidence of hematoma expansion with intensive treatment (adjusted relative risk [RR] 0.56, 95% confidence interval [CI] 0.38-0.83). Both Asian (RR 3.53, 95% CI 1.28-9.64) and non-Asian (RR 1.71, 95% CI 1.00-2.93) cohorts showed a higher incidence of cardiorenal adverse events with intensive treatment.
Poor functional outcomes and death 90 days after ICH were less common in patients from East Asia than those outside of Asia. Hematoma expansion, a potential predictor for poor clinical outcome, was attenuated by intensive BP lowering only in the Asian cohort.
NCT01176565.
This study provides Class II evidence that, for patients from East Asia with ICH, intensive blood pressure lowering significantly reduces the risk of hematoma expansion.
通过对来自不同地理位置的患者进行颅内出血（ICH）后立即强化降压对临床和血肿结局影响的比较，我们对一项随机、多国家、2 组、开放性试验的预设亚组分析进行了评估，以确定超急性期 ICH 中快速降压的疗效（抗高血压治疗急性脑出血[ATACH]-2），该试验共纳入 537 名东亚患者和 463 名非亚洲患者。
符合条件的患者被随机分配到收缩压目标 110-139mmHg（强化治疗）或 140-179mmHg（标准治疗）。预设结局为 90 天改良 Rankin 量表评分 4-6（不良功能结局）、90 天内死亡、24 小时内血肿扩大以及 7 天内心肾不良事件。
来自亚洲的患者不良功能结局（32.0% vs 45.9%）、死亡（1.9% vs 13.3%）和心肾不良事件（3.9% vs 11.2%）发生率显著低于非亚洲患者。对于任何结局，治疗与队列之间的交互作用均无统计学意义。只有亚洲患者强化治疗后血肿扩大发生率较低（校正相对风险[RR]0.56，95%置信区间[CI]0.38-0.83）。亚洲（RR 3.53，95%CI 1.28-9.64）和非亚洲（RR 1.71，95%CI 1.00-2.93）队列均显示强化治疗后心肾不良事件发生率升高。
与非亚洲患者相比，东亚ICH 患者 90 天不良功能结局和死亡发生率较低。血肿扩大是临床结局不良的潜在预测因素，仅在亚洲队列中强化降压可减轻血肿扩大。
临床试验.gov 标识符：NCT01176565。
本研究提供了 II 级证据，表明对于来自东亚的 ICH 患者，强化血压降低可显著降低血肿扩大的风险。
