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期刊来源：JAMA

文献发表时间：2023-09-05

原文链接：https://jamanetwork.com/journals/jama/article-abstract/2808995

关键点内容如下：

问题

成功的血管内卒中治疗后适度降低收缩压（SBP）目标（<140和<160 mm Hg）是否有害？

调查结果

在这项包括120名参与者的无效性设计的随机临床试验中，SBP目标低于140或160 mm Hg，而指南推荐的目标为180 mm Hg或更低，不符合随访梗死体积和90天效用加权改良Rankin量表（Mrs）评分的无效性或有害性的预先指定标准。根据效用加权Mrs评分，在未来更大规模的临床试验中，收缩压目标低于140 mm Hg或160 mm Hg与180 mm Hg或更低的预测成功概率分别为25%和14%。

意义

成功的急性缺血性卒中血管内治疗后较低的收缩压目标不符合无效标准，尽管研究结果表明，如果在未来更大规模的试验中进行测试，较低的收缩压目标获益的可能性很低。

摘要的内容如下：

重要性

急性缺血性卒中血管内治疗成功再通后适度降低收缩压（SBP）的效果尚不确定。

目的

确定血管内治疗后较低SBP目标（<140 mm Hg或160 mm Hg）与较高目标（≤180 mm Hg）相比的无效性。

研究设计和参与者

随机、开放标签、盲法终点、2期、无效性临床试验，纳入了120名急性缺血性卒中患者，这些患者于2020年1月至2022年3月在3个美国综合卒中中心成功接受了血管内治疗（最终随访，2022年6月）。

干预

在接受血管内治疗后，参与者被随机分配到3个SBP目标中的一个:40至低于140 mm Hg、40至低于160 mm Hg和40至180 mm Hg或更低（指南推荐）组，在血管再通后60分钟内开始并维持24小时。

主要结果和措施

主要无效性分析预先指定的多个主要结果是随访36（±12）小时时测量的梗死体积和90（±14）天时的效用加权改良Rankin量表（Mrs）评分（范围:0[最差]至1[最好]）。使用线性回归模型检验血管内治疗（单侧α=0.05）后，随访梗死体积增加10-mL（斜率为0.5）或效用加权Mrs评分降低0.10（斜率为-0.005），每降低20-mmHg目标收缩压的危害-无效性界限。另一个预先指定的无效标准是未来2组优势试验的预测成功概率小于25%，该试验比较了低阈值和中阈值与高阈值的收缩压目标（最大样本量为1500，与效用加权Mrs评分结果有关）。

次要结果

在随机（的120名患者中，平均[SD]年龄为69.6[14.5]岁；69名女性[58%]），113名（，94.2%的）完成了试验。小于140 mm Hg组的平均随访梗死体积为32.4 mL（95%CI，18.0至46.7 mL），小于160 mm Hg组的平均随访梗死体积为50.7 mL（95%CI，33.7至67.7 mL），小于180 mm Hg或更小组的平均随访梗死容积为46.4 mL（94%CI，24.5至68.2 mL）。低于140-mmHg组的平均效用加权Mrs评分为0.51（95%CI，0.38至0.63），低于160-mmHg组的平均效用加权Mrs评分为0.47（95%CI，0.35至0.60），高目标组的Mrs平均效用加权评分为0。SBP目标值每降低1 mm Hg，随访梗死体积的斜率（根据基线Alberta卒中计划早期CT评分调整）为-0.29，（95%CI，-0.81至∞；无效P=0.99）。血管内治疗后，SBP目标值每降低1 mm Hg，效用加权Mrs评分的斜率经基线效用加权Mrs评分校正后为-0.00 19（95%CI，-∞至0.0017；无效P=.93）。将高目标收缩压组与低目标收缩压组进行比较，未来试验的预测成功概率在140毫米汞柱以下组为25%，在160毫米汞柱以下组为14%。

结论和相关性

在急性缺血性卒中患者中，与180 mm Hg或更低的收缩压目标相比，成功的血管内治疗后低于140 mm Hg或160 mm Hg的较低收缩压目标不符合预先规定的无效标准。然而，研究结果表明，如果在未来更大规模的试验中进行测试，血管内治疗后降低收缩压目标的获益概率较低。

英文原文如下：

Key Points

Question  Are moderately low systolic blood pressure (SBP) targets (<140 and <160 mm Hg) after successful endovascular stroke treatment harmful?

Findings  In this futility-design, randomized clinical trial that included 120 participants, SBP targets of less than either 140 or 160 mm Hg vs the guideline-recommended target of 180 mm Hg or less did not meet prespecified criteria for futility or harm for follow-up infarct volume and 90-day utility-weighted modified Rankin Scale (mRS) score. Based on the utility-weighted mRS score, the predicted probability of success in a future larger clinical trial for an SBP target of less than either 140 mm Hg or 160 mm Hg vs 180 mm Hg or less was 25% and 14%, respectively.

Meaning  Lower SBP targets after successful endovascular therapy for acute ischemic stroke did not meet the criteria for futility, although the findings suggested a low probability of benefit from lower SBP targets if tested in a future larger trial.

Abstract

Importance  The effects of moderate systolic blood pressure (SBP) lowering after successful recanalization with endovascular therapy for acute ischemic stroke are uncertain.

Objective  To determine the futility of lower SBP targets after endovascular therapy (<140 mm Hg or 160 mm Hg) compared with a higher target (≤180 mm Hg).

Design, Setting, and Participants  Randomized, open-label, blinded end point, phase 2, futility clinical trial that enrolled 120 patients with acute ischemic stroke who had undergone successful endovascular therapy at 3 US comprehensive stroke centers from January 2020 to March 2022 (final follow-up, June 2022).

Intervention  After undergoing endovascular therapy, participants were randomized to 1 of 3 SBP targets: 40 to less than 140 mm Hg, 40 to less than 160 mm Hg, and 40 to 180 mm Hg or less (guideline recommended) group, initiated within 60 minutes of recanalization and maintained for 24 hours.

Main Outcomes and Measures  Prespecified multiple primary outcomes for the primary futility analysis were follow-up infarct volume measured at 36 (±12) hours and utility-weighted modified Rankin Scale (mRS) score (range, 0 [worst] to 1 [best]) at 90 (±14) days. Linear regression models were used to test the harm-futility boundaries of a 10-mL increase (slope of 0.5) in the follow-up infarct volume or a 0.10 decrease (slope of −0.005) in the utility-weighted mRS score with each 20-mm Hg SBP target reduction after endovascular therapy (1-sided α = .05). Additional prespecified futility criterion was a less than 25% predicted probability of success for a future 2-group, superiority trial comparing SBP targets of the low- and mid-thresholds with the high-threshold (maximum sample size, 1500 with respect to the utility-weighted mRS score outcome).

Results  Among 120 patients randomized (mean [SD] age, 69.6 [14.5] years; 69 females [58%]), 113 (94.2%) completed the trial. The mean follow-up infarct volume was 32.4 mL (95% CI, 18.0 to 46.7 mL) for the less than 140–mm Hg group, 50.7 mL (95% CI, 33.7 to 67.7 mL), for the less than 160–mm Hg group, and 46.4 mL (95% CI, 24.5 to 68.2 mL) for the 180–mm Hg or less group. The mean utility-weighted mRS score was 0.51 (95% CI, 0.38 to 0.63) for the less than 140–mm Hg group, 0.47 (95% CI, 0.35 to 0.60) for the less than 160–mm Hg group, and 0.58 (95% CI, 0.46 to 0.71) for the high-target group. The slope of the follow-up infarct volume for each mm Hg decrease in the SBP target, adjusted for the baseline Alberta Stroke Program Early CT score, was −0.29 (95% CI, −0.81 to ∞; futility P = .99). The slope of the utility-weighted mRS score for each mm Hg decrease in the SBP target after endovascular therapy, adjusted for baseline utility-weighted mRS score, was −0.0019 (95% CI, −∞ to 0.0017; futility P = .93). Comparing the high-target SBP group with the lower-target groups, the predicted probability of success for a future trial was 25% for the less than 140–mm Hg group and 14% for the 160–mm Hg group.

Conclusions and Relevance  Among patients with acute ischemic stroke, lower SBP targets less than either 140 mm Hg or 160 mm Hg after successful endovascular therapy did not meet prespecified criteria for futility compared with an SBP target of 180 mm Hg or less. However, the findings suggested a low probability of benefit from lower SBP targets after endovascular therapy if tested in a future larger trial.

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