Intensive Versus Conventional Blood Pressure Lowering After Successful Endovascular Thrombectomy: OPTIMAL-BP 1-Year Outcomes.

However, it remains unclear whether these adverse effects persist over the long term.

然而，这些不良效应是否长期持续仍不清楚。

Methods

The OPTIMAL-BP (Outcome in Patients Treated With Intra-Arterial Thrombectomy-Optimal Blood Pressure Control) was a phase 3, multicenter, prospective, open-label, blinded end point, randomized controlled trialwith 19 centers throughout South Korea.

OPTIMAL-BP（接受经动脉血栓切除术治疗患者的结局-最佳血压控制）是一项在韩国全国19个中心进行的3期、多中心、前瞻性、开放标签、终点盲法的随机对照试验。

Patients who underwent endovascular thrombectomy for acute ischemic stroke caused by large vessel occlusion, achieved successful reperfusion of the occluded artery, and exhibited elevated BP (systolic BP ≥140 mm Hg) on 2 measurements obtained 2 minutes apart within 2 hours after recanalization were randomly assigned to receive intensive BP management (systolic BP target <140 mm Hg) or conventional management (systolic BP target, 140-180 mm Hg) for 24 hours after enrollment.

对于因大血管闭塞引起的急性缺血性中风患者，在接受经血管内血栓切除术后，如果在血管再通后2小时内2次测量（每次间隔2分钟）的收缩压≥140毫米汞柱，则随机分配接受强化血压管理（收缩压目标<140毫米汞柱）或常规管理（收缩压目标140-180毫米汞柱），持续24小时。

This study was a 1-year follow-up extension of the OPTIMAL-BP.

本研究是OPTIMAL-BP研究的1年随访扩展。

The primary outcomes were a modified Rankin Scale score of 0 to 2 at 1 year, indicating functional independence and all-cause mortality within 1 year.

主要结果是在1年内改良Rankin量表评分为0至2分，表明功能独立以及1年内的全因死亡率。

Adjusted odds ratios were estimated using multivariable logistic regression models adjusting for age, sex, onset-to-randomization time, and baseline National Institutes of Health Stroke Scale.

使用多变量逻辑回归模型调整年龄、性别、发病至随机化时间及基线国立卫生研究院卒中量表评分后，估计了调整后的优势比。

Results

Among 306 randomized patients, 294 (96.1%) completed the 1-year follow-up.

在306名随机化患者中，有294名（96.1%）完成了1年的随访。

In the intention-to-treatanalysis, functional independence at 1 year was numerically lower in the intensive BP management group than in the conventional group (40.5% versus 52.7%; adjusted odds ratios, 0.59 [95% CI, 0.34-1.00]; P=0.051).

在意向性治疗分析中，1年后在强化血压管理组的功能独立性数值上低于常规治疗组（40.5%对比52.7%；调整后的优势比为0.59 [95%置信区间，0.34-1.00]；P=0.051）。

Consistent findings were observed in the per-protocol analysis (41.1% versus 54.7%; adjusted odds ratios, 0.56 [95% CI, 0.32-0.97]; P=0.040).

在按方案分析中观察到一致的结果（41.1%对比54.7%；调整后的优势比为0.56 [95%置信区间，0.32-0.97]；P=0.040）。

One-year mortality and distribution of modified Rankin Scale changes from 3 months to 1 year did not differ between groups.

一年内死亡率以及从3个月到1年改良Rankin量表变化的分布，在各组之间没有差异。

Conclusions

Intensive BP lowering targeting a systolic BP of <140 mm Hg resulted in worse functional outcomes at 1 year compared with conventional BP management.

针对收缩压<140毫米汞柱的强化血压降低治疗，与常规血压管理相比，导致了1年后功能结果的恶化。

These randomized data suggest that early postthrombectomy BP management has durable effects on recovery and support current recommendations against intensive BP lowering.

这些随机数据表明，早期血栓切除术后血压管理对恢复有持久效果，并支持当前不推荐过度降低血压的建议。

registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04205305.

网址: https://www.clinicaltrials.gov; 唯一标识符: NCT04205305。