Intensive Blood Pressure Control in Older Patients With Hypertension: 6-Year Results of the STEP Trial.

Study investigators conducted an extended follow-up of the STEP trial to determine the longer-term effects of intensive blood pressure (BP) control.

研究调查人员对STEP试验进行了延长随访，以确定强化血压（BP）控制的长期效果。

Methods

In this randomized controlled trial, 8,511 patients with hypertension were randomly assigned to the intensive treatment group, with an SBP target of 110 mm Hg to <130 mm Hg, or the standard treatment group, with an SBP target of 130 mm Hg to <150 mm Hg.

在这项随机对照试验中，8,511名高血压患者被随机分配到强化治疗组，其收缩压（SBP）目标为110毫米汞柱至<130毫米汞柱，或标准治疗组，其收缩压目标为130毫米汞柱至<150毫米汞柱。

After the original trial ended, all surviving patients, either in the standard group or the intensive treatment group previously, received intensive treatment in the extended period, referred to as the delayed intensive treatment group or the sustained intensive treatment group.

原始试验结束后，所有存活的患者，无论之前是在标准治疗组还是强化治疗组，都在延长期内接受了强化治疗，这被称为延迟强化治疗组或持续强化治疗组。

The primary outcome was a composite of stroke, acute coronary syndrome, acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death resulting from cardiovascular causes.

主要结果是中风、急性冠状动脉综合征、急性失代偿性心力衰竭、冠状动脉血运重建、房颤或心血管原因导致的死亡的复合终点。

The Fine-Gray subdistribution hazard model was used to estimate the HR between the 2 groups, and g-formula methods were initiated to compare overall primary outcome risks with intensive treatment initiated from randomization and initiated every year after randomization.

使用Fine-Gray亚分布风险模型估计两组之间的风险比（HR），并启动g公式方法比较从随机化开始的强化治疗与从随机化后每年开始的强化治疗对总体主要结果风险的影响。

Results

After a median follow-up of 6.11 years, the mean SBP was 127.9 mm Hg in the sustained intensive treatment group and 129.5 mm Hg in the delayed intensive treatment group.

中位随访6.11年后，持续强化治疗组的平均收缩压为127.9毫米汞柱，延迟强化治疗组为129.5毫米汞柱。

The incidencerate of primary outcome was 1.12% per year in the sustained intensive treatment group, compared with 1.33% per year in the delayed intensive treatment group (HR: 0.82; 95% CI: 0.71-0.96).

持续强化治疗组的主要结果发生率为每年1.12%，而延迟强化治疗组为每年1.33%（HR: 0.82; 95% 置信区间: 0.71-0.96）。

No difference in safety event rates between the 2 groups was observed except for hypotension, which occurred more frequently in the sustained intensive treatment group.

除了低血压的发生在持续强化治疗组更为频繁外，两组的安全事件发生率没有观察到差异。

Furthermore, analyses using the parametric g-formula showed that compared with the standard BP treatment, intensive treatment initiating from randomization (0 month) yielded the greatest benefit (relative risk [RR]: 0.83; 95% CI: 0.70-0.96), with an attenuated cardiovascular benefit for later initiation from 12 months (RR: 0.88; 95% CI: 0.76-0.99).

此外，使用参数g公式分析显示，与标准血压治疗相比，从随机分组（0个月）开始的强化治疗带来了最大的益处（相对风险[RR]：0.83；95%置信区间：0.70-0.96），而从12个月开始的治疗其心血管益处有所减弱（RR：0.88；95%置信区间：0.76-0.99）。

Conclusions

Our results suggested that sustained intensive BP control could benefit patients with hypertension compared with delayed intensive treatment in the longer-term follow-up.

我们的结果表明，与延迟强化治疗相比，持续的强化血压控制在长期随访中对高血压患者有益。

The earlier intensive treatment is initiated after the hypertension diagnosis, the greater the cardiovascular benefits will be.

高血压诊断后越早开始强化治疗，心血管获益将越大。

(Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients [STEP]; NCT03015311).

(老年高血压患者血压干预策略[STEP]; NCT03015311).