Chi Gerald, Jamil Adeel, Jamil Umer, Balouch Muhammad A, Marszalek Jolanta, Kahe Farima, Habibi Shaghayegh, Radulovic Miroslav
a Division of Cardiovascular Medicine, Department of Medicine , Beth Israel Deaconess Medical Center, Harvard Medical School , Boston , Massachusetts , USA.
b Department of Medicine , James J. Peters VA Medical Center, Icahn School of Medicine , Bronx , NY , USA.
Clin Exp Hypertens. 2018 Apr 10:1-8. doi: 10.1080/10641963.2018.1462373.
Intensive blood pressure (BP) lowering may offer protective effects against major adverse cardiac event (MACE) but is also associated with a greater risk of a serious adverse event (SAE). The risk-benefit profile of intensive versus standard BP control has not been comprehensively assessed.
Four studies were identified from a systematic literature search for randomized controlled trials comparing intensive versus standard BP lowering that reported both MACE and SAE endpoints. A previously described statistical approach was applied to characterize the efficacy-safety tradeoff of BP control. The bivariate outcome was computed to quantitatively assess the net clinical benefit (NCB) of intensive BP lowering as compared to standard treatment, with positive values indicating increased risks and negative values indicating decreased risks.
Data from the SPRINT trial demonstrated that intensive strategy was superior in MACE but inferior in SAE, thereby eroding the NCB (bivariate outcome: 0.33% [-0.50% to 1.21%]). Intensive strategy from the SPS3 trial fulfilled non-inferiority in both MACE and SAE but did not reach a favorable NCB (-1.31% [-2.25% to 0.01%]). The ACCORD trial suggested that intensive strategy was non-inferior in MACE but inferior in SAE (-0.19% [-0.79% to 1.37%]). Results from the VALISH trial were inconclusive for SAE but suggested non-inferiority in MACE (-1.19% [-3.24% to 0.68%]).
Compared to the standard blood pressure target, pooled data from randomized controlled trials suggest that intensive strategy did not achieve a net clinical benefit when weighing the benefit of MACE reduction against the risk of SAE under the bivariate framework.
Blood pressure (BP), diastolic blood pressure (DBP), major adverse cardiac event (MACE), net clinical benefit (NCB), serious adverse event (SAE), systolic blood pressure (SBP).
强化降压可能对主要不良心脏事件（MACE）具有保护作用，但也与严重不良事件（SAE）风险增加相关。强化与标准血压控制的风险效益情况尚未得到全面评估。
通过系统文献检索，从随机对照试验中识别出四项比较强化与标准降压的研究，这些研究报告了MACE和SAE终点。采用先前描述的统计方法来描述血压控制的疗效-安全性权衡。计算双变量结局以定量评估强化降压与标准治疗相比的净临床获益（NCB），正值表示风险增加，负值表示风险降低。
SPRINT试验数据表明，强化策略在MACE方面更优，但在SAE方面较差，从而削弱了NCB（双变量结局：0.33%[-0.50%至1.21%]）。SPS3试验的强化策略在MACE和SAE方面均达到非劣效性，但未达到有利的NCB（-1.31%[-2.25%至0.01%]）。ACCORD试验表明，强化策略在MACE方面非劣效，但在SAE方面较差（-0.19%[-0.79%至1.37%]）。VALISH试验结果对于SAE尚无定论，但表明在MACE方面非劣效（-1.19%[-3.24%至0.68%]）。
与标准血压目标相比，随机对照试验的汇总数据表明，在双变量框架下，权衡降低MACE的益处与SAE风险时，强化策略未实现净临床获益。
血压（BP）、舒张压（DBP）、主要不良心脏事件（MACE）、净临床获益（NCB）、严重不良事件（SAE）、收缩压（SBP）
