Gerald Chi1, Adeel Jamil2, Umer Jamil3, Muhammad A Balouch4, Jolanta Marszalek5, Farima Kahe1, Shaghayegh Habibi1, Miroslav Radulovic2. 1. a Division of Cardiovascular Medicine, Department of Medicine , Beth Israel Deaconess Medical Center, Harvard Medical School , Boston , Massachusetts , USA. 2. b Department of Medicine , James J. Peters VA Medical Center, Icahn School of Medicine , Bronx , NY , USA. 3. c Department of Medicine , MedStar Union Memorial Hospital , Baltimore , Maryland , USA. 4. d Division of Cardiology, Department of Medicine , University of Illinois at Chicago , Chicago , Illinois , USA. 5. e Department of Neurology , University of Arkansas for Medical Sciences , Little Rock , Arkansas , USA.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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%]). CONCLUSIONS: 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. ABBREVIATIONS: Blood pressure (BP), diastolic blood pressure (DBP), major adverse cardiac event (MACE), net clinical benefit (NCB), serious adverse event (SAE), systolic blood pressure (SBP).
BACKGROUND: 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. METHODS: 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. RESULTS: 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%]). CONCLUSIONS: 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. ABBREVIATIONS: Blood pressure (BP), diastolic blood pressure (DBP), major adverse cardiac event (MACE), net clinical benefit (NCB), serious adverse event (SAE), systolic blood pressure (SBP).
Entities:
Keywords:
Hypertension; blood pressure; major adverse cardiac event; net clinical benefit; serious adverse event
Authors: Harminder Singh; James A Dickinson; Guylène Thériault; Roland Grad; Stéphane Groulx; Brenda J Wilson; Olga Szafran; Neil R Bell Journal: Can Fam Physician Date: 2018-09 Impact factor: 3.275
Authors: Harminder Singh; James A Dickinson; Guylène Thériault; Roland Grad; Stéphane Groulx; Brenda J Wilson; Olga Szafran; Neil R Bell Journal: Can Fam Physician Date: 2018-09 Impact factor: 3.275