Dae Hyun Kim1, Curtis Tatsuoka2,3, Zhengyi Chen2,3, Jackson T Wright4, Michelle C Odden5, Srinivasan Beddhu6, Brandon K Bellows7, Adam Bress8, Thaddeus Carson9, William C Cushman10, Karen C Johnson10, Donald E Morisky11, Henry Punzi12, Leonardo Tamariz13, Song Yang14, Lee-Jen Wei15. 1. Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, 1200 Centre Street, Boston, MA, 02131, USA. daehyunkim@hsl.harvard.edu. 2. Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, OH, USA. 3. Department of Neurology, Case Western Reserve University, Cleveland, OH, USA. 4. Department of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA. 5. Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA. 6. Department of Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA. 7. Department of Medicine, Columbia University, New York, NY, USA. 8. Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, UT, USA. 9. Department of Medicine, Medical College of Georgia, Augusta, GA, USA. 10. Department of Preventive Medicine, The University of Tennessee Health Science Center, Memphis, TN, USA. 11. Department of Community Health Sciences, UCLA Fielding School of Public Health, Los Angeles, CA, USA. 12. Punzi Medical Center, Carrollton, TX, USA. 13. Division of Population Health and Computational Medicine, Miller School of Medicine, University of Miami, Miami, FL, USA. 14. Office of Biostatistics Research, National Heart, Lung, and Blood Institute, Bethesda, MD, USA. 15. Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA, USA.
Abstract
BACKGROUND: Communication of the benefits and harms of blood pressure lowering strategy is crucial for shared decision-making. OBJECTIVES: To quantify the effect of intensive versus standard systolic blood pressure lowering in terms of the number of event-free days DESIGN: Post hoc analysis of the Systolic Blood Pressure Intervention Trial PARTICIPANTS: A total of 9361 adults 50 years or older without diabetes or stroke who had a systolic blood pressure of 130-180 mmHg and elevated cardiovascular risk INTERVENTIONS: Intensive (systolic blood pressure goal <120 mmHg) versus standard blood pressure lowering (<140 mmHg) MAIN MEASURES: Days free of major adverse cardiovascular events (MACE), serious adverse events (SAE), and monitored adverse events (hypotension, syncope, bradycardia, electrolyte abnormalities, injurious falls, or acute kidney injury) over a median follow-up of 3.33 years KEY RESULTS: The intensive treatment group gained 14.7 more MACE-free days over 4 years (difference, 14.7 [95% confidence interval: 5.1, 24.4] days) than the standard treatment group. The benefit of the intensive treatment varied by cognitive function (normal: difference, 40.7 [13.0, 68.4] days; moderate-to-severe impairment: difference, -15.0 [-56.5, 26.4] days; p-for-interaction=0.009) and self-rated health (excellent: difference, -22.7 [-51.5, 6.1] days; poor: difference, 156.1 [31.1, 281.2] days; p-for-interaction=0.001). The mean overall SAE-free days were not significantly different between the treatments (difference, -14.8 [-35.3, 5.7] days). However, the intensive treatment group had 28.5 fewer monitored adverse event-free days than the standard treatment group (difference, -28.5 [-40.3, -16.7] days), with significant variations by frailty status (non-frail: difference, 38.8 [8.4, 69.2] days; frail: difference, -15.5 [-46.6, 15.7] days) and self-rated health (excellent: difference, -12.9 [-45.5, 19.7] days; poor: difference, 180.6 [72.9, 288.4] days; p-for-interaction <0.001). CONCLUSIONS: Over 4 years, intensive systolic blood pressure lowering provides, on average, 14.7 more MACE-free days than standard treatment, without any difference in SAE-free days. Whether this time-based effect summary improves shared decision-making remains to be elucidated. TRIAL REGISTRATION: ClinicalTrials.gov Registration: NCT01206062.
BACKGROUND: Communication of the benefits and harms of blood pressure lowering strategy is crucial for shared decision-making. OBJECTIVES: To quantify the effect of intensive versus standard systolic blood pressure lowering in terms of the number of event-free days DESIGN: Post hoc analysis of the Systolic Blood Pressure Intervention Trial PARTICIPANTS: A total of 9361 adults 50 years or older without diabetes or stroke who had a systolic blood pressure of 130-180 mmHg and elevated cardiovascular risk INTERVENTIONS: Intensive (systolic blood pressure goal <120 mmHg) versus standard blood pressure lowering (<140 mmHg) MAIN MEASURES: Days free of major adverse cardiovascular events (MACE), serious adverse events (SAE), and monitored adverse events (hypotension, syncope, bradycardia, electrolyte abnormalities, injurious falls, or acute kidney injury) over a median follow-up of 3.33 years KEY RESULTS: The intensive treatment group gained 14.7 more MACE-free days over 4 years (difference, 14.7 [95% confidence interval: 5.1, 24.4] days) than the standard treatment group. The benefit of the intensive treatment varied by cognitive function (normal: difference, 40.7 [13.0, 68.4] days; moderate-to-severe impairment: difference, -15.0 [-56.5, 26.4] days; p-for-interaction=0.009) and self-rated health (excellent: difference, -22.7 [-51.5, 6.1] days; poor: difference, 156.1 [31.1, 281.2] days; p-for-interaction=0.001). The mean overall SAE-free days were not significantly different between the treatments (difference, -14.8 [-35.3, 5.7] days). However, the intensive treatment group had 28.5 fewer monitored adverse event-free days than the standard treatment group (difference, -28.5 [-40.3, -16.7] days), with significant variations by frailty status (non-frail: difference, 38.8 [8.4, 69.2] days; frail: difference, -15.5 [-46.6, 15.7] days) and self-rated health (excellent: difference, -12.9 [-45.5, 19.7] days; poor: difference, 180.6 [72.9, 288.4] days; p-for-interaction <0.001). CONCLUSIONS: Over 4 years, intensive systolic blood pressure lowering provides, on average, 14.7 more MACE-free days than standard treatment, without any difference in SAE-free days. Whether this time-based effect summary improves shared decision-making remains to be elucidated. TRIAL REGISTRATION: ClinicalTrials.gov Registration: NCT01206062.
Authors: Daniella A Zipkin; Craig A Umscheid; Nancy L Keating; Elizabeth Allen; KoKo Aung; Rebecca Beyth; Scott Kaatz; Devin M Mann; Jeremy B Sussman; Deborah Korenstein; Connie Schardt; Avishek Nagi; Richard Sloane; David A Feldstein Journal: Ann Intern Med Date: 2014-08-19 Impact factor: 25.391
Authors: Helio P Guimarães; Renato D Lopes; Pedro G M de Barros E Silva; Idelzuita L Liporace; Roney O Sampaio; Flávio Tarasoutchi; Conrado R Hoffmann-Filho; Rodrigo de Lemos Soares Patriota; Tiago L L Leiria; Diana Lamprea; Dalton B Precoma; Fernando A Atik; Fabio S Silveira; Fabio R Farias; Diogo O Barreto; Adail P Almeida; Alexandre C Zilli; João D de Souza Neto; Margaret A Cavalcante; Fernando A M S Figueira; Flávia C S Kojima; Lucas Damiani; Renato H N Santos; Nanci Valeis; Viviane B Campos; Jose F K Saraiva; Francisco H Fonseca; Ibraim M Pinto; Carlos C Magalhães; Joao F M Ferreira; John H Alexander; Ricardo Pavanello; Alexandre B Cavalcanti; Otavio Berwanger Journal: N Engl J Med Date: 2020-11-14 Impact factor: 91.245
Authors: Hajime Uno; Janet Wittes; Haoda Fu; Scott D Solomon; Brian Claggett; Lu Tian; Tianxi Cai; Marc A Pfeffer; Scott R Evans; Lee-Jen Wei Journal: Ann Intern Med Date: 2015-07-21 Impact factor: 25.391
Authors: Ariela R Orkaby; Michael W Rich; Ryan Sun; Eliah Lux; Lee-Jen Wei; Dae Hyun Kim Journal: J Am Geriatr Soc Date: 2018-09-25 Impact factor: 5.562