| Literature DB >> 35532917 |
Tao Chen1,2, Fang Shao3, Kangyu Chen4,5, Yang Wang6, Zhenqiang Wu7, Yongjuan Wang8, Yanpei Gao8, Victoria Cornelius9, Chao Li8, Zhixin Jiang10.
Abstract
Importance: Recent guidelines recommend a systolic blood pressure (BP) goal of less than 150 mm Hg or even 130 mm Hg for adults aged 60 years or older. However, harms from intensive BP treatments occur immediately (eg, syncope, fall), and benefits for cardiovascular event reduction emerge over time. Therefore, harms with low chance of benefit need to be clearer, particularly for those with limited life expectancy. Objective: To estimate the time needed to potentially derive clinical benefit from intensive BP treatment in patients 60 years and older. Design, Setting, and Participants: This secondary analysis included individual patient data from published randomized clinical trials with 27 414 patients 60 years or older with hypertension. Patient-level survival data were reconstructed when the original data were not available. Published trials were identified by searching PubMed until October 15, 2021. Exposures: Intensive BP lowering vs standard BP lowering with the treat-to-target design. Main Outcomes and Measures: Major adverse cardiovascular event (MACE) defined by each trial, which was broadly similar with all trials including myocardial infarction, stroke, and cardiovascular mortality.Entities:
Mesh:
Substances:
Year: 2022 PMID: 35532917 PMCID: PMC9086939 DOI: 10.1001/jamainternmed.2022.1657
Source DB: PubMed Journal: JAMA Intern Med ISSN: 2168-6106 Impact factor: 44.409
Figure 1. Flowchart of the Search, Selection, and Inclusion of the Studies
ACCORD BP indicates Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial; BP, blood pressure; CVD, cardiovascular disease; KM, Kaplan-Meier; SPRINT, Systolic Blood Pressure Intervention Trial.
Characteristics of Included Studies
| Characteristic | Original data | Reconstructed data | ||||
|---|---|---|---|---|---|---|
| SPRINT[ | ACCORD BP[ | Cardio-Sis[ | JATOS[ | VALISH[ | STEP[ | |
| No. of participants | 7398 | 2897 | 1111 | 4418 | 3079 | 8511 |
| Published date | 2015 | 2010 | 2009 | 2008 | 2010 | 2021 |
| Study population | Patients without diabetes | Patients with diabetes | Patients without diabetes | Mixed patient population | Mixed patient population | Mixed patient population |
| Site performed | North America | North America | Italy | Japan | Japan | China |
| Age, mean (range), y | 71.2 (60-90) | 66.8 (60-79) | 67 (>55) | 73.6 (65-85) | 76.1 (70-84) | 66.25 (60-80) |
| Women, No. (%) | 3332 (35.6) | 2258 (47.7) | 653 (58.8) | 2701 (61.1) | 1924 (62.5) | 4560 (53.6) |
| Mean baseline SBP, mm Hg | 139.8 | 140.4 | 163.3 | 171.6 | 169.6 | 146.1 |
| BP treatment goal, mm Hg | Intensive: SBP <120 vs standard: SBP <140 | Intensive: SBP <120 vs standard: SBP <140 | Intensive: SBP | Intensive: SBP <140 vs standard: SBP <160 | Intensive: SBP <140 vs standard: SBP <150 | Intensive: SBP <130 vs standard: SBP <150 |
| Achieved SBP, mm Hg | 121.4 vs 136.2 | 119.3 vs 133.5 | 131.9 vs 135.6 | 135.9 vs 145.6 | 136.6 vs 142.0 | 127.5 vs 135.3 |
| Average/median follow-up, y | 3.3 | 4.7 | 2.0 | 2.0 | 3.1 | 3.3 |
| HR (95% CI) of MACE | 0.78 (0.65-0.93) | 0.89 (0.71-1.10) | 0.50 (0.13-0.79) | NA (0.77-1.42) | 0.89 (0.60-1.31) | 0.74 (0.60-0.92) |
Abbreviations: ACCORD BP, Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial; BP, blood pressure; Cardio-Sis, Studio Italiano Sugli Effetti Cardiovascolari del Controllo della Pressione Arteriosa Sistolica; HR, hazard ratio; JATOS; Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients; MACE, major adverse cardiovascular events; NA, not available; SBP, systolic BP; SPRINT, Systolic Blood Pressure Intervention Trial; STEP, Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients; VALISH, Valsartan in Elderly Isolated Systolic Hypertension.
Patients younger than 60 years from the SPRINT (n = 1963) and ACCORD BP (n = 1836) studies were excluded in the current analysis.
Few patients aged 55 to 60 years were included.
The MACE definition for each study was listed (see eTable 2 in the Supplement).
The HR was calculated using the Cox model from limited-access SPRINT and ACCORD BP BioLINCC data sets.
The original article included only the CI.
Figure 2. Cumulative Incidence of Major Adverse Cardiovascular Events in the Standard and Intensive Blood Pressure Treatment Groups
Cumulative incidence and hazard ratios (HRs) (calculated by stratified Cox model) of primary event in the standard and intensive blood pressure treatment groups among total and different target systolic blood pressure (SBP) of intensive treatment strategy subgroups: total (A), target SBP less than 140 mm Hg (JATOS[27] and VALISH[28] studies) (B), target SBP less than 130 mm Hg (STEP[4] and Cardio-Sis[26] studies) (C), and target SBP less than 120 mm Hg (SPRINT[24] and ACCORD BP[25] studies) (D). ACCORD BP indicates Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial; Cardio-Sis, Studio Italiano Sugli Effetti Cardiovascolari del Controllo della Pressione Arteriosa Sistolica; JATOS; Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients; SPRINT, Systolic Blood Pressure Intervention Trial; STEP, Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients; VALISH, Valsartan in Elderly Isolated Systolic Hypertension.
Time to Benefit (Months) at Specific Thresholds of Absolute Risk Reduction
| Threshold | SPRINT[ | +ACCORD BP[ | +Cardio-Sis[ | +JATOS[ | +VALISH[ | +STEP[ |
|---|---|---|---|---|---|---|
| 0.002 | 17.1 (1.1-19.5) | 17.9 (1.9-29.9) | 11.5 (2.5-23.6) | 12.6 (3.1-26.4) | 12.3 (4.0-28.0) | 9.1 (4.0-20.6) |
| 0.005 | 23.0 (5.3-38.7) | 26.3 (11.2-49.4) | 19.1 (8.8-35.9) | 20.7 (10.3-41.2) | 21.7 (11.3-43.1) | 19.1 (10.9-34.2) |
| 0.01 | 31.3 (16.6-55.4) | 37.7 (22.6-69.7) | 29.6 (17.6-49.9) | 32.2 (19.7-60.4) | 35.3 (21.7-67.8) | 34.4 (22.7-59.8) |
Abbreviations: ACCORD BP, Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial; Cardio-Sis, Studio Italiano Sugli Effetti Cardiovascolari del Controllo della Pressione Arteriosa Sistolica; JATOS; Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients; SPRINT, Systolic Blood Pressure Intervention Trial; STEP, Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients; VALISH, Valsartan in Elderly Isolated Systolic Hypertension.
Each study is added in succession starting from left to right, and the time to benefit is re-estimated with the far-right column being the summary time to benefit after including all studies.
Time to Benefit (Months) in the Subgroups for the Different Thresholds
| Included studies | Study characteristics | Time to benefit (95% CI) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| SPRINT[ | ACCORD BP[ | Cardio-Sis[ | JATOS[ | VALISH[ | STEP[ | Subgroup | 0.002 | 0.005 | 0.01 |
|
| |||||||||
| Yes | No | Yes | Yes | Yes | Yes | Diabetes only | 8.8 (3.7-19.3) | 17.7 (10.1-31.3) | 31.2 (20.9-54.0) |
| Yes | Yes | No | Yes | Yes | Yes | Cardio-Sis | 11.1 (4.6-25.7) | 22.2 (12.5-41.8) | 38.7 (25.3-71.6) |
| Yes | Yes | Yes | No | No | Yes | Target SBP <140 mm Hg | 8.2 (3.4-19.6) | 17.1 (9.3-30.6) | 30.4 (19.7-49.3) |
| Yes | Yes | Yes | No | Yes | Yes | JATOS | 8.2 (3.6-19.4) | 17.8 (10.1-32.1) | 32.6 (21.4-53.6) |
| Yes | Yes | No | No | No | Yes | Kidney outcome | 10.6 (4.1-24.8) | 20.6 (11.1-37.5) | 35.3 (22.7-58.7) |
|
| |||||||||
| No | No | Yes | No | No | Yes | Target SBP <130 mm Hg | 2.2 (0.9-9.2) | 7.6 (3.3-23.5) | 20.4 (9.8-188.6) |
| Yes | Yes | No | No | No | No | Target SBP <120 mm Hg | 18.0 (1.9-30.0) | 26.3 (11.2-49.4) | 37.7 (22.6-69.7) |
| Yes | Yes | Yes | Yes | Yes | Yes | All trials | 9.1 (4.0-20.6) | 19.1 (10.9-34.2) | 34.4 (22.7-59.8) |
Abbreviations: ACCORD BP, Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial; Cardio-Sis, Studio Italiano Sugli Effetti Cardiovascolari del Controllo della Pressione Arteriosa Sistolica; JATOS; Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients; SBP, systolic blood pressure; SPRINT, Systolic Blood Pressure Intervention Trial; STEP, Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients; VALISH, Valsartan in Elderly Isolated Systolic Hypertension.
Few patients aged 55 to 60 years were included.
Usual care group with SBP target of less than 160 mm Hg.