Intensive versus standard blood pressure control in type 2 diabetes: a restricted mean survival time analysis of a randomised controlled trial

Sandra Shi, Natalia Gouskova, Mehdi Najafzadeh, Lee-Jen Wei, Dae Hyun Kim, Sandra Shi, Natalia Gouskova, Mehdi Najafzadeh, Lee-Jen Wei, Dae Hyun Kim

Abstract

Background: Restricted mean survival time analysis offers an intuitive and robust summary of treatment effect compared with HRs.

Objective: To examine the effect of intensive versus standard blood pressure (BP) control on death or cardiovascular events in type 2 diabetes.

Design: Secondary analysis of the Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial.

Setting: 77 sites in the USA and Canada.

Participants: 4733 adults with type 2 diabetes at high risk for cardiovascular events.

Interventions: Systolic BP target <120 mm Hg (n=2371) versus <140 mm Hg (n=2362).

Measurements: Composite endpoint of death, non-fatal myocardial infarction or non-fatal stroke.

Results: The mean event-free survival time over 5 years (1825 days) was similar between intensive and standard BP control (1716 vs 1714 days; mean difference, 1.3 (95% CI -18.1 to 20.7) days). However, intensive BP treatment was more beneficial for those assigned to standard glycaemic control (1725 vs 1697 days; mean difference, 28.1 (95% CI 0.4 to 55.9) days), but not for those assigned to intensive glycaemic control (1706 vs 1731 days; mean difference, -25.2 (95% CI -52.3 to 1.9) days) (p=0.008 for interaction). In subgroup analysis, the mean event-free survival time difference between intensive and standard BP treatment was -76.0 (95% CI -131.8 to -20.3) days for those with cognitive impairment and 21.8 (95% CI -24.0 to 67.5) days for those with normal cognitive function (p=0.008 for interaction). The effect was not different by age, sex and baseline cardiovascular disease status.

Conclusions: Intensive BP treatment may reduce death and cardiovascular events among patients with type 2 diabetes receiving standard glycaemic treatment and without cognitive impairment.

Trial registration number: NCT00000620; Post-results.

Keywords: diabetes & endocrinology; geriatric medicine; hypertension.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Kaplan-Meier curves by BP control group and glycaemic control group. (A) Standard glycaemic treatment; (B) intensive glycaemic treatment. The area shaded under the curves represent restricted mean survival time, blue line for standard BP control and red line for intensive BP control. Note that in (B) with the intensive glycaemic treatment cohort there is a violation of the proportional hazard assumption. BP, blood pressure.
Figure 2
Figure 2
RMST of blood pressure treatment strategy by subgroups. Differences in RMST, in days, for standard versus intensive blood pressure control, by subgroups. CVD, cardiovascular disease; MMSE, mini-mental status examination; RMST, restricted mean survival time.

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