Evaluating intensive blood pressure control versus usual care on cardiovascular disease in patients with diabetes using win statistics: a subgroup analysis of a cluster randomized trial

Introduction

Elevated arterial pressure constitutes a significant controllable risk element associated with detrimental outcomes in cardiovascular health. In comparison to standard blood pressure (BP) control (target level: <140/90 mmHg), intensive blood pressure management aimed at achieving lower target values has demonstrated superior efficacy in diminishing the incidence of negative cardiovascular occurrences. However, there is still controversy over intensifying blood pressure control in diabetic individuals.

Objectives

Assessing the viability and efficacy of stringent blood pressure regulation in diabetic patients with hypertension.

Methods

A post hoc analysis of disaggregated data from 33,995 hypertensive patients enrolled in the China Rural Hypertension Control Project (CRHCP) trial was performed. Outcomes were evaluated using the unmatched win ratio (win ratio >1.00 indicating better outcomes) and compared with the Cox model. The principal endpoint was the occurrence of major adverse cardiovascular events (MACE), encompassing myocardial infarction, stroke, hospitalization due to heart failure, or cardiovascular mortality, over a three-year follow-up period.

Results

The analysis included 6303 adults with hypertension and diabetes (mean age 63.2 years; 2172 men). At the three-year mark, the average systolic/diastolic blood pressure measured 126.7/72.5 mmHg in the intensive blood pressure control cohort, in contrast to 147.7/80.6 mmHg in the standard care group. Intensive blood pressure management lowered the yearly incidence of major adverse cardiovascular events (MACE, 2.28 % compared to 3.28 %; HR: 1.45; 95 % CI: 1.20–1.72; P < 0.001), strokes (HR: 1.47; 95 % CI: 1.20–1.82; P = 0.015), and deaths from cardiovascular causes (HR: 1.49; 95 % CI: 1.04–2.13; P = 0.029). Symptomatic hypotension rates were similar (0.77 % vs. 0.52 %; P = 0.231). Hierarchical analysis showed more wins (31021 [8.62 %]) than losses (23985 [5.84 %]), with a win ratio of 1.46 (95 % CI: 1.22–1.76; P < 0.001). After 36 months, the mean fasting blood glucose (FBG) in the group with intensified blood pressure control was modestly elevated (9.09 mmol/L compared to 8.51 mmol/L; difference: 0.58 mmol/L; 95 % CI: 0.34–0.81; P < 0.001).

Conclusion

Intensive BP controlled by non-physician community healthcare providers reduced incident cardiovascular diseases in hypertensive patients with comorbid diabetes but was associated with an elevation of FBG.Registration: The trial is listed on ClinicalTrials.gov under the identifier NCT03527719.