European Journal of Cardiovascular Medicine

Hypertension is a leading modifiable risk factor for cardiovascular disease (CVD) and mortality globally. Despite advances in pharmacologic therapies, optimal blood pressure targets in high-risk hypertensive individuals remain controversial. While traditionally a systolic blood pressure (SBP) target of <140 mmHg has been the standard, recent studies such as the SPRINT trial have raised the possibility that more intensive control (SBP <120 mmHg) may yield superior cardiovascular outcomes.

This study aims to evaluate the comparative effectiveness of intensive versus standard blood pressure control in reducing major cardiovascular events in patients with hypertension and elevated cardiovascular risk.

Study Design and Participants

This was a prospective, randomized, open-label, blinded-endpoint (PROBE) multicenter clinical trial conducted from January 2018 to December 2022. Eligible participants were adults aged ≥50 years with SBP between 130–180 mmHg and at least one additional cardiovascular risk factor (e.g., chronic kidney disease, clinical/subclinical CVD, or elevated Framingham risk score).

Key exclusion criteria included diabetes mellitus, history of stroke, or symptomatic heart failure.

Randomization and Interventions

Participants (n=2,500) were randomized 1:1 to either:

• Intensive BP Control Group: Target SBP <120 mmHg
• Standard BP Control Group: Target SBP <140 mmHg

Antihypertensive regimens were tailored using ACE inhibitors, diuretics, calcium channel blockers, and beta-blockers as needed. BP measurements followed AHA recommendations using automated office BP monitoring.

Outcomes

The primary endpoint was a composite of:

• Nonfatal myocardial infarction (MI)
• Acute coronary syndrome (ACS) not resulting in MI
• Stroke
• Hospitalization for heart failure
• Cardiovascular death

Secondary endpoints included all-cause mortality, decline in renal function, and serious adverse events (SAEs).

Statistical Analysis

Kaplan-Meier estimates were used to assess time-to-event outcomes. Cox proportional hazards models adjusted for baseline characteristics calculated hazard ratios (HR) and 95% confidence intervals (CI). A p-value <0.05 was considered statistically significant.

Baseline Characteristics

Table 1: Baseline Characteristics

Table 2: Achieved Blood Pressure

Table 3: Primary Outcome Events

Table 4: Serious Adverse Events

Table 5: Hazard Ratios for Key Outcomes

Both groups were well matched at baseline:

Blood Pressure Achieved

• Intensive group: Mean SBP 121.4 mmHg (±2.9)
• Standard group: Mean SBP 136.2 mmHg (±3.2)

Primary Outcome

After a median follow-up of 4.5 years:

• Intensive group: 60 primary events (4.8%)
• Standard group: 86 primary events (6.9%)

HR: 0.68 (95% CI, 0.54–0.85; p< 0.001)

Secondary Outcomes

• All-cause mortality: Lower in intensive group (HR 0.78; p=0.03)
• Serious Adverse Events:
• Hypotension: 3.2% vs 1.0%
• Syncope: 1.9% vs 0.7%
• Acute kidney injury: 2.4% vs 1.1%

This study supports intensive BP control as more effective than standard treatment in reducing major cardiovascular events in high-risk hypertensive patients. The magnitude of benefit is consistent with prior large trials, including SPRINT. However, the increased risk of adverse events must be carefully weighed, particularly in older or frail patients.

The findings argue for a personalized approach: while intensive control reduces cardiovascular risk, it may not be suitable for all, especially those with pre-existing renal compromise or risk of falls.

Limitations include exclusion of diabetic patients and a relatively short follow-up period for assessing long-term renal outcomes.

Intensive blood pressure control to a target SBP <120 mmHg significantly reduces cardiovascular events in hypertensive patients at high risk. However, it is associated with higher adverse event rates, emphasizing the need for individualized treatment decisions based on patient risk profiles.

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