Intensive blood pressure control to prevent major cardiovascular events in individuals with high-normal blood pressure (prehypertension): PRINT-TAHA9 randomized clinical trial

다국어 초록 (Multilingual Abstract)

Background: The optimal treatment for individuals with high-normal blood pressure (BP, systolic BP 130–139 mmHg and diastolic BP < 90 mmHg) is debated. This study evaluates whether pharmacologically reducing systolic BP to below 130 mmHg could prevent major adverse cardiovascular events (MACE) in high-normal BP cases with no comorbidities and 10-year atherosclerotic cardiovascular disease (ASCVD) risk ≥ 7.5%.
Methods: In this randomized, controlled, parallel, unicentric trial, participants were assigned to either an intervention group (pharmacotherapy plus diet control) or a control group (diet control only). The study aimed for 1,600 participants but was terminated after the first phase due to limited resources and recruitment challenges. Fixed-dose combinations of valsartan and amlodipine were administered as BP-lowering agents. Follow-up visits every 3 months adjusted pharmacotherapy to maintain systolic BP < 130 mmHg in the intervention group and < 140 mmHg in the control group. MACE was the primary endpoint, with its components (cardiovascular death, myocardial infarction, stroke, and heart failure) as secondary endpoints. Multivariable Cox regression analysis was utilized to compare the group endpoints.
Results: Of 14,562 screened individuals, 231 in the intervention and 235 in the control group were included in the final intention-to-treat analysis. At baseline, the control group had a slightly higher mean age than the intervention group (67.7 vs. 66.1 years; P = 0.013). Females comprised a minority in both groups (19.5% in intervention vs. 16.2% in control; P = 0.397). The mean 10-year ASCVD risk was slightly higher in the control group (17.4% vs. 15.9%; P = 0.013). The MACE occurred in 9 participants (1.57 per 100 person-year) in the intensive treatment group vs. 24 (4.16 per 100 person-year) in the control group (adjusted hazard ratio [aHR], 0.26; 95% confidence interval [CI], 0.11–0.62; P = 0.003). The incidence of serious adverse events (hypotension, syncope, injurious falls, electrolyte imbalances, or acute kidney injury) was similar between the groups (aHR, 1.47; 95% CI, 0.82–2.62; P = 0.195).
Conclusions: PRINT-TAHA9 findings suggest that pharmacological BP reduction may benefit healthy asymptomatic individuals with high-normal BP and ASCVD risk ≥ 7.5%.
Trial Registration: Iranian Registry of Clinical Trials Identifier: IRCT20191002044961N1