Is intensive blood pressure strategy effective and safe in patients with cardiovascular disease? The two sides of the coin

Abstract Background/Lntroduction Recent data advocate the adoption of a more intensive treatment strategy for the management of blood pressure (BP). Purpose We sought to investigate whether the overall effects of the Systolic Blood Pressure Intervention Trial (SPRINT) are applicable to cardiovascular disease (CVD) patients. Methods In the present post-hoc analysis we analyzed data from SPRINT that randomly assigned 9361 individuals to systolic blood pressure (SBP) target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). 1562 patients had clinically evident CVD (age=70.3±9.3 years, 24% females) at study entry and were followed for 3.1 years. Further, we assessed the effect of low (<150 mm Hg) baseline SBP on clinical endpoints. Results In CVD patients, there was no benefit from the intensive treatment regarding all endpoints, except for a marginally significant benefit on all-cause mortality (hazard ratio [HR]: 0.67; 95% confidence interval [CI], 0.45 to 1.00; P=0.0509) (Figure). Further, while there was no increase in serious adverse events (SAE) in the intensive group, there was an increased HR for study-related SAE in the intensive management group (HR: 2.00; 95% CI: 1.22 to 3.26; p=0.006), a greater incidence of acute renal failure (HR: 1.57; 95% CI: 1.01 to 2.44; P=0.044), electrolyte abnormalities (HR: 1.77; 95% CI: 1.03 to 3.02; P=0.038) and specifically hyponatremia (HR: 2.24; 95% CI: 1.13 to 4.46; p=0.021). In patients with low baseline SBP there was a beneficial effect on all-cause mortality (HR: 0.56; 95% CI: 0.33 to 0.96; P=0.033), but with greater stroke incidence (HR: 2.94; 95% CI: 1.04 to 8.29; P=0.042). As far as adverse events are concerned, patients with SBP<150 mm Hg had increased risk only for study-related SAE and electrolyte abnormalities. Survival curves for the main endpoints Conclusions We confirm the beneficial effect of the intensive strategy in SPRINT study on all-cause mortality and the harmful effect on other than serious adverse outcomes in patients with CVD. However, in patients with low baseline SBP stroke increases. Acknowledgement/Funding This manuscript was prepared using SPRINT_POP Research Materials obtained from the National Heart, Lung, and Blood Institute