Abstract 502: Effect of Intensive Versus Standard Blood Pressure Control on Stroke and Serious Adverse Event: A Bivariate Analysis on the Net Clinical Benefit

Abstract

Background: Intensive blood pressure (BP) control is associated with a reduced risk of stroke but a greater risk of serious adverse event (SAE), thereby offsetting the benefit-to-risk ratio of this strategy. Methods: Using a previously described method of bivariate analysis, efficacy and safety outcomes were collectively analyzed as net clinical benefit (NCB) based on data from three randomized controlled trials comparing intensive versus standard BP control among 17,115 patients (ACCORD, SPS3, and SPRINT trials). Bivariate risk difference was assessed by the minimum distance from NCB curve to 95% CI of risk difference in all-cause stroke and SAE. Results: Compared to standard BP target, intensive strategies reduced all-cause stroke by 0.70% (95% CI: 0.19% to 1.21%; P = 0.007) and increased SAE by 1.85% (95% CI: 1.35% to 2.34%; P < 0.0001). With a non-inferiority margin of 25%, standard strategy was preferable with respect to NCB in diabetics (bivariate risk difference: 1.29% [0.40% to 2.31%]) and in patients without diabetes or prior stroke (1.55% [0.76% to 2.37%]). Among patients with stroke history, intensive strategy failed to achieve non-inferiority in NCB (-0.18% [-1.01% to 0.83%]). Conclusions: Bivariate analysis is a novel method that allows simultaneous display and assessment of efficacy and safety outcomes. Among patients with cardiovascular risk factors, intensive BP control failed to demonstrate a favorable risk-benefit profile against standard BP control with respect to the tradeoff between stroke and SAE. Figure 1. Net clinical benefit of intensive vs standard BP control Figure 2. Forest plot of bivariate risk difference in stroke and SAE