Abstract

Introduction: The primary finding of the Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated that intensive (IT, <120 mmHg) compared to standard (<140 mmHg) blood pressure (BP) treatment on an index serious adverse event (SAE), injurious falls, was similar. However, mortality after the index fall has not been well studied. We hypothesized that the occurrence of falls may be associated with reduced mortality benefits. Methods: Using the publicly available SPRINT dataset we analyzed the association of IT on the primary outcome of all-cause mortality and the secondary outcome of non-cardiovascular (CV) mortality as a function of falls. Results: Among 9,361 SPRINT participants, 7.1% (n=666) had a fall. Falls were more likely in older adults (p<0.0001), among women (45.9% vs 34.8%), and those with baseline cardiovascular disease (20.3% vs 16.4%). Among those who fell, 7.8% (52/666) died which was 14.2% of all deaths in SPRINT (52/365). In those who fell, mortality increased with age (p<0.0001) and was highest in those ≥ 80 years (13.7%, Figure ). For all-cause mortality- Falls independently and significantly were associated with increased risk (HR 1.41,1.04-1.91, p=0.03 ) while IT significantly decreased the risk (HR 0.73, 0.60-0.91, p=0.004) . The joint effect (IT+Fall) demonstrated a non-significant increased risk (HR 1.03, 0.56-1.88, p int =0.92). For non-CV mortality- Falls independently and significantly were associated with increased risk (HR 1.63, 1.16-2.29, p=0.005) while IT did not significantly lower risk (HR 0.81, 0.63-1.03, p=0.09) . The joint effect (IT+Fall) demonstrated a non-significant increased risk (HR 1.21, 0.63-2.35, p int =0.56). Conclusions: Our findings suggest that current reporting of potential harm of the treatment effects of IT, measured by the index SAE, may underrepresent true risk and overstate treatment benefits.

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