Balancing Benefit and Harm of Intensive Blood Pressure Lowering Based on Individual Outcome Profile Analysis.

backgroundIntensive blood pressure lowering prevents major adverse cardiovascular events, but some patients experience serious adverse events. Examining benefit-harm profiles may be more informative than analyzing major adverse cardiovascular events and serious adverse events separately.

methodsWe analyzed data from the Systolic Blood Pressure Intervention Trial (n = 9361), comparing intensive treatment (systolic blood pressure target <120 mm Hg) to standard treatment (<140 mm Hg). A 4-year hierarchical outcome profile was defined for each participant: 1) alive with neither major adverse cardiovascular events nor serious adverse events (most desirable); 2) alive with serious adverse events only; 3) alive with major adverse cardiovascular events only; 4) alive with both events; and 5) deceased (least desirable). We compared 4-year outcome profiles between the treatment groups in the entire population and by frailty subgroups defined using physical frailty phenotype (non-frail, pre-frail, and frail).

resultsThe proportion who died were lower with intensive treatment than standard treatment (5% vs 6%). A higher proportion of the intensive treatment group was alive with serious adverse events and no major adverse cardiovascular events (36% vs 33%), and a lower proportion were alive with both events (6% vs 5%) than the standard treatment group. The outcome profiles were more favorable among those with physical frailty phenotype who were treated with intensive treatment vs standard treatment, but outcome profiles were similar between the treatment groups among non-frail or pre-frail participants.

conclusionsThis post hoc proof-of-concept analysis demonstrates the utility of the outcome profile analysis that simultaneously examines the benefit and harm of the treatment.