BackgroundAmong older adults with frailty, evidence on the benefits and risks of discontinuing antihypertensive drugs is limited.MethodsIn a multicenter, randomized, controlled trial conducted in France, we assigned, in a 1:1 ratio, nursing home residents 80 years of age or older who were receiving more than one antihypertensive drug and had a systolic blood pressure below 130 mm Hg to a protocol-driven strategy of progressive reduction of antihypertensive treatment (step-down group) or to receive usual care (usual-care group). Patients were to be followed for up to 4 years. The primary end point was death from any cause. Secondary end points included the changes in the number of antihypertensive drugs being used from baseline to the last trial visit and the change in systolic blood pressure during the follow-up period.ResultsA total of 1048 patients underwent randomization: 528 to the step-down group and 520 to the usual-care group. The estimated median potential follow-up was 38.4 months. Between baseline and the last trial visit, the mean (±SD) number of antihypertensive drugs being used decreased from 2.6±0.7 to 1.5±1.1 in the step-down group and from 2.5±0.7 to 2.0±1.1 in the usual-care group. The adjusted mean between-group difference (step-down group minus usual-care group) in the change in systolic blood pressure during the follow-up period was 4.1 mm Hg (95% confidence interval [CI], 1.9 to 5.7). Death from any cause occurred in 326 patients (61.7%) in the step-down group and in 313 (60.2%) in the usual-care group (adjusted hazard ratio, 1.02; 95% CI, 0.86 to 1.21; P=0.78). There were no apparent differences in adverse events between the trial groups.ConclusionsAmong older nursing home residents with frailty who were receiving treatment with antihypertensive agents and had a systolic blood pressure below 130 mm Hg, an antihypertensive treatment step-down strategy did not lead to lower all-cause mortality than usual care. (Funded by the French Ministry of Health and others; RETREAT-FRAIL ClinicalTrials.gov number, NCT03453268.)