Intensive Blood-Pressure Control in Patients with Previous Ischemic Stroke

BackgroundWhether intensive blood-pressure control reduces cardiovascular risk after cerebrovascular events remains uncertain. MethodsIn this multicenter, open-label, randomized trial conducted at 30 sites in Brazil, we assigned participants with elevated blood pressure and previous ischemic stroke or transient ischemic attack to receive intensive treatment targeting a systolic blood pressure of less than 120 mm Hg or to receive standard treatment targeting a systolic blood pressure of less than 140 mm Hg. The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina or heart failure. ResultsA total of 4368 participants were enrolled, with 2172 assigned to intensive treatment and 2196 to standard treatment. The mean (±SD) age of the participants was 63.9±11.2 years, and 2093 (47.9%) were women. During the follow-up period, excluding the first 3 months, the mean systolic blood pressure was 122.0±11.5 mm Hg (median, 119.6 mm Hg) in the intensive-treatment group and 135.2±9.7 mm Hg (median, 135.0 mm Hg) in the standard-treatment group, with a between-group mean difference of 13.1 mm Hg (95% confidence interval [CI], 12.5 to 13.8). Over a median follow-up of 3.9 years, a primary-outcome event occurred in 236 participants (10.9%; 3.25 events per 100 person-years) with intensive treatment and in 297 (13.5%; 4.11 events per 100 person-years) with standard treatment (hazard ratio, 0.79; 95% CI, 0.67 to 0.94; P=0.007). The composite renal outcome (sustained reduction of ≥50% in the estimated glomerular filtration rate or progression to end-stage renal disease) was more common with intensive treatment. The overall incidence of serious adverse events was similar in the two groups. ConclusionsAmong participants with previous ischemic stroke or transient ischemic attack, targeting a systolic blood pressure of less than 120 mm Hg resulted in a lower incidence of major cardiovascular events than targeting a systolic blood pressure of less than 140 mm Hg. (Funded by Hospital Israelita Albert Einstein and the Brazilian Ministry of Health; OPTIMAL-STROKE ClinicalTrials.gov number, NCT04036409.)

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Journal
New England Journal of Medicine
Published
2026-11-07
DOI
https://doi.org/10.1056/nejmoa2612924
Primary Topic
Blood Pressure and Hypertension Studies
Type
article
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article

Intensive Blood-Pressure Control in Patients with Previous Ischemic Stroke

Rubens José Gagliardi, Silvia Regina Lamas Assis, Eva Carolina Andrade Rocha, Maria Julia Machline-Carrion et al.
2 links
New England Journal of Medicine
Blood Pressure and Hypertension Studies
article

Intensive Blood-Pressure Control in Patients with Previous Ischemic Stroke

Rubens José Gagliardi, Silvia Regina Lamas Assis, Eva Carolina Andrade Rocha, Maria Julia Machline-Carrion, Fabrício Oliveira Lima, Luiz Aparecido Bortolotto, Patrícia O. Guimarães, Carla Heloísa Cabral Moro, Adriana Bastos Conforto, Audes D. M. Feitosa, Gladys Lentz Martins, Anthony Rodgers, Karla Santo, Flávio Danni Fuchs, Otavio B Berwanger, Luciano F. Drager, Sheila Cristina Ouriques Martins, Murillo de Oliveira Antunes, Eduardo Bello Martins, Paul Kieran Whelton, João Brainer Clares de Andrade, Viviane De Hiroki Flumignan Zétola, Odílson Marcos Silvestre, César Minelli, Frederico Monfardini, Sandra Cristina Pereira Costa Fuchs, José Fernando Vilela-Martin, Jamary Oliveira‐Filho, Rodrigo Bazán, Leonardo Augusto Carbonera, Lília Nigro Maia, Gabriel Pereira Braga, Letícia Costa Rebello, Josué Nieri, Caio A.M. Tavares, Octávio Marques Pontes Neto, Wagner Avelar, Gisele Sampaio Silva, Ricardo Pereira Silva, Marcio Gonçalves Sousa
article en

Abstract

BackgroundWhether intensive blood-pressure control reduces cardiovascular risk after cerebrovascular events remains uncertain. MethodsIn this multicenter, open-label, randomized trial conducted at 30 sites in Brazil, we assigned participants with elevated blood pressure and previous ischemic stroke or transient ischemic attack to receive intensive treatment targeting a systolic blood pressure of less than 120 mm Hg or to receive standard treatment targeting a systolic blood pressure of less than 140 mm Hg. The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina or heart failure. ResultsA total of 4368 participants were enrolled, with 2172 assigned to intensive treatment and 2196 to standard treatment. The mean (±SD) age of the participants was 63.9±11.2 years, and 2093 (47.9%) were women. During the follow-up period, excluding the first 3 months, the mean systolic blood pressure was 122.0±11.5 mm Hg (median, 119.6 mm Hg) in the intensive-treatment group and 135.2±9.7 mm Hg (median, 135.0 mm Hg) in the standard-treatment group, with a between-group mean difference of 13.1 mm Hg (95% confidence interval [CI], 12.5 to 13.8). Over a median follow-up of 3.9 years, a primary-outcome event occurred in 236 participants (10.9%; 3.25 events per 100 person-years) with intensive treatment and in 297 (13.5%; 4.11 events per 100 person-years) with standard treatment (hazard ratio, 0.79; 95% CI, 0.67 to 0.94; P=0.007). The composite renal outcome (sustained reduction of ≥50% in the estimated glomerular filtration rate or progression to end-stage renal disease) was more common with intensive treatment. The overall incidence of serious adverse events was similar in the two groups. ConclusionsAmong participants with previous ischemic stroke or transient ischemic attack, targeting a systolic blood pressure of less than 120 mm Hg resulted in a lower incidence of major cardiovascular events than targeting a systolic blood pressure of less than 140 mm Hg. (Funded by Hospital Israelita Albert Einstein and the Brazilian Ministry of Health; OPTIMAL-STROKE ClinicalTrials.gov number, NCT04036409.)

New England Journal of Medicine
Tulane University (US), Universidade Federal de Mato Grosso do Sul (BR), Faculdade de Medicina de São José do Rio Preto (BR), Universidade de São Paulo (BR), Universidade Estadual de Campinas (UNICAMP) (BR), The George Institute for Global Health (GB), Hospital Israelita Albert Einstein (BR), Hospital de Base (BR), Hospital Moinhos de Vento (BR), Complexo Hospitalar Universitário Professor Edgard Santos (BR), Hospital de Clínicas de Porto Alegre (BR), Hospital Universitário Walter Cantídio (BR), The George Institute for Global Health (AU), Hospital de Clínicas Universidade Federal do Paraná (BR), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (BR), Instituto Dante Pazzanese de Cardiologia (BR), Hospital de Base (BR), Governador Celso Ramos Hospital (BR), Hospital Geral de Fortaleza (BR), Instituto do Coração - HCFMUSP (BR), Imperial College London (GB), Universidade de Pernambuco (BR), Universidade Estadual Paulista (Unesp) (BR), Universidade Federal de São Paulo (BR)
Ministério da Saúde
Good health and well-being
Openalex Percentile: Top 13%
Blood Pressure and Hypertension Studies
DOISourceOpenAlex
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