Associations of Early Systolic Blood Pressure Control and Outcome After Thrombolysis-Eligible Acute Ischemic Stroke: Results From the ENCHANTED Study
In thrombolysis-eligible patients with acute ischemic stroke, there is uncertainty over the most appropriate systolic blood pressure (SBP) lowering profile that provides an optimal balance of potential benefit (functional recovery) and harm (intracranial hemorrhage). We aimed to determine relationsh...
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| Published in | Stroke (1970) Vol. 53; no. 3; pp. 779 - 787 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Lippincott Williams & Wilkins
01.03.2022
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| Subjects | |
| Online Access | Get full text |
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| Abstract | In thrombolysis-eligible patients with acute ischemic stroke, there is uncertainty over the most appropriate systolic blood pressure (SBP) lowering profile that provides an optimal balance of potential benefit (functional recovery) and harm (intracranial hemorrhage). We aimed to determine relationships of SBP parameters and outcomes in thrombolyzed acute ischemic stroke patients.
Post hoc analyzes of the ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study), a partial-factorial trial of thrombolysis-eligible and treated acute ischemic stroke patients with high SBP (150-180 mm Hg) assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) alteplase and intensive (target SBP, 130-140 mm Hg) or guideline-recommended (target SBP <180 mm Hg) treatment. All patients were followed up for functional status and serious adverse events to 90 days. Logistic regression models were used to analyze 3 SBP summary measures postrandomization: attained (mean), variability (SD) in 1-24 hours, and magnitude of reduction in 1 hour. The primary outcome was a favorable shift on the modified Rankin Scale. The key safety outcome was any intracranial hemorrhage.
Among 4511 included participants (mean age 67 years, 38% female, 65% Asian) lower attained SBP and smaller SBP variability were associated with favorable shift on the modified Rankin Scale (per 10 mm Hg increase: odds ratio, 0.76 [95% CI, 0.71-0.82];
<0.001 and 0.86 [95% CI, 0.76-0.98];
=0.025) respectively, but not for magnitude of SBP reduction (0.98, [0.93-1.04];
=0.564). Odds of intracranial hemorrhage was associated with higher attained SBP and greater SBP variability (1.18 [1.06-1.31];
=0.002 and 1.34 [1.11-1.62];
=0.002) but not with magnitude of SBP reduction (1.05 [0.98-1.14];
=0.184).
Attaining early and consistent low levels in SBP <140 mm Hg, even as low as 110 to 120 mm Hg, over 24 hours is associated with better outcomes in thrombolyzed acute ischemic stroke patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01422616. |
|---|---|
| AbstractList | Background and Purpose:
In thrombolysis-eligible patients with acute ischemic stroke, there is uncertainty over the most appropriate systolic blood pressure (SBP) lowering profile that provides an optimal balance of potential benefit (functional recovery) and harm (intracranial hemorrhage). We aimed to determine relationships of SBP parameters and outcomes in thrombolyzed acute ischemic stroke patients.
Methods:
Post hoc analyzes of the ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study), a partial-factorial trial of thrombolysis-eligible and treated acute ischemic stroke patients with high SBP (150–180 mm Hg) assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) alteplase and intensive (target SBP, 130–140 mm Hg) or guideline-recommended (target SBP <180 mm Hg) treatment. All patients were followed up for functional status and serious adverse events to 90 days. Logistic regression models were used to analyze 3 SBP summary measures postrandomization: attained (mean), variability (SD) in 1–24 hours, and magnitude of reduction in 1 hour. The primary outcome was a favorable shift on the modified Rankin Scale. The key safety outcome was any intracranial hemorrhage.
Results:
Among 4511 included participants (mean age 67 years, 38% female, 65% Asian) lower attained SBP and smaller SBP variability were associated with favorable shift on the modified Rankin Scale (per 10 mm Hg increase: odds ratio, 0.76 [95% CI, 0.71–0.82];
P
<0.001 and 0.86 [95% CI, 0.76–0.98];
P
=0.025) respectively, but not for magnitude of SBP reduction (0.98, [0.93–1.04];
P
=0.564). Odds of intracranial hemorrhage was associated with higher attained SBP and greater SBP variability (1.18 [1.06–1.31];
P
=0.002 and 1.34 [1.11–1.62];
P
=0.002) but not with magnitude of SBP reduction (1.05 [0.98–1.14];
P
=0.184).
Conclusions:
Attaining early and consistent low levels in SBP <140 mm Hg, even as low as 110 to 120 mm Hg, over 24 hours is associated with better outcomes in thrombolyzed acute ischemic stroke patients.
Registration:
URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT01422616. BACKGROUND AND PURPOSEIn thrombolysis-eligible patients with acute ischemic stroke, there is uncertainty over the most appropriate systolic blood pressure (SBP) lowering profile that provides an optimal balance of potential benefit (functional recovery) and harm (intracranial hemorrhage). We aimed to determine relationships of SBP parameters and outcomes in thrombolyzed acute ischemic stroke patients. METHODSPost hoc analyzes of the ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study), a partial-factorial trial of thrombolysis-eligible and treated acute ischemic stroke patients with high SBP (150-180 mm Hg) assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) alteplase and intensive (target SBP, 130-140 mm Hg) or guideline-recommended (target SBP <180 mm Hg) treatment. All patients were followed up for functional status and serious adverse events to 90 days. Logistic regression models were used to analyze 3 SBP summary measures postrandomization: attained (mean), variability (SD) in 1-24 hours, and magnitude of reduction in 1 hour. The primary outcome was a favorable shift on the modified Rankin Scale. The key safety outcome was any intracranial hemorrhage. RESULTSAmong 4511 included participants (mean age 67 years, 38% female, 65% Asian) lower attained SBP and smaller SBP variability were associated with favorable shift on the modified Rankin Scale (per 10 mm Hg increase: odds ratio, 0.76 [95% CI, 0.71-0.82]; P<0.001 and 0.86 [95% CI, 0.76-0.98]; P=0.025) respectively, but not for magnitude of SBP reduction (0.98, [0.93-1.04]; P=0.564). Odds of intracranial hemorrhage was associated with higher attained SBP and greater SBP variability (1.18 [1.06-1.31]; P=0.002 and 1.34 [1.11-1.62]; P=0.002) but not with magnitude of SBP reduction (1.05 [0.98-1.14]; P=0.184). CONCLUSIONSAttaining early and consistent low levels in SBP <140 mm Hg, even as low as 110 to 120 mm Hg, over 24 hours is associated with better outcomes in thrombolyzed acute ischemic stroke patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01422616. In thrombolysis-eligible patients with acute ischemic stroke, there is uncertainty over the most appropriate systolic blood pressure (SBP) lowering profile that provides an optimal balance of potential benefit (functional recovery) and harm (intracranial hemorrhage). We aimed to determine relationships of SBP parameters and outcomes in thrombolyzed acute ischemic stroke patients. Post hoc analyzes of the ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study), a partial-factorial trial of thrombolysis-eligible and treated acute ischemic stroke patients with high SBP (150-180 mm Hg) assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) alteplase and intensive (target SBP, 130-140 mm Hg) or guideline-recommended (target SBP <180 mm Hg) treatment. All patients were followed up for functional status and serious adverse events to 90 days. Logistic regression models were used to analyze 3 SBP summary measures postrandomization: attained (mean), variability (SD) in 1-24 hours, and magnitude of reduction in 1 hour. The primary outcome was a favorable shift on the modified Rankin Scale. The key safety outcome was any intracranial hemorrhage. Among 4511 included participants (mean age 67 years, 38% female, 65% Asian) lower attained SBP and smaller SBP variability were associated with favorable shift on the modified Rankin Scale (per 10 mm Hg increase: odds ratio, 0.76 [95% CI, 0.71-0.82]; <0.001 and 0.86 [95% CI, 0.76-0.98]; =0.025) respectively, but not for magnitude of SBP reduction (0.98, [0.93-1.04]; =0.564). Odds of intracranial hemorrhage was associated with higher attained SBP and greater SBP variability (1.18 [1.06-1.31]; =0.002 and 1.34 [1.11-1.62]; =0.002) but not with magnitude of SBP reduction (1.05 [0.98-1.14]; =0.184). Attaining early and consistent low levels in SBP <140 mm Hg, even as low as 110 to 120 mm Hg, over 24 hours is associated with better outcomes in thrombolyzed acute ischemic stroke patients. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01422616. |
| Author | Donnan, Geoffrey A. Minhas, Jatinder S. Chen, Guofang Wang, Ji-Guang Moullaali, Tom J. Robinson, Thompson G. Sharma, Vijay K. Lavados, Pablo M. Thang, Nguyen H. Levi, Christopher Chen, Xiaoying Song, Lili Broderick, Joseph P. Martins, Sheila O. Lindley, Richard I. Woodward, Mark Luca Di Tanna, Gian Bath, Philip M. Demchuk, Andrew M. Sato, Shoichiro Chalmers, John Lee, Tsong-Hai Delcourt, Candice Durham, Alice C. Ricci, Stefano Pontes-Neto, Octavio M. Silva, Federico Pandian, Jeyaraj D. Parsons, Mark W. Anderson, Craig S. Olavarria, Veronica V. Wang, Xia Arima, Hisatomi |
| AuthorAffiliation | Stroke Trials Unit, School of Medicine, University of Nottingham, United Kingdom (P.M.B.) Department of Neurology, Xuzhou Central Hospital, China (G.C.) Stroke Division of Neurology Service, Hospital de Clinicas de Porto Alegre, University of Rio Grande do Sul, Porto Alegre, Brazil (S.O.M.) Yong Loo Lin School of Medicine, National University of Singapore and Division of Neurology, National University Hospital (V.K.S.) Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Canada (A.M.D.) Melbourne Brain Centre, Royal Melbourne Hospital (G.A.D.), University of Melbourne, Victoria, Australia Department of Neurosciences and Behavioral Sciences, University of Sao Paulo, Ribeirao Preto Medical School, Brazil (O.M.P.-N.) Shanghai Institute for Hypertension, Rui Jin Hospital and Shanghai Jiaotong University School of Medicine, China (J.-G.W.) Department of Neurology, Christian Medical College, Ludhiana, Punjab, India (J.D.P. |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34702064$$D View this record in MEDLINE/PubMed |
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| PublicationTitle | Stroke (1970) |
| PublicationTitleAlternate | Stroke |
| PublicationYear | 2022 |
| Publisher | Lippincott Williams & Wilkins |
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| References | e_1_3_2_26_2 e_1_3_2_27_2 e_1_3_2_28_2 e_1_3_2_29_2 Royal college of physicians intercollegiate stroke working party (e_1_3_2_5_2) e_1_3_2_20_2 e_1_3_2_21_2 e_1_3_2_22_2 e_1_3_2_23_2 e_1_3_2_24_2 e_1_3_2_25_2 e_1_3_2_9_2 e_1_3_2_15_2 e_1_3_2_8_2 e_1_3_2_16_2 e_1_3_2_7_2 e_1_3_2_17_2 e_1_3_2_6_2 e_1_3_2_18_2 e_1_3_2_19_2 e_1_3_2_10_2 e_1_3_2_11_2 e_1_3_2_4_2 e_1_3_2_12_2 e_1_3_2_3_2 e_1_3_2_13_2 e_1_3_2_2_2 e_1_3_2_14_2 |
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| Snippet | In thrombolysis-eligible patients with acute ischemic stroke, there is uncertainty over the most appropriate systolic blood pressure (SBP) lowering profile... Background and Purpose: In thrombolysis-eligible patients with acute ischemic stroke, there is uncertainty over the most appropriate systolic blood pressure... BACKGROUND AND PURPOSEIn thrombolysis-eligible patients with acute ischemic stroke, there is uncertainty over the most appropriate systolic blood pressure... |
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| SubjectTerms | Aged Aged, 80 and over Blood Pressure Humans Hypertension - complications Hypertension - physiopathology Hypertension - therapy Intracranial Hemorrhages - chemically induced Intracranial Hemorrhages - prevention & control Ischemic Stroke - etiology Ischemic Stroke - physiopathology Ischemic Stroke - therapy Middle Aged Prospective Studies Thrombolytic Therapy Tissue Plasminogen Activator - administration & dosage Tissue Plasminogen Activator - adverse effects |
| Title | Associations of Early Systolic Blood Pressure Control and Outcome After Thrombolysis-Eligible Acute Ischemic Stroke: Results From the ENCHANTED Study |
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