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  • ISSN: 2334-2307
    J Neurol Disord Stroke 1(2): 1016.
    Submitted: 18 August 2013; Accepted: 13 September 2013; Published: 13 September 2013
    Research Article
    Level of Acute Blood Pressure may Influence Long Term Outcome in Ischemic Stroke Patients: A Prospective Observational Study in a Stroke Unit Setting
    Fabio Pilato1*, Rosalinda Calandrelli2, Marisa Distefano1, Paolo Profice1, Valeria Alicino1, Valentina Tumino2, and Vincenzo Di Lazzaro3
    1Institute of Neurology, Università Cattolica, L. go A. Gemelli 8, 00168 Rome, Italy
    2Institute of Radiology, Università Cattolica, L. go A. Gemelli 8, 00168 Rome, Italy
    3Università Campus Bio-Medico di Roma, via Álvaro del Portillo 200, 00128, Rome, Italy
    *Corresponding author: Michael J. Lyerly, University of Alabama at Birmingham Stroke Program, Department of Neurology, 1813 6th Avenue South, RWUH M226, Birmingham, AL, 35294, USA, Tel: 205-934-2401, Fax: 205-975-6785; Email: mjlyerly@uab.edu
    Abstract
    Arterial blood pressure is a known risk factor for cardiovascular and cerebrovascular diseases and it is the most important for stroke prevention. On the basis of the current evidence from multiple trials, it is recommended that antihypertensive therapy be introduced for all subjects with confirmed hypertension to reduce cardio- and cerebrovascular risk, but there is no consensus about level that should be maintained and management of blood pressure in acute stroke patients. Current guidelines suggest that in acute stroke patients, high pressure should be reduced only for very high values. The aim of this study was to evaluate in acute stroke patients whether different levels of acute systolic blood pressure might influence long term outcome. We performed an observational prospective study in patients hospitalized in stroke unit within 24 hours from stroke onset. Patients were monitored from the admittance to the discharge and non-invasive blood pressure was recorded every 4 hours for a total of 6 measurements a day. Functional stroke scales were administrated daily during hospitalization and at each follow up visit. Patients were collected in 3 pre-established groups on the basis of acute systolic blood pressure values recorded in the first day. 138 patients were enrolled. Patients were collected in following 3 groups: low (<130 mmHg), moderate (between 130 and 160 mmHg) and high (higher than 160 mmHg) accordingly to mean of systolic blood pressure. We found that in high-level group long term recovery assessed at 6-month follow up visit by mean of modified Rankin Scale score was significantly better than in other groups. This study suggests that levels of systolic blood pressure, in acute stage of stroke, might influence long term outcome and although these data are not conclusive we believe that a clinical trial would be warranted to evaluate this hypothesis in a larger population.
    Keywords: Stroke; Blood pressure; Hypertension; MRI; NIHSS; Modified ranking scale; Recovery
    Introduction
    Arterial blood pressure is a known risk factor for cardiovascular and cerebrovascular diseases [1-3]. Chronic elevated blood pressure (BP) as defined by World Health Organization and International Society of Hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg) is established as the most prevalent modifiable risk factor for stroke and large-scale observational studies have demonstrated that BP values are positively and continuously associated with the risk of stroke in a log-linear fashion [4]. On the basis of evidence from multiple trials all current guidelines suggest to lower high blood pressure within normal values in all subjects and chronic antihypertensive therapy should be recommended for patients with confirmed hypertension [1,2]. In acute stroke patients things may be different. First of all, acute compensatory hypertension could be noted, also in normal blood pressure subjects, and elevated blood pressure values are present in up to 80% of patients with acute stroke [3,5]. On the other hand, increased BP in the acute stage of ischemic stroke may be associated with augmentation of cerebral edema, haemorrhagic transformation or stroke recurrence [6,7] and the optimal management of BP during acute stroke is controversial, as stressed in acute stroke management guidelines [8]. Moreover BP falls naturally over first week after stroke [9,10]. A consensus about management of blood pressure in acute phase of stroke is not established yet, even if current guidelines suggest a slight reduction of elevated BP [8,11] to decrease the risk of cerebral edema, haemorrhagic transformation and stroke recurrence [6,7,12] but other studies recommend to reduce only high BP values because of the impairment in auto-regulation of cerebral vessels that may lead to a perfusion reduction [13,14] increasing the volume of ischemic stroke [15]. Likewise low BP levels were actually harmful in some studies [13,14] and also trials about drugs increasing blood pressure have been performed [16]. Despite high prevalence of hypertension in acute stroke patients, the optimal level and management of arterial blood pressure have not been established yet and remain issues of long-lasting debate and little consensus [17,18]. Findings of a number of observational studies that evaluated the association of acute BP values with early stroke outcomes were contradictory and the available but underpowered randomized controlled trials (RCTs) have yielded inconsistent results [19,20].
    The aim of this study was to investigate whether levels of systolic blood pressure (SBP) in the acute phase of ischemic stroke were associated with function outcome and recovery and we assessed DWI volume of acute ischemic lesions to evaluate whether different levels of pressure correlated with different volumes of ischemic lesions.
    Methods
    This was a prospective observational study. The study protocol was approved by the ethics committee of the Medical Faculty of the Catholic University of Rome.
    We recorded a consecutive series of stroke patients who were hospitalized at the Stroke Unit (SU) of Policlinico Gemelli between January and December 2011.
    Patients
    All study subjects older than 18 years with first-ever acute ischemic stroke and relevant ischemic lesions on cranial computer tomography (CT) or brain magnetic resonance imaging (MRI) were enrolled. Potential study subjects were excluded if they were admitted later than 24 hours after the onset of stroke or transferred to other departments within 3 days from the admittance or if they were lost at follow-up visit.
    All patients received diagnostic evaluation and treatment according to our stroke unit care program and their needs, which include a standardized protocol for acute stroke evaluation, monitoring, medical treatment, and a multidisciplinary team for medical care, nursing, and rehabilitation. All patients underwent to a neuroimaging study (CT or MRI), carotid and vertebral echo-doppler imaging, transthoracic echocardiogram and their past and present medical history was recorded. In enrolled patients BP was recorded and treated in accordance with published guidelines for acute ischemic stroke [8]. At the discharge all patients that needed were treated with antihypertensive therapy following current guidelines [8]. Patients were prospectively followed up until 6 month by outpatient visit as part of an institutional quality-of-care program for hospitalized stroke patients.
    Blood pressure measuring
    As part of our acute stroke protocol, all patients underwent continuous non-invasive BP monitoring.
    Appropriate cuff bladder size was determined for each patient based on arm circumference. Because all patients were bedridden, supine blood pressure were recorded into the electronic medical record every 4 hours in the non-paretic arm using a monitoring device (IntelliVue MP40; Philips© Koninklijke Philips Electronics N. V. ). Mean of 2 measures, taken 30 seconds apart, were recorded. In all patients, blood pressure control was done according to current stroke guidelines [8,21,22]. All clinical characteristics, vascular risk factors, acute management strategies, and other laboratory findings were collected directly from the patient interview. The acute stage of ischemic stroke was defined as the first 24 hours period after the admittance and sub-acute stage as the period between 2nd day and until the day of discharge or transfer to rehabilitation unit in the given period of 5 to 15 days from stroke onset. Acute BP was considered as the higher value of SBP of the first 24 hours after the admission. On the basis of acute systolic blood pressure, patients were assigned to one of the 3 pre-specified groups: SBP <130 mmHg (low pressure); 130<SBP<160 mmHg (moderate pressure) ; SBP>160 (high pressure). BP recordings were continued until the 5th day after the admittance for a total of 30 measurements.
    Neuroimaging
    All patients underwent to neuroradiological evaluation. In emergency department, patients underwent CT scan to perform standard brain studies (4 detectors CT scanner, General Electric Medical Systems) and MR imaging (1.5 T, General Electric Electric Medical Systems, Milwaukee, WI, USA) was performed within 48 hours from stroke onset; the protocol included axial trace DWI, FLAIR, gradient-echo sequences, and T2 weighted imaging.
    The MRI images were transferred to a GE Workstation (Advantage Workstation Volume Share 2, AW 4.4) for the further analyses.
    Outcome measures assessment
    Outcome measures were assessed at the discharge and at 3-month and 6-month follow up visits. We recorded National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS). Moreover to evaluate short-term outcome, we assessed ∆NIHSS (admittance-discharge) and long-term improvement was assessed by ∆mRS defined as difference between admittance and 3-month or 6-month follow up visits mRS scores. Dedicated and trained stroke neurologists, blinded of group assignment, were responsible for performing the outcome assessment using the mRS and NIHSS during hospitalization [21,23].
    Ischemic volume assessment
    In each patient the volume of brain ischemia was assessed on the diffusion weighted images (DWI) by a dedicated neuroradiologist blinded of group assignment. In particular for each section, regions of interest (ROIs) were drawn around the boundary of the ischemic lesion using Volume Viewer 3.1 application, based on visual inspection. The areas contained within these ROIs were multiplied by the thickness of the section plus gap and added together to compute volume of abnormality.
    Statistical analysis
    Values are showed as mean ± SD, or as the number (%) of subjects for categorical variables.
    Comparisons of baseline characteristics were made using Mann–Whitney U test, unpaired Student t test or Χ2 according to the type of variable. All statistical analyses were performed with StatView version 5.0 (SAS institute Inc.). A 2-sided p value of <0.05 was generally considered a minimum level of statistical significance.
    Results
    Among 320 admitted in our department during enrollment period, 157 patients met the study's eligibility criteria, but 19 were finally excluded for the following reasons: 10 had incomplete BP measurements and 9 were lost at follow up visits. A total of 138 patients, 82 (59.4%) males, were included (age 65.9± 12.7 years). The mean NIHSS score at the admittance was 7±5.6 and 28 patients (20.1%) received thrombolysis.
    Baseline characteristics of eligible patients are showed in table 1 and comparisons of baseline characteristics between groups are showed in tables 2 and 3.
    Table 1 Demographic and clinical characteristics and risk factors of enrolled patients. Abbreviations: NIHSS: National Institutes of Health Stroke Scale; mRS: modified Rankin Scale; rtPA: Recombinant tissue plasminogen activator Values are number of patients (%) or mean + SD unless otherwise indicated.

    Characteristics

    Total

    Patients nr. (%)

    138 (100%)

    Age (years), mean+SD

    65.9+12.7

    Male, nr. (%)

    82 (59.4)

    Diabetes, nr. (%)

    26 (18.8)

    Complications, nr. (%)

    26 (18.8)

    • Sepsis

    5 (3.6)

    • Pneumonia

    13 (9.4)

    • Urinary tract infection

    5 (3.6)

    • Pulmonary embolism

    2 (1.4)

    • Pressure ulcer

    1 (0.7)

    Admission NIHSS, mean+SD

    7.0+5.6

    Discharge NIHSS , mean+SD

    6.5+8.7

    Admission mRS, mean+SD

    2.9+1.5

    Discharge mRS, mean+SD

    2.6+1.7

    Drugs, nr. (%)

     

    • Antihypertensive

    103 (74.6)

    • Antiplatels

    105 (76.1)

    • Anticoagulants

    57 (41.3)

    • Statins

    45 (32.6)

    • rtPA, nr. (%)

    28 (20.3)

    Lesion volume (cc),  mean+SD

    80+67

    Hospitalization (days), mean+SD

    8.8+4.9

    Dead, nr. (%)

    6 (4.3)

     

     

    Table 1 Demographic and clinical characteristics and risk factors of enrolled patients. Abbreviations: NIHSS: National Institutes of Health Stroke Scale; mRS: modified Rankin Scale; rtPA: Recombinant tissue plasminogen activator Values are number of patients (%) or mean + SD unless otherwise indicated.

    ×
    In the predefined acute and subacute stage, the number of BP measurements was 30. The mean time from admittance to discharge or transfer to rehabilitation was 8.8± 4.9 days.
    SBP values recorded at the acute stage of stroke were significant different among groups (p 0.05) (figure 1). The NIHSS values were higher in groups with higher SBP values but difference was not significant (p>0.05) (Table 2).
    Table 2 NIHSS, mRS and PA values of patients with different values of acute SBP. Abbreviations: NIHSS: National Institutes of Health Stroke Scale; mRS: modified Rankin Scale; SBP: Systolic blood pressure.

    Timepoint

    SBP<130 mmHg

    130<SBP<160 mmHg

    SBP>160 mmHg

    p-value

    Admittance

     

     

     

     

    NIHSS

    6.6+5.3

    6.7+5.5

    7.9+6.1

    p>0.05

    mRS

    2.7+1.7

    3+1.4

    3.0+1.4

    p>0.05

    SBP

    114.8+7.9

    145.5+10.3

    179.6+17.8

    *p<0.05

    Discharge

     

     

     

     

    NIHSS

    7.0+10.5

    6.2+8.1

    6.3+7.6

    p>0.05

    mRS

    2.4+1.8

    2.6+1.7

    2.6+1.6

    p>0.05

    SBP

    113+25.2

    142.4+22.8

    139+25.8

    p>0.05

    3-month follow up

     

     

     

     

    mRS

    1.3+1.7

    1.4+1.4

    1.3+1.4

    p>0.05

    6-month follow up

     

     

     

     

    mRS

    1.0+1.6

    0.8+1.3

    0.7+1.3

    p>0.05

    ∆mRS

     

     

     

     

     (Admittance-6 months)

    1.7+1.5

    2.2+1.3

    2.3+1.1

    *p<0.05

    Table 2 NIHSS, mRS and PA values of patients with different values of acute SBP. Abbreviations: NIHSS: National Institutes of Health Stroke Scale; mRS: modified Rankin Scale; SBP: Systolic blood pressure.

    ×
    In subacute stage, NIHSS showed a U-shaped trend in all three groups and NIHSS at the discharge was lower than that at the admittance in all but the low pressure group (p>0.05) (Figure 2). Short term improvement, defined as difference between NIHSS scores at the admittance and at the discharge, was not significant different among groups (Figure 3). During hospitalization, a valuable reduction of BP values was observed in group with higher SBP but it was not significant (p >0.05) (Figure 1). A progressive reduction of mRS scores was observed in follow up period (Table 2) and ∆mRS scores (admittance/6-month) were significant different between low pressure and high pressure groups with better recovery in the latter group (unpaired Student t-test, p<0.05) (Table 2). Brain lesion volumes evaluated by DWI MRI showed lower ischemic volumes in groups with low pressures but differences were not significant (Table 3).
    Figure 1 Trend of acute and subacute SBP in each group of patients recorded every 4 hours. Systolic blood pressure (SBP) values recorded at the acute stage of stroke were significant different among groups (p<0.05). During hospitalization, a valuable reduction of BP values was observed in group with higher SBP but it was not significant (p >0.05).

    Figure 1 Trend of acute and subacute SBP in each group of patients recorded every 4 hours. Systolic blood pressure (SBP) values recorded at the acute stage of stroke were significant different among groups (p<0.05). During hospitalization, a valuable reduction of BP values was observed in group with higher SBP but it was not significant (p >0.05).

    ×
    Figure 2 Daily NIHSS for each group of patients. The NIHSS values were higher in groups with higher SBP values but difference was not significant (p>0.05).

    Figure 2 Daily NIHSS for each group of patients. The NIHSS values were higher in groups with higher SBP values but difference was not significant (p>0.05).

    ×
    Figure 3 Difference between admission and discharge NIHSS score (∆NIHSS) in each group of patients. Short term improvement, defined as difference between NIHSS scores at the admittance and at the discharge, was not significant different among groups (p<0.05).

    Figure 3 Difference between admission and discharge NIHSS score (∆NIHSS) in each group of patients. Short term improvement, defined as difference between NIHSS scores at the admittance and at the discharge, was not significant different among groups (p>0.05).

    ×
    Table 3 Demographic and clinical characteristic of patients with different values of acute SBP. Abbreviations: NIHSS: National Institutes of Health Stroke Scale; mRS: modified Rankin Scale; rtPA: Recombinant tissue plasminogen activator; SBP: Systolic blood pressure; DBP: Diastolic blood pressure; Values are number of patients (%) or mean + SD unless otherwise indicated.

     

      SBP<130 (n=43)

      130<SBP<160 (n=57)

      SBP>160 (n=39)

    p-value

                                                

     

     

     

     

    Age, mean+SD

    62.3+14.7

    66.3+12.4

    69.3+9.4

    p>0.05

    Male, nr. (%)

    24 (55.8)

    35 (61.4)

    23 (59)

    p>0.05

    Diabetes

    6 (13.9)

    11(19.3)

    9 (23.1)

    p>0.05

    Complications, nr. (%)

    7 (16.3)

    11 (19.3)

    8 (20.5)

    p>0.05

    • Sepsis

    3 (7.0)

    1 (1.7)

    1 (2.6)

    p>0.05

    • Pneumonia

    3 (7.0)

    5 (8.8)

    5 (12.8)

    p>0.05

    • Urinary tract infection

    1 (2.3)

    3 (5.3)

    1 (2.6)

    p>0.05

    • Pulmonary embolism

    0

    2 (3.5)

    0

    p>0.05

    • Pressure ulcer

    0

    0

    1 (2.6)

    p>0.05

    SBP admittance, mean+SD

    114.8+7.9

    145.5+10.3

    179.6+17.8

    *p<0.05

    DBP admittance, mean+SD

    70.6+10.6

    72.6+11.8

    88.6+14.8

    p>0.05

    Drugs, nr. (%)

     

     

    • Antihypertensive

    28 (65.1)

    38 (66.7)

    37 (94.9)

    p>0.05

    • Antiplatelets

                 33 (76.7)

               39 (68.4)

             33 (84.6)

    p>0.05

    • Anticoagulants

    17 (39.5)

    27 (47.4)

    13 (33.3)

    p>0.05

    • Statins

    13 (30.2)

    18 (31.6)

    14 (35.9)

    p>0.05

    • rtPA, nr. (%)

    7 (16.3)

    10 (17.5)

    11 (25.6)

    p>0.05

    Hospitalization, mean+SD

    9.8 (5.7)

    8.2 (4.7)

    8.7 (4.0)

    p>0.05

    Lesion volume (on DWI)

    46.8

    89.1

    85.7

    p>0.05

    Dead, nr. (%)

    3 (7.0)

    2 (3.5)

    1 (2.6)

    p>0.05

    Table 3 Demographic and clinical characteristic of patients with different values of acute SBP. Abbreviations: NIHSS: National Institutes of Health Stroke Scale; mRS: modified Rankin Scale; rtPA: Recombinant tissue plasminogen activator; SBP: Systolic blood pressure; DBP: Diastolic blood pressure; Values are number of patients (%) or mean + SD unless otherwise indicated.

    ×
    Discussion
    In this observational study we evaluated the difference of long-term outcome in pre-established groups of stroke patients with different levels of SBP admitted in our stroke unit.
    This study showed an association between acute SBP values and long-term outcome in patients with first-ever stroke. Although elevated blood pressure (BP) levels are a common feature of acute stroke patients, either for ischaemic or haemorrhagic type, a long-standing debate exists regarding the management of post-stroke hypertension and about optimal BP levels that should be maintained in acute phase of stroke. Because over the first week after stroke BP falls naturally [9,10] acute BP treatment is not defined and current guidelines suggest avoiding correction of blood pressure until markedly high values [8,21]. Arguments exist in the setting of acute stroke both for lowering BP and leaving high BP levels untreated. The former may reduce the risk of stroke recurrence and edema formation and the latter, due to the absence of normal auto-regulation in acute stroke, may avoid reduction in cerebral perfusion pressure and maintain blood flow to ischemic but viable cerebral tissue [24]. This uncertainty mostly depends on the lack of randomized trials of BP-modulating agents during acute stroke and is exacerbated by the well-documented spontaneous changes of BP that occur in the first few days after stroke onset [25]. Moreover some studies demonstrated a U shaped curve for prognosis related to high and low systolic pressure [14] and others demonstrated a risk of poor outcome related to high variability of acute blood pressure values [24,26]. The objective of this study was to evaluate the effect of different levels of SBP during the acute stage of ischemic stroke on long term outcome. For acute high pressure group (SBP >160 mmHg) SBP gradually lowered, but for acute low pressure group (SBP<130 mmHg) SBP gradually increased. Mean values of SBP were significant different between groups within 24 hours from the admittance (figure 1). This was in accordance with previous studies demonstrating compensatory effects due to impairment of cerebral vascular auto-regulation [9,10]. Moreover this study demonstrated that SBP minimally affects short-term outcome. On the other hand, in this observational study the groups of acute SBP was previously determined and a better long-term outcome for the group with high values of SBP was established. This result apparently diverges from previous published data [13,14] and deserves more considerations. First of all, we pre-specified the group of analysis. Moreover patients enrolled had a quite homogenous level of SBP (Figure 1) and because high acute SBP variability is a known factor affecting outcome [24,27] some of the results might be explained by this consideration. Furthermore, we treated acute blood pressure following current ischemic stroke guidelines [8,21] and high SBP values were maintained below suggested values. There are several limitations that present study shares with the most of the studies [18] due to the observational protocol, explaining discrepancies among the results and probably more factors than only SBP blood pressure level may affect outcome as reported by some authors [26], such as sites and sizes of the brain lesion, concurrent diseases, patient's compliance etc.
    In conclusion, these data showed a better long-term outcome in patients with acute high blood-pressure values and they are in accordance with recent published data in which lowering high SBP in acute stroke patients may be harmful [20]. A careful using of lowering treatment with antihypertensive drugs should be advised to treat patients with both acute ischemic stroke and raised blood pressure. We are aware about limitations and shortcomings of this study, related to a small number of patients, and confounding factors such as drugs intake and related comorbidities that due to the small sample could not have been taken into consideration, but the strength of this study is related to a stroke unit setting that allowed common stroke management protocols and accordance to updated and currently used stroke guidelines, in terms of drugs and life style changes recommended that might have influenced final outcome and reduced the impact of above mentioned limitations. As above mentioned, this study underlines the need of trial allowing a better definition of SBP level in a large population and we believe that the trial should be performed in stroke unit setting. As previously reported [20] we think that blood pressure control is a key point in acute management of ischemic stroke patients and until convincing trials have been completed blood pressure control deserves careful consideration and routine lowering treatment should be avoided.
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    Cite this article: Pilato F, Calandrelli R, Distefano M, Profice P, Alicino V, et al. (2013) Level of Acute Blood Pressure may Influence Long Term Outcome in Ischemic Stroke Patients: A Prospective Observational Study in a Stroke Unit Setting J Neurol Disord Stroke 1(2): 1016.
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