Background: Central adjudication of stroke type is commonly implemented in large multicentre clin... more Background: Central adjudication of stroke type is commonly implemented in large multicentre clinical trials. We investigated the effect of central adjudication of diagnosis of stroke type at trial entry in the Efficacy of Nitric Oxide in Stroke (ENOS) trial. Methods: ENOS recruited patients with acute ischaemic or haemorrhagic stroke, and diagnostic adjudication was carried out using cranial scans. For this study, diagnoses made by local site clinicians were compared with those by central, masked adjudicators using kappa statistics. The trial primary analysis and subgroup analysis by stroke type were re-analysed using stroke diagnosis made by local clinicians, and simulations were used to assess the impact of increased non-differential misclassification and subgroup effects. Results: Agreement on stroke type (Ischaemic, Intracerebral Haemorrhage, Unknown stroke type, No-stroke) was high (κ = 0.92). Adjudication of stroke type had no impact on the primary outcome or subgroup analysis by stroke type. With misclassification increased to 10 times the level observed in ENOS and a simulated subgroup effect present, adjudication would have affected trial conclusions. Conclusions: Stroke type at trial entry was diagnosed accurately by local clinicians in ENOS. Adjudication of stroke type by central adjudicators had no measurable effect on trial conclusions. Diagnostic adjudication may be important if diagnosis is complex and a treatment-diagnosis interaction is expected.
IntroductionThe REGIONS Care study assesses stroke care throughout New Zealand. It includes a nat... more IntroductionThe REGIONS Care study assesses stroke care throughout New Zealand. It includes a national audit and here we present organisational survey results assessing current availability of interventions and management approaches in each hospital.MethodsAll 20 District Health Boards were invited to complete a survey about patients managed per annum, care setting, and service provision. Results were grouped into rural and urban groups to assess for geographic differences.ResultsAll NZ hospitals managing stroke patients completed the survey. Results found that of these hospitals 92% have an acute stroke unit, 85% have a TIA pathway, but only 58% offer rapid access specialist TIA services. 100% offer thrombolysis, 92% use pre-hospital notification and rapid ED triage system, and 73% an in-hospital ‘code stroke’ alert. 50% have access to thrombectomy. Only 32% offer a dedicated inpatient stroke rehabilitation unit. While 92% provide community rehabilitation, only 11% offer early supp...
Bath c , on behalf of ENOS trial investigators Objectives: High blood pressure (BP) is associated... more Bath c , on behalf of ENOS trial investigators Objectives: High blood pressure (BP) is associated with a poor outcome after acute stroke. Early reduction in BP may be associated with fewer early adverse events and deaths, and improved functional outcome. Methods: Analyses used data from the Efficacy of Nitric Oxide in Stroke trial, a multicentre randomized singlemasked and outcome-masked trial of glyceryl trinitrate vs. no glyceryl trinitrate in 4011 patients recruited within 48 h of an ischaemic or haemorrhagic stroke and with raised SBP (140-220 mmHg). Change in SBP from baseline to day 1 was categorized as: more than 15% decrease, 15-5% decrease, 5% decrease to 5% increase (no changereference) and more than 5% increase. The primary outcome was functional outcome (modified Rankin scale) score at 90 days. Results: Across all patients, both moderate (5-15%) and large (>15%) decreases in SBP were associated with beneficial shifts in the modified Rankin scale relative to patients with no change in BP: adjusted common odds ratio (OR) 0.81 [95% confidence interval (CI) 0.70-0.90] and OR 0.84 (95% CI 0.71-1.00), respectively. A moderate decrease in SBP was also associated with a lower risk of early adverse events, adjusted OR 0.69 (95% CI 0.52-0.90). Conclusion: Modest decreases in SBP in acute stroke appear to be associated with fewer early events and better long-term functional outcome.
BackgroundThere is concern that blood pressure (BP) lowering in acute stroke may compromise cereb... more BackgroundThere is concern that blood pressure (BP) lowering in acute stroke may compromise cerebral perfusion and worsen outcome in the presence of carotid stenosis. We assessed the effect of glyceryl trinitrate (GTN) in patients with carotid stenosis using data from the Efficacy of Nitric Oxide in Stroke (ENOS) Trial.MethodsENOS randomised 4011 patients with acute stroke and raised systolic BP (140–220 mm Hg) to transdermal GTN or no GTN within 48 hours of onset. Those on prestroke antihypertensives were also randomised to stop or continue their medication for 7 days. The primary outcome was the modified Rankin Scale (mRS) at day 90. Ipsilateral carotid stenosis was split: <30%; 30–<50%; 50–<70%; ≥70%. Data are ORs with 95% CIs adjusted for baseline prognostic factors.Results2023 (60.5%) ischaemic stroke participants had carotid imaging. As compared with <30%, ≥70% ipsilateral stenosis was associated with an unfavourable shift in mRS (worse outcome) at 90 days (OR 1.88...
Background and purpose Central adjudication of serious adverse events (SAEs) can be undertaken in... more Background and purpose Central adjudication of serious adverse events (SAEs) can be undertaken in clinical trials, especially for open-label studies where outcome assessment may be at risk of bias. This study explored the effect of central adjudication of SAEs on the safety results of the Efficacy of Nitric Oxide in Stroke (ENOS) Trial. Methods ENOS assigned patients with acute stroke at random to receive either transdermal glyceryl trinitrate (GTN) or no GTN and to Stop or Continue previous antihypertensive treatment. SAEs were reported by local investigators who were not blinded to treatment allocation. Central adjudicators, blinded to treatment allocation, reviewed the investigators reports and used evidence available to confirm or re-categorise the classification of event, likely causality, diagnosis and expectedness of event. Results Of 4011 patients enrolled in ENOS, 1473 SAEs were reported by local investigators; this was reduced to 1444 after the review by adjudicators, with 29 reclassified as not an SAE.
AIMS Many transient ischaemic attack (TIA) patients receive initial assessments by general practi... more AIMS Many transient ischaemic attack (TIA) patients receive initial assessments by general practitioners (GPs). In a randomised controlled trial (RCT) we showed that BPAC Inc. TIA/stroke electronic decision support (EDS) for GPs improves patient outcomes and guideline adherence. This secondary analysis assesses the impact of trial associated enhanced GP access to radiological investigation. METHODS Post-hoc analysis of a multi-centre, single blind, parallel group, cluster RCT comparing TIA/stroke EDS guided GP management with usual care to assess whether imaging requests and their appropriateness differed between study groups. RESULTS GPs requested 15/291 (5.2%) carotid ultrasounds and 19/291 (6.5%) computed tomography (CT) head scans. Scans were obtained more frequently in the intervention group (ultrasound cluster adjusted OR (95% CI) 1.41 (0.44 to 4.49), P = 0.56 and CT 13.8 (1.7 to 110.7), P < 0.001). All CTs were clinically appropriate. More ultrasounds were appropriate in t...
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, 2018
Many patients with transient ischemic attack (TIA) receive initial assessments by general practit... more Many patients with transient ischemic attack (TIA) receive initial assessments by general practitioners (GPs) who may lack TIA management experience. In a randomized controlled trial (RCT), we showed that electronic decision support for GPs improves patient outcomes and guideline adherence. Some stroke services prefer to improve referrer expertise through TIA/stroke education sessions instead of promoting TIA decision aids or triaging tools. This is a secondary analysis of whether a GP education session influenced TIA management and outcomes. Post hoc analysis of a multicenter, single blind, parallel group, cluster RCT comparing TIA/stroke electronic decision support guided GP management with usual care to assess whether a pretrial TIA/stroke education session also affected RCT outcomes. Of 181 participating GPs, 79 (43.7%) attended an education session and 140 of 291 (48.1%) trial patients were managed by these GPs. There were fewer 90-day stroke events and 90-day vascular events o...
Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS,... more Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials which aim to determine whether the routine administration of fluoxetine (20 mg daily) for six months after an acute stroke improves patients' functional outcome. The core protocol for the three trials has been published (Mead et al., Trials 20:369, 2015). The trials include patients aged 18 years and older with a clinical diagnosis of stroke and persisting focal neurological deficits at randomisation 2-15 days after stroke onset. Patients are randomised centrally via each trials' web-based randomisation system using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for six months. The primary outcome measure is the modified Rankin scale (mRS) at six months. Secondary outcomes include: living circu...
Early infection after stroke is associated with a poor outcome. We aimed to determine whether del... more Early infection after stroke is associated with a poor outcome. We aimed to determine whether delayed infections (up to 76 days post-stroke) are associated with poor outcome at 90 days. Data came from the international Efficacy of Nitric Oxide Stroke (ENOS, ISRCTN99414122) trial. Post hoc data on infections were obtained from serious adverse events reports between 1 and 76 days following stroke in this large cohort of patients. Regression models accounting for baseline covariates were used to analyse fatalities and functional outcomes (modified Rankin Scale (mRS), Barthel Index, Euro-Qol-5D) at 90 days, in patients with infection compared to those without infection. Of 4011 patients, 242 (6.0%) developed one or more serious infections. Infections were associated with an increased risk of death (p < 0.001) and an increased likelihood of dependency (measured by mRS) compared to those of all other patients (p < 0.001). This remained when only surviving patients were analysed, ind...
Telestroke uses videoconferencing (VC) technology to allow off-site experts to provide stroke thr... more Telestroke uses videoconferencing (VC) technology to allow off-site experts to provide stroke thrombolysis decision support to less experienced front line clinicians. This project aimed to assess the impact of a new telestroke service on thrombolysis rates and door-to-needle times in participating provincial hospitals and service resources to aid transition to a sustainably telestroke service. This is a sequential comparison of 'pre' (December 2015 to May 2016) and 'postr' (June 2016 to December 2016) implementation outcomes. The main outcomes were thrombolysis rate and door-to-needle time. All patient data were captured prospectively in a central database. Data captured and analyzed also included technical problems, consumer and clinician feedback, and additional service resources required. Over the study period 164 telestroke assessments were completed including the 'hub' hospital. Among participating provincial hospitals 21/343 patients (6.1%) were thrombo...
AMR has been cited as the most significant health issue of the 21st century with potentially seri... more AMR has been cited as the most significant health issue of the 21st century with potentially serious consequences for the health of global populations, including New Zealand, and its health system. Proactive approaches to combating AMR through better understanding of the causes will inform measures required to reduce potential threats. The Royal Australasian College of Physicians (RACP) identifies three pathogens where increased resistance is of concern and recommends collaborative responses to prevent emerging threats to New Zealand populations. An international best practice AMR programme would include antimicrobial stewardship (AMS) building on evidence, policy, organisational support, multidisciplinary teams and patient experience. The planned Ministry of Health-led collaborative approach to developing a national strategy and programme will provide sector direction. Implementation will require extensive engagement with the health sector and communities to develop joint solutions...
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, Jan 4, 2016
More than 50% of patients with acute intracerebral hemorrhage (ICH) are taking antihypertensive d... more More than 50% of patients with acute intracerebral hemorrhage (ICH) are taking antihypertensive drugs before ictus. Although antihypertensive therapy should be given long term for secondary prevention, whether to continue or stop such treatment during the acute phase of ICH remains unclear, a question that was addressed in the Efficacy of Nitric Oxide in Stroke (ENOS) trial. ENOS was an international multicenter, prospective, randomized, blinded endpoint trial. Among 629 patients with ICH and systolic blood pressure between 140 and 220 mmHg, 246 patients who were taking antihypertensive drugs were assigned to continue (n = 119) or to stop (n = 127) taking drugs temporarily for 7 days. The primary outcome was the modified Rankin Score at 90 days. Secondary outcomes included death, length of stay in hospital, discharge destination, activities of daily living, mood, cognition, and quality of life. Blood pressure level (baseline 171/92 mmHg) fell in both groups but was significantly low...
Background and Purpose-The Efficacy of Nitric Oxide in Stroke (ENOS) trial found that transdermal... more Background and Purpose-The Efficacy of Nitric Oxide in Stroke (ENOS) trial found that transdermal glyceryl trinitrate (GTN, a nitric oxide donor) lowered blood pressure but did not improve functional outcome in patients with acute stroke. However, GTN was associated with improved outcome if patients were randomized within 6 hours of stroke onset. Methods-In this prespecified subgroup analysis, the effect of GTN (5 mg/d for 7 days) versus no GTN was studied in 629 patients with intracerebral hemorrhage presenting within 48 hours and with systolic blood pressure ≥140 mm Hg. The primary outcome was the modified Rankin Scale at 90 days. Results-Mean blood pressure at baseline was 172/93 mm Hg and significantly lower (difference −7.5/−4.2 mm Hg; both P≤0.05) on day 1 in 310 patients allocated to GTN when compared with 319 randomized to no GTN. No difference in the modified Rankin Scale was observed between those receiving GTN versus no GTN (adjusted odds ratio for worse outcome with GTN, 1.04; 95% confidence interval, 0.78-1.37; P=0.84). In the subgroup of 61 patients randomized within 6 hours, GTN improved functional outcome with a shift in the modified Rankin Scale (odds ratio, 0.22; 95% confidence interval, 0.07-0.69; P=0.001). There was no significant difference in the rates of serious adverse events between GTN and no GTN. Conclusions-In patients with intracerebral hemorrhage within 48 hours of onset, GTN lowered blood pressure was safe but did not improve functional outcome. Very early treatment might be beneficial but needs assessment in further studies.
Background: Central adjudication of stroke type is commonly implemented in large multicentre clin... more Background: Central adjudication of stroke type is commonly implemented in large multicentre clinical trials. We investigated the effect of central adjudication of diagnosis of stroke type at trial entry in the Efficacy of Nitric Oxide in Stroke (ENOS) trial. Methods: ENOS recruited patients with acute ischaemic or haemorrhagic stroke, and diagnostic adjudication was carried out using cranial scans. For this study, diagnoses made by local site clinicians were compared with those by central, masked adjudicators using kappa statistics. The trial primary analysis and subgroup analysis by stroke type were re-analysed using stroke diagnosis made by local clinicians, and simulations were used to assess the impact of increased non-differential misclassification and subgroup effects. Results: Agreement on stroke type (Ischaemic, Intracerebral Haemorrhage, Unknown stroke type, No-stroke) was high (κ = 0.92). Adjudication of stroke type had no impact on the primary outcome or subgroup analysis by stroke type. With misclassification increased to 10 times the level observed in ENOS and a simulated subgroup effect present, adjudication would have affected trial conclusions. Conclusions: Stroke type at trial entry was diagnosed accurately by local clinicians in ENOS. Adjudication of stroke type by central adjudicators had no measurable effect on trial conclusions. Diagnostic adjudication may be important if diagnosis is complex and a treatment-diagnosis interaction is expected.
IntroductionThe REGIONS Care study assesses stroke care throughout New Zealand. It includes a nat... more IntroductionThe REGIONS Care study assesses stroke care throughout New Zealand. It includes a national audit and here we present organisational survey results assessing current availability of interventions and management approaches in each hospital.MethodsAll 20 District Health Boards were invited to complete a survey about patients managed per annum, care setting, and service provision. Results were grouped into rural and urban groups to assess for geographic differences.ResultsAll NZ hospitals managing stroke patients completed the survey. Results found that of these hospitals 92% have an acute stroke unit, 85% have a TIA pathway, but only 58% offer rapid access specialist TIA services. 100% offer thrombolysis, 92% use pre-hospital notification and rapid ED triage system, and 73% an in-hospital ‘code stroke’ alert. 50% have access to thrombectomy. Only 32% offer a dedicated inpatient stroke rehabilitation unit. While 92% provide community rehabilitation, only 11% offer early supp...
Bath c , on behalf of ENOS trial investigators Objectives: High blood pressure (BP) is associated... more Bath c , on behalf of ENOS trial investigators Objectives: High blood pressure (BP) is associated with a poor outcome after acute stroke. Early reduction in BP may be associated with fewer early adverse events and deaths, and improved functional outcome. Methods: Analyses used data from the Efficacy of Nitric Oxide in Stroke trial, a multicentre randomized singlemasked and outcome-masked trial of glyceryl trinitrate vs. no glyceryl trinitrate in 4011 patients recruited within 48 h of an ischaemic or haemorrhagic stroke and with raised SBP (140-220 mmHg). Change in SBP from baseline to day 1 was categorized as: more than 15% decrease, 15-5% decrease, 5% decrease to 5% increase (no changereference) and more than 5% increase. The primary outcome was functional outcome (modified Rankin scale) score at 90 days. Results: Across all patients, both moderate (5-15%) and large (>15%) decreases in SBP were associated with beneficial shifts in the modified Rankin scale relative to patients with no change in BP: adjusted common odds ratio (OR) 0.81 [95% confidence interval (CI) 0.70-0.90] and OR 0.84 (95% CI 0.71-1.00), respectively. A moderate decrease in SBP was also associated with a lower risk of early adverse events, adjusted OR 0.69 (95% CI 0.52-0.90). Conclusion: Modest decreases in SBP in acute stroke appear to be associated with fewer early events and better long-term functional outcome.
BackgroundThere is concern that blood pressure (BP) lowering in acute stroke may compromise cereb... more BackgroundThere is concern that blood pressure (BP) lowering in acute stroke may compromise cerebral perfusion and worsen outcome in the presence of carotid stenosis. We assessed the effect of glyceryl trinitrate (GTN) in patients with carotid stenosis using data from the Efficacy of Nitric Oxide in Stroke (ENOS) Trial.MethodsENOS randomised 4011 patients with acute stroke and raised systolic BP (140–220 mm Hg) to transdermal GTN or no GTN within 48 hours of onset. Those on prestroke antihypertensives were also randomised to stop or continue their medication for 7 days. The primary outcome was the modified Rankin Scale (mRS) at day 90. Ipsilateral carotid stenosis was split: <30%; 30–<50%; 50–<70%; ≥70%. Data are ORs with 95% CIs adjusted for baseline prognostic factors.Results2023 (60.5%) ischaemic stroke participants had carotid imaging. As compared with <30%, ≥70% ipsilateral stenosis was associated with an unfavourable shift in mRS (worse outcome) at 90 days (OR 1.88...
Background and purpose Central adjudication of serious adverse events (SAEs) can be undertaken in... more Background and purpose Central adjudication of serious adverse events (SAEs) can be undertaken in clinical trials, especially for open-label studies where outcome assessment may be at risk of bias. This study explored the effect of central adjudication of SAEs on the safety results of the Efficacy of Nitric Oxide in Stroke (ENOS) Trial. Methods ENOS assigned patients with acute stroke at random to receive either transdermal glyceryl trinitrate (GTN) or no GTN and to Stop or Continue previous antihypertensive treatment. SAEs were reported by local investigators who were not blinded to treatment allocation. Central adjudicators, blinded to treatment allocation, reviewed the investigators reports and used evidence available to confirm or re-categorise the classification of event, likely causality, diagnosis and expectedness of event. Results Of 4011 patients enrolled in ENOS, 1473 SAEs were reported by local investigators; this was reduced to 1444 after the review by adjudicators, with 29 reclassified as not an SAE.
AIMS Many transient ischaemic attack (TIA) patients receive initial assessments by general practi... more AIMS Many transient ischaemic attack (TIA) patients receive initial assessments by general practitioners (GPs). In a randomised controlled trial (RCT) we showed that BPAC Inc. TIA/stroke electronic decision support (EDS) for GPs improves patient outcomes and guideline adherence. This secondary analysis assesses the impact of trial associated enhanced GP access to radiological investigation. METHODS Post-hoc analysis of a multi-centre, single blind, parallel group, cluster RCT comparing TIA/stroke EDS guided GP management with usual care to assess whether imaging requests and their appropriateness differed between study groups. RESULTS GPs requested 15/291 (5.2%) carotid ultrasounds and 19/291 (6.5%) computed tomography (CT) head scans. Scans were obtained more frequently in the intervention group (ultrasound cluster adjusted OR (95% CI) 1.41 (0.44 to 4.49), P = 0.56 and CT 13.8 (1.7 to 110.7), P < 0.001). All CTs were clinically appropriate. More ultrasounds were appropriate in t...
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, 2018
Many patients with transient ischemic attack (TIA) receive initial assessments by general practit... more Many patients with transient ischemic attack (TIA) receive initial assessments by general practitioners (GPs) who may lack TIA management experience. In a randomized controlled trial (RCT), we showed that electronic decision support for GPs improves patient outcomes and guideline adherence. Some stroke services prefer to improve referrer expertise through TIA/stroke education sessions instead of promoting TIA decision aids or triaging tools. This is a secondary analysis of whether a GP education session influenced TIA management and outcomes. Post hoc analysis of a multicenter, single blind, parallel group, cluster RCT comparing TIA/stroke electronic decision support guided GP management with usual care to assess whether a pretrial TIA/stroke education session also affected RCT outcomes. Of 181 participating GPs, 79 (43.7%) attended an education session and 140 of 291 (48.1%) trial patients were managed by these GPs. There were fewer 90-day stroke events and 90-day vascular events o...
Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS,... more Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials which aim to determine whether the routine administration of fluoxetine (20 mg daily) for six months after an acute stroke improves patients' functional outcome. The core protocol for the three trials has been published (Mead et al., Trials 20:369, 2015). The trials include patients aged 18 years and older with a clinical diagnosis of stroke and persisting focal neurological deficits at randomisation 2-15 days after stroke onset. Patients are randomised centrally via each trials' web-based randomisation system using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for six months. The primary outcome measure is the modified Rankin scale (mRS) at six months. Secondary outcomes include: living circu...
Early infection after stroke is associated with a poor outcome. We aimed to determine whether del... more Early infection after stroke is associated with a poor outcome. We aimed to determine whether delayed infections (up to 76 days post-stroke) are associated with poor outcome at 90 days. Data came from the international Efficacy of Nitric Oxide Stroke (ENOS, ISRCTN99414122) trial. Post hoc data on infections were obtained from serious adverse events reports between 1 and 76 days following stroke in this large cohort of patients. Regression models accounting for baseline covariates were used to analyse fatalities and functional outcomes (modified Rankin Scale (mRS), Barthel Index, Euro-Qol-5D) at 90 days, in patients with infection compared to those without infection. Of 4011 patients, 242 (6.0%) developed one or more serious infections. Infections were associated with an increased risk of death (p < 0.001) and an increased likelihood of dependency (measured by mRS) compared to those of all other patients (p < 0.001). This remained when only surviving patients were analysed, ind...
Telestroke uses videoconferencing (VC) technology to allow off-site experts to provide stroke thr... more Telestroke uses videoconferencing (VC) technology to allow off-site experts to provide stroke thrombolysis decision support to less experienced front line clinicians. This project aimed to assess the impact of a new telestroke service on thrombolysis rates and door-to-needle times in participating provincial hospitals and service resources to aid transition to a sustainably telestroke service. This is a sequential comparison of 'pre' (December 2015 to May 2016) and 'postr' (June 2016 to December 2016) implementation outcomes. The main outcomes were thrombolysis rate and door-to-needle time. All patient data were captured prospectively in a central database. Data captured and analyzed also included technical problems, consumer and clinician feedback, and additional service resources required. Over the study period 164 telestroke assessments were completed including the 'hub' hospital. Among participating provincial hospitals 21/343 patients (6.1%) were thrombo...
AMR has been cited as the most significant health issue of the 21st century with potentially seri... more AMR has been cited as the most significant health issue of the 21st century with potentially serious consequences for the health of global populations, including New Zealand, and its health system. Proactive approaches to combating AMR through better understanding of the causes will inform measures required to reduce potential threats. The Royal Australasian College of Physicians (RACP) identifies three pathogens where increased resistance is of concern and recommends collaborative responses to prevent emerging threats to New Zealand populations. An international best practice AMR programme would include antimicrobial stewardship (AMS) building on evidence, policy, organisational support, multidisciplinary teams and patient experience. The planned Ministry of Health-led collaborative approach to developing a national strategy and programme will provide sector direction. Implementation will require extensive engagement with the health sector and communities to develop joint solutions...
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, Jan 4, 2016
More than 50% of patients with acute intracerebral hemorrhage (ICH) are taking antihypertensive d... more More than 50% of patients with acute intracerebral hemorrhage (ICH) are taking antihypertensive drugs before ictus. Although antihypertensive therapy should be given long term for secondary prevention, whether to continue or stop such treatment during the acute phase of ICH remains unclear, a question that was addressed in the Efficacy of Nitric Oxide in Stroke (ENOS) trial. ENOS was an international multicenter, prospective, randomized, blinded endpoint trial. Among 629 patients with ICH and systolic blood pressure between 140 and 220 mmHg, 246 patients who were taking antihypertensive drugs were assigned to continue (n = 119) or to stop (n = 127) taking drugs temporarily for 7 days. The primary outcome was the modified Rankin Score at 90 days. Secondary outcomes included death, length of stay in hospital, discharge destination, activities of daily living, mood, cognition, and quality of life. Blood pressure level (baseline 171/92 mmHg) fell in both groups but was significantly low...
Background and Purpose-The Efficacy of Nitric Oxide in Stroke (ENOS) trial found that transdermal... more Background and Purpose-The Efficacy of Nitric Oxide in Stroke (ENOS) trial found that transdermal glyceryl trinitrate (GTN, a nitric oxide donor) lowered blood pressure but did not improve functional outcome in patients with acute stroke. However, GTN was associated with improved outcome if patients were randomized within 6 hours of stroke onset. Methods-In this prespecified subgroup analysis, the effect of GTN (5 mg/d for 7 days) versus no GTN was studied in 629 patients with intracerebral hemorrhage presenting within 48 hours and with systolic blood pressure ≥140 mm Hg. The primary outcome was the modified Rankin Scale at 90 days. Results-Mean blood pressure at baseline was 172/93 mm Hg and significantly lower (difference −7.5/−4.2 mm Hg; both P≤0.05) on day 1 in 310 patients allocated to GTN when compared with 319 randomized to no GTN. No difference in the modified Rankin Scale was observed between those receiving GTN versus no GTN (adjusted odds ratio for worse outcome with GTN, 1.04; 95% confidence interval, 0.78-1.37; P=0.84). In the subgroup of 61 patients randomized within 6 hours, GTN improved functional outcome with a shift in the modified Rankin Scale (odds ratio, 0.22; 95% confidence interval, 0.07-0.69; P=0.001). There was no significant difference in the rates of serious adverse events between GTN and no GTN. Conclusions-In patients with intracerebral hemorrhage within 48 hours of onset, GTN lowered blood pressure was safe but did not improve functional outcome. Very early treatment might be beneficial but needs assessment in further studies.
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Papers by John Gommans