Venous Thromboembolism Risk in Stroke Patients Receiving Extended-Duration Enoxaparin Prophylaxis: Sub-Analysis of the EXCLAIM Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 433-433
Author(s):  
Alexander GG Turpie ◽  
Russell D Hull ◽  
Sebastian M Schellong ◽  
Victor F Tapson ◽  
Manuel Monreal ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Major Bleeding ◽  
Study Drug ◽  
Minor Bleeding ◽  
Medical Patients ◽  
Stroke Patients ◽  
Short Term ◽  
Vte Prophylaxis ◽  
Extended Duration

Abstract Background: Venous thromboembolism (VTE) is a common complication after acute ischemic stroke. Short-term (10 ± 4 days) prophylaxis reduces the risk of VTE in ischemic stroke patients (Lancet2007; 369:1347–1355), but the efficacy and safety of extended VTE prophylaxis in patients with stroke remains unknown. The EXCLAIM study demonstrated that extended-duration enoxaparin prophylaxis (28 ±4 days) reduced the risk for VTE compared with placebo (2.5% vs 4.0%, respectively: absolute difference − 1.5%, 95.8% confidence interval −2.5 to −0.5%; p= 0.002), in acutely ill medical patients with recent reduced mobility who had already received a short-term 10 ± 4 days prophylaxis regimen (J Thromb Haemost2007;5:Supp.1:O-S-001). In this analysis of the EXCLAIM study, we evaluated the benefit-to-risk ratio of extended-duration enoxaparin in a population of ischemic stroke patients at high risk for VTE. Methods: Acutely ill medical patients enrolled in EXCLAIM were aged ≥40 years and had recently reduced mobility (≤3 days). Of the 7500 patients enrolled, 7415 received enoxaparin 40mg subcutaneous (SC) once-daily for 10 ± 4 days. Of these, 6085 patients were randomized to receive double-blind therapy (enoxaparin 40mg SC once-daily or placebo) for a further 28 ± 4 days. The primary efficacy endpoint, VTE, defined as the composite of symptomatic or asymptomatic deep-vein thrombosis, symptomatic pulmonary embolism (PE), or fatal PE, was assessed at completion of the randomized treatment. The primary safety endpoint, major bleeding, was assessed through 48 hours after the last dose of randomized treatment. Secondary endpoints included symptomatic VTE and major and total (major plus minor) bleeding. Results: Of the 5,963 randomized patients who received at least 1 dose of study treatment, 389 (6.5%) had acute ischemic stroke. Of these, 198 received extended-duration enoxaparin prophylaxis and 191 received placebo. Key demographic variables were comparable in both groups. The VTE rate in the placebo group was higher in ischemic stroke patients, compared with those without (8.0% vs 3.7%). The incidence of VTE was significantly reduced in patients receiving extended-duration enoxaparin prophylaxis vs placebo (p<0.05). Major bleeding was increased in patients receiving extended-duration enoxaparin prophylaxis vs patients receiving placebo, however this difference was not statistically significant (Table). Conclusion: Our findings support that acute ischemic stroke patients are at increased risk for VTE, compared with the general medical population. Acutely ill patients with ischemic stroke receiving extended-duration enoxaparin experienced a significantly reduced risk of VTE and a non-statistically significant increase in major bleeding compared with patients receiving placebo, after all patients completed a short-term 10 ± 4 days enoxaparin regimen. These findings warrant further studies of extended-duration VTE prophylaxis in patients with acute ischemic stroke. Table. Efficacy and safety outcomes in stroke patients receiving extended-duration enoxaparin prophylaxis vs placebo. Stroke patients, n=389 Parameter Extended-duration enoxaparin, n (%) Placebo, n (%) Relative risk (95.8% CI) P-value †Efficacy endpoints were assessed in all randomized patients who received at least 1 dose of study drug and had an evaluable ultrasound. ‡Safety endpoints were assessed in all randomized patients who received at least 1 dose of study drug. Efficacy † N=166 N=150 VTE 4 (2.4) 12 (8.0) 0.30 (0.10–0.91) 0.0236 Symptomatic VTE 0 (0.0) 2 (1.3) 0.1356 Safety ‡ N=198 N=191 Major bleeding 3 (1.5) 0 (0.0) 0.0881 Major and minor bleeding 12 (6.1) 5 (2.6) 2.32 (0.83–6.45) 0.0972

Prevention of Venous Thromboembolism after Acute Ischemic Stroke with Enoxaparin Versus Unfractionated Heparin and the Impact of Stroke Severity.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 713-713 ◽  
Author(s):  
David G. Sherman ◽  
Gregory W. Albers ◽  
Christopher Bladin ◽  
Min Chen ◽  
Cesare Fieschi ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Venous Thromboembolism ◽  
Acute Ischemic Stroke ◽  
Stroke Severity ◽  
Primary Efficacy ◽  
Primary Efficacy Endpoint ◽  
Stroke Patients ◽  
Nihss Score ◽  
Vte Prophylaxis ◽  
Clinically Significant

Abstract Background: Venous thromboembolism (VTE) prophylaxis with low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) is recommended in acute ischemic stroke patients, but most studies comparing LMWH and UFH are limited in methodology or sample size. The PREVAIL study was designed to assess the superiority of enoxaparin over UFH for VTE prophylaxis in acute ischemic stroke patients and to evaluate efficacy and safety according to stroke severity. Methods: Patients with acute ischemic stroke, confirmed by CT scan, and unable to walk unassisted due to motor impairment of the leg were enrolled in this prospective, open-label, parallel group, multicenter study. Patients from 15 countries were randomized within 48 h of stroke symptoms to receive enoxaparin 40 mg SC qd or UFH 5000 IU SC q12h for 10±4 days. Patients were stratified by NIH Stroke Scale score (NIHSS; severe ≥14, less severe <14). The primary efficacy endpoint was the composite of symptomatic or asymptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), or fatal PE during treatment. DVT was confirmed primarily by venography, or ultrasonography when venography was not practical. PE was confirmed by VQ or CT scan, or angiography. Primary safety endpoints included clinically significant intracranial and major extracranial bleeding. Results: 1762 acute ischemic stroke patients were randomized. Characteristics were similar between groups; mean age was 66.0±12.9 yrs, mean NIHSS score was 11.3. In the efficacy population, enoxaparin (n=666) and UFH (n=669) were given for a mean of 10.5±3.2 days. Enoxaparin resulted in a 43% relative reduction in the risk of the primary efficacy endpoint compared with UFH (10.2% vs 18.1%; RR 0.57; 95% CI 0.44–0.76; p=0.0001, adjusted for NIHSS score). Incidences of VTE events are shown in Table 1. Reductions in the primary endpoint remained significant in patients with a NIHSS score ≥14 (16.3% vs 29.7%, p=0.0036) and <14 (8.3% vs 14.0%, p=0.0043). The composite of clinically significant intracranial and major extracranial bleeding was low and not significantly different between groups (Table 1). Conclusion: Enoxaparin 40 mg qd is superior to UFH q12h for reducing the risk of VTE in acute ischemic stroke patients, with no significant difference in clinically relevant bleeding. The reduction in VTE risk was consistent in patients with a NIHSS score ≥14 or <14. Table 1: Incidence of VTE and bleeding Endpoint Enoxaparin n/N (%, 95% CI) UFH n/N (%, 95% CI) *P<0.001 Symptomatic VTE 2/666 (0.3, 0.0–0.7) 6/669 (0.9, 0.2–1.6) Proximal DVT 30/666 (4.5, 2.9–6.1) 64/669 (9.6, 7.3–11.8)* Distal DVT 44/666 (6.6, 4.7–8.5) 85/669 (12.7, 10.2–15.2)* PE 1/666 (0.2, 0.0–0.4) 6/669 (0.9, 0.2–1.6) Composite of major extracranial and clinically significant intracranial bleeding 11/877 (1.3, 0.5–1.9) 6/872 (0.7, 0.1–1.2)

scholarly journals Impact of excessive supraventricular ectopic activity detected in the acute phase of stroke or TIA on AF detection and death within 24 months – results of the prospective MonDAFIS study

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
K G H Haeusler ◽  
M C O Olma ◽  
S T Tuetuencue ◽  
C F Fiessler ◽  
C K Kunze ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Major Bleeding ◽  
Recurrent Stroke ◽  
First Episode ◽  
Ecg Monitoring ◽  
Ectopic Activity ◽  
Stroke Patients

Abstract Background/Introduction Detection of atrial fibrillation (AF) and subsequent initiation of oral anticoagulation remain key goals in the care of stroke patients. The European Society of Cardiology guideline recommend continuous ECG monitoring for at least 72 hours in stroke patients without previously known AF. Excessive supraventricular ectopic activity (ESVEA) has been identified as a marker for patients at risk for AF in the general population. Robust data on the clinical relevance of ESVEA detected in the acute phase of ischemic stroke or transient ischemic attack (TIA) are lacking. Purpose To assess the impact of ESVEA (defined as presence of supraventricular beats ≥480/day or at least one atrial run of ≥10 and <30 seconds during continuous ECG monitoring for 72 hours) in patients with acute ischemic stroke/TIA without (previously) known AF on recurrent stroke, all-cause death and detection of a first episode of AF within 24 months. Methods The investigator-initiated, prospective, open, multicenter Systematic Monitoring for Detection of Atrial Fibrillation in Patients with Acute Ischemic Stroke study randomized 3,465 acute stroke patients without known AF 1:1 to usual diagnostic procedures for AF detection or additive Holter-ECG recording for up to seven days in-hospital (NCT02869386). ECG core-lab analysis included the number of atrial ectopic beats per day, the number of atrial runs as well as the duration of the longest atrial run per 24 hours. Patients were followed-up for two years. Secondary study objectives include the comparison of recurrent stroke, myocardial infarction, major bleeding and all-cause death in ESVEA patients, patients with newly diagnosed AF vs. non-ESVEA patients with sinus rhythm at baseline. Data were analyzed using Fisher's exact test. Results In 1,714 patients randomized to the intervention group, 1,693 (98.8%) had analyzable ECG recordings of a median duration of 121 hours (IQR 73–166). 1,435 (84.8%) patients had continuous ECG monitoring for the first 72 hours. At this time, ESVEA was detected in 363 (25.3%) of 1,435 patients, while a first episode of AF was detected in 48 (3.3%). At 24 months, AF was newly detected in 57 (15.7%) ESVEA patients vs. 53 (6.2%) non-ESVEA patients (p<0.001) with available follow-up. At 24 months, 68 (24.5%) ESVEA patients vs. 77 (9.0%) non-ESVEA patients were on oral anticoagulation (p<0.001). The composite of recurrent stroke, myocardial infarction, major bleeding and death at 24 months did not differ significantly between ESVEA patients vs. non-ESVEA patients (14.3% vs. 11.6%; p=0.389). However, all-cause death was higher in ESVEA patients (6.6% vs. 3.1% in non-ESVEA patients; p=0.01). Conclusions ESVEA detected after acute ischemic stroke/TIA identifies patients at high-risk for AF and may be used to guide prolonged ECG monitoring. The higher risk of death in ESVEA patients vs. non-ESVEA patients within 24 months after stroke/TIA deserves further investigation. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bayer Vital GmbH, Bayer HealthCare Pharmaceuticals, Germany.

The Relationship between Blood Pressure Variability, Recanalization Degree, and Clinical Outcome in Large Vessel Occlusive Stroke after an Intra-Arterial Thrombectomy

2018 ◽  
Vol 46 (5-6) ◽  
pp. 279-286 ◽  
Author(s):  
Jun Young Chang ◽  
Sang Beom Jeon ◽  
Jung Hwa Lee ◽  
O-Ki Kwon ◽  
Moon-Ku Han
Keyword(s):  
Blood Pressure ◽  
Ischemic Stroke ◽  
Clinical Outcome ◽  
Acute Ischemic Stroke ◽  
Blood Pressure Variability ◽  
Target Organ Damage ◽  
Large Vessel ◽  
Stroke Patients ◽  
Short Term ◽  
The Mean

Background: Blood pressure variability (BPV) is associated with target organ damage progression and increased cardiovascular events, including stroke. The aim of this study was to evaluate the associations between short-term BPV during acute periods and recanalization degree, early neurological deterioration (END) occurrence, and functional outcomes in acute ischemic stroke patients who had undergone intra-arterial thrombectomy (IAT). Methods: We retrospectively analyzed 303 patients with large vessel occlusive stroke who underwent IAT. The following BPV parameters, measured over 24 and 48 h after IAT, were compared: the mean, SD, coefficient of variation (CV), variation independent of the mean (VIM) for both the systolic BP (SBP) and diastolic BP, and the proportion of nocturnal SBP risers. Results: BPV parameters decreased with higher recanalization degree. The mean SBP (SBPmean) over 24 and 48 h after IAT, and the SD of SBP (SBPSD), CV of SBP (SBPCV), and VIM of SBP (SBPVIM) during the 48 h following the procedure had significant associations with recanalization degree. Patients with END had higher BPV than that of those without END, and the difference was more evident for incomplete recanalization. Increased BPV was associated with a shift toward poor functional outcome at 3 months after adjustment, including recanalization degree (OR range for significant parameters, 1.26–1.64, p = 0.006 for 48 h SBPmean, p = 0.003 for 48 h SBPCV, otherwise p < 0.002). Conclusions: Short-term BPV over 24 and 48 h after IAT in acute ischemic stroke patients was related to recanalization degree, and END occurrence, and may be an independent predictor of clinical outcome.

scholarly journals Influence of Living Alone or with a Spouse Only on the Short-Term Prognosis in Patients after an Acute Ischemic Stroke

2020 ◽  
Vol 17 (21) ◽  
pp. 8223
Author(s):  
Yohei Ishikawa ◽  
Toru Hifumi ◽  
Mitsuyoshi Urashima
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Odds Ratio ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Living Alone ◽  
Secondary Outcome ◽  
Cardiovascular Risks ◽  
Stroke Patients ◽  
Short Term

Background—This study aimed to explore whether living alone or with a spouse only affects the short-term prognosis of acute ischemic stroke patients. Methods—We conducted a retrospective cohort study of patients with a diagnosis of acute ischemic stroke from April 2014 to February 2019 in Japan. The primary outcome was defined as worsening by at least one grade on the modified Rankin Scale (mRS). The secondary outcome was set as the degree of worsening on the mRS. The outcomes were compared between three groups of patients: (1) those living alone (ALONE), (2) those living with their spouse only (SPOUSE), and (3) OTHERs. Results—In total, 365 patients were included in this study: 111 (30%) ALONE, 133 (36%) SPOUSE, and 121 (33%) OTHERs. Cardiogenic embolisms were observed more frequently in ALONE than in OTHERs. The primary outcome occurred in 88 (79.3%) patients in ALONE and in 96 (72.2%) patients in SPOUSE, both of which were higher than the 72 (59.5%) in OTHERs. After adjusting with 19 variables, the risk of worsening was higher in ALONE (odds ratio (OR): 2.90, 95% confidence interval (CI): 1.50–5.58) and SPOUSE (OR: 1.83, 95% CI: 1.00–3.33) compared with OTHERs. Conclusions—In patients with acute ischemic stroke, not only living alone but also living with a spouse only may be associated with a worse short-term prognosis, independent of other cardiovascular risks.

Abstract W P379: Pre-treatment with Selective Serotonin Reuptake Inhibitors is Associated with Improved Short-term Outcome in Acute Ischemic Stroke

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Timo Siepmann ◽  
Jessica Kepplinger ◽  
Charlotte Zerna ◽  
Ana Isabel Penzlin ◽  
Heinz Reichmann ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Functional Outcome ◽  
Serotonin Reuptake ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Stroke Patients ◽  
Short Term ◽  
Post Stroke ◽  
Pre Treatment ◽  
Favorable Functional Outcome

Background and Purpose: Treatment with Selective Serotonin Reuptake Inhibitors (SSRIs) following acute ischemic stroke was shown to improve functional and motor recovery independently of depression, possibly mediated by long-term mechanisms such as increased brain plasticity. In animal studies, chronic SSRI treatment is superior over short-term SSRI in evoking neurogenesis but the applicability of this observation to humans remains unelucidated. We hypothesized that pre-treatment with SSRI in acute ischemic stroke patients is associated with improved recovery compared to post-stroke SSRI. Subjects and Methods: We performed an exploratory analysis in consecutive acute ischemic stroke patients who were pre-treated or treated de novo either with fluoxetine, citalopram or escitalopram. Effects of SSRI-pre-treatment on short-term clinical (total NIHSS and NIHSS motor items) and functional (mRS) outcome at discharge compared to post-stroke SSRI were assessed using bivariate and multivariate analyses. Results: Of 2653 patients screened, 239 were included (aged 69±14 years, mean±SD; 42% men, baseline median NIHSS 7 [IQR, 10]). Compared to post-stroke SSRI (n=188), in the SSRI pre-treatment group (n=51) favorable functional outcome at discharge (mRS≤2) was more frequent (41% vs. 20%; p=0.002), duration of hospitalization was shorter (median: 7 versus 11 days; p<0.0001), and there was a non-significant trend toward improved motor recovery (decrease in NIHSS motor items ≥2 points or 0-1 at discharge; 63% vs. 49%; p=0.08). However there was no such difference in total NIHSS recovery (≥4 points or 0-1 at discharge; p=n.s.). Pre-treatment with SSRI was an independent predictor of favorable functional outcome (mRS≤2) at discharge (OR: 4.00; 95%CI: 1.68-9.57; p=0.002) after adjusting for age, pre-stroke mRS, baseline NIHSS and IV-thrombolysis. Conclusions: Our data suggest that pre-treatment with SSRI may be linked to early clinical recovery after acute ischemic stroke and support the hypothesis that pre-stroke SSRI might be superior to post-stroke SSRI.

Abstract P50: IV Alteplase Use Predicts Favorable Discharge Disposition in Patients With Acute Ischemic Stroke: Insights From the UTHSC Houston Stroke Registry

2011 ◽  
Vol 4 (suppl_1) ◽  
Author(s):  
Nneka Ifejika-Jones ◽  
Nusrat Harun ◽  
Elizabeth Noser ◽  
James Grotta
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Functional Status ◽  
Inpatient Rehabilitation ◽  
Level Of Care ◽  
Stroke Patients ◽  
Short Term ◽  
Post Stroke ◽  
Discharge Disposition

Introduction: Acute ischemic stroke patients receiving IV alteplase (t-PA) within 4.5 hours of symptom onset are 30% more likely to have minimal or no disability at 3 months. During hospitalization, short-term disability is subjectively measured by discharge disposition, whether to home or Inpatient Rehabilitation (IR), Skilled Nursing Facility (SNF) or Sub-acute Care (Sub). There are no studies assessing the role of IV t-PA as a predictor of short-term disability, evidenced by post-stroke disposition. Hypothesis: Low NIHSS is a predictor of high functional status. We assessed the hypothesis that similar to low NIHSS, t-PA predicts post-stroke disposition to a level of care suggestive of high functional status. Methods: All patients with acute ischemic stroke admitted to the UT Service between January 2004 and October 2009 were included. Stratification occurred for age>65, NIHSS and stroke risk factors. Using multivariate logistic regression, the data was analyzed to determine whether there were differences in post-stroke disposition among patients who received t-PA. Results: Patients with mild (NIHSS<8) and moderate (NIHSS 8 to 16) stroke were discharged to the highest level of care in each analysis. Home vs. Other Level of Care Of 2261 patients, 1032 were discharged home, 1229 to another level of care. Patients who received t-PA were 1.7 times more likely to be discharged home (P = <.0001, OR 1.663, 95% CI 1.326 to 2.085). IR vs. SNF Of 1111 patients, 731 patients were discharged to acute IR, 380 to SNF. There were no statistically significant differences in disposition between patients who received t-PA. (P = .0638, OR 1.338, 95% CI 0.983 to 1.822). SNF vs. Sub Of 498 patients, 380 were discharged to SNF, 118 to Sub. There were no significant differences in disposition between patients who received t-PA. Conclusion: Acute stroke patients who receive IV t-PA are more 1.7 times more likely to be discharged home. If post-stroke care is necessary, there is a trend toward rehabilitation at a level reflective of improved functional status (IR vs. SNF). This study is limited by its retrospective nature and the undetermined role of psychosocial factors related to discharge. Prospective studies of time to t-PA therapy in relation to post-stroke disposition are warranted.

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