scholarly journals HUBUNGAN KADAR S100B SERUM TERHADAP LUARAN KLINIS NEUROLOGIS PASIEN STROKE ISKEMIK AKUT

Author(s):  
Windri Kartikasari ◽  
Retnaningsih Retnaningsih ◽  
Amin Husni

  RELATIONSHIP OF S100B SERUM WITH NEUROLOGIC CLINICAL OUTCOME IN ACUTE ISCHEMIC STROKE PATIENTSABSTRACTIntroduction: Biomarker levels of S100B serum have a correlation with the degree of damage to brain tissue so that it can be used as a marker to determine the clinical outcomes of patients with acute ischemic stroke.Aims: To determine the association of S100B serum levels 72 hours of onset to NIHSS score changes in acute ischemic stroke patients. Determine the association of confounding factors that affecting NIHSS score changes and S100B serum levels.Method: This research is an analytic observational study with prospective cohort design. Subjects were patients diagnosed with acute ischemic stroke who meet the inclusion criteria. This study used bivariate and multivariate analysis.Result: There was a significant relationship between S100B serum levels and changes in the NIHSS score. There was a significant relationship between BMI status and NIHSS score changes. There was a significant relationship between S100B serum levels with age ≥65 years, with hypertension, and with dyslipidemia to NIHSS score changes. There was a significant relationship between S100B serum levels in subject ≥65 years old with hypertension to NIHSS score changes. There was no significant relationship between S100B serum levels with dyslipidemia, hypertension, and diabetes mellitus to NIHSS score changes.Discussion: In this study, S100B serum levels were significant correlated with NIHSS score changes in acute ischemic stroke patients. There was a correlation  between S100B serum levels with age ≥65 years, hypertension, dyslipidemia. In subjects with age ≥65 years old and hypertension, S100 serum levels was significantly associated with NIHSS score changes in acute ischemic stroke patients.Keywords: Confounding factors, NIHSS score changes, S100B serumABSTRAKPendahuluan: Kadar penanda serum S100B berkorelasi dengan derajat kerusakan jaringan otak sehingga dapat digunakan sebagai petanda untuk mengetahui luaran klinis pasien stroke iskemik akut.Tujuan: Mengetahui hubungan kadar S100B serum 72 jam pasca-onset terhadap perubahan skor NIHSS pada pasien stroke iskemik akut dan faktor-faktor menjadi perancu.Metode: Penelitian ini merupakan penelitian observasional analitik dengan pendekatan kohort prospektif. Subjek adalah pasien yang didiagnosis stroke iskemik akut pertama kali. NIHSS dikatakan membaik jika perubahan skor antara hari ke-7 dan 3 perawatan ≥2. Analisis bivariat dilanjutkan dengan analisis multivariat dilakukan antara NIHSS dengan kadar S100B dan faktor-faktor perancu lainnya.Hasil: Didapatkan hubungan bermakna antara kadar S100B serum dengan perubahan  skor NIHSS. Didapatkan hubungan bermakna antara status BMI dengan perubahan skor NIHSS. Terdapat hubungan bermakna antara kadar S100B serum dengan umur ≥65 tahun, dengan hipertensi, dan dengan dislipidemia terhadap perubahan skor NIHSS. Terdapat hubungan bermakna antara kadar S100B serum pada subjek umur ≥65 tahun dengan hipertensi terhadap perubahan skor NIHSS. Tidak terdapat hubungan antara kadar S100B serum dengan dislipidemia, hipertensi, dan DM terhadap perubahan skor NIHSS.Diskusi: Terdapat hubungan antara kadar S100B serum terhadap perubahan skor NIHSS pasien stroke iskemik akut. Terdapat hubungan antara kadar S100B serum dengan dengan umur ≥ 65 tahun, hipertensi, dan dislipidemia. Pada umur ≥65 tahun dengan hipertensi, kadar S100B berhubungan terhadap perubahan skor NIHSS pasien stroke iskemik akut.Kata kunci: Faktor-faktor perancu, perubahan skor NIHSS, S100B serum  

Author(s):  
Christina Roseville Lasma Aritonang ◽  
Retnaningsih Retnaningsih ◽  
Amin Husni

   CORRELATION OF SERUM NEURON SPECIFIC ENOLASE AND CLINICAL NEUROLOGICAL OUTCOME IN ACUTE ISCHEMIC STROKE PATIENTSABSTRACTIntroduction: Stroke is a neurological disease that cause disability. Ischemic stroke occurs in 85-87% of all cases. The biochemical markers of acute neuron injury can help in diagnosis and management of cerebrovascular injury. Neuron specific enolase (NSE) is dimeric isoenzymes of glycolytic enolase enzymes and found mainly in neurons as one of the markers in acute neuronal injury and can be estimated to assess short-term neurological outcome.Aims: To know the relationship of serum NSE level with stroke severity (? NIHHS) in acute ischemic stroke.Methods: This was an observational analytic study with a prospective cohort approach. Subjects were patients diagnosed with acute ischemic stroke who met the inclusion criteria. Numeric and categoric variables relationship test was performed using Mann-Whitney. Relationship between categoric variables with χ2 test, Fisher test and Kolmogorov- Smirnov 2 sample test. The results of bivariate analysis with p<0.25  were further analyzed by multivariate logistic regression test to determine the variables that influence the NIHSS score change.Results: There were 42 subjects with average age of 61.6±12.3 years with male sex more dominant. There was no significant relationship between serum NSE levels and ? NIHSS of acute ischemic stroke (p=0.446).Discussion: Neuron Specific Enolase levels were not related to changes in the NIHSS score of acute ischemic stroke, there was a significant relationship between BMI status and changes in NIHSS.Keywords: Acute ischemic stroke, ? NIHSS score, NSE serumABSTRAKPendahuluan: Stroke merupakan suatu penyakit neurologi dan penyebab disabilitas di seluruh dunia. Sroke Iskemik terjadi pada 85-87% dari seluruh kasus. Penanda biokimiawi dari cedera neuron akut dapat membantu diagnosis dan manajemen stroke serebrovaskular. Neuron specific enolase (NSE) merupakan isoenzim dimerik dari enzim enolase glikolitik dan ditemukan terutama di neuron adalah penanda yang dilepaskan dalam darah pada cedera neuron akut dan dapat diperkirakan dalam serum pasien untuk menilai derajat defisit neurologis jangka pendek.Tujuan: Mengetahui hubungan kadar penanda NSE serum dengan derajat keparahan stroke (? NIHSS) pada stroke iskemik akut.Metode: Penelitian ini merupakan penelitian observasional analitik dengan pendekatan kohort prospektif. Subjek adalah pasien yang didiagnosis stroke iskemik akut yang memenuhi kriteria inklusi. Uji hubungan variabel berskala numerik dan kategorial menggunakan uji Mann-Whitney. Hubungan antara variabel kategorial didapatkan dengan uji χ2, uji Fisher dan uji Kolmogorov-Smirnov 2 sampel. Hasil analisis bivariat dengan p<0,25 dianalisis lebih lanjut dengan uji multivariat regresi logistik untuk mengetahui variabel yang berpengaruh terhadap perubahan skor NIHSS.Hasil: Pada penelitian ini didapatkan 42 subjek dengan rerata usia 61,6±12,3 tahun dan jenis kelamin dominan laki-laki. Tidak didapatkan hubungan yang bermakna antara kadar NSE serum dengan ? NIHSS stroke iskemik akut (p=0,446).Diskusi: Kadar NSE serum tidak berhubungan dengan perubahan skor NIHSS stroke iskemik akut, terdapat hubungan bermakna antara status BMI dengan perubahan NIHSS.Kata kunci: NSE serum, ? NIHSS, stroke iskemik akut


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Jon W Schrock ◽  
Robert Day ◽  
Peter Morris ◽  
Steven Reed ◽  
Robert Ferguson ◽  
...  

Background: CT angiography (CTA) provides early assessment of cerebral vasculature in ED patients presenting with Acute Ischemic Stroke (AIS). Prior studies using 4 row detector CT scanners have suggested that results may be used to determine who receives thrombolytics (tPA). We sought to evaluate the rate of normal CTA and the use of tPA in AIS patients with and without blockages using modern CT technology. Methods: We conducted a retrospective cohort study of all code stroke patients presenting to our ED over a 3 year period ending in February 2011. Inclusion criteria included an ED and neurology diagnosis of AIS with a CTA performed at presentation. All patients had a NIHSS score recorded at presentation and underwent imaging using a 64 row detector scanner (Phillips) with 50cc of non-ionic contrast. Demographic, imaging, and clinical data were collected. Modified Rankin Scores (mRS) were assigned at presentation and hospital discharge. Good clinical outcome was defined as a mRS of 0-2. Data are reported as frequencies and medians with interquartile ranges (IQR) as appropriate. Rates of tPA use were evaluated using χ 2 testing. Changes in mRS were evaluated with the paired t-test. Results: A total of 209 subjects met inclusion for analysis of which 104 (50%) were male and 116 (55%) had no blockage on CTA. The median NIHSS score and mortality rates were 14 (IQR 8-19), 14 (15%) with CTA blockage, and 4 (IQR 2-7), 3 (3%) for those without. The use of tPA occurred in 46(50%) with 29 patients receiving intra-arterial therapy, and 14 (12%) patients with and without blockage respectively. Post tPA bleeding occurred in 12 (13%) patients with blockage on CTA and in 0 patients without blockage. Use of tPA was significantly more frequent in patients with a blockage on CTA, P <0.001. As a group, patients without a blockage had a significant decrease in mRS at discharge, however the overall difference was greater in the tPA group, difference = 0.4 (0.2-0.7) P<0.0002 and 1.9 (1.2-2.6) P<0.0001 respectively. Only AIS patients with a blockage and given tPA had a significant reduction of mRS, difference = 0.6 (0.2-1.0) P<0.005 compared with no tPA, difference = -0.1 (-0.4-0.3) P<0.7. Conclusion: More than half of our AIS patients presenting through our ED have no blockage on CTA. Patients with AIS and no blockage on CTA have less severe strokes and are less likely to receive tPA. Both AIS patients with and without a blockage on CTA appear to derive benefit from tPA.


2021 ◽  
Vol 14 ◽  
pp. 175628642110211
Author(s):  
Georgios Magoufis ◽  
Apostolos Safouris ◽  
Guy Raphaeli ◽  
Odysseas Kargiotis ◽  
Klearchos Psychogios ◽  
...  

Recent randomized controlled clinical trials (RCTs) have revolutionized acute ischemic stroke care by extending the use of intravenous thrombolysis and endovascular reperfusion therapies in time windows that have been originally considered futile or even unsafe. Both systemic and endovascular reperfusion therapies have been shown to improve outcome in patients with wake-up strokes or symptom onset beyond 4.5 h for intravenous thrombolysis and beyond 6 h for endovascular treatment; however, they require advanced neuroimaging to select stroke patients safely. Experts have proposed simpler imaging algorithms but high-quality data on safety and efficacy are currently missing. RCTs used diverse imaging and clinical inclusion criteria for patient selection during the dawn of this novel stroke treatment paradigm. After taking into consideration the dismal prognosis of nonrecanalized ischemic stroke patients and the substantial clinical benefit of reperfusion therapies in selected late presenters, we propose rescue reperfusion therapies for acute ischemic stroke patients not fulfilling all clinical and imaging inclusion criteria as an option in a subgroup of patients with clinical and radiological profiles suggesting low risk for complications, notably hemorrhagic transformation as well as local or remote parenchymal hemorrhage. Incorporating new data to treatment algorithms may seem perplexing to stroke physicians, since treatment and imaging capabilities of each stroke center may dictate diverse treatment pathways. This narrative review will summarize current data that will assist clinicians in the selection of those late presenters that will most likely benefit from acute reperfusion therapies. Different treatment algorithms are provided according to available neuroimaging and endovascular treatment capabilities.


Author(s):  
Betsi Sumanti ◽  
Hexanto Hexanto ◽  
Widiastuti Widiastuti

   ASSOCIATION BETWEEN ALTERED HS-CRP LEVELS AND  COGNITIVE FUNCTION OF ISCHEMIC STROKE PATIENTSABSTRACTIntroduction: The incidence of cognitive impairment in acute ischemic stroke patients is increasing. The mechanism of the inflammatory effect, such as  elevated hs-CRP level, a  non-specific inflammatory marker  sensitive to chronic inflammation due to hypoperfusion as well other vascular risk, is thought to have an effect on cognitive function.Aims: To determine the relationship of cognitive function changes in acute phase of ischemic stroke with hs-CRP level changes on day 3 and day 7 after onset.Methods: This was a cross sectional study of 31 first-timer ischemic stroke patients who met inclusion and exclusion criteria. The level of hs-CRP was checked on the 3rd day and 7th day after onset, while MoCA-Ina was assessed on the 7th day after onset. Cognitive disturbance was considered if MoCA <26. Analyses was done using SPSS 2.0Results: The average onset of day 3 Hs-CRP concentration was 0.66 (0.12-16.67)mg/dl and the onset of day 7 was 5.455 (0.14-17.34)mg/dl. The mean change of hs-CRP level between 3 day and 7 day after onset was -0,16 (-3.32-4.95). There was a significant correlation between elevated hs-CRP levels on day 3 and day 7 after onset with cognitive function of acute ischemic stroke patients.Discussion: There was a significant correlation between elevated hs-CRP levels on day 3 and day 7 after onset with cognitive function of acute ischemic stroke patients.Keyword: Acute ischemic stroke, hs-CRP, MoCA-Ina scoresABSTRAKPendahuluan: Insidens penurunan fungsi kognitif pada pasien stroke iskemik akut semakin meningkat. Hal ini diduga dipengaruhi oleh mekanisme efek inflamasi, meliputi peningkatan kadar high sensitive-C reactive protein (hs-CRP), salah satu penanda inflamasi non-spesifik yang sangat sensitif pada inflamasi kronis, akibat hipoperfusi maupun karena risiko vaskuler lainnya.Tujuan: Mengetahui hubungan perubahan fungsi kognitif pasien stroke iskemik fase akut dengan perubahan kadar hs-CRP hari ke-3 dan hari ke-7 setelah awitan.Metode: Studi potong lintang terhadap penderita stroke iskemik pertama kali yang memenuhi kriteria inklusi dan eksklusi. Dilakukan pemeriksaan kadar hs-CRP hari ke-3 dan hari ke-7 setelah awitan dan MoCA-Ina pada hari ke-7 setelah awitan. Fungsi kognitif dinyatakan terganggu jika MoCA-Ina <26. Analisis data menggunakan program SPSS 22.0.Hasil: Didapatkan rerata kadar Hs-CRP hari ke-3 setelah awitan adalah 0,66 (0,12-16,67)mg/dl dan hari ke-7 setelah awitan adalah 5,455 (0,14-17,34)mg/dl. Dengan rerata perubahan kadar hs-CRP awitan hari ke-3 dan awitan hari ke-7 adalah -0,16 (-3,32-4,95). Didapatkan hubungan yang bermakna antara perubahan kadar hs-CRP hari ke-3 setelah awitan dan hari ke-7 setelah awitan dengan fungsi kognitif pasien stroke iskemik akut.Kesimpulan: Didapatkan hubungan yang bermakna antara peningkatan kadar hs-CRP pada hari ke-7 dan kadar hari ke-3 dengan fungsi kognitif pasien stroke iskemik akut.Kata kunci: hs-CRP, MoCA-Ina, stroke iskemik akut 


2015 ◽  
Vol 38 (1) ◽  
pp. 26
Author(s):  
Ratih Ismiranti Murni ◽  
Dwi Pudjonarko ◽  
Bambang Satoto ◽  
Sukma Imawati

AbstrakStroke adalah penyebab utama ke-3 kematian di Amerika Serikat. Stroke iskemik adalah kondisi kompleks dengan etiologi dan manifestasi klinis bervariasi. CT Scan kepala adalah pencitraan darurat stroke membedakan dengan perdarahan intrakranial. Beberapa peneliti mengemukakan adanya korelasi independent dan hubungan pemeriksaan rutin biomarkers pada pasien stroke iskemik akut termasuk di dalamnya parameter inflamasi yang berperan pada patofisiologi iskemia otak. Tujuan penelitian ini mengetahui korelasi kadar LED dengan penilaian ASPECTS pada pasien stroke iskemik. Penelitian ini merupakan penelitian observasional analitik belah lintang dari catatan rekam medik. Selama periode Desember 2012 - Oktober 2014. Didapatkan 16 sampel yang memenuhi kriteria inklusi dan ekslusi. Dengan beberapa karakteristik subyek penelitian meliputi usia, jenis kelamin, hipertensi, diabetes mellitus, dislipidemia, kadar LED 1 dan 2, awitan stroke iskemik akut. Uji statistik Rank Spearman’s,dan uji bivariat maupun multivariat. Didapatkan hasil tidak ada korelasi antara nilai ASPECTS dengan kadar LED dan faktor yang mempengaruhi nilai ASPECTS.AbstractStroke is the third major cause of death in United States. Ischemic stroke results from complex conditions with various etiologies and clinical manifestations. Brain CT Scan is a stroke emergency imaging to differentiate intracranial hemorrhage. Several studies claimed there were independent correlation and relationship of biomarker in routine examination of acute ischemic stroke patients including inflammation parameters that contribute to the pathophysiology of brain ischemic. The purpose in this study was to identify correlation between ESR level and ASPECTS in ischemic stroke patients. The method of study was analytical observational cross sectional taken from medical record. It was performed in 16 patients that fulfill the inclusion and exclusion criteria during December 2012- October 2014. Several characteristics of subject that affecting ASPECTS included age, gender, hypertention, diabetes mellitus, dyslipidemia, ESR level 1 and 2, and onset of acute ischemic stroke were assessed. Analytical test was performed by Rank spearman’s test and multivariate test. There was no correlation between ASPECTS with ESR level and factors that affect ASPECTS.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Ki Woong Nam ◽  
Chi Kyung Kim ◽  
Tae Jung Kim ◽  
Sang Joon An ◽  
Kyungmi Oh ◽  
...  

Background: Stroke in cancer patients is not rare, but is a devastating event with high mortality. However, the predictors of mortality in stroke patients with cancer have not been well addressed. D-dimer could be a useful predictor because it can reflect both thromboembolic events and advanced stages of cancer. In this study, we evaluate the possibility of D-dimer as a predictor of 30-day mortality in stroke patients with active cancer. Methods: We included 210 ischemic stroke patients with active cancer. The data of 30-day mortality were collected by reviewing medical records. We also collected follow-up D-dimer levels in 106 (50%) participants to evaluate the effects of treatment response on D-dimer levels. Results: Of the 210 participants, 30-day mortality occurred in 28 (13%) patients. Higher initial NIHSS score, D-dimer levels, CRP levels, frequent cryptogenic mechanism, systemic metastasis, multiple vascular territory lesion, hemorrhagic transformation, and larger infarct volume were related to 30-day mortality. In the multivariate analysis, D-dimer [adjusted OR (aOR) = 2.19; 95% CI, 1.46-3.28, P < 0.001] predicted 30-day mortality after adjusting for confounders. Initial NIHSS score (aOR = 1.07; 95% CI, 1.00-1.14, P = 0.043) and hemorrhagic transformation (aOR = 3.02; 95% CI, 1.10-8.29, P = 0.032) were also significant independently from D-dimer levels. In the analysis of D-dimer changes after treatment, the mortality group showed no significant decrease of D-dimer levels, despite treatment, while the survivor group showed opposite responses. Conclusions: D-dimer levels may predict 30-day mortality in acute ischemic stroke patients with active cancer.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Ameer E Hassan ◽  
Jeffrey L Saver ◽  
Mayank Goyal ◽  
David S Liebeskind ◽  
Reza Jahan ◽  
...  

Background: Recent single center studies have suggested that “procedural time” independent of “time to procedure” can affect outcomes of acute ischemic stroke patients undergoing endovascular treatment (ET). We performed a pooled analysis from three ET trials to determine the effect of procedural time on angiographic and clinical outcomes. Objective: To determine the relationship between procedural time and clinical outcomes among acute ischemic stroke patients undergoing successful recanalization with ET. Methods: We analyzed data from SWIFT, STAR and SWIFT PRIME trials. Baseline demographic and clinical characteristics, NIHSS score on admission, intracranial hemorrhage rates and mRS at 3 months post procedure were analyzed. TICI scale was used to grade post procedure angiographic recanalization. Procedural time was defined by the time interval between groin puncture and recanalization. We estimated the procedural time after which favorable clinical outcome was unlikely even after recanalization (futile) after age and NIHSS score adjustment. Results: We analyzed 301 patients who underwent ET and had near complete or complete recanalization (TICI 2b or 3). The procedural time (±SD) was significantly shorter in patients who achieved a favorable outcome (mRS 0-2) compared with those who did not achieve favorable outcome (44±25 vs 51±33 minutes, p=0.04). Table 1. In the multivariate analysis (including all baseline characteristics with a p value <0.05 as independent variables), shorter procedural time was a significant predictor of lower odds of unfavorable outcome (OR 0.49, 95% CI 0.28, 0.85, p=0.012). The rates of favorable outcomes were significantly higher when the procedural time was <60 minutes compared with ≥60 minutes (62% vs 45%, p=0.020). Conclusion: Procedural time in patients undergoing mechanical thrombectomy for acute ischemic stroke is an important determinant of favorable outcomes in those with near complete or complete recanalization.


2011 ◽  
Vol 259 (2) ◽  
pp. 400-400 ◽  
Author(s):  
Heidi Ormstad ◽  
Hans Christian Dalsbotten Aass ◽  
Niels Lund-Sørensen ◽  
Karl-Friedrich Amthor ◽  
Leif Sandvik

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 713-713 ◽  
Author(s):  
David G. Sherman ◽  
Gregory W. Albers ◽  
Christopher Bladin ◽  
Min Chen ◽  
Cesare Fieschi ◽  
...  

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 &lt;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 &lt;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 &lt;14. Table 1: Incidence of VTE and bleeding Endpoint Enoxaparin n/N (%, 95% CI) UFH n/N (%, 95% CI) *P&lt;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)


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