Thomas L Ortel

Duke University Medical Center, Durham, North Carolina, United States

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Publications (201)1307.78 Total impact

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    ABSTRACT: Recurrent venous thromboembolism (VTE) occurs infrequently following a provoked event but occurs in up to 30% of individuals following an initial unprovoked event. There is limited understanding of the biological mechanisms that predispose patients to recurrent VTE. To identify whole blood gene expression profiles that distinguished patients with clinically distinct patterns of VTE. We studied 107 patients with VTE separated into 3 groups: (1) 'low-risk' patients had one or more provoked VTE; (2) 'moderate-risk' patients had a single unprovoked VTE; (3) 'high-risk' patients had ≥2 unprovoked VTE. Each patient group was also compared to twenty-five individuals with no personal history of VTE. Total RNA from whole blood was isolated and hybridized to Illumina HT-12V4 Beadchips to assay whole genome expression. Using class prediction analysis, we distinguished high-risk patients from low-risk patients and healthy controls with good receiver operating curve characteristics (AUC=0.81 and 0.84, respectively). We also distinguished moderate-risk individuals and low-risk individuals from healthy controls with AUC's of 0.69 and 0.80, respectively. Using differential expression analysis, we identified several genes previously implicated in thrombotic disorders by genetic analyses, including SELP, KLKB1, ANXA5, and CD46. Protein levels for several of the identified genes were not significantly different between the different groups. Gene expression profiles are capable of distinguishing patients with different clinical presentations of VTE, and genes relevant to VTE risk are frequently differentially expressed in these comparisons. Copyright © 2015 Elsevier Ltd. All rights reserved.
    Thrombosis Research 02/2015; 135(4). DOI:10.1016/j.thromres.2015.02.003 · 2.43 Impact Factor
  • Ian Welsby, Thomas L Ortel
    Critical Care Medicine 02/2015; 43(2):500-1. DOI:10.1097/CCM.0000000000000784 · 6.15 Impact Factor
  • Gowthami M Arepally, Thomas L Ortel
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    ABSTRACT: The target-specific oral anticoagulants are a class of agents that inhibit factor Xa or thrombin. They are effective and safe compared to warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation and for the treatment of venous thromboembolism, and they are comparable to low-molecular-weight heparin for thromboprophylaxis after hip or knee arthroplasty. For other indications, however, such as the prevention of stroke in patients with mechanical heart valves, initial studies have been unfavorable for the newer agents, leaving warfarin the anticoagulant of choice. Further studies are needed before the target-specific anticoagulants can be recommended for patients with cancer-associated thrombosis or heparin-induced thrombocytopenia. Concerns also persist about difficulties with the laboratory assessment of anticoagulant effect and the lack of a specific reversal agent. For these reasons, we anticipate that the vitamin K antagonists will continue to be important anticoagulants for years to come.
    Annual Review of Medicine 01/2015; 66(1):241-53. DOI:10.1146/annurev-med-051113-024633 · 15.48 Impact Factor
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    ABSTRACT: Mental stress-induced myocardial ischemia (MSIMI) is common in patients with ischemic heart disease (IHD) and associated with a poorer cardiovascular prognosis. Platelet hyperactivity is an important factor in acute coronary syndrome. This study examined associations between MSIMI and resting and mental stress-induced platelet activity.
    American Heart Journal 12/2014; DOI:10.1016/j.ahj.2014.12.002 · 4.56 Impact Factor
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    ABSTRACT: Background The postthrombotic syndrome (PTS) is a frequent chronic complication of deep vein thrombosis (DVT).Objective In the BioSox study we investigated whether inflammation markers predict the risk of PTS after DVT.Methods We measured C-reactive protein (CRP), intercellular adhesion molecule (ICAM)-1, interleukin (IL)-6 and IL-10, at baseline, 1 and 6 months after a first proximal DVT among 803 participants in the SOX trial. Participants were prospectively followed for 24 months for development of PTS.ResultsMedian CRP levels at 1 month, ICAM-1 at baseline, 1 and 6 months, IL-6 at 1 and 6 months, and IL-10 at 6 months were higher in patients who developed PTS than in those who did not. Multivariable regression using the median as a cutoff showed relative risks (RR) for PTS of 1.23 (95% confidence interval 1.05 – 1.45), and 1.25 (1.05 – 1.48) for ICAM-1 at 1 and 6 months, respectively; and 1.27 (1.07 – 1.51) for IL-10 at 6 months. Quartile-based analysis demonstrated a dose-response association between ICAM-1 and PTS. ICAM-1 and IL-10 were also associated with PTS severity. Analysis of biomarker trajectories after DVT demonstrated an association between the highest trajectory group of ICAM-1 and PTS.Conclusions In this prospective study ICAM-1 over time was most consistently associated with risk of PTS. Further study is required to confirm these findings and assess their potential clinical relevance.This article is protected by copyright. All rights reserved.
    Journal of Thrombosis and Haemostasis 12/2014; 13(3). DOI:10.1111/jth.12814 · 6.08 Impact Factor
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    ABSTRACT: A retrospective cohort study was conducted.•Among adult enrollees in commercial insurance.•Those with selected autoimmune diseases had higher risk of venous thromboembolism.
    Thrombosis Research 10/2014; DOI:10.1016/j.thromres.2014.10.012 · 2.43 Impact Factor
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    ABSTRACT: Background Although emotional stress is associated with ischemic heart disease (IHD) and related clinical events, sex-specific differences in the psychobiological response to mental stress have not been clearly identified. Objectives We aimed to study the differential psychological and cardiovascular responses to mental stress between male and female patients with stable IHD. Methods Patients with stable IHD enrolled in the REMIT (Responses of Mental Stress–Induced Myocardial Ischemia to Escitalopram) study underwent psychometric assessments, transthoracic echocardiography, and platelet aggregation studies at baseline and after 3 mental stress tasks. Mental stress–induced myocardial ischemia (MSIMI) was defined as the development or worsening of regional wall motion abnormality, reduction of left ventricular ejection fraction (LVEF) ≥8% by transthoracic echocardiography, and/or ischemic ST-segment change on electrocardiogram during 1 or more of the 3 mental stress tasks. Results In the 310 participants with known IHD (18% women, 82% men), most baseline characteristics were similar between women and men (including heart rate, blood pressure, and LVEF), although women were more likely to be nonwhite, living alone (p < 0.001), and unmarried (p < 0.001); they also had higher baseline depression and anxiety (p < 0.05). At rest, women had heightened platelet aggregation responses to serotonin (p = 0.007) and epinephrine (p = 0.004) compared with men. Following mental stress, women had more MSIMI (57% vs. 41%; p < 0.04), expressed more negative (p = 0.02) and less positive emotion (p < 0.001), and demonstrated higher collagen-stimulated platelet aggregation responses (p = 0.04) than men. Men were more likely than women to show changes in traditional physiological measures, such as blood pressure (p < 0.05) and double product. Conclusions In this exploratory analysis, we identified clear, measurable, and differential responses to mental stress in women and men. Further studies should test the association of sex differences in cardiovascular and platelet reactivity in response to mental stress and long-term outcomes. (Responses of Myocardial Ischemia to Escitalopram Treatment [REMIT]; NCT00574847)
    Journal of the American College of Cardiology 10/2014; 64(16):1669–1678. DOI:10.1016/j.jacc.2014.04.087 · 15.34 Impact Factor
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    Circulation 09/2014; 130(14):1192-203. DOI:10.1161/CIRCULATIONAHA.113.008428 · 14.95 Impact Factor
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    ABSTRACT: Acute deep venous thrombosis (DVT) causes leg pain. Elastic compression stockings (ECS) have potential to relieve DVT-related leg pain by diminishing the diameter of distended veins and increasing venous blood flow. It was our objective to determine whether ECS reduce leg pain in patients with acute DVT. We performed a secondary analysis of the SOX Trial, a multicentrerandomised placebo controlled trial of active ECS versus placebo ECS to prevent the post-thrombotic syndrome.The study was performed in24 hospital centres in Canada and the U.S. and included 803 patients with a first episode of acute proximal DVT. We performed active ECS (knee length, 30-40 mm Hg graduated pressure) or placebo ECS (manufactured to look identical to active ECS, but lacking therapeutic compression). Study outcome was leg pain severity assessed on an 11-point numerical pain rating scale (0, no pain; 10, worst possible pain) at baseline, 14, 30 and 60 days after randomisation. Mean age was 55 years and 60% were male. In active ECS patients (n=409), mean (SD) pain severity at baseline and at 60 days were 5.18 (3.29) and 1.39 (2.19), respectively, and in placebo ECS patients (n=394) were 5.38 (3.29) and 1.13 (1.86), respectively. There were no significant differences in pain scores between groups at any assessment point, and no evidence for subgroup interaction by age, sex or anatomical extent of DVT. Results were similar in an analysis restricted to patients who reported wearing stockings every day. In conclusion, ECS do not reduce leg pain in patients with acute proximal DVT.
    Thrombosis and Haemostasis 08/2014; 112(6). DOI:10.1160/TH14-05-0430 · 5.76 Impact Factor
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    ABSTRACT: While aspirin is generally effective for prevention of cardiovascular disease, considerable variation in drug response exists, resulting in some individuals displaying high on-treatment platelet reactivity. We used pharmacometabolomics to define pathways implicated in variation of response to treatment. We profiled serum samples from healthy subjects pre- and postaspirin (14 days, 81 mg/day) using mass spectrometry. We established a strong signature of aspirin exposure independent of response (15/34 metabolites changed). In our discovery (N = 80) and replication (N = 125) cohorts, higher serotonin levels pre- and postaspirin correlated with high, postaspirin, collagen-induced platelet aggregation. In a third cohort, platelets from subjects with the highest levels of serotonin preaspirin retained higher reactivity after incubation with aspirin than platelets from subjects with the lowest serotonin levels preaspirin (72 ± 8 vs. 61 ± 11%, P = 0.02, N = 20). Finally, ex vivo, serotonin strongly increased platelet reactivity after platelet incubation with aspirin (+20%, P = 4.9 × 10(-4), N = 12). These results suggest that serotonin is implicated in aspirin response variability.
    07/2014; 3:e125. DOI:10.1038/psp.2014.22
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    ABSTRACT: The REG2 Anticoagulation System consists of pegnivacogin, a subcutaneously administered aptamer factor IXa inhibitor, and its intravenous active control agent, anivamersen. Its effect on thrombin generation is unknown. A prospectively designed thrombin generation study was conducted within the phase 1 ascending dose study of REG2 to assess the effect of REG2 on thrombin generation kinetics. A total of 32 healthy volunteers were recruited into four cohorts of ascending dose pegnivacogin for the phase 1 study. In this pre-specified substudy, blood samples were drawn in the presence or absence of corn trypsin inhibitor at specified times within each dosing cohort. Thrombin generation was initiated with tissue factor and thrombin generation kinetics were measured using the Calibrated Automated Thrombogram (CAT). REG2 attenuated thrombin generation in a dose-dependent manner. All parameters of the CAT assay, except for lag time, showed a dose and concentration-dependent response to pegnivacogin [time to peak thrombin generation (PTm), endogenous thrombin potential, peak thrombin generation, and velocity index (VIx)]. Reversal of the effect of pegnivacogin with anivamersen demonstrated restoration of thrombin generation without rebound effect. This first-in-human study of the effect of the REG2 Anticoagulation System on thrombin generation demonstrates concentration-dependent suppression of thrombin generation that is reversible without rebound effect, as measured by the CAT assay.
    Journal of Thrombosis and Thrombolysis 06/2014; 38(3). DOI:10.1007/s11239-014-1081-6 · 2.04 Impact Factor
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    ABSTRACT: Current classification criteria for definite Antiphospholipid Syndrome (APS) require the use of three laboratory assays to detect antiphospholipid antibodies (aCL, anti-β2GPI and LA) in the presence of at least one of the two major clinical manifestations (i.e. thrombosis or pregnancy morbidity) of the syndrome. However, several other autoantibodies shown to be directed to other proteins or their complex with phospholipids have been proposed to be relevant to APS but their clinical utility and their diagnostic value remains elusive. This report summarises the findings, conclusions and recommendations of the "APS Task Force 3 - Laboratory Diagnostics and Trends" meeting that took place during the 14th International Congress on Antiphospholipid Antibodies (APLA 2013, September 18-21, Rio de Janeiro, RJ, Brazil).
    Autoimmunity reviews 05/2014; DOI:10.1016/j.autrev.2014.05.001 · 6.37 Impact Factor
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    ABSTRACT: According to classification criteria for antiphospholipid syndrome (APS), laboratory diagnosis is based on the detection of antiphospholipid antibodies (aPL) by immunological assays with cardiolipin (aCL) and/or β2 glycoprotein I (aβ2 GPI) as antigen and/or lupus anticoagulants (LA)[1]. There is a large variety of assays assessing aPL and despite consensus guidelines, some issues remain unanswered[2]. Factors that contribute to result variability include pre-, post- and analytical conditions, calibration, and assay-specific issues[3]. Recommendations published in 2009 by this Subcommittee for the detection of LA have proven useful in standardization of this assay[4]. Likewise, recommendations for detection of aCL and aβ2 GPI antibodies by immunoassays are needed. This article is protected by copyright. All rights reserved.
    Journal of Thrombosis and Haemostasis 03/2014; DOI:10.1111/jth.12537 · 6.08 Impact Factor
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    ABSTRACT: Background Post-thrombotic syndrome (PTS) is a common and burdensome complication of deep venous thrombosis (DVT). Previous trials suggesting benefit of elastic compression stockings (ECS) to prevent PTS were small, single-centre studies without placebo control. We aimed to assess the efficacy of ECS, compared with placebo stockings, for the prevention of PTS. Methods We did a multicentre randomised placebo-controlled trial of active versus placebo ECS used for 2 years to prevent PTS after a first proximal DVT in centres in Canada and the USA. Patients were randomly assigned to study groups with a web-based randomisation system. Patients presenting with a first symptomatic, proximal DVT were potentially eligible to participate. They were excluded if the use of compression stockings was contraindicated, they had an expected lifespan of less than 6 months, geographical inaccessibility precluded return for follow-up visits, they were unable to apply stockings, or they received thrombolytic therapy for the initial treatment of acute DVT. The primary outcome was PTS diagnosed at 6 months or later using Ginsberg's criteria (leg pain and swelling of >= 1 month duration). We used a modified intention to treat Cox regression analysis, supplemented by a prespecified per-protocol analysis of patients who reported frequent use of their allocated treatment. This study is registered with ClinicalTrials.gov, number NCT00143598, and Current Controlled Trials, number ISRCTN71334751. Findings From 2004 to 2010, 410 patients were randomly assigned to receive active ECS and 396 placebo ECS. The cumulative incidence of PTS was 14.2% in active ECS versus 12.7% in placebo ECS (hazard ratio adjusted for centre 1.13, 95% CI 0.73-1.76; p=0.58). Results were similar in a prespecified per-protocol analysis of patients who reported frequent use of stockings. Interpretation ECS did not prevent PTS after a first proximal DVT, hence our findings do not support routine wearing of ECS after DVT.
    The Lancet 03/2014; 383(9920):880–888. DOI:10.1016/S0140-6736(13)61902-9 · 39.21 Impact Factor
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    ABSTRACT: Previous research has suggested autoimmune diseases are risk factors for developing venous thromboembolism (VTE). We assessed whether having diagnoses of selected autoimmune diseases associated with antiphospholipid antibodies-autoimmune hemolytic anemia (AIHA), immune thrombocytopenic purpura (ITP), rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE)-were associated with having a VTE diagnosis among US adult hospitalizations. A cross-sectional study was conducted using the 2010 Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality. VTE and autoimmune diseases were identified using International Classification of Diseases, Ninth Revision, Clinical Modification coded diagnoses information. The percentages of hospitalizations with a VTE diagnosis among all non-maternal adult hospitalizations without any of the four autoimmune diseases of interest and among those with AIHA, ITP, RA, and SLE diagnoses were 2.28, 4.46, 3.35, 2.65 and 2.77 %, respectively. The adjusted odds ratios (OR) for having a diagnosis of VTE among non-maternal adult hospitalizations with diagnoses of AIHA, ITP, RA, and SLE were 1.25 [95 % confidence interval (CI) 1.05-1.49], 1.20 (95 % CI 1.07-1.34), 1.17 (95 % CI 1.13-1.21), and 1.23 (95 % CI 1.15-1.32), respectively, when compared to those without the corresponding conditions. The adjusted OR for a diagnosis of VTE associated with a diagnosis of any of the four autoimmune diseases was 1.20 (95 % CI 1.16-1.24). The presence of a diagnosis of AIHA, ITP, RA, and SLE was associated with an increased likelihood of having a VTE diagnosis among the group of all non-maternal adult hospitalizations.
    Journal of Thrombosis and Thrombolysis 01/2014; 38(3). DOI:10.1007/s11239-014-1050-0 · 1.99 Impact Factor
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    ABSTRACT: Antiphospholipid Syndrome (APS) is characterized by vascular thrombosis and/or pregnancy morbidity occurring in patients with persistent antiphospholipid antibodies (aPL). The primary objective of the APS Treatment Trends Task Force, created as part of the 14th International Congress on aPL, was to systematically review the potential future treatment strategies for aPL-positive patients. The task force chose as future clinical research directions: a) determining the necessity for venous thrombosis controlled clinical trials with the new oral direct thrombin or anti-Factor Xa inhibitors pending the results of ongoing rivaroxaban in APS (RAPS) trial, and designing controlled clinical trials in other forms of thrombotic APS; b) systematically analyzing the literature as well as aPL/APS registries, and creating specific registries for non warfarin/heparin anticoagulants; c) increasing recruitment for an ongoing primary thrombosis prevention trial, and designing secondary thrombosis and pregnancy morbidity prevention trials with hydroxychloroquine; d) determining surrogate markers to select patients for statin trials; e) designing controlled studies with rituximab and other anti B-cell agents; f) designing mechanistic and clinical studies with eculizumab and other complement inhibitors; and g) chemically modifying peptide therapy to improve the half-life and minimize immunogenicity. The report also includes recommendations for clinicians who consider using these agents in difficult-to-manage aPL-positive patients.
    Autoimmunity reviews 01/2014; DOI:10.1016/j.autrev.2014.01.053 · 6.37 Impact Factor
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    ABSTRACT: Background The clinical utility of genotype-guided (pharmacogenetically based) dosing of warfarin has been tested only in small clinical trials or observational studies, with equivocal results. Methods We randomly assigned 1015 patients to receive doses of warfarin during the first 5 days of therapy that were determined according to a dosing algorithm that included both clinical variables and genotype data or to one that included clinical variables only. All patients and clinicians were unaware of the dose of warfarin during the first 4 weeks of therapy. The primary outcome was the percentage of time that the international normalized ratio (INR) was in the therapeutic range from day 4 or 5 through day 28 of therapy. Results At 4 weeks, the mean percentage of time in the therapeutic range was 45.2% in the genotype-guided group and 45.4% in the clinically guided group (adjusted mean difference, [genotype-guided group minus clinically guided group], -0.2; 95% confidence interval, -3.4 to 3.1; P=0.91). There also was no significant between-group difference among patients with a predicted dose difference between the two algorithms of 1 mg per day or more. There was, however, a significant interaction between dosing strategy and race (P=0.003). Among black patients, the mean percentage of time in the therapeutic range was less in the genotype-guided group than in the clinically guided group. The rates of the combined outcome of any INR of 4 or more, major bleeding, or thromboembolism did not differ significantly according to dosing strategy. Conclusions Genotype-guided dosing of warfarin did not improve anticoagulation control during the first 4 weeks of therapy. (Funded by the National Heart, Lung, and Blood Institute and others; COAG ClinicalTrials.gov number, NCT00839657 .).
    New England Journal of Medicine 11/2013; DOI:10.1056/NEJMoa1310669 · 54.42 Impact Factor
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    ABSTRACT: Black women have an increased risk of adverse pregnancy outcomes and the characteristics of thrombotic risk factors in this population are unknown. The objective of this study was to examine the racial differences in thrombotic risk factors among women with adverse pregnancy outcomes. Uniform data were collected in women with adverse pregnancy outcomes (pregnancy losses, intrauterine growth restriction (IUGR), prematurity, placental abruption and preeclampsia) referred to Thrombosis Network Centers funded by the Centers for Disease Control and Prevention (CDC). Among 343 white and 66 black women seen for adverse pregnancy outcomes, protein S and antithrombin deficiencies were more common in black women. The prevalence of diagnosed thrombophilia was higher among whites compared to blacks largely due to Factor V Leiden mutation. The prevalence of a personal history of venous thromboembolism (VTE) did not differ significantly by race. A family history of VTE, thrombophilia, and stroke or myocardial infarction (MI) was higher among whites. Black women had a higher body mass index, and a higher prevalence of hypertension, while the prevalence of sickle cell disease was approximately 27 fold higher compared to the general US black population. Thrombotic risk factors differ significantly in white and black women with adverse pregnancy outcomes. Such differences highlight the importance of considering race separately when assessing thrombotic risk factors for adverse pregnancy outcomes.
    Thrombosis Research 11/2013; DOI:10.1016/j.thromres.2013.10.035 · 2.43 Impact Factor
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    ABSTRACT: Objectives The aim of this study was to examine the associations between depressive symptoms and mental stress-induced myocardial ischemia (MSIMI) in patients with coronary heart disease (CHD).Methods Adult patients with documented CHD were recruited for baseline mental stress and exercise stress screening testing as a part of the enrollment process of the Responses of Myocardial Ischemia to Escitalopram Treatment trial. Patients were administered the Beck Depression Inventory II and the Center for Epidemiologic Studies Depression Scale. After a 24-48-hour β-blocker withdrawal, participants completed three mental stress tests followed by a treadmill exercise test. Ischemia was defined as a) any development or worsening of any wall motion abnormality and b) reduction of left ventricular ejection fraction at least 8% by transthoracic echocardiography and/or ischemic ST-segment change by electrocardiography during stress testing. MSIMI was considered present when ischemia occurred in at least one mental test. Data were analyzed using logistic regression adjusting for age, sex, and resting left ventricular ejection fraction.ResultsOne hundred twenty-five (44.2%) of 283 patients were found to have MSIMI, and 93 (32.9%) had ESIMI. Unadjusted analysis showed that Beck Depression Inventory II scores were positively associated with the probability of MSIMI (odds ratio = 0.1.30: 95% confidence interval = 1.06-1.60, p = .013) and number of MSIMI-positive tasks (all p < .005). These associations were still significant after adjustment for covariates (p values <.05).Conclusions In patients with CHD, depressive symptoms were associated with a higher probability of MSIMI. These observations may enhance our understanding of the mechanisms contributing to the association of depressive symptoms to future cardiovascular events.Trial RegistrationClinicaltrials.gov identifier: NCT00574847.
    Psychosomatic Medicine 10/2013; 75(9). DOI:10.1097/PSY.0b013e3182a893ae · 4.09 Impact Factor
  • Alex C Spyropoulos, Thomas L Ortel
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    ABSTRACT: To the Editor: Baron et al. (May 30 issue)(1) make important suggestions in their review article; however, we propose that quantitative assessment of iatrogenic bleeding hazards must be considered as well as thrombosis prevention.(1) Although CHA2DS2-VASc scoring for atrial fibrillation is mentioned, the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly (HAS-BLED) score for bleeding has also been validated.(2) Both scores calculate estimated annual risks and benefits and hence can guide future therapy. Among the diverse causes of major bleeding outcomes associated with antithrombotic agents are periprocedural, intracranial, and gastrointestinal . . .
    New England Journal of Medicine 09/2013; 369(11):1078. DOI:10.1056/NEJMc1308259#SA3 · 54.42 Impact Factor

Publication Stats

5k Citations
1,307.78 Total Impact Points

Institutions

  • 1990–2015
    • Duke University Medical Center
      • • Department of Pathology
      • • Division of Hematology
      • • Department of Medicine
      • • Department of Surgery
      • • Department of Radiology
      Durham, North Carolina, United States
  • 2000–2014
    • Duke University
      • • Department of Medicine
      • • Department of Anesthesiology
      Durham, North Carolina, United States
  • 2009
    • University of Pennsylvania
      • Department of Medicine
      Philadelphia, PA, United States
  • 2008
    • Washington University in St. Louis
      • Department of Medicine
      San Luis, Missouri, United States
  • 2005
    • American Society of Hematology
      Washington, Washington, D.C., United States
  • 2004
    • Maastricht University
      • Department of Biochemistry
      Maestricht, Limburg, Netherlands