Identifying Bleeding Risk In Medical Inpatients

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2933-2933
Author(s):  
John P. Winters ◽  
Michael Desarno ◽  
Damon Houghton ◽  
Samuel A Merrill ◽  
Peter Callas ◽  
...  

Abstract Introduction Expert guidelines and regulatory agencies recommend that all medical inpatients be assessed for venous thrombosis (VT) risk and pharmacologic prophylaxis provided to at-risk patients. However, anticoagulant prophylaxis may increase the risk of major bleeding in medical inpatients and the incidence and risk factors for major bleeding are not established. Our goal was to determine the rate of hospital-acquired major bleeding in medical inpatients and whether patients at increased risk of hospital-acquired VT were also at increased risk for hospital-acquired major bleeding. Methods All cases of hospital-acquired major bleeding on medical services (cardiology, hematology/oncology, intensive care, internal medicine) were identified at Fletcher Allen Health Care (500-bed teaching hospital for the University of Vermont) between June 2009 and April 2012. Major bleeding was defined as symptomatic bleeding in a critical area (intracranial, intraspinal, intraocular, retroperitoneal and peritoneal by ICD-9 discharge codes with the present on admission flag marked as ‘no') or any bleeding that caused a fall in hemoglobin of 2g/dL within 24 hours (assessed from the laboratory database after the patient had been admitted for 24 hours) and required a red blood cell transfusion. The sensitivity and specificity of the definition was confirmed by chart review of 20 cases of hospital-acquired major bleeding and 20 non-cases. Logistic regression was used to calculate odds ratios (OR) for major bleeding for age, use of anticoagulation, and risk factors for hospital-acquired VT contained in the Medical Inpatient Thrombosis (MITH) score (Table). The MITH score was calculated for each patient using data present on admission: history of heart failure = 5 points, history of rheumatologic disease = 4 points, history of fracture in past 3 months = 3 points, history of cancer in past 12 months = 1 point, tachycardia (HR>100 at admission) = 2 points, respiratory dysfunction (SpO2<90% at admission or intubated on hospital day 1) = 1 point, white blood cell count >11 x 103/µL = 1 points, platelet count >350 x 103/µL = 1 point). Major bleeding rate was calculated for MITH score using the following cut off points: 0-1, 2-5, ≥6. Results 241 cases of major bleeding complicated 20,946 medical admissions (11.1 per 1000 admissions). The sensitivity and specificity of our definition of hospital-acquired major bleeding was 100% and 83%, respectively. Prophylactic anticoagulation ordered on admission was not associated with major bleeding (OR 1.1) but full anticoagulation on admission was associated with major bleeding (OR 1.4). Of the MITH score variables, respiratory dysfunction (OR 2.2), prior history of congestive heart failure (OR 2.2) and white cell count ≥11 x 103/µL (OR 2.0) on admission were associated with major bleeding (table 1). For MITH scores 0-1, 2-5, and ≥5, major bleeding occurred in 6, 11, and 19 per 1000 admissions, respectively. The corresponding incidence of hospital-acquired venous thrombosis for a MITH score of 0-1, 2-5, and ≥6 were 2, 7, and 14 per 1000 admissions. Hospital-acquired VT was strongly associated with major bleeding (OR 20.4; 95% CI 12.4, 33.7). Conclusion Major bleeding is a more common complication of hospital admission than VT. Risk factors and an aggregate risk score for hospital-acquired VT were associated with the risk of major bleeding. Evidence-based models which assess both bleeding and thrombosis risk are urgently needed to help risk stratify medical patients for appropriate VT prophylaxis. Disclosures: No relevant conflicts of interest to declare.

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2931-2931
Author(s):  
Damon E Houghton ◽  
Michael Desarno ◽  
Peter Callas ◽  
Allen B Repp ◽  
Mary Cushman ◽  
...  

Abstract Introduction Governmental agencies recommend risk assessment of venous thrombosis (VT) for medical inpatients at admission and provision of VT prophylaxis for moderate to high risk patients. While several risk factor models for predicting hospital-acquired VT have been proposed, none have been widely accepted and few have been prospectively validated. We sought to validate the recently published MITH VT risk assessment model in an independent cohort of medical inpatients (Zakai et al, Journal of Thrombosis and Haemostasis 2013). Methods Hospital-acquired VT and risk factors present at admission were collected from adult inpatients between June 2009 and April 2012 admitted to the medicine, medical intensive care, hematology/oncology, or cardiology services at Fletcher Allen Hospital (500 bed teaching hospital for the University of Vermont). Hospital-acquired VT was defined using VT discharge ICD-9 codes (flagged as not present on admission) and record of an imaging study that could diagnosis VT (such as duplex ultrasound, computed tomography angiography, or ventilation perfusions scan). Inpatients with VT ICD-9 codes flagged as present on admission were excluded. The sensitivity and specificity of the definition was confirmed by chart review of 30 cases of hospital-acquired VTE and 30 non-cases. Risk factors for hospital-acquired VT were captured using ICD-9 codes from the problem list, discharge codes, vital signs, and laboratory values at admission. The MITH score was calculated for each patient based on the points for each risk factor: history of heart failure = 5 pts, history of rheumatologic disease = 4 pts, history of fracture in past 3 months = 3 pts, history of cancer in past 12 months = 1 pt, tachycardia (HR>100 at admission) = 2pt, respiratory dysfunction (SpO2<90% at admission or intubated on hospital day 1) = 1 pt, white blood cell count >11 = 1 pt, platelet count >350 = 1 pt. The absolute rates of hospital-acquired VT for different cut points of the score were calculated and compared qualitatively to those previously published for the MITH score. Results There were 120 hospital-acquired VT events complicating 20,334 medical admissions (5.9 cases per 1,000 hospital admissions). The sensitivity and specificity of our definition of hospital-acquired VT was 100% and 91%, respectively. The table presents the prevalence of the MITH score at various cut-offs in cases and non-cases as well as the incidence of VT. In the derivation of the MITH score, the rate of VT per 1000 admissions for a score <1, <2, or <3 was 1.0, 1.5, and 2.1 compared with 0.7, 1.8, and 2.2 VT per 1000 admissions for the validation cohort. The incidence of VTE in the derivation of the MITH score for a score ≥1, ≥2, and ≥3 was 6.0, 8.9, and 12.4 per 1000 admissions compared with 7.9, 9.0, and 10.3 per 1000 admissions in the validation cohort. Conclusions We have validated a previously published VT risk score for hospitalized medical patients in an independent population. Determination of a patient's risk of VT at admission using readily available clinical and laboratory data could allow physicians to make informed decisions about risks and benefits of DVT prophylaxis. Further work is required to determine at what level of risk pharmacologic VT prophylaxis is warranted in this patient population. Disclosures: No relevant conflicts of interest to declare.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2258-2258
Author(s):  
Matthew E. Lebow ◽  
Michael DeSarno ◽  
Damon Eugene Houghton ◽  
John P. Winters ◽  
Samuel A. Merrill ◽  
...  

Abstract Introduction: There is little data on the incidence and consequences of hospital-acquired (HA) platelet count drops and no consensus on how to define HA-thrombocytopenia. We evaluated the incidence of relative and absolute HA-drops in platelet count among medical patients (general medicine, cardiology, and intensive care unit) to determine their association with mortality, HA-venous thromboembolism (VTE), and HA-bleeding. Methods: Data was abstracted from the electronic medical record at the University of Vermont Medical Center, a 540-bed tertiary care hospital in Burlington, VT for admissions between 2009-12. Exclusion criteria were age &lt;18, pregnant, admitted to a non-medical service or to the oncology service, and platelet count &lt;150 thousand (k) at admission. HA-platelet count drops were defined as listed in the table (absolute nadir, relative drop, absolute platelet count). We used logistic regression to evaluate the association of various definitions of platelet count drops with HA-VTE, HA-bleeding (based on the International Society of Thrombosis and Haemostasis definition), and in-hospital mortality. Models were adjusted for age, sex, service, admission platelet count, and for known risk factors for HA-VTE, HA-bleeding, and mortality (Table). Results: Of 11,863 admissions without thrombocytopenia on admission, 1,905 (16.1%) patients developed a platelet count &lt;150k, 6,971 (58.8%) had at least a 10% drop in their platelet count, and 6,737 (56.8%) at least a 25k drop (Table). There were 939 (7.9%) deaths, 48 (0.4%) HA-VTE, and 106 (0.9%) HA-bleeding events. HA-platelet count drops were associated with increasing age, male sex, and admission to an intensive care unit (all p &lt; 0.05). All definitions of platelet count drops were associated with mortality, HA-VTE, and HA-bleeding (Table). A 10% platelet count drop was associated with increased mortality (OR 1.52, CI: 95% 1.30-1.79), HA-VTE (OR 5.19, CI: 95% 1.83-14.74), and HA-bleeding (OR 8.83, CI: 95% 3.20-24.36) and an absolute 25k drop was associated with increased mortality (OR 1.60, CI: 95% 1.36-1.88), HA-VTE (OR 4.27, CI: 95% 1.64-11.11), and HA-bleeding (OR 5.22, CI: 95% 2.38-11.49). Conclusion: Platelet count drops, even those considered clinically insignificant, identify a large number of hospitalized medical patients at increased risk for mortality, HA-VTE, and HA-bleeding. Our findings are not driven by severe HA-thrombocytopenia as only 2% of admissions developed platelet counts &lt;100,000. HA-platelet count drops are likely a good marker of illness severity in this population and could identify patients at increased risk for mortality, HA-VTE and HA-bleeding allowing targeted interventions to improve patient outcomes. Table 1. Association of Hospital-Acquired Platelet Count Drops with Mortality, HA-VTE and HA-Bleeding in Medical Patients Platelet Drop Admissions = 11,863 Odds Ratio (95% Confidence Interval) N, % Mortality N = 939 HA-VTE N = 48 HA-Bleeding N = 106 Absolute Nadir &lt;150k 1,905 (16.1%) 2.0 (1.7, 2.5) 4.3 (2.3, 7.9) 2.7 (1.8, 4.2) &lt;100k 235 (2.0%) 4.4 (3.0, 6.3) 5.4 (2.3, 12.5) 3.2 (1.8, 5.8) Relative Drop 50% 371 (3.1%) 3.8 (2.8, 5.2) 6.3 (3.1, 12.8) 5.0 (3.1, 8.0) 30% 1,748 (14.7%) 2.5 (2.1, 3.0) 4.2 (2.2, 7.9) 3.6 (2.3, 5.6) 10% 6,971 (58.8%) 1.5 (1.3, 1.8) 5.2 (1.8, 14.7) 8.8 (3.2, 24.4) Absolute Drop 100k 1,186 (10.0%) 2.7 (2.2, 3.3) 6.4 (3.2, 12.8) 4.3 (2.8, 6.8) 75k 2,019 (17.0%) 2.4 (2.0, 2.3) 5.0 (2.6, 9.9) 4.8 (3.1, 7.7) 50k 3,594 (30.3%) 1.9 (1.7, 2.3) 3.3 (1.7, 6.6) 5.5 (3.2, 9.4) 25k 6,737 (56.8%) 1.6 (1.4, 1.9) 4.3 (1.6, 11.1) 5.2 (2.4, 11.5) Mortality - Adjusted additionally for: Respiratory Rate, Respiratory Dysfunction (intubated or oxygen saturation &lt;90%), Heart Rate, Temperature, Diabetes, Cancer, and HIV (Brabrand, PLoS ONE 2015) HA-VTE - Adjusted additionally for: Anticoagulation (prophylactic and full dose), Cancer, Heart Failure, Respiratory Dysfunction, Rheumatologic or Inflammatory Disease, and Tachycardia (Zakai, JTH 2013) HA-Bleeding - Adjusted additionally for: Anticoagulation (prophylactic and full dose), Cancer, Renal Function, Heart Failure, Respiratory Dysfunction, Rheumatologic or Inflammatory Disease, and Tachycardia (Decousis, Chest 2011) Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3689-3689
Author(s):  
Shumei Kato ◽  
Koichi Takahashi ◽  
Kengo Ayabe ◽  
Reza Samad ◽  
Eri Fukaya ◽  
...  

Abstract Abstract 3689 Background: Heparin-induced thrombocytopenia (HIT) is an unpredictable drug reaction to heparin characterized by thrombocytopenia and increased risk of life threatening venous and/or arterial thrombosis. Although HIT is uncommon, it is a serious side effect in patients receiving heparin. Data are lacking if there are additional risk factors that may be associated with the development of HIT. Accordingly, the aim of this study was to identify the risk factors that may be associated with the development of HIT in medical inpatients receiving heparin. Methods: This is a retrospective cohort study with 25,653 patients who were admitted to the medicine service and received heparin products (unfractionated heparin [UFH] or enoxaparin) in an urban teaching hospital in New York City from August 2005 to January 2010. Computerized discharge summaries, medical charts, radiology and laboratory reports were used in this retrospective study. Demographics such as age, gender and race were recorded. Details of medical history and hospital course of each patient was reviewed to obtain the known risk factors for HIT as well as possible confounding factors that may be related to the development of HIT. The diagnosis of HIT was confirmed if the platelet count dropped >50% from baseline and there was a positive laboratory HIT assay. Results: Fifty-five cases of in-hospital HIT (raw incidence, 0.21%, 95% CI [0.16, 0.28]) were observed (Table 1). After multivariate analysis, patients whose race was either Asian or Hispanic demonstrated an increased risk of developing HIT (relative risk [RR]= 2.61; 95% CI [1.10, 6.17]; p= 0.03 and RR= 2.21; 95% CI [1.22, 4.02]; p= 0.01 respectively). Additionally, patients who received full anticoagulation dose with UFH (RR= 3.66; 95% CI [1.98, 6.75]; p= <0.0001) or were exposed to heparin products for more than 5 days also had an increased risk of HIT (RR= 5.51; 95% CI [2.48, 12.2]; p= <0.0001 if heparin given 5 to 10 days, RR= 7.66; 95% CI [3.31, 17.8]; p= <0.0001 if heparin given more than 10 days). Moreover, patients who were on hemodialysis, carried a diagnosis of autoimmune disease, gout or heart failure remained as a independent risk factor for HIT (RR= 9.68; 95% CI [4.90, 19.1]; p= <0.0001, RR= 3.47; 95% CI [1.93, 6.26]; p= <0.0001, RR= 2.89; 95% CI [1.09, 7.68]; p= 0.03, and RR= 2.10; 95% CI [1.09, 4.08]; p= 0.03 respectively) (Table 2). Conclusion: Among patients admitted to inpatient medicine service receiving heparin products, patients who were Asian or Hispanic, who were treated with full anticoagulation dose with UFH or who received heparin product >5 days were at increased risk of HIT. Furthermore, patients who were on hemodialysis, had autoimmune disease, gout and heart failure were also at increased risk of in-hospital HIT. The results suggest that when using heparin products in these patient cohorts, increased surveillance of HIT is necessary. Disclosures: No relevant conflicts of interest to declare.


2021 ◽  
Vol 10 (5) ◽  
pp. 923
Author(s):  
Sandro Ninni ◽  
Gilles Lemesle ◽  
Thibaud Meurice ◽  
Olivier Tricot ◽  
Nicolas Lamblin ◽  
...  

Introduction: Incident heart failure (HF), ischemic stroke and systemic embolism (IS/SE), and major bleeding related to anticoagulation therapy are still the most frequent events occurring in patients with atrial fibrillation (AF). The aim of this study was to assess the 3-year incidence, predictors, and related mortality of IS/SE, major bleeding, and HF in a large cohort of AF outpatients. Methods and results: We studied 4973 outpatients with prevalent AF included in the CARDIONOR registry. The mean age was 72.9 ± 11.2 years, 24.1% had diabetes mellitus and 78.9% had anticoagulant therapy at baseline. The mean CHA2DS2Vasc score was 3.4 ± 1.7. After a median follow-up of 3.2 years (IQR: 2.8 to 3.5), incident HF, IS/SE and major bleeding occurred in 10.5%, 3.3% and 2.1% of patients, respectively. When analyzed as time-dependent variables, IS/SE, major bleeding and hospitalization for decompensated HF were all strongly associated with mortality. The independent predictors of incident HF were age, women, hypertension, diabetes mellitus, coronary artery disease and a previous history of HF. A sensitivity analysis in patients without history of HF at inclusion revealed that incident HF remained the most frequent adverse event, occurring in 5.3% of patients, compared to IS/SE (1.7%) and major bleeding (2.5%). Conclusion: HF is a common residual cardiovascular adverse event occurring in AF outpatients and is associated with a very high mortality. Since modifiable risk factors are associated with incident HF, upstream intensive management of these risk factors would be of interest.


2021 ◽  
Vol 8 (1) ◽  
pp. e000454
Author(s):  
Sofia Ajeganova ◽  
Ingiäld Hafström ◽  
Johan Frostegård

ObjectiveSLE is a strong risk factor for premature cardiovascular (CV) disease and mortality. We investigated which factors could explain poor prognosis in SLE compared with controls.MethodsPatients with SLE and population controls without history of clinical CV events who performed carotid ultrasound examination were recruited for this study. The outcome was incident CV event and death. Event-free survival rates were compared using Kaplan-Meier curves. Relative HR (95% CI) was used to estimate risk of outcome.ResultsPatients (n=99, 87% female), aged 47 (13) years and with a disease duration of 12 (9) years, had mild disease at inclusion, Systemic Lupus Erythematosus Diseases Activity Index score of 3 (1–6) and Systemic Lupus International Collaborating Clinics (SLICC) Damage Index score of 0 (0–1). The controls (n=109, 91% female) were 49 (12) years old. Baseline carotid intima-media thickness (cIMT) did not differ between the groups, but plaques were more prevalent in patients (p=0.068). During 10.1 (9.8-10.2) years, 12 patients and 4 controls reached the outcome (p=0.022). Compared with the controls, the risk of the adverse outcome in patients increased threefold to fourfold taking into account age, gender, history of smoking and diabetes, family history of CV, baseline body mass index, waist circumference, C reactive protein, total cholesterol, high-density lipoprotein, low-density lipoprotein, dyslipidaemia, cIMT and presence of carotid plaque. In patients, higher SLICC score and SLE-antiphospholipid syndrome (SLE-APS) were associated with increased risk of the adverse outcome, with respective HRs of 1.66 (95% CI 1.20 to 2.28) and 9.08 (95% CI 2.71 to 30.5), as was cIMT with an HR of 1.006 (95% CI 1.002 to 1.01). The combination of SLICC and SLE-APS with cIMT significantly improved prediction of the adverse outcome (p<0.001).ConclusionIn patients with mild SLE of more than 10 years duration, there is a threefold to fourfold increased risk of CV events and death compared with persons who do not have SLE with similar pattern of traditional CV risk factors, cIMT and presence of carotid plaque. SLICC, SLE-APS and subclinical atherosclerosis may indicate a group at risk of worse outcome in SLE.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Max Ruge ◽  
Joanne Michelle D Gomez ◽  
Gatha G Nair ◽  
Setri Fugar ◽  
Jeanne du Fay de Lavallaz ◽  
...  

Introduction: The coronavirus disease 2019 (COVID-19) pandemic has killed hundreds of thousands worldwide. Those with cardiovascular disease represent a vulnerable population with higher risk for contracting COVID-19 and worse prognosis with higher case fatality rates. Congestive heart failure (CHF) may lead to worsening COVID-19 symptoms. However, it is unclear if CHF is an independent risk factor for severe COVID-19 infection or if other accompanying comorbidities are responsible for the increased risk. Methods: From March to June 2020, data was obtained from adult patients diagnosed with COVID-19 infection who were admitted in the Rush University System for Health (RUSH) in Illinois. Heart failure patients, determined by ICD code assignments extracted from the electronic medical records, were identified. Multivariable logistic regression was performed between predictor variables and a composite outcome of severe infection consisting of Intensive Care Unit (ICU) admission, intubation, or in-hospital mortality. Results: In this cohort (n=1136), CHF [odds ratio (OR) 1.02] alone did not predict a more severe illness. Prior myocardial infarction [(MI), OR 3.55], history of atrial fibrillation [(AF), OR 2.14], and male sex (OR 1.55) were all significantly (p<0.001) associated with more severe COVID-19 illness course when controlling for CHF (Figure 1). In the 178 CHF patients, more advanced age (68.8 years vs. 63.8 years; p<0.05) and female sex (54.5% vs. 39.1%; p<0.05) were associated with increased severity of illness. Conclusions: Prior MI, history of AF, and male sex predicted more severe COVID-19 illness course in our cohort, but pre-existing heart failure alone did not. However, CHF patients who are females and older in age are at risk for severe infection. These findings help clinicians identify patients with comorbidities early at risk for severe COVID-19 illness.


Author(s):  
Cassie A Simmons ◽  
Nicolas Poupore ◽  
Fernando Gonzalez ◽  
Thomas I Nathaniel

Introduction : Age is the single most important risk factor for stroke and an estimated 75% of all strokes occur in people >65 years of age. In addition, adults >75 years’ experience more hospitalization stays and higher mortality rates with an estimated 50% in the occurrence of all strokes. Several comorbidities have been linked to an increased risk and severity of acute ischemic stroke (AIS). How these factors differentially contribute to the severity of stroke in patients ages >65 and <75 as well as those ≥75 is not known. In this study, we aim to investigate how age, coupled with various clinical risk factors, affects AIS severity within these two age categories. Methods : This retrospective data analysis study was conducted using the data collected from the PRISMA Health Stroke Registry between 2010 and 2016. Baseline clinical and demographic data for patients ages >65 and <75 as well as those ≥75 was analyzed using univariate analysis. Receiver operating characteristic (ROC) curve analysis and multivariate regression models were used to examine the association of specific baseline risk factors or comorbidities associated with worsening or improving neurologic functions. The primary functions were risk factors associated with improving or worsening neurologic outcome in each age category. Results : Adjusted multivariate analysis showed that AIS population of patients >65 and <75 experiencing heart failure (OR = 4.398, 95% CI, 3.912 – 494.613, P = 0.002) and elevated HDL levels (OR = 1.066, 95% CI, 1.009 – 1.126, P = 0.024) trended towards worsening neurologic functions while patients experiencing obesity (OR = 0.177, 95% CI, 0.041 – 0.760, P = 0.020) exhibited improving neurologic functions. For the patients ≥75 years of age, direct admission (OR = 0.270, 95% CI, 0.085 – 0.856, P = 0.026) was associated with improvement of patients treated in the telestroke. Conclusions : Age is a strong risk factor for AIS, and aged stroke patients have higher morbidity and worsening functional recovery than younger patients. In this study, we observed differences in stroke risk factor profiles for >65 and <75 and ≥75 age categories. Heart failure and elevated HDL levels were significantly associated with worsening neurologic functions among AIS for patients aged >65 and <75. Obese patients and individuals ≥75 years who were directly admitted were most likely to exhibit improving neurologic functions. Most importantly, findings from this study reveal specific risk factors that can be managed to improve the care in older stroke patients treated in the telestroke network.


Circulation ◽  
2014 ◽  
Vol 129 (suppl_1) ◽  
Author(s):  
Elena Salmoirago-Blotcher ◽  
Kathleen M Hovey ◽  
Judith K Ockene ◽  
Chris A Andrews ◽  
Jennifer Robinson ◽  
...  

Background: Statin therapy is recommended for treatment of hypercholesterolemia and prevention of cardiovascular events. Concerns have been raised about a potentially higher risk of hemorrhagic stroke in statin users; however, there is limited information in women and in older populations. We evaluated whether statin treatment was associated with increased risk of hemorrhagic stroke among women enrolled in the Women’s Health Initiative (WHI). Methods: This secondary data analysis was conducted among 68,132 women enrolled in the WHI Clinical Trials (CTs). Participants were 50 to 79 yrs old; postmenopausal; and were followed through 2005 (parent study) and for an additional 5 yrs (through September 30, 2010) in the WHI extension study. Statin use was assessed at baseline and at follow-up (FU) visits at 1, 3, 6, and 9 years. Women brought all medications in original containers for inventory. Strokes were self-reported annually and adjudicated by medical record review. Risk of hemorrhagic stroke by statin use (modeled as a time-varying covariate, with the “no use” category as the referent) was estimated from Cox proportional hazard regression models adjusted for age (model 1); risk factors for hemorrhagic stroke (model 2); and possible confounders by indication (model 3). All models adjusted for enrollment in the different CTs and in the extension study. Participants were censored at the date of last contact or loss to FU. Pre-specified subgroup analyses were conducted according to use or non-use of antiplatelet medications (including aspirin) or anticoagulants, and prior history of stroke. Results: Final models included 67,882 women (mean age at baseline 63 ± 7 yrs). Over a mean FU of 12 yrs, incidence rates of hemorrhagic stroke were 6.4/10,000 person-years among women on statins and 5.0/10,000 person-years among women not taking statins. The unadjusted risk of hemorrhagic stroke in statin users vs. non-users was 1.21 (CI: 0.96, 1.53). The HR was attenuated to 0.98 (CI: 0.76, 1.26) after adjusting for age, hypertension, and other risk factors for hemorrhagic stroke. Planned subgroups analyses showed that women taking both statins and antiplatelet agents had a higher risk of hemorrhagic stroke than women taking antiplatelet medications without statins (HR: 1.59; CI: 1.02, 2.46), whereas women not taking antiplatelet medications had no risk elevation with statins (HR=0.79; CI: 0.58-1.08); P for interaction = .01. No significant interactions were found for anticoagulant use or prior history of stroke, but the statistical power for these analyses was low. Conclusion: Statin use was not associated with an overall increased risk of hemorrhagic stroke among older community-dwelling women. However, women taking statins in conjunction with antiplatelet medications had elevated risk; a finding that warrants further study and potential incorporation into clinical decision making.


2010 ◽  
Vol 54 (5) ◽  
pp. 488-497 ◽  
Author(s):  
Arnaldo Schainberg ◽  
Antônio Ribeiro-Oliveira Jr. ◽  
José Marcio Ribeiro

It has been well documented that there is an increased prevalence of standard cardiovascular (CV) risk factors in association with diabetes and with diabetes-related abnormalities. Hyperglycemia, in particular, also plays an important role. Heart failure (HF) has become a frequent manifestation of cardiovascular disease (CVD) among individuals with diabetes mellitus. Epidemiological studies suggest that the effect of hyperglycemia on HF risk is independent of other known risk factors. Analysis of datasets from populations including individuals with dysglycemia suggests the pathogenic role of hyperglycemia on left ventricular function and on the natural history of HF. Despite substantial epidemiological evidence of the relationship between diabetes and HF, data from available interventional trials assessing the effect of a glucose-lowering strategy on CV outcomes are limited. To provide some insight into these issues, we describe in this review the recent important data to understand the natural course of CV disease in diabetic individuals and the role of hyperglycemia at different times in the progression of HF.


Lupus ◽  
2018 ◽  
Vol 27 (10) ◽  
pp. 1679-1686 ◽  
Author(s):  
C M Yelnik ◽  
M Lambert ◽  
E Drumez ◽  
V Le Guern ◽  
J-L Bacri ◽  
...  

Purpose The purpose of this study was to evaluate the safety of antithrombotic treatments prescribed during pregnancy in patients with antiphospholipid syndrome (APS). Methods This international, multicenter study included two cohorts of patients: a retrospective French cohort and a prospective US cohort (PROMISSE study). Inclusion criteria were (1) APS (Sydney criteria), (2) live pregnancy at 12 weeks of gestation (WG) with (3) follow-up data until six weeks post-partum. According to APS standard of care, patients were treated with aspirin and/or low-molecular weight heparin (LMWH) at prophylactic (pure obstetric APS) or therapeutic doses (history of thrombosis). Major bleeding was defined as abnormal blood loss during the pregnancy and/or post-partum period requiring intervention for hemostasis or transfusion, or during the peripartum period greater than 500 mL and/or requiring surgery or transfusion. Other bleeding events were classified as minor. Results Two hundred and sixty-four pregnancies (87 prospectively collected) in 204 patients were included (46% with history of thrombosis, 23% with associated systemic lupus). During pregnancy, treatment included LMWH ( n = 253; 96%) or low-dose aspirin ( n = 223; 84%), and 215 (81%) patients received both therapies. The live birth rate was 89% and 82% in the retrospective and prospective cohorts, respectively. Adverse pregnancy outcomes occurred in 28% of the retrospective cohort and in 40% of the prospective cohort. No maternal death was observed in either cohort. A combined total of 45 hemorrhagic events (25%) occurred in the retrospective cohort, but major bleeding was reported in only six pregnancies (3%). Neither heparin nor aspirin alone nor combined therapy increased the risk of hemorrhage. We also did not observe an increased rate of bleeding in the case of a short interval between last LMWH (less than 24 hours) or aspirin (less than five days) doses and delivery. Only emergency Caesarean section was significantly associated with an increased risk of bleeding (odds ratio (OR) 5.03 (1.41–17.96); p=.016). In the prospective cohort, only one minor bleeding event was reported (vaginal bleeding). Conclusion Our findings support the safety of antithrombotic therapy with aspirin and/or LMWH during pregnancy in high-risk women with APS, and highlight the need for better treatments to improve pregnancy outcomes in APS. PROMISSE Study ClinicalTrials.gov identifier: NCT00198068.


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