Peri-operative Adverse Outcomes in Patients with Atrial Fibrillation Taking Warfarin or Edoxaban: Analysis of the ENGAGE AF-TIMI 48 Trial

2018 ◽  
Vol 118 (06) ◽  
pp. 1001-1008 ◽  
Author(s):  
James Douketis ◽  
Sabina Murphy ◽  
Elliott Antman ◽  
Laura Grip ◽  
Michele Mercuri ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Invasive Procedure ◽  
Operative Management ◽  
Adverse Outcomes ◽  
Systemic Embolism ◽  
Chi Square ◽  
Treatment Groups ◽  
Post Procedure ◽  
Chi Square Test ◽  
Anticoagulated Patients

Background Peri-operative management of anticoagulated patients with atrial fibrillation (AF) is challenging. To gain information on the peri-operative management of edoxaban, we compared outcomes in patients on warfarin or edoxaban enrolled in ENGAGE AF-TIMI 48 who underwent a surgery or invasive procedure. Methods Data from patients undergoing their first surgery/procedure were analysed and results compared by anticoagulant (warfarin vs. higher- or lower-dose edoxaban regimen [HDER and LDER, respectively]). Patients were classified by procedural management: anticoagulant interrupted (last dose 4–10 days pre-procedure) or anticoagulant continued (last dose ≤ 3 days pre-procedure). Stroke/systemic embolism (SSE), major bleeding (MB), MB or clinically relevant non-MB (CRNMB) and death were assessed from 7 days pre- until 30 days post-procedure. The chi-square test was used to compare outcomes across treatment groups. Results A total of 7,193 patients (34%) underwent surgery/procedure: 3,116 had anticoagulant interrupted, 4,077 had anticoagulant continued. Among patients on warfarin, HDER and LDER who had anticoagulant interrupted, rates of SSE were 0.6, 0.5 and 0.9% (p = 0.53), rates of MB were 1.0, 1.2 and 1.1% (p = 0.94) and rates of MB or CRNMB were 3.9, 4.2 and 3.6% (p = 0.78); among patients on warfarin, HDER and LDER who had anticoagulant continued, rates of SSE were 1.1, 0.7 and 0.9% (p = 0.51), rates of MB were 3.6, 2.6 and 2.4% (p = 0.13) and rates of MB or CRNMB were 8.5, 7.9 and 6.6% (p = 0.17). Conclusion In patients requiring surgery/procedure in ENGAGE AF-TIMI 48, peri-operative rates of SSE, MB and death were not significantly different in patients who received edoxaban or warfarin.

F-Test Alternatives to Fisher’s Exact Test and to the Chi-Square Test of Homogeneity in 2 × 2 Tables

1983 ◽  
Vol 8 (1) ◽  
pp. 59-73 ◽  
Author(s):  
John E. Overall ◽  
Robert R. Starbuck
Keyword(s):  
Beta Distribution ◽  
Binary Response ◽  
Binomial Model ◽  
Chi Square ◽  
Exact Probability ◽  
Exact Test ◽  
Mutual Dependence ◽  
Treatment Groups ◽  
Test Of Homogeneity ◽  
Chi Square Test

A binomial model is proposed for testing the significance of differences in binary response probabilities in two independent treatment groups. Without correction for continuity, the binomial statistic is essentially equivalent to Fisher’s exact probability. With correction for continuity, the binomial statistic approaches Pearson’s chi-square. Due to mutual dependence of the binomial and F distributions on the beta distribution, a simple F statistic can be used for computation instead of the binomial.

scholarly journals Age differences in clinical features and outcomes in patients with COVID-19, Jiangsu, China: a retrospective, multi-center cohort study

2020 ◽  
Author(s):  
Huanyuan Luo ◽  
Songqiao Liu ◽  
Yuancheng Wang ◽  
Penelope A. Phillips-Howard ◽  
Yi Yang ◽  
...  
Keyword(s):  
Cohort Study ◽  
Intensive Care ◽  
Respiratory Failure ◽  
Hospital Stay ◽  
Older Patients ◽  
Adverse Outcomes ◽  
Trend Test ◽  
Chronic Obstructive ◽  
Chi Square ◽  
Chi Square Test

Objectives To determine the age-specific clinical presentations and incidence of adverse outcomes among patients with COVID-19 in Jiangsu, China. Design and setting This is a retrospective, multi-center cohort study performed at twenty-four hospitals in Jiangsu, China. Participants From January 10 to March 15, 2020, 625 patients with COVID-19 were involved. Results Of the 625 patients (median age, 46 years; 329 [52.6%] males), 37 (5.9%) were children (18 years or less), 261 (40%) young adults (19-44 years), 248 (39.7%) middle-aged adults (45-64 years), and 79 (12.6%) elderly (65 years or more). The incidence of hypertension, coronary heart disease, chronic obstructive pulmonary disease, and diabetes comorbidities increased with age (trend test, P < .0001, P = 0.0003, P < .0001, and P < .0001 respectively). Fever, cough, and shortness of breath occurred more commonly among older patients, especially the elderly, compared to children (Chi-square test, P = 0.0008, 0.0146, and 0.0282, respectively). The quadrant score and pulmonary opacity score increased with age (trend test, both P < .0001). Older patients had significantly more abnormal values in many laboratory parameters than younger patients. Elderly patients contributed the highest proportion of severe or critically-ill cases (33.0%, Chi-square test P < 0.001), intensive care unit (ICU) (35.4%, Chi-square test P < 0.001), and respiratory failure (31.6%, Chi-square test P = 0.0266), and longest hospital stay (21 days, ANOVA-test P < 0.001). Conclusions Elderly (≥65) patients with COVID-19 had the highest risk of severe or critical illness, intensive care use, respiratory failure, and the longest hospital stay, which may be due partly to that they had higher incidence of comorbidities and poor immune responses to COVID-19.

Maternal and Perinatal Outcomes in Women with Eclampsia by Mode of delivery at Riley Mother Baby Hospital: A longitudinal case-series study

2020 ◽  
Author(s):  
Philippe Amubuomombe Poli ◽  
Koech MMED Irene ◽  
Richard Mogeni ◽  
Ann Mwangi ◽  
Andrew Cheruiyot ◽  
...  
Keyword(s):  
Mode Of Delivery ◽  
Case Series ◽  
Perinatal Outcomes ◽  
Adverse Outcomes ◽  
Sub Saharan Africa ◽  
Categorical Variables ◽  
Chi Square ◽  
Case Series Study ◽  
Chi Square Test ◽  
Series Study

Abstract Background Eclampsia, considered a serious complication of preeclampsia, remains a life-threatening condition among pregnant women. It accounts for 12% of maternal deaths and 16–31% of perinatal deaths worldwide. Most deaths from eclampsia occurred in resource-limited settings of sub-Saharan Africa. This study was performed to determine the optimum mode of delivery, as well as factors associated with the mode of delivery, in women admitted with eclampsia at Riley Mother and Baby Hospital. Methods This was a hospital-based longitudinal case-series study conducted at the largest and busiest obstetric unit of the tertiary hospital of western Kenya. Maternal and perinatal variables, such as age, parity, medications, initiation of labour, mode of delivery, admission to the intensive care unit, admission to the newborn care unit, organ injuries, and mortality, were analysed using the Statistical Package for the Social Sciences software version 20.0. Quantitative data were described using frequencies and percentages. The significance of the obtained results was judged at the 5% level. The chi-square test was used for categorical variables, and Fisher’s exact test or the Monte Carlo correction was used for correction of the chi-square test when more than 20% of the cells had an expected count of less than 5. Results During the study period, 53 patients diagnosed with eclampsia were treated and followed up to 6 weeks postpartum. There was zero maternal mortality; however, perinatal mortality was reported in 9.4%. Parity was statistically associated with an increased odds of adverse perinatal outcomes (p = 0.004, OR = 9.1, 95% CI = 2.0-40.8) and caesarean delivery (p = 0.020, OR = 4.7, 95% CI = 1.3–17.1). In addition, the induction of labour decreased the risk of adverse outcomes (p = 0.232, OR = 0.3, 95% CI = 0.1-2.0). Conclusion There is no benefit of emergency caesarean section for women with eclampsia. Instead, it increases the risk of perinatal adverse outcomes, including the risk of admission to the newborn unit and perinatal death.

Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease

Heart ◽  
2018 ◽  
Vol 104 (15) ◽  
pp. 1292-1299 ◽  
Author(s):  
Dragos Vinereanu ◽  
Alice Wang ◽  
Hillary Mulder ◽  
Renato D Lopes ◽  
Petr Jansky ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trial ◽  
Major Bleeding ◽  
Treatment Effect ◽  
P Value ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Clinical Trial Registration ◽  
Safety Outcomes ◽  
Anticoagulated Patients

ObjectiveTo assess stroke/systemic embolism, major bleeding and other outcomes, and treatment effect of apixaban versus warfarin, in patients with atrial fibrillation (AF) and different types of valvular heart disease (VHD), using data from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial.MethodsThere were 14 793 patients with known VHD status, categorised as having moderate or severe mitral regurgitation (MR) (n=3382), aortic regurgitation (AR) (n=842) or aortic stenosis (AS) (n=324); patients with moderate or severe mitral stenosis were excluded from the trial. Baseline characteristics, efficacy and safety outcomes were compared between each type and no significant VHD. Treatment effect was assessed using an adjusted model.ResultsPatients with MR or AR had similar rates of stroke/systemic embolism and bleeding compared with patients without MR or AR, respectively. Patients with AS had significantly higher event rates (presented as rate per 100 patient-years of follow-up) of stroke/systemic embolism (3.47 vs 1.36; adjusted HR (adjHR) 2.21, 95% CI 1.35 to 3.63), death (8.30 vs 3.53; adjHR 1.92, 95% CI 1.41 to 2.61), major bleeding (5.31 vs 2.53; adjHR 1.80, 95% CI 1.19 to 2.75) and intracranial bleeding (1.29 vs 0.51; adjHR 2.54, 95% CI 1.08 to 5.96) than patients without AS. The superiority of apixaban over warfarin on stroke/systemic embolism was similar in patients with versus without MR (HR 0.69, 95% CI 0.46 to 1.04 vs HR 0.79, 95% CI 0.63 to 1.00; interaction P value 0.52), with versus without AR (HR 0.57, 95% CI 0.27 to 1.20 vs HR 0.78, 95% CI 0.63 to 0.96; interaction P value 0.52), and with versus without AS (HR 0.44, 95% CI 0.17 to 1.13 vs HR 0.79, 95% CI 0.64 to 0.97; interaction P value 0.19). For each of the primary and secondary efficacy and safety outcomes, there was no evidence of a different effect of apixaban over warfarin in patients with any VHD subcategory.ConclusionsIn anticoagulated patients with AF, AS is associated with a higher risk of stroke/systemic embolism, bleeding and death. The efficacy and safety benefits of apixaban compared with warfarin were consistent, regardless of presence of MR, AR or AS.Clinical trial registrationARISTOTLE clinical trial number NCT00412984.

scholarly journals Research Article. Characteristics of Sleep Apnea Assessed Before Discharge in Patients Hospitalized with Acute Heart Failure

2017 ◽  
Vol 63 (1) ◽  
pp. 19-22
Author(s):  
Ildikó Kocsis ◽  
Lajos Fehérvári ◽  
Zoltán Fogarasi ◽  
István Adorján Szabó ◽  
Attila Frigy
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Sleep Apnea ◽  
Acute Heart Failure ◽  
Stable Condition ◽  
Descriptive Statistics ◽  
Chi Square ◽  
Related Factors ◽  
Research Article ◽  
Chi Square Test

AbstractObjectives. Evaluation of the characteristics of sleep apnea (SA) in patients hospitalized with acute heart failure, considering that undiagnosed SA could contribute to early rehospitalization. Methods. 56 consecutive patients (13 women, 43 men, mean age 63.12 years) with acute heart failure, in stable condition, underwent nocturnal polygraphy before hospital discharge. The type and severity of SA was determined. Besides descriptive statistics, correlations between the severity of SA and clinical and paraclinical characteristics were also analyzed (t-test, chi-square test, significancy at alpha < 0.05). Results. 12 (21.4%) subjects were free of SA (AHI - apnea-hipopnea index <5/h), 15 (26.7%) had mild SA (AHI=5-14/h), 17 (30.3%) had moderate SA (AHI 15-30/h), and 12 (21.4 %) had severe SA (AHI>30/h). The apnea was predominantly obstructive (32 cases vs. 12 with central SA). Comparing the patients with mild or no SA with those with severe SA, we did not find statistically significant correlations (p>0.05) between the severity of SA and the majority of main clinical and paraclinical characteristics - age, sex, BMI, cardiac substrates of heart failure, comorbidities. Paradoxically, arterial hypertension (p=0.028) and atrial fibrillation (p=0.041) were significantly more prevalent in the group with mild or no SA. Conclusions. Before discharge, in the majority of patients hospitalized with acute heart failure moderate and severe SA is present, and is not related to the majority of patient related factors. Finding of significant SA in this setting is important, because its therapy could play an important role in preventing readmissions and improving prognosis.

Comparison of 5-FU versus capecitabine in combination with mitomycin or cisplatin in the treatment of anal cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 680-680 ◽  
Author(s):  
Irene S. Yu ◽  
Winson Y. Cheung
Keyword(s):  
Anal Cancer ◽  
Cancer Survival ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Operative Management ◽  
Population Based ◽  
Chi Square ◽  
Curative Intent ◽  
Treatment Groups ◽  
The Difference

680 Background: Capecitabine is used as an alternative fluoropyrimidine to infusional 5-FU in the non-operative management of anal cancer due to its ease of administration. However, its patterns of use and long-term outcomes in the real world are poorly described. Our objectives were to determine the frequency of capecitabine use, compare the difference in outcomes, and examine the difference in treatment-related adverse events between oral and intravenous fluoropyrimidines. Methods: All anal cancer patients who received either capecitabine or infusional 5-FU as part of their curative intent chemoradiotherapy from 2010 to 2013 at any 1 of 6 comprehensive cancer centers in British Columbia were included. Chi-square and Wilcoxon-Mann tests were used to assess for associations between treatment groups and clinical characteristics and outcomes. Results: A total of 237 patients were identified; median age was 59 (IQR 53-67) years, 71 (30%) were men, 202 (85%) had ECOG 0/1, and 12 (5%) were HIV positive. Median total radiation dose was 54 cGy (IQR 50.4-54.0) and 21 (9%) underwent a colostomy prior to chemoradiation. Baseline characteristics were balanced between the two groups with respect to age, gender, ECOG, and HIV status (all p > 0.05). Overall, 155 patients (65%) received capecitabine. Comparing patients who received capecitabine vs 5-FU, overall (69% vs 74%, p = 0.388) and disease-free survival rates (68% vs 71%, p = 0.637) at 5 years from diagnosis were similar between treatment groups. There were no differences with respect to rates of subsequent colostomy (16% vs 23%, p = 0.185) and abdominoperineal resection (11% vs 12%, p = 0.777). However, patients who received capecitabine were less likely to report adverse effects (51% vs 26%, p < 0.001) than those who underwent 5-FU. The capecitabine group had a lower incidence of stomatitis (6% vs 40%, p < 0.001) whereas the 5-FU cohort reported less frequent hand-foot syndrome (1% vs 8%, p = 0.036). Conclusions: This population-based study demonstrates a preference for capecitabine use in place of 5-FU in the curative management of anal cancer. Survival outcomes are similar between the two treatment groups, but capecitabine may be better tolerated.

Three-Month Cumulative Incidence of Thromboembolism and Bleeding After Periprocedural Anticoagulation Management of Patients with Active Cancer.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 491-491 ◽  
Author(s):  
Alfonso J Tafur ◽  
Edyta Wolny ◽  
Robert McBane ◽  
Edyta Sutkowska ◽  
Joshua P Slusser ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Conflicts Of Interest ◽  
Mechanical Heart Valve ◽  
Invasive Procedure ◽  
Anticoagulation Management ◽  
Entire Cohort ◽  
Post Procedure ◽  
Increased Risk ◽  
Anticoagulated Patients ◽  
Active Cancer

Abstract Abstract 491 Introduction: Chronically-anticoagulated patients with active cancer (Ca) often require temporary interruption of warfarin for an invasive diagnostic or therapeutic procedure. While such patients may be at increased risk for periprocedural thromboembolism and bleeding, there are virtually no estimates of these outcomes among Ca patients or the most appropriate periprocedural anticoagulation management. The aims of this study were to estimate rates of these outcomes among Ca patients and to test active cancer and “bridging” low molecular weight heparin (LMWH) as potential predictors of these outcomes. Patients and Methods: In a retrospective cohort study, all chronically-anticoagulated patients referred to the Mayo Clinic Thrombophilia Center for periprocedural anticoagulation management over the 11-year period, 1997-2007, were followed forward in time for the outcomes of venous and arterial thromboembolism (VTE; ATE), major bleeding and vital status within 3 months of consultation. Warfarin was stopped 4-5 days prior to the procedure and patients received bridging LMWH according to the estimated risk of thromboembolism and bleeding. All outcome events were centrally adjudicated using pre specified criteria. Results: The total cohort (n=2517) included 500 patients with Ca. Chronic anticoagulation indications included prior VTE (n=1033), mechanical heart valve (n=669), atrial fibrillation (n=530) and other (mainly vascular bypass; n=285). 65% and 64% of patients with and without Ca received bridging LMWH, respectively. Prior VTE was more common among Ca patients compared to those without CA, both in the bridged (56% vs 37%; p<0.001) and the non-bridged (48% vs 39%; p<0.05) groups. The 3 month rate for the composite of VTE, ATE or bleeding was higher among Ca patients compared to patients without Ca (5% vs 2%; p=0.004) due to higher post procedure rates of VTE (1% vs 0.2%; p<0.001) and major bleeding (4% vs 1.7%; p=0.009); the post procedure ATE rates were low in both groups (0.40% vs 0.45%). For the entire cohort, patients receiving bridging LMWH had a significantly higher rate of post procedure bleeding (5% vs 1%; p<0.05). Finally, there were significantly more deaths in Ca patients compared to non-Ca patients (5% vs. 1%; p<0.001). Conclusions: The three-month rates of VTE, major bleeding and death among patients with Ca in whom anticoagulation is temporarily interrupted for an invasive procedure is significantly higher than in patients without Ca, especially the major bleeding rate. Use of heparin increases this rate even farther, suggesting that bridging should be used with caution in patients with active cancer. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Comparative evaluation of the modified Scarff-Bloom-Richardson grading system on breast carcinoma aspirates and histopathology

CytoJournal ◽  
2012 ◽  
Vol 9 ◽  
pp. 4 ◽  
Author(s):  
Cherry Bansal ◽  
U. S. Singh ◽  
Sanjeev Misra ◽  
Kiran Lata Sharma ◽  
Vandana Tiwari ◽  
...  
Keyword(s):  
Ductal Carcinoma ◽  
Invasive Procedure ◽  
Needle Aspiration ◽  
Lower Grade ◽  
Chi Square ◽  
Fine Needle ◽  
Fine Needle Aspirates ◽  
Peripheral Portion ◽  
Chi Square Test ◽  
Tissue Specimens

Background: Fine needle aspiration (FNA) is a quick, minimally invasive procedure for evaluation of breast tumors. The Scarff-Bloom-Richardson (SBR) grade on histological sections is a well-established tool to guide selection of adjuvant systemic therapy. Grade evaluation is possible on cytology smears to avoid and minimize the morbidity associated with overtreatment of lower grade tumors. Aim: The aim was to test the hypothesis whether breast FNA from the peripheral portion of the lesion is representative of Scarff-Bloom-Richardson grade on histopathology as compared to FNA from the central portion. Materials and Methods: Fine-needle aspirates and subsequent tissue specimens from 45 women with ductal carcinoma (not otherwise specified) were studied. FNAs were performed under ultrasound guidance from the central as well as the peripheral third of the lesion for each case avoiding areas of necrosis/calcification. The SBR grading was compared on alcohol fixed aspirates and tissue sections for each case. Results: Comparative analysis of SBR grade on aspirates from the peripheral portion and histopathology by the Pearson chi-square test (χ2 =78.00) showed that it was statistically significant (P<0.001) with 93% concordance. Lower mitotic score on aspirates from the peripheral portion was observed in only 4 out of 45 (9%) cases. The results of the Pearson chi-square test (χ2 = 75.824) with statistically significant (P=0.000). Conclusion: This prospective study shows that FNA smears from the peripheral portion of the lesion are representative of the grading performed on the corresponding histopathological sections. It is possible to score and grade by SBR system on FNA smears.

scholarly journals Heart rate and adverse outcomes in patients with prevalent atrial fibrillation

Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001606
Author(s):  
Giorgio Moschovitis ◽  
Linda S B Johnson ◽  
Steffen Blum ◽  
Stefanie Aeschbacher ◽  
Maria Luisa De Perna ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Heart Rate ◽  
Cox Regression ◽  
Threshold Effect ◽  
Adverse Outcomes ◽  
Systemic Embolism ◽  
Target Heart Rate ◽  
Heart Failure Hospitalisation

ObjectiveThe optimal target heart rate in patients with prevalent atrial fibrillation (AF) is not well defined. The aim of this study was to analyse the associations between heart rate and adverse outcomes in a large contemporary cohort of patients with prevalent AF.MethodsFrom two prospective cohort studies, we included stable AF outpatients who were in AF on the baseline ECG. The main outcome events assessed during prospective follow-up were heart failure hospitalisation, stroke or systemic embolism and death. The associations between heart rate and adverse outcomes were evaluated using multivariable Cox regression models.ResultsThe study population consisted of 1679 patients who had prevalent AF at baseline. Mean age was 74 years, and 24.6% were women. The mean heart rate on the baseline ECG was 78 (±19) beats per minute (bpm). The median follow-up was 3.9 years (IQR 2.2–5.0). Heart rate was not significantly associated with heart failure hospitalisation (adjusted HR (aHR) per 10 bpm increase, 1.00, 95% CI 0.94 to 1.07, p=0.95), stroke or systemic embolism (aHR 0.95, 95% CI 0.84 to 1.07, p=0.38) or death (aHR 1.02, 95% CI 0.95 to 1.09, p=0.66). There was no evidence of a threshold effect for heart rates <60 bpm or >100 bpm.ConclusionsIn this large contemporary cohort of outpatients with prevalent AF, we found no association between heart rate and adverse outcome events. These data are in line with recommendations that strict heart rate control is not needed in otherwise stable outpatients with AF.

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