scholarly journals Incidence and risk factors of major bleeding following major orthopaedic surgery with fondaparinux thromboprophylaxis. A time-to-event analysis

2018 ◽  
Vol 84 (10) ◽  
pp. 2242-2251 ◽  
Author(s):  
P. J. Zufferey ◽  
E. Ollier ◽  
X. Delavenne ◽  
S. Laporte ◽  
P. Mismetti ◽  
...  
Keyword(s):  
Risk Factors ◽  
Major Bleeding ◽  
Orthopaedic Surgery ◽  
Event Analysis ◽  
Time To Event ◽  
Major Orthopaedic Surgery

scholarly journals 547. Risk Factors Associated with 30-Day Mortality in a Large Cohort of Patients who Received Remdesivir and Corticosteroids for Severe COVID-19

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S375-S376
Author(s):  
Kartik Gupta ◽  
Lea Monday ◽  
Milan Kaushik ◽  
George J Alangaden ◽  
Indira Brar
Keyword(s):  
Risk Factors ◽  
Logistic Regression ◽  
Health System ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Antiviral Agent ◽  
Advanced Age ◽  
Event Analysis ◽  
Time To Event ◽  
Factors Associated

Abstract Background Remdesivir (RDV), an antiviral agent, is approved by Food and Drug Administration (FDA) for the treatment of patients (pts) admitted with SARS-COV-2 infection (COVID-19). Earlier RDV studies (such as ACCT-1) prior to widespread use of corticosteroids (CS), showed a 30-day mortality of 11%. Advanced age, obesity, and certain comorbidities are known risk factors for death in COVID-19, but whether these risks vary in pts treated with RDV and CS is unknown. As of March 20, 2020 CS were routinely used for the treatment of pts admitted with COVID19 in our health care system. The objective of this study was to identify risk factors associated with 30 -Day mortality in a cohort of pts admitted with COVID-19 and who received RDV and CS. Methods This retrospective cohort study evaluated pts admitted to a health system in South East Michigan with COVID-19 between March and November 2020 who received ≥1 dose RDV. Demographics, comorbidities, and characteristics including quick sequential organ failure assessment (qSOFA) score were collected and compared between patients who died versus survived. Primary outcome was 30 day mortality. Secondary outcomes were risk factors for death using logistic regression and time-to-event analysis. Results A total of 1,591 pts received RDV and were included in the study; median age 67 years, 56% male and 18% Black. RDV use increased after emergency use authorization and FDA approval (Fig 1). Death within 30 days occurred in 15.3%. Patients who died were older males with higher rates of hypertension, kidney disease, diabetes, and were more likely to have qSOFA ≥2 on arrival (Table 1). In a multivariable logistic model, advanced age, male gender, pulmonary disease, CKD, obesity, and qSOFA≥2 were independent predictors of death (Figure 2). Among these, age and qSOFA≥2 were the most important risk factors (Figure 2). Patients receiving remdesivir (red) were included in the study. Routine use of corticosteroids was adopted on all patients in our health system beginning March 20, 2020. System-wide use of remdesivir increased following Food and Drug Administration approval in fall 2020. On both logistic regression and time-to-event analysis, advanced age and qSOFA ≥ 2 had the highest predictive value for mortality. Others comorbidities were similar and comparable in importance. Conclusion The population in our Real-world study was older with more comorbidities as compared to ACCT-1, and the 30 day mortality was 15%. Despite the use of CS and RDV advanced age and qSOFA were the most important drivers of mortality. Future, therapeutic strategies need to focus on this group which is at the highest risk of dying from COVID-19 infection. Disclosures All Authors: No reported disclosures

Benefit-to-harm ratio of thromboprophylaxis for patients undergoing major orthopaedic surgery

2014 ◽  
Vol 111 (02) ◽  
pp. 199-212 ◽  
Author(s):  
Jane Liang ◽  
David Bergqvist ◽  
Roger Yusen ◽  
Russell Hull
Keyword(s):  
Major Bleeding ◽  
Orthopaedic Surgery ◽  
Bleeding Event ◽  
Phase Iii ◽  
Number Needed To Treat ◽  
Vte Prophylaxis ◽  
Major Orthopaedic Surgery ◽  
Definition Of ◽  
Newer Anticoagulants ◽  
Number Needed To Harm

SummarySurgeons consider the benefit-to-harm ratio when making decisions regarding the use of anticoagulant venous thromboembolism (VTE) prophylaxis. We evaluated the benefit-to-harm ratio of the use of newer anticoagulants as thromboprophylaxis in patients undergoing major orthopaedic surgery using the likelihood of being helped or harmed (LHH), and assessed the effects of variation in the definition of major bleeding on the results. A systematic literature search was performed to identify phase II and phase III studies that compared regulatory authority-approved newer anticoagulants to the low-molecularweight heparin enoxaparin in patients undergoing major orthopaedic surgery. Analysis of outcomes data estimated the clinical benefit (number-needed-to-treat [NNT] to prevent one symptomatic VTE) and clinical harm (number-needed-to-harm [NNH] or the NNT to cause one major bleeding event) of therapies. We estimated each trial’s benefitto-harm ratio from NNT and NNH values, and expressed this as LHH = (1/NNT)/(1/NNH) = NNH/NNT. Based on reporting of efficacy and safety outcomes, most studies favoured enoxaparin over fondaparinux, and rivaroxaban over enoxaparin. However, when using the LHH metric, most trials favoured enoxaparin over both fondaparinux and rivaroxaban when they included surgical-site bleeding that did not require reoperation in the definition of major bleeding. The exclusion of bleeding at surgical site which did not require reoperation shifted the benefit-to-harm ratio in favour of the newer agents. Variations in the definitions of major bleeding may change the benefit-to-harm ratio and subsequently affect its interpretation. Clinical trials should attempt to improve the consistency of major bleeding reporting.

A Pooled Analysis of Four Pivotal Studies of Rivaroxaban for the Prevention of Venous Thromboembolism after Orthopaedic Surgery: Effect on Symptomatic Venous Thromboembolism, Death, and Bleeding

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 36-36 ◽  
Author(s):  
Alexander GG Turpie ◽  
Michael Rud Lassen ◽  
Ajay K Kakkar ◽  
Bengt Eriksson ◽  
Frank Misselwitz ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Active Treatment ◽  
Orthopaedic Surgery ◽  
Pooled Analysis ◽  
Study Medication ◽  
Double Blind ◽  
Study Duration ◽  
Major Orthopaedic Surgery

Abstract Four multinational, randomized, double-blind, double-dummy phase III studies (RECORD1, 2, 3 and 4) investigated the oral, direct Factor Xa inhibitor rivaroxaban for the prevention of venous thromboembolism (VTE) in patients undergoing major orthopaedic surgery. A total of 12,729 patients were randomized to receive oral rivaroxaban 10 mg once daily (od) starting 6–8 hours after surgery, or subcutaneous enoxaparin 40 mg od starting the evening before surgery (RECORD1–3), or 30 mg bid starting 12–24 hours after wound closure or adequate hemostasis (RECORD4). In both RECORD1 and 2, patients undergoing total hip replacement (THR) were given rivaroxaban for 31–39 days. Enoxaparin was given for 31–39 days in RECORD1 or 10–14 days in RECORD2. In RECORD3 and 4, patients undergoing total knee replacement (TKR) received prophylaxis for 10–14 days. All patients were followed up for 30–35 days after the last dose of study medication. All outcomes, including symptomatic outcomes, were adjudicated by the same independent, blinded committees for all four studies. In each of the studies, the rivaroxaban regimens tested significantly reduced the incidence of the primary efficacy outcome (total VTE; the composite of any deep vein thrombosis [DVT], non-fatal pulmonary embolism [PE], and all-cause mortality) compared with enoxaparin regimens tested, with similar rates of bleeding in both groups. The rivaroxaban regimens also consistently reduced the incidence of major VTE (the composite of proximal DVT, non-fatal PE, and VTE-related death) in all four trials compared with the enoxaparin regimens tested. This pre-specified pooled analysis was performed on all randomized patients who received at least one dose of double-blind study medication to evaluate the effect of rivaroxaban on the composite of symptomatic VTE (comprising DVT or PE) and death, and bleeding. These primary outcomes were analyzed at day 12±2 in the active treatment pool (i.e. during the enoxaparin-controlled period common to all studies, to allow for unbiased comparison with enoxaparin), and for the total study duration pool (planned treatment period and 30–35 days follow-up). The results are shown in the table. Rivaroxaban significantly reduced the incidence of symptomatic VTE and death compared with enoxaparin regimens at day 12±2 (0.47% vs 0.97%; p=0.001) and for the total study duration (0.81% vs 1.63%; p<0.001). Rivaroxaban was not associated with a statistically significant increased risk of major bleeding (Table). These data demonstrate that in the regimens tested, rivaroxaban reduced the composite of major clinical outcomes compared with enoxaparin regimens, with no significant increase in the risk of major bleeding in patients undergoing major orthopaedic surgery. Rivaroxaban n=6183 n (%) Enoxaparin n=6200 n (%) p-value *Total study duration pool: active study drug period and 30–35 days follow-up including the placebo phase in RECORD2. †Bleeding after initiation of study medication, regardless of onset after last dose of study medication. ‡Post hoc analysis. p-values refer to Cox regression with treatment and study as covariates (two-sided Wald-test). Symptomatic VTE and death (primary outcome) 29 (0.5) 60 (1.0) 0.001 Day 12±2 active treatment pool 50 (0.8) 101 (1.6) <0.001 Total study duration pool* Death 6 (0.1) 10 (0.2) 0.320 Day 12±2 active treatment pool 13 (0.2) 25 (0.4) 0.055 Total study duration pool* PE or death 12 (0.2) 24 (0.4) 0.049 Day 12±2 active treatment pool 29 (0.5) 47 (0.8) 0.039 Total study duration pool* Major bleeding 21 (0.3) 13 (0.2) 0.175 Day 12±2 active treatment pool 27 (0.4) 17 (0.3) 0.135 Total study duration pool† Any bleeding 409 (6.6) 384 (6.2) 0.376 Day 12±2 active treatment pool 452 (7.3) 415 (6.7) 0.207 Total study duration pool† Composite of major clinical outcomes (death, myocardial infarction, stroke, symptomatic VTE, and major bleeding)*‡ 96 (1.6) 139 (2.2) 0.004

Indirect comparison meta-analysis of two enoxaparin regimens in patients undergoing major orthopaedic surgery

2014 ◽  
Vol 112 (09) ◽  
pp. 503-510 ◽  
Author(s):  
Céline Chapelle ◽  
Laurent Bertoletti ◽  
Jean-Christophe Lega ◽  
Michel Cucherat ◽  
Paul Zufferey ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Orthopaedic Surgery ◽  
Meta Analysis ◽  
Indirect Comparison ◽  
Thromboembolism Prophylaxis ◽  
Double Blind ◽  
Once Daily ◽  
Increased Risk ◽  
Major Orthopaedic Surgery

SummaryTwo enoxaparin dosage regimens are used as comparators to evaluate new anticoagulants for thromboprophylaxis in patients undergoing major orthopaedic surgery, but so far no satisfactory direct comparison between them has been published. Our objective was to compare the efficacy and safety of enoxaparin 3,000 anti-Xa IU twice daily and enoxaparin 4,000 anti-Xa IU once daily in this clinical setting by indirect comparison meta-analysis, using Bucher’s method. We selected randomised controlled trials comparing another anticoagulant, placebo (or no treatment) with either enoxaparin regimen for venous thromboembolism prophylaxis after hip or knee replacement or hip fracture surgery, provided that the second regimen was assessed elsewhere versus the same comparator. Two authors independently evaluated study eligibility, extracted the data, and assessed the risk of bias. The primary efficacy outcome was the incidence of venous thomboembolism. The main safety outcome was the incidence of major bleeding. Overall, 44 randomised comparisons in 56,423 patients were selected, 35 being double-blind (54,117 patients). Compared with enoxaparin 4,000 anti-Xa IU once daily, enoxaparin 3,000 anti-Xa IU twice daily was associated with a reduced risk of venous thromboembolism (relative risk [RR]: 0.53, 95% confidence interval [CI]: 0.40 to 0.69), but an increased risk of major bleeding (RR: 2.01, 95% CI: 1.23 to 3.29). In conclusion, when interpreting the benefit-risk ratio of new anticoagulant drugs versus enoxaparin for thromboprophylaxis after major orthopaedic surgery, the apparently greater efficacy but higher bleeding risk of the twice-daily 3,000 anti-Xa IU enoxaparin regimen compared to the once-daily 4,000 anti-Xa IU regimen should be taken into account.

W1122 Serology Testing, Genotype, and Other Risk Factors for Repeat Ileocolic Resection in Crohn's Disease: A Time-to-Event Analysis

2008 ◽  
Vol 134 (4) ◽  
pp. A-637-A-638 ◽  
Author(s):  
Christian D. Stone ◽  
Jiajing Chen ◽  
Jonathan T. Unkart ◽  
Elizabeth Gorbe ◽  
Casey K. McCullough ◽  
...  
Keyword(s):  
Risk Factors ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Event Analysis ◽  
Ileocolic Resection ◽  
Time To Event ◽  
Serology Testing

Su1420 Risk Factors for Prolonged Cecal Intubation Time During Colonoscopy; A Prospective Time-to-Event Analysis

2012 ◽  
Vol 75 (4) ◽  
pp. AB326
Author(s):  
Fumio Omata ◽  
Noriyuki Horiki ◽  
Yasuhisa Kumakura ◽  
Katsunori Masuda
Keyword(s):  
Risk Factors ◽  
Event Analysis ◽  
Intubation Time ◽  
Time To Event ◽  
Cecal Intubation ◽  
Cecal Intubation Time

Tu1317 Risk Factors for Prolonged Cecal Intubation Time During Colonoscopy; a Prospective Time-to-Event Analysis

2013 ◽  
Vol 77 (5) ◽  
pp. AB497
Author(s):  
Fumio Omata ◽  
Yasuhisa Kumakura ◽  
Noriyuki Horiki ◽  
Katsunori Masuda ◽  
Tsuguya Fukui
Keyword(s):  
Risk Factors ◽  
Event Analysis ◽  
Intubation Time ◽  
Time To Event ◽  
Cecal Intubation ◽  
Cecal Intubation Time

scholarly journals An audit of unnecessary preoperative urea and electrolyte panel tests in patients undergoing major orthopaedic surgery at a quaternary South African hospital

2021 ◽  
pp. 36-39
Author(s):  
Y Moodley ◽  
SS Mashele
Keyword(s):  
Risk Factors ◽  
South African ◽  
Orthopaedic Surgery ◽  
Kidney Injury ◽  
Healthcare Sector ◽  
Major Surgery ◽  
Public Healthcare ◽  
Hospital Data ◽  
Retrospective Audit ◽  
Major Orthopaedic Surgery

Background: Preoperative urea and electrolyte (U&E) panels are frequently requested for major surgery patients at risk for postoperative acute kidney injury (AKI). There is only one published study that has audited unnecessary preoperative U&E test panel utilisation in major surgery patients at a South African (SA) public sector hospital. This has significant implications for laboratory workloads, healthcare expenditure, and patient-friendly practice in the resource-limited SA public healthcare sector. Objective: To audit preoperative U&E panel requests in a sample of SA patients undergoing major orthopaedic surgery. Methods: We conducted a retrospective audit of adult primary hip arthroplasty patients who attended a quaternary SA hospital. Data on demographics, medical history, preoperative anaesthetic evaluations, operation details, and U&E panel requests were collected from each patient’s medical chart. The National Institute for Health and Care Excellence (NICE) guidelines, based on American Society of Anesthesiologists (ASA) grading and the presence of AKI risk factors, was used to distinguish between necessary and unnecessary preoperative U&E requests. We used descriptive statistics to analyse our study data. Results: Of the 175 patients comprising our study sample, 23 (13.1%) had preoperative U&E panels requested unnecessarily. All 23 patients were otherwise healthy and did not have any AKI risk factors. Conclusion: A small proportion of preoperative U&E test panels in our study sample of major orthopaedic surgery patients were deemed unnecessary. With that being said, there is still room for improvement in practices around preoperative U&E panel requests, which could be achieved through educational, computerised, and audit feedback interventions.

Abstract 13595: Association of Costal Cartilage Calcification With Cardiovascular Events and Risk Factors in Multi-Ethnic Study of Atherosclerosis (MESA); The MESArthritis Study

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Mahsima Shabani ◽  
Farhad Pishgar ◽  
Sepehr Akhtarkhavari ◽  
Thiago Q Silva ◽  
Matthew J Budoff ◽  
...  
Keyword(s):  
Risk Factors ◽  
Costal Cartilage ◽  
Johns Hopkins Hospital ◽  
Event Analysis ◽  
Calcium Scoring ◽  
Time To Event ◽  
Cvd Risk ◽  
Cross Sectional ◽  
Cartilage Calcification ◽  
And Gender

Introduction: Costal cartilage calcification (CCC) is an evident yet usually neglected finding in calcium scoring CT scans. Although CAC score is a well-known predictive marker for CVD, little is known about the potential association between CCC and CVD risk factors (RFs) and events. Hypothesis: CCC is associated with CVD RFs and is predictive of CVD events independent from CAC score. Methods: Cardiac CAC score images from Johns Hopkins Hospital field center acquired within the fifth exam of the MESA cohort (2010-2012) were re-analyzed as part of the MESArthritis ancillary study. The CCC was measured bilaterally for the first pair of cartilages at the superior end of image FOVs using calcium scoring package (VScore, Vitrea 7.11, Vital Images) with a 180 HU cut-off. Outlier values were excluded using the IQR-based outlier fence estimates. Association of CCC with CVD RFs, and CVD and mortality time-to-event was investigated by multivariable linear regression and Cox proportional hazard models, respectively. Results: After exclusion of 3 outliers, 329 participants (53% female) with a mean age of 70.1 (±8.75) were included. In cross-sectional analysis, in addition to age (β=8.86, p:.003) and gender (376.0, p<.001), CCC was associated with diabetes (141.42, p:.019) and glucose level (2.85, p:.006). CCC was correlated with Framingham global CVD risk score (FRS) (coefficient:0.39, p<.001), but not with CAC when adjusted for age and gender. In time-to-event analysis, adjusted CCC was positively associated with CHD (HR:1.17, p:.039) and CVD (1.14, p:.012) risk. Compared with CAC score (C-index: 0.76) and FRS (0.74) individually, models with CCC addition to FRS (0.85) and both CAC and FRS (0.84) had higher C-index for CHD prediction. Conclusions: CCC is associated with diabetes and can be used to predict CHD and CVD events and augment the predictive power of the highly validated CAC and FRS for CHD events. However, this scoring should be validated in other larger cohorts.

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