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Background Patients with gastrointestinal cancer (GICA) are at high risk for venous thromboembolism (VTE). Data from randomized clinical trials in cancer-associated VTE suggest that direct oral anticoagulants (DOACs) conferred similar or superior efficacy but a heterogeneous safety profile in patients with GICA. We compared the safety and effectiveness of DOACs in patients with GICA and VTE at MD Anderson Cancer Center. Materials and Methods This was a retrospective chart review of patients with GICA and VTE receiving treatment with DOACs for a minimum of 6 months. Primary outcomes were the proportion of patients experiencing major bleeding (MB), clinically relevant non-major bleeding (CRNMB), and recurrent VTE. Secondary outcomes were time to bleeding and recurrent VTE. Results A cohort of 433 patients with GICA who were prescribed apixaban (n = 300), or rivaroxaban (n = 133) were included. MB occurred in 3.7% (95% confidence interval [CI] 2.1-5.9), CRNMB in 5.3% (95% CI 3.4-7.9), and recurrent VTE in 7.4% (95% CI 5.1-10.3). The cumulative incidence rates of CRNMB and recurrent VTE were not significantly different when comparing apixaban to rivaroxaban. Conclusion Apixaban and rivaroxaban had a similar risk of recurrent VTE and bleeding and could be considered as anticoagulant options in selected patients with GICA and VTE. Patients with cancer are at increased risk for venous thromboembolism. This article evaluates the safety and effectiveness of direct oral anticoagulants in patients with gastrointestinal cancer and cancer-associated venous thromboembolism.

Background Cancer, particularly gastrointestinal cancer, is associated with a higher risk of venous thromboembolism. Recent studies have increasingly compared direct oral anticoagulants (DOACs) with low molecular weight heparin (LMWH) for treating venous thromboembolism (VTE) in patients with gastrointestinal cancer. This meta-analysis aimed to investigate the efficacy of DOACs compared to LMWH for VTE in patients with gastrointestinal cancer. Methods PubMed, the Cochrane Library, Scopus, and Web of Science were systematically searched from the inception to February 20, 2025, to identify randomized controlled trials (RCTs) or cohort studies comparing the effect of DOACs with LMWH on VTE recurrence, clinically relevant non-major bleeding, and major bleeding among patients with active gastrointestinal cancer suffering from VTE. Results Finally, 13 studies, including 8 cohort studies and 5 RCTs, were included. The random-effects model revealed that compared to using LMWH, the risk of VTE recurrence (risk ratio (RR) 0.75, 95% confidence interval (CI) (0.59, 0.97), I 2  = 0.00%) was significantly decreased and the risk of clinically relevant non-major bleeding (RR 1.64, 95% CI (1.10, 2.45), I 2  = 59.79%) was significantly increased when using DOACs; however, the risk of major bleeding (RR 1.16, 95% CI (0.86, 1.56), I 2  = 28.51%) did not significantly change. RCTs suggested no significant change (RR 0.80, 95% CI (0.50, 1.27), I 2  = 0.00%) in the risk of VTE recurrence, but cohort studies indicated a decreased risk (RR 0.73, 95% CI (0.54, 0.99), I 2  = 0.00%) of VTE recurrence when using DOACs instead of LMWH. Both cohort studies (RR 1.02, 95% CI (0.75, 1.39), I 2  = 20.43%) and RCTs (RR 1.65, 95% CI (0.89, 3.07), I 2  = 26.59%) showed no significant difference in the risk of major bleeding when using DOACs instead of LMWH. RCTs showed an elevated risk (RR 2.32, 95% CI (1.48, 3.64), I 2  = 0.00%) of clinically relevant non-major bleeding when using DOACs, but cohort studies reported no significant change (RR 1.40, 95% CI (0.86, 2.29), I 2  = 60.84%) in the risk of clinically relevant non-major bleeding. Conclusion Among patients with gastrointestinal cancer, compared to LMWH, DOACs may not increase the risk of VTE recurrence and major bleeding, but may increase the risk of clinically relevant non-major bleeding.

Background: There is scanty evidence concerning the ability of Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) and Acute Catheterization and Urgent Intervention Triage Strategy and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (ACUITY-HORIZONS) scores to predict out-of-hospital bleeding risk after percutaneous coronary interventions (PCIs) with drug-eluting stents (DES) in patients receiving dual antiplatelet therapy. We aimed to assess and compare the long-term prognostic value of these scores regarding out-of-hospital bleeding risk in such patients. Methods: We performed a prospective observational study of 10,724 patients undergoing PCI between January and December 2013 in Fuwai Hospital, China. All patients were followed up for 2 years and evaluated through the Fuwai Hospital Follow-up Center. Major bleeding was defined as Types 2, 3, and 5 according to Bleeding Academic Research Consortium Definition criteria. Results: During a 2-year follow-up, 245 of 9782 patients (2.5%) had major bleeding (MB). CRUSADE (21.00 [12.00, 29.75] vs. 18.00 [11.00, 26.00], P < 0.001) and ACUITY-HORIZONS (9.00 [3.00, 14.00] vs. 6.00 [3.00, 12.00], P < 0.001) risk scores were both significantly higher in the MB than non-MB groups. Both scores showed a moderate predictive value for MB in the whole study cohort (area under the receiver-operating characteristics curve [AUROC], 0.565; 95% confidence interval [CI], 0.529-0.601, P = 0.001; AUROC, 0.566; 95% CI, 0.529-0.603, P < 0.001, respectively) and in the acute coronary syndrome (ACS) subgroup (AUROC: 0.579, 95% CI: 0.531-0.627, P = 0.001; AUROC, 0.591; 95% CI, 0.544-0.638, P < 0.001, respectively). However, neither score was a significant predictor in the non-ACS subgroup (P > 0.05). The value of CRUSADE and ACUITY-HORIZONS scores did not differ significantly (P > 0.05) in the whole cohort, ACS subgroup, or non-ACS subgroup. Conclusions: CRUSADE and ACUITY-HORIZONS scores showed statistically significant but relatively limited long-term prognostic value for out-of-hospital MB after PCI with DES in a cohort of Chinese patients. The value of CRUSADE and ACUITY-HORIZONS scores did not differ significantly (P > 0.05) in the whole cohort, ACS subgroup, or non-ACS subgroup.

Background Severe trauma represents a major global public health burden and the management of post-traumatic bleeding continues to challenge healthcare systems around the world. Post-traumatic bleeding and associated traumatic coagulopathy remain leading causes of potentially preventable multiorgan failure and death if not diagnosed and managed in an appropriate and timely manner. This sixth edition of the European guideline on the management of major bleeding and coagulopathy following traumatic injury aims to advise clinicians who care for the bleeding trauma patient during the initial diagnostic and therapeutic phases of patient management. Methods The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma included representatives from six European professional societies and convened to assess and update the previous version of this guideline using a structured, evidence-based consensus approach. Structured literature searches covered the period since the last edition of the guideline, but considered evidence cited previously. The format of this edition has been adjusted to reflect the trend towards concise guideline documents that cite only the highest-quality studies and most relevant literature rather than attempting to provide a comprehensive literature review to accompany each recommendation. Results This guideline comprises 39 clinical practice recommendations that follow an approximate temporal path for management of the bleeding trauma patient, with recommendations grouped behind key decision points. While approximately one-third of patients who have experienced severe trauma arrive in hospital in a coagulopathic state, a systematic diagnostic and therapeutic approach has been shown to reduce the number of preventable deaths attributable to traumatic injury. Conclusion A multidisciplinary approach and adherence to evidence-based guidelines are pillars of best practice in the management of severely injured trauma patients. Further improvement in outcomes will be achieved by optimising and standardising trauma care in line with the available evidence across Europe and beyond. Key messages Immediate detection and management of traumatic coagulopathy improves outcomes of severely injured patients. This guideline follows management of the severe trauma patient in chronological order, with a focus on prevention of possible exsanguination. These structured recommendations support measures that prioritise the optimisation of resources for the benefit of bleeding control based on scientific evidence. Empirical management should not be implemented unless no method of monitoring bleeding and coagulation is available. Optimal organisation of the resuscitation team for the bleeding trauma patient includes implementation of these guidelines.

The severity of bleeding events is heterogeneously defined during peripheral veno-arterial extracorporeal membrane oxygenation (pVA-ECMO). We studied three bleeding definitions in pVA-ECMO: the Extracorporeal Life Support Organization (ELSO)-serious bleeding, the Bleeding Academic Research Consortium (BARC), and the universal definition of postoperative bleeding (UPDB) classifications. We included consecutive adult patients supported by pVA-ECMO for refractory cardiogenic shock admitted to Lille academic hospitals between January 2013 and December 2019. We assessed the association of bleeding definitions with the primary endpoint of 28-day all-cause mortality with the use of multivariate models accounting for time-dependent and competing variables. We compared models' performances using the Harrell's C-Index and the Akaike information criteria. Twenty-eight-day mortality occurred in 128/308 (42%) 308 patients. The ELSO-serious bleeding (hazard ratio [HR], 1.67; 95% confidence interval [CI], 1.09 to 2.56) and BARC ≥ type 2 (HR, 1.55; 95% CI, 1.01 to 2.37) were associated with 28-day mortality (Harrell's C-index, 0.69; 95% CI, 0.63 to 0.74 for both). Predictors of ELSO-serious bleeding were postcardiotomy, body mass index, baseline platelets count, fibrinogen, and hemoglobin levels. Extracorporeal Life Support Organization-serious bleeding and BARC ≥ type 2 are relevant definitions of major bleeding regarding their association with mortality in critically ill patients who survived the first 24 hr while supported with pVA-ECMO for cardiogenic shock. CERAR (IRB 00010254-2022-050, Paris, France); first submitted on 18 April 2022.

The advent of potent antiplatelet and antithrombotic agents over the past decade has resulted in significant improvement in reducing ischemic events in acute coronary syndrome (ACS). However, the use of antiplatelet and antithrombotic combination therapy, often in the settings of percutaneous coronary intervention (PCI), has led to an increase in the risk of bleeding. In patients with non-ST elevation myocardial infarction treated with antithrombotic agents, bleeding has been reported to occur in 0.4%-10% of patients, whereas in patients undergoing PCI, periprocedural bleeding occurs in 2.2%-14% of cases. Until recently, bleeding was considered an intrinsic risk of antithrombotic therapy, and efforts to reduce bleeding have received little attention. There have been increasing data demonstrating that bleeding is associated with adverse outcomes, including myocardial infarction, stroke, and death. Therefore, it is imperative to optimize patient outcomes by adopting pharmacological and nonpharmacological strategies to minimize bleeding while maximizing treatment efficacy. In this paper, we present a review of the bleeding classifications used in large-scale clinical trials in patients with ACS and those undergoing PCI treated with antiplatelets and antithrombotic agents, adverse outcomes, particularly mortality associated with bleeding complications, and suggested predictive risk factors. Potential mechanisms of the association between bleeding and mortality and strategies to reduce bleeding complications are also discussed.

Background: Gastrointestinal (GI) bleeding is the most common type of major bleeding associated with oral anticoagulant (OAC) treatment. Patients with major bleeding are at an increased risk of a stroke if an OAC is not reinitiated. Methods: Non-valvular atrial fibrillation (NVAF) patients initiating OACs were identified from the Centers for Medicare and Medicaid Services (CMS) Medicare data and four US commercial claims databases. Patients who had a major GI bleeding event (hospitalization with primary diagnosis of GI bleeding) while on an OAC were selected. A control cohort of patients without a major GI bleed during OAC treatment was matched to major GI bleeding patients using propensity scores. Stroke/systemic embolism (SE), major bleeding, and mortality (in the CMS population) were examined using Cox proportional hazards models with robust sandwich estimates. Results: A total of 15,888 patients with major GI bleeding and 833,052 patients without major GI bleeding were included in the study. Within 90 days of the major GI bleed, 58% of patients discontinued the initial OAC treatment. Patients with a major GI bleed had a higher risk of stroke/SE [hazard ratio (HR): 1.57, 95% confidence interval (CI): 1.42–1.74], major bleeding (HR: 2.79, 95% CI: 2.64–2.95), and all-cause mortality (HR: 1.29, 95% CI: 1.23–1.36) than patients without a major GI bleed. Conclusion: Patients with a major GI bleed on OAC had a high rate of OAC discontinuation and significantly higher risk of stroke/SE, major bleeding, and mortality after hospital discharge than those without. Effective management strategies are needed for patients with risk factors for major GI bleeding.

Warfarin is a widely used anticoagulant, and bleeding complications are the main reason why patients discontinue the drug. Currently, there is no nomogram model for warfarin-associated bleeding risk. The aim of this study was to develop a risk-prediction nomogram model for warfarin-related major and clinically relevant non-major (CRNM) bleeding. A total of 280 heart disease outpatients taking warfarin were enrolled, 42 of whom experienced major or CRNM bleeding at the one-year follow-up. The Least Absolute Shrinkage and Selection Operator regression model was employed to identify potential predictors. Backward stepwise selection with the Akaike information criterion was used to establish the optimal predictive nomogram model. The receiver operating characteristic (ROC) curve, calibration plot, Hosmer–Lemeshow goodness-of-fit test, and decision curve analysis (DCA) were used to evaluate the performance of the nomogram. The nomogram consisted of four predictors: female (OR = 1.85; 95% CI: 0.91-3.94), TIA (OR = 6.47; 95% CI: 1.85-22.7), TTR (OR = 0.99; 95% CI: 0.97-1.00), and anemia (OR = 2.30; 95% CI: 1.06-4.84). The model had acceptable discrimination (area under the ROC curve = 0.68, 95% CI: 0.59-0.78), and was significantly better than the existing nine warfarin-related bleeding prediction scoring systems. The calibration plot and Hosmer–Lemeshow test (χ² = 7.557; P = .478) indicated well-calibrated data in the model. The DCA demonstrated good clinical utility. In this study, we developed a nomogram to predict the risk of warfarin-related major or CRNM bleeding. The model has good performance, allows rapid risk stratification of warfarin users, and provides a basis for personalized treatment.

•ML models outperformed conventional scores in predicting major bleeding in AF.•Random forest achieved an AUC of 0.76 vs HAS-BLED's AUC of 0.57 (p < 0.001).•SHAP analysis identified new bleeding risk factors like BMI and cholesterol profile.•Study included 24,468 AF patients on DOACs with a 5-year follow-up for bleeding events.•ML models offer more personalized bleeding risk assessment for AF patients on DOACs. Predicting major bleeding in nonvalvular atrial fibrillation (AF) patients on direct oral anticoagulants (DOACs) is crucial for personalized care. Alternatives like left atrial appendage closure devices lower stroke risk with fewer nonprocedural bleeds. This study compares machine learning (ML) models with conventional bleeding risk scores (HAS-BLED, ORBIT, and ATRIA) for predicting bleeding events requiring hospitalization in AF patients on DOACs at their index cardiologist visit. This retrospective cohort study used electronic health records from 2010 to 2022 at the University of Pittsburgh Medical Center. It included 24,468 nonvalvular AF patients (age ≥18) on DOACs, excluding those with prior significant bleeding or warfarin use. The primary outcome was hospitalization for bleeding within one year, with follow-up at one, two, and five years. ML algorithms (logistic regression, classification trees, random forest, XGBoost, k-nearest neighbor, naïve Bayes) were compared for performance. Of 24,468 patients, 553 (2.3%) had bleeding within one year, 829 (3.5%) within two years, and 1,292 (5.8%) within five years. ML models outperformed HAS-BLED, ATRIA, and ORBIT in 1-year predictions. The random forest model achieved an AUC of 0.76 (0.70 to 0.81), G-Mean of 0.67, and net reclassification index of 0.14 compared to HAS-BLED's AUC of 0.57 (p < 0.001). ML models showed superior results across all timepoints and for hemorrhagic stroke. SHAP analysis identified new risk factors, including BMI, cholesterol profile, and insurance type. In conclusion, ML models demonstrated improved performance to conventional bleeding risk scores and uncovered novel risk factors, offering potential for more personalized bleeding risk assessment in AF patients on DOACs.