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1.
BMC Med ; 22(1): 148, 2024 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-38561738

RESUMO

BACKGROUND: Indobufen is widely used in patients with aspirin intolerance in East Asia. The OPTION trial launched by our cardiac center examined the performance of indobufen based dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). However, the vast majority of patients with acute coronary syndrome (ACS) and aspirin intolerance were excluded. We aimed to explore this question in a real-world population. METHODS: Patients enrolled in the ASPIRATION registry were grouped according to the DAPT strategy that they received after PCI. The primary endpoints were major adverse cardiovascular and cerebrovascular events (MACCE) and Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Propensity score matching (PSM) was adopted for confounder adjustment. RESULTS: A total of 7135 patients were reviewed. After one-year follow-up, the indobufen group was associated with the same risk of MACCE versus the aspirin group after PSM (6.5% vs. 6.5%, hazard ratio [HR] = 0.99, 95% confidence interval [CI] = 0.65 to 1.52, P = 0.978). However, BARC type 2, 3, or 5 bleeding was significantly reduced (3.0% vs. 11.9%, HR = 0.24, 95% CI = 0.15 to 0.40, P < 0.001). These results were generally consistent across different subgroups including aspirin intolerance, except that indobufen appeared to increase the risk of MACCE in patients with ACS. CONCLUSIONS: Indobufen shared the same risk of MACCE but a lower risk of bleeding after PCI versus aspirin from a real-world perspective. Due to the observational nature of the current analysis, future studies are still warranted to further evaluate the efficacy of indobufen based DAPT, especially in patients with ACS. TRIAL REGISTRATION: Chinese Clinical Trial Register ( https://www.chictr.org.cn ); Number: ChiCTR2300067274.


Assuntos
Síndrome Coronariana Aguda , Isoindóis , Intervenção Coronária Percutânea , Fenilbutiratos , Humanos , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Aspirina/efeitos adversos , Quimioterapia Combinada , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/efeitos adversos , Sistema de Registros , Resultado do Tratamento
2.
Circ Cardiovasc Interv ; 17(4): e013000, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38626080

RESUMO

BACKGROUND: Oncological patients with coronary artery disease face an elevated risk of hemorrhagic and ischemic events following percutaneous coronary intervention. Despite medical guidelines recommending minimal dual antiplatelet therapy (DAPT) duration for patients with cancer, dedicated data on abbreviated DAPT in this population is lacking. This study aims to evaluate the occurrence of ischemic and hemorrhagic events in patients with cancer compared with other high-bleeding risk individuals. METHODS: Patient-level data from 4 high-bleeding risk coronary drug-eluting stent studies (ONYX One, LEADERS FREE, LEADERS FREE II, and SENIOR trials) treated with short DAPT were analyzed. The comparison focused on patients with high-bleeding risk with and without cancer, assessing 1-year rates of net adverse clinical events (all-cause death, myocardial infarction, stroke, revascularization, and Bleeding Academic Research Consortium [BARC] types 3 to 5 bleeding) and major adverse clinical events (all-cause death, myocardial infarction, stroke). RESULTS: A total of 5232 patients were included, of whom 574 individuals had cancer, and 4658 were at high-bleeding risk without previous cancer. Despite being younger with fewer risk factors, patients with cancer had higher net adverse clinical event (HR, 1.25; P=0.01) and major adverse clinical event (HR, 1.26; P=0.02), primarily driven by all-cause mortality and major bleeding (BARC 3-5), but not myocardial infarction, stroke, stent thrombosis, or repeat revascularization. Cancer was an independent predictor of net adverse clinical event (P=0.005), major adverse clinical event (P=0.01), and major bleeding (P=0.03). CONCLUSIONS: The present work is the first report on abbreviated DAPT dedicated to patients with cancer. Cancer is a major marker of adverse outcomes and these events had high lethality. Despite short DAPT, patients with cancer experienced higher rates of major bleeding compared with patients without cancer with high-bleeding risk, which occurred mainly after DAPT discontinuation. These findings reinforce the need for a more detailed and individualized stratification of those patients. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03344653, NCT01623180, NCT02843633, NCT0284.


Assuntos
Stents Farmacológicos , Infarto do Miocárdio , Neoplasias , Intervenção Coronária Percutânea , Acidente Vascular Cerebral , Humanos , Inibidores da Agregação Plaquetária , Stents Farmacológicos/efeitos adversos , Intervenção Coronária Percutânea/efeitos adversos , Resultado do Tratamento , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Infarto do Miocárdio/etiologia , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Quimioterapia Combinada , Neoplasias/diagnóstico , Neoplasias/epidemiologia , Neoplasias/terapia
3.
Pharmacoepidemiol Drug Saf ; 33(4): e5786, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38565524

RESUMO

PURPOSE: Among patients with atrial fibrillation (AF), a nonpharmacologic option (e.g., percutaneous left atrial appendage occlusion [LAAO]) is needed for patients with oral anticoagulant (OAC) contraindications. Among beneficiaries in the Medicare fee-for-service coverage 20% sample databases (2015-18) who had AF and an elevated CHA2DS2-VASc score, we assessed the association between percutaneous LAAO versus OAC use and risk of stroke, hospitalized bleeding, and death. METHODS: Patients undergoing percutaneous LAAO were matched to up to five OAC users by sex, age, date of enrollment, index date, CHA2DS2-VASc score, and HAS-BLED score. Overall, 17 156 patients with AF (2905 with percutaneous LAAO) were matched (average ± SD 78 ± 6 years, 44% female). Cox proportional hazards model were used. RESULTS: Median follow-up was 10.3 months. After multivariable adjustments, no significant difference for risk of stroke or death was noted when patients with percutaneous LAAO were compared with OAC users (HRs [95% CIs]: 1.14 [0.86-1.52], 0.98 [0.86-1.10]). There was a 2.94-fold (95% CI: 2.50-3.45) increased risk for hospitalized bleeding for percutaneous LAAO compared with OAC use. Among patients 65 to <78 years old, those undergoing percutaneous LAAO had higher risk of stroke compared with OAC users. No association was present in those ≥78 years. CONCLUSION: In this analysis of real-world AF patients, percutaneous LAAO versus OAC use was associated with similar risk of death, nonsignificantly elevated risk of stroke, and an elevated risk of bleeding in the post-procedural period. Overall, these results support results of randomized trials that percutaneous LAAO may be an alternative to OAC use for patients with contraindications.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Feminino , Idoso , Estados Unidos/epidemiologia , Masculino , Apêndice Atrial/cirurgia , Resultado do Tratamento , Medicare , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Fibrilação Atrial/complicações , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/induzido quimicamente , Anticoagulantes/efeitos adversos
4.
Int J Clin Pharmacol Ther ; 62(5): 195-203, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38469705

RESUMO

BACKGROUND: COVID-19 induces a pro-coagulant state with thrombotic events. This meta-analysis explores the efficacy and safety of antiplatelet-based therapy in COVID-19 patients through randomized controlled trials (RCTs). MATERIALS AND METHODS: A systematic literature search until March 10, 2023, identified 7 RCTs involving 23,415 inpatients. Of these, 11,891 received antiplatelet-based treatment, and 11,524 received placebo/other drugs. Statistical analysis was performed using Review Manager 5.4. RESULTS: The included trials involved patients with a mean age ranging from 54.3 to 62.0 years and a prevalence of hypertension ranging from 10.9 to 65.0% and coronary artery disease ranging from 3.2 to 32.7%. The pooled analysis showed no significant difference in overall mortality between groups (RR 1.0, 95% CI 0.99 - 1.01, p = 0.76). However, antiplatelet therapy significantly reduced major thrombotic events (RR 0.86, 95% CI 0.75 - 0.99, p = 0.04). Conversely, it increased major bleeding risks (RR 1.62, 95% CI 1.24 - 2.12, p = 0.0005). There was no significant difference in the incidence of invasive mechanical ventilation and respiratory death. CONCLUSION: Antiplatelet therapy does not confer mortality benefit in COVID-19 patients but lowers major thrombotic events while increasing major bleeding risks. Ongoing large RCTs will provide more information on the therapeutic value of this therapy.


Assuntos
COVID-19 , Trombose , Humanos , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Trombose/prevenção & controle , Trombose/induzido quimicamente , Trombose/tratamento farmacológico , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia
5.
Cardiovasc Toxicol ; 24(4): 365-374, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38499940

RESUMO

In this study, we leveraged machine learning (ML) approach to develop and validate new assessment tools for predicting stroke and bleeding among patients with atrial fibrillation (AFib) and cancer. We conducted a retrospective cohort study including patients who were newly diagnosed with AFib with a record of cancer from the 2012-2018 Surveillance, Epidemiology, and End Results (SEER)-Medicare database. The ML algorithms were developed and validated separately for each outcome by fitting elastic net, random forest (RF), extreme gradient boosting (XGBoost), support vector machine (SVM), and neural network models with tenfold cross-validation (train:test = 7:3). We obtained area under the curve (AUC), sensitivity, specificity, and F2 score as performance metrics. Model calibration was assessed using Brier score. In sensitivity analysis, we resampled data using Synthetic Minority Oversampling Technique (SMOTE). Among 18,388 patients with AFib and cancer, 523 (2.84%) had ischemic stroke and 221 (1.20%) had major bleeding within one year after AFib diagnosis. In prediction of ischemic stroke, RF significantly outperformed other ML models [AUC (0.916, 95% CI 0.887-0.945), sensitivity 0.868, specificity 0.801, F2 score 0.375, Brier score = 0.035]. However, the performance of ML algorithms in prediction of major bleeding was low with highest AUC achieved by RF (0.623, 95% CI 0.554-0.692). RF models performed better than CHA2DS2-VASc and HAS-BLED scores. SMOTE did not improve the performance of the ML algorithms. Our study demonstrated a promising application of ML in stroke prediction among patients with AFib and cancer. This tool may be leveraged in assisting clinicians to identify patients at high risk of stroke and optimize treatment decisions.


Assuntos
Fibrilação Atrial , AVC Isquêmico , Neoplasias , Acidente Vascular Cerebral , Humanos , Idoso , Estados Unidos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , AVC Isquêmico/diagnóstico , AVC Isquêmico/epidemiologia , Estudos Retrospectivos , Medição de Risco , Medicare , Hemorragia/induzido quimicamente , Hemorragia/diagnóstico , Hemorragia/epidemiologia , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Algoritmos , Neoplasias/complicações , Neoplasias/diagnóstico , Neoplasias/epidemiologia , Aprendizado de Máquina
6.
Ned Tijdschr Geneeskd ; 1682024 01 29.
Artigo em Holandês | MEDLINE | ID: mdl-38525862

RESUMO

OBJECTIVE: To investigate whether frail elderly people with atrial fibrillation (AF) who are currently using a vitamin K antagonist (VKA) should be switched to a direct-acting oral anticoagulant (DOAC). DESIGN: Randomized clinical trial. METHODS: 662 frail elderly AF patients were switched to a DOAC, and 661 patients continued their VKA. The primary endpoint was a major or clinically relevant non-major bleeding during 1 year of follow-up. Secondary endpoints included thrombo-embolic events. RESULTS: The mean age of the included patients was 83 years. In the 'switch to DOAC arm', 101 bleeding events (15.3%) occurred and in the 'continue with VKA arm', 62 bleeding events (9.4%); an increase of 69% more bleeding events (P-value 0.001). The number of thrombo-embolic events was not significantly different between both groups. CONCLUSION: Switching from a VKA to a DOAC in frail elderly people with AF leads to 69% more bleeding, without a difference in thrombo-embolic events.


Assuntos
Anticoagulantes , Fibrilação Atrial , Cumarínicos , Idoso , Idoso de 80 Anos ou mais , Humanos , Administração Oral , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Cumarínicos/efeitos adversos , Idoso Fragilizado , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Vitamina K
7.
Expert Opin Drug Saf ; 23(4): 487-495, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38497691

RESUMO

BACKGROUND: Hemorrhage represents the most common and serious side effect of antithrombotic agents. Many studies have compared the risk of bleeding between different antithrombotic agents, but analysis of time-to-onset for hemorrhage induced by these drugs is yet sparse. METHODS: We conducted a retrospective study based on the adverse drug reaction reports on antithrombotic agents collected by the Henan Adverse Drug Reaction Monitoring Center. We assessed the reporting odds ratio to determine the disproportionate reporting signals for bleeding and the Weibull shape parameter was used to evaluate the time-to-onset data. RESULTS: In the signal detection, crude low molecular weight heparin-hemorrhage was found as a positive signal. The hemorrhage for most antithrombotic agents was random failure profiles. In particular, the hazard of hemorrhage decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole. CONCLUSION: We found that the risk of bleeding in patients taking Crude low molecular weight heparins was significantly higher compared to other antithrombotic agents, but with a small magnificence, which may be attributed to the severely irrational use of this medication under improper management. Statistics in days, results showed that the risk of bleeding decreased over time for warfarin and clopidogrel and increased for alteplase, nadroparin, and dipyridamole.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Fibrinolíticos , Humanos , Fibrinolíticos/efeitos adversos , Varfarina/efeitos adversos , Nadroparina/efeitos adversos , Clopidogrel/efeitos adversos , Ativador de Plasminogênio Tecidual/efeitos adversos , Estudos Retrospectivos , Farmacovigilância , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Anticoagulantes/efeitos adversos , Dipiridamol/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos
8.
JAMA Netw Open ; 7(3): e240877, 2024 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-38451525

RESUMO

Importance: P2Y12 inhibitor monotherapy after dual antiplatelet therapy (DAPT; a P2Y12 inhibitor plus aspirin) for a brief duration has recently emerged as an attractive alternative for patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent. Objective: To investigate whether P2Y12 inhibitor monotherapy after 3 months of DAPT was noninferior to 12 months of DAPT following PCI with a drug-eluting stent. Design, Setting, and Participants: The Short-Term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-Eluting Stent (SHARE) open-label, noninferiority randomized clinical trial was conducted from December 15, 2017, through December 14, 2020. Final 1-year clinical follow-up was completed in January 2022. This study was a multicenter trial that was conducted at 20 hospitals in South Korea. Patients who underwent successful PCI with bioabsorbable polymer everolimus-eluting stents were enrolled. Interventions: Patients were randomly assigned to receive P2Y12 inhibitor monotherapy after 3 months of DAPT (n = 694) or 12 months of DAPT (n = 693). Main Outcomes and Measures: The primary outcome was a net adverse clinical event, a composite of major bleeding (based on Bleeding Academic Research Consortium type 3 or type 5 bleeding) and major adverse cardiac and cerebrovascular events (cardiac death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target lesion revascularization) between 3 and 12 months after the index PCI. The major secondary outcomes were major adverse cardiac and cerebrovascular events and major bleeding. The noninferiority margin was 3.0%. Results: Of the total 1452 eligible patients, 65 patients were excluded before the 3-month follow-up, and 1387 patients (mean [SD] age, 63.0 [10.7] years; 1055 men [76.1%]) were assigned to P2Y12 inhibitor monotherapy (n = 694) or DAPT (n = 693). Between 3 and 12 months of follow-up, the primary outcome (using Kaplan-Meier estimates) occurred in 9 patients (1.7%) in the P2Y12 inhibitor monotherapy group and in 16 patients (2.6%) in the DAPT group (absolute difference, -0.93 [1-sided 95% CI, -2.64 to 0.77] percentage points; P < .001 for noninferiority). For the major secondary outcomes (using Kaplan-Meier estimates), major adverse cardiac and cerebrovascular events occurred in 8 patients (1.5%) in the P2Y12 inhibitor monotherapy group and in 12 patients (2.0%) in the DAPT group (absolute difference, -0.49 [95% CI, -2.07 to 1.09] percentage points; P = .54). Major bleeding occurred in 1 patient (0.2%) in the P2Y12 inhibitor monotherapy group and in 5 patients (0.8%) in the DAPT group (absolute difference, -0.60 [95% CI, -1.33 to 0.12] percentage points; P = .10). Conclusions and Relevance: In patients with coronary artery disease undergoing PCI with the latest generation of drug-eluting stents, P2Y12 inhibitor monotherapy after 3-month DAPT was not inferior to 12-month DAPT for net adverse clinical events. Considering the study population and lower-than-expected event rates, further research is required in other populations. Trial Registration: ClinicalTrials.gov Identifier: NCT03447379.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Masculino , Humanos , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/uso terapêutico , Everolimo/uso terapêutico , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Polímeros
9.
JAMA Netw Open ; 7(3): e243208, 2024 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-38517440

RESUMO

Importance: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed antidepressants associated with a small increased risk of major bleeding. However, the risk of bleeding associated with the concomitant use of SSRIs and oral anticoagulants (OACs) has not been well characterized. Objectives: To assess whether concomitant use of SSRIs with OACs is associated with an increased risk of major bleeding compared with OAC use alone, describe how the risk varies with duration of use, and identify key clinical characteristics modifying this risk. Design, Setting, and Participants: A population-based, nested case-control study was conducted among patients with atrial fibrillation initiating OACs between January 2, 1998, and March 29, 2021. Patients were from approximately 2000 general practices in the UK contributing to the Clinical Practice Research Datalink. With the use of risk-set sampling, for each case of major bleeding during follow-up, up to 30 controls were selected from risk sets defined by the case and matched on age, sex, cohort entry date, and follow-up duration. Exposures: Concomitant use of SSRIs and OACs (direct OACs and vitamin K antagonists [VKAs]) compared with OAC use alone. Main Outcomes and Measures: The main outcome was incidence rate ratios (IRRs) of hospitalization for bleeding or death due to bleeding. Results: There were 42 190 patients with major bleeding (mean [SD] age, 74.2 [9.3] years; 59.8% men) matched to 1 156 641 controls (mean [SD] age, 74.2 [9.3] years; 59.8% men). Concomitant use of SSRIs and OACs was associated with an increased risk of major bleeding compared with OACs alone (IRR, 1.33; 95% CI, 1.24-1.42). The risk peaked during the initial months of treatment (first 30 days of use: IRR, 1.74; 95% CI, 1.37-2.22) and persisted for up to 6 months. The risk did not vary with age, sex, history of bleeding, chronic kidney disease, and potency of SSRIs. An association was present both with concomitant use of SSRIs and direct OACs compared with direct OAC use alone (IRR, 1.25; 95% CI, 1.12-1.40) and concomitant use of SSRIs and VKAs compared with VKA use alone (IRR, 1.36; 95% CI, 1.25-1.47). Conclusions and Relevance: This study suggests that among patients with atrial fibrillation, concomitant use of SSRIs and OACs was associated with an increased risk of major bleeding compared with OAC use alone, requiring close monitoring and management of risk factors for bleeding, particularly in the first few months of use.


Assuntos
Fibrilação Atrial , Inibidores Seletivos de Recaptação de Serotonina , Idoso , Feminino , Humanos , Masculino , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Estudos de Casos e Controles , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Inibidores Seletivos de Recaptação de Serotonina/efeitos adversos , Idoso de 80 Anos ou mais
10.
Pediatr Blood Cancer ; 71(5): e30926, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38449356

RESUMO

BACKGROUND: Pediatric venous thromboembolism has increased by 130%-200%, specifically in hospitalized children, and direct oral anticoagulants (DOACs) offer several therapeutic advantages. METHODS: This study aims to evaluate the real-world epidemiological and outcome data from a retrospective review of pediatric patients treated with DOACs from January 1, 2013 to December 31, 2022. In this single-center, IRB-approved study, 65 patients were identified and analyzed using SPSS statistical software, and a descriptive statistical analysis was conducted. RESULTS: Of the 65 patients, 37% were on apixaban, 61.5% were on rivaroxaban, and 1.5% were on dabigatran. Per the 2023 ISTH outcome definitions, one (2%) patient had a major bleeding episode, six (9%) had clinically relevant non-major bleeding, three (5%) patients had patient-important heavy menstrual bleeding (HMB), and one (1.5%) patient had minor bleeding. Seven (19%) of 37 postmenarchal patients had evidence of HMB. Six (9.2%) patients had recurrent venous thromboembolism while on a DOAC (one was on apixaban, and five were on rivaroxaban) and were transitioned to other forms of anticoagulation. CONCLUSION: Thus, bleeding rates after DOAC therapy are comparable to previous DOAC trials, as well as other anticoagulants in pediatrics. HMB is an important outcome measure and should continue to be investigated. This study reports a higher rate of recurrent thrombosis (9.2%) compared to other trials. However, this observation may be attributed to patients who had ongoing risk factors, as well as a longer duration of study follow-up. Additional multicentered outcome studies evaluating DOAC use in children are needed to determine long-term recurrence and HMB risks.


Assuntos
Menorragia , Tromboembolia Venosa , Feminino , Humanos , Criança , Rivaroxabana/efeitos adversos , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/epidemiologia , Anticoagulantes/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/complicações , Dabigatrana/efeitos adversos , Menorragia/complicações , Piridonas/efeitos adversos , Estudos Retrospectivos , Administração Oral
11.
Thromb Res ; 236: 209-219, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38461615

RESUMO

INTRODUCTION: There are few large-scale, population-based studies detailing the risks of thrombosis, hemorrhage, leukemic transformation in patients with myeloproliferative neoplasms (MPNs), including essential thrombocythemia (ET), polycythemia vera (PV), and primary myelofibrosis (PMF). METHODS: We performed a nationwide longitudinal cohort study using the Korean National Health Insurance System (NHIS) database. MPN patients (n = 11,991) and their 1:4 age- and sex-matched controls (n = 47,964) were enrolled. The risk of thrombosis, hemorrhage, leukemic transformation was estimated using a Cox proportional hazards regression, and stratified analyses were performed for related factors. RESULTS: During a median of 7.8 years of follow-up, 30.1 % of MPN patients (3614/11,991) and 19.0 % of the matched controls (9141/47,964) developed arterial thrombosis, 11.6 % of MPN patients (1397/11,991) and 6.4 % of the matched controls (3099/47,964) developed venous thrombosis and 18.7 % of MPN patients (2251/11,991) and 12.1 % of the matched controls (5836/47,964) developed hemorrhage. 4.9 % of MPN patients (597/11,991) and 0.1 % of matched controls (50/47,964) developed leukemia. The overall risk of developing thrombosis, hemorrhage, leukemic transformation was higher in MPN patients (adjusted hazard ratio [aHR] 1.695, 95 % confidence interval [CI]: 1.629-1.765 for arterial thrombosis, aHR 1.963, 95 % CI: 1.838-2.096 for venous thrombosis, and aHR 1.714, 95 % CI: 1.630-1.802 for hemorrhage) than in the controls. Patients with MPNs had a 10-year cumulative incidence of leukemic transformation of 6.2 %. CONCLUSION: The patients with MPNs have a higher risk of thrombosis, hemorrhage, and leukemic transformation than matched controls. Strategies are warranted to reduce the risk of thrombosis, hemorrhage, and leukemic transformation in MPN patients.


Assuntos
Transtornos Mieloproliferativos , Policitemia Vera , Trombose , Trombose Venosa , Humanos , Estudos Longitudinais , Transtornos Mieloproliferativos/complicações , Trombose/etiologia , Policitemia Vera/epidemiologia , Hemorragia/etiologia , Hemorragia/epidemiologia , Estudos de Coortes
12.
BMC Cardiovasc Disord ; 24(1): 179, 2024 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-38528469

RESUMO

OBJECTIVE: The aim of this study is to develop a nomogram model for predicting the occurrence of intramyocardial hemorrhage (IMH) in patients with Acute Myocardial Infarction (AMI) following Percutaneous Coronary Intervention (PCI). The model is constructed utilizing clinical data and the SYNTAX Score (SS), and its predictive value is thoroughly evaluated. METHODS: A retrospective study was conducted, including 216 patients with AMI who underwent Cardiac Magnetic Resonance (CMR) within a week post-PCI. Clinical data were collected for all patients, and their SS were calculated based on coronary angiography results. Based on the presence or absence of IMH as indicated by CMR, patients were categorized into two groups: the IMH group (109 patients) and the non-IMH group (107 patients). The patients were randomly divided in a 7:3 ratio into a training set (151 patients) and a validation set (65 patients). A nomogram model was constructed using univariate and multivariate logistic regression analyses. The predictive capability of the model was assessed using Receiver Operating Characteristic (ROC) curve analysis, comparing the predictive value based on the area under the ROC curve (AUC). RESULTS: In the training set, IMH post-PCI was observed in 78 AMI patients on CMR, while 73 did not show IMH. Variables with a significance level of P < 0.05 were screened using univariate logistic regression analysis. Twelve indicators were selected for multivariate logistic regression analysis: heart rate, diastolic blood pressure, ST segment elevation on electrocardiogram, culprit vessel, symptom onset to reperfusion time, C-reactive protein, aspartate aminotransferase, lactate dehydrogenase, creatine kinase, creatine kinase-MB, high-sensitivity troponin T (HS-TnT), and SYNTAX Score. Based on multivariate logistic regression results, two independent predictive factors were identified: HS-TnT (Odds Ratio [OR] = 1.61, 95% Confidence Interval [CI]: 1.21-2.25, P = 0.003) and SS (OR = 2.54, 95% CI: 1.42-4.90, P = 0.003). Consequently, a nomogram model was constructed based on these findings. The AUC of the nomogram model in the training set was 0.893 (95% CI: 0.840-0.946), and in the validation set, it was 0.910 (95% CI: 0.823-0.970). Good consistency and accuracy of the model were demonstrated by calibration and decision curve analysis. CONCLUSION: The nomogram model, constructed utilizing HS-TnT and SS, demonstrates accurate predictive capability for the risk of IMH post-PCI in patients with AMI. This model offers significant guidance and theoretical support for the clinical diagnosis and treatment of these patients.


Assuntos
Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Nomogramas , Estudos Retrospectivos , Infarto do Miocárdio/diagnóstico , Hemorragia/diagnóstico por imagem , Hemorragia/etiologia , Hemorragia/epidemiologia
13.
Scand J Trauma Resusc Emerg Med ; 32(1): 24, 2024 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-38528572

RESUMO

BACKGROUND: Major traumatic haemorrhage is potentially preventable with rapid haemorrhage control and improved resuscitation techniques. Although advances in prehospital trauma management, haemorrhage is still associated with high mortality. The aim of this study was to use a recent pragmatic transfusion-based definition of major bleeding to characterize patients at risk of major bleeding and associated outcomes in this cohort after trauma. METHODS: This was a retrospective cohort study including all trauma patients (n = 7020) admitted to a tertiary trauma center from January 2015 to June 2020. The major bleeding cohort (n = 145) was defined as transfusion of 4 units of any blood components (red blood cells, plasma, or platelets) within 2 h of injury. Univariate and multivariable logistic regression analyses were performed to identify risk factors for 24-hour and 30-day mortality post trauma admission. RESULTS: In the major bleeding cohort (n = 145; 145/7020, 2.1% of the trauma population), there were 77% men (n = 112) and 23% women (n = 33), median age 39 years [IQR 26-53] and median Injury Severity Score (ISS) was 22 [IQR 13-34]. Blunt trauma dominated over penetrating trauma (58% vs. 42%) where high-energy fall was the most common blunt mechanism and knife injury was the most common penetrating mechanism. The major bleeding cohort was younger (OR 0.99; 95% CI 0.98 to 0.998, P = 0.012), less female gender (OR 0.66; 95% CI 0.45 to 0.98, P = 0.04), and had more penetrating trauma (OR 4.54; 95% CI 3.24 to 6.36, P = 0.001) than the rest of the trauma cohort. A prehospital (OR 2.39; 95% CI 1.34 to 4.28; P = 0.003) and emergency department (ED) (OR 6.91; 95% CI 4.49 to 10.66, P = 0.001) systolic blood pressure < 90 mmHg was associated with the major bleeding cohort as well as ED blood gas base excess < -3 (OR 7.72; 95% CI 5.37 to 11.11; P < 0.001) and INR > 1.2 (OR 3.09; 95% CI 2.16 to 4.43; P = 0.001). Emergency damage control laparotomy was performed more frequently in the major bleeding cohort (21.4% [n = 31] vs. 1.5% [n = 106]; OR 3.90; 95% CI 2.50 to 6.08; P < 0.001). There was no difference in transportation time from alarm to hospital arrival between the major bleeding cohort and the rest of the trauma cohort (47 [IQR 38;59] vs. 49 [IQR 40;62] minutes; P = 0.17). However, the major bleeding cohort had a shorter time from ED to first emergency procedure (71.5 [IQR 10.0;129.0] vs. 109.00 [IQR 54.0; 259.0] minutes, P < 0.001). In the major bleeding cohort, patients with penetrating trauma, compared to blunt trauma, had a shorter alarm to hospital arrival time (44.0 [IQR 35.5;54.0] vs. 50.0 [IQR 41.5;61.0], P = 0.013). The 24-hour mortality in the major bleeding cohort was 6.9% (10/145). All fatalities were due to blunt trauma; 40% (4/10) high energy fall, 20% (2/10) motor vehicle accident, 10% (1/10) motorcycle accident, 10% (1/10) traffic pedestrian, 10% (1/10) traffic other, and 10% (1/10) struck/hit by blunt object. In the logistic regression model, prehospital cardiac arrest (OR 83.4; 95% CI 3.37 to 2063; P = 0.007) and transportation time (OR 0.95, 95% CI 0.91 to 0.99, P = 0.02) were associated with 24-hour mortality. RESULTS: Early identification of patients at high risk of major bleeding is challenging but essential for rapid definitive haemorrhage control. The major bleeding trauma cohort is a small part of the entire trauma population, and is characterized of being younger, male gender, higher ISS, and exposed to more penetrating trauma. Early identification of patients at high risk of major bleeding is challenging but essential for rapid definitive haemorrhage control.


Assuntos
Ferimentos e Lesões , Ferimentos não Penetrantes , Ferimentos Penetrantes , Humanos , Masculino , Feminino , Adulto , Centros de Traumatologia , Estudos Retrospectivos , Hemorragia/epidemiologia , Hemorragia/etiologia , Hemorragia/terapia , Ressuscitação/métodos , Ferimentos Penetrantes/complicações , Ferimentos não Penetrantes/complicações , Ferimentos não Penetrantes/epidemiologia , Ferimentos não Penetrantes/terapia , Escala de Gravidade do Ferimento , Ferimentos e Lesões/epidemiologia , Ferimentos e Lesões/terapia , Ferimentos e Lesões/complicações
14.
Sci Rep ; 14(1): 7348, 2024 03 28.
Artigo em Inglês | MEDLINE | ID: mdl-38538978

RESUMO

To evaluate the current incidence of pulmonary hemorrhage and the potential factors contributing to its increased risk after percutaneous CT-guided pulmonary nodule biopsy and to summarize the technical recommendations for its treatment. In this observational study, patient data were collected from ten medical centers from April 2021 to April 2022. The incidence of pulmonary hemorrhage was as follows: grade 0, 36.1% (214/593); grade 1, 36.8% (218/593); grade 2, 18.9% (112/593); grade 3, 3.5% (21/593); and grade 4, 4.7% (28/593). High-grade hemorrhage (HGH) occurred in 27.2% (161/593) of the patients. The use of preoperative breathing exercises (PBE, p =0.000), semiautomatic cutting needles (SCN, p = 0.004), immediate contrast enhancement (ICE, p =0.021), and the coaxial technique (CoT, p = 0.000) were found to be protective factors for HGH. A greater length of puncture (p =0.021), the presence of hilar nodules (p = 0.001), the presence of intermediate nodules (p = 0.026), a main pulmonary artery diameter (mPAD) larger than 29 mm (p = 0.015), and a small nodule size (p = 0.014) were risk factors for high-grade hemorrhage. The area under the curve (AUC) was 0.783. These findings contribute to a deeper understanding of the risks associated with percutaneous CT-guided pulmonary nodule biopsy and provide valuable insights for developing strategies to minimize pulmonary hemorrhage.


Assuntos
Anormalidades Cardiovasculares , Pneumopatias , Neoplasias Pulmonares , Nódulo Pulmonar Solitário , Humanos , Incidência , Pneumopatias/diagnóstico por imagem , Pneumopatias/epidemiologia , Pneumopatias/etiologia , Hemorragia/epidemiologia , Hemorragia/etiologia , Biópsia Guiada por Imagem/efeitos adversos , Tomografia Computadorizada por Raios X/métodos , Fatores de Risco , Estudos Retrospectivos , Anormalidades Cardiovasculares/etiologia , Neoplasias Pulmonares/patologia , Nódulo Pulmonar Solitário/diagnóstico por imagem
15.
Pharmacoepidemiol Drug Saf ; 33(2): e5756, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38357810

RESUMO

BACKGROUND: Distinguishing warfarin-related bleeding risk at the bedside remains challenging. Studies indicate that warfarin therapy should be suspended when international normalized ratio (INR) ≥ 4.5, or it may sharply increase the risk of bleeding. We aim to develop and validate a model to predict the high bleeding risk in valve replacement patients during hospitalization. METHOD: Cardiac valve replacement patients from January 2016 to December 2021 across Nanjing First Hospital were collected. Five different machine-learning (ML) models were used to establish the prediction model. High bleeding risk was an INR ≥4.5. The area under the receiver operating characteristic curve (AUC) was used for evaluating the prediction performance of different models. The SHapley Additive exPlanations (SHAP) was used for interpreting the model. We also compared ML with ATRIA score and ORBIT score. RESULTS: A total of 2376 patients were finally enrolled in this model, 131 (5.5%) of whom experienced the high bleeding risk after anticoagulation therapy of warfarin during hospitalization. The extreme gradient boosting (XGBoost) exhibited the best overall prediction performance (AUC: 0.882, confidence interval [CI] 0.817-0.946, Brier score, 0.158) compared to other prediction models. It also shows superior performance compared with ATRIA score and ORBIT score. The top 5 most influential features in XGBoost model were platelet, thyroid stimulation hormone, body surface area, serum creatinine and white blood cell. CONCLUSION: A model for predicting high bleeding risk in valve replacement patients who treated with warfarin during hospitalization was successfully developed by using machine learning, which may well assist clinicians to identify patients at high risk of bleeding and allow timely adjust therapeutic strategies in evaluating individual patient.


Assuntos
Anticoagulantes , Varfarina , Humanos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Valvas Cardíacas/cirurgia , Aprendizado de Máquina
16.
Sci Rep ; 14(1): 4011, 2024 02 18.
Artigo em Inglês | MEDLINE | ID: mdl-38369533

RESUMO

The aim of the study was to investigate whether morphology (i.e. compact/diffuse) of brain arteriovenous malformations (bAVMs) correlates with the incidence of hemorrhagic events in patients receiving Stereotactic Radiosurgery (SRS) for unruptured bAVMs. This retrospective study included 262 adult patients with unruptured bAVMs who underwent upfront SRS. Hemorrhagic events were defined as evidence of blood on CT or MRI. The morphology of bAVMs was evaluated using automated segmentation which calculated the proportion of vessel, brain tissue, and cerebrospinal fluid in bAVMs on T2-weighted MRI. Compactness index, defined as the ratio of vessel to brain tissue, categorized bAVMs into compact and diffuse types based on the optimal cutoff. Cox proportional hazard model was used to identify the independent factors for post-SRS hemorrhage. The median clinical follow-ups was 62.1 months. Post-SRS hemorrhage occurred in 13 (5.0%) patients and one of them had two bleeds, resulting in an annual bleeding rate of 0.8%. Multivariable analysis revealed bAVM morphology (compact versus diffuse), bAVM volume, and prescribed margin dose were significant predictors. The post-SRS hemorrhage rate increased with larger bAVM volume only among the diffuse nidi (1.7 versus 14.9 versus 30.6 hemorrhage per 1000 person-years in bAVM volume < 20 cm3 versus 20-40 cm3 versus > 40 cm3; p = 0.022). The significantly higher post-SRS hemorrhage rate of Spetzler-Martin grade IV-V compared with grade I-III bAVMs (20.0 versus 3.3 hemorrhages per 1000 person-years; p = 0.001) mainly originated from the diffuse bAVMs rather than the compact subgroup (30.9 versus 4.8 hemorrhages per 1000 person-years; p = 0.035). Compact and smaller bAVMs, with higher prescribed margin dose harbor lower risks of post-SRS hemorrhage. The post-SRS hemorrhage rate exceeded 2.2% annually within the diffuse and large (> 40 cm3) bAVMs and the diffuse Spetzler-Martin IV-V bAVMs. These findings may help guide patient selection of SRS for the unruptured bAVMs.


Assuntos
Malformações Arteriovenosas Intracranianas , Radiocirurgia , Adulto , Humanos , Estudos Retrospectivos , Resultado do Tratamento , Radiocirurgia/efeitos adversos , Radiocirurgia/métodos , Encéfalo , Malformações Arteriovenosas Intracranianas/diagnóstico por imagem , Malformações Arteriovenosas Intracranianas/epidemiologia , Malformações Arteriovenosas Intracranianas/etiologia , Hemorragia/epidemiologia , Hemorragia/etiologia , Seguimentos
17.
Clin Interv Aging ; 19: 247-254, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38375240

RESUMO

Objective: This study explored whether anticoagulation is safe for frail and non-frail elderly patients who have nonvalvular atrial fibrillation (NVAF). Methods: At hospital discharge, the anticoagulant regimen and frailty status were recorded for 361 elderly patients (aged ≥75 y) with NVAF. The patients were followed for 12 months. The endpoints included occurrence of thrombosis; bleeding; all-cause death; and cardiovascular events. Results: At hospital discharge, frailty affected 50.42% of the population and the anticoagulation rate was 44.04%. At discharge, age (OR 0.948, P = 0.006), paroxysmal NVAF (OR 0.384, P < 0.001), and bleeding history (OR 0.396, P = 0.001) were associated with a decrease in rate of receiving anticoagulation, while thrombotic events during hospitalization (OR 2.281, P = 0.021) were associated with an increase. Relative to non-frail patients, those with frailty showed a higher rate of ischemic stroke (5.33% cf. 3.01%), bleeding (P = 0.006) events, and all-cause mortality (P = 0.001). Relative to the group without anticoagulation, in those with anticoagulation the rate of thrombotic events was lower (6.99 cf. 10.98%) and bleeding events were higher (20.98 cf. 12.72%), but the risk of major bleeding was comparable. Conclusion: In the elderly patients with NVAF, the decision toward anticoagulation therapy at hospital discharge was influenced by age, bleeding history, paroxysmal atrial fibrillation diagnosis, and absence of thrombosis. Frail patients were at greater risk of bleeding and all-cause mortality. Anticoagulation tended to reduce the risk of thrombotic events.


Assuntos
Fibrilação Atrial , Fragilidade , Acidente Vascular Cerebral , Trombose , Idoso , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Fragilidade/complicações , Anticoagulantes/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Trombose/induzido quimicamente , Fatores de Risco
18.
J Am Coll Cardiol ; 83(6): 669-678, 2024 Feb 13.
Artigo em Inglês | MEDLINE | ID: mdl-38325992

RESUMO

BACKGROUND: Phase II trials of asundexian were underpowered to detect important differences in bleeding. OBJECTIVES: The goal of this study was to obtain best estimates of effects of asundexian vs active control/placebo on major and clinically relevant nonmajor (CRNM) and all bleeding, describe most common sites of bleeding, and explore association between asundexian exposure and bleeding. METHODS: We performed a pooled analysis of 3 phase II trials of asundexian in patients with atrial fibrillation (AF), recent acute myocardial infarction (AMI), or stroke. Bleeding was defined according to the International Society on Thrombosis and Hemostasis (ISTH) criteria. RESULTS: In patients with AF (n = 755), both asundexian 20 mg and 50 mg once daily vs apixaban had fewer major/CRNM events (3 of 249; incidence rate [IR] per 100 patient-years 5.47 vs 1 of 254 [IR: not calculable] vs 6 of 250 [IR: 11.10]) and all bleeding (12 of 249 [IR: 22.26] vs 10 of 254 [IR: 18.21] vs 26 of 250 [IR: 50.56]). In patients with recent AMI or stroke (n = 3,409), asundexian 10 mg, 20 mg, and 50 mg once daily compared with placebo had similar rates of major/CRNM events (44 of 840 [IR: 7.55] vs 42 of 843 [IR: 7.04] vs 56 of 845 [IR: 9.63] vs 41 of 851 [IR: 6.99]) and all bleeding (107 of 840 [IR: 19.57] vs 123 of 843 [IR: 22.45] vs 130 of 845 [IR: 24.19] vs 129 of 851 [IR: 23.84]). Most common sites of major/CRNM bleeding with asundexian were gastrointestinal, respiratory, urogenital, and skin. There was no significant association between asundexian exposure and major/CRNM bleeding. CONCLUSIONS: Analyses of phase II trials involving >500 bleeds highlight the potential for improved safety of asundexian compared with apixaban and similar safety compared with placebo. Further evidence on the efficacy of asundexian awaits the results of ongoing phase III trials.


Assuntos
Fibrilação Atrial , Infarto do Miocárdio , Acidente Vascular Cerebral , Humanos , Anticoagulantes/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/complicações , Piridonas/efeitos adversos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Fibrilação Atrial/complicações , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/epidemiologia
19.
Cardiovasc Interv Ther ; 39(2): 145-155, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38349574

RESUMO

Real-world data on coronary events (CE) in elderly patients with atrial fibrillation (AF) are lacking in the direct oral anticoagulant era. This prespecified sub-analysis of the ANAFIE Registry, a prospective observational study in > 30,000 Japanese patients aged ≥ 75 years with non-valvular AF (NVAF), investigated CE incidence and risk factors. The incidence and risk factors for new-onset CE (a composite of myocardial infarction [MI] and cardiac intervention for coronary heart diseases other than MI), MI, and cardiac intervention for coronary heart diseases other than MI during the 2-year follow-up were assessed. Bleeding events in CE patients were also examined. Among 32,275 patients, the incidence rate per 100 patient-years was 0.48 (95% confidence interval (CI): 0.42-0.53) for CE during the 2-year follow-up, 0.20 (0.16-0.23) for MI, and 0.29 (0.25-0.33) for cardiac intervention for coronary heart diseases other than MI; that of stroke/systemic embolism was 1.62 (1.52-1.73). Patients with CE (n = 287) likely had lower creatinine clearance (CrCL) and higher CHADS2 and HAS-BLED scores than patients without CE (n = 31,988). Significant risk factors associated with new-onset CE were male sex, systolic blood pressure of ≥ 130 mmHg, diabetes mellitus (glycated hemoglobin ≥ 6.0%), CE history, antiplatelet agent use, and CrCL < 50 mL/min. Major bleeding incidence was significantly higher in patients with new-onset CE vs without CE (odds ratio [95% CI], 3.35 [2.06-5.43]). In elderly patients with NVAF, CE incidence was lower than stroke/systemic embolism incidence. New-onset CE (vs no CE) was associated with a higher incidence of major bleeding.Trial registration: UMIN000024006.


Assuntos
Fibrilação Atrial , Doença das Coronárias , Embolia , Infarto do Miocárdio , Acidente Vascular Cerebral , Idoso , Humanos , Masculino , Feminino , Fibrilação Atrial/complicações , Fibrilação Atrial/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Fatores de Risco , Embolia/epidemiologia , Embolia/etiologia , Infarto do Miocárdio/complicações , Sistema de Registros , Doença das Coronárias/complicações , Anticoagulantes/uso terapêutico
20.
Lancet ; 403(10431): 1051-1060, 2024 Mar 16.
Artigo em Inglês | MEDLINE | ID: mdl-38368901

RESUMO

BACKGROUND: Prophylactic anticoagulation in emergency department patients with lower limb trauma requiring immobilisation is controversial. The Thrombosis Risk Prediction for Patients with Cast Immobilisation-TRiP(cast)-score could identify a large subgroup of patients at low risk of venous thromboembolism for whom prophylactic anticoagulation can be safely withheld. We aimed to prospectively assess the safety of withholding anticoagulation for patients with lower limb trauma at low risk of venous thromboembolism, defined by a TRiP(cast) score of less than 7. METHODS: CASTING was a stepped-wedge, multicentre, cluster-randomised trial with blinded outcome assessment. 15 emergency departments in France and Belgium were selected and randomly assigned staggered start dates for switching from the control phase (ie, anticoagulation prescription according to the physician's usual practice) to the intervention phase (ie, targeted anticoagulation according to TRiP(cast) score: no prescription if score <7 and anticoagulation if score was ≥7). Patients were included if they presented to a participating emergency department with lower limb trauma requiring immobilisation for at least 7 days and were aged 18 years or older. The primary outcome was the 3-month cumulative rate of symptomatic venous thromboembolism during the intervention phase in patients with a TRiP(cast) score of less than 7. The targeted strategy was considered safe if this rate was less than 1% with an upper 95% CI of less than 2%. The primary analysis was performed in the intention-to-treat population. This study is registered at ClinicalTrials.gov (NCT04064489). FINDINGS: Between June 16, 2020, and Sept 15, 2021, 15 clusters and 2120 patients were included. Of the 1505 patients analysed in the intervention phase, 1159 (77·0%) had a TRiP(cast) score of less than 7 and did not receive anticoagulant treatment. The symptomatic venous thromboembolism rate was 0·7% (95% CI 0·3-1·4, n=8/1159). There was no difference between the control and the intervention phases in the cumulative rate of symptomatic venous thromboembolism or in bleeding rates. INTERPRETATION: Patients with a TRiP(cast) score of less than 7 who are not receiving anticoagulation have a very low risk of venous thromboembolism. A large proportion of patients with lower limb trauma and immobilisation could safely avoid thromboprophylaxis. FUNDING: French Ministry of Health.


Assuntos
Anticoagulantes , Tromboembolia Venosa , Humanos , Anticoagulantes/efeitos adversos , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/tratamento farmacológico , Coagulação Sanguínea , Extremidade Inferior , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/tratamento farmacológico
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