RESUMEN
ABSTRACT: In this study, we investigated the safety and efficacy of fondaparinux sodium in postpercutaneous coronary intervention (PCI) anticoagulation therapy for patients with ST-segment elevation myocardial infarction. There are a total of 200 patients with ST segment elevation myocardial infarction underwent PCI and anticoagulation therapy. They were randomly split into experimental (n = 108) and control groups (n = 92). The experimental group received postoperative fondaparinux sodium (2.5 mg q.d), while the control group received enoxaparin (4000 IU q12 h). We did not use a loading dose for enoxaparin. Bleeding incidence and major adverse cardiovascular/cerebrovascular events were monitored during hospitalization, and at 1, 3, and 6 months postsurgery. The primary end points, including bleeding, mortality, and myocardial infarction during hospitalization, were not significantly different between the 2 groups. For secondary end points, the incidence of combined end point events at 1 month, 3 months, and 6 months after surgery in the experimental group was lower than in the control group (P < 0.05). According to Cox regression analysis, the risk of bleeding in the experimental group was significantly lower than that in the control group [hazard ratios: 0.506, 95% confidence interval (CI): 0.284-0.900] (P = 0.020). The risk of mortality in the experimental group was significantly lower than in the control group (hazard ratio: 0.188, 95% CI: 0.040-0.889) (P = 0.035). In summary, perioperative use of fondaparinux sodium during PCI in patients with STEMI in this study was associated with a lower risk of bleeding and death compared with enoxaparin use in the absence of loading dose.
Asunto(s)
Enoxaparina , Fondaparinux , Hemorragia , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Fondaparinux/uso terapéutico , Fondaparinux/efectos adversos , Fondaparinux/administración & dosificación , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Masculino , Femenino , Persona de Mediana Edad , Anciano , Infarto del Miocardio con Elevación del ST/terapia , Infarto del Miocardio con Elevación del ST/mortalidad , Infarto del Miocardio con Elevación del ST/diagnóstico , China/epidemiología , Resultado del Tratamiento , Hemorragia/inducido químicamente , Enoxaparina/efectos adversos , Enoxaparina/administración & dosificación , Enoxaparina/uso terapéutico , Factores de Riesgo , Factores de Tiempo , Anticoagulantes/efectos adversos , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/uso terapéutico , Estudios ProspectivosRESUMEN
OBJECTIVE: Patients undergoing gynecologic cancer surgery at our centre are recommended up to 28 days of enoxaparin for extended post-operative thromboprophylaxis (EP). Baseline survey revealed 92% patient adherence, but highlighted negative effects on patient experience due to the injectable route of administration. We aimed to improve patient experience by reducing pain and bruising by 50%, increasing adherence by 5%, and reducing out-of-pocket cost after introducing apixaban as an oral alternative for EP. METHODS: In this interrupted time series quality improvement study, gynecologic cancer patients were offered a choice between apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously once daily) at time of discharge. A multidisciplinary team informed project design, implementation, and evaluation. Process interventions included standardized orders, patient and care team education programs. Telephone survey at 1 and 6 weeks and chart audit informed outcome, process, and balancing measures. RESULTS: From August to October 2022, 127 consecutive patients were included. Apixaban was chosen by 84%. Survey response rate was 74%. Patients who chose apixaban reported significantly reduced pain, bruising, increased confidence with administration, and less negative impact of the medication (p < 0.0001 for all). Adherence was unchanged (92%). The proportion of patients paying less than $125 (apixaban cost threshold) increased from 45% to 91%. There was no difference in bleeding and no VTE events. CONCLUSIONS: Introduction of apixaban for EP was associated with significant improvement in patient-reported quality measures and reduced financial toxicity with no effect on adherence or balancing measures. Apixaban is the preferred anticoagulant for EP at our centre.
Asunto(s)
Enoxaparina , Neoplasias de los Genitales Femeninos , Procedimientos Quirúrgicos Ginecológicos , Pirazoles , Piridonas , Mejoramiento de la Calidad , Tromboembolia Venosa , Humanos , Femenino , Piridonas/administración & dosificación , Piridonas/efectos adversos , Piridonas/economía , Piridonas/uso terapéutico , Neoplasias de los Genitales Femeninos/cirugía , Pirazoles/administración & dosificación , Pirazoles/economía , Pirazoles/efectos adversos , Pirazoles/uso terapéutico , Persona de Mediana Edad , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Tromboembolia Venosa/prevención & control , Tromboembolia Venosa/etiología , Enoxaparina/administración & dosificación , Enoxaparina/economía , Enoxaparina/efectos adversos , Anciano , Anticoagulantes/administración & dosificación , Anticoagulantes/economía , Anticoagulantes/efectos adversos , Complicaciones Posoperatorias/prevención & control , Análisis de Series de Tiempo Interrumpido , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/economía , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/uso terapéutico , AdultoRESUMEN
Perioperative enoxaparin is often avoided in patients undergoing transoral robotic (TORS) oropharyngectomy. Our goal was to quantify the risk of postoperative hemorrhage (POH) in patients receiving enoxaparin after TORS oropharyngectomy. This was a retrospective database cohort study set up in 89 separate healthcare organizations. The TriNetX electronic database was queried for patients with OPSCC who underwent TORS oropharyngectomy. Propensity-score matching was used to create two cohorts, one receiving and one not receiving perioperative enoxaparin. Outcome measures were the POH rate within 1 day of surgery ("primary") and POH rate within 2-30 days of surgery ("secondary"). 1109 patients undergoing TORS for OPSCC were identified, 400 of which received perioperative enoxaparin. One-to-one propensity score matching resulted in 310 patients per cohort. After matching, the primary POH rates between patients receiving and not receiving enoxaparin were 3.23% for both cohorts (OR 1.000, 95% CI 0.410 to 2.438). The secondary POH rates between those receiving and not receiving enoxaparin were 5.47% vs. 3.54% (OR 1.577, 95% CI 0.726 to 3.424). The number needed to harm (NNH) with perioperative enoxaparin use for secondary POH after TORS was 53; no difference was found in primary POH rates. While not statistically significant, the use of perioperative enoxaparin after TORS is associated with increased odds of secondary POH with a NNH of 53; no difference was found in rates of primary POH. For patients undergoing TORS, enoxaparin use requires careful weighing of the risks and benefits.
Asunto(s)
Anticoagulantes , Enoxaparina , Hemorragia Posoperatoria , Procedimientos Quirúrgicos Robotizados , Humanos , Enoxaparina/administración & dosificación , Enoxaparina/efectos adversos , Masculino , Estudios Retrospectivos , Hemorragia Posoperatoria/prevención & control , Hemorragia Posoperatoria/epidemiología , Femenino , Persona de Mediana Edad , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodos , Anciano , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Puntaje de Propensión , Neoplasias Orofaríngeas/cirugía , Atención Perioperativa/métodos , OrofaringeRESUMEN
PURPOSE: Guidelines recommend low-molecular-weight heparins (LMWHs) for patients with cancer-associated thrombosis. However, until recently, only dalteparin and tinzaparin were approved in the European Economic Area (EEA) for these patients. This study compares the benefit-risk profile of enoxaparin with dalteparin and tinzaparin for the extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrence in adult patients with active cancer. METHODS: A semi-quantitative structured benefit-risk assessment was conducted for the label-extension application of enoxaparin based on the benefit-risk action team descriptive framework: define decision context; determine key benefit and risk outcomes; identify data sources; extract data; interpret results. RESULTS: The key benefits were defined as reduced all-cause mortality and venous thromboembolism (VTE) recurrence (including symptomatic DVT, fatal PE or non-fatal PE); the key risks were major and non-major bleeding of clinical significance, and heparin-induced thrombocytopenia (HIT). Enoxaparin demonstrated comparable effects for the reduction of VTE recurrence and all-cause mortality versus other EEA-approved LMWHs (dalteparin, tinzaparin). There was no evidence of a significant difference between enoxaparin and the comparator groups with regard to incidence of major and non-major bleeding. The data on HIT were too limited to assess the difference between the two groups. CONCLUSIONS: The assessment demonstrated a favourable benefit-risk profile for enoxaparin similar to that of other EEA-approved LMWHs for the treatment of DVT and PE and the prevention of recurrence in patients with active cancer and thus supported the label-extension approval.
Asunto(s)
Dalteparina , Enoxaparina , Heparina de Bajo-Peso-Molecular , Neoplasias , Embolia Pulmonar , Tinzaparina , Trombosis de la Vena , Humanos , Enoxaparina/administración & dosificación , Enoxaparina/efectos adversos , Enoxaparina/uso terapéutico , Embolia Pulmonar/prevención & control , Embolia Pulmonar/tratamiento farmacológico , Trombosis de la Vena/prevención & control , Trombosis de la Vena/tratamiento farmacológico , Medición de Riesgo , Neoplasias/tratamiento farmacológico , Neoplasias/complicaciones , Dalteparina/administración & dosificación , Dalteparina/efectos adversos , Dalteparina/uso terapéutico , Tinzaparina/administración & dosificación , Tinzaparina/uso terapéutico , Heparina de Bajo-Peso-Molecular/administración & dosificación , Heparina de Bajo-Peso-Molecular/efectos adversos , Heparina de Bajo-Peso-Molecular/uso terapéutico , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Prevención Secundaria/métodos , Hemorragia/inducido químicamente , AdultoRESUMEN
BACKGROUND: The direct oral anticoagulants (DOACs) are now commonly regarded as first line anticoagulants in most cases of venous thromboembolism (VTE). However, the optimal choice of subsequent anticoagulant in instances of first line DOAC failure is unclear. OBJECTIVES: To describe and compare outcomes with second line anticoagulants used after DOAC failure. METHODS: Patients seen at an urban hospital system for an episode of acute VTE initially treated with either apixaban or rivaroxaban who experienced a subsequent recurrent thrombosis while on anticoagulation (1st recurrent thrombosis) were included. RESULTS: In total, 166 patients after apixaban or rivaroxaban failure were included. Following DOAC failure (1st recurrent thrombosis), the subsequent anticoagulant was warfarin in 60 patients (36%), dabigatran in 42 patients (25%), and enoxaparin in 64 patients (39%). Enoxaparin was preferentially prescribed in patients with a malignancy-associated etiology for 1st recurrent thrombosis (p < 0.01). The median follow-up time in our cohort was 16 months. There was no difference in 2nd recurrent thrombosis-free survival (p = 0.72) or risk for major bleeding event (p = 0.30) among patients treated with dabigatran, warfarin, or enoxaparin. CONCLUSIONS: In this retrospective analysis of patients failing first line DOAC therapy, rates of 2nd recurrent thrombosis and bleeding did not differ among subsequently chosen anticoagulants. Our study provides evidence that the optimal 2nd anticoagulant is not clear, and the choice of 2nd anticoagulant should continue to balance patient preference, cost, and provider experience.
Asunto(s)
Anticoagulantes , Dabigatrán , Enoxaparina , Tromboembolia Venosa , Warfarina , Humanos , Dabigatrán/efectos adversos , Dabigatrán/administración & dosificación , Dabigatrán/uso terapéutico , Enoxaparina/efectos adversos , Enoxaparina/administración & dosificación , Anticoagulantes/efectos adversos , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Masculino , Femenino , Warfarina/efectos adversos , Warfarina/administración & dosificación , Anciano , Persona de Mediana Edad , Tromboembolia Venosa/tratamiento farmacológico , Administración Oral , Hemorragia/inducido químicamente , Estudios Retrospectivos , Insuficiencia del Tratamiento , Trombosis/prevención & control , Trombosis/inducido químicamente , Trombosis/etiología , Trombosis/tratamiento farmacológico , Rivaroxabán/efectos adversos , Rivaroxabán/administración & dosificación , Rivaroxabán/uso terapéutico , Pirazoles , PiridonasRESUMEN
Warfarin is the only oral anticoagulant recommended in women who are breastfeeding. Although warfarin is a compatible and recommended agent in the postpartum period and during lactation, little is known regarding changes to warfarin dose requirements in this patient population. Here, we report the case of a 40-year-old woman who transitioned from enoxaparin monotherapy back to warfarin at 2 months postpartum, while she was breastfeeding. Despite resuming warfarin at her previously therapeutic dose, her international normalized ratio (INR) remained subtherapeutic and required multiple dose increases. She ultimately required a 100% increase in her warfarin dose postpartum, compared to pre-pregnancy, to achieve a therapeutic INR. This case suggests patients may require higher warfarin doses postpartum, compared to pre-pregnancy, especially if breastfeeding. Clinicians should closely monitor these patients and adjust warfarin doses as necessary.
Asunto(s)
Anticoagulantes , Lactancia Materna , Relación Normalizada Internacional , Periodo Posparto , Warfarina , Humanos , Femenino , Adulto , Warfarina/administración & dosificación , Warfarina/efectos adversos , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Relación Dosis-Respuesta a Droga , Enoxaparina/administración & dosificación , Enoxaparina/efectos adversos , Enoxaparina/uso terapéuticoRESUMEN
Enoxaparin and daikenchuto are commonly administered to prevent venous thromboembolism and intestinal obstruction after gynecological malignancy surgery. However, the effects of their combined use on hepatic function are not well studied. This study aimed to clarify the effects of the coadministration of enoxaparin and daikenchuto on hepatic function. First, Japanese Adverse Drug Event Report (JADER) data were analyzed to identify signals of hepatic disorders. Second, a retrospective observational study of patients who underwent surgery for gynecological malignancies was conducted. This study defined hepatic disorders as an increase in aspartate aminotransferase (AST) or alanine aminotransaminase (ALT) levels above the reference values, using 1-h postoperative values as the baseline. The analysis of JADER data revealed an increased risk for hepatic disorders with the coadministration of enoxaparin and daikenchuto. An observational study also showed higher odds ratios (95% confidence intervals) for the occurrence of hepatic disorders in the coadministration group (4.27; 2.11-8.64) and enoxaparin alone group (2.48; 1.31-4.69) than in the daikenchuto alone group. The median increase in the ALT level was also higher in the coadministration group (34; 15-59) than in the enoxaparin alone (19; 6-38) and daikenchuto alone groups (8; 3-33). In conclusion, our study suggests that compared with the use of enoxaparin or daikenchuto alone, enoxaparin and daikenchuto coadministration increases the risk of hepatic disorders, with more significant increases in AST and ALT levels. Healthcare workers need to be aware of these potential side effects when combining these drugs after surgery for gynecological malignancies.
Asunto(s)
Neoplasias de los Genitales Femeninos , Panax , Extractos Vegetales , Zanthoxylum , Zingiberaceae , Femenino , Humanos , Enoxaparina/efectos adversos , Neoplasias de los Genitales Femeninos/cirugía , Neoplasias de los Genitales Femeninos/tratamiento farmacológico , Anticoagulantes/efectos adversos , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/inducido químicamente , Complicaciones Posoperatorias/tratamiento farmacológicoRESUMEN
BACKGROUND: Low molecular weight heparin has proven to be safe and effective but is not without potential risks such as spontaneous bleeding in the abdominal cavity. There is limited evidence evaluating the true incidence of this potential risk and the available literature is primarily via case reports. CASE SUMMARY: The purpose of this study was to identify the incidence and risk factors associated with enoxaparin use (prophylaxis or treatment) abdominal hematomas in a 350-bed community hospital during an 8-month time period. A total of 44 patients were identified as clinically significant bleeds receiving enoxaparin treatment or prophylactic therapy. Ultimately, 25 patients were excluded from the analysis due to an external cause of the abdominal hematoma or a temporal mismatch in enoxaparin administration and hematoma formation. After exclusion, there were a total of 19 patients that were assessed for the risk factors such as age, gender, renal function, and weight. After evaluation of risks, over half of the patients developing a clinically significant bleed were considered elderly (>65 years of age) and impaired renal function with a creatinine clearance of 60ml/min or less. CONCLUSION: Patients at risk for an enoxaparin associated hematoma include female patients with a CrCl <60ml/min and/or BMI >30 kg/m2 receiving enoxaparin treatment dosing.
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Enoxaparina , Heparina de Bajo-Peso-Molecular , Humanos , Femenino , Anciano , Enoxaparina/efectos adversos , Heparina de Bajo-Peso-Molecular/uso terapéutico , Hematoma/inducido químicamente , Hemorragia Gastrointestinal/inducido químicamente , Factores de Riesgo , Anticoagulantes/efectos adversosAsunto(s)
Anticoagulantes , Cirugía Bariátrica , Enoxaparina , Fibrinolíticos , Hemorragia , Obesidad , Tromboembolia Venosa , Enoxaparina/administración & dosificación , Enoxaparina/efectos adversos , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Fibrinolíticos/administración & dosificación , Fibrinolíticos/efectos adversos , Hemorragia/inducido químicamente , Riesgo , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & control , Obesidad/complicaciones , Obesidad/cirugía , Derivación Gástrica , Humanos , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Relación Dosis-Respuesta a DrogaRESUMEN
INTRODUCTION: Degenerative spine surgeries often require postoperative immobilization or reduced mobility, predisposing patients to the formation of thrombosis and higher risk of thromboembolic complications. Despite the significance of this issue, there remains a lack of consensus on the optimal anticoagulant agent for postoperative thromboprophylaxis in spinal stenosis and degenerative spine surgeries. Low molecular weight heparins and direct Xa inhibitors represent two anticoagulant groups with high chemoprophylactic potential. METHODS: This study included a prospective cohort of patients undergoing posterior decompressive surgery with or without instrumentation for degenerative spine disease and/or spinal stenosis. Patients receiving postoperative prophylactic Enoxaparin and Apixaban were selected to evaluate the rate of complications, as assessed by Clavien-Dindo classification, thromboembolic events, and 30-day mortality, readmission, and reoperation rate between the two anticoagulants. RESULTS: 130 patients were included in the analysis. 65 patients received Apixaban and Enoxaparin in each group. Mean age of the participants was 57.6±11.0. 83.1% underwent laminectomy and posterior spinal fusion, while 22 patients underwent decompressive surgery only. The incidence of venous thromboembolism (P-value=0.403), deep vein thrombosis (p-value=0.999), hematoma formation (p-value=0.403), surgical site infection (p-value=0.901), readmission (p-value=0.545), reoperation (p=0.510), mortality (p=0.648), and complications rate (p-value=0.232) were not statistically different between Enoxaparin and Apixaban. DISCUSSION: Both Apixaban and Enoxaparin may be viable options for postoperative thromboprophylaxis in spine surgeries with comparable efficacy and safety profile. Future research endeavors should investigate the efficacy of these agents in comparison to placebo in a randomized setting.
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Pirazoles , Piridonas , Estenosis Espinal , Tromboembolia Venosa , Humanos , Enoxaparina/efectos adversos , Anticoagulantes/efectos adversos , Tromboembolia Venosa/epidemiología , Estenosis Espinal/cirugía , Estenosis Espinal/complicaciones , Estudios ProspectivosRESUMEN
OBJECTIVES: To evaluate safety, efficacy, and feasibility of apixaban for postoperative venous thromboembolism (VTE) prophylaxis following open gynecologic cancer surgery at a comprehensive cancer center. METHODS: This retrospective, cohort study included patients with gynecologic cancer who underwent open surgery between 3/2021 and 3/2023 and received 28-day postoperative VTE prophylaxis. Patients on therapeutic anticoagulation preoperatively were excluded. Predictors of 90- and 30-day VTE and 30-day bleeding events were determined using multivariable logistic regression, adjusting for known confounders. RESULTS: 452 patients were included in the cohort: 348 received apixaban and 104 received enoxaparin. Those who received enoxaparin were more likely to be American Society of Anesthesiologists class III/IV (compared to I/II) (p = 0.033), current or former smokers (p = 0.012) and have a higher BMI (p < 0.001), Charlson Comorbidity Index (p = 0.005), and age (p = 0.046). 30-day VTE rate was significantly lower in the apixaban group (0.6%) compared to the enoxaparin group (6.2%) (adjusted OR 0.13, 95% CI 0.03-0.56; p = 0.006). 90-day VTE rate was 2.7% and 6.2% in the apixaban and enoxaparin groups, respectively (adjusted OR 0.85, 95% CI 0.38-1.92; p = 0.704). Major bleeding complications (2.4% vs. 2.0%) and minor bleeding complications (0.9% vs. 3.0%) were similar in the apixaban and enoxaparin groups, respectively, on multivariate analyses. The median patient out of pocket cost was $10 (IQR 0.0-40.0) for apixaban and $20 (IQR 3.7-67.7) for enoxaparin (p = 0.001). CONCLUSIONS: Our findings along with previously published data suggest that apixaban should be considered the standard of care for VTE prophylaxis in patients undergoing open surgery for gynecologic malignancies.
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Enoxaparina , Estudios de Factibilidad , Neoplasias de los Genitales Femeninos , Complicaciones Posoperatorias , Pirazoles , Piridonas , Tromboembolia Venosa , Humanos , Femenino , Piridonas/administración & dosificación , Piridonas/efectos adversos , Piridonas/uso terapéutico , Tromboembolia Venosa/prevención & control , Tromboembolia Venosa/etiología , Pirazoles/efectos adversos , Pirazoles/administración & dosificación , Pirazoles/uso terapéutico , Neoplasias de los Genitales Femeninos/cirugía , Estudios Retrospectivos , Persona de Mediana Edad , Complicaciones Posoperatorias/prevención & control , Enoxaparina/administración & dosificación , Enoxaparina/efectos adversos , Enoxaparina/uso terapéutico , Anciano , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Procedimientos Quirúrgicos Ginecológicos/métodos , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/uso terapéutico , Estudios de Cohortes , Adulto , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéuticoRESUMEN
BACKGROUND: Postprocedural anticoagulation (PPA) is frequently administered after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction, although no conclusive data support this practice. METHODS: The RIGHT trial (Comparison of Anticoagulation Prolongation vs no Anticoagulation in STEMI Patients After Primary PCI) was an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled, superiority trial conducted at 53 centers in China. Patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention were randomly assigned by center to receive low-dose PPA or matching placebo for at least 48 hours. Before trial initiation, each center selected 1 of 3 PPA regimens (40 mg of enoxaparin once daily subcutaneously; 10 U·kg·h of unfractionated heparin intravenously, adjusted to maintain activated clotting time between 150 and 220 seconds; or 0.2 mg·kg·h of bivalirudin intravenously). The primary efficacy objective was to demonstrate superiority of PPA to reduce the primary efficacy end point of all-cause death, nonfatal myocardial infarction, nonfatal stroke, stent thrombosis (definite), or urgent revascularization (any vessel) within 30 days. The key secondary objective was to evaluate the effect of each specific anticoagulation regimen (enoxaparin, unfractionated heparin, or bivalirudin) on the primary efficacy end point. The primary safety end point was Bleeding Academic Research Consortium 3 to 5 bleeding at 30 days. RESULTS: Between January 10, 2019, and September 18, 2021, a total of 2989 patients were randomized. The primary efficacy end point occurred in 37 patients (2.5%) in both the PPA and placebo groups (hazard ratio, 1.00 [95% CI, 0.63 to 1.57]). The incidence of Bleeding Academic Research Consortium 3 to 5 bleeding did not differ between the PPA and placebo groups (8 [0.5%] vs 11 [0.7%] patients; hazard ratio, 0.74 [95% CI, 0.30 to 1.83]). CONCLUSIONS: Routine PPA after primary percutaneous coronary intervention was safe but did not reduce 30-day ischemic events. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03664180.
Asunto(s)
Infarto del Miocardio , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Anticoagulantes/efectos adversos , Enoxaparina/efectos adversos , Hemorragia/inducido químicamente , Hemorragia/tratamiento farmacológico , Heparina/efectos adversos , Infarto del Miocardio/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Fragmentos de Péptidos/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Proteínas Recombinantes , Infarto del Miocardio con Elevación del ST/tratamiento farmacológico , Resultado del TratamientoRESUMEN
Enoxaparin is a hydrophilic drug with obesity having little effect on its apparent volume of distribution, therefore patients with obesity receiving standard 1 mg/kg dosing may be at a higher risk of supratherapeutic dosing. Conversely, dose reducing patients with obesity could place already at risk patients at higher risk of a thrombotic event. Data and recommendations are variable for the most appropriate weight-based dose of therapeutic enoxaparin in obese patients, particularly those a weight > 100 kg or a body mass index (BMI) ≥ 40 kg/m2. The purpose of this systematic review was to globally evaluate these data to surmise optimal dosing recommendations for patients with obesity. A systematic review of English language studies was conducted and identified articles via Pubmed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) searches. Studies were included if they reported therapeutic enoxaparin use in adult patients with a BMI ≥ 40 kg/m2 or body weight > 100 kg and the percentage of patients achieving a therapeutic anti-Xa based on a weight-based dose or the weight-based dose required to produce a therapeutic anti-Xa level. Therapeutic attainment of anti-Xa levels were assessed across enoxaparin weight-based dosing categories including a very low dose group: < 0.75 mg/kg, low dose group: 0.75-0.85 mg/kg, and standard dose group: ≥ 0.95 mg/kg. Rates of bleeding and thrombosis were also evaluated. A total of eight studies were included. For anti-Xa level assessment, 682 patients were included. A total of 62% of anti-Xa levels were therapeutic in the very low dose group, 66% in the low dose group, and 42% in the standard dose group. Overall rates of total bleeding and thrombosis were assessed in 798 patients. A total of 29 bleedings (3.6%) occurred, and 27 reported a relationship to dose. Most bleedings, 85.2% (n = 23/27), occurred with doses in the standard dose group (≥ 0.95 mg/kg). Thrombosis occurred in 5 patients (0.6%). Utilization of a reduced weight-based dosing strategy for therapeutic enoxaparin in obese patients may increase the percentage of patients with a therapeutic anti-Xa level.
Asunto(s)
Enoxaparina , Obesidad , Enoxaparina/administración & dosificación , Enoxaparina/efectos adversos , Humanos , Obesidad/tratamiento farmacológico , Obesidad/complicaciones , Índice de Masa Corporal , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Relación Dosis-Respuesta a Droga , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/uso terapéuticoRESUMEN
PURPOSE: Cancer is an independent risk factor for the development of venous thromboembolism (VTE). However, patients with high-grade glioma (HGG) including glioblastoma (GBM) are at a particularly high risk of VTE with an incidence up to 20-30% per year. Patients are often placed on anticoagulation if they are found to have VTE. However, patients with primary brain tumors such as HGG are at increased risk for intracerebral hemorrhage (ICH) even without the administration of anticoagulation. The combination of risk factors for ICH with anticoagulation and HGG complicates decision-making. Currently it is not known which of the direct oral anticoagulants (DOACs) are safest for patients with HGG in terms of adverse bleeding-related outcomes such as ICH. Furthermore, a deeper understanding of the clinical and molecular determinants of bleeding-related adverse outcomes in HGG is not fully characterized. METHODS: In this retrospective study, we identified and gathered data on 75 consecutive patients with pathology-confirmed HGG with hospital encounters at two academic medical center hospitals in Austin between July 1, 2017 and June 30, 2022. We compared clinical and treatment-related factors among cohorts who had received various forms of anticoagulation or no anticoagulation. RESULTS: Patients who were on rivaroxaban (3/7 (43%)) had a statistically significant association with more bleeding-related adverse events compared to those on apixaban (0/12 (0%)) or enoxaparin (0/5 (0%), p = 0.022) even though the groups were similar in characteristics including total time on the respective anticoagulation. Patients on anticoagulation vs those never on anticoagulation did not differ in terms of their studied demographic and clinical characteristics. Intriguingly, logistic regression analysis revealed that patients Astrocytoma, isocitrate dehydrogenase (IDH) mutant, grade 4 had a significant association with more adverse bleeding-related events even when controlling for other relevant factors (Odds Ratio compared to reference GBM: 49.4, 95% CI: 2.8, 2084.7; p = 0.013). CONCLUSION: In this study we found that the use of rivaroxaban was associated with more bleeding-related events compared to apixaban and enoxaparin in patients with high-grade glioma. In this study we also found that the diagnosis of astrocytoma, IDH mutant, grade 4 was associated with more bleeding events. However, this is based on a small study and there is a need for larger studies to further evaluate these results.
Asunto(s)
Astrocitoma , Glioma , Tromboembolia Venosa , Humanos , Anticoagulantes/efectos adversos , Rivaroxabán/efectos adversos , Enoxaparina/efectos adversos , Estudios Retrospectivos , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/epidemiología , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Glioma/complicaciones , Glioma/tratamiento farmacológico , Astrocitoma/complicacionesRESUMEN
Coronavirus disease 2019 (COVID-19) carries a high risk of vascular thrombosis. However, whether a specific anticoagulation intensity strategy may prevent clinical worsening in severe COVID-19 patients is still debated. We conducted a joint analysis of two randomized controlled trials, COVID-19 HD (NCT044082359) and EMOS-COVID (NCT04646655), to assess the efficacy and safety of two anticoagulant regimens in hospitalized severe COVID-19 patients. Subjects with COVID-19-associated respiratory compromise and/or coagulopathy were randomly assigned to low (4000 IU qd) or high (70 IU Kg-1 every 12 h) enoxaparin dose. The primary efficacy endpoint was clinical worsening within 30 days, defined as the occurrence of at least one of the following events, whichever came first: in-hospital death, evidence of arterial or venous thromboembolism, acute myocardial infarction, need for either continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) in patients receiving standard oxygen therapy or none at randomization, and need for mechanical ventilation in any patient. The safety endpoint was major bleeding. We estimated the relative risk (RR) and its 95% confidence interval (CI) for the outcomes. Among 283 patients included in the study (144 in the low-dose and 139 in the high-dose group), 118 (41.7%) were on NIV or CPAP at randomization. 23/139 (16.5%) patients in the high-dose group reached the primary endpoint compared to 33/144 (22.9%) in the low-dose group (RR 0.72, 95% CI 0.45-1.17). No major bleeding was observed. No significant differences were found in the clinical worsening of hospitalized COVID-19 patients treated with high versus low doses of enoxaparin.
Asunto(s)
COVID-19 , Heparina de Bajo-Peso-Molecular , Humanos , Anticoagulantes/efectos adversos , COVID-19/complicaciones , Enoxaparina/efectos adversos , Hemorragia/inducido químicamente , Heparina de Bajo-Peso-Molecular/efectos adversos , Mortalidad Hospitalaria , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: We aimed to describe the event rates and risk-factors for symptomatic venous thromboembolism (VTE) and major bleeding in a population of hospitalized acutely ill medical patients. METHODS: Patients ≥40 years old and hospitalized for acute medical illness who initiated enoxaparin prophylaxis were selected from the US Optum research database. Rates of symptomatic VTE and major bleeding at 90-days were estimated via the Kaplan-Meier (KM) method. Risk factors were identified via the Cox proportional hazards model. RESULTS: A total of 123,022 patients met the selection criteria. The KM rates of VTE and major bleeding at 90-days were 3.5 % and 2.2 %, respectively. Among subgroups, the risk of VTE varied from 3.0 % in patients with ischemic stroke to 6.9 % in patients with a cancer-related hospitalization, and the risk of major bleeding varied from 1.9 % in patients with inflammatory conditions to 3.6 % in patients with ischemic stroke. Key risk factors for VTE were prior VTE (HR=4.15, 95 % confidence interval [CI] 3.80-4.53), cancer-related hospitalization (HR=2.35, 95 % CI 2.10-2.64), and thrombophilia (HR=1.64, 95 % CI 1.29-2.08). Key risk factors for major bleeding were history of major bleeding (HR=2.17, 95 % CI 1.72-2.74), history of non-major bleeding (HR=2.46, 95 % CI 2.24-2.70), and hospitalization for ischemic stroke (2.42, 95 % CI 2.11-2.78). CONCLUSION: There is substantial heterogeneity in the event rates for VTE and major bleeding in acute medically ill patients. History of VTE and cancer related hospitalization represent profiles with a high risk of VTE, where continued VTE prophylaxis may be warranted.
Asunto(s)
Accidente Cerebrovascular Isquémico , Neoplasias , Tromboembolia Venosa , Adulto , Humanos , Enoxaparina/efectos adversos , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/prevención & control , Tromboembolia Venosa/etiología , Anticoagulantes/efectos adversos , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Hemorragia/complicaciones , Hospitalización , Factores de Riesgo , Neoplasias/tratamiento farmacológicoRESUMEN
BACKGROUND: Patients with left ventricular assist devices (LVADs) require systemic anticoagulation. The use of enoxaparin for bridging to warfarin remains understudied in this population. METHODS: This single-center retrospective study was performed to characterize enoxaparin use and associated thrombotic and bleeding outcomes in adult outpatients with LVADs from January 2018 to July 2021. RESULTS: Fifty-four enoxaparin bridging events were evaluated in 49 patients. Most patients with HeartMate II (HM2) and HeartWare (HVAD) devices received enoxaparin dosed 1 mg/kg every 12 h. In patients with HeartMate 3 (HM3) devices, an equal number of patients received 0.5 mg/kg every 12 h and 1 mg/kg every 12 h, with a smaller subset receiving intermediate doses. The median duration of bridging was 6 days (4-8 [IQR]). One major bleeding event required discontinuation of enoxaparin and hospitalization in a patient with an HM3 device. Thrombotic events occurred in four patients with two incidents of pump thrombosis requiring pump exchange and two ischemic strokes. All thrombotic events occurred in patients with HVAD or HM2 devices. CONCLUSION: These results suggest that enoxaparin bridging in LVAD patients was well-tolerated with low bleeding and thrombotic rates, particularly with the HM3 device.