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1.
Eur J Anaesthesiol ; 35(2): 147-153, 2018 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-29112546

RESUMEN

: A systematic literature search was performed and patients were selected as obese patients undergoing bariatric surgery or obese patients undergoing nonbariatric surgical procedures. In addition, patients were stratified according to low risk of venous thromboembolism and high risk of venous thromboembolism (age >55 years, BMI >55 kg m, history of venous thromboembolism, venous disease, sleep apnoea, hypercoagulability or pulmonary hypertension). Prophylaxis of venous thromboembolism was analysed depending on the type of modality: compression devices of the lower extremities (including intermittent pneumatic compression and graduated compression stockings), pharmacological prophylaxis or inferior vena cava filters. Two prospective studies compared mechanical devices and pharmacological prophylaxis vs. a mechanical device alone without significant differences. A few randomised controlled studies and most of the prospective nonrandomised studies showed that low-dose low molecular weight heparin (3000 to 4000 anti-Xa IU 12 h subcutaneously) was acceptable for obese patients with a lower risk of venous thromboembolism, but a higher dose of low molecular weight heparin (4000 to 6000 anti-Xa IU 12 h subcutaneously) should be proposed for obese patients with a higher risk of venous thromboembolism. Extended prophylaxis for 10 to 15 days was well tolerated for obese patients with a high risk of venous thromboembolism in the postdischarge period. The safety and efficacy of inferior vena cava filters in bariatric surgical patients is highly heterogeneous. There were no randomised trials that analysed prophylaxis of venous thromboembolism in obese patients undergoing nonbariatric surgery. Higher doses of anticoagulants could be proposed for obese patients with a BMI more than 40 kg m. The lack of good quality randomised trials with a low risk of bias did not allow us to propose strong recommendations.


Asunto(s)
Obesidad/complicaciones , Atención Perioperativa/normas , Complicaciones Posoperatorias/prevención & control , Procedimientos Quirúrgicos Operativos/efectos adversos , Tromboembolia Venosa/prevención & control , Anestesiología/normas , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Anticoagulantes/normas , Ensayos Clínicos como Asunto , Relación Dosis-Respuesta a Droga , Unión Europea , Hemorragia/inducido químicamente , Hemorragia/prevención & control , Heparina de Bajo-Peso-Molecular/administración & dosificación , Heparina de Bajo-Peso-Molecular/efectos adversos , Heparina de Bajo-Peso-Molecular/normas , Humanos , Incidencia , Aparatos de Compresión Neumática Intermitente , Obesidad/cirugía , Atención Perioperativa/instrumentación , Atención Perioperativa/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Factores de Riesgo , Sociedades Médicas/normas , Factores de Tiempo , Filtros de Vena Cava , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/etiología
3.
J Clin Oncol ; 41(16): 3063-3071, 2023 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-37075273

RESUMEN

PURPOSE: To conduct an update of the ASCO venous thromboembolism (VTE) guideline. METHODS: After publication of potentially practice-changing clinical trials, identified through ASCO's signals approach to updating, an updated systematic review was performed for two guideline questions: perioperative thromboprophylaxis and treatment of VTE. PubMed and the Cochrane Library were searched for randomized controlled trials (RCTs) published between November 1, 2018, and June 6, 2022. RESULTS: Five RCTs provided information that contributed to changes to the 2019 recommendations. Two RCTs addressed direct factor Xa inhibitors (either rivaroxaban or apixaban) for extended thromboprophylaxis after surgery. Each of these postoperative trials had important limitations but suggested that these two oral anticoagulants are safe and effective in the settings studied. An additional three RCTs addressed apixaban in the setting of VTE treatment. Apixaban was effective in reducing the risk of recurrent VTE, with a low risk of major bleeding. RECOMMENDATIONS: Apixaban and rivaroxaban were added as options for extended pharmacologic thromboprophylaxis after cancer surgery, with a weak strength of recommendation. Apixaban was also added as an option for the treatment of VTE, with high quality of evidence and a strong recommendation.Additional information is available at www.asco.org/supportive-care-guidelines.


Asunto(s)
Neoplasias , Tromboembolia Venosa , Humanos , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & control , Rivaroxabán/efectos adversos , Anticoagulantes/efectos adversos , Hemorragia/inducido químicamente , Hemorragia/tratamiento farmacológico , Neoplasias/complicaciones , Neoplasias/tratamiento farmacológico , Neoplasias/cirugía
4.
Thromb Res ; 230: 27-32, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37625200

RESUMEN

BACKGROUND: Antithrombotic treatment may improve the disease course in non-critically ill, symptomatic COVID-19 outpatients. METHODS: We performed an individual patient-level analysis of the OVID and ETHIC randomized controlled trials, which compared enoxaparin thromboprophylaxis for either 14 (OVID) or 21 days (ETHIC) vs. no thromboprophylaxis for outpatients with symptomatic COVID-19 and at least one additional risk factor. The primary efficacy outcome included all-cause hospitalization and all-cause death within 30 days from randomization. Both studies were prematurely stopped for futility. Secondary efficacy outcomes were major symptomatic venous thromboembolic events, arterial cardiovascular events, or their composite occurring within 30 days from randomization. The same outcomes were assessed over a 90-day follow-up. The primary safety outcome was major bleeding (ISTH criteria). RESULTS: A total of 691 patients were randomized: 339 to receive enoxaparin and 352 to the control group. Over 30-day follow-up, the primary efficacy outcome occurred in 6.0 % of patients in the enoxaparin group vs. 5.8 % of controls for a risk ratio (RR) of 1.05 (95%CI 0.57-1.92). The incidence of major symptomatic venous thromboembolic events and arterial cardiovascular events was 0.9 % vs. 1.8 %, respectively (RR 0.52; 95%CI 0.13-2.06). Most cardiovascular thromboembolic events were represented by symptomatic venous thromboembolic events, occurring in 0.6 % vs. 1.5 % of patients, respectively. A similar distribution of outcomes between the treatment groups was observed over 90 days. No major bleeding occurred in the enoxaparin group vs. one (0.3 %) in the control group. CONCLUSIONS: We found no evidence for the clinical benefit of early administration of enoxaparin thromboprophylaxis in outpatients with symptomatic COVID-19. These results should be interpreted taking into consideration the relatively low occurrence of events.

6.
Chest ; 162(5): 1127-1139, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-35964703

RESUMEN

BACKGROUND: The American College of Chest Physicians Clinical Practice Guideline on the Perioperative Management of Antithrombotic Therapy addresses 43 Patients-Interventions-Comparators-Outcomes (PICO) questions related to the perioperative management of patients who are receiving long-term oral anticoagulant or antiplatelet therapy and require an elective surgery/procedure. This guideline is separated into four broad categories, encompassing the management of patients who are receiving: (1) a vitamin K antagonist (VKA), mainly warfarin; (2) if receiving a VKA, the use of perioperative heparin bridging, typically with a low-molecular-weight heparin; (3) a direct oral anticoagulant (DOAC); and (4) an antiplatelet drug. METHODS: Strong or conditional practice recommendations are generated based on high, moderate, low, and very low certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology for clinical practice guidelines. RESULTS: A multidisciplinary panel generated 44 guideline recommendations for the perioperative management of VKAs, heparin bridging, DOACs, and antiplatelet drugs, of which two are strong recommendations: (1) against the use of heparin bridging in patients with atrial fibrillation; and (2) continuation of VKA therapy in patients having a pacemaker or internal cardiac defibrillator implantation. There are separate recommendations on the perioperative management of patients who are undergoing minor procedures, comprising dental, dermatologic, ophthalmologic, pacemaker/internal cardiac defibrillator implantation, and GI (endoscopic) procedures. CONCLUSIONS: Substantial new evidence has emerged since the 2012 iteration of these guidelines, especially to inform best practices for the perioperative management of patients who are receiving a VKA and may require heparin bridging, for the perioperative management of patients who are receiving a DOAC, and for patients who are receiving one or more antiplatelet drugs. Despite this new knowledge, uncertainty remains as to best practices for the majority of perioperative management questions.


Asunto(s)
Fibrinolíticos , Médicos , Humanos , Fibrinolíticos/uso terapéutico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Anticoagulantes/efectos adversos , Heparina/efectos adversos
7.
Chest ; 162(5): e207-e243, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-35964704

RESUMEN

BACKGROUND: The American College of Chest Physicians Clinical Practice Guideline on the Perioperative Management of Antithrombotic Therapy addresses 43 Patients-Interventions-Comparators-Outcomes (PICO) questions related to the perioperative management of patients who are receiving long-term oral anticoagulant or antiplatelet therapy and require an elective surgery/procedure. This guideline is separated into four broad categories, encompassing the management of patients who are receiving: (1) a vitamin K antagonist (VKA), mainly warfarin; (2) if receiving a VKA, the use of perioperative heparin bridging, typically with a low-molecular-weight heparin; (3) a direct oral anticoagulant (DOAC); and (4) an antiplatelet drug. METHODS: Strong or conditional practice recommendations are generated based on high, moderate, low, and very low certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology for clinical practice guidelines. RESULTS: A multidisciplinary panel generated 44 guideline recommendations for the perioperative management of VKAs, heparin bridging, DOACs, and antiplatelet drugs, of which two are strong recommendations: (1) against the use of heparin bridging in patients with atrial fibrillation; and (2) continuation of VKA therapy in patients having a pacemaker or internal cardiac defibrillator implantation. There are separate recommendations on the perioperative management of patients who are undergoing minor procedures, comprising dental, dermatologic, ophthalmologic, pacemaker/internal cardiac defibrillator implantation, and GI (endoscopic) procedures. CONCLUSIONS: Substantial new evidence has emerged since the 2012 iteration of these guidelines, especially to inform best practices for the perioperative management of patients who are receiving a VKA and may require heparin bridging, for the perioperative management of patients who are receiving a DOAC, and for patients who are receiving one or more antiplatelet drugs. Despite this new knowledge, uncertainty remains as to best practices for the majority of perioperative management questions.


Asunto(s)
Fibrinolíticos , Médicos , Humanos , Fibrinolíticos/uso terapéutico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Anticoagulantes/efectos adversos , Heparina/efectos adversos
8.
Lancet Haematol ; 9(8): e594-e604, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35779560

RESUMEN

BACKGROUND: COVID-19 is associated with inflammation and an increased risk of thromboembolic complications. Prophylactic doses of low-molecular-weight heparin have been used in hospitalised and non-critically ill patients with COVID-19. We aimed to evaluate the efficacy and safety of prophylactic low-molecular-weight heparin (enoxaparin) versus standard of care (no enoxaparin) in at-risk outpatients with COVID-19. METHODS: This open-label, multicentre, randomised, controlled, phase 3b trial (ETHIC) was done at 15 centres in six countries (Belgium, Brazil, India, South Africa, Spain, and the UK). We consecutively enrolled participants aged at least 30 years who had not received a COVID-19 vaccine and had symptomatic, confirmed COVID-19 in the outpatient setting plus at least one risk factor for severe disease. Within 9 days of symptom onset and by use of a web-based random block design (block size either 2 or 4), eligible participants were randomly assigned (1:1) to receive either subcutaneous enoxaparin for 21 days (40 mg once daily if they weighed <100 kg and 40 mg twice daily if they weighed ≥100 kg) or standard of care (without enoxaparin). The primary efficacy endpoint was the composite of all-cause hospitalisation and all-cause mortality at 21 days after randomisation and, in our main analysis, was analysed in the intention-to-treat population, which comprised all patients who were randomly assigned. Safety was also analysed in the intention-to-treat population for our main analysis. This trial is registered with ClinicalTrials.gov, NCT04492254, and is complete. FINDINGS: Following the advice of the Data and Safety Monitoring Board, this study was terminated early due to slow enrolment and a lower-than-expected event rate. Between Oct 27, 2020, and Nov 8, 2021, 230 patients with COVID-19 were assessed for eligibility, of whom 219 were enrolled and randomly assigned to receive standard of care (n=114) or enoxaparin (n=105). 96 (44%) patients were women, 122 (56%) were men, and one patient had missing sex data. 141 (65%) of 218 participants with data on race and ethnicity were White, 60 (28%) were Asian, and 16 (7%) were Black, mixed race, or Arab or Middle Eastern. Median follow-up in both groups was 21 days (IQR 21-21). There was no difference in the composite of all-cause mortality and hospitalisation at 21 days between the enoxaparin group (12 [11%] of 105 patients) and the standard-of-care group (12 [11%] of 114 patients; unadjusted hazard ratio 1·09 [95% CI 0·49-2·43]; log-rank p=0·83). At 21 days, two (2%) of 105 patients in the enoxaparin group (one minor bleed and one bleed of unknown severity) and one (1%) of 114 patients in the standard-of-care group (major abnormal uterine bleeding) had a bleeding event. 22 (21%) patients in the enoxaparin group and 13 (11%) patients in the standard-of-care group had adverse events. The most common adverse event in both groups was COVID-19-related pneumonia (six [6%] patients in the enoxaparin group and five [4%] patients in the standard-of-care group). One patient in the enoxaparin group died and their cause of death was unknown. INTERPRETATION: The ETHIC trial results suggest that prophylaxis with low-molecular-weight heparin had no benefit for at-risk outpatients with COVID-19. Although the trial was terminated early, our data, combined with data from similar studies, provide further insights to inform international guidelines and influence clinical practice. FUNDING: The Thrombosis Research Institute and Sanofi UK.


Asunto(s)
COVID-19 , Vacunas contra la COVID-19 , Enoxaparina/efectos adversos , Femenino , Hemorragia/inducido químicamente , Heparina de Bajo-Peso-Molecular/uso terapéutico , Humanos , Masculino , Pacientes Ambulatorios , Nivel de Atención , Resultado del Tratamiento
9.
Lancet Haematol ; 9(9): e698-e706, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36055334

RESUMEN

The International Consortium for Health Outcomes Measurement assembled an international working group of venous thromboembolism experts and patient representatives to develop a standardised minimum set of outcomes and outcome measurements for integration into clinical practice and potentially research to support clinical decision making and benchmarking of quality of care. 15 core outcomes important to patients and health-care professionals were selected and categorised into four domains: patient-reported outcomes, long term consequences of the disease, disease-specific complications, and treatment-related complications. The outcomes and outcome measures were designed to apply to all patients with venous thromboembolism aged 16 years or older. A measurement tool package was selected for inclusion in the core standard set, with a minimum number of items to be measured at predefined timepoints, which capture all core outcomes. Additional measures can be introduced to the user by a cascade opt-in system that allows for further assessment if required. This set of outcomes and measurement tools will facilitate the implementation of the use of patient-centred outcomes in daily practice.


Asunto(s)
Tromboembolia Venosa , Consenso , Humanos , Evaluación de Resultado en la Atención de Salud , Medición de Resultados Informados por el Paciente , Tromboembolia Venosa/terapia
10.
J Clin Oncol ; 38(5): 496-520, 2020 02 10.
Artículo en Inglés | MEDLINE | ID: mdl-31381464

RESUMEN

PURPOSE: To provide updated recommendations about prophylaxis and treatment of venous thromboembolism (VTE) in patients with cancer. METHODS: PubMed and the Cochrane Library were searched for randomized controlled trials (RCTs) and meta-analyses of RCTs published from August 1, 2014, through December 4, 2018. ASCO convened an Expert Panel to review the evidence and revise previous recommendations as needed. RESULTS: The systematic review included 35 publications on VTE prophylaxis and treatment and 18 publications on VTE risk assessment. Two RCTs of direct oral anticoagulants (DOACs) for the treatment of VTE in patients with cancer reported that edoxaban and rivaroxaban are effective but are linked with a higher risk of bleeding compared with low-molecular-weight heparin (LMWH) in patients with GI and potentially genitourinary cancers. Two additional RCTs reported on DOACs for thromboprophylaxis in ambulatory patients with cancer at increased risk of VTE. RECOMMENDATIONS: Changes to previous recommendations: Clinicians may offer thromboprophylaxis with apixaban, rivaroxaban, or LMWH to selected high-risk outpatients with cancer; rivaroxaban and edoxaban have been added as options for VTE treatment; patients with brain metastases are now addressed in the VTE treatment section; and the recommendation regarding long-term postoperative LMWH has been expanded. Re-affirmed recommendations: Most hospitalized patients with cancer and an acute medical condition require thromboprophylaxis throughout hospitalization. Thromboprophylaxis is not routinely recommended for all outpatients with cancer. Patients undergoing major cancer surgery should receive prophylaxis starting before surgery and continuing for at least 7 to 10 days. Patients with cancer should be periodically assessed for VTE risk, and oncology professionals should provide patient education about the signs and symptoms of VTE.Additional information is available at www.asco.org/supportive-care-guidelines.


Asunto(s)
Neoplasias/complicaciones , Tromboembolia Venosa/terapia , Anticoagulantes/administración & dosificación , Humanos , Metaanálisis como Asunto , Neoplasias/patología , Ensayos Clínicos Controlados Aleatorios como Asunto , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/patología , Tromboembolia Venosa/prevención & control
12.
Surg Technol Int ; 18: 55-62, 2009 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-19585415

RESUMEN

Postoperative venous thromboembolism (VTE) represents a serious and potentially fatal complication that affects 40% to 60% of patients undergoing major orthopedic surgery and not receiving antithrombotic prophylaxis. Several prophylactic modalities, including pharmacological agents such as oral vitamin K antagonists (VKA) and low molecular weight heparins (LMWH), have been shown to be effective and safe for most patients at high risk for VTE. However, some patients undergoing cancer or major orthopedic surgery remain at some residual VTE risk despite the use of these methods. Approaches to improve the results of prophylaxis include optimizing the timing and duration of pharmacological prophylaxis, combining mechanical methods with anticoagulants, and the development of new antithrombotics.


Asunto(s)
Anticoagulantes/administración & dosificación , Fibrinolíticos/administración & dosificación , Trombolisis Mecánica/métodos , Trombolisis Mecánica/tendencias , Complicaciones Posoperatorias/prevención & control , Tromboembolia Venosa/prevención & control , Humanos
13.
Thromb Haemost ; 98(4): 756-64, 2007 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-17938798

RESUMEN

Venous thromboembolism (VTE) is often asymptomatic, mis-diagnosed, and unrecognized at death, and there is a lack of routine postmortem examinations. These factors are thought to result in marked underestimates ofVTE incidence. The objective of our study was to estimate the total burden of VTE within the European Union (EU) per annum. An epidemiological model was constructed to estimate the number of community- and hospital-acquired incidents and recurrent cases (attack rate) of nonfatal VTE and VTE-related deaths, as well as incident and prevalent cases of post-thrombotic syndrome (PTS) and chronic thromboembolic pulmonary hypertension (PH) occurring in the EU per annum. Individual models were developed for six EU countries. The models were populated with data from published literature and, where necessary, expert opinions. The findings were tested using probabilistic sensitivity analyses. The estimated total number of symptomaticVTE events (range based on probabilistic sensitivity analysis) per annum within the six EU countries was 465,715 (404,664-538,189) cases of deep-vein thrombosis, 295,982 (242,450-360,363) cases of pulmonary embolism (PE), and 370,012 (300,193-483,108) VTE-related deaths. Of these deaths, an estimated 27,473 (7%) were diagnosed as being antemortem; 126,145 (34%) were sudden fatal PE, and 217,394 (59%) followed undiagnosed PE. Almost three-quarters of all VTE-related deaths were from hospital-acquired VTE. VTE is a major health problem in the EU, with over one million VTE events or deaths per annum in the six countries examined. Given the availability of effective VTE prophylaxis, many of these events and deaths could have been prevented. These results have important implications for the allocation of healthcare resources.


Asunto(s)
Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/mortalidad , Trombosis de la Vena/epidemiología , Trombosis de la Vena/mortalidad , Algoritmos , Anticoagulantes/uso terapéutico , Europa (Continente) , Femenino , Hospitales , Humanos , Hipertensión Pulmonar/epidemiología , Hipertensión Pulmonar/mortalidad , Masculino , Morbilidad , Síndrome Postrombótico/epidemiología , Síndrome Postrombótico/mortalidad , Embolia Pulmonar/epidemiología , Embolia Pulmonar/mortalidad , Sistema de Registros , Riesgo
14.
Orthopedics ; 29(6): 506-16, 2006 06.
Artículo en Inglés | MEDLINE | ID: mdl-16786943

RESUMEN

Guidelines recommend thromboprophylaxis for at least 10 days to prevent venous thromboembolism in patients undergoing high-risk orthopedic surgery, such as total hip arthroplasty (THA) or total knee arthroplasty (TKA). Furthermore, the recently updated ACCP guidelines also recommend extending the duration of thromboprophylaxis for 28 to 35 days following THA or hip fracture surgery as the risk for venous thromboembolism persists for up to 3 months after surgery. Extended-duration thromboprophylaxis (up to 6 weeks) with low-molecular-weight heparin is significantly more effective in preventing venous thromboembolism in orthopedic surgery patients than the recommended practice of at least 10 days. Extended-duration thromboprophylaxis may require risk stratification to identify high-risk patients. Current risk-assessment models have limitations and are not specific to orthopedic surgery patients; therefore, improvements may facilitate the use of extended-duration thromboprophylaxis in high-risk patients, thereby reducing the burden of venous thromboembolism.


Asunto(s)
Procedimientos Ortopédicos , Alta del Paciente , Complicaciones Posoperatorias/prevención & control , Trombosis de la Vena/prevención & control , Cuidados Posteriores , Anticoagulantes/economía , Anticoagulantes/uso terapéutico , Humanos , Incidencia , Medición de Riesgo , Factores de Riesgo , Trombosis de la Vena/etiología
15.
Thromb Haemost ; 94(4): 750-9, 2005 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-16270626

RESUMEN

Hospitalized patients with acute medical conditions are at significant risk of venous thromboembolism (VTE): approximately 10-30% of general medical patients may develop deep-vein thrombosis or pulmonary embolism, and the latter is a leading contributor to deaths in hospital. Despite consensus-group recommendations that at-risk medical patients should receive thromboprophylaxis, there is currently no consensus as to which patients are at risk, and many patients may not receive appropriate thromboprophylaxis. This paper reviews evidence for the risk of VTE associated with different medical conditions and risk factors, and presents a risk-assessment model for risk stratification in medical patients. Medical conditions associated with a moderate to high risk of VTE include cardiac disease, cancer, respiratory disease, inflammatory bowel disease, and infectious diseases. Importantly, analyses of data from the MEDENOX study show that thromboprophylaxis significantly reduces the risk of VTE in these patient subgroups. Risk factors in medical patients include a history of VTE, history of malignancy, increasing age, thrombophilia, prolonged immobility, and obesity. These medical conditions and risk factors are included in a risk-assessment model which is hoped will provide a simple means of assisting clinicians in deciding whether thromboprophylaxis should be used in an individual patient.


Asunto(s)
Tromboembolia/epidemiología , Tromboembolia/prevención & control , Trombosis de la Vena/epidemiología , Trombosis de la Vena/prevención & control , Enfermedad Aguda , Anticoagulantes/uso terapéutico , Árboles de Decisión , Humanos , Factores de Riesgo , Conducta de Reducción del Riesgo , Tromboembolia/tratamiento farmacológico , Trombosis de la Vena/tratamiento farmacológico
16.
Clin Appl Thromb Hemost ; 21(4): 297-308, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-25504999

RESUMEN

Anticoagulation therapy is the standard treatment of patients with symptomatic venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism. Until recently, treatment of VTE was based on parenteral or low-molecular-weight heparin for initial therapy (5-10 days) and oral vitamin K antagonists for long-term therapy. Those treatments have some limitations, including parenteral administration (heparins), the need for frequent monitoring and dose adjustments, interactions with several medications, and dietary restrictions (vitamin K antagonists). Rivaroxaban is a new oral direct factor Xa inhibitor with a wide therapeutic window, predictable anticoagulant effect, no food interactions, and few drug interactions. Consequently, no periodic monitoring of anticoagulation is needed, and fixed doses can be prescribed. EINSTEIN program demonstrated that rivaroxaban was as effective as and significantly safer than standard therapy for treatment of VTE. Rivaroxaban was recently authorized so doubts exist about how to use it in daily clinical practice. This document aims to clarify common questions formulated by clinicians regarding the use of this new drug.


Asunto(s)
Inhibidores del Factor Xa/farmacocinética , Inhibidores del Factor Xa/uso terapéutico , Rivaroxabán/farmacocinética , Rivaroxabán/uso terapéutico , Tromboembolia Venosa/prevención & control , Interacciones Farmacológicas , Monitoreo de Drogas , Humanos , Recurrencia , Tromboembolia Venosa/sangre
18.
Clin Appl Thromb Hemost ; 20(8): 772-8, 2014 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-24798686

RESUMEN

OBJECTIVES: Registro Informatizado de Enfermedad TromboEmbólica (RIETE) database was used to investigate whether neurosurgical patients with venous thromboembolism (VTE) were more likely to die of bleeding or VTE and the influence of anticoagulation on these outcomes. METHODS: Clinical characteristics, treatment details, and 3-month outcomes were assessed in those who developed VTE after neurosurgery. RESULTS: Of 40 663 patients enrolled, 392 (0.96%) had VTE in less than 60 days after neurosurgery. Most patients in the cohort (89%) received initial therapy with low-molecular-weight heparin, (33% received subtherapeutic doses). In the first week, 10 (2.6%) patients died (8 with pulmonary embolism [PE], no bleeding deaths; P = .005). After the first week, 20 (5.1%) patients died (2 with fatal bleeding, none from PE). Overall, this cohort was more likely to develop a fatal PE than a fatal bleed (8 vs 2 deaths, P = .058). CONCLUSIONS: Neurosurgical patients developing VTE were more likely to die from PE than from bleeding in the first week, despite anticoagulation.


Asunto(s)
Procedimientos Neuroquirúrgicos/efectos adversos , Complicaciones Posoperatorias/tratamiento farmacológico , Sistema de Registros , Tromboembolia Venosa/tratamiento farmacológico , Adulto , Anciano , Anticoagulantes/uso terapéutico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Embolia Pulmonar/mortalidad , Tromboembolia Venosa/etiología , Tromboembolia Venosa/mortalidad
19.
Thromb Res ; 131(6): e240-6, 2013 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-23578359

RESUMEN

BACKGROUND: Venous thromboembolism (VTE) is major health problem worldwide with substantial morbidity and mortality. This study aimed to assess post-operative VTE prophylaxis duration and adherence to the American College of Chest Physicians (ACCP) 2008 guidelines in patients having undergone major orthopaedic surgery (MOS). METHODS: This multinational, longitudinal, observational registry recruited consecutive patients (≥ 18 years of age) who underwent total hip replacement (THR), total knee replacement (TKR), and hip fracture surgery (HFS). There were 3 study visits: at admission to hospital, at discharge, and 4/6 weeks after surgery. Data on demographics, medical history, VTE risk factors, type and duration of mechanical and pharmacological prophylaxis, complications, and adherence to the ACCP 2008 guidelines were collected using case report forms. RESULTS: Between October 2009 and July 2011, 2162 eligible patients were analyzed: THR: 646, TKR: 740, HFS: 776 (mean age [SD]: 64.5 [15.0] years; female: 61.3%; and mean hospitalization duration [SD]: 9.1 [8.2] days). VTE prophylaxis was prescribed to 96.2% of patients during hospitalization and 89.7% of patients after hospital discharge. Prophylaxis was prescribed according to the ACCP 2008 guidelines in 85.7% of patients during hospitalization and 63.4% of patients after hospital discharge. The main reasons for non-adherence to guidelines were no prescription and inadequate duration of prophylaxis. The low molecular weight heparin-enoxaparin-was the most commonly prescribed prophylaxis. CONCLUSION: We observed a gap between real life VTE prophylaxis and the ACCP 2008 recommendations. Improved prescription of extended thromboprophylaxis is warranted to ensure adherence to international guidelines.


Asunto(s)
Enoxaparina/uso terapéutico , Fibrinolíticos/uso terapéutico , Trombolisis Mecánica/métodos , Terapia Trombolítica/métodos , Tromboembolia Venosa/terapia , Anciano , Anciano de 80 o más Años , Femenino , Adhesión a Directriz , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Ortopedia , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/epidemiología
20.
Thromb Haemost ; 107(2): 270-9, 2012 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-22186708

RESUMEN

Real-life data on post-discharge venous thromboembolism (VTE) prophylaxis practices and treatments are lacking. We assessed post-operative VTE prophylaxis prescribed and received in a prospective registry, compared with the 2004 American College of Chest Physicians (ACCP) guidelines in high-risk orthopaedic surgery patients. Consecutive patients undergoing total hip arthroplasty (THA), hip fracture surgery (HFS), or knee arthroplasty (KA) were enrolled at discharge from 161 centres in 17 European countries if they had received in-hospital VTE prophylaxis that was considered in accordance with the ACCP guidelines by the treating physician. Data on prescribed and actual prophylaxis were obtained from hospital charts and patient post-discharge diaries. Post-operative prophylaxis prescribed and actual prophylaxis received were considered adherent or adequate, respectively, if recommended therapies were used for ≥28 days (HFS and THA) or ≥10 days (KA). Among 4,388 patients, 69.9% were prescribed ACCP-adherent VTE prophylaxis (THA: 1,411/2,217 [63.6%]; HFS: 701/1,112 [63.0%]; KA: 955/1,059 [90.2%]). Actual prophylaxis received was described in 3,939 patients with an available diary after discharge (non-evaluability rate of 10%). Mean actual durations of pharmacological prophylaxis from surgery were: 28.4 ± 13.7 (THA), 29.3 ± 13.9 (HFS), and 28.7 ± 14.1 days (KA). ACCP-adequate VTE prophylaxis was received by 66.5% of patients (60.9% THA, 55.4% HFS, and 88.7% KA). Prophylaxis inadequacies were mainly due to inadequate prescription, non-recommended prophylaxis prescription at discharge, or too short prophylaxis prescribed. In high-risk orthopaedic surgery patients with hospital-initiated prophylaxis, there is a gap between ACCP recommendations, prescribed and actual prophylaxis received, mainly due to inadequate prescription at discharge.


Asunto(s)
Adhesión a Directriz/estadística & datos numéricos , Procedimientos Ortopédicos , Complicaciones Posoperatorias/prevención & control , Tromboembolia Venosa/prevención & control , Anciano , Anticoagulantes/administración & dosificación , Anticoagulantes/normas , Europa (Continente) , Femenino , Fondaparinux , Heparina de Bajo-Peso-Molecular/administración & dosificación , Humanos , Cooperación Internacional , Masculino , Alta del Paciente , Polisacáridos/administración & dosificación , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Guías de Práctica Clínica como Asunto , Sistema de Registros , Riesgo , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/etiología
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