Presentación del tema: "Casos clínicos Profilaxis en pacientes médicos. CHEST 2012; 141(2)(Suppl):e195S–e226S."— Transcripción de la presentación:
Casos clínicos Profilaxis en pacientes médicos
CHEST 2012; 141(2)(Suppl):e195S–e226S
2013 International Society on Thrombosis and Haemostasis
The American College of Chest Physicians (ACCP) had distinguished itself in previous decades as a producer of excellent antithrombotic guidelines used worldwide; guidelines that dealt simply and primarily with evidence and not opinion. Sadly in the last decade methodologists have hijacked the role of the ACCP panellists, their analyses and writing. This is revealed in a letter sent to the journal recently which discusses the reliability of clinical trial data. This subject is at the heart of the changes to the ACCP 2012 recommendations which shares a number of authors with this letter International Society on Thrombosis and Haemostasis
The antithrombotic therapy data has been downgraded by an unproven methodology allowing for three main changes: – firstly dangerous extrapolations, (AAS en profilaxis ortopédica) – secondly the consideration of so called patient preferences and the feeling thermometerETV manifiestamente clínica ( o clínicamente sintomática) como ETV importante para el paciente – and thirdly the potential for bias ( se autocitan, basándose en sus trabajos que no han demostrado su validez) 2013 International Society on Thrombosis and Haemostasis
The use of neologisms, unscientific terminology and opaque language has made the guidelines impenetrable. There is an apparent intellectual bias in the writing which manifests itself in many ways. One example is giving clinically-presenting VTE the sobriquet patient important VTE(2). ETV manifiestamente clínica ( o clínicamente sintomática) como ETV importante para el paciente 2013 International Society on Thrombosis and Haemostasis
The main significant finding of ACCP 9 (2012) is that when compared to ACCP 8 (2008) there is a highly significant relative risk reduction (180 versus 29) in 1A recommendations (a reduction greater than 80%) despite almost no change in data. Now that, based on their methodology, is the really shocking finding! The tragedy is that as a result of those changes many patients may receive less effective therapies and more likely to be exposed to life-threatening VTE 2013 International Society on Thrombosis and Haemostasis
Peculiaridades de la metodología: mis comentarios Termómetro de sentimientos: validado? Quién lo puntúa? Preferencias del paciente en cuanto al tratamiento trombótico: obtenido del escenario de FA ¿Es igual que el de la ETEV? Preferencia del paciente en cuanto al tipo de profilaxis farmacológica ? Por qué desestiman determinados resultados positivos de buena calidad? Sangrado con HBPM vs HNF Por qué en cambio, extrapolan del escenario quirúrgico?- CNI Puntuación de los outcomes: ¿es igual una ETEV sintomática que una hemorragia mayor?. Le dan 1:1 y al ETEV sintomática vs hemorragia intracraneal 1: 2,5. No es infravalorar la HIC?. Por otro lado no toda ETEV sintomática es igual ni debería tener el mismo peso ( TVP poplítea vs TEP masivo???)
Una gordita de viaje.....
Mujer de 32 años, con IMC 34 kg/m 2, fumadora de 10 cig día,en tratamiento con anticonceptivos orales y una estatina por hipercolesterolemia. Consulta sobre la conveniencia de realizar alguna medida preventiva porque tiene previsto realizar un vuelo de 8 horas de duración.
¿Cuál es el riesgo de la paciente de desarrollar una ETEV? 1.Bajo 2.Medio 3.Alto 4.Muy alto
Ultimas guías ACCP Symptomatic VTE is rare in passengers returning from long flights. Travelers at increased risk of VTE, defined as: previous VTE, thrombophilic disorders, severe obesity recent major surgery o trauma, active malignancy, pregnancy, estrogen use advanced age, limited mobility, who are traveling on flights > 6 h, CHEST 2012; 141(2)(Suppl):e195S–e226S
Qué la recomendaría? 1.Nada 2.Que cogiera un asiento de pasillo y caminara, que hiciera ejercicios de flexoextensión del pie, bebiera mucho agua, no bebiera alcohol. 3.Que se pusiera unas medias de compresión ligera hasta la rodilla 4.HBPM a dosis profiláctica 5.La daría a elegir lo que ella prefiriera porque eso es lo que dicen las guías. 6.AAS 7.Combinaría medidas físicas con farmacológicas
Ultimas guías ACCP CHEST 2012; 141(2)(Suppl):e195S–e226S For long-distance travelers at increased risk of VTE (including previous VTE, recent surgery or trauma, active malignancy, pregnancy, estrogen use, advanced age, limited mobility, severe obesity, or known thrombophilic disorder), we suggest: frequent ambulation, calf muscle exercise, or sitting in an aisle seat if feasible (Grade 2C). use of properly fitted, below-knee GCS providing 15 to 30 mm Hg of pressure at the ankle during travel (Grade 2C). For all other long-distance travelers, we suggest against the use of GCS (Grade 2C).
Ultimas guías ACCP Until further, methodologically appropriate studies are available, decisions regarding pharmacologic thromboprophylaxis for travelers who are considered to be at particularly high risk for VTE must be made on an individual basis, considering that adverse effects may outweigh any benefit. CHEST 2012; 141(2)(Suppl):e195S–e226S
De cuáles de estas medidas hay evidencia de su asociación a reducción de riesgo? Asiento de pasillo Caminar Ejercicios de flexoextensión del pie, Beber mucha agua, No beber alcohol. Medias 1.Todas 2.Ninguna 3.Solo medias
Prolonged air travel results in a very small absolute incidence of VTE. RR of 2.8 (95% CI, ). Incidence of a symptomatic VTE in the month following a flight > 4 h is 1 in 4,600 flights, with a reported incidence of asymptomatic VTE on arrival from a trip ranging from 0% to 1.5%. For those on flights > 4 h, immobility during the flight and window seating (especially for obese persons) also increase the risk of VTE. Especially tall or short passengers may have an increased risk. There is no definitive evidence that dehydration, travel in economy class, and drinking alcoholi drinking alcoholic beverages on the flight are related to VTE risk. Epidemiologia CHEST 2012; 141(2)(Suppl):e195S–e226S
Considera que el estar tomando una estatina modifica su riesgo trombótico? 1.Si 2.No 3.Ni idea 4.Depende de qué estatina.
Si el viaje en lugar de en avión fuera en un autobús, cambiaria de actitud? 1.Si 2.No 3.Depende del tipo de autobus 4.No lo tengo muy claro
Most individuals with travel-associated VTE have one or more known risk factors for thrombosis, including previous VTE, recent surgery or trauma, active malignancy, pregnancy, estrogen use, advanced age, limited mobility, severe obesity, or a thrombophilic disorder. Among healthy volunteers, coagulation activation observed after an 8-h fl ight was greater in carriers of factor V Leiden and in women taking oral contraceptives. Case-control studies have reported an increased risk of VTE in travelers who have thrombophilia and use oral contraceptives. Brands of below-knee GCS (providing mm Hg compression at the ankle) reduced the rate of asymptomatic DVT detected by screening from 3.6% to 0.2% (RR, 0.10; 95% CI, ); In a small study of high-dose enoxaparin (1 mg/kg), administered once 2 to 4 h before travel lasting 7 to 8 h, vs aspirin, one dose daily for 3 days starting 12 h before the beginning of the fl ight, vs control, there were zero of 82, three of 84, and four of 83 asymptomatic DVT in the three groups, respectively, but no symptomatic DVT or PE events in any group, although follow-up ended after the subjects left the airport. Cesarone. Angiologia de 2002.
Varón EPOC, hepatópata que ingresa por infección respiratoria
79 años O2 domiciliario. Solo se desplaza al servicio (Nivel de inmovilización 2) Obesidad Sangrado por varices esofágicas dos meses antes Hb 12 gd/dl. Plaquetas , INR 1,5 FGE 58 ml/m Ingreso por infección respiratoria con insuficiencia respiratoria global.
¿cuál es mayor su riesgo trombótico o hemorrágico? 1.El hemorrágico 2.El trombótico 3.Similares
Padua Prediction Score. CHEST 2012; 141(2)(Suppl):e195S–e226S low risk ( = 4 points) for VTE. A Patients with local or distant metastases and/or in whom chemotherapy or radiotherapy had been performed in the previous 6 mo. B Anticipated bed rest with bathroom privileges (either because of patients limitations or on physicians order) for at least 3 d. C Carriage of defects of antithrombin, protein C or S, factor V Leiden, G20210A prothrombin mutation, antiphospholipid syndrome. Padua Prediction Score
Bajo riesgo de sangrado
¿Utilizaría tromboprofilaxis durante el ingreso? 1.No 2.Sí, con medios físicos 3.Sí, con medios farmacológicos 4.Sí, con ambos
Ultimas guías ACCP For acutely ill hospitalized medical patients at increased risk of thrombosis who are bleeding or are at high risk for major bleeding, we suggest mechanical thromboprophylaxis with graduated compression stockings (GCS) (Grade 2C) or intermittent pneumatic compression (IPC) (Grade 2C). Uncertainty in the estimates of benefits, risks, and burden; benefi ts, risk, and burden may be closely balanced. Calidad de la evidencia pobre. CHEST 2012; 141(2)(Suppl):e195S–e226S
¿Reduciría el riesgo trombótico la utilización de medias además de la tromboprofilaxis farmacológica? 1.No 2.Sí 3.No hay evidencia
Si utilizara tromboprofilaxis farmacológico ¿ qué utilizaria? 1.HBPM a dosis de bajo riesgo 2.HBPM a dosis de alto riesgo 3.HNF cada 12 horas 4.HNF cada 8 horas 5.Fondaparinux 6.Rivaroxaban 10 mg/días 7.Apixaban 2,5 mg/d
Ultimas guías ACCP For acutely ill hospitalized medical patients at increased risk of thrombosis, we recommend anticoagulant thromboprophylaxis with low- molecular-weight heparin (LMWH), low-dose unfractionated heparin (LDUH) bid, LDUH tid, or fondaparinux (Grade 1B) Benefi ts clearly outweigh risk and burdens or viceversa. Calidad de la evidencia media CHEST 2012; 141(2)(Suppl):e195S–e226S
Remarks: In choosing the specific anticoagulant drug to be used for pharmacoprophylaxis, choices should be based on patient preference, compliance, and ease of administration (eg, daily vs bid vs tid dosing), as well as on local factors affecting acquisition costs (eg, prices of various pharmacologic agents in individual hospital formularies).
Semin Thromb Hemost.Semin Thromb Hemost Apr;37(3): Prevention of venous thromboembolism in medical patients with thrombocytopenia or with platelet dysfunction: a review of the literature. Tufano A, al.Tufano Aal. –At variance with severe thrombocytopenia ( 50,000/μL) should not interfere with VTE prevention decisions. –In severe thrombocytopenia, prophylaxis should be considered on an individual basis: –Low platelet number/function and clotting abnormalities are common in patients with liver cirrhosis. However, these patients have a high incidence of portal and idiopathic venous thromboses, implying that cirrhotic coagulopathy does not protect against thrombosis. –
Anciana institucionalizada con ingreso hospitalario por ITU
Paciente de 88 años, con deterioro cognitivo moderado por enfermedad de Alzheimer. Obesidad. Vive en una residencia. Vida cama/sillón. Dependiente para todas las actividades de la vida diaria. Incapacidad para deambular Antecedentes de TVP tras cirugía de cadera hace 2 años. Ingresa por cuadro febril y deterioro de función renal secundario a ITU, permaneciendo ingresada durante 7 días con sueroterapia y antibioterapia y enoxaparina 40 mg cc/24 hs. Alta aconsejando mantener 7 días más la TP
1.No 2.Si, medias elásticas 3.Sí, AAS 500 mg al día 4.Sí HBPM 5.Si ribaroxaban Tras el alta, y pasados esos 7 días, continuaría con tromboprofilaxis ?
Ultimas guías ACCP CHEST 2012; 141(2)(Suppl):e195S–e226S In chronically immobilized persons residing at home or at a nursing home, we suggest against the routine use of thromboprophylaxis (Grade 2C).
Si optara por mantener la HBPM al alta, cuánto tiempo la mantendría ? 1.Hasta que volviera a su situación basal una vez finalizada la antibioterapia. 2.Hasta completar 15 días desde el inicio de la HBPM 3.Hasta completar 3 semanas. 4.Indefinida.
The available data suggest that nursing home patients have an incidence of symptomatic VTE of 1% annually and postacute care patients have an incidence of 1.0% to 2.4% during their stay at the facility. These data offer some indirect support for prophylaxis of immobile patients in postacute or subacute care facilities, as their incidence of VTE may be similar to that of acutely ill hospitalized patients. Randomized trials are needed to determine if the benefits of anticoagulant thromboprophylaxis outweigh the risks in this population. CHEST 2012; 141(2)(Suppl):e195S–e226S
EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) studyEXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study.. Beneficio solo en mujeres, > 75 años y aquellos con inmovilización completa. ( nivel 1) (no desplazaminmetos al servicio) Incidencia bajísima de ETEV sintomática Alta incidencia de hemorragias ( similar a la encontrada en ensayos de tratamiento vs placebo). Ann Intern Med Jul 6; 153(1):8-18
Stroke.Stroke Jan;44(1): Venous thromboembolism risk in ischemic stroke patients receiving extended-duration enoxaparin prophylaxis: results from the EXCLAIM study. Turpie AGTurpie AG, et all EXCLAIM Investigators.EXCLAIM Investigators BACKGROUND AND PURPOSE: The optimal duration of venous thromboembolism prophylaxis in acute stroke patients is unknown. This subanalysis of the Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization (EXCLAIM) study investigated extended-duration thromboprophylaxis with enoxaparin, compared with placebo following standard-duration enoxaparin, in ischemic stroke patients. METHODS: Acutely ill medical patients with recently reduced mobility received open-label enoxaparin 40 mg for 10±4 days, and they were then randomized to double-blind enoxaparin 40 mg daily or placebo for further 28±4 days. Venous thromboembolism incidence (symptomatic/asymptomatic deep-vein thrombosis, symptomatic/fatal pulmonary embolism) up to day 28 after randomization and major bleeding rates up to 48 h after the last dose of study treatment were reported. RESULTS: In total, 389 of 5963 (6.5%) randomized patients had ischemic stroke: 198 received extended-duration prophylaxis and 191 placebo. Extended-duration prophylaxis reduced venous thromboembolism incidence versus placebo (2.4% versus 8.0%; absolute risk difference, -5.6%; 95% CI, -10.5% to -0.7%), but it was associated with an increase in major bleeding (1.5% versus 0% in enoxaparin and placebo groups; absolute risk difference, +1.5%; 95% CI, -0.2% to 3.2%). CONCLUSIONS: Extended-duration thromboprophylaxis with enoxaparin was associated with reduced venous thromboembolism risk and increased major bleeding in the subgroup of patients with ischemic stroke in the EXCLAIM study.
Bajo riesgo de sangrado
N Engl J Med.N Engl J Med Nov 22;367(21): Low-dose aspirin for preventing recurrent venous thromboembolism. Brighton TABrighton TA, Eikelboom JW, Mann K, Mister R, Gallus A, Ockelford P, Gibbs H, Hague W, Xavier D, Diaz R, Kirby A, Simes J; ASPIRE Investigators.Eikelboom JWMann KMister RGallus AOckelford PGibbs HHague WXavier DDiaz RKirby ASimes J ASPIRE Investigators The following toggler user interface control may not be accessible. Tab to the next button to revert the control to an accessible version. Department of Haematology, South Eastern Area Laboratory Services (SEALS), Prince of Wales Hospital, Sydney, Australia. Abstract BACKGROUND: Patients who have had a first episode of unprovoked venous thromboembolism have a high risk of recurrence after anticoagulants are discontinued. Aspirin may be effective in preventing a recurrence of venous thromboembolism. METHODS: We randomly assigned 822 patients who had completed initial anticoagulant therapy after a first episode of unprovoked venous thromboembolism to receive aspirin, at a dose of 100 mg daily, or placebo for up to 4 years. The primary outcome was a recurrence of venous thromboembolism. RESULTS: During a median follow-up period of 37.2 months, venous thromboembolism recurred in 73 of 411 patients assigned to placebo and in 57 of 411 assigned to aspirin (a rate of 6.5% per year vs. 4.8% per year; hazard ratio with aspirin, 0.74; 95% confidence interval [CI], 0.52 to 1.05; P=0.09). Aspirin reduced the rate of the two prespecified secondary composite outcomes: the rate of venous thromboembolism, myocardial infarction, stroke, or cardiovascular death was reduced by 34% (a rate of 8.0% per year with placebo vs. 5.2% per year with aspirin; hazard ratio with aspirin, 0.66; 95% CI, 0.48 to 0.92; P=0.01), and the rate of venous thromboembolism, myocardial infarction, stroke, major bleeding, or death from any cause was reduced by 33% (hazard ratio, 0.67; 95% CI, 0.49 to 0.91; P=0.01). There was no significant between-group difference in the rates of major or clinically relevant nonmajor bleeding episodes (rate of 0.6% per year with placebo vs. 1.1% per year with aspirin, P=0.22) or serious adverse events. CONCLUSIONS: In this study, aspirin, as compared with placebo, did not significantly reduce the rate of recurrence of venous thromboembolism but resulted in a significant reduction in the rate of major vascular events, with improved net clinical benefit. These results substantiate earlier evidence of a therapeutic benefit of aspirin when it is given to patients after initial anticoagulant therapy for a first episode of unprovoked venous thromboembolism
N Engl J Med.N Engl J Med May 24;366(21): doi: /NEJMoa Aspirin for preventing the recurrence of venous thromboembolism. Becattini CBecattini C, Agnelli G, Schenone A, Eichinger S, Bucherini E, Silingardi M, Bianchi M, Moia M, Ageno W, Vandelli MR, Grandone E, Prandoni P; WARFASA Investigators.Agnelli GSchenone AEichinger SBucherini ESilingardi MBianchi MMoia MAgeno WVandelli MR Grandone EPrandoni PWARFASA Investigators Division of Internal and Cardiovascular Medicine and Stroke Unit, Department of Internal Medicine, University of Perugia, Perugia, Italy. Erratum in N Engl J Med Oct 18;367(16):1573. Abstract BACKGROUND: About 20% of patients with unprovoked venous thromboembolism have a recurrence within 2 years after the withdrawal of oral anticoagulant therapy. Extending anticoagulation prevents recurrences but is associated with increased bleeding. The benefit of aspirin for the prevention of recurrent venous thromboembolism is unknown. METHODS: In this multicenter, investigator-initiated, double-blind study, patients with first-ever unprovoked venous thromboembolism who had completed 6 to 18 months of oral anticoagulant treatment were randomly assigned to aspirin, 100 mg daily, or placebo for 2 years, with the option of extending the study treatment. The primary efficacy outcome was recurrence of venous thromboembolism, and major bleeding was the primary safety outcome. RESULTS: Venous thromboembolism recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6% vs. 11.2% per year; hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.93) (median study period, 24.6 months). During a median treatment period of 23.9 months, 23 patients taking aspirin and 39 taking placebo had a recurrence (5.9% vs. 11.0% per year; hazard ratio, 0.55; 95% CI, 0.33 to 0.92). One patient in each treatment group had a major bleeding episode. Adverse events were similar in the two groups. CONCLUSIONS: Aspirin reduced the risk of recurrence when given to patients with unprovoked venous thromboembolism who had discontinued anticoagulant treatment, with no apparent increase in the risk of major bleeding. (Funded by the University of Perugia and others; WARFASA
NACO vs HBPM Drugs.Drugs Sep 10;72(13): Prevention of venous thromboembolism with new oral anticoagulants versus standard pharmacological treatment in acute medically ill patients: a systematic review and meta-analysis.Albertsen IE, Larsen TB, Rasmussen LH, Overvad TF, Lip GY.Albertsen IELarsen TB Rasmussen LHOvervad TFLip GY NTRODUCTION: Venous thromboembolism (VTE) is a common and potentially avoidable cause of morbidity and mortality in patients hospitalized for acute medical illness. OBJECTIVE: Our objective was to conduct a systematic review of studies that assessed the efficacy and safety of new oral anticoagulant (OAC) drugs versus standard pharmacological drugs and/or placebo in prevention of VTE in acute medically ill patients. RESULTS: Compared with subjects treated with enoxaparin followed by placebo, the RR of the primary outcome during the prolonged treatment period was 0.79 (95% CI 0.66, 0.94), the RR for the primary outcome during the first short- term treatment period was 1.03 (95% CI 0.81, 1.31). For major bleeding during the prolonged treatment period, the RR was 2.69 (95% CI 1.65, 4.39) for patients treated with an FXa inhibitor compared with enoxaparin/placebo. For major bleeding during the shorter treatment period, the RR was 2.01 (95% CI 1.10, 3.65) in favour of enoxaparin. CONCLUSION: In acute medically ill patients, prolonged thromboprophylaxis with an oral FXa inhibitor is more protective than regular short-term treatment with enoxaparin. However, treatment with FXa inhibitors is significantly associated with major bleeding, both in long- and short-term treatment compared with enoxaparin
Conclusions CHEST 2012; 141(2)(Suppl):e195S–e226S Decisions regarding prophylaxis in nonsurgical patients should be made after consideration of risk factors for both thrombosis and bleeding, clinical context, and patients values and preferences. Ultimas guías ACCP