Casos clnicos Profilaxis en pacientes mdicos CHEST 2012

Casos clínicos Profilaxis en pacientes médicos

CHEST 2012; 141(2)(Suppl): e 195 S–e 226 S

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. ” 2013 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 thermometer” “ETV 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 1 A 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. . .

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. 2. 3. 4. Bajo Medio Alto 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): e 195 S–e 226 S

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 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 2 C). • use of properly fitted, below-knee GCS providing 15 to 30 mm Hg of pressure at the ankle during travel (Grade 2 C). For all other long-distance travelers, we suggest against the use of GCS (Grade 2 C). CHEST 2012; 141(2)(Suppl): e 195 S–e 226 S

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): e 195 S–e 226 S

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. 2. 3. Todas Ninguna Solo medias

Epidemiologia • Prolonged air travel results in a very small absolute incidence of VTE. RR of 2. 8 (95% CI, 2. 2 -3. 7). • 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 alcoholic beverages on the flight are related to VTE risk. CHEST 2012; 141(2)(Suppl): e 195 S–e 226 S

Considera que el estar tomando una estatina modifica su riesgo trombótico? 1. 2. 3. 4. Si No Ni idea Depende de qué estatina.

Ultimas guías ACCP CHEST 2012; 141(2)(Suppl): e 195 S–e 226 S

September 18, 2012

Si el viaje en lugar de en avión fuera en un autobús, cambiaria de actitud? 1. 2. 3. 4. Si No Depende del tipo de autobus No lo tengo muy claro

Varón EPOC, hepatópata que ingresa por infección respiratoria

Varón EPOC, hepatópata que ingresa por infección respiratoria • 79 años • O 2 domiciliario. Solo se desplaza al servicio (Nivel de inmovilización 2) • Obesidad • Sangrado por varices esofágicas dos meses antes • Hb 12 gd/dl. Plaquetas 40. 000, 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 low risk ( < 4 points; ) or high 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 patient’s limitations or on physician’s order) for at least 3 d. C Carriage of defects of antithrombin, protein C or S, factor V Leiden, G 20210 A prothrombin mutation, antiphospholipid syndrome. CHEST 2012; 141(2)(Suppl): e 195 S–e 226 S

Bajo riesgo de sangrado

¿Utilizaría tromboprofilaxis durante el ingreso? 1. 2. 3. 4. No Sí, con medios físicos Sí, con medios farmacológicos 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 2 C) or intermittent pneumatic compression (IPC) (Grade 2 C). 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): e 195 S–e 226 S

¿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. 2. 3. 4. 5. 6. 7. HBPM a dosis de bajo riesgo HBPM a dosis de alto riesgo HNF cada 12 horas HNF cada 8 horas Fondaparinux Rivaroxaban 10 mg/días Apixaban 2, 5 mg/d

Ultimas guías ACCP • For acutely ill hospitalized medical patients at increased risk of thrombosis, we recommend anticoagulant thromboprophylaxis with lowmolecular-weight heparin (LMWH), low-dose unfractionated heparin (LDUH) bid, LDUH tid, or fondaparinux (Grade 1 B) Benefi ts clearly outweigh risk and burdens or viceversa. Calidad de la evidencia media CHEST 2012; 141(2)(Suppl): e 195 S–e 226 S

• 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).

Anciana institucionalizada con ingreso hospitalario por ITU

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

Analítica • • Hb 9, 2 gr/dl Plaq 85. 000 Cr: 1, 2 mg/dl. FGE 50 ml/m

Tras el alta, y pasados esos 7 días, continuaría con tromboprofilaxis ? 1. 2. 3. 4. 5. No Si, medias elásticas Sí, AAS 500 mg al día Sí HBPM Si ribaroxaban

Ultimas guías ACCP In chronically immobilized persons residing at home or at a nursing home, we suggest against the routine use of thromboprophylaxis (Grade 2 C). CHEST 2012; 141(2)(Suppl): e 195 S–e 226 S

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): e 195 S–e 226 S

EXCLAIM (Extended Prophylaxis for Venous Thrombo. Embolism 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. 2010 Jul 6; 153(1): 8 -18

Stroke. 2013 Jan; 44(1): 249 -51. Venous thromboembolism risk in ischemic stroke patients receiving extended-duration enoxaparin prophylaxis: results from the EXCLAIM study. Turpie AG, et all 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 Thrombo. Embolism 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

NACO vs HBPM Drugs. 2012 Sep 10; 72(13): 1755 -64. 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. 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 shortterm 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

Ultimas guías ACCP Conclusions 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. CHEST 2012; 141(2)(Suppl): e 195 S–e 226 S