Casos clínicosProfilaxis en pacientes médicos
CHEST 2012; 141(2)(Suppl):e195S–e226S
2013 International Society on Thrombosis and Haemostasis
“The American College of Chest Physicians (ACCP) haddistinguished itself in previous decades as a producer ofexcellent “antithrombotic” guidelines used worldwide;guidelines that dealt simply and primarily with evidenceand not opinion. Sadly in the last decade methodologistshave hijacked the role of the ACCP panellists, theiranalyses and writing. This is revealed in a letter sent tothe journal recently which discusses the reliability ofclinical trial data . This subject is at the heart of thechanges to the ACCP 2012 recommendations whichshares a number of authors with this letter .”
2013 International Society on Thrombosis and Haemostasis
•The antithrombotic therapy data has beendowngraded by an unproven methodologyallowing for three main changes:
– firstly dangerous extrapolations, (AAS en profilaxis ortopédica)
– secondly the consideration of so called “patientpreferences” and the “feeling thermometer” “ETVmanifiestamente clínica ( o clínicamente sintomática) como ETV importantepara el paciente”
– and thirdly the potential for bias ( se autocitan, basándoseen sus trabajos que no han demostrado su validez)
2013 International Society on Thrombosis and Haemostasis
•The use of neologisms, unscientific terminology andopaque language has made the guidelines impenetrable.
•There is an apparent intellectual bias in the writing whichmanifests itself in many ways. One example is givingclinically-presenting VTE the sobriquet ‘patient importantVTE’(2).
•“ETV manifiestamente clínica ( o clínicamentesintomática) 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) thereis a highly significant relative risk reduction (180versus 29) in 1A recommendations (a reductiongreater than 80%) despite almost no change indata.
Now that, based on their methodology, is thereally shocking finding! The tragedy is that as aresult of those changes many patients mayreceive less effective therapies and more likelyto 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 buenacalidad? Sangrado con HBPM vs HNF
•Por qué en cambio, extrapolan del escenario quirúrgico?- CNI
•Puntuación de los outcomes: ¿es igual una ETEV sintomática que unahemorragia mayor?. Le dan 1:1 y al ETEV sintomática vs hemorragiaintracraneal 1: 2,5. No es infravalorar la HIC?. Por otro lado no todaETEV sintomática es igual ni debería tener el mismo peso ( TVPpoplítea vs TEP masivo???)
Una gordita de viaje.....
Una gordita de viaje.....
•Mujer de 32 años, con IMC 34 kg/m2,fumadora de 10 cig día,en tratamiento conanticonceptivos orales y una estatina porhipercolesterolemia.
•Consulta sobre la conveniencia derealizar alguna medida preventiva porquetiene previsto realizar un vuelo de 8 horasde duración.
¿Cuál es el riesgo de la paciente dedesarrollar una ETEV?
1.Bajo
2.Medio
3.Alto
4.Muy alto
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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, quehiciera ejercicios de flexoextensión del pie, bebieramucho agua, no bebiera alcohol.
3.Que se pusiera unas medias de compresión ligerahasta la rodilla
4.HBPM a dosis profiláctica
5.La daría a elegir lo que ella prefiriera porque eso es loque dicen las guías.
6.AAS
7.Combinaría medidas físicas con farmacológicas
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CHEST 2012; 141(2)(Suppl):e195S–e226S
For long-distance travelers at increased risk of VTE (includingprevious VTE, recent surgery or trauma, active malignancy,pregnancy, estrogen use, advanced age, limited mobility, severeobesity, or known thrombophilic disorder), we suggest:
• frequent ambulation, calf muscle exercise, or sitting in anaisle seat if feasible (Grade 2C) .
• use of properly fitted, below-knee GCS providing 15 to 30mm Hg of pressure at the ankle during travel (Grade 2C) .
For all other long-distance travelers, we suggest against the useof GCS (Grade 2C) .
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Until further, methodologically appropriatestudies are available, decisions regardingpharmacologic thromboprophylaxis fortravelers who are considered to be atparticularly high risk for VTE must bemade on an individual basis, consideringthat adverse effects may outweigh anybenefit.
CHEST 2012; 141(2)(Suppl):e195S–e226S
De cuáles de estas medidas hay evidenciade 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 ofVTE. RR of 2.8 (95% CI, 2.2-3.7).
•Incidence of a symptomatic VTE in the month following a flight > 4 his 1 in 4,600 flights, with a reported incidence of asymptomatic VTEon arrival from a trip ranging from 0% to 1.5%.
•For those on flights > 4 h, immobility during the flight and windowseating (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 economyclass, and drinking alcoholi drinking alcoholic beverages on the flightare related to VTE risk.
Epidemiologia
CHEST 2012; 141(2)(Suppl):e195S–e226S
Considera que el estar tomando unaestatina modifica su riesgo trombótico?
1.Si
2.No
3.Ni idea
4.Depende de qué estatina.
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CHEST 2012; 141(2)(Suppl):e195S–e226S
September 18, 2012
Si el viaje en lugar de en avión fuera enun 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 forthrombosis, including previous VTE, recent surgery or trauma, active malignancy,pregnancy, estrogen use, advanced age, limited mobility, severe obesity, or athrombophilic disorder.
•Among healthy volunteers, coagulation activation observed after an 8-h fl ight wasgreater 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 havethrombophilia and use oral contraceptives.
•Brands of below-knee GCS (providing 15-30 mm Hg compression at the ankle) reducedthe rate of asymptomatic DVT detected by screening from 3.6% to 0.2% (RR, 0.10; 95%CI, 0.04-0.25);
•In a small study of high-dose enoxaparin (1 mg/kg), administered once 2 to 4 h beforetravel lasting 7 to 8 h, vs aspirin, one dose daily for 3 days starting 12 h before thebeginning of the fl ight, vs control, there were zero of 82, three of 84, and four of 83asymptomatic DVT in the three groups, respectively, but no symptomatic DVT or PEevents in any group, although follow-up ended after the subjects left the airport.Cesarone. Angiologia de 2002.
Varón EPOC, hepatópata que ingresapor infección respiratoria
Varón EPOC, hepatópata que ingresa porinfección respiratoria
•79 años
•O2 domiciliario. Solo se desplaza al servicio (Nivel deinmovilización 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 insuficienciarespiratoria global.
¿cuál es mayor su riesgo trombótico ohemorrágico?
1.El hemorrágico
2.El trombótico
3.Similares
Padua Prediction Score.
CHEST 2012; 141(2)(Suppl):e195S–e226S
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, G20210A prothrombin mutation, antiphospholipid syndrome.
Padua Prediction Score
Bajo riesgo de sangrado
¿Utilizaría tromboprofilaxisdurante el ingreso?
1.No
2.Sí, con medios físicos
3.Sí, con medios farmacológicos
4.Sí, con ambos
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• For acutely ill hospitalized medicalpatients at increased risk of thrombosiswho are bleeding or are at high risk formajor bleeding, we suggest mechanicalthromboprophylaxis with graduatedcompression stockings (GCS) (Grade 2C)or intermittent pneumatic compression(IPC) (Grade 2C). Uncertainty in the estimates ofbenefits, risks, and burden; benefi ts, risk, and burdenmay be closely balanced. Calidad de la evidencia pobre.
CHEST 2012; 141(2)(Suppl):e195S–e226S
¿Reduciría el riesgo trombótico la utilización demedias además de la tromboprofilaxisfarmacológica?
1.No
2.Sí
3.No hay evidencia
Si utilizara tromboprofilaxisfarmacológico ¿ 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
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• For acutely ill hospitalized medical patients atincreased risk of thrombosis, we recommendanticoagulant thromboprophylaxis with low-molecular-weight heparin (LMWH), low-doseunfractionated heparin (LDUH) bid, LDUH tid, orfondaparinux (Grade 1B) Benefi ts clearlyoutweigh risk and burdens or viceversa. Calidadde la evidencia media
CHEST 2012; 141(2)(Suppl):e195S–e226S
•Remarks:
In choosing the specific anticoagulant drug to beused for pharmacoprophylaxis, choices shouldbe based on patient preference, compliance,and ease of administration (eg, daily vs bid vs tiddosing), as well as on local factors affectingacquisition costs (eg, prices of variouspharmacologic agents in individual hospitalformularies).
Semin Thromb Hemost. 2011 Apr;37(3):267-74.
Prevention of venous thromboembolism in medicalpatients with thrombocytopenia or with plateletdysfunction: a review of the literature. Tufano A, al.
–At variance with severe thrombocytopenia (< 50,000/μL),mild/moderate thrombocytopenia (> 50,000/μL) should notinterfere with VTE prevention decisions.
–In severe thrombocytopenia, prophylaxis should be considered onan individual basis:
–Low platelet number/function and clotting abnormalities arecommon in patients with liver cirrhosis. However, these patientshave a high incidence of portal and idiopathic venous thromboses,implying that cirrhotic coagulopathy does not protect againstthrombosis.
–
Anciana institucionalizada con ingresohospitalario por ITU
Anciana institucionalizada con ingresohospitalario por ITU
•Paciente de 88 años, con deterioro cognitivo moderadopor enfermedad de Alzheimer. Obesidad.
•Vive en una residencia. Vida cama/sillón. Dependientepara todas las actividades de la vida diaria. Incapacidadpara deambular
•Antecedentes de TVP tras cirugía de cadera hace 2años.
•Ingresa por cuadro febril y deterioro de función renalsecundario a ITU, permaneciendo ingresada durante 7días con sueroterapia y antibioterapia y enoxaparina 40mg 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
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, continuaríacon tromboprofilaxis ?
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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, cuántotiempo la mantendría ?
1.Hasta que volviera a su situación basaluna vez finalizada la antibioterapia.
2.Hasta completar 15 días desde el iniciode la HBPM
3.Hasta completar 3 semanas.
4.Indefinida.
The available data suggest that nursing home patients have anincidence of symptomatic VTE of 1% annually and postacute carepatients have an incidence of 1.0% to 2.4% during their stay at the
facility.
These data offer some indirect support for prophylaxis of immobilepatients in postacute or subacute care facilities, as their incidence ofVTE may be similar to that of acutely ill hospitalized patients.
Randomized trials are needed to determine if the benefits ofanticoagulant thromboprophylaxis outweigh the risks in thispopulation.
CHEST 2012; 141(2)(Suppl):e195S–e226S
•Beneficio solo en mujeres, > 75 años yaquellos con inmovilización completa. ( nivel 1)(no desplazaminmetos al servicio)
•Incidencia bajísima de ETEV sintomática
• Alta incidencia de hemorragias ( similar a laencontrada en ensayos de tratamiento vsplacebo).
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 enoxaparinprophylaxis: results from the EXCLAIM study.
BACKGROUND AND PURPOSE:
The optimal duration of venous thromboembolism prophylaxis in acute stroke patients is unknown. Thissubanalysis of the Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients WithProlonged Immobilization (EXCLAIM) study investigated extended-duration thromboprophylaxis withenoxaparin, 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±4days, and they were then randomized to double-blind enoxaparin 40 mg daily or placebo for further 28±4days. Venous thromboembolism incidence (symptomatic/asymptomatic deep-vein thrombosis,symptomatic/fatal pulmonary embolism) up to day 28 after randomization and major bleeding rates up to48 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-durationprophylaxis and 191 placebo. Extended-duration prophylaxis reduced venous thromboembolism incidenceversus placebo (2.4% versus 8.0%; absolute risk difference, -5.6%; 95% CI, -10.5% to -0.7%), but it wasassociated 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 venousthromboembolism risk and increased major bleeding in the subgroup of patients with ischemic stroke in theEXCLAIM study.
Bajo riesgo de sangrado
Low-dose aspirin for preventing recurrent venous thromboembolism.
Brighton 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.
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Department of Haematology, South Eastern Area Laboratory Services (SEALS), Prince of Wales Hospital, Sydney, Australia.aspire@ctc.usyd.edu.au
Abstract
BACKGROUND:
Patients who have had a first episode of unprovoked venous thromboembolism have a high risk of recurrence after anticoagulantsare 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 venousthromboembolism to receive aspirin, at a dose of 100 mg daily, or placebo for up to 4 years. The primary outcome was arecurrence of venous thromboembolism.
RESULTS:
During a median follow-up period of 37.2 months, venous thromboembolism recurred in 73 of 411 patients assigned to placeboand 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 compositeoutcomes: 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 causewas reduced by 33% (hazard ratio, 0.67; 95% CI, 0.49 to 0.91; P=0.01). There was no significant between-group differencein the rates of major or clinically relevant nonmajor bleeding episodes (rate of 0.6% per year with placebo vs. 1.1% per yearwith 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 butresulted in a significant reduction in the rate of major vascular events, with improved net clinical benefit. These resultssubstantiate earlier evidence of a therapeutic benefit of aspirin when it is given to patients after initial anticoagulant therapyfor a first episode of unprovoked venous thromboembolism
N Engl J Med. 2012 May 24;366(21):1959-67. doi: 10.1056/NEJMoa1114238.
Aspirin for preventing the recurrence of venous thromboembolism.
Becattini 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.
Division of Internal and Cardiovascular Medicine and Stroke Unit, Department of Internal Medicine, University ofPerugia, Perugia, Italy. cecilia.becattini@unipg.it
Erratum in
N Engl J Med. 2012 Oct 18;367(16):1573.
Abstract
BACKGROUND:
About 20% of patients with unprovoked venous thromboembolism have a recurrence within 2 years after the withdrawalof oral anticoagulant therapy. Extending anticoagulation prevents recurrences but is associated with increasedbleeding. 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 venousthromboembolism who had completed 6 to 18 months of oral anticoagulant treatment were randomly assigned toaspirin, 100 mg daily, or placebo for 2 years, with the option of extending the study treatment. The primary efficacyoutcome 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 whoreceived placebo (6.6% vs. 11.2% per year; hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.93) (medianstudy period, 24.6 months). During a median treatment period of 23.9 months, 23 patients taking aspirin and 39taking placebo had a recurrence (5.9% vs. 11.0% per year; hazard ratio, 0.55; 95% CI, 0.33 to 0.92). One patientin 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 haddiscontinued anticoagulant treatment, with no apparent increase in the risk of major bleeding. (Funded by theUniversity of Perugia and others; WARFASA
NACO vs HBPM
Drugs. 2012 Sep 10;72(13):1755-64.
Prevention of venous thromboembolism with new oral anticoagulants versus standard pharmacologicaltreatment 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 patientshospitalized for acute medical illness.
OBJECTIVE:
Our objective was to conduct a systematic review of studies that assessed the efficacy and safety of new oralanticoagulant (OAC) drugs versus standard pharmacological drugs and/or placebo in prevention of VTE in acutemedically ill patients.
RESULTS:
Compared with subjects treated with enoxaparin followed by placebo, the RR of the primary outcome during theprolonged 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, theRR was 2.69 (95% CI 1.65, 4.39) for patients treated with an FXa inhibitor compared with enoxaparin/placebo. Formajor 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 thanregular short-term treatment with enoxaparin. However, treatment with FXa inhibitors is significantly associatedwith major bleeding, both in long- and short-term treatment compared with enoxaparin
Conclusions
CHEST 2012; 141(2)(Suppl):e195S–e226S
Decisions regarding prophylaxis in nonsurgicalpatients should be made after consideration of riskfactors for both thrombosis and bleeding, clinicalcontext, and patients’ values and preferences.
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