Presentazione sul tema: "Paziente medico e chirurgico: schemi di trattamento Walter Ageno Dipartimento di Medicina Clinica Università dellInsubria - Varese."— Transcript della presentazione:
Paziente medico e chirurgico: schemi di trattamento Walter Ageno Dipartimento di Medicina Clinica Università dellInsubria - Varese
MEDENOX (enoxaparin) 40age 40 years, 6hospitalization 6 days and CHF (NYHA III/IV) Acute resp. disease Infectious disease, acute rheumatic and IBD + 1 predefined RF *+ 1 predefined RF * PREVENT (dalteparin) 40age 40 years, 6hospitalization 6 days and CHF (NYHA III/IV) Acute resp. disease Infectious disease, acute rheumatic and IBD + 1 predefined RF *+ 1 predefined RF * ARTEMIS (fondaparinux) 0age 60 years, 6hospitalization 6 days and CHF (NYHA III/IV) Acute and chronic resp. disease Acute infectious or inflammatory disease No additional RFNo additional RF Main clinical trials in medical patients age> 75 years, cancer, VTE history, obesity, varicose veins, oral contraceptives, chronic heart failure, chronic respiratory failure
PE RR = 0.43; 95% CI: Fatal PE RR = 0.38; 95% CI: Symptomatic DVT RR = 0.47; 95% CI: Mortality RR = 0.97; 95% CI: Major bleeding RR = 1.32; 95% CI: NINE SELECTED STUDIES 19,958 PATIENTS Dentali F et al. Ann Intern Med 2007; 146: Thromboprophylaxis in medical patients: meta-analysis on treatment period
Linee guida SPREAD 2010: stroke ischemico Grado B: In pazienti a rischio elevato (pazienti plegici, con alterazione dello stato di coscienza, obesi, con pregressa patologia venosa agli arti inferiori) è indicato luso di eparina calcica non frazionata 5000 UI x 2 o eparina a basso peso molecolare In pazienti non a rischio elevato di trombosi venose profonde, il ricorso sistematico alleparina comporta un bilancio beneficio/rischio di complicanze emorragiche intracerebrali e/o sistemiche inaccettabile
Efficacy of low-dose unfractionated heparin (UFH) in prevention of DVT after major surgery s.c. low-dose UFH pre-operative and b.i.d.post-operative 78 high-risk patients Patients with DVT (%) p < Pharmacological prevention of thrombosis in surgical patients Kakkar VV et al. Lancet 1972;2:
LMWH vs. no treatment or placebo (8 studies, 5520 patients) RR [CI 95%] 0.28 [0.14–0.54] 0.29 [0.11–0.73] DVT (n=513) Clinical VTE (n=4890) Major bleeding (n=5456) Death (n=5142 ) 2.03 [1.37–3.01] 0.54 [0.27–1.10] LMWH better [0.08–0.79]Clinical PE (n=5456) Placebo/No treatment better Relative risk LMWH for the prevention of VTE in general surgery Mismetti P et al. Br J Surg 2001;88:
Guidelines: Prophylaxis of VTE in surgical patients 1.Geerts WH et al. Chest Hill J et al BMJ 2007 For higher-risk general surgery patients who are undergoing a major procedure for cancer, we recommend thromboprophylaxis with LMWH, LDUH three times a day, or Fondaparinux (each Grade 1A) 1 For moderate-risk general surgery patients who are undergoing a major procedure for benign disease, we recommend thromboprophylaxis with LMWH, LDUH, or fondaparinux (each Grade 1A). NICE guidelines UK SettingNo risk factorsRisk factors GeneralMechanical Mechanical surgery+ LMWH or fondaparinux
ENOXACAN II 1 Total DVT (%) 1 week 4 weeks 12.0% 4.8% p= % 7.3% FAME 2 p=0.012 *Deep Vein Thrombosis ** Venous Thromboembolism Incidence of Total DVT*Incidence of VTE** Enoxaparin: n=165 Dalteparin: n=343 60% cancer surgery in 1 week group 56% cancer surgery in 4 weeks group 1.Berqvist D et al. New Engl J Med 2002;346: Rasmussen MS et al. J Thromb Haemost 2006;4: Extended prophylaxis with LMWH after cancer surgery 1 week4 weeks VTE (%)
Recommendations: Elective Hip and Knee Replacement We recommend the routine use of one of the following options: (1) LMWH (at a usual high-risk dose); (2) Fondaparinux (2.5 mg); (3) Adjusted dose VKA started preoperatively or the evening of the surgical day (INR target, 2.5; INR range, 2.0 to 3.0) (all Grade 1A) Geerts et al Chest 2008
EFFICACY LMWH 12 h preop LMWH h post-op DVT % 14 Studies patients Timing of the first prophylactic dose of LMWH: results of a meta-analysis LMWH periop. 19.2% (17-21) 12.4% (10-14) 14.4% (12-17) Strebel, Arch Int Med, 2002
Geerts et al Chest 2008 Timing of Thromboprophylaxis Initiation For patients receiving LMWH as thromboprophylaxis in major orthopedic surgery, we recommend starting either preoperatively or postoperatively (Grade 1A). For patients receiving fondaparinux as thromboprophylaxis in major orthopedic surgery, we recommend starting either 6 to 8 h after surgery or the next day (Grade 1A).
Extended thromboprophylaxis: rationale JW Eikelboom et al. Lancet 2001 Symptomatic VTE 1.3% 3.3% HEP C OR 0.38
Geerts et al Chest 2008 Duration of Thromboprophylaxis For patients undergoing THR, TKR, or HFS, we recommend thromboprophylaxis with one of the recommended options for at least 10 days (Grade 1A). We recommend that thromboprophylaxis be extended beyond 10 days and up to 35 days after surgery (Grade 1A THR, Grade 2B TKR, Grade 1A HFS). The recommended options for extended thromboprophylaxis in THR include LMWH, a VKA, or fondaparinux.
Renal Impairment and Anticoagulant Dosing We recommend that renal function be considered when making decisions about the use and/or the dose of LMWH, fondaparinux, and other antithrombotic drugs that are cleared by the kidneys, particularly in elderly patients, patients with diabetes mellitus, and those at high risk for bleeding (Grade 1A). Depending on the circumstances, we recommend one of the following options in this situation: avoiding the use of an anticoagulant that bioaccumulates in the presence of renal impairment, using a lower dose of the agent, or monitoring the drug level or its anticoagulant effect (Grade 1B). Geerts et al Chest 2008