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Identikit del paziente ricoverato da sottoporre a profilassi del TEV
Il punto di vista dell’Internista
C. Cimminiello – Vimercate (MB)
Oncologo e Internista insieme nella gestione del paziente neoplastico a rischio di TEV
Roma 13-14 giugno 2012
Relazioni con soggetti portatori di interessi commerciali in campo sanitario
• Ai sensi dell’art. 3.3 sul Conflitto di Interessi, pag. 17 del Regolamento Applicativo dell’Accordo Stato-Regione del 5 novembre 2009, dichiaro che negli ultimi due anni ho avuto i seguenti rapporti anche di finanziamento con soggetti portatori di interessi commerciali in campo sanitario:
– Bayer
– Boehringer Ingelheim
– sanofi aventis
Il paziente oncologico ricoverato in Medicina Interna
• Diagnosi di malattia non nota: segni e sintomi acuti e sottostante neoplasia ancora indiagnosticata
• Malattia nota: progressione della stessa/ patologia concomitante
• Malattia nota: complicanze del trattamento (es. neutropenia febbrile)
*Only includes patients age 65 years
Frequency of Venous Thrombosis in Hospitalized Patients With Cancer
Study No. of Hospitalization or Patients
Events No. %
Levitan et al* 1,211,944 7,238 0.6
Sallah et al 1,041 81 7.8
Khorana et al 66,106 5,272 5.4
Khorana et al 1,015,598 41,666 4.1
Francis CW JCO 2009
MEDENOX 1,102 1%
Incidence of Venous Thromboembolism in Patients Hospitalized with Cancer
Patients discharged from 1979 through 1999 with diagnosis of DVT/PE (National Hospital Discharge Survey).
Stein PD et al Am J Med 2006; 119: 60-68
Pts without malignancy 66,2309,000 with VTE 6,854,000 1.0% Pts with malignancy 40,787,000 with VTE 837,000 2.0%
Incidence of Venous Thromboembolism in Patients Hospitalized with Cancer
Patients discharged from 1979 through 1999 with diagnosis of DVT/PE (National Hospital Discharge Survey).
Stein PD et al Am J Med 2006; 119: 60-68
Pts without malignancy 66,2309,000 with VTE 6,854,000 1.0% Pts with malignancy 40,787,000 with VTE 837,000 2.0%
Acute Medical Illness and VTE
Multivariate Logistic Regression Model for Definite Venous Thromboembolism (VTE)
Alikhan R, Cohen A, et al. Arch Intern Med. 2004;164:963-968
Risk Factor Odds Ratio (95% CI)
X2
Age > 75 years Cancer
Previous VTE
1.03 (1.00-1.06) 1.62 (0.93-2.75) 2.06 (1.10-3.69)
0.0001 0.08 0.02
Acute infectious disease 1.74 (1.12-2.75) 0.02
Venous thromboembolism risk stratification in medically-ill hospitalized cancer patients. A comprehensive cancer center experience
606 cancer pts admitted to regular medical units between August and December 2008 and followed-up to 2 months after discharge
Abdel Razeq H et al J Thromb Thrombolysis 2010;30:286-293
Venous thromboembolism risk stratification in medically-ill hospitalized cancer patients. A comprehensive cancer center experience
606 cancer pts admitted to regular medical units between August and December 2008 and followed-up to 2 months after discharge
Abdel Razeq H et al J Thromb Thrombolysis 2010;30:286-293
Venous thromboembolism risk stratification in medically-ill hospitalized cancer patients. A comprehensive cancer center experience
606 cancer pts admitted to regular medical units between August and December 2008 and followed-up to 2 months after discharge
Abdel Razeq H et al J Thromb Thrombolysis 2010;30:286-293
Venous thromboembolism risk stratification in medically-ill hospitalized cancer patients.
A comprehensive cancer center experience
606 cancer pts admitted to regular medical units between August and December 2008 and folloed-up to 2 months after discharge
Abdel Razeq H et al J Thromb Thrombolysis 2010;30:286-293
6
5
4
3
2
1
3.38%
4.2%
0
Low risk Moderate risk High risk
2-m
on
th V
TE in
cid
ence
Low risk group: prophylaxis in 25.9% Moderate risk group: prophylaxis in 53.3% High risk group: prophylaxis in 62.2%
Cancer-associated acute venous thromboembolism Findings from the MASTER Registry
Imberti D et al Haematologica 2008; 93:273-278
With cancer N: 424
Without cancer N: 1695
V
TE in
cid
ence
in p
atie
nts
wit
h
seve
re m
edic
al d
isea
se 12.7%
7.1%
P < .001
12
10
8
6
4
2
14
Thromboembolism in Hospitalized Neutropenic Cancer Patients
Retrospective cohort study (discharge database of the University Health System Consortium) including 66,106 adult neutropenic cancer patients with 88,074 hospitalizations between 1995 and 2002 at 115 medical centers in the United States
Predictors of Venous Thromboembolism by Multivariate Logistic Regression Analysis
Khorana AA et al J Clin Oncol 2006; 24:484-490
Thromboembolism in Hospitalized Neutropenic Cancer Patients
Retrospective cohort study (discharge database of the University Health System Consortium) including 66,106 adult neutropenic cancer patients with 88,074 hospitalizations between 1995 and 2002 at 115 medical centers in the United States
Thromboembolism and inpatient mortality
Khorana AA et al J Clin Oncol 2006; 24:484-490
Multicenter evaluation of the use of venous thromboembolism prophylaxis in acutely ill medical patients in Canada
The CURVE Study Aim: to determine the frequency, determinants and appropriateness of thromboprophylaxis in 1894 medical pts in
29 Canadian hospitals
Kahn S et al Thromb Res2007;119:145-155
Predictors of use of any prophylaxis in study population
Multicenter evaluation of the use of venous thromboembolism prophylaxis in acutely ill medical patients in Canada
The CURVE Study Aim: to determine the frequency, determinants and appropriateness of thromboprophylaxis in 1894 medical pts in
29 Canadian hospitals
Kahn S et al Thromb Res2007;119:145-155
Predictors of use of mechanical prophylaxis in study population
Lack of prophylaxis before the onset of acute venous thromboembolism among hospitalized cancer patients: the SWIss
Venous ThromboEmbolism Registry (SWIVTER)
257 cancer patients (61 ± 15 years) with acute VTE and prior hospitalization for acute medical illness or surgery within 30 days
Kucher N et al Ann Oncol 2010; 21: 931–935
Lack of prophylaxis before the onset of acute venous thromboembolism among hospitalized cancer patients: the SWIss
Venous ThromboEmbolism Registry (SWIVTER)
Kucher N et al Ann Oncol 2010; 21: 931–935
Independent clinical predictors of prophylaxis in patients with cancer
In-hospital symptomatic venous thromboembolism and antithrombotic prophylaxis in Internal Medicine
Findings from GEMINI Study Multivariable regression analysis to correlate known risk factors for VTE and prescription of
antithrombotic prophylaxis during hospital stay.
Gussoni G et al Thromb Haemost 2009; 101: 893–901
Percentage of antithrombotic prophylaxis administration in cancer patients, according to the number of additional known risk factors for VTE
In-hospital symptomatic venous thromboembolism and antithrombotic prophylaxis in Internal Medicine
Findings from GEMINI Study
Gussoni G et al Thromb Haemost 2009; 101: 893–901
Prophylaxis rate in a cancer population with VTE according to number of risk factors
Abdel-Razeq H et al J Thromb Thrombolysis 2011 ;31:107-12
Prophylaxis rate in a cancer population with VTE in relation to recent hospitalization
Abdel-Razeq H et al J Thromb Thrombolysis 2011 ;31:107-12
Trials of Anticoagulant Prophylaxis for Venous Thromboembolism in Hospitalized Medical Patients
Study Total No. of Patients
Patients With Cancer
No. %
Relative Risk
Placebo Events
No./Total No. % No./Total No. %
ARTEMIS 849† 131 15.4 34/323 10.5 18/321 5.6 0.47 0.08 to 0.69 .029
MEDENOX 579 72 12.4 43/288 14.9 16/291 5.5 0.37 0.22 to 0.63 .001
PREVENT 3,706 190 5.1 73/1,473 4.96 42/1,518 2.77 0.55 0.38 to 0.8 .0015
Treatment Events
95% CI
P
Francis CW JCO 2009
Cosa dicono le CONSENSUS e le Lineeguida
1. Hospitalized patients with malignancies and concomitant acute medical illness should receive prophylactic doses of LMWH or fondaparinux (grade A)
2.3. 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 1B)
S. Siragusa et al. Thrombosis Research 2012; 129: e171–e176
Kahn S et al. CHEST 2012; 141(2)(Suppl):e195S–e226S
“No studies are available in which prophylaxis has been evaluated in a population limited to patients with cancer….. However, patients with cancer have an increased risk for bleeding, resulting from factors such as thrombocytopenia and the performance of invasive procedures that occurs more commonly than in other medical patients. Thus, care should be exercised in administering anticoagulant prophylaxis…”
Francis CW JCO 2009
EXCLAIM Symptomatic VTE Bleeding
MAGELLAN Bleeding
ADOPT VTE Bleeding
VTE
Extended Prophylaxis: the “Big Three”
Età >75 anni o Storia pregressa di TEV
o Diagnosi di neoplasia
+ Mobilità Livello 1
(pazienti totalmente allettati o sedentari)
Mobilità Livello 2
(livello 1 con possibilità di raggiungere il bagno)
oppure
Studio EXCLAIM: selezione dei pazienti Età ≥40 anni Allettamento (≤3 giorni) Patologia medica acuta
scompenso cardiaco, classe NYHA III/IV
insufficienza respiratoria acuta
altre condizioni mediche acute, inclusi:
ictus ischemico post-acuto
infezione acuta in assenza di shock settico
neoplasia in fase attiva
Hull RD et al. J Thromb Thrombolysis 2006;22:31-38
Hull RD et al. J Thromb Thrombolysis 2006;22:31-38
Profilassi prolungata: per quali pazienti?
CONCLUSIONI
• Il paziente neoplastico ricoverato è ad elevato rischio di TEV se coesistono altri fattori di rischio.
• La profilassi del TEV viene sottoutilizzata in questi pazienti.
• Non esistono dati specifici, raccolti in casistiche di soli pazienti neoplastici, sull’efficacia e sulla SICUREZZA della profilassi farmacologica del TEV.
• La profilassi protratta – sul modello EXCLAIM – potrebbe essere considerata in alcune tipologie di pazienti neoplastici ricoverati (es. oltre i 75 anni e con ipomobilità perdurante)