De Trousseau aux anticoagulants directs
Transcript of De Trousseau aux anticoagulants directs
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De Trousseau aux anticoagulants
directs
Guy Meyer
Université Paris Descartes
Hopital Europeen Georges Pompidou,
INSERM UMRS 970, CIC 1418 Paris, France
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Conflits d’intérêt G Meyer
• Investigateur: Bayer, Daichi-Sankyo, Sanofi
Aventis, Leo Pharma
• Subvention de recherche: Leo Pharma,
Boehringer-Ingelheim, Bayer
• Interventions, boards non rémunérés: Sanofi
Aventis, Leo Pharma, Bayer, Boehringer-
Ingelheim, Pfizer
• Invitations congrès: Leo Pharma, Boehringer-
Ingelheim, Bayer, Daichi-Sankyo
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« Lorsque vous hésitez sur la nature d’une maladie de l’estomac, entre une gastrite chronique, un ulcère banal ou un cancer, une phlegmatiaalba dolensau niveau d’une jambe ou d’un bras mettra fin à votre indécision. »
« Je suis perdu, une phlébite qui vient de se déclarer cette nuit ne me laisse plus aucun doute sur la nature de mon mal. »
Le syndrome « de Trousseau »
rousseau A. Phlegmasia alba dolens; in Clinique médicale de l’Hotel‐Dieu de Paris. Paris, Bailliere 1865; 3: 654–712.
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Le syndrome « de Trousseau »
Bouillaud JB, Arch Gen Med 1823
« Si la masse ganglionnaire appuie sur la veine cave abdominale …cela peut déterminer aussi la coagulation du sang dans ces vaisseaux et leur oblitération »
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Le diagnostic
The diagnosis of pulmonary embolism is rarely proved
before death. The diagnosis in life rests on a combination
of symptoms and signs in the chest and legs and changes
in the radiogram and electrocardiogram; and in the less
severe cases the diagnosis is more uncertain.
Barritt DW, Jordan SC. Lancet 1960 275; 7138: 1309-12
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Le diagnostic
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PIOPED!!
Almost all patients with pulmonary embolism had abnormal scans
of high, intermediate, or low probability, but so did most without
pulmonary embolism (sensitivity, 98%; specificity, 10%). Of 116
patients with high-probability scans and definitive angiograms, 102
(88%) had pulmonary embolism, but only a minority with
pulmonary embolism had high-probability scans (sensitivity, 41%;
specificity, 97%). Of 322 with intermediate-probability scans and
definitive angiograms, 105 (33%) had pulmonary embolism.
Follow-up and angiography together suggest pulmonary embolism
occurred among 12% of patients with low-probability scans.
Clinical assessment combined with the ventilation/perfusion scan
established the diagnosis or exclusion of pulmonary embolism only
for a minority of patients—those with clear and concordant clinical
and ventilation/perfusion scan findings.
PIOPED Investigators. JAMA 1990;263:2753-9.
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PIOPED!!
• Almost all patients with pulmonary embolism had abnormal
scans
• but so did most without pulmonary embolism
• sensitivity, 98%; specificity, 10%.
PIOPED Investigators. JAMA 1990;263:2753-9.
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PIOPED!!
• 88% of patients with high-probability scans had pulmonary
embolism,
• but only a minority with pulmonary embolism had high-
probability scans
• (sensitivity, 41%; specificity, 97%).
• pulmonary embolism occurred among 12% of patients with low-
probability scans.
PIOPED Investigators. JAMA 1990;263:2753-9.
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PIOPED!!
Clinical assessment combined with the
ventilation/perfusion scan established the
diagnosis or exclusion of pulmonary embolism
only for a minority of patients—those with clear
and concordant clinical and ventilation/perfusion
scan findings.
PIOPED Investigators. JAMA 1990;263:2753-9.
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Théorème de Bayes
P(B/A) x P(A)
P(B/A) x P(A) + P(B/A) x P(A) P(A|B) =
A: le patient est malade
A: le patient n’est pas malade
B: le test est positif
Patients with clear and concordant clinical and test findings.
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D-dimères!
Bounameaux H et al. Lancet 1988;2(8611):628-9.
99 patients with suspected PE
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Age et performance des D-dimer
Righini M. et al. Am J Med 2000; 109: 357-61
1029 patients suspects d’EP
Age Sensibilité Spécificité
Tous 100 (98-100) 47 (44-51)
< 40 (195) 100 (86-100) 67 (60-74)
70-79 (203) 99 (93-100) 28 (20-35)
> 80 (165) 100 (95-100) 10 (5-18)
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4420 évalués
1074 exclus
3324 inclus
2898: PC non forte 426: PC forte
817 (24,6%) D-di < 500 µg/L
337 (10,1%) D-di > 500 µg/L et < age x 10
1744 (52,5%) D-di > age x 10
ADJUST: Schéma général de l’étude
Righini M. et al. JAMA 2014; 311: 1117-24
Scanner 1 VTE/817 (0,1%)
1VTE/331(0,3%)
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ADJUST: patients âgés de plus de 75 ans
• 766 patients > 75 ans
• 673 probabilité clinique faible ou intermédiaire
• D-dimère < 500 µg/L: 43 (6.4%)
• D-dimère > 500 et < âge x 10: 157 (23,3%)
• D-dimères < âge x 10: 200 (29.7%)
• Evènement à 3 mois: 0/195 (IC 95%: 0-1,9%)
Righini M. et al. JAMA 2014; 311: 1117-24
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D-dimer: à la carte?
• Ajusté à l'âge
• Ajusté au terrain
– Grossesse
– Cancer
– Niveau de probabilité clinique
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Angioscanner spiralé
• 75 patients evaluated with spiral CT and pulmonary angiography
• Findings from both studies were positive in 39 patients.
• Sensitivity: 91%,
• Specificity: 78%,
• PPV: 100%,
• NPV: 89%.
• Technical failures (n = 3); inconclusive CT findings (n = 7)
• CONCLUSION: Spiral CT can reliably depict central PE and may be introduced into the classic diagnostic algorithms
Remy-Jardin M. et al. Radiology 1996;200:699-706
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Baisse de la prévalence dans les séries diagnostiques
USA Europe/Canada
PE Prevalence 2.5% 10.7%
Negative Ddi 76% 69%
Pernod G. et al PLoS ONE 2017; 12(1): e0169268.
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EP sous-segmentaire isolée
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SDCT MDCT (4) MDCT (16) MDCT (64)
Rate SSPE 4.7 (2.5-7.6) 7.1 (3.8-11.3) 6.9 (0.7-23.3) 15.0 (7.7-24.1)
Recurrent
VTE*
0.9 (0.4-1.4) 1.4 (0.7-2.7) 0.6 (0.1-1.6) 0.8 (0.1-3.0)
EP sous-segmentaire isolée
Carrier M. et al. J Thromb Haemost 2010; 8: 1716–22.
*: when lef untreated after a negative CT
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Interobserver agreement is lower for SSPE than for more proximal PE
290 MDCT examinations
4 radiologists vs consensus panel
Kappa overall 0.88 (0.85-0.92)
Kappa lobar 0.83 (0.68-0.91)
Kappa segmental 0.61 (0.40-0.80)
Kappa sub-
segmental 0.38 (0.0-0.89)
Ghanima W. et al. Acta radiol 2007; 2: 165-70
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EP sous-segmentaire
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Le traitement
Barritt DW, Jordan SC. Lancet 1960 275; 7138: 1309-12
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AVK dès le premier jour!
• 266 patients TVP ou EP, stables
• AVK à J1 ou à J8
AVK J1 AVK J8
Récidive prouvée 2.2% 3.1%
Toutes récidives 3.6% 4.7%
Hémorragie majeure 3.9% 1.6%
Déces 3.6% 2.4%
Gallus A. et al. Lancet 1986 ;2(8519):1293-6.
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HNF ou HBPM?
HNF HBPM Odds Ratio
Récidives tt initial 51/3030 74/3030 0.68 [ 0.48, 0.97 ]
Récidives fin de suivi 165/4541 226/4301 0.70 [ 0.57, 0.85 ]
Hémorragies majeures tt initial
44/3860 77/3984 0.58 [ 0.40, 0.83 ]
Mortalité fin de suivi 199/4553 245/4221 0.77 [ 0.63, 0.93 ]
Erkens PMG, Prins MH. Cochrane Database of Systematic Reviews 2010, Issue 9
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Toutes valeurs 2000 2003
N = 675 N = 736
Zone cible 43,0% 46,1%
< 2 25,0% 28,0%
> 3 32,0% 25,9%
Suivi 2000 2003
N = 509 N = 565
Zone cible 44,4% 48,5%
< 2 21,8% 26,7%
> 3 33,8% 24,8%
2 enquêtes,
• 255 labos
(2000)
• 209 labos
(2003)
• 2976 et 2452
patients
Equilibration de l’INR
Source ansm
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Hémorragies sous anticoagulants
• Anticoagulants: 1ers médicaments responsables
d’accidents iatrogènes graves
• AVK: la plus forte incidence d’hospitalisations
pour effets indésirables (12,3%)
• Entre 5000 et 6000 hémorragies mortelles sous
AVK par an
Enquête ENEIS 2, Etude Emir
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Anticoagulants oraux directs
• Voie orale
• Posologie fixe
• Pas de surveillance en routine (dosages possibles)
• C max: 2-4h
• Cible: Xa ou IIa
• Demi-vie: 10-17h
• Elimination: rein: 35-85%
• (Très) Peu d’interactions significatives
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AOD: efficacité: récidives et décès par EP
van Es N. et al. Blood 2014; 124: 1968-75
Combined
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AOD: hémorragies majeures
van Es N. et al. Blood 2014; 124: 1968-75
Combined
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ACCP 2016
In Patients with DVT of the leg or PE and no cancer, as long-term (first 3 months) anticoagulant therapy, we suggest dabigatran, rivaroxaban, apixaban or edoxaban over VKA therapy (all Grade 2B).
Kearon C. et al. Chest 2016; 149 :315-52.
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• 581 patients acute PE
Home treatment for PE; Hestia criteria
Zondag W. et al. J.Thromb Haemost 2011; 9: 1500–1507
• Hospitalization: 243
• Hestia criteria
• Outpatient tt: 297 (51%)
• Yes: 243
• No: 338
3-month outcomes
Recurrent VTE 6 2.0% (0.7–4.3)
Major bleeding 2 0.7% (0.1–2.4)
Death 3 1.0% (0.2–2.9)
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Less is more…..
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Day 2 Day 7 Day 30
R
DOUBLE
BLIND
VKA
Seconra
y O
uto
mes, S
AE
Prim
ary
Outc
om
e, S
econ
dary
Outc
om
es
Confirmed acute
symptomatic PE
Absence of hemodynamic
collapse
Confirmed RV dysfunction +
myocardial injury
UFH infusion
UFH, LMWH or
Fondaparinux
UFH infusion
Tenecteplase
(weight-adapted bolus)
Placebo
VKA UFH
bolus i.v.
<2 h
UFH, LMWH or
Fondaparinux
Pulmonary embolism Thrombolytic Trial
PEITHO Steering Committee. Am Heart J 2012;163:33-38.
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Tenecteplase (n=506)
Placebo (n=499) P value
n (%) n (%)
All-cause mortality or hemodynamic collapse within 7 days of randomization
13 (2.6) 28 (5.6) 0.015
ITT population The PEITHO Investigators
PEITHO: critère de jugement principal
1.00 0
0.23 0.44
2.00 Odds ratio
0.88
The PEITHO investigators. N Engl J Med 2014; 370:1402-11.
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Tenecteplase (n=506)
Placebo (n=499) P value
n (%) n (%)
All-cause mortality within 7 days
6 (1.2) 9 (1.8) 0.43
Hemodynamic collapse within 7 days
8 (1.6) 25 (5.0) 0.002
Critères secondaires d’efficacité
The PEITHO investigators. N Engl J Med 2014; 370:1402-11.
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Tenecteplase (n=506)
Placebo (n=499) P value
n (%) n (%)
Non-intracranial bleeding
Major 32 (6.3) 6 (1.5) <0.001
Minor 165 (32.6) 43 (8.6) <0.001
The PEITHO Investigators
Tolérance
Strokes by day 7 12 (2.4) 1 (0.2) 0.003
Hemorrhagic 10 1
Ischemic 2 0
The PEITHO investigators. N Engl J Med 2014; 370:1402-11.
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« Peut-être le médecin pourrait-il placer
une barrière entre le caillot et le cœur? »
Trousseau A, Phlegmatia alba dolens, Clinique médicale de l'Hôtel-Dieu de Paris, 1868, vol 3, p 670.
Interruption de veine
cave, une vieille idée..
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EP + TVP
Age > 75
Cancer
RVD
IRC ou ICC
TVP
bilatérale
anticoagulant
Retrait du filtre
Essai randomisé multicentrique avec adjudication
indépendante des évènements critiques
6 mois
de suivi ®
Filtre + anticoagulant anticoagulant
3-mois
de suivi
anticoagulant
Filtre retirable et anticoagulants. PREPIC2
Mismetti P. et al. JAMA 2015;313:1627-635
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Filtre retirable et anticoagulants. PREPIC2
Filtre
N = 200
Controle
N = 199
RR
Récidive 3 mo 6 (3%) 3 (1.5%) 2.00 (0.51-7.89)
Récidive 6 mo
7 (3.5%) 4 (2%) 1.75 (0.52-5.88)
Mismetti P. et al. JAMA 2015;313:1627-163
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AOD en prévention secondaire
Agnelli G. et al. N Engl J Med 2013;368: 699-708 Einstein Investigators. N Engl J Med 2010; 363: 2499-510
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Risque de récidive à long-terme
Eichinger S. et al. Circulation 2010; 121: 1630-36
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Le bénéfice est-il maintenu sur le long-terme?
Couturaud F. et al. JAMA. 2015;314(1):31-40
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Thrombophilie biologique
% de malades atteints de MTEV porteurs d’une anomalie
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adjusted HR 1.4 (0.9–2.2).
Risque de récidive et thrombophilie
Christiansen SC, et al. JAMA 2005;293:2352–2361
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Kearon C. et al. Chest 2016; 149 :315-52.
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Variants nucleotidiques associés au risque de TVP
De Haan H. et al. Blood 2012;120:656-663
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Variants nucleotidiques associés au risque de TVP
De Haan H. et al. Blood 2012;120:656-663
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• Primary outcome: confirmed cancer that was missed by the
screening strategy and detected by the end of the 1-year
follow-up period.
Recherche de cancer occulte après MTEV non-provoquée
Carrier M. et al. N Engl J Med 2015;373:697-704.
occult cancer
• limited-screening:
• 14 patients (3.2%; 95% CI, 1.9 to 5.4)
• 4 of 14 occult cancers (29%; 95% CI, 8 to 58) missed by
screening
• limited-screening-plus CT:
• 19 patients (4.5%; 95% CI, 2.9 to 6.9) (P = 0.28)
• 5 of 19 occult cancers (26%; 95% CI, 9 to 51) missed by
screening (p = 1.0)
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TEP vs controle
Robin PY. et al. Lancet Oncol 2015
Cancer à l’issue du bilan initial:
•TEP: 11 (5,6%) patients
•Bilan limité: 4 (2,0%) patients
•Différence: 3,6%, 95% CI: 0,4 - 7,9; p=0,07.
Cancer durant le suivi
•TEP: 1 (0,5%) chez 186 patients
•Bilan limité: 9 (4,7%) chez 193 patients
•Difference: 4,1%, 95% CI 0,8 - 8,4; p=0,01
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Strasbourg
Cannes
Valenciennes
Paris
Brest
Montpellier
St Etienne Grenoble
Nice
Rouen
Lille
Toulouse
Besançon
Clermont
Caen
Nancy
Angers
Agen
Bordeaux
Dijon
Limoges
Lyon
Nantes
Nîmes
Orthez
Roanne
Créteil
Bichat
Vernon
Amiens
Arras
Toulon
Annecy
Langres Le Mans Quimper
Clinical Investigation Centres (12 CIC)
Biological Resource Centre (1)
University Research Units (2)
Clinical sites (56)
Biological and imaging Units
Marseille
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"Ne croyez pas trop à la parole du maître, ne restez pas des écoliers serviles ; allez, voyez, comparez."