Pr. Jean-Louis MAS Hpital Sainte-Anne, Paris Universit de Paris, - - PowerPoint PPT Presentation

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Pr. Jean-Louis MAS Hpital Sainte-Anne, Paris Universit de Paris, - - PowerPoint PPT Presentation

Feb 27, 2024 189 likes •391 views

MES BONNES INDICATIONS DE FERMETURE APRES UN INFARCTUS CEREBRAL Pr. Jean-Louis MAS Hpital Sainte-Anne, Paris Universit de Paris, INSERM 1266 DCLARATION DE LIENS D'INTRT AVEC LA PRSENTATION Speaker's name : Jean-Louis MAS, Paris

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SLIDE 1

MES BONNES INDICATIONS DE FERMETURE APRES UN INFARCTUS CEREBRAL

  • Pr. Jean-Louis MAS

Hôpital Sainte-Anne, Paris Université de Paris, INSERM 1266

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SLIDE 2

DÉCLARATION DE LIENS D'INTÉRÊT AVEC LA PRÉSENTATION

Speaker's name : Jean-Louis MAS, Paris ☑ Je n'ai pas de lien d'intérêt potentiel à déclarer

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SLIDE 3

RCT N Age (yrs) mean IS/TIA, onset to rando. Characteristics of PFO Comparison FU, mean (years) Stroke recurrence HR (95%CI), P CLOSURE 1 (2012) 909 18 - 60 46.0

  • Crypt. IS or TIA, < 6 mo.

Unselected PFO PFO closure1 vs antithrombic treatment 2 0.90 (0.41 – 1.98) P = 0.79 PC trial (2013) 414 < 60 44.5

  • Crypt. IS, m=4.4 mo.

Unselected PFO PFO closure2 vs antithrombic treatment 4.1 0.20 (0.02 – 1.72) P = 0.14 RESPECT (2013, 2017) 980 18 - 60 45.9

  • Crypt. IS, < 9 mo.

Unselected PFO PFO closure2 vs antithrombic treatment 2.1 / 5.9 0.49 (0.22 – 1.11), P = 0.08 0.55 (0.31 – 0.999) P = 0.046 CLOSE (2017) 473 (663) 16 - 60 43.4

  • Crypt. IS, < 6 mo.

PFO + ASA (> 10 mm)

  • r PFO > 30 mb

PFO closure3 vs antiplatelet treatment 5.3 0.03 (0.00 – 0.26) P < 0.001 REDUCE (2017) 664 18 - < 60 45.2

  • Crypt. IS, < 6 mo.

Unselected PFO PFO closure4 vs antiplatelet treatment 3.4 0.23 (0.09 – 0.62) P = 0.002 DEFENSE-PFO (2018) 120 18 - 80 51.8

  • Crypt. IS, < 6 mo.

PFO + ASA

  • r PFO >= 2mm

PFO closure2 vs antithrombic treatment 2.8 (RR) 0.09 (0.01- 1.61) P = 0.013

Fermeture du FOP vs Tt antithrombotique

Essais randomisés

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SLIDE 4

RCT N Age (yrs) mean IS/TIA, onset to rando. Characteristics of PFO Comparison FU, mean (years) Stroke recurrence HR (95%CI), P CLOSURE 1 (2012) 909 18 - 60 46.0

  • Crypt. IS or TIA, < 6 mo.

Unselected PFO PFO closure1 vs antithrombic treatment 2 0.90 (0.41 – 1.98) P = 0.79 PC trial (2013) 414 < 60 44.5

  • Crypt. IS, m=4.4 mo.

Unselected PFO PFO closure2 vs antithrombic treatment 4.1 0.20 (0.02 – 1.72) P = 0.14 RESPECT (2013, 2017) 980 18 - 60 45.9

  • Crypt. IS, < 9 mo.

Unselected PFO PFO closure2 vs antithrombic treatment 2.1 / 5.9 0.49 (0.22 – 1.11), P = 0.08 0.55 (0.31 – 0.999) P = 0.046 CLOSE (2017) 473 (663) 16 - 60 43.4

  • Crypt. IS, < 6 mo.

PFO + ASA (> 10 mm)

  • r PFO > 30 mb

PFO closure3 vs antiplatelet treatment 5.3 0.03 (0.00 – 0.26) P < 0.001 REDUCE (2017) 664 18 - < 60 45.2

  • Crypt. IS, < 6 mo.

Unselected PFO PFO closure4 vs antiplatelet treatment 3.4 0.23 (0.09 – 0.62) P = 0.002 DEFENSE-PFO (2018) 120 18 - 80 51.8

  • Crypt. IS, < 6 mo.

PFO + ASA

  • r PFO >= 2mm

PFO closure2 vs antithrombic treatment 2.8 (RR) 0.09 (0.01- 1.61) P = 0.013

Fermeture du FOP vs Tt antithrombotique

Essais randomisés

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SLIDE 5

RCT N Age (yrs) mean IS/TIA, onset to rando. Characteristics of PFO Comparison FU, mean (years) Stroke recurrence HR (95%CI), P CLOSURE 1 (2012) 909 18 - 60 46.0

  • Crypt. IS or TIA, < 6 mo.

Unselected PFO PFO closure1 vs antithrombic treatment 2 0.90 (0.41 – 1.98) P = 0.79 PC trial (2013) 414 < 60 44.5

  • Crypt. IS, m=4.4 mo.

Unselected PFO PFO closure2 vs antithrombic treatment 4.1 0.20 (0.02 – 1.72) P = 0.14 RESPECT (2013, 2017) 980 18 - 60 45.9

  • Crypt. IS, < 9 mo.

Unselected PFO PFO closure2 vs antithrombic treatment 2.1 / 5.9 0.49 (0.22 – 1.11), P = 0.08 0.55 (0.31 – 0.999) P = 0.046 CLOSE (2017) 473 (663) 16 - 60 43.4

  • Crypt. IS, < 6 mo.

PFO + ASA (> 10 mm)

  • r PFO > 30 mb

PFO closure3 vs antiplatelet treatment 5.3 0.03 (0.00 – 0.26) P < 0.001 REDUCE (2017) 664 18 - < 60 45.2

  • Crypt. IS, < 6 mo.

Unselected PFO PFO closure4 vs antiplatelet treatment 3.4 0.23 (0.09 – 0.62) P = 0.002 DEFENSE-PFO (2018) 120 18 - 80 51.8

  • Crypt. IS, < 6 mo.

PFO + ASA

  • r PFO >= 2mm

PFO closure2 vs antithrombic treatment 2.8 (RR) 0.09 (0.01- 1.61) P = 0.013

  • 1. STARFlex Septal Closure System; 2. Amplatzer PFO Occluder; 3. multiple devices; 4. Helex Septal or Cardioform Septal Occluder

Fermeture du FOP vs Tt antithrombotique

Essais randomisés

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SLIDE 6

RCT N Age (yrs) mean IS/TIA, onset to rando. Characteristics of PFO Comparison FU, mean (years) Stroke recurrence HR (95%CI), P CLOSURE 1 (2012) 909 18 - 60 46.0

  • Crypt. IS or TIA, < 6 mo.

Unselected PFO PFO closure1 vs antithrombic treatment 2 0.90 (0.41 – 1.98) P = 0.79 PC trial (2013) 414 < 60 44.5

  • Crypt. IS, m=4.4 mo.

Unselected PFO PFO closure2 vs antithrombic treatment 4.1 0.20 (0.02 – 1.72) P = 0.14 RESPECT (2013, 2017) 980 18 - 60 45.9

  • Crypt. IS, < 9 mo.

Unselected PFO PFO closure2 vs antithrombic treatment 2.1 / 5.9 0.49 (0.22 – 1.11), P = 0.08 0.55 (0.31 – 0.999) P = 0.046 CLOSE (2017) 473 (663) 16 - 60 43.4

  • Crypt. IS, < 6 mo.

PFO + ASA (> 10 mm)

  • r PFO > 30 mb

PFO closure3 vs antiplatelet treatment 5.3 0.03 (0.00 – 0.26) P < 0.001 REDUCE (2017) 664 18 - < 60 45.2

  • Crypt. IS, < 6 mo.

Unselected PFO PFO closure4 vs antiplatelet treatment 3.4 0.23 (0.09 – 0.62) P = 0.002 DEFENSE-PFO (2018) 120 18 - 80 51.8

  • Crypt. IS, < 6 mo.

PFO + ASA

  • r PFO >= 2mm

PFO closure2 vs antithrombic treatment 2.8 (RR) 0.09 (0.01- 1.61) P = 0.013

  • 1. STARFlex Septal Closure System; 2. Amplatzer PFO Occluder; 3. multiple devices; 4. Helex Septal or Cardioform Septal Occluder

Fermeture du FOP vs Tt antithrombotique

Essais randomisés

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SLIDE 7

Annual risk of stroke recurrence: 0.29 vs 1.27 per 100 person-years

Stroke recurrence Turc et al, JAHA 2018

Fermeture du FOP vs Tt antithrombotique

Méta-analyse des essais randomisés

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SLIDE 8
  • Atrial fibrillation : 5%

−

RR 4.33, 95% CI, 2.37–7.89, P<0.001

  • Other procedure/device-related

complications : 2.9%

−

Vascular access site complications

−

Thrombus formation on the device

−

Cardiac perforation, tamponade

−

Device dislocation

−

Air embolism

−

Stroke

−

…

Fermeture du FOP

Risques

  • Deaths

−

13 (among 1844 rand. to PFO closure) vs 15 (among 1667 rand. to antithrombotic therapy)

−

RR 0.79, 95% CI, 0.39–1.60, P=0.51

  • Major bleeding

−

34 (among 1820 rand. to PFO closure) vs 28 (among 1583 rand. to antithrombotic therapy)

−

RR 0.97, 95% CI, 0.43–2.20, P=0.94

  • Serious adverse events

−

No difference between PFO closure and medical treatment Turc et al, JAHA 2018

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SLIDE 9

CLOSE

HR, 0.03 (0 to 0.26) P < 0.001

DEFENSE-PFO

P = 0.013

RESPECT

HR, 0.55 (0.31 to 0.999) P = 0.046

REDUCE

HR, 0.23 (0.09 to 0.62) P = 0.002 Mas et al, N Eng J Med 2017; Saver et al, N Eng J Med 2017; Lee et al, JACC 2018; Kasner et al, N Eng J Med 2017

Fermeture du FOP

Quels patients en bénéficient le plus?

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SLIDE 10

Saver et al (unpublished data)

Patients with substantial shunt or ASA Patients with no substantial shunt nor ASA

RESPECT

Fermeture du FOP

Quels patients en bénéficient le plus?

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SLIDE 11

Stroke recurrence

Turc et al, JAHA 2018

Fermeture du FOP

Quels patients en bénéficient le plus?

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SLIDE 12

PFO with large shunt only 5/161 (3.1%) PFO and ASA 9/74 (12.1%)

CLOSE1

  • 1. Mas et al, NEJM 2017, 2. NEJM 2001

PFO-ASA study2

Fermeture du FOP

FOP+ASA versus FOP seul

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SLIDE 13

Oral anticoagulants vs Antiplatelet therapy

HR = 0.43 (95% CI, 0.1 - 1.45); P = 0.17 Oral anticoagulants (n = 187) Antiplatelet therapy (n = 174) Oral anticoagulants Antiplatelet therapy

PFO closure vs Oral anticoagulants

HR = 0.14 (95% CI, 0.00 - 1.45); P = 0.08 Oral anticoagulants (n = 180) PFO closure (n = 173) Oral anticoagulants PFO closure

CLOSE

Quid des anticoagulants oraux?

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SLIDE 14

Mir et al, BMJ Open 2018

Combined Kaplan-Meier curves of individual participant data in the included trials, by type of intervention for the outcome ischaemic stroke

Combined Kaplan-Meier curves of individual patient time-to-event data, by type on intervention for the outcome ischemic stroke

CLOSE, REDUCE PC, RESPECT CLOSE CLOSE, PC, RESPECT, REDUCE

Quid des anticoagulants oraux?

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SLIDE 15

PFO device closure1 plus long-term antiplatelet therapy is recommended over long-term antithrombotic therapy alone provided all the following criteria are met :

– Age 18 to 60 years2 – Recent (<= 6 months3) (non lacunar) embolic ischemic stroke – PFO associated with an ASA (> 10 mm) or PFO > 20 microbubbles4 or >= 2 mm – PFO is felt to be the most likely cause of the stroke following a thorough etiological evaluation by a stroke specialist

  • 1. Transcatheter PFO closure has be performed in a centre with expertise in structural interventional as soon as the

patient’s condition allows it.

  • 2. The DEFENSE-PFO trial enrolled 120 patients 18 to 80 years old. About 75% of patients were less than 60 years and

mean age was 51.8 ans.

  • 3. This delay will be extended if a prolonged recording of the heart rhythm is necessary.
  • 4. Definition of a large shunt varied according to the trials : > 20, 25 or 30 microbubbles

Consensus d’experts

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SLIDE 16

In patients with PFO-associated ischemic stroke who do not meet all of the above criteria, the decision to close the PFO must take into account the following arguments to assess the probability of a causal relationship between PFO and the patient’s cerebral ischemic event

PFO

  • Atrial septal aneurysm
  • Large shunt/PFO
  • Chiari’s network
  • Eustachian valve

Stroke

  • Embolic infarct
  • Other cause of stroke

(accountability)

  • Prior stroke, on APT/OAC

Patient

  • Age
  • Burden of stroke risk

factors

  • RoPE score

Clues for Paradox. Emb.

  • Concurrent VTE
  • Recent immobility
  • Hypercoagulable state
  • Valsalva at stroke onset

Consensus d’experts

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SLIDE 17
  • Oral anticoagulants

– Contra-indication to PFO closure or patient refusal – Life-long anticoagulation indicated for another reason (e.g. venous thrombo- embolism) – Prevention of early stroke recurrence before PFO closure

  • Antiplatelet therapy

– Dual antiplatelet therapy (aspirin 75mg/ and clopidogrel 75 mg/j) for 1 to 6 months after PFO closure, followed by single antiplatelet therapy for at least 5 years (?) – No indication for PFO closure or oral anticoagulation

Consensus d’experts

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SLIDE 18
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SLIDE 19

Merci de votre attention