MES BONNES INDICATIONS DE FERMETURE APRES UN INFARCTUS CEREBRAL Pr. Jean-Louis MAS Hôpital Sainte-Anne, Paris Université de Paris, INSERM 1266
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
Fermeture du FOP vs Tt antithrombotique Essais randomisés Age (yrs) IS/TIA, onset to rando. FU, mean Stroke recurrence RCT N Comparison mean Characteristics of PFO (years) HR (95%CI), P CLOSURE 1 18 - 60 Crypt. IS or TIA, < 6 mo. PFO closure 1 vs 0.90 (0.41 – 1.98) 909 2 P = 0.79 (2012) 46.0 Unselected PFO antithrombic treatment PFO closure 2 vs PC trial < 60 Crypt. IS, m=4.4 mo. 0.20 (0.02 – 1.72) 414 4.1 P = 0.14 (2013) 44.5 Unselected PFO antithrombic treatment 0.49 (0.22 – 1.11), PFO closure 2 vs RESPECT 18 - 60 Crypt. IS, < 9 mo. P = 0.08 980 2.1 / 5.9 0.55 (0.31 – 0.999) (2013, 2017) 45.9 Unselected PFO antithrombic treatment P = 0.046 Crypt. IS, < 6 mo. PFO closure 3 vs CLOSE 473 16 - 60 0.03 (0.00 – 0.26) PFO + ASA (> 10 mm) 5.3 P < 0.001 (2017) (663) 43.4 antiplatelet treatment or PFO > 30 mb PFO closure 4 vs REDUCE 18 - < 60 Crypt. IS, < 6 mo. 0.23 (0.09 – 0.62) 664 3.4 P = 0.002 (2017) 45.2 Unselected PFO antiplatelet treatment Crypt. IS, < 6 mo. PFO closure 2 vs DEFENSE-PFO 18 - 80 (RR) 0.09 (0.01- 1.61) 120 PFO + ASA 2.8 P = 0.013 (2018) 51.8 antithrombic treatment or PFO >= 2mm
Fermeture du FOP vs Tt antithrombotique Essais randomisés Age (yrs) IS/TIA, onset to rando. FU, mean Stroke recurrence RCT N Comparison mean Characteristics of PFO (years) HR (95%CI), P CLOSURE 1 18 - 60 Crypt. IS or TIA, < 6 mo. PFO closure 1 vs 0.90 (0.41 – 1.98) 909 2 P = 0.79 (2012) 46.0 Unselected PFO antithrombic treatment PFO closure 2 vs PC trial < 60 Crypt. IS, m=4.4 mo. 0.20 (0.02 – 1.72) 414 4.1 P = 0.14 (2013) 44.5 Unselected PFO antithrombic treatment 0.49 (0.22 – 1.11), PFO closure 2 vs RESPECT 18 - 60 Crypt. IS, < 9 mo. P = 0.08 980 2.1 / 5.9 0.55 (0.31 – 0.999) (2013, 2017) 45.9 Unselected PFO antithrombic treatment P = 0.046 Crypt. IS, < 6 mo. PFO closure 3 vs CLOSE 473 16 - 60 0.03 (0.00 – 0.26) PFO + ASA (> 10 mm) 5.3 P < 0.001 (2017) (663) 43.4 antiplatelet treatment or PFO > 30 mb PFO closure 4 vs REDUCE 18 - < 60 Crypt. IS, < 6 mo. 0.23 (0.09 – 0.62) 664 3.4 P = 0.002 (2017) 45.2 Unselected PFO antiplatelet treatment Crypt. IS, < 6 mo. PFO closure 2 vs DEFENSE-PFO 18 - 80 (RR) 0.09 (0.01- 1.61) 120 PFO + ASA 2.8 P = 0.013 (2018) 51.8 antithrombic treatment or PFO >= 2mm
Fermeture du FOP vs Tt antithrombotique Essais randomisés Age (yrs) IS/TIA, onset to rando. FU, mean Stroke recurrence RCT N Comparison mean Characteristics of PFO (years) HR (95%CI), P CLOSURE 1 18 - 60 Crypt. IS or TIA, < 6 mo. PFO closure 1 vs 0.90 (0.41 – 1.98) 909 2 P = 0.79 (2012) 46.0 Unselected PFO antithrombic treatment PFO closure 2 vs PC trial < 60 Crypt. IS, m=4.4 mo. 0.20 (0.02 – 1.72) 414 4.1 P = 0.14 (2013) 44.5 Unselected PFO antithrombic treatment 0.49 (0.22 – 1.11), PFO closure 2 vs RESPECT 18 - 60 Crypt. IS, < 9 mo. P = 0.08 980 2.1 / 5.9 0.55 (0.31 – 0.999) (2013, 2017) 45.9 Unselected PFO antithrombic treatment P = 0.046 Crypt. IS, < 6 mo. PFO closure 3 vs CLOSE 473 16 - 60 0.03 (0.00 – 0.26) PFO + ASA (> 10 mm) 5.3 P < 0.001 (2017) (663) 43.4 antiplatelet treatment or PFO > 30 mb PFO closure 4 vs REDUCE 18 - < 60 Crypt. IS, < 6 mo. 0.23 (0.09 – 0.62) 664 3.4 P = 0.002 (2017) 45.2 Unselected PFO antiplatelet treatment Crypt. IS, < 6 mo. PFO closure 2 vs DEFENSE-PFO 18 - 80 (RR) 0.09 (0.01- 1.61) 120 PFO + ASA 2.8 P = 0.013 (2018) 51.8 antithrombic treatment or PFO >= 2mm 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 Age (yrs) IS/TIA, onset to rando. FU, mean Stroke recurrence RCT N Comparison mean Characteristics of PFO (years) HR (95%CI), P CLOSURE 1 18 - 60 Crypt. IS or TIA, < 6 mo. PFO closure 1 vs 0.90 (0.41 – 1.98) 909 2 P = 0.79 (2012) 46.0 Unselected PFO antithrombic treatment PFO closure 2 vs PC trial < 60 Crypt. IS, m=4.4 mo. 0.20 (0.02 – 1.72) 414 4.1 P = 0.14 (2013) 44.5 Unselected PFO antithrombic treatment 0.49 (0.22 – 1.11), PFO closure 2 vs RESPECT 18 - 60 Crypt. IS, < 9 mo. P = 0.08 980 2.1 / 5.9 0.55 (0.31 – 0.999) (2013, 2017) 45.9 Unselected PFO antithrombic treatment P = 0.046 Crypt. IS, < 6 mo. PFO closure 3 vs CLOSE 473 16 - 60 0.03 (0.00 – 0.26) PFO + ASA (> 10 mm) 5.3 P < 0.001 (2017) (663) 43.4 antiplatelet treatment or PFO > 30 mb PFO closure 4 vs REDUCE 18 - < 60 Crypt. IS, < 6 mo. 0.23 (0.09 – 0.62) 664 3.4 P = 0.002 (2017) 45.2 Unselected PFO antiplatelet treatment Crypt. IS, < 6 mo. PFO closure 2 vs DEFENSE-PFO 18 - 80 (RR) 0.09 (0.01- 1.61) 120 PFO + ASA 2.8 P = 0.013 (2018) 51.8 antithrombic treatment or PFO >= 2mm 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 Méta-analyse des essais randomisés Stroke recurrence Annual risk of stroke recurrence: 0.29 vs 1.27 per 100 person-years Turc et al, JAHA 2018
Fermeture du FOP Risques ● Atrial fibrillation : 5% ● Deaths − RR 4.33, 95% CI, 2.37 – 7.89, P<0.001 − 13 (among 1844 rand. to PFO closure) vs 15 (among 1667 rand. to antithrombotic therapy) ● Other procedure/device-related − RR 0.79, 95% CI, 0.39 – 1.60, P=0.51 complications : 2.9% ● Major bleeding − Vascular access site complications − 34 (among 1820 rand. to PFO closure) vs − Thrombus formation on the device 28 (among 1583 rand. to antithrombotic therapy) − Cardiac perforation, tamponade − RR 0.97, 95% CI, 0.43 – 2.20, P=0.94 − Device dislocation − Air embolism ● Serious adverse events − Stroke − No difference between PFO closure and medical − … treatment Turc et al, JAHA 2018
Fermeture du FOP Quels patients en bénéficient le plus? CLOSE RESPECT HR, 0.55 (0.31 to 0.999) HR, 0.03 (0 to 0.26) P = 0.046 P < 0.001 DEFENSE-PFO REDUCE HR, 0.23 (0.09 to 0.62) P = 0.002 P = 0.013 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? RESPECT Patients with substantial shunt or ASA Patients with no substantial shunt nor ASA Saver et al (unpublished data)
Fermeture du FOP Quels patients en bénéficient le plus? Stroke recurrence Turc et al, JAHA 2018
Fermeture du FOP FOP+ASA versus FOP seul CLOSE 1 PFO-ASA study 2 PFO with large shunt only 5/161 (3.1%) PFO and ASA 9/74 (12.1%) 1. Mas et al, NEJM 2017, 2. NEJM 2001
Quid des anticoagulants oraux? CLOSE Oral anticoagulants vs PFO closure vs Antiplatelet therapy Oral anticoagulants PFO closure Oral anticoagulants Oral anticoagulants Antiplatelet therapy Oral anticoagulants (n = 180) Oral anticoagulants (n = 187) PFO closure (n = 173) Antiplatelet therapy (n = 174) HR = 0.14 (95% CI, 0.00 - 1.45); P = 0.08 HR = 0.43 (95% CI, 0.1 - 1.45); P = 0.17
Quid des anticoagulants oraux? Combined Kaplan-Meier curves of individual patient time-to-event data, Combined Kaplan-Meier curves of individual participant data in the included trials, by type of intervention for the outcome ischaemic stroke by type on intervention for the outcome ischemic stroke CLOSE, PC, RESPECT, REDUCE CLOSE PC, RESPECT CLOSE, REDUCE Mir et al, BMJ Open 2018
Consensus d’experts PFO device closure 1 plus long-term antiplatelet therapy is recommended over long-term antithrombotic therapy alone provided all the following criteria are met : – Age 18 to 60 years 2 – Recent (<= 6 months 3 ) (non lacunar) embolic ischemic stroke – PFO associated with an ASA (> 10 mm) or PFO > 20 microbubbles 4 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 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 Stroke Clues for Paradox. Emb. Patient ● Concurrent VTE ● Atrial septal aneurysm ● Embolic infarct ● Age ● Recent immobility ● Large shunt/PFO ● Other cause of stroke ● Burden of stroke risk (accountability) factors ● Hypercoagulable state ● Chiari’s network ● Prior stroke, on APT/OAC ● RoPE score ● Valsalva at stroke onset ● Eustachian valve
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