La fibrinolyse est- elle sous- u1lisée en France?
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1 La fibrinolyse est- elle sous- u1lisée en France? Nicolas DANCHIN, HEGP, Paris Research grants: Astra- Zeneca, Eli- Lilly, GSK, Merck, Novar1s, Pfizer, sanofi- aven1s, Servier, The MedCo Fees for lectures and/or consul1ng: Amgen, Astra- Zeneca, Bayer, BMS, Boehringer- Ingelheim, GSK, Eli- Lilly, MSD- Schering, Novo- Nordisk, Pfizer, Pierre Fabre, Roche, sanofi- aven1s, Servier, The MedCo Past chairman of the CNAM Scien4fic Advisory Commi9ee
2 Evolu1on des traitements de reperfusion en France : % des patients PCI primaire Fibrinolyse Pas de reperfusion PCI précoce : 9.9% 24% 58% 55% PCI après lyse: 15% 60% 84% 87%
3 MINAP data: Dras1c change in type of reperfusion therapy MINAP 11 th report No change in % with no reperfusion Rx
4 RIKS- HIA : reperfusion therapy PPCI Thrombolysis Jernberg et al. JAMA 2011
5 Evolu1on de la mortalité à 30 jours en fonc1on de l u1lisa1on des traitements de reperfusion 20 18, ,3 10, ,7 8,2 8,7 6,4 6,3 4,5 4,7 2,1 3,2 0 Pas de reperfusion Lyse PCI primaire OR ajusté (2010 vs 1995) % CI, OR ajusté (2010 vs 1995) % CI, OR ajusté (2010 vs 1995) % CI,
6 Evolu1on de la mortalité à 30 jours en fonc1on de l u1lisa1on des traitements de reperfusion ,2 8,7 6,4 6,3 4,5 4,7 2,1 3,2 0 Lyse OR ajusté (2010 vs 1995) % CI, PCI primaire OR ajusté (2010 vs 1995) % CI,
7 Pourquoi envisager une fibrinolyse? La stratégie pharmaco- invasive Importance des délais de reperfusion
8 Risque élevé de récidive ischémique et de récidive d'infarctus après traitement fibrinoly1que u1lisé isolément Keeley, Boura & Grines. Lancet 2003 On- site lysis vs transfer for emergent PCI
9 Time is muscle: Impact of Rx delay on 35- day mortality afer fibrinolysis for STEMI Absolute benefit per 1,000 treated patients p < Boersma. Lancet 1996 Treatment delay (h)
10 Theore1cal rela1onship between the dura1on of symptoms of AMI before reperfusion therapy, mortality reduc1on, and extent of myocardial damage Mortality reduc4on % D C Extent of myocardial salvage B A Shi[s in poten4al outcomes with different treatment strategies A to B No benefit A to C Benefit B to C Benefit D to B Harm D to C Harm Time from symptom onset to reperfusion therapy (hrs) Cri4cal 4me- dependent period. Goal: myocardial salvage Time- independent period. Goal: open infarct- related artery Gersh BJ. JAMA 2005;293:
11 Aborted MI: Pre- Hospital lysis vs In- Hospital lysis pa1ents with PHT 266 pa1ents with IHT P< PHT IHT Lamfers et al. Am J Cardiol 1998
12 Les données françaises : angioplas1e primaire
13 FAST- MI 2010: one- year mortality according to 1me from onset to ppci 10 6,9 5,6 5 3, >360 GRACE score
14 FASY- MI 2010: propor1on of pa1ents mee1ng recommended 1melines Defini4on of appropriate 4melines: Primary PCI: T- ECG- PCI <90 min if onset <120 min or <120 min if 1me from onset >120 min Fibrinolysis: T- ECG- lysis 30 min Fibrinolysis Primary PCI Median 1me (min): 21 [12; 37] 109 [78; 178] 57
15 Propor1on of pa1ents mee1ng recommended 1melines by 1me from onset to diagnos1c ECG (intended primary PCI) Time to ECG <120 minutes 62 Time to ECG 120 minutes
16 FAST- MI 2010 : % with primary PCI 60 min from ECG No Yes P< ,9 13,3 11,1 9,5 P< ,5 5 1,8 0 SAMU first Call < 120 min Cath lab on site
17 FAST- MI 2010: Mee1ng guidelines requirements for primary PCI influences survival Median 4me from ECG to PCI: 110 min [78; 185] Only 55% met the recommended 4melines ,1 % in- hospital death Adjusted OR: 2.92 ( ) P=0.02 3,5 0 Time ECG to PPCI within GL Time ECG to PPCI > GL
18 Correlates of in- hospital mortality OR (95% CI) P Value Age 1.07 ( ) Admission Killip ( ) <0.001 Admission SBP 0.98 ( ) <0.001 Reperfusion off 4melines 3.12 ( ) 0.03
19 CathPCI registry : Evolu1on of D2B 1me and mortality Menees et al. NEJM 2013
20 CathPCI registry : Recommended D2B Ame and mortality Menees et al. NEJM 2013
21 FAST- MI 2010 Correlates of one- year death: impact of call- to- balloon 1me according to 1me from onset Call- to- ppci 4me >120 minutes versus 120 minutes: - If symptom onset- to- call 60 minutes - If symptom onset- to- call minutes - If symptom onset- to- call >180 minutes Hazard ra4o (95% confidence interval) 2.69 ( ) 1.57 ( ) 1.22 ( ) P value Cox mul1variate analysis NEJM 2014
22 Impact of 1me from onset on prognos1c impact of prehospital medica1ons Time onset to call 60 minutes % mortality ,4 2,9 2,3 5,9 6 5,7 1,8 1,9 Time onset to call > 60 minutes % mortality Lysis + - Any antiplatelet DAPT 2,72,8 3,0 3,0 2,5 2,4 Heparins 4,8 2,6 N. Danchin, personal data on file 0 Lysis Any antiplatelet DAPT Heparins
23 PCI vs Lysis: Importance of Time Data from NRMI 2, 3 and 4 Registries 2.0 Odds of Death with Fibrinolysis PCI Be9er Fibrinolysis Be9er PCI Related D elay (D B- D N) (min) Pinto et al. Circula(on 2006
24 How to choose between PPCI and lysis. Data from NRMI 2, 3 and 4 PCI Related Delay (DB- DN) Where PCI and Fibrinoly4c Mortality Are Equal (Min) NonAnt MI 65+ YRS Ant MI 65+ YRS NonAnt MI <65 YRS Ant MI <65 YRS Pinto et al. Circula1on, 2006 Prehospital Delay (min)
25 Steg et al. EHJ 2012 ESC 2012 STEMI guidelines
26 La comparaison stratégie pharmaco- invasive vs ppci
27 STREAM trial: PROTOCOL STEMI <3 hrs from onset symptoms, PPCI <60 min not possible, 2 mm ST-elevation in 2 leads RANDOMIZATION 1:1 by IVRS, OPEN LABEL Strategy A: pharmaco-invasive Strategy B: primary PCI Ambulance/ER <75y:full dose Aspirin Clopidogrel: LD 300 mg + 75 mg QD Enoxaparin: 30 mg IV + 1 mg/kg SC Q12h 75y: ½ dose TNK * Aspirin Clopidogrel: 75 mg QD Enoxaparin: 0.75 mg/kg SC Q12h no lytic Antiplatelet and antithrombin treatment according to local standards PCI Hospital ECG at 90 min: ST resolution 50% YES angio >6 to 24 hrs PCI/CABG if indicated NO immediate angio + rescue PCI if indicated Standard primary PCI Primary endpoint: composite of all cause death or shock or CHF or reinfarction up to day 30 Armstrong et al. NEJM 2013 * AKer 20% of the planned recruitment, the TNK dose was reduced by 50% among paaents 75 years of age.
28 STREAM: PRIMARY ENDPOINT TNK vs PPCI Rela1ve Risk 0.86, 95%CI ( ) Dth/Shock/CHF/ReMI (%) PPCI 14.3% TNK 12.4% p=0.24
29 FAST- MI 2005: Five- year survival according to reperfusion strategy Adjusted HR [95% CI] (reference no reperfusion) - Primary PCI: 0.57 [ ] - IV fibrinolysis: 0.48 [ ] Adjusted HR [95% CI] (reference ppci) - PH fibrinolysis: 0.57 [ ] - IH fibrinolysis: 1.19 [ ] Adjusted HR [95% CI] fibrinolysis vs ppci 0.73 [ ] STREAM- like cohort LVEF 53 ± 12 vs 51 ± 13 Danchin et al. Circula1on 2014, in press
30 FAST- MI 2010 IV lysis Primary PCI No reperfusion Rx Crude HR (lysis vs primary PCI): 0.69 ( ) GRACE score- adjusted HR: 1.14 ( )
31 FAST- MI 2010: one- year death according to type of reperfusion therapy Hazard Ra1o (95% CI) (pharma- invasive vs late ppci) ppci within GL 1melines ppci off GL 1melines Pharmaco- invasive strategy Crude HR: 0.52 ( ) Adjusted HR: 0.91 ( )
32 FAST- MI 2010: one- year survival 10 P=0.02 7,4 Timely ppci ppci off GL P=0.69 6,9 8 5 Fibrinolysis 5,3 2,9 3,6 0 Onset to call 4h Onset to call > 4 h Adjusted HR: 0.81 ( )
33 FAST- MI 2010 U1lisa1on des 2 méthodes de reperfusion selon la durée des symptômes ppci within GL 1melines 34,4 8,3 16,9 1,4 9,5 29,6 ppci beyond GL 1melines Lysis 4 h Lysis >4h ppci off GL 4h ppci off GL >4h ppci GL 4h ppci GL >4h 46 % des pa4ents ayant appelé avant 4 heures et traités par ppci ont un geste "tardif"
34 Conclusion Le délai de réalisa1on de l'angioplas1e primaire, une fois le diagnos1c posé, compte d'autant plus que l'appel a été précoce. Près d'un pa1ent sur deux ayant appelé dans les 4 premières heures et traités par ppci ont le geste effectué au- delà des délais recommandés. Chez ces pa1ents, la fibrinolyse u1lisée dans le cadre d'une stratégie pharmaco- invasive fait au moins jeu égal avec l'angioplas1e. C'est dans ce}e popula1on (30% de l'ensemble des pa1ents reperfusés) que la fibrinolyse pourrait être proposée.
35 STROKE RATES Pharmaco- invasive PPCI P- value TOTAL POPULATION (N=1892) Total stroke 15/939 (1.60%) 5/946 (0.53%) 0.03 fatal stroke 7/939 (0.75%) 4/946 (0.42%) 0.39 Haemorrhagic stroke 9/939 (0.96%) 2/946 (0.21%) 0.04 fatal haemorrhagic stroke 6/939 (0.64%) 2/946 (0.21%) 0.18 POST AMENDMENT POPULATION (N=1503) Total stroke 9/747 (1.20%) 5/756 (0.66%) 0.30 fatal stroke 3/747 (0.40%) 4/756 (0.53%) >0.999 Haemorrhagic stroke 4/747 (0.54%) 2/756 (0.26%) 0.45 fatal haemorrhagic stroke 2/747 (0.27%) 2/756 (0.26%) >0.999
36 SINGLE ENDPOINTS UP TO 30 DAYS Pharmaco- invasive PPCI P- value (N=944) (N=948) All cause death (43/939) 4.6% (42/946) 4.4% 0.88 Cardiac death (31/939) 3.3% (32/946) 3.4% 0.92 Conges4ve heart failure (57/939) 6.1% (72/943) 7.6% 0.18 Cardiogenic shock (41/939) 4.4% (56/944) 5.9% 0.13 Reinfarc4on (23/938) 2.5% (21/944) 2.2% 0.74
37 MINAP Myocardial Ischaemia Na1onal Audit Project Mandatory par1cipa1on of all centres in England, Wales, and Belfast Focused on organisa1on and quality of care Annual publica1on of MINAP reports with data from individual centres
38 MINAP: Thirty- day mortality
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