Disclosures. The FAST-MI registry is a registry of the French Society of Cardiology, supported by unrestricted grants from:

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1 Impact on early complications of non-compliance with guidelines-recommended timelines for reperfusion therapy in STEMI patients. The FAST-MI 2010 registry E. Puymirat 1, L. Lorgis 2, P. Coste 3, S. Charpentier 4, G. Lemesle 5, E. Durand 1, D. Pateron 6, V. Bataille 4, T. Simon 7, N. Danchin 1 for the FAST-MI investigators (1) AP-HP - European Hospital Georges Pompidou, Paris, France (2) University Hospital Center - Hospital of Bocage, Dijon, France (3) University Hospital of Bordeaux - Hospital Haut Leveque, Pessac, France (4) University Hospital of Toulouse-Rangueil Hospital, Toulouse, France (5) Hospital Regional University of Lille, France (7) AP-HP - Hospital Saint-Antoine, Faculty of Medicine Pierre & Marie Curie Paris 6, Paris, France

2 Disclosures The FAST-MI registry is a registry of the French Society of Cardiology, supported by unrestricted grants from: Merck, the Eli-Lilly-Daiichi-Sankyo alliance, AstraZeneca, sanofi-aventis, GSK, Novartis Dr Puymirat: no disclosures

3 Background In STEMI patients, the ESC 2008 guidelines recommend primary PCI as the preferred mode of reperfusion therapy Primary PCI, however, is judged suitable only if the time from qualifying ECG to PCI (T-ECG-PCI) is <90 minutes for patients with symptom onset <120 minutes, and <120 minutes when symptom onset is > 120 minutes. Likewise fibrinolysis should be administered <30 minutes from ECG (T-ECG-lysis).

4 Study purpose To assess in-hospital outcomes and 30-day mortality in patients with fibrinolysis or primary PCI (PPCI) according to whether the recommended timelines for reperfusion therapy were met.

5 FAST-MI: population and methods Nationwide French study in patients admitted to CCU/ICUs with recent AMI in October-December 2010 Inclusion of all consecutive adult patients with acute myocardial infarctions (STEMI and NSTEMI) with symptom onset 48 hours : Inclusion of consecutive patients over 1 month for all centers Prolongation of up to one additional month in 132 centers 213 centers; 4169 patients

6 FAST-MI: population and methods All type of institutions: academic teaching hospitals, community and regional hospitals, private clinics (for profit and not-for-profit) and army hospitals. Collaboration with the SAMU for recording prehospital data One physician in charge at each institution. Data collected on e-crf with immediate queries generation by independent clinical study technicians/nurses Baseline demographic, social, clinical data; prehospital and in-hospital management. All medications administered recorded. Biology collection in larger centers (DNA, RNA, serum) Ten-year follow-up centralised at the French Society of Cardiology.

7 FAST-MI centres Inclusion from October patients included 3079 patients included during the first month

8 Patients 4169 patients 2235 with STEMI 1740 (78%) had reperfusion therapy 1611 (93%) with time from onset to call and time from ECG to reperfusion available Definition of appropriate timelines: Primary PCI: T-ECG-PCI <90 min if onset <120 min or <120 min if time from onset >120 min Fibrinolysis: T-ECG- lysis 30 min

9 Proportion of patients meeting recommended timelines Fibrinolysis Primary PCI Median time (min): 21 [12; 37] 109 [78; 178]

10 Proportion of patients meeting recommended timelines by time from onset to diagnostic ECG (intended primary PCI) Time to ECG <120 minutes 62 Time to ECG 120 minutes

11 P (timing OK vs off limits): * <0.05; **<0.01 Baseline characteristics according to timing of reperfusion PPCI within GL (n=552) PPCI off GL (n=742) Lysis within GL (n=216) Lysis off GL (n=101) Age (years) 61.8 ± ± ± ± 12.1 Sex (% F) * Hypertension Diabetes Hypercholesterolemia Current smoking ** Family Hx No CHD Hx Hx of stroke/tia Hx of PAD ** Typical chest pain ** Cardiac arrest Anterior MI

12 P (timing OK vs off limits): * <0.05; **<0.01 Early management according to timing of reperfusion PPCI within GL (n=552) PPCI off GL (n=742) Lysis within GL (n=216) Lysis off GL (n=101) Aspirin Clopidogrel *** Prasugrel GP IIb-IIIa inhibitors * LMWH Statins Beta-blockers ACE-I/ARB Diuretics Nitrates ** Inotropes **

13 FAST-MI 2010 Meeting the ESC requirements of the guidelines influences survival 3,5 3 2,5 2 1,5 1 0,5 0 Percent in-hospital mortality Adjusted P=0.01 OR: 3.40 ( ) P=0.02 1,2 Time ECG to PPCI/lysis within GL 3,0 Time ECG to PPCI/lysis off GL

14 FAST-MI 2010 Meeting ESC requirements is a correlate of lower mortality both for PPCI and fibrinolytic-treated patients 3,5 3 2,5 2 1,5 1 0,5 0 1,1 Time ECG to PPCI within GL Percent in-hospital mortality 3,0 Time ECG to PPCI off GL 1,4 Time ECG to lysis within GL 3,0 Time to lysis off GL

15 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 timelines 3.12 ( ) 0.03

16 Other in-hospital complications Within GL Off GL times 10,510,4 5 2,6 3,6 4, ,7 Recurrent MI 0,5 1,1 Stent thrombosis VF AF Any bleed or transfusion

17 Conclusion Less than 60% of the patients with primary PCI had their angiography performed within recommended timelines. Just above two thirds of lytic-treated patients received fibrinolysis within recommended timelines. Timely administration of reperfusion is an independent correlate of improved early survival. When meeting the ESC guidelines for PPCI seems unlikely, timely administration of fibrinolysis should be considered.

18 Acknowledgements FAST-MI is a registry of the French Society of Cardiology Supported by: We are indebted to: The patients who accepted to participate in the surveys All companies having provided urestricted grants for the studies: Merck, the Daiichi-Sankyo/Eli-Lilly alliance, GSK, Sanofi-aventis, Novartis All clinicians involved in the studies All the devoted personnel involved at the Société Française de Cardiologie, and URCEST, AP-HP, Hôpital St Antoine.

19 Special thanks to: Tabassome Simon, PI for the biology programme Jean Ferrières and Vincent Bataille, epidemiology and data management Geneviève Mulak, general organisation, SFC Elodie Drouet, URCEST and SFC Benoit Pace, Eric Schultz, CRF design and data management, SFC Frédérique Fortin, secretarial assistance, SFC

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