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
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
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).
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.
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
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.
FAST-MI 2010 213 centres Inclusion from October 2010 4169 patients included 3079 patients included during the first month
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
Proportion of patients meeting recommended timelines 100 90 80 70 60 50 40 30 20 10 0 68 57 Fibrinolysis Primary PCI Median time (min): 21 [12; 37] 109 [78; 178]
Proportion of patients meeting recommended timelines by time from onset to diagnostic ECG (intended primary PCI) 100 80 60 40 20 0 53 Time to ECG <120 minutes 62 Time to ECG 120 minutes
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 ± 13.2 62.0 ± 14.0 57.7 ± 12.9 60.9 ± 12.1 Sex (% F) * 22 25.5 18 18 Hypertension 43 44 39 46.5 Diabetes 12 14 10 13 Hypercholesterolemia 36 41 38 36 Current smoking ** 47 42.5 58 44 Family Hx 27 28 27 34 No CHD Hx 85 86 91 92 Hx of stroke/tia 3.3 3.1 0.9 0 Hx of PAD ** 2.4 6.1 2.8 2.0 Typical chest pain ** 91.5 85 95 94 Cardiac arrest 1.4 2.2 1.4 2 Anterior MI 40 43 35 42
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 98 98 98 94 Clopidogrel *** 61 73 80 83 Prasugrel 47 40 32 32 GP IIb-IIIa inhibitors * 60 58 13 16 LMWH 59 60 74 74 Statins 94 93 96 94 Beta-blockers 84 84 86 78 ACE-I/ARB 69 65 66 56 Diuretics 22 20 15 14 Nitrates ** 39 48 35 54.5 Inotropes ** 3.1 5.5 1.4 4.0
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 (1.19-9.69) P=0.02 1,2 Time ECG to PPCI/lysis within GL 3,0 Time ECG to PPCI/lysis off GL
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
Correlates of in-hospital mortality OR (95% CI) P Value Age 1.07 (1.03-1.11) 0.001 Admission Killip 2 3.03 (1.17-7.86) <0.001 Admission SBP 0.98 (0.96-0.99) <0.001 Reperfusion off timelines 3.12 (1.10-8.85) 0.03
Other in-hospital complications 15 10 Within GL Off GL times 10,510,4 5 2,6 3,6 4,3 5 0 1 0,7 Recurrent MI 0,5 1,1 Stent thrombosis VF AF Any bleed or transfusion
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.
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.
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