Angor Stable: de COURAGE à FAME 2. Maladie coronaire stable et coronarographie en De COURAGE à FAME 2
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1 Maladie coronaire stable et coronarographie en 2013 De COURAGE à FAME 2 Bernard De Bruyne, MD, PhD Cardiovascular Center Aalst OLV-Clinic Aalst, Belgium
2
3 COURAGE Trial Aim To compare optimal medical therapy (OMT) alone to the combination of OMT and PCI in patients with stable coronary artery disease Boden WE et al New Engl J Med 2007,356
4 COURAGE Trial Method Between June 1999 and January 2004 (55 months) 2287 patients (95% with objective signs of ischemia) 50 centers Boden WE et al New Engl J Med 2007,356
5 COURAGE Trial Boden WE et al New Engl J Med 2007,356
6 COURAGE Trial Conclusion Optimal medical therapy should be proposed as initial management strategy for patients with stable CAD
7 β-blocker Use and Clinical Outcomes in Stable Outpatients With and Without Coronary Artery Disease Bangalore S, Steg G et al JAMA 2012,308:1340
8 Available on-line on Aug 28, 2012 on
9 FAME 2 : BACKGROUND FFR No revascularization DEFER 5 years, 2011 FAME 1, 2009 Muller et al, 2011 Hamilos et al, 2010 Puymirat et al, 2012 Revascularization? COURAGE,
10 Flow Chart Stable CAD patients scheduled for 1, 2 or 3 vessel DES-PCI N = 1220 Randomized Trial FFR in all target lesions Registry At least 1 stenosis with FFR 0.80 (n=888) RandomizaBon 1:1 When all FFR > 0.80 (n=332) PCI + MT 73% MT 27% MT 50% randomly assigned to FU Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years
11 Primary Outcomes Cumulative incidence (%) No. at risk MT PCI+MT Registry PCI+MT vs. MT: HR 0.32 ( ); p<0.001 PCI+MT vs. Registry: HR 1.29 ( ); p=0.61 MT vs. Registry: HR 4.32 ( ); p< Months after randomization
12 Death from any Cause Cumulative incidence (%) No. at risk MT PCI+MT Registry PCI+MT vs. MT: HR 0.33 ( ); p=0.31 PCI+MT vs. Registry: HR 1.12 ( ); p=0.54 MT vs. Registry: HR 2.66 ( ); p= Months after randomization
13 Myocardial Infarction Cumulative incidence (%) No. at risk MT PCI+MT Registry PCI+MT vs. MT: MT vs. Registry: HR 1.05 ( ); p=0.89 PCI+MT vs. Registry: HR 1.61 ( ); p=0.41 HR 1.65 ( ); p= Months after randomization
14 Urgent Revascularization Cumulative incidence (%) No. at risk MT PCI+MT Registry PCI+MT vs. MT: MT vs. Registry: HR 0.13 ( ); p<0.001 PCI+MT vs. Registry: HR 0.63 ( ); p=0.43 HR 4.65 ( ); p= Months after randomization
15 Urgent Revascularization Cumulative incidence (%) No. at risk MT PCI+MT Registry PCI+MT vs. MT: MT vs. Registry: HR 0.13 ( ); p<0.001 PCI+MT vs. Registry: HR 0.63 ( ); p=0.43 HR 4.65 ( ); p= Months after randomization De Bruyne B et al NEJM 2012
16 Non-Urgent Revascularisation Cumulative incidence (%) No. at risk OMT PCI+OMT Registry PCI+MT vs. MT: HR 0.17 ( , p<0.0001) PCI+MT vs. Registry: HR 1.28 ( , p=0.76) MT vs. Registry: HR 7.24 ( , p=0.001) Months after randomization De Bruyne B et al NEJM 2012
17 Total Revascularization Cumulative incidence (%) No. at risk OMT PCI+OMT Registry PCI+MT vs. MT: HR 0.14 ( , p<0.0001) PCI+MT vs. Registry: HR 0.84 ( , p<0.0001) MT vs. Registry: HR 5.76 ( , p<0.0001) Months after randomization De Bruyne B et al NEJM 2012
18 Why are these results so different from those of COURAGE, (as patients are supposedly the same)?
19 Proportion of Patients with Documented Myocardial Ischemia in Most Previous Studies (Including COURAGE)
20 In all Studies Comparing two Treatment Strategies All patients (are Supposed to) Have Documented Ischemia MC Morice NEJM 2002 (RAVEL trial) JW Moses NEJM 2003 (Sirius) S. Windecker Lancet 2008 (Leaders) PW Serruys EuroIntervention 2005 (ARTS II) W E Boden NEJM 2007 (COURAGE) BARI-2D
21 Proportion of Patients with Documented Myocardial Ischemia in COURAGE LJ Shaw et al Circulation, 2008
22 Proportion of Patients with Documented Myocardial Ischemia in COURAGE Adapted from LJ Shaw et al Circulation, 2008
23 Importance of Ischemia in Patients Selection COURAGE FAME 2
24 Primary Outcomes Cumulative incidence (%) No. at risk MT PCI+MT Registry MT vs. Registry: HR 4.32 ( ); p< Months after randomization De Bruyne B et al NEJM 2012
25 Inclusion rates COURAGE FAME pt/mo/center 3.4 pt/mo/center
26 Primary Outcomes Biomarkers Cumulative incidence (%) No. at risk MT PCI+MT Registry PCI+MT vs. MT: HR 0.32 ( ); p<0.001 PCI+MT vs. Registry: HR 1.29 ( ); p=0.61 MT vs. Registry: HR 4.32 ( ); p<0.001 Unstable angina only ECG Months after randomization
27 Unstable angina only Patients with urgent revascularization Myocardial Infarction Unstable angina +evidence of ischemia on ECG
28 Unstable angina only Patients with urgent revascularization Myocardial Infarction Unstable angina +evidence of ischemia on ECG
29 Primary Outcomes (with only the urgent revascularizations based on positive biomarkers or EKG changes) Biomarkers Unstable angina only ECG +
30 Urgent Revascularizations based on positive biomarkers or EKG changes) Biomarkers Unstable angina only ECG +
31 Kaplan-Meier plots of Landmark Analysis of Death or MI Cumulative incidence (%) 30 >8 days 7 days: HR 7.99 ( ); p=0.038 > 8 days: HR 0.42 ( ); p=0.053 p-interaction: p=0.003 PCI plus MT MT alone 7 days 0 7days Months after randomization MT alone PCI plus MT
32 Event Rates(%) 20 % Relationship between Stenosis Severity and Clinical Outcome FAME 2: Patients with angiographically significant stenoses and treated with the best available medical therapy 0 FFR > <0.50 PCI Stenosis Severity (FFR)
33 FAME 2 : CONCLUSION FFR No revascularization DEFER 5 years, 2011 FAME 1, 2009 Muller et al, 2011 Hamilos et al, 2010 Puymirat et al, 2012 Revascularization? COURAGE, 2007 FAME 2,
34 Maladie coronaire stable et coronarographie en 2013 De COURAGE à FAME 2 Bernard De Bruyne, MD, PhD Cardiovascular Center Aalst OLV-Clinic Aalst, Belgium
35 Diagnostic Algorithm in patients with (suspected) stable CAD 2005 Bugiardini et al, JAMA, 2005
36 Diagnostic Algorithm in patients with (suspected) stable CAD 2011 Park SJ et al. Circulation 2011;124:951
37 Diagnostic Algorithm in patients with (suspected) stable CAD 2012 Qasem A et al Annals Int Med, 2012,157,729
38 2020?
39 Suspicion de maladie coronaire Anamnèse (+ langage corporel!) 2013? Catheterization + FFR, IMR,... ± ad hoc appropriate treatment
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