Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary. London 27/1/2005

Transcription

1 Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary AB London 27/1/2005

2 Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins AB Tony s Comments 15mins

3 ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS AB

4 ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose ESC München 2004

5 Inclusion criteria Design Anginal symptoms at rest < 24 hours Troponin T concentration 0.03 ng/l And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression 0.05 mv Transient ST-segment elevation T-wave changes 0.2 mv in two contiguous leads ESC München 2004

6 Study design Design Selective invasive Refractory angina Medical Rx CAG / PCI / CABG + ETT - NSTE-ACS Trop T pos Aspirin Enoxaparin Clopidogrel Statins Death, MI, or ACS Early invasive CAG Medical Rx Chest pain - 24 hrs Random. 0 hrs PCI / CABG hrs 1 year Abciximab during all PCI procedures ESC München 2004

7 Statistics Design 1 o endpoint: Death, MI*, Rehospitalization for ACS Power: Sample size: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power 2 x 600 patients *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN ESC München 2004

8 Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20 th 2004), 98% complete ESC München 2004

9 Revascularization over time Results 100% 80% Early invasive Selective invasive 73% 60% 47% 40% Highest Angio/Revascularisation Rate 20% Early invasive: 97% CAG Time (days) Selective invasive: 67% CAG ESC München 2004

10 Death, MI, Rehospitalization for ACS Results 30% Early invasive Selective invasive 21.7% 20% 20.4% 10% Relative Risk: % CI: P = Time (days) ESC München 2004

11 Events at one year Results Early invasive (%) Selective invasive (%) Relative Risk P-value Death New or recurrent MI Rehosp. for ACS Primary endpoint No difference in Angina ESC München 2004

12 Conclusion 1. An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS 2. Use of active risk stratification, and liberal use of coronary angiography is a good treatment option 3. The treadmill is back! AB

13 MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy AB

14 MERLIN Is rescue angioplasty worth it? Mark de Belder The James Cook University Hospital Middlesbrough

15 Inclusion Criteria MERLIN METHODS STEMI and evidence of failure to reperfuse Presentation to hospital within 10 hours of symptoms Failure to reperfuse at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50%

16 Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months

17 MERLIN Results: 30 days % 30 P=0.3 % 50 p= P= P=0.7 P=0.3 P= p= Primary endpoint 0 Death ReMI Stroke Unplanned revasc Composite secondary endpoint CCF Transfusions Rescue N:154 Conservative N: % Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44: Rescue 1.3 Conservative

18 MERLIN Results in the elderly MERLIN: 30 day deaths % Cons Rescue 0 < >75

19 30 day Kaplan-Meier survival curve % 100 p= Rescue Conservative Days

20 30 day Kaplan-Meier event free survival % 100 curve Rescue 75 Conservative p= Days

21 MERLIN 1yr event free survival 100 p=0.005 Conservative Rescue Days

22 MERLIN 1yr survival 100 Conservative Rescue Days

23 Conclusion 1. No early mortality benefit 2. Less urgent revascularisations 3. At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG AB

24 REACT Comparison of Rescue angioplasty, repeat thrombolysis and conservative treatment for failed thrombolysis AB

25 Steering Committee Data & Safety Kim Fox J. Birkhead M. Bland All Investigators Dr I Squire Dr I Hudson Dr N Uren Dr A de Belder Dr J Davis Dr M Pitt Dr F Alamgir Dr A Banning David de Bono Dr A Baumbach Dr MF Shiu Dr B Vallance Dr P Schofield Dr K Dawkins Prof P Weissberg Dr R Henderson Dr W Penny A.H.Gershlick (PI) M de Belder H Swanton R.Wilcox K Abrams Dr D Smith Dr E Leatham Dr M Malekian Dr M Millar-Craig Dr S Redwood Dr S Odemuyiwa Dr P Walker Dr E Lee Trial Co-Ordinators/ Monitors Sarah Hughes Amanda Stephens-Lloyd Independent Statistician Suzanne Stevens/ Alan Skene End Point Committee J.Hampton S Davies Dr M.Norell Dr K Oldroyd Dr D O'Neill Dr N Curzen Dr S Hood Dr D Hackett Dr C Lawson Dr H Swanton Dr R Foale

26 REACT (REscue Angioplasty v Conservative treatment or repeat Thrombolysis) ECG 90 min post (any) thrombolytic ST < 50 % resolution (with or without pain) CONSENT & RANDOMISE (IF PCI possible within 12hrs of CP) Conservative 2 nd thrombolytic Coronary Angio 24 iv heparin Acelerated tpa or +/- PCI Reteplase P. End point: 6/12 ~death/re-infarction/cva / severe HF

27 RESULTS n=427 R -LYSIS (n=142) CONS (n=141) R-PCI (n=144) Age 61.3 (10.3) y 61.0 (10.7) y 61.1 (11.9) y Overall Anterior infarct 38.0% 46.8% 42.7% 42.5% FIRST LYTIC rpa 30.3% 19.9% 29.2% 26.5% SK 57.7% 62.4% 58.3% 59.5% TNK 1.4% 3.5% 2.1% 2.3% tpa 10.6% 14.2% 10.4% 11.7% Stents 68.5% GP IIb/IIIa 43.4%

28 6 Months RESULTS Primary composite endpoint: Death and non-fatal re-ami, CVA, Severe HF p = Gr A N=142 R-LYSIS 44 (31.0%) Gr B N=141 Conservative 42 (29.8%) Gr C N=144 R-PCI 22 (15.3%) p= 0.78 p = 0.002

29 RESULTS 6 months R-PCI 84.6% (ci 78.7%-90.5%) Conserv 70.1% (ci 62.5%-77.7%) R-Lysis 68.7% (ci 61.1%-76.4%) Rank log p=0.004

30 Mortality at 6 months R-PCI 93.8% (ci 89.8%-97.7%) Conserv 87.2% (ci 81.7%-92.7%) R-Lysis 87.3% (ci 81.9%-92.8%) p=0.13

31 Hierarchical Analysis at 6 Months Re-Lysis (A) Conservative (B) R-PCI (C) Death 12.7 (10.6) 12.8 (9.9) 6.3(5.6) Re AMI A v B v C p=0.007 B v C p=0.06 CVA Severe HF

32 % MAJOR 22/27 Bleeding Outcomes MINOR (82%) ( > 3g/dl) ( 2g/dl -3 g/dl) sheath OVERT Bld No OVERT Bld OVERT Bld No OVERT Bld 20 < /9 (100%) sheath Fatal Bleeding complications 6.2 Rescue: 0ns Conservative: 3 Repeat 3.5 Thrombolysis: Lysis C RPCI Lysis C RPCI Lysis C RPCI Lysis C RPCI

33 Conclusion 1. REACT shows a clear benefit of rescue angioplasty for failed thrombolysis 2. Comparison with MERLIN will be important 3. Forget Re-thrombolysis! AB