University of Leipzig Heart Center

Transcription

1 Randomized comparison of intraaortic balloon counterpulsation versus optimal medical therapy in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock Holger Thiele, MD Uwe Zeymer, MD; Franz-Josef Neumann, MD; Miroslaw Ferenc, MD; Hans-Georg Olbrich, MD; Jörg Hausleiter, MD; Gert Richardt, MD; Marcus Hennersdorf, MD; Klaus Empen, MD; Georg Fuernau, MD; Steffen Desch, MD; Ingo Eitel, MD; Rainer Hambrecht, MD; Jörg Fuhrmann, MD; Michael Böhm, MD; Henning Ebelt, MD; Steffen Schneider, PhD; Gerhard Schuler, MD; Karl Werdan, MD on behalf of the IABP-SHOCK II Trial Investigators University of Leipzig Heart Center

2 Disclosures Funding: German Research Foundation German Heart Research Foundation German Cardiac Society Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte University of Leipzig Heart Center Unrestricted grant by: Maquet Cardiopulmonary AG, Hirrlingen, Germany Teleflex Medical, Everett, MA, USA Potential Conflict of Interest: Research Funding: Terumo, Lilly, Maquet Cardiovascular, Teleflex Medical Consulting: Maquet Cardiovascular, Lilly Speaker Honoraria: Lilly, Astra Zeneca, Daiichi Sankyo, Boehringer Ingelheim, Maquet Cardiovascular, Medicines Company

3 Background IABP in Cardiogenic Shock History: 1962 Animal studies Moulopoulos et al. Am Heart J 1962;63: First clinical description in shock Kantrowitz et al. JAMA 1968;203: Hemodynamic effects in shock, Mortality unchanged Scheidt et al. NEJM 1973;288: > 40 years > 1 Million patients treated, low complication rate, Benchmark registry Ferguson et al. JACC 2001;38:

4 Background Guidelines Van de Werf et al. Eur Heart J 2008;29: Wijns et al. Eur Heart J 2010;31: Antman et al. Circulation 2004;110: IABP in AMI complicated by cardiogenic shock ESC Class IC ACC/AHA Class IB

5 Background Mortality IABP vs no IABP - Metaanalysis Trial IABP n/n No IABP n/n 30-day mortality Risk difference No reperfusion Moloupoulos 24/34 15/15 Overall 24/34 15/ (-0.47 to -0.12) Thrombolysis Stomel 28/51 10/13 Kovack 10/27 13/19 Bengtson Waksman 48/99 11/20 58/101 17/21 GUSTO-1 SHOCK registry 30/62 220/ / /417 NRMI-2 TT 1068/ /3501 Overall 1415/ / (-0.20 to -0.16) Primary PCI NRMI-2 PCI AMC CS 956/ / /955 26/93 Overall 1049/ / (0.03 to 0.10) Overall 2488/ / (-0.13 to -0.09) IABP better No IABP better Sjauw et al. Eur Heart J 2009;30:

6 Methods Study Sites and Organisation DSMB: Kurt Huber Ferenc Follath Bernhard Maisch Johannes Haerting Steering committee: Holger Thiele Karl Werdan Uwe Zeymer Gerhard Schuler Support + Patronage:

7 Results Trial Flow and Treatment 790 patients with AMI and cardiogenic shock screened 600 randomized 190 excluded because of exclusion criteria - 60 no informed consent - 47 resuscitation >30 minutes - 19 shock duration >12 hours - 18 severe peripheral artery disease - 14 participation in another trial - 13 no intrinsic heart activity - 9 mechanical complication - 3 shock of other cause - 3 comorbidity with life expectancy <6 months - 2 severe cerebral deficit - 2 age >90 years 301 randomized to IABP 288 received IABP 13 did not receive IABP - 10 died before IABP insertion - 3 protocol violation (2 not suitable for revascularization, 1 serious kinking) Allocation 299 randomized to control 269 received control therapy 30 cross-over to IABP (22 first day, 8 day 1-8) - 4 mechanical complications - 25 protocol violation - 1 unknown reason 301 intended early revascularization 287 primary PCI 3 primary CABG 11 no revascularization - 3 not suitable for revascularization - 4 coronary artery disease with no identifiable culprit lesion - 4 no coronary artery disease Revascularization 299 intended early revascularization 288 primary PCI 3 primary CABG 8 no revascularization - 1 not suitable for revascularization - 2 coronary artery disease with no identifiable culprit lesion - 5 no coronary artery disease 300 with 30-day follow-up - 1 lost to follow-up 300 primary endpoint analysis Follow-up Primary endpoint analysis 298 with 30-day follow-up - 1 withdrew informed consent 298 primary endpoint analysis

8 Results Primary Study Endpoint (30-Day Mortality) Mortality (%) Control IABP 41.3% 39.7% P=0.92 by log-rank test Relative risk 0.96; 95% CI ; P=0.69 by Chi 2 -Test Time after Randomization (Days)

9 Results Subgroups (30-Day Mortality) Baseline Variable N 30-Day Mortality (%) IABP Control Relative Risk (95% CI) P-Value for Interaction Female Male ( ) 0.92 ( ) 0.61 Age <50 years Age years Age >75 years ( ) 0.95 ( ) 1.07 ( ) 0.09 Diabetes No diabetes ( ) 0.96 ( ) 0.82 Hypertension No hypertension ( ) 0.67 ( ) 0.05 STEMI/LBBB NSTEMI ( ) 0.98 ( ) 0.76 Anterior STEMI Non-anterior STEMI ( ) 1.16 ( ) 0.14 Previous infarction No previous infarction ( ) 0.86 ( ) 0.04 Hypothermia No hypothermia ( ) 0.89 ( ) 0.31 Blood pressure <80 mmhg Blood pressure 80 mmhg ( ) 0.92 ( ) IABP better Control better

10 Summary + Conclusions IABP support in cardiogenic shock is safe without significant inherent complications. However, IABP support did not reduce 30-day mortality in this large, randomized, multicenter trial in cardiogenic shock patients complicating myocardial infarction undergoing early revascularization. The primary study endpoint results are supported by a lack of benefit in secondary endpoints.

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