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Dr. Jan Jacob Piek,
Prof. Holger Thiele
Presenter abstractDiscussant reportAll the Scientific resources on ESC Congress 365
By Holger ThieleOther authors: Prof. Dr. Uwe Zeymer, MD; Prof. Dr. Franz-Josef Neumann, MD; Dr. Miroslaw Ferenc, MD; Prof. Dr. Hans-Georg Olbrich, MD; Prof. Dr. Jörg Hausleiter, MD; Prof. Dr. Gert Richardt, MD; Prof. Dr. Marcus Hennersdorf, MD; Dr. Klaus Empen, MD; Dr. Georg Fuernau, MD; Dr. Steffen Desch, MD; Dr. Ingo Eitel, MD; Prof. Dr. Rainer Hambrecht, MD; Prof. Dr. Bernward Lauer, MD; Prof. Dr. Michael Böhm, MD; Dr. Henning Ebelt, MD; Dr. Steffen Schneider, PhD; Prof. Dr. Karl Werdan, MD; Prof. Dr. Gerhard Schuler, MD; on behalf of the Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) Trial Investigators; All investigators in GermanyBackground:In the IABP-SHOCK II trial, IABP support did not result in a 30-day mortality benefit in comparison to optimal medical therapy in patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization. However, some previous trials in cardiogenic shock showed a mortality benefit at longer follow-up. Therefore, a longer follow-up is warranted and predefined according to the IABP-SHOCK II protocol.
Methods:In this randomized, prospective, open-label, multicenter trial 600 patients with cardiogenic shock complicating acute myocardial infarction were randomized to either IABP (n=301) versus control (n=299) on the background of early revascularization by mainly PCI or alternatively bypass surgery and optimal medical therapy. The primary efficacy endpoint was 30-day all-cause mortality, but also 12-month follow-up was performed in addition to quality-of-life assessment for all survivors using the Euroqol-5D questionnaire.
Results:At the time of abstract submission 590 (98.3%) of the 600 patients had 12-month follow-up data available. Preliminary data indicate that at 12-month follow-up 157 patients (52.7%) in the IABP group and 151 patients (51.7%) in the control group had died (relative risk 1.02; 95% confidence interval 0.87 to 1.19; P=0.81). For all survivors the quality-of-life was not different between the study groups for all the components of quality-of-life assessment.The final study results including complete 12-month follow-up, quality-of-life scores as well as clinical and laboratory predictors of mortality will be available during the time of presentation at the European Society of Cardiology annual meeting. This trial is registered under www.clinicaltrials.gov: NCT00491036 and the study design as well as 30-day results have been published recently.(1, 2)Conclusions:The 12-month follow-up data support that IABP did not significantly reduce mortality in patients with cardiogenic shock complicating acute myocardial infarction with an early revascularization strategy. For cardiogenic shock survivors the quality-of-life is good.
Jan Jacob Piek
Discussant IABP-SHOCK II; 12 month results: Prof. Dr. Jan J. Piek
Mortality in cardiogenic shock (CS) continues to be associated with high mortality (40-50%)(3). The intra-aortic balloon pump (IABP), introduced in 1968, is the most widely used mechanical assist device in the cathaterization laboratory and was thought to improve outcome in CS. Primarily based on two previously reported meta-analyses and acknowledging the conflicting evidence from registries, the AHA-ACC and ESC guidelines recently downgraded the recommendations for IABP therapy in acute myocardial infarction (AMI) complicated by CS from respectively IB and IC (‘should be used’) to IIa B and IIb B (‘can/may be used’) (4-6).
Previous ESC congress, Thiele et al. reported the 30-day outcomes of the multi-center IABP-SHOCK II trial that randomized 600 patients with AMI complicated by CS and treated with early revascularization, to either IABP therapy or routine care(2). There were no differences in the primary efficacy endpoint of 30-day mortality (IABP group 39.7%, no IABP group 41.3%; p=0.69) and safety endpoints.
Thiele et al. now present the 12-month results. There was no difference in 12-month mortality between both groups (IABP group 51.8%, no IABP group 51.4%; p=0.91) and there were no meaningful differences in the subgroup analyses. Importantly, no divergence in the mortality curves was observed, as was seen with the long-term results of the SHOCK trial(7). Furthermore there were no significant differences between groups in the frequency of re-infarction, stroke, functional class or quality of life indices. Being in concordance with the aforementioned meta-analyses, the IABP-SHOCK II trial endorses the downgraded recommendations for IABP therapy in AMI complicated by CS. Most important, this successfully conducted large-scale trial should be an encouragement for further research, since mortality in CS is still unacceptably high.
1. Thiele H, Schuler G, Neumann F-J, et al. Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock: Design and rationale of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial. Am Heart J 2012;163:938-45.2. Thiele H, Zeymer U, Neumann F-J, et al. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med 2012;367:1287-96.
3. Goldberg RJ, Spencer FA, Gore JM, Lessard D, Yarzebski J. Circulation 2009; 119(9):1211-9. Thirty-year trends (1975 to 2005) in the magnitude of, management of, and hospital death rates associated with cardiogenic shock in patients with acute myocardial infarction: a population-based perspective.
4. Sjauw KD, Engstrom AE, Vis MM, van der Schaaf RJ, Baan J, Jr., Koch KT, et al. A systematic review and meta-analysis of intra aortic balloon pump therapy in ST-elevation myocardial infarction: should we change the guidelines? Eur Heart J.2009;30:459-68.
5. O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127(4):e362-425.
6. Steg PG, James SK, Atar D, Badano LP, Blömstrom-Lundqvist C, Borger MA, et al. Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC). ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation Eur Heart J. 2012;33(20):2569-619.
7. Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, et al. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK investigators. Should we emergently revascularize occluded coronaries for cardiogenic shock. N Engl J Med. 1999;341:625–34.
IABP-SHOCK II: Intraaortic Balloon Support for Myocardial Infarction with Cardiogenic Shock
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