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IABP-SHOCK II: Randomized comparison of intraaortic balloon counterpulsation versus optimal medical therapy in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock

See the press release:
Munich, Germany – August 27 2012: A balloon pump inserted in the aorta is currently the most widely used support device in the treatment of cardiogenic shock and, since its introduction in 1968, has been used in several million people. However, there is still only limited evidence that the intraaortic balloon pump (IABP), one of the oldest medical devices in cardiology, is actually beneficial for the patient. Only a few registry studies and clinical trials have shown that the IABP can improve blood pressure and the perfusion of the coronary arteries...
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Acute Coronary Syndromes (ACS)


Presenter | see Discussant report

Access to the congress content withESC Congress 365

Holger Thiele

List of Authors: 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

Abstract:

Background
In current international guidelines intraaortic balloon pumping (IABP) is considered a class 1 indication in cardiogenic shock complicating acute myocardial infarction. However, evidence is mainly based on retrospective or prospective registries with a lack of randomized clinical trials.
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 percutaneous coronary intervention or bypass surgery and optimal medical therapy. The primary efficacy endpoint was 30-day all-cause mortality. Safety was assessed by major bleeding, peripheral ischemic complications, sepsis and stroke.
Results
At 30 days 119 patients (39.7%) in the IABP group and 123 patients (41.3%) in the control group had died (relative risk 0.96; 95% confidence interval 0.79 to 1.17; P=0.69). There were also no differences in secondary study endpoints such as time to hemodynamic stabilization, length of intensive care unit stay, serum lactate levels, catecholamine doses and duration, and renal function. Major bleeding rates (3.3% versus 4.4%; P=0.51), peripheral ischemic complications (4.3% versus 3.4%; P=0.53), sepsis (15.7% versus 20.5%; P=0.15), and stroke rates (0.7% versus 1.7%; P=0.28) were unaffected by IABP compared to control.
Conclusions
IABP did not significantly reduce 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarction with an early revascularization strategy.

Discussant | see Presenter abstract

Access to the congress content with ESC Congress 365

UC Hoppe

Report:

Mortality rates remain high in myocardial infarction complicated by cardiogenic shock. The ACC/AHA[1] and ESC[2]  STEMI guidelines list intra-aortic balloon pump (IABP) therapy in cardiogenic shock as a class IB and IC recommendation, respectively. Given the lack of randomized trials, so far any recommendation for adjunctive IABP treatment in STEMI with cardiogenic shock was based on pathophysiological considerations and expert opinion only. The IABP improves peak diastolic pressure and coronary blood flow, and reduces end-systolic pressure, afterload and myocardial oxygen consumption, while however only modestly affecting cardiac output. In the fibrinolytic era there is some evidence for a potential benefit of IABP therapy on clinical outcome[3 - 4], and a small randomized pilot study showed reduced BNP levels in infarct patients with cardiogenic shock treated by primary PCI with additional IABP.[5]  However, cohort studies of the GUSTO 1  trial[6]  and NRMI 2[7]  indicated no or even negative effects of IABP therapy on survival in patients undergoing early revascularization in cardiogenic shock, thus challenging current guidelines.
The authors of the IABP SHOCK II trial are congratulated on assessing the impact of adjunctive IABP therapy versus optimal medical treatment alone in the first multicenter, randomized trial in 600 patients with an intention of early revascularization for acute myocardial infarction complicated by cardiogenic shock. Patient characteristics were well balanced between groups. Approximately 30% of patients were referred with NSTEMI. More than 95% underwent primary PCI, with stent implantation in 90%. IABP treatment did not affect renal function, had no impact on serum lactate as a marker for microcirculation, and did not prevent/ attenuate CRP increase as a parameter of inflammatory reactions (SIRS). Consistently, the primary study endpoint of 30-day mortality did not differ between groups (39.7% vs. 41.3%, p=0.92). Only in the subgroup of young patients <50 years, IABP use appeared to be beneficial, which will have to be confirmed in a further prospective study. IABP therapy was not associated with any significant increase of adverse events such as bleeding, stroke or sepsis.
The study was well designed and performed. A cross-over of 10% to IABP therapy and more frequent use of LVADs (7.4% vs. 3.7%) in control patients might to some extent have influenced the results. Moreover, timing of IABP implantation, which has not yet been analyzed, might have had an impact on the outcome of the study. Given that the SHOCK trial[8]  was also negative at 30 days and only became positive after 6 and 12 months, further follow-up of the IABP SHOCK II trial, which is a predefined secondary endpoint, will be of interest.
In conclusion, improved hemodynamic status alone, previously shown for IABP support, is not a surrogate marker for survival in myocardial infarction complicated by cardiogenic shock. The neutral effect of IABP use on outcome in the present study might in part be due to the fact that unlike fibrinolysis, PCI/ stenting are treatment modalities which do not rely on coronary perfusion pressure to establish patency, but might also underscore the more complex pathophysiology of cardiogenic shock. Thus, remaining high mortality rates in cardiogenic shock are unlikely caused by an “underuse” of IABP therapy. Conversely, results of the IABP SHOCK II trial do not support general IABP implantation in patients undergoing primary revascularization for myocardial infarction complicated by cardiogenic shock. The present study rather suggests that guidelines might need to be reconsidered, particularly, if 6- and 12-month data will confirm the neutral effect of IABP treatment observed for the 30-day outcome. 
References
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5. Prondzinsky R, Lemm H, Swyter M, Wegener N, Unverzagt S, Carter JM, Russ M, Schlitt A, Buerke U, Christoph A, Schmidt H, Winkler M, Thiery J, Werdan K, Buerke M. Intra-aortic balloon counterpulsation in patients with acute myocardial infarction complicated by cardiogenic shock: the prospective, randomized IABP SHOCK Trial for attenuation of multiorgan dysfunction syndrome.
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6. Berger PB, Holmes DR, Jr., Stebbins AL, Bates ER, Califf RM, Topol EJ. Impact of an aggressive invasive catheterization and revascularization strategy on mortality in patients with cardiogenic shock in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO-I) trial. An observational study.
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References


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SessionTitle:

Hot Line II: Late Breaking Trials on Interventions

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.