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Circulation. 2018 Nov 11; doi: 10.1161/CIRCULATIONAHA.118.038201. Epub 2018 Nov 11.

Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction: Long-Term 6-Year Outcome of the Randomized IABP-SHOCK II Trial.

Circulation

Holger Thiele, Uwe Zeymer, Nathalie Thelemann, Franz-Josef Neumann, Jörg Hausleiter, Mohamed Abdel-Wahab, Roza Meyer-Saraei, Georg Fuernau, Ingo Eitel, Rainer Hambrecht, Michael Böhm, Karl Werdan, Stephan B Felix, Marcus Hennersdorf, Steffen Schneider, Taoufik Ouarrak, Steffen Desch, Suzanne de Waha-Thiele,

Affiliations

  1. University of Leipzig - Heart Center, GERMANY.
  2. Medizinische Klinik B, Klinikum Ludwigshafen, GERMANY.
  3. Medical Clinic II, University Heartcenter Luebeck, GERMANY.
  4. Heart Center, University of Freiburg, GERMANY.
  5. MED I, Klinikum Großhadern, GERMANY.
  6. Cardiology Department, Heart Center Leipzig - University Hospital, GERMANY.
  7. Heart Center Luebeck, GERMANY.
  8. Medical Clinic II (Cardiology, Angiology, Intensive Care Medicine), University Heart Center Lübeck, GERMANY.
  9. Cardiology, Medical Clinic II; University Heart Center Lübeck, GERMANY.
  10. Heart Center Bremen, GERMANY.
  11. Internal Medicine III, Uniklinikum des Saarlandes, GERMANY.
  12. Department of Medicine III, Martin Luther University Halle-Wittenberg, GERMANY.
  13. Internal Medicine B, University of Greifswald, GERMANY.
  14. Dept. of Cardiology, SLK Kiniken Heilbronn, GERMANY.
  15. Institute of Myocardial Infarction Research, GERMANY.
  16. Biometrie, Institut für Herzinfarktforschung, GERMANY.
  17. University Heart Center Lübeck, University of Lübeck, GERMANY.
  18. Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Luebeck, GERMANY.

PMID: 30586721 DOI: 10.1161/CIRCULATIONAHA.118.038201

Abstract

BACKGROUND: The role of intraaortic balloon counterpulsation (IABP) in cardiogenic shock is still a subject of intense debate despite the neutral results of the IABP-SHOCK II trial (Intraaortic Balloon Pump in Cardiogenic Shock II) with subsequent downgrading in international guidelines. So far, randomized data on the impact of IABP on long-term clinical outcomes in patients with cardiogenic shock complicating acute myocardial infarction are lacking. Furthermore, only limited evidence is available on general long-term outcomes of patients with cardiogenic shock treated by contemporary practice.

METHODS: The IABP-SHOCK II trial is a multicenter, randomized, openlabel trial. Between 2009 and 2012, 600 patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization were randomized to IABP versus control.

RESULTS: Long-term follow-up was performed 6.2 years (interquartile range 5.6-6.7) after initial randomization. Follow-up was completed for 591 of 600 patients (98.5%). Mortality was not different between the IABP and the control group (66.3% versus 67.0%; relative risk, 0.99; 95% CI, 0.88-1.11; P=0.98). There were also no differences in recurrent myocardial infarction, stroke, repeat revascularization, or rehospitalization for cardiac reasons (all P>0.05). Survivors' quality of life as assessed by the EuroQol 5D questionnaire and the New York Heart Association class did not differ between groups.

CONCLUSIONS: IABP has no effect on all-cause mortality at 6-year longterm follow-up. Mortality is still very high, with two thirds of patients with cardiogenic shock dying despite contemporary treatment with revascularization therapy.

CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov/. Unique identifier: NCT00491036.

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