Intraaortic Balloon Pump in Cardiogenic Shock II - IABP-SHOCK II

Dec 03, 2018
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
German Research Foundation, German Heart Research Foundation, German Cardiac Society, University of Leipzig – Heart Center, Maquet Cardiopulmonary AG, and Teleflex Medical
Date Presented:
01/01/2012
Date Published:
11/11/2018
Date Updated:
12/03/2018
Original Posted Date:
08/27/2012
References

Contribution To Literature:

The IABP-SHOCK II trial failed to show that mechanical support with IABP improved outcomes in AMI with cardiogenic shock.


Description:

The goal of the trial was to evaluate treatment with intra-aortic balloon counterpulsation (IABP) compared with no IABP among patients with acute myocardial infarction (AMI) and cardiogenic shock.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patient Populations:

  • Patients with AMI complicated by cardiogenic shock and early planned revascularization
  • Definition of cardiogenic shock:
    - Systolic blood pressure <90 mm Hg for at least 30 minutes or the need for catecholamine infusion to support systolic blood pressure >90 mm Hg and
    - Pulmonary congestion and
    - Impaired end-organ perfusion (altered mental status, cold/clamming skin/extremities, oliguria with urine output <30 cc/hour, or serum lactate >2 mmol/L)

    Number of screened applicants: 790
    Number of enrollees: 600
    Duration of follow-up: 30 days
    Median patient age: 70 years 
    Percentage female: 33%
    Mean ejection fraction: 35%

Exclusions:

  • >30 minutes of resuscitation
  • No intrinsic heart action
  • Coma with fixed dilated pupils
  • Mechanical cause of cardiogenic shock or alternative cause of shock
  • Massive pulmonary embolism
  • Severe peripheral arterial disease
  • At least moderate aortic regurgitation
  • Age >90 years
  • Life expectancy <6 months

Primary Endpoints:

  • All-cause mortality at 30 days

Secondary Endpoints:

  • Major bleeding
  • Peripheral ischemic complications
  • Sepsis
  • Stroke

Drug/Procedures Used:

Patients with AMI and cardiogenic shock were randomized to IABP (n = 301) versus no IABP (n = 299). All patients received early revascularization and best available medical therapy.

IABP was placed immediately before or after percutaneous coronary intervention (PCI).

Principal Findings:

Overall, 600 patients were randomized. The median age was 70 years, 33% were women, 35% had diabetes, 24% had prior myocardial infarction, 32% had a qualifying non-ST-elevation MI, 42% had been resuscitated before randomization, median left ventricular ejection fraction was 35%, median blood pressure as 89/55 mm Hg, 96% received primary PCI (42% with drug-eluting stents), 30% received immediate PCI of nonculprit vessels, 3.5% underwent immediate bypass surgery, 5.5% received a ventricular assist device, and median duration of IABP support was 3 days.

At 30 days, all-cause mortality had occurred in 39.7% of the IABP group versus 41.3% of the no IABP group (p = 0.69). There was no difference in subgroups, except for patients with no prior MI where there was relatively more benefit than among patients with prior MI.

  • Reinfarction in hospital: 3.0% versus 1.3% (p = 0.16)
  • Stent thrombosis in hospital: 1.3% versus 1.0% (p = 0.71)
  • Major bleeding: 3.3% versus 4.4% (p = 0.51)
  • Peripheral ischemic complications requiring intervention: 4.3% versus 3.4% (p = 0.53)
  • Sepsis: 15.7% versus 20.5% (p = 0.15)
  • Stroke: 0.7% versus 1.7% (p = 0.28)
  • Serum lactate and renal function: remained similar between the groups

Results at 6 years:

  • All-cause mortality at 6 years: 66.3% with IABP versus 67.0% with no IABP (p = 0.98)
  • Stroke at 6 years: 1.0% with IABP versus 6.2% with no IABP (p = 0.06)

Interpretation:

Among patients with AMI and cardiogenic shock, the use of IABP did not reduce early or late mortality. This was also true among patients who received IABP support immediately prior to PCI. Overall mortality was slightly lower than expected, which could have contributed to the null finding. Also, the hemodynamic improvement from IABP may be too modest to affect mortality. It is unknown if a stronger mechanical support device such as Impella would have resulted in different outcomes.

Despite no benefit on the primary outcome, there were no important safety concerns from the use of IABP. This multicenter study downgraded the use of IABP in AMI complicated by cardiogenic shock (Class III in European guidelines and Class IIb in United States guidelines).

References:

Thiele H, Zeymer U, Thelemann N, et al., on behalf of the IABP-SHOCK II Trial (Intraaortic Balloon Pump in Cardiogenic Shock II) Investigators. Intraaortic Balloon Pump in Cardiogenic Shock Complicating Acute Myocardial Infarction: Long-Term 6-Year Outcome of the Randomized IABP-SHOCK II Trial. Circulation 2018;Nov 11:[Epub ahead of print].

Thiele H, Zeymer U, Neumann FJ, et al., on behalf of the IABP-SHOCK II Trial Investigators. Intraaortic Balloon Support for Myocardial Infarction With Cardiogenic Shock. N Engl J Med 2012;367:1287-96.

Presented by Dr. Holger Thiele at the European Society of Cardiology Congress, Munich, August 27, 2012.

Keywords: Myocardial Infarction, Stroke, Drug-Eluting Stents, Heart-Assist Devices, Catecholamines, Blood Pressure, Cold Temperature, Oliguria, Percutaneous Coronary Intervention, Lactates, Shock, Cardiogenic, Thrombosis, Stroke Volume, Intra-Aortic Balloon Pumping, Diabetes Mellitus


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