A Systematic Review and Metaanalysis of the Value of Intraaortic Balloon Pump Therapy in Patients wi

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A Systematic Review and Meta-analysis of the
Value of Intra-aortic Balloon Pump Therapy in
Patients with STEMI.
Should we change the guidelines?
Sjauw KD, Engström AE, Vis MM, van der Schaaf RJ,
Baan Jr J, Koch KT, de Winter RJ, Piek JJ,
Tijssen JG, Henriques JPS

• Dr. José P.S. Henriques
• Head of Cath-lab

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Disclosures or conflict of interest

• KD Sjauw none
• AE Engström none
• MM Vis none
• RJ van der Schaaf none
• J Baan Jr none
• KT Koch none
• RJ de Winter none
• JJ Piek none
• JGP Tijssen none
• JPS Henriques none

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Incidence in Cardiogenic Shock
AMC
AMC
1997-2005
Goldberg et al. NEJM 1999
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Hospital Mortality
Primary PCI ? IABP?
Thrombolysis era
pre-Thrombolysis
Goldberg et al. NEJM 1999 Hochman et al. NEJM
1999
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SHOCK Trial
Early intervention vs. Conservative medical
management
30-day Mortality 44.0 vs 53.3
Hochman et al. NEJM 1999
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Intra Aortic Balloon Counterpulsation

• Hemodynamic stabilization
• ? cardiac index ? and early diastolic
  pressure ?
• diastolic blood flow augmentation in the coronary
  and systemic circulation
• systolic reduction in afterload and aortic
  impedance
• LV recovery / infarct size reduction
• peak left ventricular wall stress ?
• myocardial oxygen consumption ?

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IABP in daily clinical practice
Stone GW et al. JACC 2003
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The Guidelines
IABP in STEMI complicated by cardiogenic shock
Class 1B
ACC/AHA
Strongly recommended
ESC
Antman et al. Circulation 2004 / van de Werf et
al. EHJ 2002
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Limited body of evidence

• IABP vs. No IABP
• Only a few RCTs in the setting of STEMI
• No RCTs in the setting of STEMI with CS
• Guidelines only based on non-randomized studies

Meta-analysis of RCTs of IABP in
STEMI Meta-analysis of cohort studies of IABP in
STEMI with CS
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Search Strategy Meta-analysis
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Methods

• Primary efficacy endpoint for both meta-analysis
  was 30-day mortality
• Secondary endpoints for the meta-analysis of RCTs
  in STEMI
• LVEF at follow up
• Major bleeding and stroke rates
• Outcomes were combined with the Mantel-Haenzel or
  inverse variance fixed-effect models.
• Study was performed in compliance with the
  Quality of Reporting of Meta-analysis (QUOROM)
  guidelines

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Meta-analysis of RCTs of IABP in STEMI
7 RCTs High Risk STEMI
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IABP vs Control in HR-STEMI 30-day mortality
Randomized controlled trials
Sjauw KD, Tijssen JG, Henriques JP et al.
submitted.
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IABP vs Control in HR-STEMI LVEF
Randomized controlled trials
Sjauw KD, Tijssen JG, Henriques JP et al.
submitted.
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IABP vs Control in HR-STEMI Stroke / Bleeding
Randomized controlled trials
Complications not outweighed by any benefits
IABP 6 increase in Bleeding
IABP 2 increase in Stroke
Sjauw KD, Tijssen JG, Henriques JP et al.
submitted.
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Meta-analysis of cohorts of IABP in STEMI with CS
8 cohorts STEMI complicated by CS
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IABP vs Control in CS 30-day mortality
Cohort Studies
18 decrease in 30-day mortality
6 increase in 30-day mortality
Sjauw KD, Tijssen JG, Henriques JP et al.
submitted.
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IABP vs Control in CS 30-day mortality
Thrombolysis studies
18 decrease in 30-day mortality

• Supports hypothesis of myocardial and organ
  recovery due to IABP
• Supports hypothesis of improved efficacy of
  trombolysis due to IABP

3 other explanations

• IABP pts were younger ? 67 vs 73 yrs
• IABP pts were more likely to be male ? 48 vs 38

• IABP pts had higher rates of revascularization ?
  39 vs 10

• Sicker patients to ill to recieve IABP or died
  before they could
• receive IABP ? bias towards poor outcome in
  no IABP group

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Revascularization IABP vs. no IABP
Sjauw KD, Tijssen JG, Henriques JP et al.
submitted.
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IABP vs Control in CS 30-day mortality
Thrombolysis studies
18 decrease in 30-day mortality
Lower mortality due to confounding and
bias, rather than to a beneficial effect of IABP
per se
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IABP vs Control in CS 30-day mortality
Primary PCI studies
6 increase in 30-day mortality with IABP

• Contrasts hypothesis of myocardial and organ
  recovery
• Opposes the suggestion of a relation between the
  underutilization of
• IABP therapy and the remainingly high mortality
  in CS

2 other explanations

• Confounding
• However, in NRMI-2 after multivariate adjustment
  IABP
• remained associated with higher mortality

• IABP therapy preferentially given to sicker
  patients

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IABP vs Control in CS 30-day mortality
Primary PCI studies
6 increase in 30-day mortality with IABP
Unexpected, truly detrimental effect vs.
confounding / Bias Results must be cautiously
interpreted
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Conclusion

• Meta-analysis of RCTs in STEMI
• No support for the use of routine IABP in
  HR-STEMI

• Meta-analysis of cohorts in STEMI with CS
• Support for IABP adjunctive to thrombolysis
• importantly hampered by confounders
• No support for IABP adjunctive to primary PCI

These meta-analyses challenge the current
guideline recommendation for IABP in STEMI with
CS
Sjauw KD, Tijssen JG, Henriques JP et al.
submitted.
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Implications for the guidelines

• IABP in HR-STEMI is not explicitly addressed in
  the
• guidelines
• An appropriate classification of recommendation
  and level of evidence should be considered

• IABP in STEMI with CS is strongly recomended in
  the
• current guidelines (class IB)
• There is insufficient scientific evidence
  endorsing this recommendation
• Any recommendation can only be based on expert
  opinion.

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Implications for ongoing research

• The value of IABP adjunctive to contemporary
  STEMI CS treatment is open for research (again)
• Also the promising new mechanical assist devices
  need scientific evidence from RCTs.

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Thank you