Key result
IABP fails to reduce 3-year mortality in long-term observational analysis.
Why the study?
Randomized trials have not shown a survival benefit with intra-aortic balloon pump therapy in STEMI patients with cardiogenic shock, while observational data suggest increased mortality potentially due to bias and confounding.
Observational (n=700)
Yes
Hazard Ratio: 1.23 (95% CI 0.84–1.8)
Absolute Event Rate: 40.3% vs 35.3%
p-value: p=0.288
Supports rigorous risk adjustment in IABP analyses; leaves open whether adjusted observational data resolve apparent harm in STEMI shock.
BACKGROUND: Cardiogenic shock complicating ST-elevation myocardial infarction (STEMI) is associated with significant morbidity and mortality. In the primary percutaneous coronary intervention (PPCI) era, randomized trials have not shown a survival benefit with intra-aortic balloon pump (IABP) therapy. This differs to observational data which show a detrimental effect, potentially reflecting bias and confounding. Without robust and valid risk adjustment, findings from non-randomized studies may remain biased. METHODS: We compared long-term mortality following IABP therapy in patients with cardiogenic shock undergoing PPCI during 2008-2013 from the British Columbia Cardiac Registry. We addressed measured and unmeasured confounding using propensity score and instrumental variable methods. RESULTS: A total of 12,105 patients with STEMI were treated with PPCI during the study period. Of these, 700 patients (5.8%) had cardiogenic shock. Of the patients with cardiogenic shock, 255 patients (36%) received IABP therapy. Multivariable analyses identified IABP therapy to be associated with increased mortality up to 3 years (HR = 1.67, 95% CI:1.20-2.67, p<0.001). This association was lost in propensity-matched analyses (HR = 1.23, 95% CI: 0.84-1.80, p = 0.288). When addressing measured and unmeasured confounders, instrumental variable analyses demonstrated that IABP therapy was not associated with mortality at 3 years (Δ = 16.7%, 95% CI: -12.7%, 46.1%, p = 0.281). Subgroup analyses demonstrated IABP was associated with increased mortality in non-diabetics; patients not undergoing multivessel intervention; patients without renal disease and patients not having received prior thrombolysis. CONCLUSIONS: In this observational analysis of patients with STEMI and cardiogenic shock, when adjusting for confounding, IABP therapy had a neutral effect with no association with long-term mortality. These findings differ to previously reported observational studies, but are in keeping with randomized trial data.
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Iqbal et al. (2016) conducted an observational in ST-elevation myocardial infarction and cardiogenic shock (n=700). Intra-Aortic Balloon Pump (IABP) therapy vs. No IABP was evaluated on All-cause mortality at 3 years (propensity-matched analysis) (HR 1.23, 95% CI 0.84-1.80, p=0.288). Intra-aortic balloon pump therapy was not associated with a significant reduction in long-term mortality up to 3 years (HR 1.23) when adjusting for measured and unmeasured confounders.
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