Iqbal M Bilal, Robinson Simon D, Ding Lillian, Fung Anthony, Aymong Eve, Chan Albert W, Hodge Steven, Della Siega Anthony, Nadra Imad J
Department of Cardiology, Victoria Heart Institute Foundation, Victoria, BC, Canada.
Department of Cardiology, Royal Jubilee Hospital, Victoria, BC, Canada.
PLoS One. 2016 Feb 12;11(2):e0148931. doi: 10.1371/journal.pone.0148931. eCollection 2016.
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.
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.
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.
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.
心源性休克并发ST段抬高型心肌梗死(STEMI)与显著的发病率和死亡率相关。在直接经皮冠状动脉介入治疗(PPCI)时代,随机试验未显示主动脉内球囊反搏(IABP)治疗能带来生存获益。这与观察性数据不同,后者显示IABP治疗有不利影响,这可能反映了偏倚和混杂因素。如果没有强大且有效的风险调整,非随机研究的结果可能仍存在偏倚。
我们比较了2008年至2013年期间来自不列颠哥伦比亚心脏登记处的接受PPCI治疗的心源性休克患者接受IABP治疗后的长期死亡率。我们使用倾向评分和工具变量方法处理已测量和未测量的混杂因素。
在研究期间,共有12105例STEMI患者接受了PPCI治疗。其中,700例患者(5.8%)发生心源性休克。在心源性休克患者中,255例患者(36%)接受了IABP治疗。多变量分析确定IABP治疗与长达3年的死亡率增加相关(HR = 1.67,95% CI:1.20 - 2.67,p < 0.001)。这种关联在倾向匹配分析中消失(HR = 1.23,95% CI:0.84 - 1.80,p = 0.288)。在处理已测量和未测量的混杂因素时,工具变量分析表明IABP治疗与3年死亡率无关(Δ = 16.7%,95% CI: - 12.7%,46.1%,p = 0.281)。亚组分析表明,IABP与非糖尿病患者、未接受多支血管介入治疗的患者、无肾脏疾病的患者以及未接受过先前溶栓治疗的患者的死亡率增加相关。
在这项对STEMI和心源性休克患者的观察性分析中,在调整混杂因素后,IABP治疗具有中性作用,与长期死亡率无关。这些发现与先前报道的观察性研究不同,但与随机试验数据一致。