Abstract

Literature studying the door-to-balloon time-outcome relation in coronary intervention is limited by the potential of residual biases from unobserved confounders. This study re-examines the time-outcome relation with further consideration of the unobserved factors and reports the population average effect. Adults with ST-elevation myocardial infarction admitted to one of the six registry participating hospitals in Australia were included in this study. The exposure variable was patient-level door-to-balloon time. Primary outcomes assessed included in-hospital and 30 days mortality. 4343 patients fulfilled the study criteria. 38.0% (1651) experienced a door-to-balloon delay of >90 minutes. The absolute risk differences for in-hospital and 30-day deaths between the two exposure subgroups with balanced covariates were 2.81 (95% CI 1.04, 4.58) and 3.37 (95% CI 1.49, 5.26) per 100 population. When unmeasured factors were taken into consideration, the risk difference were 20.7 (95% CI −2.6, 44.0) and 22.6 (95% CI −1.7, 47.0) per 100 population. Despite further adjustment of the observed and unobserved factors, this study suggests a directionally consistent linkage between longer door-to-balloon delay and higher risk of adverse outcomes at the population level. Greater uncertainties were observed when unmeasured factors were taken into consideration.

Highlights

  • Literature studying the door-to-balloon time-outcome relation in coronary intervention is limited by the potential of residual biases from unobserved confounders

  • Relative risk reporting in instrumental variable (IV) analysis requires a different modelling approach was not performed. Among those undergoing primary percutaneous coronary intervention (pPCI) in Victoria, Australia during 2005 to 2015, we observed a trend indicating a consistent link between longer D2B delay and higher risk of adverse ST-elevation myocardial infarction (STEMI) outcomes despite the added confounding consideration

  • This observation was based on a propensity score analysis implemented through the covariates balancing propensity score (CBPS) algorithm and an IV analysis that used patient-level “differential distance” as a pseudo-randomizer

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Summary

Introduction

Literature studying the door-to-balloon time-outcome relation in coronary intervention is limited by the potential of residual biases from unobserved confounders. This study re-examines the time-outcome relation with further consideration of the unobserved factors and reports the population average effect. Despite further adjustment of the observed and unobserved factors, this study suggests a directionally consistent linkage between longer door-to-balloon delay and higher risk of adverse outcomes at the population level. Common confounding domains that lack consideration in many of the previous reports include pre-hospital delays, day-time and institutional factors. Existing studies reported almost exclusively the effect of D2B delay on STEMI outcomes in relative term, based mainly on conventional regression method. Relative estimates derived using regression adjustment, the logistic and proportional hazard models, have important limitations They do not provide the magnitude of the effect size in absolute term, which is important to population-level decision making. Generalizing this quantitative relationship to the population level can be misguiding[12,13]

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