Development and external validation of a diagnostic model for in-hospital bleeding in patients with acute ST elevation myocardial infarction

Background Bleeding complications in patients with acute ST segment elevation myocardial infarction (STEMI) are associated with an increased risk of subsequent adverse consequences. We want to develop and externally validate a diagnostic model of in-hospital bleeding in the population of unselected real-world patients with acute STEMI. Methods Design: Multivariable logistic regression of a cohort for hospitalized patients with acute STEMI. Setting: Emergency department ward of a university hospital. Participants: Diagnostic model development: Totally 4262 hospitalized patients with acute STEMI from January 2002 to December 2013 in Beijing Anzhen Hospital, Capital Medical University. External validation: Totally 6015 hospitalized patients with acute STEMI from January 2014 to August 2019 in Beijing Anzhen Hospital, Capital Medical University. Outcomes: All-cause in-hospital bleeding not related to coronary artery bypass graft surgery or catheterization. Results In-hospital bleeding occurred in 2.6% (112/4262) of patients in the development data set (117/6015) of patients in the validation data set. The strongest predictors of in-hospital bleeding were advanced age and high Killip classification. We developed a diagnostic model of in-hospital bleeding. The area under the receiver operating characteristic ROC curve (AUC) was 0.777±0.021, 95% confidence interval(CI) = 0.73576 ~ 0.81823. We constructed a nomograms using the development database based on age, and Killip classification. The AUC was 0.7234±0.0252, 95% CI = 0.67392 ~ 0.77289 in the validation data set. Discrimination, calibration, and decision curve analysis were satisfactory. Conclusions We developed and externally validated a moderate diagnostic model of in-hospital bleeding in patients with acute STEMI. We registered this study with WHO International Clinical Trials Registry Platform (ICTRP) (registration number: ChiCTR1900027578; registered date: 19 Novmober 2019). . ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ChiCTR1900027578 ### Funding Statement This research received no external funding. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethic committee approved the study. Name of the ethic committee:Ethics committee of Beijing Anzhen Hospital Capital Medical University. Approved No. of ethic committee: 2019044X. It was a retrospective analysis and informed consent was waived by Ethics Committee of Beijing Anzhen Hospital Capital Medical University. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data generated or analysed during this study are included in this published article [and its supplementary information files]. Supplementary materials The data are demographic, and clinical characteristics of hospitalized patients with acute STEMI. AGE=age; ALLAF=atrial fibrillation; AVB=atrioventricular block; BLOOD=all-cause bleeding; CABG =history of coronary artery bypass grafting; CKD=history of chronic kidney disease; DM=history of diabetes; HBP = history of hypertension; HCD= history of cerebrovascular disease; HPCI=history of percutaneous coronary intervention; KI = Killip I; KII = Killip II;KIII = Killip III; KIV = Killip IV; OMI=history of myocardial infarction; PCI=underwent PCI during hospitalization; S = sex.