Coronary artery disease
In-Hospital Major Bleeding During ST-Elevation and Non–ST-Elevation Myocardial Infarction Care: Derivation and Validation of a Model from the ACTION Registry®-GWTG™

https://doi.org/10.1016/j.amjcard.2010.12.009Get rights and content

Bleeding, a common complication of acute myocardial infarction (AMI) treatment, is associated with worse outcomes. A contemporary model for major bleeding associated with AMI treatment can stratify patients at elevated risk for bleeding and is needed to risk-adjust AMI practice and outcomes. Using the Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With the Guidelines (ACTION Registry–GWTG) database, an in-hospital major bleeding risk model was developed in a population of patients with ST-segment elevation myocardial infarction and non–ST-segment elevation myocardial infarction. The model used only baseline variables and was developed (n = 72,313) and validated (n = 17,960) in patients with AMI (at 251 United States centers from January 2007 to December 2008). The 12 most statistically and clinically significant variables were incorporated into the final regression model. The calibration plots are shown, and the model discrimination is demonstrated in derivation and validation cohorts, as well as across key subgroups. The rate of major bleeding in the overall population was 10.8%. The 12 factors associated with major bleeding in the model were heart rate, baseline hemoglobin, female gender, baseline serum creatinine, age, electrocardiographic changes, heart failure or shock, diabetes, peripheral artery disease, body weight, systolic blood pressure, and home warfarin use. The risk model discriminated well in the derivation (C-statistic = 0.73) and validation (C-statistic = 0.71) cohorts. A risk score for major bleeding corresponded well with observed bleeding: very low risk (3.9%), low risk (7.3%), moderate risk (16.1%), high risk (29.0%), and very high risk (39.8%). In conclusion, the ACTION Registry–GWTG in-hospital major bleeding model stratifies risk for major bleeding using variables at presentation and enables risk-adjusted bleeding outcomes for quality improvement initiatives and clinical decision making.

Section snippets

Methods

The ACTION Registry–GWTG is an ongoing National Cardiovascular Data Registry program for patients with ST-segment elevation myocardial infarction (STEMI) and those with non-STEMI (NSTEMI) admitted to participating hospitals across the United States.1 The registry is an initiative of the American College of Cardiology Foundation and the American Heart Association, with partnering support from the Society of Chest Pain Centers, the Society of Hospital Medicine, and the American College of

Results

A total of 103,890 patients with AMI were admitted to 316 participating hospitals. After exclusions, the final population consisted of 90,273 patients enrolled across 251 United States centers (Figure 1). Derivation (80% [n = 72,313]) and validation (20% [n = 17,960]) cohorts were then randomly created. In-hospital major bleeding occurred in 10.8% in the derivation and validation cohorts. Major bleeding occurred in 10.2% of patients with NSTEMI and 11.8% of those with STEMI in the derivation

Discussion

Treatment for AMI should be selected with an understanding of an individual's baseline risk for ischemic outcomes, as well as for bleeding complications.3, 4, 5, 6, 7, 8, 9 The test performance measures on excess antithrombotic dosing target safety of care, but comparisons of hospitals related to their AMI care should be risk adjusted. The ACTION Registry–GWTG major bleeding model allows such risk adjustment of bleeding on site feedback reports. In addition, the model enables baseline risk

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    In contrast, blood parameters can be quickly measured and provide objective information. To date, several blood biomarkers have been reported to be potential tools for predicting the incidence of bleeding complications in patients with AMI [6–13]. Given that these biomarkers may reflect various aspects of a patient's condition, we hypothesized that a combination of biomarkers might provide more accurate and useful information for risk stratification than the information provided by an individual biomarker.

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The Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With the Guidelines (ACTION Registry–GWTG) is an initiative of the American College of Cardiology Foundation, Washington, District of Columbia, and the American Heart Association, Dallas, Texas, with partnering support from Society of Chest Pain Centers, Dublin, Ohio, the Society of Hospital Medicine, Philadelphia, Pennsylvania, and the American College of Emergency Physicians, Irving, Texas. The registry is sponsored by Bristol-Myers Squibb (New York, New York)/Sanofi Pharmaceuticals (St. Louis, Missouri). This project received infrastructure support from the Agency for Healthcare Research and Quality, Rockville, Maryland, under grant U18HS016964. The content is solely the responsibility of the investigators and does not necessarily represent the official views of the Agency for Healthcare Research and Quality. The funding source had no role in the design or implementation of the study or in the decision to seek publication.

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