Use of Aldosterone Antagonists at Discharge After MI
Use of Aldosterone Antagonists at Discharge After MI
The ACTION Registry-GWTG collects and reports data for patients with acute MI from participating centers across the United States. Trained hospital personnel at each center collect data from the medical record using standardized data definitions, which have been previously described in detail. Abstracted data include patient demographics, clinical information, medical therapies, use and timing of cardiac procedures, and inhospital outcomes; patient-level data are deidentified before submission to the registry. The individual institutional review board of each reporting hospital has approved participation in the registry.
From January 1, 2007, through March 31, 2011, 289,322 patients were enrolled in the registry. To define the population potentially eligible for AldA therapy, we sequentially excluded patients in centers using a limited data collection form that lacked relevant clinical and laboratory data (n = 21,717); patients who died during hospitalization (n = 12,090); patients transferred out from an ACTION hospital (n = 15,081); patients who left the hospital against medical advice or chose comfort care (n = 5,096); patients in shock on presentation (n = 6,916); missing data on AldA use or blinded for AldA use at discharge (n = 950); missing data on clinical HF, DM, or ejection fraction (n = 5,431); and patients' missing data on sex or renal function (n = 800). After the above exclusions, our analysis cohort comprised 221,241 patients. The 19,028 (8.6%) patients in whom an AldA contraindication was documented were further excluded when determining the proportion of patients eligible for AldA. Thus, the eligibility prevalence analysis was based on 202,213 patients at 526 participating US sites.
Patients were defined as eligible for AldA in the present study if they had both a documented class I indication and no documented contraindication for AldA therapy. Indication for AldA for patients with acute MI was defined based on the 2007 ACC/AHA guidelines for ST-elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI), as follows: LVEF <40% with either comorbid DM or clinical HF. Patients were considered ineligible if they had 1 or more of the following contraindications: serum creatinine >2.5 mg/dL (men) or >2.0 mg/dL (women), dialysis-dependent renal failure, or documented contraindication to angiotensin-converting enzyme inhibitor (ACE-I) and angiotensin receptor blocker (ARB). Patients not taking an ACE-I or ARB but without documented contraindication were considered eligible for AldA at discharge.
To determine the proportion of AldA use at discharge among eligible patients, 181,941 ineligible patients for AldA were further excluded, leaving an analysis cohort of 20,272 patients from 490 participating centers. For analyses exploring hospital variation of AldA use, hospitals with ≤40 patients were excluded (90 hospitals with a total of 1,579 patients).
The medications used to define optimal medical therapy at discharge were as follows: aspirin, adenosine diphosphate (ADP) receptor inhibitor (in either revascularized or medically managed patients), β-blocker, and statin in all patients and either ACE-I or ARB for patients with LVEF <40%. Optimal medical therapy at discharge was calculated as the percent of patients who receive "perfect care" based on their eligibility for each performance measure. If a patient failed to receive even a single therapy for which he or she was eligible, that patient failed to meet the "optimal medical therapy" criteria and would be removed from the numerator. Hospital performance score was defined as patients discharged on optimal medical therapy, and it was calculated as the sum of a hospital's "correctly" provided care out of the total number of care "opportunities" encountered by the hospital in treating its patients with MI.
The proportion of AldA-eligible patients at hospital discharge was determined. All further patient-level analyses were limited to AldA-eligible patients. The proportion of AldA-eligible patients who received an AldA at hospital discharge was reported for the overall analysis cohort and annually. The P value for linear trend over time was assessed using a logistic regression model fitting patient's year of hospital arrival as an ordinal covariate. Patient demographics, clinical characteristics, and inhospital clinical outcomes were compared between AldA-eligible patients discharged with and without AldA using Wilcoxon rank sum 2-sample tests for continuous variables and χ tests for categorical variables.
To explore hospital variation of AldA use at discharge, percentages of AldA use among eligible patients without AldA contraindication for each hospital were calculated. Hospitals were categorized into quartiles based on the percentage of eligible patients receiving AldA therapy at discharge. Hospital characteristics, discharge medications, and hospital performance score were compared across quartiles of hospital of AldA use using Kruskal-Wallis tests for continuous variables and χ tests for categorical variables. All analyses were performed with SAS software (version 9.2; SAS Institute, Cary, NC). A P value <.05 was considered statistically significant, and all tests of statistical significance were 2 tailed.
This research was supported by the ACC Foundation's NCDR. ACTION Registry-GWTG is an initiative of the ACC Foundation and the AHA, with partnering support from the Society of Chest Pain Centers, the American College of Emergency Physicians, and the Society of Hospital Medicine. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the manuscript, and its final contents. The views expressed in this manuscript represent those of the authors and do not necessarily represent the official views of the NCDR or its associated professional societies identified at http://www.ncdr.com.
Methods
Data Collection
The ACTION Registry-GWTG collects and reports data for patients with acute MI from participating centers across the United States. Trained hospital personnel at each center collect data from the medical record using standardized data definitions, which have been previously described in detail. Abstracted data include patient demographics, clinical information, medical therapies, use and timing of cardiac procedures, and inhospital outcomes; patient-level data are deidentified before submission to the registry. The individual institutional review board of each reporting hospital has approved participation in the registry.
Study Population and Definition of AldA Eligibility
From January 1, 2007, through March 31, 2011, 289,322 patients were enrolled in the registry. To define the population potentially eligible for AldA therapy, we sequentially excluded patients in centers using a limited data collection form that lacked relevant clinical and laboratory data (n = 21,717); patients who died during hospitalization (n = 12,090); patients transferred out from an ACTION hospital (n = 15,081); patients who left the hospital against medical advice or chose comfort care (n = 5,096); patients in shock on presentation (n = 6,916); missing data on AldA use or blinded for AldA use at discharge (n = 950); missing data on clinical HF, DM, or ejection fraction (n = 5,431); and patients' missing data on sex or renal function (n = 800). After the above exclusions, our analysis cohort comprised 221,241 patients. The 19,028 (8.6%) patients in whom an AldA contraindication was documented were further excluded when determining the proportion of patients eligible for AldA. Thus, the eligibility prevalence analysis was based on 202,213 patients at 526 participating US sites.
Patients were defined as eligible for AldA in the present study if they had both a documented class I indication and no documented contraindication for AldA therapy. Indication for AldA for patients with acute MI was defined based on the 2007 ACC/AHA guidelines for ST-elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI), as follows: LVEF <40% with either comorbid DM or clinical HF. Patients were considered ineligible if they had 1 or more of the following contraindications: serum creatinine >2.5 mg/dL (men) or >2.0 mg/dL (women), dialysis-dependent renal failure, or documented contraindication to angiotensin-converting enzyme inhibitor (ACE-I) and angiotensin receptor blocker (ARB). Patients not taking an ACE-I or ARB but without documented contraindication were considered eligible for AldA at discharge.
To determine the proportion of AldA use at discharge among eligible patients, 181,941 ineligible patients for AldA were further excluded, leaving an analysis cohort of 20,272 patients from 490 participating centers. For analyses exploring hospital variation of AldA use, hospitals with ≤40 patients were excluded (90 hospitals with a total of 1,579 patients).
Definition of Optimal Medical Therapy
The medications used to define optimal medical therapy at discharge were as follows: aspirin, adenosine diphosphate (ADP) receptor inhibitor (in either revascularized or medically managed patients), β-blocker, and statin in all patients and either ACE-I or ARB for patients with LVEF <40%. Optimal medical therapy at discharge was calculated as the percent of patients who receive "perfect care" based on their eligibility for each performance measure. If a patient failed to receive even a single therapy for which he or she was eligible, that patient failed to meet the "optimal medical therapy" criteria and would be removed from the numerator. Hospital performance score was defined as patients discharged on optimal medical therapy, and it was calculated as the sum of a hospital's "correctly" provided care out of the total number of care "opportunities" encountered by the hospital in treating its patients with MI.
Statistical Analysis
The proportion of AldA-eligible patients at hospital discharge was determined. All further patient-level analyses were limited to AldA-eligible patients. The proportion of AldA-eligible patients who received an AldA at hospital discharge was reported for the overall analysis cohort and annually. The P value for linear trend over time was assessed using a logistic regression model fitting patient's year of hospital arrival as an ordinal covariate. Patient demographics, clinical characteristics, and inhospital clinical outcomes were compared between AldA-eligible patients discharged with and without AldA using Wilcoxon rank sum 2-sample tests for continuous variables and χ tests for categorical variables.
To explore hospital variation of AldA use at discharge, percentages of AldA use among eligible patients without AldA contraindication for each hospital were calculated. Hospitals were categorized into quartiles based on the percentage of eligible patients receiving AldA therapy at discharge. Hospital characteristics, discharge medications, and hospital performance score were compared across quartiles of hospital of AldA use using Kruskal-Wallis tests for continuous variables and χ tests for categorical variables. All analyses were performed with SAS software (version 9.2; SAS Institute, Cary, NC). A P value <.05 was considered statistically significant, and all tests of statistical significance were 2 tailed.
Sources of Funding
This research was supported by the ACC Foundation's NCDR. ACTION Registry-GWTG is an initiative of the ACC Foundation and the AHA, with partnering support from the Society of Chest Pain Centers, the American College of Emergency Physicians, and the Society of Hospital Medicine. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the manuscript, and its final contents. The views expressed in this manuscript represent those of the authors and do not necessarily represent the official views of the NCDR or its associated professional societies identified at http://www.ncdr.com.