Methods

Details of the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients’ Health Status (TRIUMPH) study, including the study design, patient selection, site characteristics, informed consent, appropriate treatment of research subjects, and follow-up assessments, have been previously published. From April 2005 to December 2008, patients from 24 US hospitals were enrolled into the TRIUMPH registry. Patients were required to have biomarker evidence of myocardial necrosis and additional clinical evidence supporting the diagnosis of an AMI, such as prolonged ischemic signs/symptoms (≥20 minutes) or electrocardiographic ST changes during the initial 24 hours of admission. For this analysis, only patients with established DM were included, which was defined as a chart-documented history of DM or taking any glucose-lowering medication on admission.

Baseline sociodemographic and clinical data were obtained through chart abstraction and a detailed structured interview within 24 to 72 hours of admission. Lipid-lowering medications (type and dose) were documented at admission and hospital discharge. Statins prescribed at discharge were categorized as intensive (expected low-density lipoprotein cholesterol [LDL-C] lowering of >50% ; i.e., atorvastatin 80 mg or rosuvastatin ≥20 mg daily) or moderate (all other statins). As a sensitivity analysis, given the new cholesterol guidelines, we also considered atorvastatin 40 mg as intensive statin therapy (estimated LDL-C lowering of 45% to 50%). In addition, as a second sensitivity analysis, to account for hospitals with restrictive formularies, we excluded the 4 hospitals with limited access to intensive statins. Patients with documented allergies or contraindications to statin therapy were excluded from the analysis. Institutional review board approval was obtained at each participating hospital, and informed consent was obtained from all patients for baseline and follow-up assessments.

The demographic and clinical characteristics of patients with DM who did and who did not receive intensive statin therapy at discharge after AMI were compared using chi-square test for categorical variables and t test for continuous variables. We used hierarchical modified Poisson regression with robust standard errors to examine the factors associated with prescription of intensive statin therapy at hospital discharge because our primary metric of interest (frequency of intensive statin prescription) was not rare, to avoid an overestimation of effect sizes, as could result from using logistic regression. Covariates included in the multivariable model were selected a priori based on clinical judgment and included sociodemographics (age, sex, race, marital status, and prescription drug insurance), clinical features (history of smoking and body mass index), characteristics of the qualifying AMI event (ST-elevation myocardial infarction [STEMI] and Global Registry of Acute Coronary Events [GRACE] score—an assessment of the severity of AMI where higher scores indicate a higher risk of mortality ), severity of DM (duration of DM, class of DM therapy [diet vs oral medications only vs any insulin therapy]), HbA1c level ≥7%, and LDL-C level. Participating center was entered as a random effect to account for clustering of patients within hospitals. Site variability in the rates of intensive statin therapy was evaluated using median rate ratios, which estimates the relative difference in risk ratios of 2 hypothetically identical patients for being discharged on intensive statin therapy at 2 different sites. All analyses were conducted using SAS v9.2 (SAS Institute, Inc., Cary, North Carolina), and statistical significance was determined by a 2-sided p value of <0.05.

Results

Of the 4,340 patients enrolled in TRIUMPH, 4,316 survived to hospital discharge, of whom 1,331 (31%) had an established diagnosis of DM at admission. Statin dose was not available for 12 patients with DM, and 19 had a documented contraindication to statins, which resulted in an analytic population of 1,300 patients ( Figure 1 ). The mean age of the population was 61 years, 59% were men, and 58% were Caucasian ( Table 1 ). About 1/3 of patients presented with an STEMI, and 66% underwent invasive management of their AMI. The mean duration of DM was 12 years, mean HbA1c was 8.3%, and 32% were on insulin at admission ( Table 2 ).

Flowchart of analytic cohort.

Table 2

Diabetes and lipid characteristics

Variable	All Patients, n = 1,300	Intensive Statin Prescribed		p Value
		Yes, n = 280	No, n = 1,020
DM duration (yrs)	12 ± 11	12 ± 11	12 ± 11	0.271
DM treatments				0.758
Diet only	29	31	29
Oral medications only	39	38	39
Insulin	32	31	32
LDL-C (mg/dl)	100 ± 45	110 ± 53	97 ± 42	<0.001
Hemoglobin A1c	8.3 ± 2.6	8.7 ± 3.7	8.1 ± 2.2	0.007
Hemoglobin A1c ≥ 7%	66	68	65	0.324
Statin on arrival	49	52	48	0.202

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