Early clopidogrel versus prasugrel use among contemporary STEMI and NSTEMI patients in the US: insights from the National Cardiovascular Data Registry.

BACKGROUND: P2Y12 antagonist therapy improves outcomes in acute myocardial infarction (MI) patients. Novel agents in this class are now available in the US. We studied the introduction of prasugrel into contemporary MI practice to understand the appropriateness of its use and assess for changes in antiplatelet management practices. METHODS AND RESULTS: Using ACTION Registry-GWTG (Get-with-the-Guidelines), we evaluated patterns of P2Y12 antagonist use within 24 hours of admission in 100 228 ST elevation myocardial infarction (STEMI) and 158 492 Non-ST elevation myocardial infarction (NSTEMI) patients at 548 hospitals between October 2009 and September 2012. Rates of early P2Y12 antagonist use were approximately 90% among STEMI and 57% among NSTEMI patients. From 2009 to 2012, prasugrel use increased significantly from 3% to 18% (5% to 30% in STEMI; 2% to 10% in NSTEMI; P for trend <0.001 for all). During the same period, we observed a decrease in use of early but not discharge P2Y12 antagonist among NSTEMI patients. Although contraindicated, 3.0% of patients with prior stroke received prasugrel. Prasugrel was used in 1.9% of patients ≥75 years and 4.5% of patients with weight <60 kg. In both STEMI and NSTEMI, prasugrel was most frequently used in patients at the lowest predicted risk for bleeding and mortality. Despite lack of supporting evidence, prasugrel was initiated before cardiac catheterization in 18% of NSTEMI patients. CONCLUSIONS: With prasugrel as an antiplatelet treatment option, contemporary practice shows low uptake of prasugrel and delays in P2Y12 antagonist initiation among NSTEMI patients. We also note concerning evidence of inappropriate use of prasugrel, and inadequate targeting of this more potent therapy to maximize the benefit/risk ratio.

Comparison of the prognostic value of peak creatine kinase-MB and troponin levels among patients with acute myocardial infarction: a report from the Acute Coronary Treatment and Intervention Outcomes Network Registry-get with the guidelines.

BACKGROUND: Although peak creatine kinase-myocardial band (CK-MB) and troponin levels have been correlated with mortality among patients with acute myocardial infarction (AMI), the independent prognostic implications of these markers have not been compared. HYPOTHESIS: We hypothesized that in patients with AMI, peak troponin levels (as compared to peak CK-MB levels) would have greater prognostic value. METHODS: We examined AMI patients in the National Cardiovascular Data Registry ACTION Registry-GWTG (Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines) with CK-MB and troponin I levels recorded, excluding patients who were transferred in or out. Peak marker levels, standardized by the local laboratory upper limit of normal and assay standard deviation, were fitted into the previously validated ACTION Registry-GWTG mortality model to compare prognostic value. RESULTS: Between January 2007 and March 2009, 16 009 ST-segment elevation myocardial infarction (STEMI) and 26854 non-ST-segment elevation myocardial infarction (NSTEMI) patients were identified. Peak marker ratios were directly associated with in-hospital mortality in both STEMI and NSTEMI patients. Peak CK-MB had slightly greater discrimination compared with peak troponin I in predicting mortality in both STEMI (model C-statistic 0.881 vs 0.877, P = 0.011) and NSTEMI (C-statistic 0.831 vs 0.824, P = 0.001) patients. CONCLUSIONS: Both peak CK-MB and peak troponin I levels are independently associated with in-hospital mortality in this large contemporary database of AMI patients treated in routine practice. Peak marker values slightly improved model performance in prognosticating in-hospital mortality; the incremental value was higher with CK-MB than with troponin I. These findings may help to guide future risk stratification algorithms and contribute to more efficient use of serial cardiac marker measurements in clinical practice.

Effect of spironolactone on patients with atrial fibrillation and structural heart disease.

BACKGROUND: Several studies have shown that the modulation of fibrotic scar in cardiac diseases has beneficial effects on cardiac arrhythmias. In addition, recent reports suggest a potential role of mineralocorticoid receptor upregulation in atrial fibrillation (AF). The role of spironolactone, a mineralocorticoid receptor blocker and a potent antifibrotic agent, in AF is as yet unexplored. The aim of this study was to determine if spironolactone, a mineralocorticoid receptor blocker with potent antifibrotic properties, has beneficial effects on AF. HYPOTHESIS: Spironolactone therapy in patients with atrial fibrillation provides additional clinical benefits in addition to the current conventional pharmacological agents. METHODS: A comprehensive retrospective analysis was performed on 83 patients with AF, including 23 who were treated with spironolactone for ≥3 months. The combined primary outcome of hospitalization for AF or direct current cardioversion (DCCV) was compared between patients treated with spironolactone in addition to the usual care for AF and those receiving conventional medical therapy alone. RESULTS: Patients receiving spironolactone had significantly fewer primary outcome events (AF-related hospitalizations or DCCV) (22% vs 53%, P = 0.027). CONCLUSIONS: Spironolactone therapy is associated with a reduction in the burden of AF, as reflected by a combination of hospitalizations for AF and DCCV. Larger randomized controlled studies should be performed to evaluate the efficacy and safety of spironolactone as an adjunctive therapy for patients with AF.

The GoodNEWS (Genes, Nutrition, Exercise, Wellness, and Spiritual Growth) Trial: a community-based participatory research (CBPR) trial with African-American church congregations for reducing cardiovascular disease risk factors--recruitment, measurement, and randomization.

INTRODUCTION: Although cardiovascular diseases (CVD) are the leading cause of death among Americans, significant disparities persist in CVD prevalence, morbidity, and mortality based on race and ethnicity. However, few studies have examined risk factor reduction among the poor and ethnic minorities. METHODS: Community-based participatory research (CBPR) study using a cluster randomized design--African-American church congregations are the units of randomization and individuals within the congregations are the units of analysis. Outcome variables include dietary change (Diet History Questionnaire), level of physical activity (7-Day Physical Activity Recall), lipoprotein levels, blood pressure, fasting glucose, and hemoglobin A1c. RESULTS: Eighteen (18) church congregations were randomized to either a health maintenance intervention or a control condition. Complete data were obtained on 392 African-American individuals, 18 to 70 years of age, predominantly employed women with more than a high school diploma. Treatment and intervention groups were similar at baseline on saturated fat intake, metabolic equivalent of tasks (METS) per day, and other risk factors for CVD. CONCLUSIONS: The GoodNEWS trial successfully recruited and evaluated CVD-related risk among African-American participants using a CBPR approach. Several logistical challenges resulted in extending the recruitment, preliminary training, and measurement periods. The challenges were overcome with the assistance of a local community consultant and a professional event planner. Our experience supports the need for incorporating non-traditional community-based staff into the design and operational plan of CBPR trials.

Treatment delay in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction: a key process analysis of patient and program factors.

BACKGROUND: Most hospitals that perform primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) in the United States exceed the recommended door-to-balloon time. There is heightened interest in identifying and eliminating factors that introduce delay. METHODS: We performed a key process analysis of our primary PCI program, assessed the relative contribution of individual time intervals on total ischemic time, and identified predictors of delay. RESULTS: Median times and predictors of delay within each time interval were determined for the entire STEMI cohort ("real world") and after exclusion of patients with atypical symptoms and/or presentations of STEMI that resulted in inherent delay in diagnosis and treatment ("ideal world"). Delays in therapy were symptom onset to presentation (120 minutes [interquartile range, IQR, 60-310 minutes, ideal world] and 150 minutes [IQR 60-360 minutes, real world]; predictors of delay were peripheral vascular disease, self-transportation, daytime and weekend presentation); door-to-balloon time (118.5 minutes [IQR 96-141 minutes, ideal world] and 125 minutes [IQR 100-170 minutes, real world]; predictors of delay were female sex, previous stroke, nighttime and weekend presentation, and cardiogenic shock); and symptom onset to first balloon inflation (272 minutes [IQR 187-465 minutes, ideal world] and 297 minutes [IQR 198-560 minutes, real world]; predictors of delay were peripheral vascular disease, weekend presentation, and self-transportation). CONCLUSIONS: Key process analysis of a primary PCI program identifies treatment delays unique to the hospital and the patient population it serves.

Racial disparity in clinical outcomes following primary percutaneous coronary intervention for ST elevation myocardial infarction: influence of process of care.

Previous studies have shown that compared with white patients, non-white patients with ST elevation myocardial infarction (STEMI) have worse clinical outcomes. Differences in co-morbidities, extent and severity of coronary artery disease, health insurance, and socioeconomic status have been identified as possible reasons for this disparity. However, an alternative explanation for such observed disparities in outcomes could be differences in process of care. For example, in most of these studies, non-white patients were less likely to receive reperfusion therapy, and if treated, were more likely to receive thrombolysis than to undergo primary percutaneous coronary intervention (PCI). We hypothesized that if all patients were treated similarly with primary PCI, there would be no difference in clinical outcomes. We analyzed the demographic, angiographic, in-hospital clinical outcomes, and long-term mortality rates of a racially diverse group of patients presenting to the same hospital with STEMI, all of whom were treated with primary PCI. Our data demonstrate that compared with white patients, non-white patients with STEMI who undergo primary PCI have similar in-hospital clinical outcomes and one-year mortality. This suggests that the previously observed differences in mortality rates may be, at least in part, attributable to differences in the process of care, and not solely to differences in patient factors or differential therapeutic effects.

Evaluation of the time saved by prehospital initiation of reteplase for ST-elevation myocardial infarction: results of The Early Retavase-Thrombolysis in Myocardial Infarction (ER-TIMI) 19 trial.

OBJECTIVES: The Early Retavase-Thrombolysis In Myocardial Infarction (ER-TIMI) 19 trial tested the feasibility of prehospital initiation of the bolus fibrinolytic reteplase (rPA) and determined the time saved by prehospital rPA in the setting of contemporary emergency cardiac care. BACKGROUND: Newer bolus fibrinolytics have undergone only limited evaluation for prehospital administration. In addition, as door-to-drug times have decreased, the relevance of findings from prior trials of prehospital fibrinolysis has become less certain. METHODS: Patients (n = 315) with ST-elevation myocardial infarction (STEMI) were enrolled in 20 emergency medical systems in North America. The time from emergency medical service (EMS) arrival to administration of a fibrinolytic was compared between study patients receiving prehospital rPA and sequential control patients from 6 to 12 months before the study who received a fibrinolytic in the hospital. RESULTS: Acute myocardial infarction was confirmed in 98%. The median time from EMS arrival to initiation of rPA was 31 min (25th to 75th percentile, 24 min to 37 min). The time from EMS arrival to in-hospital fibrinolytic for 630 control patients was 63 min (25th to 75th percentile, 48 min to 89 min), resulting in a time saved of 32 min (p < 0.0001). By 30 min after first medical contact, 49% of study patients had received the first bolus of fibrinolytic compared with only 5% of controls (p < 0.0001). In-hospital mortality was 4.7%. Intracranial hemorrhage occurred in 1.0%. CONCLUSIONS: Prehospital administration of rPA is a feasible approach to accelerating reperfusion in patients with STEMI. Valuable time savings can be achieved in the setting of contemporary transport and door-to-drug times and may translate into an improvement in clinical outcomes.