Charles V. Pollack

Advanced Age, Antithrombotic Strategy, and Bleeding in Non–ST-Segment Elevation Acute Coronary Syndromes : Results From the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial

OBJECTIVES This study sought to evaluate the impact of age on outcomes in patients with moderate- and high-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) enrolled in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial. BACKGROUND Aging-associated changes in physiology and metabolism may alter the risk and benefit of therapeutic strategies from that observed in younger people. METHODS We performed a pre-specified analysis of 30-day and 1-year outcomes in 4 age groups, overall and among those undergoing percutaneous coronary intervention (PCI). RESULTS Of 13,819 patients in the ACUITY trial, 3,655 (26.4%) were <55 years of age, 3,940 (28.5%) were 55 to 64 years of age, 3,783 (27.4%) were 65 to 74 years of age, and 2,441 (17.7%) were > or =75 years of age. Older patients had more cardiovascular risk factors and had a higher acuity at presentation. Patients age > or =75 years treated with bivalirudin alone had similar ischemic outcomes, but significantly lower rates of bleeding compared with those treated with heparin and glycoprotein IIb/IIIa inhibitors overall and in the PCI subset. The number needed to treat with bivalirudin alone to avoid 1 major bleeding event was lower in this age group (23 overall and 16 for PCI-treated patients) than in any other. CONCLUSIONS Ischemic and bleeding complications after NSTE-ACS increase with age. Although ischemic event rates are not statistically different with either bivalirudin alone or a heparin plus glycoprotein IIb/IIIa inhibitor, bleeding complications are significantly less frequent with bivalirudin alone. Because of the substantial risk of bleeding in patients age > or =75 years, the number needed to treat to avoid 1 major bleeding event using bivalirudin alone was the lowest in the elderly group, especially among those undergoing PCI.

A prospective multicenter study of factors associated with hospital admission among adults with acute asthma

PURPOSE We sought to determine patient characteristics associated with hospital admission after emergency treatment for asthma, and whether disposition guidelines are followed. SUBJECTS AND METHODS We performed a prospective multicenter cohort study involving 64 emergency departments in the United States and Canada. Consecutive adult patients with asthma exacerbations were interviewed, and their charts were reviewed using standardized protocols. Telephone follow-up at 2 weeks determined relapse. RESULTS Of 1805 patients, 363 (20%; 95% confidence interval [CI]: 18% to 22%) were hospitalized. Among patients with severe exacerbations (final peak flow <50% of predicted), 122 (49%; 95% CI: 43% to 55%) were hospitalized. Admission was associated with final peak flow, female sex, nonwhite race, severity of chronic illness, and severity of exacerbation. Admission predictors were similar regardless of hospital funding, region, or size. Among patients with mild or moderate exacerbations of asthma (peak flow >or=50% predicted), the likelihood of admission was associated significantly with the number of predefined risk factors for death from asthma. Of patients who were discharged from the emergency department, 62 (5%; 95% CI: 4% to 6%) relapsed within 72 hours. Relapse was not associated with final peak flow (P = 0.39). CONCLUSION Associations between patient characteristics and disposition were similar across sites. Despite guidelines to the contrary, half of patients with final peak flow <50% were discharged. After emergency department treatment and discharge, short-term relapse was uncommon among patients with asthma, suggesting that strict peak flow cutoffs may be unnecessary if risk factors in patients with mild or moderate exacerbations are considered.

Changing the model of care for patients with acute coronary syndromes

Acute coronary syndromes (ACS) represent a major cause of morbidity and mortality for patients with cardiovascular disease, but evidence-based therapies shown to improve outcomes for ACS are often underused in clinically eligible patients. Although clinical practice guidelines have been developed to provide standards for the diagnosis and treatment of patients with ACS and to provide physicians with a framework for clinical decision-making, multiple obstacles have hindered their implementation and questions remain about the applicability of guidelines for diverse clinical situations. Systematic reviews of quality-improvement studies have shown that multifaceted approaches using targeted educational interventions, creation of quality standards, and regular performance feedback are needed to ensure sustained improvements in care. Approaches to quality improvement thus are being redirected to focus on multidisciplinary collaborations designed to improve the entire process of care for patients with ACS. Multiple large observational registries and quality-improvement initiatives now are capturing data regarding adherence to practice guidelines and contemporary patterns of care for ACS. This comprehensive evaluation of ACS treatment will help guide efforts designed to promote evidence-based care and ultimately determine the effect of widespread implementation of practice guidelines on clinical outcomes. The shifting model of care for ACS therefore suggests that quality improvement and monitoring of adherence to practice guidelines should be considered components of optimal clinical practice.

Safety and efficacy of bivalirudin monotherapy in patients with diabetes mellitus and acute coronary syndromes: a report from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial.

OBJECTIVES We sought to evaluate clinical outcomes of patients with diabetes mellitus in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, overall and by treatment arm. BACKGROUND In the ACUITY trial, 13,819 patients with moderate- or high-risk acute coronary syndromes (ACS) were randomized to heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy. Compared with heparin plus GPI, bivalirudin monotherapy resulted in similar protection from ischemic events with less major bleeding. Whether these results apply to patients with diabetes is unknown. METHODS We evaluated the impact of diabetes on 30-day net adverse clinical outcomes (composite ischemia [death, myocardial infarction, or unplanned ischemic revascularization] or major bleeding), overall and by antithrombotic strategy. RESULTS Diabetes was present in 3,852 randomized patients (27.9%). Compared with nondiabetic patients, diabetic patients had higher 30-day rates of net adverse clinical outcomes (12.9% vs. 10.6%; p < 0.001), composite ischemia (8.7% vs. 7.2%; p = 0.003), and major bleeding (5.7% vs. 4.2%; p < 0.001). Among diabetic patients, compared with heparin plus GPI, bivalirudin plus GPI resulted in similar rates of net adverse clinical outcomes (14.0% vs. 13.8%; p = 0.89), while bivalirudin monotherapy resulted in a similar rate of composite ischemia (7.9% vs. 8.9%; p = 0.39) and less major bleeding (3.7% vs. 7.1%; p < 0.001), yielding fewer net adverse clinical outcomes (10.9% vs. 13.8%; p = 0.02). CONCLUSIONS Diabetic patients with ACS managed invasively have higher rates of composite ischemia and major bleeding. Compared with treatment with heparin plus GPI, bivalirudin monotherapy provides similar protection from ischemic events with less major bleeding, resulting in a significant reduction in net adverse clinical outcomes.

Practice patterns, outcomes, and end-organ dysfunction for patients with acute severe hypertension: The Studying the Treatment of Acute hyperTension (STAT) Registry

BACKGROUND Limited data are available on the care of patients with acute severe hypertension requiring hospitalization. We characterized contemporary practice patterns and outcomes for this population. METHODS STAT is a 25-institution, US registry of consecutive patients with acute severe hypertension (>180 mm Hg systolic and/or >110 mm Hg diastolic; >140 and/or >90 for subarachnoid hemorrhage) treated with intravenous therapy in a critical care setting. RESULTS One thousand five hundred eighty-eight patients were enrolled (January 2007 to April 2008). Median age was 58 years (interquartile range 49-70 years), 779 (49%) were women, and 892 (56%) were African American; 27% (n = 425) had a prior admission for acute hypertension and 486 (31%) had chronic kidney disease. Median qualifying blood pressure (BP) was 200 (186, 220) systolic and 110 (93, 123) mm Hg diastolic. Initial intravenous antihypertensive therapies used to control BP varied, with 1,009 (64%) patients requiring multiple drugs. Median time to achieve a systolic BP <160 mm Hg (<140 mm Hg for subarachnoid hemorrhage) was 4.0 (0.8, 12) hours; 893 (60%) had reelevation to >180 (>140 for subarachnoid hemorrhage) after initial control; and 63 (4.0%) developed iatrogenic hypotension. Hospital mortality was 6.9% (n = 109) with an aggregate 90-day mortality rate of 11% (174/1,588); 59% (n = 943) had acute/worsening end-organ dysfunction during hospitalization. The 90-day readmission rate was 37% (523/1,415), of which one quarter (132/523) was due to recurrent acute severe hypertension. CONCLUSION This study highlights heterogeneity in care, BP control, and outcomes of patients hospitalized with acute severe hypertension.

Comparative trends in guidelines adherence among patients with non–ST-segment elevation acute coronary syndromes treated with invasive versus conservative management strategies: Results from the CRUSADE quality improvement initiative

BACKGROUND Prior studies have demonstrated differences in adherence to non-ST-segment elevation acute coronary syndromes (NSTE ACS) guidelines-recommended therapies among patients managed conservatively without cardiac catheterization compared with those managed invasively. We evaluated the degree of yearly change in use of guidelines-recommended therapies for patients with NSTE ACS in CRUSADE stratified by use of cardiac catheterization and revascularization procedures. METHODS We analyzed data from 138,714 high-risk patients with NSTE ACS treated at 547 hospitals during the first 4 years of the CRUSADE initiative. Patients were categorized as no cardiac catheterization (29% of the total population), cardiac catheterization without revascularization (21%), percutaneous coronary intervention (40%), and coronary artery bypass graft surgery (11%). Composite guidelines adherence scores were used to compare yearly changes in use of guidelines-recommended therapies among the groups. RESULTS Although guidelines adherence improved in all 4 groups each year and was consistently highest in the percutaneous coronary intervention group, the adjusted yearly increase in the use of acute guidelines-recommended medications was highest in the no cardiac catheterization group, and the adjusted yearly increase in the use of discharge medications was highest in the coronary artery bypass graft surgery group. CONCLUSIONS Improvements in the use of guidelines-recommended therapies were seen among all patients with NSTE ACS in CRUSADE over a 4-year period regardless of management strategy, and the trajectory of improvement in acute care was greatest in patients managed conservatively.

Lack of utility of telemetry monitoring for identification of cardiac death and life-threatening ventricular dysrhythmias in low-risk patients with chest pain.

STUDY OBJECTIVE Low-risk patients with chest pain are often admitted to monitored beds; however, the use of telemetry beds in this cohort is not evidence based. We tested the hypothesis that monitoring admitted low-risk patients with chest pain for dysrhythmia is low yield (<1% detection of life-threatening dysrhythmias requiring treatment). METHODS We conducted a prospective cohort study of emergency department (ED) patients with chest pain with a Goldman risk score of less than 8%, a normal initial creatine kinase-MB level, and a negative initial troponin I level admitted to non-ICU monitored beds. Investigators followed the hospital course daily. The main outcome was cardiovascular death and life-threatening ventricular dysrhythmia during telemetry. RESULTS Of 3,681 patients with chest pain who presented to the ED, 1,750 patients were admitted to non-ICU monitored beds. Of these, 1,029 patients had a Goldman risk score of less than 8%, a troponin I level of less than 0.3 ng/mL, and a creatine kinase-MB level of less than 5 ng/mL (accounting for 59% of all chest pain telemetry admissions). During hospitalization, there were no patients with sustained ventricular tachycardia/ventricular fibrillation requiring treatment on the telemetry service (0%; 95% confidence interval [CI] 0% to 0.3%). There were 2 deaths: neither was cardiovascular in nature or preventable by monitoring (cardiovascular preventable death rate=0%; 95% CI 0.0% to 0.3%). CONCLUSION The routine use of telemetry monitoring for low-risk patients with chest pain is of limited utility. Admission to nonmonitored beds might help alleviate ED crowding without increasing risk of adverse events caused by dysrhythmia in patients with a Goldman risk of less than 8%, an initial troponin I level of less than 0.3 ng/mL, and a creatine kinase-MB level of less than 5 ng/mL.

Patterns of transfer for patients with non–ST-segment elevation acute coronary syndrome from community to tertiary care hospitals

BACKGROUND Practice guidelines for non-ST-segment elevation acute coronary syndromes (NSTE ACS) recommend early invasive management (cardiac catheterization and revascularization within 48 hours of hospital presentation) for high-risk patients, but interhospital transfer is necessary to provide rapid access to revascularization procedures for patients who present to community hospitals without revascularization capabilities. METHODS We analyzed patterns and factors associated with interhospital transfer among 19,238 patients with NSTE ACS (positive cardiac markers and/or ischemic ST-segment changes) from 124 community hospitals without revascularization capabilities in the Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines quality improvement initiative from January 2001 through June 2004. RESULTS Less than half of the patients (46.3%) admitted to community hospitals were transferred to tertiary hospitals, and fewer (20%) were transferred early (within 48 hours of presentation). Early transfer rates increased by 16% over 10 quarters in patients with a predicted low or moderate risk of inhospital mortality, compared with 5% in high-risk patients. By the last quarter of the analysis, 41.4% of low-risk patients were transferred early versus 12.5% of high-risk patients. Factors significantly associated with early transfer included younger age, lack of prior heart failure, cardiology inpatient care, and ischemic ST-segment electrocardiographic changes. Among patients who were not transferred, 29% had no further risk stratification performed with stress testing, ejection fraction measurement, or diagnostic cardiac catheterization (at hospitals with catheterization laboratories). CONCLUSIONS Most patients with NSTE ACS presenting to community hospitals without revascularization capabilities are not rapidly transferred to tertiary hospitals, and lower-risk patients appear to be preferentially transferred early. Further investigation is needed to determine if improved risk-based triage at community hospitals can optimize transfer decision making for high-risk patients with NSTE ACS.

Unfractionated heparin dosing and risk of major bleeding in non-ST-segment elevation acute coronary syndromes.

BACKGROUND Unfractionated heparin (UFH) is a mainstay of treatment for patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS), but the practice of weight-adjusted bolus and infusion dosing has not been carefully evaluated. METHODS Using data from 31,445 high-risk patients with NSTE ACS enrolled at 420 hospitals in the CRUSADE initiative, we evaluated initial UFH dosing relative to guideline recommendations and determined factors associated with excess weight-adjusted dosing and major bleeding, overall and among subgroups. Excess dose was defined as >70 U/kg for bolus or >15 U/kg per hour for infusion. RESULTS The most frequent bolus dose was 5,000 U (42.7%) and infusion dose was 1,000 U/h (46%). An excess weight-adjusted UFH bolus or infusion dose was administered 35% of the time. Factors strongly associated with excess weight-adjusted dosing were age (per 10-year increase) (odds ratio [OR] 1.11, 95% CI 1.08-1.15) and female sex (OR 1.45, 95% CI 1.33-1.59). Rate of major bleeding increased proportionally in relation to dose of UFH for both bolus and infusion, specifically when dose was above the recommended weight-adjusted range (>70 U/kg for bolus or >15 U/kg per hour for infusion). Both excess bolus (OR 1.03, 95% CI 1.00-1.06) and infusion (OR 1.16, 95% CI 1.05-1.28) were individually associated with increased bleeding. The relationship between weight-adjusted UFH dose and major bleeding did not vary independently by sex or age. CONCLUSIONS In high-risk patients with NSTE ACS, initial UFH bolus and infusion dosing were frequently higher than recommended weight-adjusted ranges, particularly in patients with lower body weight. Excess bolus and infusion rate dosing was associated with more bleeding and was common among elderly and females. Attention to dosing by weight rather than standard bolus and infusion dosing should lead to improved safety in the use of UFH.

Hospital Performance and Differences by Kidney Function in the Use of Recommended Therapies After Non–ST-Elevation Acute Coronary Syndromes

BACKGROUND Chronic kidney disease (CKD) is associated with an increased risk of cardiac events and death; however, underuse of guideline-recommended therapies is widespread. The extent to which hospital performance affects the care of patients with CKD and non-ST-segment elevation acute coronary syndromes (NSTE ACSs) is unknown. STUDY DESIGN Observational cohort. SETTING & PARTICIPANTS 81,374 patients with NSTE ACSs treated at 327 US hospitals. PREDICTOR Hospital performance, measured by quartiles of composite adherence to American Heart Association class I guidelines for therapy acutely (aspirin, beta-blockers, clopidogrel, heparin, and glycoprotein IIb/IIIa inhibitors) and at discharge (aspirin, clopidogrel, angiotensin-converting enzyme inhibitors, and lipid-lowering agents) in eligible patients. OUTCOMES & MEASUREMENTS Use of each American Heart Association class I acute and discharge therapy stratified by continuous estimated glomerular filtration rate (eGFR). Multivariable models were adjusted for demographics, clinical factors, and hospital features. RESULTS Better-performing hospitals had lower prescribing rates for most therapies (5 of 9) with lower levels of kidney function, whereas lower-performing hospitals were more likely to have similar prescribing rates across the eGFR spectrum, suggesting that prescribing patterns at these hospitals were insensitive to differences in eGFR. LIMITATIONS Observational design, selection bias of study cohort. CONCLUSION Patients with lower levels of kidney function admitted with NSTE ACSs are less likely to receive evidence-based therapies. Treatment disparities related to CKD are most evident at top-performing hospitals.