Guideline-recommended Medications Research Articles

Comparison of Baseline Characteristics, Management and Outcome of Patients With Non–ST-Segment Elevation Acute Coronary Syndrome in Versus Not in Clinical Trials

Previous studies have questioned the external validity of randomized controlled trial results of acute coronary syndrome (ACS) because of potential selection bias toward healthier patients. We sought to evaluate differences in clinical characteristics and management of patients admitted with non-ST-elevation ACS according to participation in clinical trials over the previous decade. The Canadian ACS I (1999 to 2001), ACS II (2002-2003), GRACE (2004-2007), and CANRACE (2008) were prospective, multicenter registries of patients admitted to hospitals with ACS. We examined 13,556 patients with non-ST-elevation ACS, of whom 1,126 (8.3%) participated in clinical trials. Data were collected on baseline characteristics, medication use at admission and discharge, in-hospital procedures, and in-hospital adverse events. Patients enrolled in clinical trials were younger, more likely to be men, and had fewer co-morbidities. They were significantly more likely to be on several guideline-recommended medications and were significantly more likely to undergo invasive procedures, including coronary angiography, percutaneous coronary intervention, and coronary bypass surgery (all p values <0.001). Unadjusted in-hospital (2.1% vs 0.7%, p = 0.001) and 1-year (8.9% vs 6.3%, p = 0.037) mortality rates were higher in non-enrolled patients. In multivariable analysis, patients who were older, women, had a history of heart failure, and increased creatinine levels on presentation were less likely to be enrolled into clinical trials. In conclusion, significant differences persist in baseline characteristics, treatment, and outcomes between patients enrolled and those not enrolled in clinical trials. Consequently, generalization of ACS clinical trials over the previous decade to the "real-world" patient may remain in question.

Changes in guideline-recommended medication possession after implementing Kendra's law in New York.

This study examined changes in possession of guideline-recommended medication among three groups of New York State Medicaid enrollees with severe mental illness: those who received an involuntary outpatient commitment order, voluntary enhanced services, or neither of these interventions. An observational study was conducted with New York State Medicaid claims data for enrollees with bipolar, schizophrenia, or schizoaffective disorders in New York City, Long Island, and the Hudson River regions from 2000 to 2005 (N=7,762). With adjustment for clinical and demographic characteristics, logistic regression models predicted the probability of a monthly medication possession ratio (MPR) ≥ 80% for medications recommended by expert guidelines or by the U.S. Food and Drug Administration for the indicated psychiatric diagnosis. Separate models were fit by region and for patients who ever received assisted outpatient treatment (AOT), voluntary enhanced services but never AOT, or neither treatment. In all three regions, for all three groups, the predicted probability of an MPR ≥ 80% improved over time (AOT improved by 31-40 percentage points, followed by enhanced services, which improved by 15-22 points, and "neither treatment," improving 8-19 points). Some regional differences in MPR trajectories were observed. After New York implemented AOT and increased community resources for enhanced services, guideline-recommended medication possession improved among Medicaid enrollees with severe mental illness--even among those who never received these interventions or services. However, further study is needed to understand why there were different regional trajectories and why some groups did not gain similarly across regions.

E0277 Use of traditional Chinese medicine preparations in outpatients with coronary heart disease in China and its influence on the use of guideline-recommended therapies: Results from the Bridging the Gap on CHD Secondary Prevention in China (BRIG) Project

ObjectiveTo probe into the use of TCM preparations in the secondary prevention and treatment of CHD in China and investigate its influencing factors and relationship with guideline-recommended therapies.MethodsA cross-sectional survey...

Introduction to the Special Section on Assisted Outpatient Treatment in New York State

Introduction to the Special Section on Assisted Outpatient Treatment in New York State

Changes in Guideline-Recommended Medication Possession After Implementing Kendra's Law in New York

Changes in Guideline-Recommended Medication Possession After Implementing Kendra's Law in New York

The role of the hospitalist in quality improvement: Systems for improving the care of patients with acute coronary syndrome

Quality improvement (QI) initiatives for systems of care are vital to deliver quality care for patients with acute coronary syndrome (ACS) and hospitalists are instrumental to the QI process. Core hospitalist competencies include the development of protocols and outcomes measures that support quality of care measures established for ACS. The hospitalist may lead, coordinate, or participate in a multidisciplinary team that designs, implements, and assesses an institutional system of care to address rapid identification of patients with ACS, medication safety, safe discharge, and meeting core measures that are quality benchmarks for ACS. The use of metrics and tools such as process flow mapping and run charts can identify quality gaps and show progress toward goals. These tools may be used to assess whether critical timeframes are met, such as the time to fibrinolysis or percutaneous coronary intervention (PCI), or whether patients receive guideline-recommended medications and counseling. At the institutional level, Project BOOST (Better Outcomes for Older Adults Through Safe Transitions) is an initiative designed to improve outcomes in elderly patients who are at higher risk for adverse events during the transition from inpatient to outpatient care. BOOST offers resources related to project management and data collection, and tools for patients and physicians. Collection and analysis of objective data are essential for documenting quality gaps or achievement of quality benchmarks. Through QI initiatives, the hospitalist has an opportunity to contribute to an institution's success beyond direct patient care, particularly as required for public disclosure of institutional performance and financial incentives promoted by regulatory agencies.

Treatment disparities and effect on late mortality in patients with diabetes presenting with acute myocardial infarction: observations from the ACACIA registry

To compare the use of evidence-based pharmacological and invasive treatments and 12-month mortality rates between patients with and without diabetes who present with acute myocardial infarction (MI), and to explore the relationship between these treatments and late clinical outcomes. Prospective, nationwide multicentre registry: the Acute Coronary Syndrome Prospective Audit (ACACIA). Patients presenting to 24 metropolitan and 15 non-metropolitan hospitals with acute coronary syndrome (ACS) and a final discharge diagnosis of acute MI between November 2005 and July 2007. All-cause mortality at 12 months. Nearly a quarter of 1744 patients with a final diagnosis of acute MI had a history of diabetes on presentation. Patients with diabetes were older, with a greater prevalence of comorbidities than non-diabetic patients, and were less likely to be treated at discharge with evidence-based medications (aspirin, clopidogrel, a statin and/or a beta-blocker) or to receive early invasive procedures. After adjusting for baseline characteristics and therapeutic interventions, diabetes at presentation was independently associated with a higher mortality at 12 months after MI (hazard ratio, 1.79; 95% CI, 1.18-2.72; P=0.007). Early invasive management and discharge prescription of guideline-recommended medications were associated with a significantly reduced hazard of mortality at 12 months. Patients with diabetes have a higher risk than non-diabetic patients of late mortality following an acute MI, yet receive fewer guideline-recommended medications and early invasive procedures. Increased application of proven pharmacotherapies and an early invasive management strategy in patients with diabetes presenting with ACS might improve their outcomes. STUDY PROTOCOL NUMBER (SANOFI-AVENTIS): PML-0051.

Outcomes Among Patients With Non–ST-Segment Elevation Myocardial Infarction Presenting to Interventional Hospitals With and Without On-Site Cardiac Surgery

The goals of this analysis were: 1) to evaluate outcomes among non-ST-segment elevation myocardial infarction (NSTEMI) patients presenting to hospitals with on-site cardiac surgery (OHS hospitals) and without on-site cardiac surgery (No-OHS hospitals); and 2) to specifically examine outcomes among the subset of NSTEMI patients undergoing percutaneous coronary intervention (PCI). Whether backup cardiac surgery improves outcomes among NSTEMI patients or is simply a marker of better adherence to guideline recommendations is unknown. The NRMI (National Registry of Myocardial Infarction) enrolled 100,071 NSTEMI patients from 2004 to 2006. Outcomes were evaluated in the population as a whole and in propensity-matched analyses in the entire population and in the subset of patients undergoing PCI. In-hospital mortality was significantly lower at OHS hospitals (5.0% vs. 8.8%, p < 0.001). Patients presenting to OHS hospitals were significantly more likely to receive aspirin, beta-blockers, and statins (p < 0.05 for all) and to undergo PCI (38.4% vs. 14.1%, p < 0.001). In the propensity-matched model, the difference in mortality remained significant (5.9% vs. 8.5%, p < 0.001). After adjusting for differences in medications administered within 24 h of arrival and hospital characteristics, the difference in mortality was nearly attenuated (hazard ratio: 0.89, 95% confidence interval: 0.79 to 1.00, p = 0.050). When the propensity-matched model was restricted to patients undergoing PCI, there was no significant difference in mortality (1.3% vs. 1.0%, p = 0.51). NSTEMI patients presenting to No-OHS hospitals have significantly higher mortality. This appears to be due to both modifiable (lower use of guideline-recommended medications) and nonmodifiable factors (hospital size, myocardial infarction volume). In a propensity-matched analysis of patients undergoing PCI for NSTEMI, there was no significant difference in mortality.

Is there an acceptable ceiling for bleeding for an antithrombotic drug dose to be tested in a phase 3 trial?

This editorial refers to ‘Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial’†, by M. Sabatine, published in the Lancet , 2009;374:787–795. The SEPIA-ACS1 TIMI 42 (Study to Evaluate the Pharmacodynamics, the Safety and Tolerability, and the Pharmacokinetics of Several Intravenous Regimens of the Factor Xa Inhibitor Otamixaban (XRP0673), in Comparison to Intravenous Unfractionated Heparin-Acute Coronary Syndromes-Thrombolysis In Myocardial Infarction) trial is a well performed trial. It tested otamixaban, which is a short-acting i.v. direct factor Xa inhibitor with a half-life of 30 min, compared with unfractionated heparin (UFH) plus eptifibatide in patients with non-ST elevation acute coronary syndrome (NSTEACS). The trial identified a signal for reduction in ischaemic events with otamixaban but also a signal associated with increased bleeding. This is an important study with a high rate of angiography (98%) and guideline-recommended medications. The trial was a large dose-ranging trial in 3241 patients with NSTEACS following a dose-ranging trial in 947 patients undergoing non urgent percutaneous coronary intervention (PCI; SEPIA PCI trial).1 This is to be compared with a previous era when small numbers of patients were investigated in order to select a dose for a phase III trial, e.g. in GUSTO2 <100 patients were tested with the streptokinase–tissue plasminogen activator (tPA) combination, and in GUSTO IIa <50 patients were tested with the hirudin dose that was evaluated in GUSTO IIa.3 The patients enrolled in SEPIA-ACS14 were at …

Age- and Gender-Related Differences in Quality of Care and Outcomes of Patients Hospitalized With Heart Failure (from OPTIMIZE-HF)

Previous studies have suggested that female and elderly patients with heart failure (HF) are less likely to receive guideline-recommended therapies, but these studies have involved select patient populations. We evaluated the differences in medical care and patient outcomes by age and gender among a broad cohort of hospitalized patients with HF. The Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure (OPTIMIZE-HF) is a registry and performance-improvement program involving 48,612 patients with HF from 259 hospitals. The data were analyzed by gender, age <75 years, and age > or =75 years. Appropriate angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and beta-blocker use were similar between women and men (p = 0.244 and p = 0.237, respectively). However, compared with men, fewer women received hospital discharge instructions (p <0.001) and the length of stay was longer (p <0.001). Risk-adjusted in-hospital and postdischarge mortality were similar. All guideline-recommended cardiac medications were prescribed less frequently at discharge to eligible patients > or =75 than to those <75 years (all p <0.001). Older age was independently associated with in-hospital and postdischarge mortality risk increases (76% and 62%, respectively; p <0.001 for both). In conclusion, among the OPTIMIZE-HF hospitals, female patients with HF generally received similar medical care and had similar risks of adverse clinical outcomes compared with male patients. Older patients with HF were less likely to receive guideline-recommended therapies and remained at greater risk of adverse outcomes.

Long-term Medication Adherence after Myocardial Infarction: Experience of a Community

Background Adherence to evidence-based medications after myocardial infarction is associated with improved outcomes. However, long-term data on factors affecting medication adherence after myocardial infarction are lacking. Methods Olmsted County residents hospitalized with myocardial infarction from 1997-2006 were identified. Adherence to HMG-CoA reductase inhibitors (statins), beta blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers, were examined. Cox proportional hazard regression was used to determine the factors associated with medication adherence over time. Results Among 292 subjects with incident myocardial infarction (63% men, mean age 65 years), patients were followed for an average of 52 ± 31 months. Adherence to guideline-recommended medications decreased over time, with 3-year medication continuation rates of 44%, 48%, and 43% for statins, beta-blockers, and angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, respectively. Enrollment in a cardiac rehabilitation program was associated with an improved likelihood of continuing medications, with adjusted hazard ratio (95% confidence interval) for discontinuation of statins and beta-blockers among cardiac rehabilitation participants of 0.66 (0.45-0.92) and 0.70 (0.49-0.98), respectively. Smoking at the time of myocardial infarction was associated with a decreased likelihood of continuing medications, although results did not reach statistical significance. There were no observed associations between demographic characteristics, clinical characteristics of the myocardial infarction, and medication adherence. Conclusions After myocardial infarction, a large proportion of patients discontinue use of medications over time. Enrollment in cardiac rehabilitation after myocardial infarction is associated with improved medication adherence.

Medication Underuse During Long-Term Follow-Up in Patients With Peripheral Arterial Disease

Patients with peripheral arterial disease constitute a high-risk population. Guideline-recommended medical therapy use is therefore of utmost importance. The aims of our study were to establish the patterns of guideline-recommended medication use in patients with PAD at the time of vascular surgery and after 3 years of follow up, and to evaluate the effect of these therapies on long-term mortality in this patient group. Data on 711 consecutive patients with peripheral arterial disease undergoing vascular surgery were collected from 11 hospitals in the Netherlands (enrollment between May and December 2004). After 3.1+/-0.1 years of follow-up, information on medication use was obtained by a questionnaire (n=465; 84% response rate among survivors). Guideline-recommended medical therapy use for the combination of aspirin and statins in all patients and beta-blockers in patients with ischemic heart disease was 41% in the perioperative period. The use of perioperative evidence-based medication was associated with a reduction of 3-year mortality after adjustment for clinical characteristics (hazard ratio, 0.65; 95% CI, 0.45 to 0.94). After 3 years of follow-up, aspirin was used in 74%, statins in 69%, and beta-blockers in 54% of the patients respectively. Guideline-recommended medical therapy use for the combination of aspirin, statins, and beta-blockers was 50%. The use of guideline recommended therapies in the perioperative period was associated with reduction in long-term mortality in patients with peripheral arterial disease. However, the proportion of patients receiving these evidence-based treatments-both at baseline and 3 years after vascular surgery-was lower than expected based on the current guidelines. These data highlight a clear opportunity to improve the quality of care in this high-risk group of patients.

In-Hospital and 1-Year Outcomes Among Percutaneous Coronary Intervention Patients With Chronic Kidney Disease in the Era of Drug-Eluting Stents: A Report From the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) Registry

This study sought to evaluate ischemic and bleeding outcomes in patients with chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Previous studies have shown that CKD is associated with poor outcomes after PCI. However, these studies were largely conducted before the introduction of DES and aggressive antithrombotic therapy or were performed in the setting of randomized trials. With data from a contemporary registry, we evaluated the influence of CKD on major cardiovascular events and bleeding complications in unselected "real-world" patients undergoing PCI. Data from 4,791 patients enrolled in the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) Registry between July 2004 and September 2005 were analyzed. Patients were stratified into 4 groups: creatinine clearance (CrCl) >75, 50 to 75, 30 to 49 and <30 ml/min. During the index hospital stay, there was a step-wise increase in bleeding complications with decreasing CrCl (3.3%, 5.0%, 8.8%, and 14.3%; p < 0.0001 for trend). Lower CrCl was also associated with more frequent death or myocardial infarction (MI) during the initial hospital stay (p = 0.001) and at 1 year (p < 0.001). These findings were confirmed in multivariate analyses that adjusted for baseline differences in demographic, clinical, and angiographic factors. Use of guideline-recommended medications at 1 year, including aspirin, clopidogrel, angiotensin-converting enzyme inhibitors, and statins, also decreased with declining renal function. Renal function is an independent and powerful predictor of bleeding and ischemic complications in the era of DES and contemporary antithrombotic therapy in patients undergoing PCI. The low use of guideline-recommended drugs among patients with CKD undergoing PCI might contribute to these adverse outcomes and warrants further evaluation.

124: Treatment of Acute Decompensated Heart Failure in Canadian Emergency Departments: Sub-Optimal Use of Guideline-Recommended Medications

124: Treatment of Acute Decompensated Heart Failure in Canadian Emergency Departments: Sub-Optimal Use of Guideline-Recommended Medications

Performance Measures and Outcomes for Patients Hospitalized With Heart Failure

To the Editor: Dr Fonarow and colleagues studied the association between heart failure performance measures and mortality and rehospitalization. While adherence to guidelines is important and could affect hard clinical end points, neither this study nor the American College of Cardiology/American HeartAssociation(ACC/AHA)clinicalperformancemeasures for adults with chronic heart failure addresses patient medication adherence, an important aspect of this complex issue. There is evidence that 15% to 30% of patients discontinue guideline-recommended medications within 1 year, and, in some cases, do so as early as 30 days. Therefore, assessing quality of care based on performance measures at discharge without also considering patient medication adherence introduces potential for significant bias. Using such measures to judge the quality of efforts at facilities or by physicians who serve population subgroups less likely to adhere to medications is akin to ignoring case mix—an approach that would be judged unfair. While we agree with Fonarow et al that additional measures and better methods are needed to accurately assess and improve the care of patients with heart failure, such measures must consider all factors with significant influence on patient outcomes. Developing a “multilevel” performance measure that captures both physicians’ adherence to evidence-based guidelines and patients’ adherence to these regimens would better reflect quality in heart failure care and enable a more accurate assessment of performance in the delivery of health care for this and other chronic diseases.

How Are Substance Use Disorders Addressed in VA Psychiatric and Primary Care Settings? Results of a National Survey

This study examined interventions for substance use disorders within the Department of Veterans Affairs (VA) psychiatric and primary care settings. National random samples of 83 VA psychiatry program directors and 102 primary care practitioners were surveyed by telephone. The survey assessed screening practices to detect substance use disorders, protocols for treating patients with substance use disorders, and available treatments for substance use disorders. Respondents reported extensive contact with patients with substance use problems. However, a majority reported being ill equipped to treat substance use disorders themselves; they usually referred such patients to specialty substance use disorder treatment programs. Offering fewer specialty substance use disorder services within the VA may be problematic: providers can refer patients to specialty programs only if such programs exist. Caring for veterans with substance use disorders may require increasing the capacity of and establishing new specialty programs or expanding the ability of psychiatric programs and primary care practitioners to provide such care.

The Treatment-Risk Paradox: More Complex Than We Think

Evidence reveals that patients at highest risk for poor outcomes are less likely than those at low risk to receive appropriate therapy, a phenomenon termed the “treatment-risk paradox.” In a prospective cohort study, researchers looked at use of guideline-recommended medications in patients with angiographically proven coronary heart disease, with a focus on functional capacity and depressive symptoms (factors likely to “fly under the radar” because they are not coded). One month after catheterization, nearly 4000 patients reported on …

The influence of risk status on guideline adherence for patients with non–ST-segment elevation acute coronary syndromes

Practice guidelines for patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) recommend targeting evidence-based therapies for the highest-risk patients. We characterized guideline adherence for NSTE ACS by risk status. We analyzed inhospital treatments and outcomes for 77760 patients with NSTE ACS (ischemic ST-segment changes and/or positive cardiac markers) included in the CRUSADE initiative from January 2001 to September 2003 at 457 US hospitals. Compliance with the American College of Cardiology/American Heart Association Class guideline recommendations for NSTE ACS was evaluated in subgroups of eligible patients without listed contraindications at increased risk for mortality and among risk categories designated by an adapted version of the PURSUIT risk model designed to predict inhospital mortality. Inhospital mortality was increased in patients with diabetes mellitus (5.8% vs 4.3%), renal insufficiency (10.0% vs 3.9%), signs of congestive heart failure on presentation (10.6% vs 3.1%), and age > or = 75 years (8.6% vs 2.7%), compared with patients without these features. Use of guideline-recommended acute medications, invasive cardiac procedures, and discharge medications and interventions was significantly lower in patients with these high-risk features. Patients designated as high-risk for inhospital mortality were less likely to be treated with guideline-recommended therapies compared with low-risk and moderate-risk patients. Patients with NSTE ACS with the highest risk of mortality are less likely to receive guideline-recommended therapies and interventions. These findings highlight the need to clarify guideline recommendations for high-risk patients and to develop novel quality improvement approaches that target undertreated subgroups of patients with NSTE ACS.

Implementation of evidence–based therapy in patients with systolic heart failure from 1998–2000

In recent years, the incidence of systolic heart failure has increased. Besides a complete revascularization, guideline-based medication represents the most effective therapeutic approach. Analysis of adherence of guideline-recommended and actual medication during inpatient cardiac rehabilitation as well as under subsequent outpatient conditions. From 01/1998 to 12/ 2000, 1346 consecutive patients (64 +/- 10 years, 73% male, LVEF 36.3 +/- 8%, 88% ischemic, 6.7% valvular cardiomyopathy, 5.3% other causes, 11.8% atrial fibrillation) were included in a singlecenter prospective register. Medication was recorded at discharge and after the follow-up period of 731 +/- 215 days. Trends in prescription rates were analyzed based on nonparametric correlations (Spearman's-Rho). Changes in medication from in- to outpatient settings were analyzed using exact McNemar test. At discharge 75.3% (67.9%/68.9%/ 86.6% in 1998/1999/2000, p <0.001) of the patients were treated as recommended. This rate dropped to 68.3% at followup (p <0.0001). Mortality within the follow-up period was low (12.6%). It could be shown that from 1998 to 2000 inpatient guideline conformity was implementable adequately. Outpatient conformity was significantly lower. Although a high proportion of correctly prescribed CHF medication could be demonstrated, a further effort to improve guideline adherence in the management of heart failure patients is desirable.

Quality of Care by Classification of Myocardial Infarction

Practice guidelines for acute ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) recommend similar therapies and interventions, but differences in patterns of care between MI categories have not been well described in contemporary practice. In-hospital treatments with similar recommendations from practice guidelines were compared with outcomes in 185 968 eligible patients (without listed contraindications) with STEMI (n = 53 417; 29%) vs NSTEMI (n = 132 551; 71%) from 1247 US hospitals participating in the National Registry of Myocardial Infarction 4 between July 1, 2000, and June 30, 2002. Hierarchical logistic regression modeling was used to determine adjusted differences in treatment patterns in MI categories. Unadjusted in-hospital mortality rates were high for NSTEMI (12.5%) and STEMI (14.3%), and the use of guideline-recommended medications and interventions was suboptimal in both categories of patients with MI. The adjusted likelihood of receiving early (within 24 hours of presentation) aspirin, beta-blockers, and angiotensin-converting enzyme inhibitors was higher in patients with STEMI. Similar patterns of care were noted at hospital discharge: the adjusted likelihood of receiving aspirin, beta-blockers, angiotensin-converting enzyme inhibitors, lipid-lowering agents, smoking cessation counseling, and cardiac rehabilitation referral was higher in patients with STEMI. Evidence-based medications and lifestyle modification interventions were used less frequently in patients with NSTEMI. Quality improvement interventions designed to narrow the gaps in care between NSTEMI and STEMI and to improve adherence to guidelines for both categories of patients with MI may reduce the high mortality rates associated with acute MI in contemporary practice.