Thiazide-type diuretics are associated with an increased incidence of diabetes as compared to other anti-hypertension medications. In this study we determined long-term cardiovascular disease (CVD) consequences of incident diuretic-associated diabetes compared to the effects of incident diabetes associated with calcium channel and ACE inhibitor use.
Methods and Results
22,418 participants from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial with baseline diabetes, incident diabetes (7.5% with chlorthalidone, 5.6% with amlodipine, and 4.3% with lisinopril), or no diabetes at 2 years of in-trial follow-up were followed for a mean total of 6.9 years (2.9 years in-trial and 4 additional years post-trial through the use of national data bases). The primary outcome was CVD mortality (death due to coronary heart disease [CHD], stroke, heart failure, or other CVD). Among other outcomes were all-cause mortality, non-CVD mortality, and CHD (nonfatal myocardial infarction/fatal CHD). Participants on chlorthalidone with incident diabetes versus no diabetes had consistently lower, non-significant risk for CVD mortality (hazard ratio [HR] 1.04, 95% confidence interval (CI 0.74–1.47), all-cause mortality (HR 1.04, 95% CI 0.82–1.30), and non-CVD mortality (HR 1.05, 95% CI 0.77–1.42) than participants with incident diabetes on amlodipine or lisinopril (HR’s 1.22–1.53). Participants with incident diabetes had elevated CHD risk compared to those with no diabetes (HR 1.46, 95% CI 1.09–1.96) but those on chlorthalidone had significantly lower risk than those on lisinopril (HR 1.18 versus 2.57, p for interaction = 0.04).
Our findings suggest that thiazide-related incident diabetes has less adverse long-term CVD impact than incident diabetes that develops on other antihypertensive medications.
diabetes mellitus; diuretics; cardiovascular diseases; mortality; ALLHAT
The use of coronary artery bypass grafting (CABG) surgery in China is growing, but little is known about hospital-level performance. We sought to characterize the variation in performance across hospitals participating in a national registry in China.
Methods and results
The study sample was drawn from the Chinese Cardiac Surgery Registry (CCSR), a national multi-center database that includes 43 hospitals across 13 provinces and 4 direct-controlled municipalities in China. We assessed consecutive patients undergoing isolated CABG surgery during the period of January 1, 2007 through December 31, 2008. Hierarchical generalized linear models were used to estimate hospital-level risk-standardized in-hospital all-cause mortality rates (RSMR) and major complication rates (RSMCR), which included death, myocardial infarction, reoperation for bleeding, mediastinal infection, stroke, re-intubation, and renal failure. Among 8739 patients who underwent isolated CABG surgery, the mean age was 62.2 years (Standard Deviation [SD]=9.2) and 78% were male. Observed in-hospital mortality and complication rates were 2.2% (95% Confidence Interval [CI], 1.9%–2.5%) and 6.6% (95% CI, 6.1%–7.1%) respectively. The mean RSMR was 1.9% (SD=1.1) with a range of 0.7% to 5.8%, and the mean RSMCR was 6.4% (SD=1.5) with a range of 3.8% to 10.1%. The odds of dying and the odds of having a complication after CABG surgery at a hospital one SD below the average relative to a hospital one SD above the average were 2.06 (95% CI, 1.40–3.04) and 1.53 (95% CI, 1.31–1.79) respectively. The Eastern region had the lowest RSMR and RSMCR (1.6% and 5.8%, respectively), whereas the Central region had the highest RSMR (2.5%) and the Southern region had the highest RSMCR (7.7%).
Mortality and complication rates after CABG surgery in the Chinese Cardiac Surgery Registry are generally low but vary by hospital and region within China. These results suggest that there are opportunities to improve outcomes in some CABG facilities.
CABG; outcomes research
Improvements in prevention have led to declines in incidence and mortality of MI in selected populations. However, no studies have examined regional differences in recent trends in MI incidence, and few have examined whether known regional disparities in MI care have narrowed over time.
Methods and Results
We compared trends in incidence rates of MI, associated procedures and mortality for all U.S. Census Divisions (regions) in Medicare fee-for-service patients between 2000 and 2008 (292,773,151 patient-years). Two-stage hierarchical models were used to account for patient characteristics and state-level random effects. To assess trends in geographical disparities, we calculated changes in between-state variance for outcomes over time. While the incidence of MI declined in all regions (P < 0.001 for trend for each) between 2000 and 2008, adjusted rates of decline varied by region (annual declines ranging from 2.9% to 6.1%). Widening geographical disparities, as measured by percent change of between-state variance from 2000 to 2008, were observed for MI incidence (37.6% increase, P = 0.03) and PCI rates (31.4% increase, P = 0.06). Significant declines in risk-adjusted 30-day mortality were observed in all regions, with the fastest declines observed in states with higher baseline mortality rates.
In a large contemporary analysis of geographic trends in MI epidemiology, the incidence of MI and associated mortality declined significantly in all U.S. Census Divisions between 2000 and 2008. While geographical disparities in MI incidence may have increased, regional differences in MI-associated mortality have narrowed.
myocardial infarction; Medicare; trends; disparities
The survival difference between off-pump and on-pump coronary artery bypass graft (CABG) surgery for follow-up longer than 5 years is not well understood. The objective of this study is to examine the difference in 7-year mortality after these two procedures.
Methods and Results
New York State’s Cardiac Surgery Reporting System was used to identify the 2,640 off-pump and 5,940 on-pump isolated CABG patients discharged from July through December, 2000. The National Death Index was used to ascertain patients’ vital statuses through 2007. A logistic regression model was fit to predict the probability of receiving an off-pump procedure using baseline patient characteristics. Off-pump and on-pump patients were matched with a 1:1 ratio based on the probability of receiving an off-pump procedure. Kaplan-Meier survival curves for the 2 procedures were compared using the propensity-matched data, and the hazard ratio for death for off-pump in comparison to on-pump procedures was obtained. In subgroup analyses, the significance of interactions between type of surgery and baseline risk factors was tested. In this study, 2,631 pairs of off-pump and on-pump patients were propensity matched. The 7-year Kaplan-Meier survival rates were 71.2% and 73.4% (P=0.07) for off-pump and on-pump surgery, respectively. The hazard ratio for death (off-pump vs. on-pump) was 1.10 (95% confidence interval: 0.99-1.21, P=0.07). No statistical significance was detected for the interaction terms between type of surgery and a number of different baseline risk factors.
The difference in long-term morality between on-pump and off-pump CABG surgery is not statistically significant.
CABG; coronary artery disease; follow-up studies; mortality; off-pump surgery
Atrial fibrillation (AF) is a common and costly problem among older persons. The frequency of AF increases with age, but representative national data about incidence and prevalence are limited. We examined the annual incidence, prevalence, and mortality associated with AF among older persons.
Methods and Results
In a retrospective cohort study of Medicare beneficiaries 65 years and older diagnosed with AF between 1993 and 2007, we measured annual age- and sex-adjusted incidence and prevalence of AF and mortality following an AF diagnosis. Among 433,123 patients with incident AF, the mean age was 80 years, 55% were women, and 92% were white. The incidence of AF remained steady during the 14-year study period, ranging from 27.3 to 28.3 per 1000 person-years. Incidence rates were consistently higher among men and white beneficiaries. The prevalence of AF increased across the study period (mean, 5% per year) and was robust to sensitivity analyses. Among beneficiaries with incident AF in 2007, 36% had heart failure, 84% had hypertension, 30% had cerebrovascular disease, and 8% had dementia. Mortality after AF diagnosis declined slightly over time but remained high. In 2007, the age- and sex-adjusted mortality rates were 11% at 30 days and 25% at 1 year.
Among older Medicare beneficiaries, incident AF is common and has remained relatively stable for more than a decade. Incident AF is associated with significant comorbidity and mortality; death occurs in one-quarter of beneficiaries within 1 year.
atrial fibrillation; mortality; outcome assessment (health care)
The Centers for Medicare and Medicaid Services is considering developing a 30-day ischemic stroke hospital-level mortality model using administrative data. We examined whether inclusion of the NIH Stroke Scale (NIHSS), a measure of stroke severity not included in administrative data, would alter 30-day mortality rates in the Veterans Health Administration (VHA).
2562 veterans admitted with ischemic stroke to 64 VHA Hospitals in fiscal year 2007 were included. First, we examined the distribution of unadjusted mortality rates across the VHA. Second, we estimated 30-day-all-cause-risk standardized-mortality rates (RSMR) for each hospital by adjusting for age, gender and comorbid conditions using hierarchical models with and without inclusion of the NIHSS. Finally, we examined whether adjustment for the NIHSS significantly changed RSMRs for each hospital compared to other hospitals.
The median unadjusted mortality rate was 3.6%. The RSMR inter-quartile range without the NIHSS ranged from 5.1% to 5.6%. Adjustment with the NIHSS did not change the RSMR inter-quartile range (5.1% to 5.6%). Among veterans ≥ 65 years, the RSMR inter-quartile range without the NIHSS ranged from 9.2% to 10.3%. With adjustment for the NIHSS, the RSMR inter-quartile range changed to 9.4% to 10.0%. The plot of 30-day RSMRs estimated with and without the inclusion of the NIHSS in the model demonstrated overlapping 95% confidence intervals across all hospitals, with no hospital significantly below or above the mean unadjusted 30-day mortality rate. The 30-day mortality measure did not discriminate well among hospitals.
The impact of the NIHSS on RSMRs was limited. The small number of stroke admissions and the narrow range of 30-day stroke mortality rates at the facility level in the VHA cast doubt on the value of using 30-day RSMRs as a means of identifying outlier hospitals based on their stroke care quality.
stroke; outcome assessment (health care); hospital mortality
Clopidogrel use following drug eluting coronary artery stent (DES) implant is essential for prevention of early in-stent thrombosis, but clopidogrel use among older DES recipients has not been widely studied. We sought to identify characteristics associated with failure to fill a clopidogrel prescription and to examine the relationship between a clopidogrel prescription fill and hospitalization for acute myocardial infarction (AMI) or death.
Methods and Results
Retrospective analysis of administrative data (20% sample) for 15,996 Medicare Part D enrollees receiving a DES 2006–2007. We modeled the adjusted probability and odds of clopidogrel prescription fill within 7 and 90 days of discharge and its association with AMI hospitalization or death. 19.7% of individuals did not fill a clopidogrel prescription within 7 days of discharge, falling to 13.3% by day 90. The adjusted probability of filling a clopidogrel prescription within 7 or 90 days of discharge was lower for patient with dementia (20.2% less likely, 95% CI 10.4–30.1%), depression (10.7% less likely, 95% CI 6.9–14.5%), age >84 compared to age 65–69 (10.6% less likely, 95% CI 8.6–12.7%), black race (6.6% less likely, 95% CI 4.2–9.0%), intermediate levels of medication cost-share (5.2% less likely, 95% CI 2.9–7.6%), and female sex (3.3% less likely, 95% CI 2.1–4.5%). It was higher for patients initially hospitalized for an AMI (12.5% more likely, 95% CI 11.3–13.6%). Failure to fill a clopidogrel prescription within 7 days of discharge was associated with a higher adjusted odds ratio of death during days 8–90 (OR 2.44, 95% CI 1.76–3.38) but was not associated with an increased risk of hospitalization for AMI.
One in five patients failed to fill a prescription for clopidogrel following DES at 7 days and one in seven failed by 3 months. Individual characteristics available at the time of hospital discharge were associated with a clopidogrel prescription fill. Those mostly strongly associated with nonadherence, including age >84, not having an AMI, depression, and dementia, may guide clinicians and health systems seeking to target this high-risk population and improve health outcomes following percutaneous coronary intervention (PCI).
stents; coronary disease; medication adherence
Patient-centered health care interventions, such as heart failure disease management programs, are under increasing pressure to demonstrate good value. Variability in costing methods and assumptions in economic evaluations of such interventions limit the comparability of cost estimates across studies. Valid cost estimation is critical to conducting economic evaluations and for program budgeting and reimbursement negotiations.
Methods and Results
Using sound economic principles, we developed the Tools for Economic Analysis of Patient Management Interventions in Heart Failure (TEAM-HF) Costing Tool, a spreadsheet program that can be used by researchers or health care managers to systematically generate cost estimates for economic evaluations and to inform budgetary decisions. The tool guides users on data collection and cost assignment for associated personnel, facilities, equipment, supplies, patient incentives, miscellaneous items, and start-up activities. The tool generates estimates of total program costs, cost per patient, and cost per week and presents results using both standardized and customized unit costs for side-by-side comparisons. Results from pilot testing indicated that the tool was well-formatted, easy to use, and followed a logical order. Cost estimates of a 12-week exercise training program in patients with heart failure were generated with the costing tool and were found to be consistent with estimates published in a recent study.
The TEAM-HF Costing Tool could prove to be a valuable resource for researchers and health care managers to generate comprehensive cost estimates of patient-centered interventions in heart failure or other conditions for conducting high-quality economic evaluations and making well-informed health care management decisions.
Computing Methodologies; Disease Management; Health Care Costs
Reporting of quality indicators (QIs) in Veterans Health Administration Medical Centers is complicated by estimation error due to small numbers of eligible patients per facility. We applied multilevel modeling and empirical Bayes (EB) estimation in addressing this issue in performance reporting of stroke care quality in the Medical Centers.
Methods and Results
We studied a retrospective cohort of 3812 veterans admitted to 106 Medical Centers with ischemic stroke during fiscal year 2007. The median number of study patients per facility was 34 (range: 12-105). Inpatient stroke care quality was measured with thirteen evidence-based QIs. Eligible patients could either pass or fail each indicator. Multilevel modeling of a patient’s pass/fail on individual QIs was used to produce facility-level EB estimated QI pass rates and confidence intervals. The EB estimation reduced inter-facility variation in QI rates. Small facilities and those with exceptionally high or low rates were most affected. We recommended 8 of the 13 QIs for performance reporting: dysphagia screening, NIH Stroke Scale documentation, early ambulation, fall risk assessment, pressure ulcer risk assessment, Functional Independence Measure documentation, lipid management, and deep vein thrombosis prophylaxis. These QIs displayed sufficient variation across facilities, had room for improvement, and identified sites with performance that was significantly above or below the population average. The remaining 5 QIs were not recommended because of too few eligible patients or high pass rates with little variation.
Considerations of statistical uncertainty should inform the choice of QIs and their application to performance reporting.
acute stroke; performance measurement; quality indicators; stroke management; statistics
Many believe that variation in vascular practice may affect limb salvage rates in patients with severe PAD. However, the extent of variation in procedural vascular care obtained by patients with critical limb ischemia (CLI) remains unknown.
Methods and Results
Using Medicare 2003–2006, we identified all patients with CLI who underwent major lower extremity amputation in the 306 hospital referral regions (HRRs) described in the Dartmouth Atlas of Healthcare. For each patient, we studied the use of lower extremity vascular procedures (open surgery or endovascular intervention) in the year prior to amputation. Our main outcome measure was the intensity of vascular care, defined as the proportion of patients in the HRR undergoing vascular procedure in the year before amputation. Overall, 20,464 patients with CLI underwent major lower extremity amputations during the study period, and collectively underwent 25,800 vascular procedures in the year prior to undergoing amputation. However, these procedures were not distributed evenly − 54% of patients had no vascular procedures performed in the year prior to amputation, 14% underwent 1 vascular procedure, and 21% underwent more than one vascular procedure. In the regions in the lowest quintile of vascular intensity, vascular procedures were performed in 32% of patients. Conversely, in the regions in the highest quintile of vascular intensity, revascularization was performed in 58% of patients in the year prior to amputation (p<0.0001). In analyses accounting for differences in age, sex, race, and comorbidities, patients in high intensity regions were 2.4 times as likely to undergo revascularization in the year prior to amputation than patients in low intensity regions (adjusted OR=2.4, 95% CI 2.1–2.6, p<0.001).
Significant variation exists in the intensity of vascular care provided to patients in the year prior to major amputation. In some regions, patients receive intensive care, while in other regions, far less vascular care is provided. Future work is needed to determine the association between intensity of vascular care and limb salvage.
epidemiology; outcomes research; peripheral vascular disease; treatment disparities; vascular disease
Measurement of hospital quality has traditionally focused on processes of care and post-procedure outcomes. Appropriateness measures for percutaneous coronary intervention (PCI) assess quality as it relates to patient selection in the context of anticipated benefits relative to potential harm. The association, if any, between patient selection for PCI and processes of care and post-procedural outcomes is unknown. Defining whether these measures are redundant or complementary can inform the optimal range of metrics for monitoring quality.
We included patients undergoing non-acute (elective) PCI within the NCDR CathPCI Registry® between July 2009 and April 2011. We examined the association between a hospital’s proportion of non-acute PCIs categorized as inappropriate by the 2009 Appropriate Use Criteria (AUC) for Coronary Revascularization and in-hospital mortality, bleeding complications, and use of optimal guideline-directed medical therapy at discharge (i.e. aspirin, thienopyridines, and statins).
A total of 203,531 non-acute PCIs from 779 hospitals were classified by the AUC. Of these, 101,779 (50.0%) were classified as appropriate, 77,220 (35.5%) as uncertain, and 24,532 (12.1%) as inappropriate. When categorized as hospital tertiles, the range of inappropriate PCI was 0.0 to 8.1% in the lowest-tertile, 8.1 to 15.2% in the middle-tertile, and 15.2 to 58.6% in the highest-tertile. Compared with lowest-tertile hospitals, mortality was not significantly different at middle-tertile (adjusted odds ratio [OR] 0.93; 95% confidence interval [CI] 0.73 to 1.19) or highest-tertile hospitals (OR 1.12; 95% CI 0.88 to 1.43; p=0.35 for differences between any tertile). Similarly, risk-adjusted bleeding did not vary significantly (middle-tertile OR 1.13; 95% CI 1.02 to 1.16; highest-tertile OR 1.02; 95% CI 0.91 to 1.16; p=0.07 for differences between any tertile) nor did use of optimal therapy at discharge after PCI (85.3% vs. 85.7% vs. 85.2%; P=0.58).
In a national cohort of non-acute PCIs, a hospital’s proportion of inappropriate PCIs was not associated with in-hospital mortality, bleeding, or medical therapy at discharge. These findings suggest that PCI appropriateness measures aspects of hospital PCI quality that are independent of, and complementary to, traditional quality metrics.
Appropriateness criteria; Coronary artery disease; Percutaneous coronary intervention; Utilization; Hospital; Quality of care; Health services research
Trials comparing hypertension monotherapies have found either no difference or modest differences in blood pressure (BP) and cardiovascular (CV) events. However, no trial has assessed the comparative effectiveness of second-line therapy in patients whose BP was not controlled on a thiazide diuretic.
Methods and Results
Observational study conducted using a hypertension registry of adults enrolled in 3 large integrated healthcare delivery systems from 2002-2007. Patients newly started on thiazide monotherapy whose BP remained uncontrolled were observed following addition of either an ACE inhibitor or beta-blocker for subsequent BP control and CV events. Patients for whom either add-on drug was indicated or contraindicated were excluded.
After adjustment for patient characteristics and study year, BP control during the subsequent 6-18 months was comparable for the two agents (70.5% ACE, 69.0% Beta-blockers; p=0.09). Rates of incident myocardial infarction (HR 1.05, 95% CI 0.69 – 1.58) and stroke (1.01. 95% CI 0.68 – 1.52) were also similar for the ACE inhibitor and beta-blocker groups during an average of 2. 3 years of follow-up. There were also no differences in heart failure or renal function.
ACE inhibitors and beta-blockers are equally effective in lowering blood pressure and preventing cardiovascular events for patients whose blood pressure is not controlled on a thiazide diuretic alone and who have no compelling indication for a specific second-line agent.
hypertension; comparative effectiveness; diuretics; cardiovascular diseases
Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, the implementation of risk-reducing practices remains poor. This paper describes the results of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of cardiovascular disease risk reduction delivered by nurse practitioner/community health worker (NP/CHW) teams versus enhanced usual care (EUC) to improve lipids, blood pressure, glycated hemoglobin (HbA1c), and patients’ perceptions of the quality of their chronic illness care in patients in urban community health centers.
Methods and Results
A total of 525 patients with documented cardiovascular disease, type 2 diabetes, hypercholesterolemia, or hypertension and levels of LDL-cholesterol, blood pressure or HbA1c that exceeded goals established by national guidelines were randomized to NP/CHW (n=261) or EUC (n=264) groups. The NP/CHW intervention included aggressive pharmacologic management and tailored educational and behavioral counseling for lifestyle modification and problem solving to address barriers to adherence and control. As compared to EUC, patients in the NP/CHW group had significantly greater 12 month improvement in total cholesterol (difference, 19.7mg/dL), LDL cholesterol (difference,15.9 mg/dL), triglycerides (difference, 16.3 mg/dL), systolic blood pressure (difference, 6.2 mm Hg), diastolic blood pressure (difference, 3.1 mm Hg), HbA1c (difference, 0.5%), and perceptions of the quality of their chronic illness care (difference, 1.2 points).
An intervention delivered by a NP/CHW team using individualized treatment regimens based on treat-to-target algorithms can be an effective approach to improve risk factor status and perceptions of chronic illnes care in high risk patients.
Randomized trial; Cardiovascular disease; Diabetes; Prevention
Elevated scores on depression symptom questionnaires predict rehospitalization after acute myocardial infarction (AMI). Whether DSM-IV depressive disorders predict rehospitalization after AMI is unknown.
Methods and Results
Participants (n=766) in an ENRICHD ancillary study were classified by diagnostic interview as having no depression, minor depression, or major depression after AMI. Cardiac rehospitalizations were tracked for up to 42 months. Cox proportional hazards regression was used to model the effect of depressive disorder on time to first cardiac rehospitalization, controlling for mortality risk factors. Logistic regression was used to compare the accuracy with which rehospitalization could be predicted by depression diagnosis or by the Beck Depression Inventory (BDI). Secondary analyses examined the effects of depression on the cumulative number of all-cause rehospitalizations, length of stay, and emergency department visits. Compared to nondepressed patients, those with either major or minor depression were hospitalized sooner (minor: adjusted HR, 2.22; 95% CI, 1.59 to 3.08; P<.001; major: adjusted HR, 2.54; 95% CI, 1.84 to 3.53; P<.001), had more hospitalizations (minor: P<.001; major: P<.001) and emergency department visits (minor: P=.003; major: P<.001), and spent more days in the hospital (minor: P<.001; major: P<.001). The interview and questionnaire methods of assessing depression did not significantly differ in their overall accuracy of predicting rehospitalization.
Depressive disorders increase the risk of rehospitalization after AMI. Future work should focus on developing multivariable models to predict risk of rehospitalization after AMI, and depression should be included in these.
myocardial Infarction; depression; depressive disorder; patient readmission
Although the informed consent process is supposed to help potential research participants make informed and voluntary decisions about participating in research, little is known about how participants react to language in the informed consent document and whether their reactions are related to their willingness to enroll in clinical trials. We examined the relationship between patients' reactions to standard informed consent language and their willingness to participate in a hypothetical clinical trial.
Methods and Results
We simulated the consent process for a hypothetical cardiology clinical trial with 470 patients in an outpatient cardiovascular medicine clinic at a large academic medical center. We analyzed the spontaneous comments and questions that participants made during the interviews about each section of the informed consent document. Few participants made positive comments. Participants made the most negative comments about the sections on risks, study purpose or protocol, and payment for injury. Having a negative reaction to any section was associated with a lower likelihood of participating in the clinical trial. Using a multivariable model, we found that negative reactions in the patient rights, financial disclosure, and confidentiality sections predicted willingness to participate (P < .001).
Recognizing elements of informed consent that elicit questions and concerns from potential research participants may help investigators design clinical research trials and model language in a way that reduces concerns or increases participant understanding, and thereby enhancing informed consent for research.
Informed Consent; Biomedical Research; Conflict of Interest; Confidentiality
Reducing blood pressure (BP) after stroke reduces risk for recurrent events. Our aim was to describe hypertension care among veterans with ischemic stroke including BP control by discharge and over the 6 months post stroke event.
Methods and Results
The Office of Quality and Performance Stroke Special Study included a systematic sample of veterans hospitalized for ischemic stroke in 2007. We examined BP control (<140/90 mmHg) at discharge excluding those who died, enrolled in hospice, or had unknown discharge disposition (N=3640, 3382 adjusted analysis). The second outcome was BP control (<140/90 mmHg) within 6-months post-stroke, excluding patients who died /readmitted within 30 days, lost to follow-up or did not have a BP recorded (N=2054, 1915 adjusted analysis). The population was white (62.7 %) and male (97.7%); 46.9% were <65 years of age; 29% and 37% had a history of cerebrovascular or cardiovascular disease, respectively. Among the 3640 stroke patients 1573(43%) had their last documented BP prior to discharge >140/90 mmHg. Black race (adjusted OR 0.77 [95% CI 0.65, 0.91]), diabetes (OR 0.73 [95% CI 0.62, 0.86]) and hypertension history (OR 0.51 [95% CI 0.42, 0.63]) were associated with lower odds for controlled BP at discharge. Of the 2054 stroke patients seen within 6 months from their index event, 673 (32.8%) remained uncontrolled. By 6 months post event, neither race nor diabetes was associated with BP control; whereas history of hypertension continued to have lower odds of BP control. For each 10 point increase in systolic BP > 140 mmHg at discharge, odds of BP control within 6 months post discharge decreased by 12% (95% CI (8%, 18%)).
BP values in excess of national guidelines are common after stroke. Forty three percent of patients were discharged with an elevated BP and 33% remained uncontrolled by 6 months.
hypertension; quality of care; secondary prevention; stroke prevention
Communicating prognosis to enable shared decision-making is strongly endorsed by heart failure (HF) guidelines. Patients are concerned with both their quantity and quality of life (QoL). To facilitate the recognition of patients at high risk for unfavorable future QoL or death, we created a simple prognostic tool to estimate this combined outcome.
Methods and Results
We identified factors associated with 6-month mortality or persistently unfavorable QoL, defined by Kansas City Cardiomyopathy Questionnaire (KCCQ) scores <45 at 1 and 24 weeks after hospital discharge, among 1458 patients from the Efficacy of Vasopressin Antagonism in HF Outcome Study with Tolvaptan (EVEREST). Within 24 weeks of discharge, 478 (32.8%) patients had died and 192 (13.2%) patients had serial KCCQ scores < 45. After adjusting for 23 pre-discharge covariates, independent predictors of the combined end point included low admission KCCQ score, high B-type natriuretic peptide, hyponatremia, tachycardia, hypotension, absence of β-blocker therapy, and history of diabetes mellitus and arrhythmia. A simplified pre-discharge HF score for subsequent death or unfavorable QoL had moderate discrimination (c-statistic 0.72). Pre-discharge clinical covariates were substantially different in predicting the QoL end point as compared with traditional death or rehospitalization end points.
At the time of hospital discharge, readily available clinical characteristics are associated with HF patients at high risk for suffering persistently unfavorable QoL or death over the next 6 months. Such information can target patients for whom aggressive treatment options (e.g., devices or transplantation) and/or end-of-life discussions should be strongly considered prior to discharge.
heart failure; prognosis; risk factors; quality of life; health status
Whether hepatitis C (HCV) confers additional coronary heart disease (CHD) risk among Human Immunodeficiency Virus (HIV) infected individuals is unclear. Without appropriate adjustment for antiretroviral therapy, CD4 count, and HIV-1 RNA, and substantially different mortality rates among those with and without HIV and HCV infection, the association between HIV, HCV, and CHD may be obscured.
Methods and Results
We analyzed data on 8579 participants (28% HIV+, 9% HIV+HCV+) from the Veterans Aging Cohort Study Virtual Cohort who participated in the 1999 Large Health Study of Veteran Enrollees. We analyzed data collected on HIV and HCV status, risk factors for and the incidence of CHD, and mortality from 1/2000–7/2007. We compared models to assess CHD risk when death was treated as a censoring event and as a competing risk. During the median 7.3 years of follow-up, there were 194 CHD events and 1186 deaths. Compared with HIV−HCV− Veterans, HIV+ HCV+ Veterans had a significantly higher risk of CHD regardless of whether death was adjusted for as a censoring event (adjusted hazard ratio (HR)=2.03, 95% CI=1.28–3.21) or a competing risk (adjusted HR=2.45, 95% CI=1.83–3.27 respectively). Compared with HIV+HCV− Veterans, HIV+ HCV+ Veterans also had a significantly higher adjusted risk of CHD regardless of whether death was treated as a censored event (adjusted HR=1.93, 95% CI=1.02–3.62) or a competing risk (adjusted HR =1.46, 95% CI=1.03–2.07).
HIV+HCV+ Veterans have an increased risk of CHD compared to HIV+HCV−, and HIV−HCV− Veterans.
viruses; coronary disease; mortality; multi morbidity
Black patients with myocardial infarction (MI) have worse outcomes than white patients, including higher mortality, more angina, and worse quality of life. The TRIUMPH study was designed to examine whether racial differences in socioeconomic, clinical, genetic, metabolic, biomarker or treatment characteristics mediate observed disparities in outcomes.
Methods and Results
Between June 1, 2005 and December 31, 2008, 31567 patients with MI were prospectively screened, 6152 had an eligible MI, and 4340 (71%) were enrolled from 24 US centers. Consenting patients had detailed chart abstractions of their medical history and processes of inpatient care, supplemented with a detailed baseline interview. Detailed genetic and metabolic data were obtained at hospital discharge in 2979 (69%) and 3013 patients (69%), respectively. In a subset of patients, blood and urine samples were obtained at 1-month (obtained in 27% of survivors) and blood samples at 6-months (obtained in 19% of survivors). Centralized follow-up interviews sought to quantify patients’ post-discharge care and outcomes, with a focus on their health status (symptoms, function, and quality of life). At 1, 6 and 12 months, 23%, 27% and 24% were lost to follow-up. Vital status was available for 99% of patients at 12-months.
TRIUMPH is a novel MI registry with detailed information on patients’ socio-demographic, clinical, treatment, health status, metabolic, and genetic characteristics. The wealth of patient data collected in TRIUMPH will provide unique opportunities to examine factors that may mediate racial differences in mortality and health status after MI and the complex interactions between genetic and environmental determinants of post-MI outcomes.
myocardial infarction; angina; outcomes research; health status; registries
Anemia is common among patients hospitalized with acute myocardial infarction (AMI), and is associated with poor outcomes. Less is known about the incidence, correlates, and prognostic implications of acute, hospital-acquired anemia (HAA).
Methods and Results
We identified 2909 patients with AMI who had normal hemoglobin (Hgb) on admission in the multi-center TRIUMPH registry. We used hierarchical Poisson regression to identify independent correlates of HAA, and multivariable proportional hazards regression to identify the association of HAA with mortality and health status. At discharge, 1321 (45.4%) patients had HAA, of whom 348 (26.3%) developed moderate-severe anemia (Hgb 9.1–11). The incidence of HAA varied substantially across hospitals (range: 33.3% to 69.2%, median rate ratio for HAA development 1.13 (95% CI 1.07–1.23) controlling for patient characteristics). Although documented bleeding was more frequent with more severe HAA, fewer than half of patients with moderate-severe HAA had any documented bleeding. Independent correlates of HAA included age, female gender, white race, chronic kidney disease, ST segment elevation MI, acute renal failure, use of glycoprotein IIb/IIIa inhibitors, in-hospital complications (cardiogenic shock, bleeding and bleeding severity), and length of stay. After adjustment for GRACE score and bleeding, patients with moderate-severe HAA had higher mortality (HR 1.82 (95% CI 1.11–2.98) vs. no HAA), as well as poorer health status at 1-year.
HAA develops in nearly half of AMI hospitalizations, commonly in the absence of documented bleeding, and is associated with worse mortality and health status. Better understanding of how HAA can be prevented, and whether its prevention can improve patient outcomes is needed.
myocardial infarction; anemia; hemoglobin; outcomes
National attention has increasingly focused on readmission as a target for quality improvement. We present the development and validation of a model approved by the National Quality Forum and used by the Centers for Medicare & Medicaid Services for hospital-level public reporting of risk-standardized readmission rates for patients discharged from the hospital after an acute myocardial infarction.
Methods and Results
We developed a hierarchical logistic regression model to calculate hospital risk-standardized 30-day all-cause readmission rates for patients hospitalized with acute myocardial infarction. The model was derived using Medicare claims data for a 2006 cohort and validated using claims and medical record data. The unadjusted readmission rate was 18.9%. The final model included 31 variables and had discrimination ranging from 8% observed 30-day readmission rate in the lowest predictive decile to 32% in the highest decile and a C statistic of 0.63. The 25th and 75th percentiles of the risk-standardized readmission rates across 3890 hospitals were 18.6% and 19.1%, with fifth and 95th percentiles of 18.0% and 19.9%, respectively. The odds of all-cause readmission for a hospital 1 SD above average were 1.35 times that of a hospital 1 SD below average. Hospital-level adjusted readmission rates developed using the claims model were similar to rates produced for the same cohort using a medical record model (correlation, 0.98; median difference, 0.02 percentage points).
This claims-based model of hospital risk-standardized readmission rates for patients with acute myocardial infarction produces estimates that are excellent surrogates for those produced from a medical record model.
myocardial infarction; health policy; quality of health care
An emerging body of research suggests that depressive symptoms may confer an “accelerated risk” for cardiovascular disease (CVD) in African-Americans, compared with whites. Research in this area has been limited to cardiovascular risk factors and early markers; less is known about black-white differences in associations with important clinical endpoints.
The authors examined the association between depressive symptoms and overall CVD mortality, ischemic heart disease (IHD) mortality, and stroke mortality in a sample of 6,158 (62% African-American; 61% female) community-dwelling older adults. Cox proportional hazards models were used to model time-to-CVD, IHD and stroke death over follow-up.
In race-stratified models adjusted for age and sex, elevated depressive symptoms were associated with CVD mortality over follow-up in African-Americans (HR=1.95, 95% CI= 1.61-2.36, p<.001), but were not significantly associated with CVD mortality in whites (HR=1.26, 95% CI=.95-1.68, p=.11; race by depressive symptoms interaction p=.03). Similar findings were observed for IHD mortality (African-American HR=1.99, 95% CI=1.49-2.64, p<.001; white HR=1.28, 95% CI=.86-1.89, p=.23); and stroke mortality (African-American HR=2.08, 95% CI=1.32-3.27, p=.002; white HR=1.32, 95% CI=.69-2.52, p=.40). Findings for total CVD mortality and IHD mortality were attenuated, but remained significant after adjusting for standard risk factors. Findings for stroke were reduced to marginal significance.
Elevated depressive symptoms were associated with multiple indicators of CVD mortality in older African-Americans, but not whites. Findings were not completely explained by standard risk factors. Efforts aimed at reducing depressive symptoms in African-Americans may ultimately prove beneficial for their cardiovascular health.
Depressive Symptoms; cardiovascular disease (CVD); race; psychosocial risk factors; epidemiology
Despite the known benefit of intensive statin therapy for reducing future cardiovascular events, its effectiveness in women has been questioned by some.
Methods and Results
In the Pravastatin or Atorvastatin Evaluation and Infection Therapy–Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) trial, 911 (21.9%) women and 3251 (78.1%) men were randomized to intensive statin (atorvastatin 80 mg) versus standard therapy (pravastatin 40 mg) for a median duration of 2.1 years. The primary endpoint was death, myocardial infarction (MI), unstable angina (UA), revascularization (occurring after 30 days) or stroke. Safety endpoints included elevations in liver function tests, creatine kinase and myalgias/myositis. Women had a reduction in LDL of 42.8% from baseline at 30 days (to a median of 60 mg/dL) in the intensive therapy arm with 88.8% reaching LDL goal of <100 mg/dL and 65.0% with <70 mg/dL as compared with a 16.8% reduction in LDL (to a median of 88 mg/dL) in the standard therapy. Women on intensive statin therapy had a significant 25% relative reduction over standard-dose (hazard ratio [HR] 0.75; 95% confidence interval [CI] 0.57-0.99; p=0.04) for primary composite endpoint, compared with a 14% reduction for men (HR 0.86; 95% CI 0.75-0.99; p=0.04), p-interaction=0.38. No differences were observed between genders for safety (all p-interaction ≥0.11).
This trial provides evidence that both women and men derived benefit from intensive statin therapy following ACS and thus gender should not be a factor in determining who should be treated with intensive statin therapy.
statin; gender; acute coronary syndrome; prognosis; secondary prevention