Composite Endpoint Of Hospitalization Research Articles

Outcomes of SGLT-2i and GLP-1RA Therapy Among Patients With Type 2 Diabetes and Varying NAFLD Status

Nonalcoholic fatty liver disease (NAFLD) is a cardiovascular risk factor, but whether sodium-glucose cotransporter-2 inhibitors (SGLT-2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) are associated with reduced cardiovascular risk in patients with type 2 diabetes (T2D) and concomitant NAFLD remains uncertain. To investigate the outcomes of SGLT-2i and GLP-1RA therapy among patients with T2D varied by the presence or absence of NAFLD. This retrospective, population-based, nationwide cohort study used an active-comparator new-user design. Two distinct new-user active-comparator cohorts of patients aged 40 years and older who initiated SGLT-2i or GLP-1RA were propensity score matched to patients who initiated dipeptidyl peptidase-4 inhibitors (DPP-4i). The study was conducted in South Korea from January 2013 to December 2020, and data analysis was conducted from October 2022 to March 2023. The main outcomes were (1) major adverse cardiovascular events (MACE), a composite end point of hospitalization for myocardial infarction, hospitalization for stroke, and cardiovascular death, and (2) hospitalization for heart failure (HHF). Cox proportional hazards models were used to estimate hazard ratios (HRs). The Wald test was applied to assess heterogeneity by NAFLD. After 1:1 propensity score matching, 140 438 patients were retrieved in the first cohort (SGLT-2i vs DPP-4i; mean [SD] age, 57.5 [10.3] years; 79 633 [56.7%] male) and 34 886 patients were identified in the second cohort (GLP-1RA vs DPP-4i; mean [SD] age, 59.5 [10.5] years; 17 894 [51.3%] male). Compared with DPP-4i, SGLT-2i therapy was associated with a lower risk of MACE (HR, 0.78 [95% CI, 0.71-0.85]) and HHF (HR, 0.62 [95% CI, 0.48-0.81]). GLP-1RA therapy was associated with a decreased risk of MACE (HR, 0.49 [95% CI, 0.39-0.62]) but had statistically nonsignificant findings regarding HHF (HR, 0.64 [95% CI, 0.39-1.07]). Stratified analysis by NAFLD status yielded consistent results for SGLT-2i (MACE with NAFLD: HR, 0.73 [95% CI, 0.62-0.86]; without NAFLD: HR, 0.81 [95% CI, 0.72-0.91]; HHF with NAFLD: HR, 0.76 [95% CI, 0.49-1.17]; without NAFLD: HR, 0.56 [95% CI, 0.40-0.78]) and for GLP-1RA (MACE with NAFLD: HR, 0.49 [95% CI, 0.32-0.77]; without NAFLD: HR, 0.49 [95% CI, 0.37-0.65]; HHF with NAFLD: HR, 0.82 [95% CI, 0.38-1.76]; without NAFLD: HR, 0.54 [95% CI, 0.27-1.06]). In this population-based cohort study, SGLT-2i therapy was associated with a decreased risk of MACE and HHF, while GLP-1RA therapy was associated with a decreased risk of MACE among patients with T2D, irrespective of baseline NAFLD status.

PREDICTIVE VALUE OF PROTEIN-BOUND UREMIC TOXINS FOR HEART FAILURE EVENTS IN PATIENTS WITH CHRONIC KIDNEY DISEASE

Objective: Evaluate whether the plasma free fraction of four important protein-bound uremic toxins (PBUTs), indoxyl sulfate (IxS), p-cresyl sulfate (pCS), p-cresyl glucuronide (pCG) and hippuric acid (HA), are independently associated with new heart failure (HF) events in patients with chronic kidney disease (CKD), not on dialysis. Design and method: Retrospective, single center analysis. 526 patients with CKD stages G1-G5 (not on dialysis), were included between January 2011 and January 2014. Outcome parameters were monitored until June 2017. Exclusion criteria were pregnancy, age <18 years, active infection, active malignancy, history of transplantation or a cardiovascular event within the past three months. Free fractions of uremic toxins were quantified by ultrahigh-performance liquid chromatography. Kaplan-Meier survival curves were constructed to investigate the univariate association between PBUTs and the composite endpoint of hospitalization or death due to HF. Multivariate Cox regression models were used to study the independent association of PBUTs with outcome. Results: The study population (57.8% male) had a median age of 66 years and varying degrees of CKD: stage G1 (12.2%), 2 (16.3%), 3A (21.1%), 3B (27.8%), 4 (19.2%) and 5 (3.4%). After a median follow up of 5.4 years 43 patients (8.4%) developed the primary endpoint, 18.6% (8/43) were fatal. In Cox regression analysis with adjustment for age, gender, body mass index, diabetes and systolic blood pressure, the free fractions of all four PBUTs remained independent predictors of new heart failure events [IxS: HR 1.46 (95% CI: 1.06 – 2.01; P = 0.019); pCS: HR 1.75 (95% CI: 1.21 - 2.54; P = 0.003); pCG: HR 1.65 (95% CI: 1.17 - 2.32; P = 0.004); HA: HR 1.43 (95% CI: 1.05 - 1.95; P = 0.022)]. Univariate survival analyses are shown in Figure 1. Conclusions: Free fraction of the PBUTs indoxyl sulfate, p-cresyl sulfate, p-cresyl glucuronide and hippuric acid were independently associated with hospitalization and mortality due to HF in patients with CKD. The pathophysiological pathways by which these toxins may contribute to heart failure remain to be elucidated.

Real-Life Comparison of Fosfomycin to Nitrofurantoin for the Treatment of Uncomplicated Lower Urinary Tract Infection in Women

In this study, we compared the failure rates of fosfomycin and nitrofurantoin for uncomplicated urinary tract infections. We used Meuhedet Health Services' large database to collect data on all female patients, older than 18 years, who were prescribed either antibiotic during 2013-2018. Treatment failure was a composite endpoint of hospitalization, emergency-room visit, IV antibiotic treatment, or prescription of a different antibiotic, within seven days of the initial prescription. Reinfection was considered when one of these endpoints appeared 8-30 days following the initial prescription. We found 33,759 eligible patients. Treatment failure was more common in the fosfomycin group than the nitrofurantoin group (8.16% vs. 6.87%, p-value < 0.0001). However, reinfection rates were higher among patients who received nitrofurantoin (9.21% vs. 7.76%, p-value < 0.001). Among patients younger than 40 years, patients treated with nitrofurantoin had more reinfections (8.68% vs. 7.47%, p value = 0.024). Treatment failure rates were mildly higher in patients treated with fosfomycin, despite having less reinfections. We suggest that this effect is related to a shorter duration of treatment (one vs. five days) and encourage clinicians to be more patient before declaring fosfomycin failure and prescribing another antibiotic.

Left atrial reservoir strain as a predictor of cardiac outcome in patients with heart failure: the HaFaC cohort study

BackgroundThe left atrium (LA) is a key player in the pathophysiology of systolic and diastolic heart failure (HF). Speckle tracking derived LA reservoir strain (LASr) can be used as a prognostic surrogate for elevated left ventricular filling pressure similar to NT-proBNP. The aim of the study is to investigate the correlation between LASr and NT-proBNP and its prognostic value with regards to the composite endpoint of HF hospitalization and all-cause mortality within 1 year.MethodsOutpatients, sent to the echocardiography core lab because of HF, were enrolled into this study. Patients underwent a transthoracic echocardiographic examination, commercially available software was used to measure LASr. Blood samples were collected directly after the echocardiographic examination to determine NT-proBNP.ResultsWe included 174 HF patients, 43% with reduced, 36% with mildly reduced, and 21% with preserved ejection fraction. The study population showed a strong inverse correlation between LASr and log-transformed NT-proBNP (r = − 0.75, p < 0.01). Compared to NT-proBNP, LASr predicts the endpoint with a comparable specificity (83% vs. 84%), however with a lower sensitivity (70% vs. 61%).ConclusionLASr is inversely correlated with NT-proBNP and a good echocardiographic predictor for the composite endpoint of hospitalization and all-cause mortality in patients with HF.Trial registration:https://www.trialregister.nl/trial/7268

Predictors of clinical decompensation in patients presenting with COVID-19 in an urban hospital health system

IntroductionSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in a pandemic which has infected more than 128 million people and led to over 2.8 million deaths worldwide. Although the introduction of efficacious vaccines has led to overall declines in the incidence of SARS-CoV-2 infection, there has been a recent increase in infections once more due to the appearance of mutant strains with higher virulence. It therefore remains vital to identify predictors of poor outcomes in this patient population.PurposeThe objective of our study was to identify predictors of prolonged hospitalization, intensive care unit (ICU) admission, intubation, and death in patients infected with SARS-CoV-2.MethodsWe conducted a retrospective analysis of all patients hospitalized with SARS-CoV-2 at our health system that includes one tertiary care center and two community hospitals located in the Chicago metropolitan area. The main outcome was a composite endpoint of hospitalization >28 days, ICU admission, intubation, and death.Explanatory variables associated with the primary outcome in the bivariate analysis (p<0.05) were included in the multivariable logistic regression model. Statistical analysis was performed using IBM SPSS 25.0.ResultsBetween March 1, 2020 and May 31, 2020, 1029 patients hospitalized with SARS-CoV-2 were included in our analysis. Of these patients, 379 met the composite endpoint. Baseline demographics are described in Table 1. Of note, our cohort consisted of a predominantly minority patient population including 47% Hispanic, 17% African American, 16% Caucasian, and 16% other.In bivariate analysis, age, hypertension, tobacco and alcohol abuse, obesity, coronary artery disease, arrhythmias, valvular heart disease, dyslipidemia, hypertension, stroke, diabetes, documented thrombosis, troponin, CRP, ESR, ferritin, LDH, BNP, D-dimer >5x the upper limit of normal, lactate, and right ventricular outflow tract velocity time integral <9.5 were significant.After multivariable adjustment, explanatory variables associated with the composite endpoint included troponin (OR 2.36; 95% CI 1.08–5.17, p 0.03), D-dimer (OR 1.5; 95% CI 1.23–1.98, p<0.01, lactate (OR 1.58; 95% CI 1.28–1.95, p<0.01), and documented thrombosis (OR 3.56; 95% CI 1.30–8.70, p<.05). Race was not a predictor of poor outcomes in the bivariate or multivariate analysis (Table 2).ConclusionsIn a large urban cohort with a predominantly minority population, we identified several clinical predictors of poor outcomes. Of note, race was not a predictor of the primary endpoint in this study. While recent literature has demonstrated worse outcomes among racial minorities infected with SARS-CoV-2, our data suggests these variations are related to social determinants of health rather than biologic causes.Funding AcknowledgementType of funding sources: Public hospital(s). Main funding source(s): Loyola University Medical Center

Impact of atrial fibrillation and biventricular pacing percentage on long-term outcome in patients with heart failure treated with cardiac resynchronization therapy

Abstract Introduction A history of preoperative atrial fibrillation (AF) has been found to be associated with unfavorable outcomes, higher risks of non-response to cardiac resynchronization therapy (CRT) and loss of biventricular pacing (BivP). We aimed to assess the impact of AF and BivP on long-term outcomes in heart failure patients treated with CRT. Methods We retrospectively enrolled 227 patients undergoing CRT implantation between 2013 and 2020 according to the current guidelines. 118 patients were included in our analysis, from whom all data were available. Clinical, electrocardiographic and echocardiographic parameters were evaluated at baseline and 6 months after CRT. Response to CRT was defined as an increase in left ventricular ejection fraction (LVEF) &amp;gt;10%. We considered an effective delivery of BivP &amp;gt;98%. The primary endpoint was the composite endpoint of hospitalization due to HF or death for any cause. Results 118 patients were included (mean age 69±11 years, 66.1% males, 39.8% ischemic etiology; baseline LVEF was 27,6±6%). Patients were divided into AF (n=42; 35,6%) and sinus rhythm (SR (n=76); 18 patients had permanent AF. AF patients had higher index left atrial volume and left ventricular mass (p&amp;lt;0.001). Mean follow-up time was 43±18 months. BivP percentage was significantly superior in SR than in AF patients (98.1±2.1% vs 94.7±4.5%, p&amp;lt;0.001), with 75% of SR patients having BivP&amp;gt;98% vs 30,3% of AF patients (p&amp;lt;0.001). There were no differences in preoperative parameters between them. The response rate to CRT was higher in SR patients when compared to AF patients (63,2% vs 40,5%, p=0.021). Indeed, the variation of LVEF was higher in SR patients (12±10% vs 7±9%, p=0.012). During follow-up, there were significant differences between AF and SR patients in the primary endpoint (73,8% vs 42,6%, p&amp;lt;0.001), and mortality for any cause (26,2% vs 9,2% p=0.014; p&amp;lt;0.001). In a multivariate logistic regression analysis pre-procedural AF and BivP (%) were the only independent predictors of primary endpoint (HR 8.949, 95% CI 2.429 – 32.972, p=0.001; HR 0.719, 95% CI 0.526 – 0.982, p=0.038, respectively). Kaplan-Meier curves showed that event survival free was higher in SR patients when compared to AF (69±4 vs 24±3 months, p&amp;lt;0.001) Conclusion Pre - procedural AF and BivP are independent predictors of the occurrence of a primary endpoint of hospitalization due to HF or death for any cause in HF patients submitted to CRT. Funding Acknowledgement Type of funding sources: None.

Prognostic Value of Ventricular-Arterial Coupling After Transcatheter Aortic Valve Replacement on Midterm Clinical Outcomes.

BackgroundVentricular‐arterial coupling predicts outcomes in patients with heart failure. The arterial elastance to end‐systolic elastance ratio (Ea/Ees) is a noninvasively assessed index that reflects ventricular‐arterial coupling. We aimed to determine the prognostic value of ventricular‐arterial coupling assessed through Ea/Ees after transcatheter aortic valve replacement to predict clinical events.Methods and ResultsWe retrieved data on 1378 patients (70% women) who underwent transcatheter aortic valve replacement between October 2013 and May 2017 from the OCEAN‐TAVI (Optimized transCathEter vAlvular iNtervention) Japanese multicenter registry. We determined the association between Ea/Ees and the composite end point of hospitalization for heart failure and cardiovascular death by classifying the patients into quartiles based on Ea/Ees values (group 1: <0.326; group 2: 0.326–0.453; group 3: 0.453–0.666; and group 4: >0.666) during the midterm follow‐up after transcatheter aortic valve replacement. During a median follow‐up period of 736 days (interquartile range, 414–956), there were 247 (17.9%) all‐cause deaths, 89 (6.5%) cardiovascular deaths, 130 (9.4%) hospitalizations for heart failure, and 199 (14.4%) composite events of hospitalization for heart failure and cardiovascular death. The incidence of the composite end point was significantly higher in group 2 (hazard ratio [HR], 1.76; 95% CI, 1.08–2.87 [P=0.024]), group 3 (HR, 2.43; 95% CI, 1.53–3.86 [P<0.001]), and group 4 (HR, 2.89; 95% CI, 1.83–4.57 [P<0.001]) than that in group 1. On adjusted multivariable Cox analysis, Ea/Ees was significantly associated with composite events (HR, 1.47 per 1‐unit increase; 95% CI, 1.08–2.01 [P=0.015]).ConclusionsThese findings suggest that a higher Ea/Ees at discharge after transcatheter aortic valve replacement is associated with adverse clinical outcomes during midterm follow‐up.RegistrationURL: https://www.upload.umin.ac.jp/. Unique identifier: UMIN000020423.

REDUCED BLOOD PRESSURE VARIABILITY AS A PREDICTOR OF CARDIAC EVENTS AFTER MYOCARDIAL INFARCTION

Objective: The impact of blood pressure variability (BPV) on cardiac function has been mainly examined through the prism of congestive heart failure and hypertension, but not in the setting of an acute coronary syndrome (ACS). The aim of this study is to determine the association between in-hospital short-term BPV and the development and aggravation of cardiac dysfunction in patients with acute myocardial infarction (AMI). Design and method: A total population of 57 AMI patients [74.5% male; mean age: 67.56 years;75.4% hypertensives]underwent 24hr ambulatory BP measurement during hospitalization.At 6 months a follow-up was scheduled for each patient in order to collect data on hospitalizations for heart failure (HF), but also to assess the overall cardiovascular outcome.The latter was defined as the composite end-point ofhospitalizations for heart failure (n = 8), decline in ejection fraction (EF%) compared to the in-hospital value (n = 11), deterioration of NYHA class (n = 3) and new onset of heart failure symptoms (n = 2). In-hospital BPV was assessedusing standard deviation (SD) and average real variability (ARV). The study population was divided intoa STEMI group (n = 24) and a non-STEMI (n = 33) one. Results: BPV was not associated with hospitalizations for HF. However, when the composite end-point was assessed, ARV of systolic BP demonstrated a significant negativeassociation [B = -0.430; odds ratio, 0.651; CI, 0.473–0.895 (P = 0.008)]in the total population. A relatively significant predictive roleof ARV was shown after splitting the population into the STEMI [B = −0.531; odds ratio, 0.588; CI, 0.339–1.019 (P = 0.058)]and non-STEMI group[B = −0.4; odds ratio, 0.670; CI, 0.443–1.014 (P = 0.058)]. Multinomial logistic regression analysis of incidence of cardiovascular events highlightedsystolic BP ARVas the onlyindependent predictor during a 6-month follow-up [B = −0.508; odds ratio, 0.602; CI, 0.407–0.891 (P = 0.011)] regardless the ACS type. Conclusions: In the setting of ACS, reduced in-hospital systolic BP ARV was associated with cardiovascular morbidity during the 6 months of follow-up. This finding could be attributed to a dysautonomic state of the cardiovascular system related to the pathophysiology of ACS, linking BP regulation mechanisms to worse overall outcome in this high risk setting.

Association Between Medication Adherence and the Outcomes of Heart Failure.

Previous studies of heart failure patients demonstrated an association between cardiovascular medication adherence and hospitalizations or a composite end point of hospitalization and death. Few studies have assessed the impact of treatment adherence within large general medical populations that distinguish the health outcomes of emergency department visits, hospitalization, and death. To determine the association of incremental cardiovascular medication adherence on emergency department visits, hospitalization, and death in adult heart failure patients in Indiana. Retrospective cohort study conducted using electronic health record data from the statewide Indiana Network for Patient Care between 2004 and 2009. Patients were at least 18 years of age with a diagnosis of heart failure and prescribed at least one cardiovascular medication for heart failure. Adherence was measured as the proportion of days covered (PDC) using pharmacy transaction data. Clinical end points included emergency department visits, hospital admissions, length of hospital stay, and mortality. Generalized linear models were used to determine the effect of a 10% increase in PDC on clinical end points adjusting for age, sex, race, Charlson Comorbidity Index, and medications. Electronic health records were available for 55,312 patients (mean age ± standard deviation 68 ± 16 yrs; 54% women; 65% white). Mean PDC for all heart failure medications was 63% ± 23%. For every 10% increase in PDC, emergency department visits decreased 11% (rate ratio [RR] 0.89, 95% confidence interval [CI] 0.89-0.89), hospital admissions decreased 6% (RR 0.94, 95% CI 0.94-0.94), total length of hospital stay decreased 1% (RR 0.99, 95% CI 0.99-1.00), and all-cause mortality decreased 9% (odds ratio 0.91; 95% CI 0.90-0.92). Incremental medication adherence was associated with reductions in emergency department visits, hospital admissions, length of hospital stay, and all-cause mortality.

Relative Prognostic Value of Cardiac Troponin I and C-Reactive Protein in the General Population (from the Nord-Trøndelag Health [HUNT] Study)

C-reactive protein and cardiac troponin I measured with high-sensitivity assays (high-sensitivity C-reactive protein [hs-CRP] and high-sensitivity troponin I [hs-TnI]) have been associated with risk of fatal and nonfatal cardiovascular events in the general population. The relative prognostic merits of hs-CRP and hs-TnI, and whether these markers of inflammation and subclinical myocardial injury provide incremental information to established cardiovascular risk prediction models, remain unclear. hs-CRP and hs-TnI were measured in 9,005 participants from the prospective observational Nord-Trøndelag Health (HUNT) study. All study subjects were free from known cardiovascular disease at baseline. During a median follow-up period of 13.9 years, 733 participants reached the composite end point of hospitalization for acute myocardial infarction or heart failure, or cardiovascular death. In adjusted models, increased hs-TnI concentrations (>10 ng/L for women and >12 ng/L for men) were associated with the incidence of the composite end point (hazard ratio 3.61, 95% confidence interval [CI] 2.89 to 4.51]), whereas the risk associated with increased hs-CRP concentrations (>3 mg/L for both genders) appeared to be weaker (HR 1.71, 95% CI 1.40 to 2.10). The addition of hs-TnI to established cardiovascular risk prediction models led to a net reclassification improvement of 0.35 (95% CI 0.27 to 0.42), superior to that of hs-CRP (0.21, 95% CI 0.13 to 0.28). The prognostic accuracy of hs-TnI, assessed by C-statistics, was significantly greater than that of hs-CRP (0.753, 95% CI 0.735 to 0.772, vs 0.644, 95% CI 0.625 to 0.663). In conclusion, in subjects from the general population without a history of cardiovascular disease, hs-TnI provides prognostic information superior to that provided by hs-CRP and may therefore be a preferred marker for targeted prevention.

Prognostic Value of Late Gadolinium Enhancement in Nonischemic Cardiomyopathy

The purpose of this study was to determine the prognostic value of late gadolinium enhancement seen on cardiac magnetic resonance (CMR) imaging in patients with nonischemic cardiomyopathy (NICMP). Patients with NICMP are at increased risk for cardiovascular events and death. The presence of late gadolinium enhancement (LGE) in CMR may be associated with a poor prognosis, but its significance is still under investigation. We retrospectively studied 105 consecutive patients with NICMP and left ventricular ejection fraction (LVEF) ≤40% referred for CMR. The cohort was analyzed for the presence of LGE and left and right ventricular functional parameters. Patients were followed for the composite end point of hospitalization for congestive heart failure, appropriate implantable cardioverter-defibrillator therapy, or all-cause mortality. LGE was observed in 68% (n= 71) of the cohort. Both groups were similar in age, LVEF and LV end-diastolic volume. The LGE+ patients were more often men and had larger right ventricular volumes. At a mean follow-up of 806 ± 582days, there were 26 patients (23 in the LGE+ group) who reached the primary end point. Event-free survival was significantly worse for the LGE+ patients. After adjusting for traditional risk factors (age, gender, and LVEF), patients with LGE had an increased risk of experiencing the primary end point (hazard ratio 4.47, 95% CIs 1.27 to 15.74, p= 0.02). The presence of LGE in patients with NICMP strongly predicts the occurrence of adverse events. In conclusion, this may be important in risk stratification and management.

Association of Hypothyroidism With Adverse Events in Patients With Heart Failure Receiving Cardiac Resynchronization Therapy

Hypothyroidism is associated with an adverse prognosis in cardiac patients in general and in particular in patients with heart failure (HF). The aim of this study was to evaluate the impact of hypothyroidism on patients with HF receiving cardiac resynchronization therapy (CRT). Additionally, the impact of level of control of hypothyroidism on risk of adverse events after CRT implantation was also evaluated. We included consecutive patients in whom a CRT device was implanted from April 2004 to April 2010 at our institution with sufficient follow-up data available for analysis; 511 patients were included (age 68.5±12.4 years, women 20.4%); 84 patients with a clinical history of hypothyroidism, on treatment with thyroid hormone repletion or serum thyroid-stimulating hormone level≥5.00 μU/ml, were included in the hypothyroid group. The patients were followed for up to 3 years after implant for a composite end point of hospitalization for HF, left ventricular assist device placement, or heart transplant and cardiac death; 215 composite end point events were noted in this period. In a multivariate model, hypothyroidism (hazard ratio [HR] 1.46, 95% confidence interval [CI] 1.027 to 2.085, p=0.035), female gender (HR 0.64, 95% CI 0.428 to 0.963, p=0.032), and creatinine (HR 1.26, 95% CI 1.145 to 1.382, p<0.001) were significantly associated with occurrence of the composite end point; 53.6% of patients with hypothyroidism at baseline developed the composite end point compared with 39.8% of those with euthyroidism (p=0.02). In conclusion, hypothyroidism is associated with a worse prognosis after CRT implantation.

A Randomized Controlled Trial of Telemonitoring in Older Adults With Multiple Health Issues to Prevent Hospitalizations and Emergency Department Visits

Efficiently caring for frail older adults will become an increasingly important part of health care reform;telemonitoring within homes may be an answer to improve outcomes. This study sought to assess differences in hospitalizations and emergency department (ED) visits among older adults using telemonitoring vs usual care. A randomized controlled trial was performed among adults older than 60 years at high risk for rehospitalization. Participants were randomized to telemonitoring (with daily input) or to patient-driven usual care. Telemonitoring was accomplished by daily biometrics,symptom reporting, and videoconference. The primary outcome was a composite end point of hospitalizations and ED visits in the 12 months following enrollment. Secondary end points included hospitalizations,ED visits, and total hospital days. Intent-to-treat analysis was performed. Two hundred five participants were enrolled,with a mean age of 80.3 years. The primary outcome of hospitalizations and ED visits did not differ between the telemonitoring group (63.7%) and the usual care group(57.3%) (P=.35). No differences were observed in secondary end points, including hospitalizations, ED visits,and total hospital days. No significant group differences in hospitalizations and ED visits were found between the pre-enrollment period vs the post-enrollment period. Mortality was higher in the telemonitoring group (14.7%)than in the usual care group (3.9%) (P=.008). Among older patients, telemonitoring did not result in fewer hospitalizations or ED visits. Secondary outcomes demonstrated no significant differences between the telemonitoring group and the usual care group.The cause of greater mortality in the telemonitoring group is unknown.

Relationship of Persistent Symptoms of Anxiety to Morbidity and Mortality Outcomes in Patients With Coronary Heart Disease

To examine the association of symptoms of persistent anxiety with the development of acute cardiac events in patients with coronary heart disease (CHD) followed for 2 years. The prevalence of symptoms of anxiety is high in patients with CHD, but their effect on cardiac events and mortality has not been well characterized. Of 3522 patients with confirmed CHD enrolled, data on symptoms of anxiety were available at two time points in 3048 patients who were then followed up for detection of the composite end point of hospitalization for myocardial infarction, unstable or stable angina, other cardiac causes, or all-cause mortality. A composite anxiety symptoms score composed of baseline and 3-month anxiety data, in which the continuous-level scores were used, was tested using Cox proportional hazards regression model. Groups (persistent anxiety [anxiety at both time points] versus nonanxious [no anxiety at either time point] versus not persistently anxious [anxiety only at one time point]) were also compared. Symptoms of persistent anxiety, whether considered as a continuous- or categorical-level variable, were associated with shorter time to event. Persistent anxiety remained as an independent predictor of the end point after controlling for multiple variables (persistent anxiety as a summary score [hazard ratio = 1.27, 95% confidence interval = 1.067-1.514] and persistent anxiety as a categorical variable [hazard ratio = 1.52, 95% confidence interval = 1.149-2.015]). By measuring anxiety symptoms at more than one time point and controlling for relevant sociodemographic, comorbidity, risk factor, and psychological covariates, we illustrate that symptoms of persistent anxiety are a strong, independent predictor of cardiac event-free survival.

American Heart Association 68th Scientific Sessions, Anaheim, California, November 13 to 15, 1995.

Dr Elliott Antman, of Harvard Medical School and Brigham and Women’s Hospital in Boston, Massachusetts, presented the results of the Thrombolysis in Myocardial Infarction (TIMI) 9B study at a Satellite Symposium sponsored by George Washington University immediately prior to the American Heart Association Meetings in Anaheim, California, in November 1995. The TIMI 9 trial was a randomized, double-blind study conducted in 150 clinical centers that was designed to compare the efficacy and safety of intravenous heparin versus the direct-acting thrombin inhibitor hirudin in patients with acute myocardial infarction (<12 hours from onset) treated with a thrombolytic agent (streptokinase or tissue-type plasminogen activator [TPA], at the discretion of the treating physician). The TIMI 9A study (n=757) was suspended in April 1994 because of excessive bleeding in both the heparin and hirudin groups. The TIMI 9B trial was restarted in May 1994 with lower doses of both heparin and hirudin; enrollment (n=3002) continued through August 1995. The primary end point of the study was the 30-day incidence of death, myocardial infarction, congestive heart failure, and shock. At 30 days, there was no significant difference in the primary end point between heparin (11.8%) and hirudin (12.8%) and no difference in the incidence of death and myocardial infarction (9.3% in the heparin group, 9.6% in the hirudin group). Similarly, there was no significant difference in major bleeding events (including intracranial hemorrhage) between treatment groups. The TIMI 9 Investigators concluded that hirudin was equally effective as but not superior to heparin with respect to either clinical outcome or bleeding risk in patients with acute myocardial infarction receiving thrombolytic therapy. Also at the George Washington University Satellite Symposium, Dr Eugene Braunwald, of Harvard Medical School and Brigham and Women’s Hospital in Boston, presented the results of the TIMI 10A phase I trial. TIMI 10A is an …