Search

Background: The benefits of tPA (tissue-type plasminogen activator) in acute ischemic stroke are time-dependent. However, delivery of thrombolytic therapy rapidly after hospital arrival was initially occurring infrequently in hospitals in the United States, discrepant with national guidelines. Methods: We evaluated door-to-needle (DTN) times and clinical outcomes among patients with acute ischemic stroke receiving tPA before and after initiation of 2 successive nationwide quality improvement initiatives: Target: Stroke Phase I (2010–2013) and Target: Stroke Phase II (2014–2018) from 913 Get With The Guidelines-Stroke hospitals in the United States between April 2003 and September 2018. Results: Among 154 221 patients receiving tPA within 3 hours of stroke symptom onset (median age 72 years, 50.1% female), median DTN times decreased from 78 minutes (interquartile range, 60–98) preintervention, to 66 minutes (51–87) during Phase I, and 50 minutes (37–66) during Phase II ( P P P Conclusions: A nationwide quality improvement program for acute ischemic stroke was associated with substantial improvement in the timeliness of thrombolytic therapy start, increased thrombolytic treatment, and improved clinical outcomes.

AIMS To evaluate the performance of the WATCH-DM risk score, a clinical risk score for heart failure (HF), in patients with dysglycaemia and in combination with natriuretic peptides (NPs). METHODS AND RESULTS Adults with diabetes/pre-diabetes free of HF at baseline from four cohort studies (ARIC, CHS, FHS, and MESA) were included. The machine learning- [WATCH-DM(ml)] and integer-based [WATCH-DM(i)] scores were used to estimate the 5-year risk of incident HF. Discrimination was assessed by Harrell's concordance index (C-index) and calibration by the Greenwood-Nam-D'Agostino (GND) statistic. Improvement in model performance with the addition of NP levels was assessed by C-index and continuous net reclassification improvement (NRI). Of the 8938 participants included, 3554 (39.8%) had diabetes and 432 (4.8%) developed HF within 5 years. The WATCH-DM(ml) and WATCH-DM(i) scores demonstrated high discrimination for predicting HF risk among individuals with dysglycaemia (C-indices = 0.80 and 0.71, respectively), with no evidence of miscalibration (GND P ≥0.10). The C-index of elevated NP levels alone for predicting incident HF among individuals with dysglycaemia was significantly higher among participants with low/intermediate (

Background Non-statin lipid lowering therapies (LLTs) provide additional treatment options for patients. Use patterns and patient perceptions of non-statin LLT remain incompletely described. Hypothesis The guideline-recommended statin intensity remains underutilized in patients treated with and without non-statin LLT. Methods The PALM Registry collected LLT information on patients with or at risk of ASCVD treated at 125 US clinics in 2015. We compared patient perceptions, lipid levels and statin use among patients treated with and without non-statin LLT. Results Among 7720 patients, 1930 (25.0%) were treated with a non-statin LLT (1249 fish oil, 417 fibrates, 329 ezetimibe, 196 niacin). Concurrent statin treatment occurred in 73.7%, of which 45.4% were dosed under the guideline-recommended intensity. Compared with patients on statin alone, patients receiving both a statin and non-statin LLT (n = 1423) were more likely to be male, white race and to perceive themselves as higher risk of ASCVD compared with their peers (38.5% vs. 34.9%, p = .047). Only 27.4% of patients treated with non-statin LLT alone perceived themselves at higher risk. Most (75.7%) patients treated with a non-statin LLT alone reported never being treated with a statin, despite ASCVD in 30.8% of these patients. Among those previously treated with a statin, 59.3% reported being willing to try a statin again. Conclusions Non-statin LLT is used in one in four patients with or at risk for ASCVD; its use is frequently in place of statin therapy or in the absence of guideline-recommended statin intensity. More work is needed to establish statins as first line therapy.

Direct oral anticoagulants (DOACs) have partial renal clearance and generally require dosage adjustments based on renal function. While current US and European guidance recommends dose adjustments in patients with moderate chronic kidney disease (CKD), it is unclear how often this is done appropriately in routine clinical practice. We examined rates of appropriate and inappropriate dosing in patients with atrial fibrillation (AF) and moderate CKD, as determined by creatinine clearance (CrCl) of 30–50 mL/min calculated with the Cockcroft–Gault formula. Descriptive statistics were used to describe the rate of appropriate and inappropriate dosing as well as event rates. Among 1134 patients (8.5% of the overall ORBIT-AF II registry) with AF and CrCl 30–50 mL/min, the median age was 82 (25th, 75th percentile: 78, 86), 38% were male, and the median CHA2DS2VASC score was 4 (25th, 75th percentile: 4, 5). At baseline, more than one-third (34%) of patients with moderate CKD were inappropriately dosed with DOACs. When evaluating the specific prescribed doses in those with moderate CKD, 15% (N = 170/1134) were underdosed, 66% (743/1134) were appropriately dosed, and 20% (N = 221/1134) were overdosed. There were no significant differences in comorbid medical conditions between patients with moderate CKD who were appropriately and inappropriately dosed with a DOAC. In routine clinical practice, prescribing of DOACs in patients with AF with moderate CKD is often inconsistent with drug labeling, with up to one-third of patients being inappropriately dosed.

Background and aims Identifying patient subgroups with cardiovascular disease (CVD) at highest risk for recurrent events remains challenging. Angiographic features may provide incremental value in risk prediction beyond clinical characteristics. Methods We included all cardiac catheterization patients from the Duke Databank for Cardiovascular Disease with significant coronary artery disease (CAD; 07/01/2007–12/31/2012) and an outpatient follow-up visit with a primary care physician or cardiologist in the same health system within 3 months post-catheterization. Follow-up occurred for 3 years for the primary major adverse cardiovascular event endpoint (time to all-cause death, myocardial infarction [MI], or stroke). A multivariable model to predict recurrent events was developed based on clinical variables only, then adding angiographic variables from the catheterization. Next, we compared discrimination of clinical vs. clinical plus angiographic risk prediction models. Results Among 3366 patients with angiographically-defined CAD, 633 (19.2%) experienced cardiovascular events (death, MI, or stroke) within 3 years. A multivariable model including 18 baseline clinical factors and initial revascularization had modest ability to predict future atherosclerotic cardiovascular disease events (c-statistic = 0.716). Among angiographic predictors, number of diseased vessels, left main stenosis, left anterior descending stenosis, and the Duke CAD Index had the highest value for secondary risk prediction; however, the clinical plus angiographic model only slightly improved discrimination (c-statistic = 0.724; delta 0.008). The net benefit for angiographic features was also small, with a relative integrated discrimination improvement of 0.05 (95% confidence interval: 0.03–0.08). Conclusions The inclusion of coronary angiographic features added little incremental value in secondary risk prediction beyond clinical characteristics.

We sought to determine if the absence of hypertension in older adults can be used to identify those at lower risk of atherosclerotic cardiovascular disease (ASCVD). We identified participants ≥75 years old free of cardiovascular disease (CVD) in the National Institutes of Health Pooled Cohorts with and without hypertension. We assessed the association between systolic blood pressure (BP), diastolic BP, and cardiovascular events using multivariable modeling. The association between predicted ASCVD risk and observed events was compared. Of 2667 adults aged ≥75 years, 67.9% had hypertension. Lower systolic BP correlated with lower CVD event rates. ASCVD predicted risk score and systolic BP were both independently associated with ASCVD event rates. Among adults with similar ASCVD predicted risk estimates, those without (vs. with) hypertension had lower observed event rates across the predicted risk spectrum. The absence of hypertension may help refine the risk stratification of older adults, particularly those with intermediate predicted risk.

Purpose To determine the association between low molecular weight heparin (LMWH) use and mortality in hospitalized COVID-19 patients. Methods We conducted a retrospective study of patients consecutively enrolled from two major academic hospitals exclusively for COVID-19 in Wuhan, China, from January 26, 2020, to March 26, 2020. The primary outcome was adjusted in-hospital mortality in the LMWH group compared with the non-LMWH group using the propensity score. Results Overall, 525 patients with COVID-19 enrolled with a median age of 64 years (IQR 19), and 49.33% men. Among these, 120 (22.86%) were treated with LMWH. Compared with the non-LMWH group, the LMWH group was more likely to be older and male; had a history of hypertension, diabetes, coronary heart disease (CHD), or stroke; and had more severe COVID-19 parameters such as higher inflammatory cytokines or D-dimer. Compared with non-LMWH group, LMWH group had a higher unadjusted in-hospital mortality rate (21.70% vs. 11.10%; p = 0.004), but a lower adjusted mortality risk (adjusted odds ratio [OR], 0.20; 95% CI, 0.09–0.46). A propensity score-weighting analysis demonstrated similar findings (adjusted OR, 0.18; 95% CI, 0.10–0.30). Subgroup analysis showed a significant survival benefit among those who were severely (adjusted OR, 0.07; 95% CI, 0.02–0.23) and critically ill (adjusted OR, 0.32; 95% CI, 0.15–0.65), as well as among the elderly patients’ age > 65, IL-6 > 10 times upper limit level, and D-dimer > 5 times upper limit level. Conclusions Among hospitalized COVID-19 patients, LMWH use was associated with lower all-cause in-hospital mortality than non-LMWH users. The survival benefit was particularly significant among more severely ill patients.

Routine intensive care unit (ICU) utilization for patients with initially stable non-ST segment elevation myocardial infarction is not associated with improved short- or long-term patient outcomes; however, the association with patient experience has not been reported. Using Hospital Consumer Assessment of Healthcare Providers and Systems patient survey data linked to ICU use data from the National Cardiovascular Data Registry, we found no association between hospital-level ICU utilization and metrics of patient experience, including communication, staff responsiveness, and overall satisfaction.

Introduction This study examines the dose–response relationship between moderate-to-vigorous physical activity and cardiometabolic measures in adolescents. Methods Cross-sectional spline analyses were performed using 2003–2016 National Health and Nutrition Examination Survey data among adolescents (aged 12–19 years, N=9,195) on objectively measured (2003–2006) and self-reported (2007–2016) weekly mean minutes of moderate-to-vigorous physical activity and cardiometabolic measures (systolic and diastolic blood pressure, total cholesterol, high-density lipoprotein, BMI, and cardiorespiratory fitness). Inflection points were determined for nonlinear relationships. Results For objective moderate-to-vigorous physical activity, female adolescents had significant nonlinear associations with inflection points at 90 minutes/week for BMI percentile and systolic blood pressure. Male adolescents had inflection points at 150 weekly minutes of objective activity for BMI percentile and cardiorespiratory fitness. BMI percentile was about 7% lower for female and male adolescents at 150 weekly minutes of objectively measured moderate-to-vigorous physical activity than at 0 minutes. For self-reported moderate-to-vigorous physical activity, inflection points were at 375 minutes/week (diastolic blood pressure for female adolescents) and 500 minutes/week (systolic blood pressure for male adolescents). Conclusions Among several significant dose–response relationships between physical activity and cardiometabolic health in adolescents, consistent and often nonlinear relationships were identified for BMI, with inflection points at 90–150 minutes of objective moderate-to-vigorous physical activity. Notable differences in associations and linearity were identified by sex and physical activity measure (objective or self-reported). These results support calls for any increase in physical activity among adolescents and suggest that recommendations closer to the adult guidelines of 150 weekly minutes of physical activity may be health promoting and more attainable for youth than the current recommendation of 420 weekly minutes.

The growing population of older adults (age ≥65 years) is expected to lead to higher rates of cardiovascular disease. The expansion of digital health (encompassing telehealth, telemedicine, mobile health, and remote patient monitoring), Internet access, and cellular technologies provides an opportunity to enhance patient care and improve health outcomes—opportunities that are particularly relevant during the current coronavirus disease-2019 pandemic. Insufficient dexterity, visual impairment, and cognitive dysfunction, found commonly in older adults should be taken into consideration in the development and utilization of existing technologies. If not implemented strategically and appropriately, these can lead to inequities propagating digital divides among older adults, across disease severities and socioeconomic distributions. A systematic approach, therefore, is needed to study and implement digital health strategies in older adults. This review will focus on current knowledge of the benefits, barriers, and use of digital health in older adults for cardiovascular disease management.

BackgroundLong-term outcomes for Medicare beneficiaries hospitalised with transient ischaemic attack (TIA) and role of ABCD2 score in identifying high-risk individuals are not studied.MethodsWe identified 40 825 Medicare beneficiaries hospitalised from 2011 to 2014 for a TIA to a Get With The Guidelines (GWTG)-Stroke hospital and classified them using ABCD2 score. Proportional hazards models were used to assess 1-year event rates of mortality and rehospitalisation (all-cause, ischaemic stroke, haemorrhagic stroke, myocardial infarction, and gastrointestinal and intracranial haemorrhage) for high-risk versus low-risk groups adjusted for patient and hospital characteristics.ResultsOf the 40 825 patients, 35 118 (86%) were high risk (ABCD2 ≥4) and 5707 (14%) were low risk (ABCD2=0–3). Overall rate of mortality during 1-year follow-up after hospital discharge for the index TIA was 11.7%, 44.3% were rehospitalised for any reason and 3.6% were readmitted due to stroke. Patients with ABCD2 score ≥4 had higher mortality at 1 year than not (adjusted HR 1.18, 95% CI 1.07 to 1.30). Adjusted risks for ischaemic stroke, all-cause readmission and mortality/all-cause readmission at 1 year were also significantly higher for patients with ABCD2 score ≥4 vs 0–3. In contrast, haemorrhagic stroke, myocardial infarction, gastrointestinal bleeding and intracranial haemorrhage risk were not significantly different by ABCD2 score.ConclusionsThis study validates the use of ABCD2 score for long-term risk assessment after TIA in patients aged 65 years and older. Attentive efforts for community-based follow-up care after TIA are needed for ongoing prevention in Medicare beneficiaries who were hospitalised for TIA.

Triglyceride (TG) levels encompass several lipoproteins that have been implicated in atherogenic pathways. Whether TG levels independently associate with cardiovascular disease both overall and, in particular among patients with established coronary artery disease (CAD) and type 2 diabetes (T2DM), remains controversial. Data from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial was used to evaluate patients with T2DM and CAD. Cox proportional hazards models were used to determine the association between TG levels and outcomes. Stepwise adjustment was performed for demographics, clinical factors, lipid profile and statin treatment. The primary composite outcome was time to CV death, myocardial infarction (MI), or stroke and secondary outcome was CV death. Among 2,307 patients with T2DM and CAD, the mean (±SD) TG levels were 181 (±136) with a median (Q1-Q3) 148mg/dL (104-219). Overall, 51% of patients had TG150 mg/dL, 18% 150-199 mg/dL, 28% 200-499 mg/dL and 3% ≥500 mg/dL. Participants with elevated TG levels (≥150 mg/dL) were younger (61 vs 63 years, p0.001), had higher BMI (32 vs 30 kg/m

Whereas the burgeoning population of older adults is intrinsically vulnerable to cardiovascular disease, the utility of many management precepts that were validated in younger adults is often unclear. Whereas biomarker- and imaging-based tests are a major part of cardiovascular disease care, basic assumptions about their use and efficacy cannot be simply extrapolated to many older adults. Biology, physiology, and body composition change with aging, with important influences on cardiovascular disease testing procedures and their interpretation. Furthermore, clinical priorities of older adults are more heterogeneous, potentially undercutting the utility of testing data that are collected. The American College of Cardiology and the National Institutes on Aging, in collaboration with the American Geriatrics Society, convened, at the American College of Cardiology Heart House, a 2-day multidisciplinary workshop, "Diagnostic Testing in Older Adults with Cardiovascular Disease," to address these issues. This review summarizes key concepts, clinical limitations, and important opportunities for research.

Purpose Guidelines recommend 150 minutes of weekly moderate-to-vigorous physical activity (MVPA) for all adults, although physical activity level correlation with cardiometabolic health is not well characterized for young adults. We determined the dose–response relationship of MVPA on measures of cardiometabolic health in young adults. Methods We examined young adults (aged 20–29 years; N = 5,395, 47.9% female) in the 2003–2016 National Health and Nutrition Examination Survey. Exposures were objective (accelerometer based) and self-reported weekly mean minutes of MVPA. Cardiometabolic outcome measures were body mass index (BMI), high-density lipoprotein (HDL), total cholesterol, systolic blood pressure, and diastolic blood pressure. The dose–response relationships were assessed with unadjusted spline analyses. Sex-stratified outcomes were modeled using multivariable linear regression with mean estimated change presented for 150-minute dose increases of MVPA. Results Among females, associations between objective activity and cardiometabolic measures were all linear. Compared with no activity, 150 minutes of objective activity was associated with a lower BMI (−1.37 kg/m2) and total cholesterol (−4.89 mg/dL), whereas 150 minutes of self-reported activity was associated with a higher HDL (1 mg/dL) and lower diastolic blood pressure (−.42 mm Hg). Among males, an inflection point was identified in the dose–response curves for objective activity with BMI around 100 minutes. Compared with no activity, 150 self-reported minutes was associated with lower BMI (−.26 kg/m2), higher HDL (.52 mg/dL), and lower total cholesterol (−1.35 mg/dL). Conclusions The dose–response relationships between physical activity and cardiometabolic markers in young adults were predominantly linear, supporting public health calls for any increase in physical activity in this population.

Background There is limited information describing the characteristics and clinical outcomes of patients infected with coronavirus disease 2019 (COVID‐19) especially those in underserved urban area with minority population in the United States. Methods This is a retrospective single center study for patients who were admitted with COVID‐19 infection. Data collection was from March 1 through April 24,2020. Demographic, clinical, laboratory, and treatment data were presented using descriptive statistics and frequencies. Chi‐square test and multivariate logistic regression were used to determine association of risk factors and clinical outcomes. Results A total of 242 inpatients were included with a mean age of 66 ±14.75 (±SD). 50% were female and 70% were African American. Comorbidities included hypertension (74%), diabetes mellitus (49%), and 19% had either COPD or asthma. Older age was associated with higher risk of inpatient death OR 1.056 [95% CI 1.023 to 1.090; p=0.001]. Inpatient mortality occurred in 70% who needed mechanical ventilation (OR: 29.51; 95% CI: 13.28‐65.60; p

BackgroundCardioversion is common among patients with atrial fibrillation (AF). We hypothesised that novel oral anticoagulants (NOAC) used in clinical practice resulted in similar rates of stroke compared with vitamin K antagonists (VKA) for cardioversion.MethodsUsing the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II, patients with AF who had a cardioversion, follow-up data and an AF diagnosis within 6 months of enrolment were identified retrospectively. Clinical outcomes were compared for patients receiving a NOAC or VKA for 1 year following cardioversion.ResultsAmong 13 004 patients with AF, 2260 (17%) underwent cardioversion. 1613 met the inclusion criteria for this analysis. At the time of cardioversion, 283 (17.5%) were receiving a VKA and 1330 (82.5%) a NOAC. A transoesophageal echocardiogram (TOE) was performed in 403 (25%) cardioversions. The incidence of stroke/transient ischaemic attack (TIA) at 30 days was the same for patients having (3.04 per 100 patient-years) or not having (3.04 per 100 patient-years) a TOE (p=0.99). There were no differences in the incidence of death (HR 1.19, 95% CI 0.62 to 2.28, p=0.61), cardiovascular hospitalisation (HR 1.02, 95% CI 0.76 to 1.35, p=0.91), stroke/TIA (HR 1.18, 95% CI 0.30 to 4.74, p=0.81) or bleeding-related hospitalisation (HR 1.29, 95% CI 0.66 to 2.52, p=0.45) at 1 year for patients treated with either a NOAC or VKA.ConclusionsCardioversion was a low-risk procedure for patients treated with NOAC, and there were statistically similar rates of stroke/TIA 30 days after cardioversion as for patients treated with VKA. There were no statically significant differences in death, stroke/TIA or major bleeding at 1 year among patients treated with NOAC compared with VKA after cardioversion.

BACKGROUND The best timing for early invasive therapy in non-ST-segment elevation myocardial infarction (NSTEMI) patients remains controversial. We sought to determine the optimal timing of early catheterization in order to improve long-term outcomes in elderly (>65 years old) patients with NSTEMI. METHODS Using data from the CRUSADE registry linked to Medicare claims, we evaluated the association of early catheterization within the first 24 h or earlier time cut-points of NSTEMI presentation with long-term mortality among older Medicare beneficiaries. RESULTS Of 15 575 NSTEMI patients from 398 CRUSADE hospitals (2003-2006), 3880 (24.9%) received early (≤12 h) catheterization. Compared with those undergoing later catheterization, patients treated early were younger and had less comorbid illness. Relative to those treated later, patients receiving early catheterization had similar 1-year all-cause mortality (11.8% vs 11.9%, P = 0.90). Using on- vs off-hour presentation as an instrumental variable, balancing potential measured and unmeasured confounders, early and later catheterization patients had nonsignificant differences in 1-year mortality (+5.6% [-11.5%, +22.7%]). Similar results were observed in clinically relevant subgroups, such as age (< or ≥75 years), gender, diabetes status, Global Registry of Acute Coronary Events score (< or ≥140), presence of heart failure, and sensitivity analyses of alternative definitions of early catheterization (≤6 and ≤24 h). CONCLUSIONS Among older NSTEMI patients, we found that

Background The adoption of 2 classes of new diabetes medications, glucagon-like peptide 1 receptor agonists (GLP1RA) and sodium-glucose co-transporter-2 inhibitors (SGLT2i), has been slow in the United States despite their cardiovascular benefits in addition to their glucose-lowering effect. The objective of this study was to identify providers' perspectives about prescribing GLP1RA and SGLT2i. Methods In this survey study, a questionnaire was administered between May 17, 2018, and June 11, 2018, in a large academic health care system. Ninety providers who practice in endocrinology, primary care, or cardiology responded the questionnaire, with a 36.3% response rate. The questionnaire explored knowledge, comfort level, beliefs, perceived barriers, and hypothetical clinical decisions about prescribing GLP1RA and SGLT2i. Results Findings suggested a division of views from endocrinology and primary care providers versus cardiology providers. More than 88% of endocrinology providers and about 50% of primary care providers prescribed GLP1RA or SGLT2i at least 6 times a year, whereas less than 7% of cardiology providers prescribed either medication. All endocrinology providers, approximately 78% of primary care providers, and only 21% of cardiology providers were very comfortable or comfortable in all 4 knowledge aspects about GLP1RA and SGLT2i. Major barriers to prescribing GLP1RA and SGLT2i for endocrinology and primary care providers were cost and nonapproved prior authorizations, yet the top 3 reported barriers for cardiology providers were lack of knowledge about these medications, concerns of introducing confusion into diabetes care, and discomfort of prescribing diabetes medications. Conclusions Barriers to prescribing GLP1RA or SGLT2i are unique for endocrinology, primary care, and cardiology providers. Given the cardiovascular benefits of these medications, this study suggests specific areas and potential opportunities for clinicians to improve care for patients with diabetes and cardiovascular disease.

Background The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a promising strategy to provide high-quality clinical care and deliver behavioral treatment in local park and recreation settings. The Hearts & Parks study has three broad objectives: (1) evaluate the effectiveness of the clinic-community model for the treatment of child obesity, (2) define microbiome and metabolomic signatures of obesity and response to lifestyle change, and (3) inform the implementation of similar models in clinical systems. Methods Methods are designed for a pragmatic randomized, controlled clinical trial (n = 270) to test the effectiveness of an integrated clinic-community child obesity intervention as compared with usual care. We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months. Secondary outcomes include changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life. Through collection of biospecimens (serum and stool), additional exploratory outcomes include microbiome and metabolomics biomarkers of response to lifestyle modification. Discussion We present the study design, enrollment strategy, and intervention details for a randomized clinical trial to measure the effectiveness of a clinic-community child obesity treatment intervention. This study will inform a critical area in child obesity and cardiovascular risk research—defining outcomes, implementation feasibility, and identifying potential molecular mechanisms of treatment response. Clinical trial registration NCT03339440.

The TOPCAT trial investigated spironolactone vs placebo in patients with heart failure with preserved ejection fraction (HFpEF). Although the primary endpoint was not statistically significant, treatment with spironolactone did reduce heart failure hospitalizations compared with placebo. TOPCAT's impact on prescribing patterns in the United States is not well-characterized. We performed a retrospective analysis of discharge prescribing data in the Get With The Guidelines-Heart Failure Registry among patients with left ventricular ejection fraction ≥50% discharged between January 2009 and December 2016 to assess prescribing trends upon dissemination of TOPCAT results. Of 142,201 patients included in the study, 18,581 (13.1%) were prescribed mineralocorticoid receptor antagonists (MRAs) at discharge. Compared with those not prescribed MRAs, patients discharged on MRAs were generally younger (75 vs 78 years), and report white race (76.7% vs 72.0%), more likely to have had prior heart failure hospitalizations (75.5% vs 65.7%), lower brain natriuretic peptide levels (492 vs 545 pg/mL), but similar serum creatinine levels (1.2 vs 1.2 mg/dL) upon admission. MRA prescribing modestly increased over time (p

Both medication and surgical interventions can be used to treat obesity, yet their use and effectiveness in routine clinical practice are not clear. This study sought to characterize the prevalence and management of patients with obesity within a large U.S. academic medical center.All patients aged ≥18 years who were seen in a primary care clinic within the Duke Health System between 2013 and 2016 were included. Patients were categorized according to baseline BMI as underweight or normal weight (25 kg/mOf the 173,462 included patients, most were overweight (32%) or obese (40%). Overall,1% (n=295) of obese patients were prescribed medication for weight loss or underwent bariatric surgery within the 3-year study period. Most patients had no change in BMI class (70%) at 3 years.Despite a high prevalence of obesity within primary care clinics of a large, U.S. academic health center, the use of pharmacologic and surgical therapies was low, and most patients had no weight change over 3 years. This highlights the significant need for improvement in obesity care at a health system level.

Aims To determine the extent of shared decision-making (SDM), during selection of oral anticoagulant (OAC) and rhythm control treatments, in patients with newly diagnosed atrial fibrillation (AF). Methods and results We evaluated survey data from 1006 patients with new-onset AF enrolled at 56 US sites participating in the SATELLITE substudy of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT II). Patients completed surveys at enrolment and at 6-month follow-up. Patients were asked about who made their AF treatment decisions. Shared decision-making was classified as one that the patient felt was an autonomous decision or a shared decision with their healthcare provider (HCP). Approximately half of patients reported that their OAC treatment decisions were made entirely by their HCP. Compared with those reporting no SDM, patients reporting SDM for OAC were more often female (47.2% vs. 38.4%), while patients reporting SDM for rhythm control were more often male (62.2% vs. 57.6%). The most important factors cited by patients during decision-making for OAC were reducing stroke and bleeding risk, and their HCP’s recommendations. After adjustment, patients with self-reported understanding of OAC, and rhythm control options, had higher odds of having participated in SDM [odds ratio (OR) 2.54, confidence interval (CI): 1.75–3.68 and OR 2.36, CI: 1.50–3.71, both P ≤ 0.001, respectively]. Conclusion Shared decision-making is not widely implemented in contemporary AF practice. Patient understanding about available therapeutic options is associated with a more than a two-fold higher likelihood of SDM, and may be a potential target for future interventions.

Background Obstructive sleep apnea (OSA) is a known risk factor for atrial fibrillation (AF). However, it remains unclear whether OSA is independently associated with worse cardiovascular and neurological outcomes in patients with AF. Methods We used the ORBIT-AF I and ORBIT-AF II to conduct a retrospective cohort study of 22,760 patients with AF with and without OSA. Adjusted multivariable Cox proportional hazards models was used to determine whether OSA was associated with increased risk for major adverse cardiac and neurologic events (MACNEs) (cardiovascular death, myocardial infarction, stroke/transient ischemic attack/non–central nervous system embolism (stroke/SE), and new-onset heart failure], combined and individually. Results A total of 4,045 (17.8%) patients had OSA at baseline. Median follow-up time was 1.5 (interquartile range: 1-2.2) years, and 1,895 patients experienced a MACNE. OSA patients were younger (median [interquartile range] 68 [61-75] years vs 74 [66-81] years), were more likely male (70.7% vs 55.3%), and had increased body mass index (median 34.6 kg/m2 [29.8-40.2] vs 28.7 kg/m2 [25.2-33.0]). Those with OSA had a higher prevalence of concomitant comorbidities such as diabetes, chronic obstructive pulmonary disease, and heart failure. OSA patients had higher use of antithrombotic therapy. After adjustment, the presence of OSA was significantly associated with MACNE (hazard ratio: 1.16 [95% CI: 1.03-1.31], P = .011). OSA was also an independent risk factor for stroke/SE beyond the CHA2DS2-VASc risk factors (HR: 1.38 [95% CI 1.12-1.70], P = .003) but not cardiovascular death, myocardial infarction, new-onset heart failure, or major bleeding. Conclusions Among patients with AF, OSA is an independent risk factor for MACNE and, more specifically, stroke/SE.

Background There is limited evidence on the effectiveness and safety of direct-acting oral anticoagulants in patients with nonvalvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD). This study compared the risks of ischemic stroke/systemic embolism (ISSE) and major bleeding in patients with NVAF and stage IV-V CKD treated with rivaroxaban or warfarin. Methods Patients with NVAF and stage IV-V CKD who initiated rivaroxaban or warfarin treatment between November 2011 and June 2018 were selected from the Optum® Deidentified Electronic Health Record Database. Propensity score matching was used to balance rivaroxaban and warfarin patients on 112 measured baseline covariates. ISSE and major bleeding events over 2 years following treatment initiation were ascertained with validated end point definitions. Outcomes were analyzed as time-to-event data using Kaplan-Meier survival estimators and Cox regression. Results A total of 781 eligible rivaroxaban-treated patients were propensity score–matched to 1,536 warfarin-treated patients; baseline covariates were well balanced after matching (absolute standardized differences Conclusions No statistically significant difference in the risk of ISSE or major bleeding was found between rivaroxaban- and warfarin-treated patients. Although further study is needed, rivaroxaban appears to be a reasonable alternative to warfarin for ISSE prevention in the setting of NVAF and stage IV-V CKD.

Background Atrial fibrillation (AF) is common in patients with end-stage renal disease (ESRD). The impact of oral anticoagulation (OAC) in ESRD patients is uncertain. Objectives The purpose of this study was to describe patterns of OAC use in ESRD patients with AF and their associations with cardiovascular outcomes. Methods Using Medicare fee-for-service 5% claims data from 2007 to 2013, we analyzed treatment and outcomes in a cohort of patients with ESRD and AF. Prescription drug benefit information was used to determine the timing of OAC therapy. Cox proportional hazards modeling was used to compare outcomes including death, all-cause stroke, ischemic stroke, hemorrhagic stroke, and bleeding hospitalizations in ESRD patients treated with or without OAC. Results The cohort included 8,410 patients with AF and ESRD. A total of 3,043 (36.2%) patients were treated with OAC at some time during the study period. Propensity scores used to match 1,519 patients with AF and ESRD on OAC with 3,018 ESRD patients without OAC. Treatment with OAC was not associated with hospitalization for stroke (hazard ratio [HR]: 1.00; 95% confidence interval [CI]: 0.23 to 1.35; p = 0.97) or death (HR: 1.02; 95% CI: 0.94 to 1.10; p = 0.62). OAC was associated with an increased risk of hospitalization for bleeding (HR: 1.26; 95% CI: 1.09 to 1.46; p = 0.0017) and intracranial hemorrhage (HR: 1.30; 95% CI: 1.07 to 1.59; p = 0.0094). Conclusions OAC utilization was low in patients with AF and ESRD. We found no association between OAC use and reduced risk of stroke or death. OAC use was associated with increased risks of hospitalization for bleeding or intracranial hemorrhage. Alternative stroke prevention strategies are needed in patients with ESRD and AF.

Background Despite a higher prevalence of sudden cardiac death (SCD), black individuals are less likely than whites to have an implantable cardioverter defibrillator (ICD) implanted. Racial differences in ICD utilization is in part explained by higher refusal rates in black individuals. Decision support can assist with treatment-related uncertainty and prepare patients to make well-informed decisions. Methods The Videos to reduce racial disparities in ICD therapy Via Innovative Designs (VIVID) study will randomize 350 black individuals with a primary prevention indication for an ICD to a racially concordant/discordant video-based decision support tool or usual care. The composite primary outcome is (1) the decision for ICD placement in the combined video groups compared with usual care and (2) the decision for ICD placement in the racially concordant relative to discordant video group. Additional outcomes include knowledge of ICD therapy and SCD risk; decisional conflict; ICD receipt at 90 days; and a qualitative assessment of ICD decision making in acceptors, decliners, and those undecided. Conclusions In addition to assessing the efficacy of decision support on ICD acceptance among black individuals, VIVID will provide insight into the role of racial concordance in medical decision making. Given the similarities in the root causes of racial/ethnic disparities in care across health disciplines, our approach and findings may be generalizable to decision making in other health care settings.

Amiodarone is the most effective antiarrhythmic drug (AAD) for atrial fibrillation (AF), but it has a high incidence of adverse effects.Using the ORBIT AF registry, patients with AF on amiodarone at enrollment, prescribed amiodarone during follow-up, or never on amiodarone were analyzed for the proportion treated with a guideline-based indication for amiodarone, the variability in amiodarone use across sites, and the outcomes (mortality, hospitalization, and stroke) among patients treated with amiodarone. Hierarchical logistic regression modeling with site-specific random intercepts compared rates of amiodarone use across 170 sites. A logistic regression model for propensity to receive amiodarone created a propensity-matched cohort. Cox proportional hazards modeling, stratified by matched pairs evaluated the association between amiodarone and outcomes.Among 6,987 AF patients, 867 (12%) were on amiodarone at baseline and 451 (6%) started on incident amiodarone during the 3-year follow-up. Use of amiodarone varied among sites from 3% in the lowest tertile to 21% in the highest (p0.0001). Among those treated, 32% had documented contraindications to other AADs or had failed another AAD in the past. Mortality, cardiovascular hospitalization, and stroke were similar among matched patients on and not on amiodarone at baseline, while incident amiodarone use in matched patients was associated with higher all-cause mortality (adjusted HR 2.06, 95% CI 1.35-3.16).Use of amiodarone among AF patients in community practice is highly variable. More than 2 out of 3 patients treated with amiodarone appeared to be eligible for a different AAD.

Background and objectives Patients on maintenance dialysis with in-hospital cardiac arrest have been reported to have worse outcomes relative to those not on dialysis; however, it is unknown if poor outcomes are related to the quality of resuscitation. Using the Get With The Guidelines-Resuscitation (GWTG-R) registry, we examined processes of care and outcomes of in-hospital cardiac arrest for patients on maintenance dialysis compared with nondialysis patients. Design, setting, participants, & measurements We used GWTG-R data linked to Centers for Medicare and Medicaid data to identify patients with ESKD receiving maintenance dialysis from 2000 to 2012. We then case-matched adult patients on maintenance dialysis to nondialysis patients in a 1:3 ratio on the basis of age, sex, race, hospital, and year of arrest. Logistic regression models with generalized estimating equations were used to assess the association of in-hospital cardiac arrest and outcomes by dialysis status. Results After matching, there were a total of 31,144 GWTG-R patients from 372 sites, of which 8498 (27%) were on maintenance dialysis. Patients on maintenance dialysis were less likely to have a shockable initial rhythm (20% versus 21%) and less likely to be within the intensive care unit at the time of arrest (46% versus 47%) compared with nondialysis patients; they also had lower composite scores for resuscitation quality (89% versus 90%) and were less likely to have defibrillation within 2 minutes (54% versus 58%). After adjustment, patients on maintenance dialysis had similar adjusted odds of survival to discharge (odds ratio [OR], 1.05; 95% confidence interval [95% CI], 0.97 to 1.13), better acute survival (OR, 1.33; 95% CI, 1.26 to 1.40), and were more likely to have favorable neurologic status (OR, 1.12; 95% CI, 1.04 to 1.22) compared with nondialysis patients. Conclusions Although there appears to be opportunities to improve the quality of in-hospital cardiac arrest care for among those on maintenance dialysis, survival to discharge was similar for these patients compared with nondialysis patients.

Background Comorbidities are common in patients with atrial fibrillation (AF) and affect prognosis, yet are often undertreated. However, contemporary rates of use of guideline-directed therapies (GDT) for non-AF comorbidities and their association with outcomes are not well described. Methods We used the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF) to test the association between GDT for non-AF comorbidities and major adverse cardiac or neurovascular events (MACNE; cardiovascular death, myocardial infarction, stroke/thromboembolism, or new-onset heart failure), all-cause mortality, new-onset heart failure, and AF progression. Adjustment was performed using Cox proportional hazards models and logistic regression. Results Only 6,782 (33%) of the 20,434 patients eligible for 1 or more GDT for non-AF comorbidities received all indicated therapies. Use of all comorbidity-specific GDT was highest for patients with hyperlipidemia (75.6%) and lowest for those with diabetes mellitus (43.1%). Use of “all eligible” GDT was associated with a nonsignificant trend toward lower rates of MACNE (HR 0.90 [0.79-1.02]) and all-cause mortality (HR 0.90 [0.80-1.01]). Use of GDT for heart failure was associated with a lower risk of all-cause mortality (HR 0.77 [0.67-0.89]), and treatment of obstructive sleep apnea was associated with a lower risk of AF progression (OR 0.75 [0.62-0.90]). Conclusions In AF patients, there is underuse of GDT for non-AF comorbidities. The association between GDT use and outcomes was strongest in heart failure and obstructive sleep apnea patients where use of GDT was associated with lower mortality and less AF progression.

Background Obesity is a risk factor for type 2 diabetes (T2D) and cardiovascular disease (CVD). Whether obesity affects outcomes among those with T2D and atherosclerotic CVD (ASCVD) remains uncertain. Our objective was to investigate the relationship between body mass index (BMI) and ASCVD outcomes among TECOS participants with T2D and ASCVD. Methods BMI categories were defined as underweight/normal weight (BMI 2 ), overweight (25-29.9 kg/m 2 ), obese class I (30-34.9 kg/m 2 ), obese class II (35-39.9 kg/m 2 ), and obese class III (≥ 40 kg/m 2 ). Asian-specific BMI categories were applied to Asian participants. Kaplan-Meier survival analysis and Cox proportional hazards models were used to examine associations between baseline BMI and a composite CV outcome (CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina). Results For 14,534 TECOS patients with available BMI, mean age was 65.5 years; 29.3% were female, 32.0% non-White, and 23.1% insulin-treated, with median 3 years' follow-up. At baseline, 11.6% (n = 1686) were underweight/normal weight, 38.1% (n = 5532) overweight, 32.2% (n = 4683) obese class I, 12.4% (n = 1806) obese class II, and 5.7% (n = 827) obese class III. The composite CV outcome occurred in 11.4% (n = 1663) of participants; the outcome risk was lower, compared with under/normal weight, in overweight (HR 0.83, 95% CI 0.71-0.98) and obese class I (HR 0.79, 95% CI 0.67-0.93) individuals. Obesity was not associated with worse glycemic control. Conclusions The majority of TECOS participants with ASCVD and T2D were overweight or obese, yet overweight or obese class I individuals had lower CV risk than those who were under/normal weight. These results suggest the presence of an obesity paradox, but this paradox may reflect an epidemiological artifact rather than a true negative association between normal weight and clinical outcomes.

Background Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes. Methods We performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from 7 randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5,839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage. Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the 2. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection. Results Among the 5,839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2% vs 5.2%; adjusted κ 0.99), MI (2.2% vs 2.3%; adjusted κ 0.96), stroke (0.7% vs 0.7%; adjusted κ 0.99), and any revascularization (7.4% vs 7.9%; adjusted κ 0.95). Of events detected by claims yet not reported by CEC, a minority were reported by sites but negatively adjudicated by CEC (39% of MIs and 18% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the 3 approaches for each outcome of interest. Conclusions Claims- versus site-based (+CEC) follow-up identified similar overall cardiovascular event rates despite meaningful differences in the events detected. Randomized treatment effects were similar using the 2 methods, suggesting claims data could be used to support clinical research leveraging routinely collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology.

For 4 decades, antithrombotic therapy with aspirin has been a cornerstone of secondary prevention for patients with chronic atherosclerotic cardiovascular disease (ASCVD). Unfortunately, despite the use of evidence-based therapies, patients with ASCVD continue to have recurrent major adverse cardiovascular events including death, myocardial infarction, and stroke-at a rate of approximately 2%-4% per year. To combat this continuing risk, several recent trials have evaluated the efficacy and safety of more intensive antithrombotic strategies through prolonged dual antiplatelet therapy (DAPT), combining a P2Y12 receptor antagonists and low-dose aspirin, or alternatively applying a dual pathway inhibition approach, combining low-dose non-vitamin K antagonist anticoagulant and low-dose aspirin. Both combination strategies have been shown to reduce recurrent ischemic events but at the cost of increased bleeding events. The clinical application of these antithrombotic strategies requires clinicians to assess and balance the risk of recurrent ischemic and bleeding events in an individual patient. Furthermore, clinicians may also need to adapt their antithrombotic strategies to achieve best patient outcomes, as ASCVD is a progressive disease and the risks of cardiovascular ischemic and bleeding events may shift over time. This state-of-the-art article reviews evidence from the trials and provides a practical approach to the application of DAPT and dual pathway antithrombotic therapy in the long-term management of patients with chronic ASCVD.

Objectives This study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex. Background Black patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear. Methods The ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines–Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria. Results Among 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p Conclusions Patients with HF seen in U.S. practice and eligible for the ASCEND-HF trial had worse clinical outcomes than those enrolled in the trial. After accounting for clinical characteristics, trial-eligible real-world patients continued to have higher rates of 30-day readmission, driven by differences among black patients and women. Social, behavioral, and other unmeasured factors may impair representativeness of patients enrolled in HF trials, particularly among racial/ethnic minorities and women. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852)

BACKGROUND Angiotensin-converting enzyme inhibitor (ACEi) and angiotensin-receptor blocker (ARB) are cornerstones in the treatment of heart failure with reduced ejection (HFrEF). However, there are limited data on their risk-benefit profile in patients with acute heart failure requiring hospitalizations. METHODS We did a meta-analysis pooling data from all studies examining the use of ACEi/ARB in patients hospitalized for heart failure compared to patients without ACEi/ARB use. We calculated pooled hazard ratios (HR) and their 95% confidence intervals (CI) using a random-effects model. RESULTS Twenty-five studies were included in the meta-analysis. Continued use of ACEi/ARBs in hospitalized patients with HFrEF was associated with lower 1-year mortality risk (pooled HR 0.68 [0.60-0.77] p

OBJECTIVE Phenotypic heterogeneity among patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) is ill defined. We used cluster analysis machine-learning algorithms to identify phenotypes among trial participants with T2DM and ASCVD. RESEARCH DESIGN AND METHODS We used data from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study (n = 14,671), a cardiovascular outcome safety trial comparing sitagliptin with placebo in patients with T2DM and ASCVD (median follow-up 3.0 years). Cluster analysis using 40 baseline variables was conducted, with associations between clusters and the primary composite outcome (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina) assessed by Cox proportional hazards models. We replicated the results using the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. RESULTS Four distinct phenotypes were identified: cluster I included Caucasian men with a high prevalence of coronary artery disease; cluster II included Asian patients with a low BMI; cluster III included women with noncoronary ASCVD disease; and cluster IV included patients with heart failure and kidney dysfunction. The primary outcome occurred, respectively, in 11.6%, 8.6%, 10.3%, and 16.8% of patients in clusters I to IV. The crude difference in cardiovascular risk for the highest versus lowest risk cluster (cluster IV vs. II) was statistically significant (hazard ratio 2.74 [95% CI 2.29–3.29]). Similar phenotypes and outcomes were identified in EXSCEL. CONCLUSIONS In patients with T2DM and ASCVD, cluster analysis identified four clinically distinct groups. Further cardiovascular phenotyping is warranted to inform patient care and optimize clinical trial designs.

Background and Purpose: Many older patients presenting with acute ischemic stroke were already taking aspirin before admission. However, the management strategy for patients with aspirin treatment failure has not been fully established. Methods: We used data from the American Heart Association Get With The Guidelines Stroke Registry to describe discharge antithrombotic treatment patterns among Medicare beneficiaries with ischemic stroke who were taking aspirin before their stroke and were discharged alive from 1734 hospitals in the United States between October 2012 and December 2017. Results: Of 261 634 ischemic stroke survivors, 100 016 (38.2%) were taking aspirin monotherapy before stroke. Among them, 44.4% of patients remained on aspirin monotherapy at discharge (20.9% 81 mg, 18.2% 325 mg, 5.3% other or unknown dose). The next most common therapy choice was dual antiplatelet therapy (24.6%), followed by clopidogrel monotherapy (17.8%). The remaining 13.2% of patients were discharged on either aspirin/dipyridamole, warfarin, or nonvitamin K antagonist oral anticoagulants with or without antiplatelet, or no antithrombotic therapy at all. Conclusions: Nearly half of patients with ischemic stroke while on preventive therapy with aspirin are discharged on aspirin monotherapy without changing antithrombotic class, while the other half are discharged on clopidogrel monotherapy, dual antiplatelet therapy, or other less common agents. These findings emphasize the need for future research to identify best management strategies for this very common and complex clinical scenario.

Background Patients with symptomatic severe aortic stenosis (ssAS) have a high mortality risk and compromised quality of life. Surgical/transcatheter aortic valve replacement (AVR) is a Class I recommendation, but it is unclear if this recommendation is uniformly applied. We determined the impact of managing cardiologists on the likelihood of ssAS treatment. Methods and Results Using natural language processing of Optum electronic health records, we identified 26 438 patients with newly diagnosed ssAS (2011–2016). Multilevel, multivariable Fine‐Gray competing risk models clustered by cardiologists were used to determine the impact of cardiologists on the likelihood of 1‐year AVR treatment. Within 1 year of diagnosis, 35.6% of patients with ssAS received an AVR; however, rates varied widely among managing cardiologists (0%, lowest quartile; 100%, highest quartile [median, 29.6%; 25th–75th percentiles, 13.3%–47.0%]). The odds of receiving AVR varied >2‐fold depending on the cardiologist (median odds ratio for AVR, 2.25; 95% CI, 2.14–2.36). Compared with patients with ssAS of cardiologists with the highest treatment rates, those treated by cardiologists with the lowest AVR rates experienced significantly higher 1‐year mortality (lowest quartile, adjusted hazard ratio, 1.22, 95% CI, 1.13–1.33). Conclusions Overall AVR rates for ssAS were low, highlighting a potential challenge for ssAS management in the United States. Cardiologist AVR use varied substantially; patients treated by cardiologists with lower AVR rates had higher mortality rates than those treated by cardiologists with higher AVR rates.

Background We sought to determine national trends and long term outcomes of post myocardial infarction (MI) heart failure. An MI can be complicated by heart failure; there are limited data describing the contemporary patterns and clinical implications of post-MI heart failure. Methods and Results We studied patients with an MI aged 65 years or older from 2000 to 2013 in a Medicare database. New-onset heart failure after an MI was defined as either heart failure during the index MI admission or a hospitalization for heart failure within 1 year of the index MI event. A trend analysis of the incidence of heart failure was performed, and differences were examined by Gray tests. The 5-year mortality rates were evaluated and differences among heart failure cohorts were ascertained by Gray tests. There were a total of 1,531,638 patients with an MI and 565,291 patients had heart failure (36.0%). The rate of heart failure during index admission was 32.3% and the frequency of heart failure hospitalization within 1 year was 10.4%. Patients with heart failure were older (81 years vs 77 years). The temporal trend from 2001 to 2012 suggested a decrease in the incidence of heart failure during index admission (2001: 34.7%, 2012: 31.2%, Ptrend Conclusions Post-MI heart failure in older adults occurs in 1 in 3 patients within 1 year; heart failure portends significantly higher long-term mortality.

Corresponding Author

The complexity and costs associated with traditional randomized, controlled trials have increased exponentially over time, and now threaten to stifle the development of new drugs and devices. Nevertheless, the growing use of electronic health records, mobile applications, and wearable devices offers significant promise for transforming clinical trials, making them more pragmatic and efficient. However, many challenges must be overcome before these innovations can be implemented routinely in randomized, controlled trial operations. In October of 2018, a diverse stakeholder group convened in Washington, DC, to examine how electronic health record, mobile, and wearable technologies could be applied to clinical trials. The group specifically examined how these technologies might streamline the execution of clinical trial components, delineated innovative trial designs facilitated by technological developments, identified barriers to implementation, and determined the optimal frameworks needed for regulatory oversight. The group concluded that the application of novel technologies to clinical trials provided enormous potential, yet these changes needed to be iterative and facilitated by continuous learning and pilot studies.

BACKGROUND: The purpose of the study was to examine the association between the type of preceding oral anticoagulant use (warfarin or direct oral anticoagulants [DOACs]) and in-hospital mortality among patients admitted with gastrointestinal bleeding.METHODS: In this observational cohort study, all patients admitted with a first-time gastrointestinal bleeding from January 2011 to March 2017 while receiving any oral anticoagulant therapy prior to admission were identified using data from Danish nationwide registries. The risk of in-hospital mortality according to type of oral anticoagulation therapy was examined by multivariable logistic regression models.RESULTS: Among 5,774 patients admitted with gastrointestinal bleeding (median age, 78 years [25th-75th percentile, 71-85 years]; 56.8% men), 2,038 (35.3%) were receiving DOACs and 3,736 (64.7%) were receiving warfarin prior to admission. The unadjusted in-hospital mortality rates were 7.5% for DOAC (7.2% for dabigatran, 6.4% for rivaroxaban, and 10.1% for apixaban) and 6.5% for warfarin. After adjustment for baseline demographic and clinical characteristics, there was no statistically significant difference in in-hospital mortality between prior use of any DOAC and warfarin (unadjusted odds ratio [OR] 1.18 [95% CI 0.95-1.45], adjusted OR 0.97 [95% CI 0.77-1.24]). Similar results were found for each individual DOAC as compared with warfarin (dabigatran: unadjusted OR 1.12 [95% CI 0.84-1.49], adjusted OR 0.96 [95% CI 0.71-1.30]); rivaroxaban: unadjusted OR 0.98 [95% CI 0.71-1.37], adjusted OR 0.84 [95% CI 0.59-1.21]; and apixaban: unadjusted OR 1.62 [95% CI 0.84-1.49], adjusted OR 1.22 [95% CI 0.83-1.79]).CONCLUSIONS: Among patients admitted with gastrointestinal bleeding, there was no statistically significant difference in in-hospital mortality between prior use of DOAC and warfarin.

Background To examine the effects of the DPP-4i sitagliptin on CV outcomes during and after incident MI in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Methods TECOS randomized 14,671 participants with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) to sitagliptin or placebo, in addition to usual care. For those who had a within-trial MI, we analyzed case fatality, and for those with a nonfatal MI, we examined a composite cardiovascular (CV) outcome (CV death or hospitalization for heart failure [hHF]) by treatment group, using Cox proportional hazards models left-censored at the time of the first within-trial MI, without and with adjustment for potential confounders, in intention-to-treat analyses. Results During TECOS, 616 participants had ≥ 1 MI (sitagliptin group 300, placebo group 316, HR 0.95, 95% CI 0.81–1.11, P = 0.49), of which 25 were fatal [11 and 14, respectively]). Of the 591 patients with a nonfatal MI, 87 (15%) died subsequently, with 66 (11%) being CV deaths, and 57 (10%) experiencing hHF. The composite outcome occurred in 58 (20.1%; 13.9 per 100 person-years) sitagliptin group participants and 50 (16.6%; 11.7 per 100 person-years) placebo group participants (HR 1.21, 95% CI 0.83–1.77, P = 0.32, adjusted HR 1.23, 95% CI 0.83–1.82, P = 0.31). On-treatment sensitivity analyses also showed no significant between-group differences in post-MI outcomes. Conclusions In patients with type 2 diabetes and ASCVD experiencing an MI, sitagliptin did not reduce subsequent risk of CV death or hHF, contrary to expectations derived from preclinical animal models. Trial registration clinicaltrials.gov no. NCT00790205

Evidence‐based therapy that target hyperlipidemia, hypertension, smoking cessation, and weight loss have demonstrated significant benefits in reducing cardiovascular risks and related events. Although the benefit of intensively lowering blood glucose is unclear, newer antidiabetic drugs (glucagon‐like peptide‐1 receptor agonists and sodium‐glucose cotransporter‐2 inhibitors) have shown cardiovascular benefits in addition to their antihyperglycemic effect. Yet, studies suggest that recent use of evidence‐based therapy and management of cardiovascular risk among individuals with type 2 diabetes (T2D) and cardiovascular disease (CVD) remains largely suboptimal. The following narrative review first identifies barriers to translating research evidence to clinical practice at the levels of provider, health system, patient, and cost. Then it synthesizes previous implementation strategies that addressed multifaceted barriers and attempted to improve care for patients with T2D and CVD. In conclusion, team‐based care coordination, reminding systems in combination to pharmacist consultation and patient education, provider education compatible with clinical workflow, and coupled incentives between providers and patients appeared to be effective in reducing cardiovascular risks for patients with T2D and CVD, though the scalability and long‐term clinical effect of these strategies as well as the possibility of interventions involving payers and health systems remain uncertain.

Background/objectives Elevated low-density lipoprotein cholesterol (LDL-C) in early adulthood is associated with increased risk of atherosclerotic cardiovascular disease (ASCVD). The strength of the association between LDL-C and ASCVD among older adults, however, is less understood. Design We examined individual-level cohort data from the National Institutes of Health Pooled Cohorts (Framingham Study, Framingham Offspring Study, Multi-Ethnic Study of Atherosclerosis, and Cardiovascular Health Study), which prospectively measured CVD risk factors and incident disease. Setting Prospective cohort study. Participants Adults, aged 75 years or older, free of ASCVD. Measurements We evaluated the associations between LDL-C and incident ASCVD (stroke, myocardial infarction, and cardiovascular death) in unadjusted analysis and in multivariable-adjusted Cox proportional hazards models. We assessed 5-year Kaplan-Meier ASCVD event rates in patients with and without hyperlipidemia (LDL-C ≥130 mg/dL or on lipid-lowering medications), stratified by the number of other risk factors, including smoking, diabetes, and hypertension. Results We included 2667 adults, aged 75 years or older (59% female), free of ASCVD; median age was 78 years, with median LDL-C of 117 mg/dL. In both unadjusted and adjusted analyses, there was no association between LDL-C and ASCVD (adjusted hazard ratio = 1.022; 95% confidence interval = 0.998-1.046; P = .07). Among adults without other risk factors (free of smoking, diabetes, and hypertension), event rates were similar between those with and without hyperlipidemia (Kaplan-Meier rates = 5.8% and 7.0%, respectively). Among adults with one or two or more other risk factors, the presence of hyperlipidemia was also not associated with 5-year CVD event rates (Kaplan-Meier rates = 12.8% vs 15.0% [P = .44] for one other risk factor and 21.9% vs 24.0% [P = .59] for two or more other risk factors). Conclusion Among a well-characterized cohort, LDL-C was not associated with CVD risk among adults aged 75 years or older, even in the presence of other risk factors. J Am Geriatr Soc 67:2560-2567, 2019.

Background Extended elevations of non–high-density lipoprotein cholesterol (non–HDL-C) across a lifespan are associated with increased risk of cardiovascular disease (CVD). However, optimal testing intervals to identify individuals with high lipid-related CVD risk are unknown. Objectives This study determined the extent to which lipid levels in young adulthood predict future lipid trajectories and associated long-term CVD risk. Methods A sample of 2,516 Framingham Offspring study participants 25 to 40 years of age free of CVD and diabetes had their non–HDL-C progression modeled over 8 study examinations (mean follow-up 32.6 years) using group-based methods. CVD risk based on 25 to 30 years of follow-up was evaluated using Kaplan-Meier analyses for those with mean non–HDL-C ≥160 mg/dl (“high”) and Results The trajectories of the lipid levels were generally stable over the 30-year life course; mean non–HDL-C measured in young adulthood were highly predictive of levels later in life. Individuals could be reliably assigned to high and low non–HDL-C groups based on 2 measurements collected between 25 to 40 years of age. Overall, 80% of those with non–HDL-C ≥160 mg/dl at the first 2 exams remained in the high group on subsequent 25-year testing, whereas 88% of those with non–HDL-C Conclusions Most adults with elevated non–HDL-C early in life continue to have high non–HDL-C over their life course, leading to significantly increased risk of CVD. The results demonstrate that early lipid monitoring before 40 years of age would identify a majority of those with a high likelihood for lifetime elevated lipid levels who also have a high long-term risk for CVD. This information could facilitate informed patient–provider discussion about the potential benefits of preventive lipid-lowering efforts during the early midlife period.