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Background: Cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (CVD) risk based on the pooled cohort equations to guide treatment decisions and engage patients in shared decision-making. We sought to determine patient perceived versus actual risk of atherosclerotic CVD and associations with willingness for preventive therapy. Methods: We evaluated calculated and perceived CVD risk among 4187 patients across 124 sites in the Patient and Provider Assessment of Lipid Management Registry. Ten-year risk was assessed using the pooled cohort equations; risk relative-to-peers was determined based on age-, sex-, and race-based percentiles; and patient estimates of risk were assessed using patient surveys. Poisson regression models evaluated associations between risk estimates, statin use, and willingness to take prevention therapy. Results: Overall, there was no correlation between patients’ estimates of their 10-year CVD risk and calculated 10-year risk (ρ=−0.01, P correlation =0.46), regardless of age, sex, race, or socioeconomic status. The majority (72.2%) overestimated their 10-year CVD risk relative to the pooled cohorts equation (mean perceived 33.3% versus mean calculated 17.1%, P difference P P =0.18) but was associated with willingness to consider future prevention therapy ( P Conclusions: When asked, most patients overestimate their 10-year risk but hold an optimistic bias of their risk relative to age-, race-, and sex-matched peers. Providing accurate absolute risk assessments to patients without proper context may paradoxically decrease many patients’ perceived risk of CVD, thereby disincentivizing initiation of CVD risk reduction therapy.

Background: Cardiovascular disease (CVD) is the leading cause of hospitalization in the United States, and patients with CVD are at a high risk of readmission after discharge. We examined whether patients’ perceived risk of readmission at discharge was associated with actual 30-day readmissions in patients hospitalized with CVD. Methods: We recruited 730 patients from the Duke Heart Center who were admitted for treatment of CVD between January 1, 2015, and August 31, 2017. A standardized survey was linked with electronic health records to ascertain patients’ perceived risk of readmission, and other sociodemographic, psychosocial, behavioral, and clinical data before discharge. All-cause readmission within 30 days after discharge was examined. Results: Nearly 1-in-3 patients perceived a high risk of readmission at index admission and those who perceived a high risk had significantly more readmissions within 30 days than patients who perceived low risks of readmission (23.6% versus 15.8%, P =0.016). Among those who perceived a high risk of readmission, non-White patients (odds ratio [OR], 2.07 [95% CI, 1.28–3.36]), those with poor self-rated health (OR, 2.30 [95% CI, 1.38–3.85]), difficulty accessing care (OR, 2.72 [95% CI, 1.24–6.00]), and prior hospitalizations in the past year (OR, 2.13 [95% CI, 1.21–3.74]) were more likely to be readmitted. Among those who perceived a low risk of readmission, patients who were widowed (OR, 2.69 [95% CI, 1.60–4.51]) and reported difficulty accessing care (OR, 1.89 [95% CI, 1.07–3.33]) were more likely to be readmitted. Conclusions: Patients who perceived a high risk of readmission had a higher rate of 30-day readmission than patients who perceived a low risk. These findings have important implications for identifying CVD patients at a high risk of 30-day readmission and targeting the factors associated with perceived and actual risks of readmission.

Background: Nationwide, intensive care unit (ICU) utilization for initially stable patients with non-ST-segment elevation myocardial infarction (NSTEMI) is not associated with patient risk. Use of the ACTION ICU risk score, which predicts clinical deterioration requiring ICU care in initially stable NSTEMI patients, could guide admission of high-risk patients to the ICU and low-risk patients to a lower acuity unit. Methods: We created a modified best practice advisory (BPA) within the electronic health record (EHR) at a single institution. The BPA semi-automatically calculates the ACTION ICU score (5 elements automatically populate from the EHR and 4 are entered manually) and recommends a location for admission based on a 10% risk threshold for clinical deterioration over the course of admission. The BPA was triggered for all ED patients with serum 4 th generation troponin T above the local upper limit of normal. Physicians could temporarily hide the BPA, permanently cancel it if they felt the patient’s presentation was not primarily due to NSTEMI, or generate the ACTION ICU score. We measured how ED physicians used the BPA, and clinical and utilization outcomes for patients admitted through the ED with a discharge diagnosis of NSTEMI in the 12 months before and after BPA roll-out. Results: Between August 14, 2017 and August 13, 2018, the BPA triggered 972 times. It was hidden until the patient left the ED 230 times (23.7%) and canceled 561 times (57.7%). Providers opted to calculate a risk score 181 times (18.6%), and a score was successfully calculated 146 times. Among 135 patients for whom the BPA triggered that had a final hospital diagnosis of NSTEMI, the BPA was inappropriately canceled in 62 (45.9%) and hidden in 16 (11.9%). Overall, there were 190 NSTEMI admissions through the ED in the year after BPA integration into the EHR and 253 in the year prior. In the year after BPA integration 32.6% of the NSTEMI patients were admitted directly to the ICU compared with 37.5% admitted to ICU prior to BPA (p=0.32). No change was found in the distribution of ACTION ICU scores of NSTEMI patients admitted to the ICU prior to vs after BPA integration, as well as no differences in ICU length of stay (p=0.96), hospital length of stay (p=0.27), the proportion of patients transferred from the ward to the ICU (p=0.78), or in-hospital mortality (p=0.18). Conclusions: Embedding the ACTION ICU risk score into the EHR did not affect clinical or utilization outcomes for patients presenting to the ED with NSTEMI, but was limited by inappropriate cancellation of the risk score calculator. Better EHR mapping to enable risk calculation without the need for user input may be needed for successful deployment of predictive analytics in this patient population.

Introduction: The accuracy of electronic health record (EHR) data to identify prevalent disease status and/or clinical events is a major concern for the use of ‘real world’ data for research. We assessed the accuracy of EHR data for specific CV conditions based on EHR data compared with manual chart review. Methods: Using a cloud-based infrastructure, Cerner’s HealtheIntent EHR data from two health systems were de-identified and aggregated. We created EHR-based computable phenotypes for patients with ASCVD, (based on prior diagnosis and procedure codes, to identify comorbidities and hospitalizations with acute limb ischemia (ALI), bleeding, acute coronary syndrome (ACS), and cerebrovascular events (stroke/transient ischemic attack/intracranial hemorrhage). Chart reviews were performed (n=1,869) to validate the hospitalization final diagnosis and prevalent comorbidities, with the first 100 charts undergoing review by two concurrent chart reviewers. When reviewers noted an absence of a comorbidity, but EHR data indicated it may be present, an automated cue was presented to the reviewer of “Are you Sure?”. Cohen’s kappas (κ) were calculated to indicate agreement inter-review of event types and comorbidities. The PPV of EHR data for hospitalization diagnosis and comorbidities compared with cue-augmented chart review as gold standard were assessed. Results: The inter-rater agreement for the hospitalization diagnosis was very good overall and highest for ACS (0.83), followed by ALI (0.75), , and cerebrovascular events (0.69). The PPV of EHR-based diagnoses for single chart reviewers was 0.93 for cerebrovascular events, 0.81 for bleeding, 0.78 for ACS, and 0.51 for ALI. Similarly, the predictive accuracy of the EHR-based computable phenotypes for comorbidities and events was variable: as high as 0.93 for hypertension, 0.87 for atrial fibrillation, and 0.86 for peripheral arterial disease, to as low as 0.13 for type 1 diabetes, 0.38 for prior transient ischemic attack, and 0.56 for heart failure with reduced ejection fraction. Providing the chart reviewer with automated cue for comorbidities improved PPV. Conclusions: Many, but not all, clinical outcomes and comorbidities can be identified using EHR-based algorithms, with variable performance depending on the condition. Human chart reviews, long considered a gold standard, may be improved using EHR data.

Background: Cost is frequently cited as a barrier to optimal medication use, but the extent to which copayment assistance interventions are used when available, and their impact on evidence-based medication persistence and major adverse cardiovascular events is unknown. Methods and Results: The ARTEMIS trial (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) randomized 301 hospitals to usual care versus the ability to provide patients with vouchers that offset copayment costs when filling P2Y 12 inhibitors in the 1 year post-myocardial infarction. In the intervention group, we used multivariable logistic regression to identify patient and medication cost characteristics associated with voucher use. We then used this model to stratify both intervention and usual care patients by likelihood of voucher use, and examined the impact of the voucher intervention on 1-year P2Y 12 inhibitor persistence (no gap in pharmacy supply >30 days) and major adverse cardiovascular events (all-cause death, myocardial infarction, or stroke). Among 10 102 enrolled patients, 6135 patients were treated at hospitals randomized to the copayment intervention. Of these, 1742 (28.4%) never used the voucher, although 1729 (99.2%) voucher never-users filled at least one P2Y 12 inhibitor prescription in the 1 year post-myocardial infarction. Characteristics most associated with voucher use included: discharge on ticagrelor, planned 1-year course of P2Y 12 inhibitor treatment, white race, commercial insurance, and higher out-of-pocket medication costs (c-statistic 0.74). Applying this propensity model to stratify all enrolled patients by likelihood of voucher use, the intervention improved medication persistence the most in patients with high likelihood of voucher use (adjusted interaction P =0.03, odds ratio, 1.86 [95% CI, 1.48–2.33]). The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56–1.16]) among patients with high likelihood of voucher use (adjusted interaction P =0.04). Conclusions: Among patients discharged after myocardial infarction, those with higher copayments and greater out-of-pocket medication costs were more likely to use a copayment assistance voucher, but some classes of patients were less likely to use a copayment assistance voucher. Patients at low likelihood of voucher use benefitted least from copayment assistance, and other interventions may be needed to improve medication-taking behaviors and clinical outcomes in these patients. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02406677.

Background: The Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire has recently been validated to measure the impact of atrial fibrillation on quality of life, but a clinically important difference in AFEQT score has not been well defined. Methods and Results: To determine the clinically important difference in overall AFEQT (score range= 0 [worst] to 100 [best]) and selected subscales, we analyzed data in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry, a United States-based outpatient atrial fibrillation registry. AFEQT was assessed at baseline and 1 year in a subset of 1347 ORBIT-AF patients from 80 US sites participating in ORBIT-AF from June 2010 to August 2011. The mean change method was used to relate changes in 1-year AFEQT scores to clinically important changes in the physician assessment of European Heart Rhythm Association functional status (1 class improvement and separately 1 class deterioration). Clinically important differences and 95% CI corresponding to either a 1 European Heart Rhythm Association class improvement or deterioration were 5.4 (3.6–7.2) and −4.2 (−6.9 to −1.5) AFEQT points, respectively. Similarly, clinically important difference values were seen for a 1 European Heart Rhythm Association class improvement for the AFEQT subscales Activities of Daily Living and Symptoms: 5.1 (2.5–7.6) and 7.1 (5.3–9.0) AFEQT points, respectively. Conclusions: Based on the anchor of 1 European Heart Rhythm Association class change, changes in AFEQT score of + or −5 points are clinically important changes in patients’ health. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT01165710.

Background: Stroke is the leading cause of death in China. Despite the wide dissemination of evidence-based guidelines, data about adherence to these in routine clinical practice are scarce. We conducted a study using a nationwide registry to evaluate the implementation of evidence-based stroke performance indicators and associated guidelines, for patients with an ischemic stroke in China. Methods and Results: The China National Stroke Registry is a prospective cohort study, including 12 416 patients diagnosed with acute ischemic stroke from 132 hospitals across China, for 1 year beginning September 2007. Twelve performance indicators were selected to evaluate the quality of stroke care. Multivariable Cox models were used to determine the association between optimal compliance and clinical outcomes. Conformity with performance measures ranged from a median of 6.5% for the use of intravenous tPA (tissue-type plasminogen activator) to 81.8% for early use of antithrombotics. The optimal compliance with all in-hospital measures was associated with 1-year death after admission (hazard ratio, 0.66; 95% CI, 0.55–0.79). The optimal compliance with all discharge measures was associated with the 1-year death after discharge (hazard ratio, 0.55; 95% CI, 0.44–0.69), 1-year stroke recurrence (hazard ratio, 0.81; 95% CI, 0.70–0.93), and favorable functional outcomes (defined as modified Rankin Scale score of ≤2) (hazard ratio, 1.10; 95% CI, 1.04–1.16). Conclusions: Adherence to evidence-based ischemic stroke care measures in China revealed substantial gaps, and select measures were associated with improved outcomes. These findings support the need for ongoing quality measurement and improvement in stroke care in China.

Background— The use of transcatheter aortic valve replacement (TAVR) to treat aortic stenosis in the United States is growing, yet little is known about the variation in procedural outcomes in community practice. We developed a TAVR in-hospital mortality risk model and used it to quantify variation in mortality rates across United States (US) TAVR centers. Methods and Results— We analyzed data from 22 248 TAVR procedures performed at 318 sites participating in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 to October 2014). A Bayesian hierarchical model was developed to estimate hospital-specific risk-adjusted mortality rates adjusting for 40 patient baseline factors. A total of 1130 in-hospital deaths (5.1%) were observed. Reliability-adjusted risk-adjusted mortality rate estimates ranged from 3.4% to 7.7% with an interquartile range of 4.8% to 5.4%. A patient’s predicted odds of dying was 80% higher if treated by a hospital 1 standard deviation above the mean compared with a hospital 1 standard deviation below the mean (odds ratio =1.8; 95% credible interval, 1.4%–2.2%). Conclusions— Risk modeling of TAVR in-hospital mortality revealed variation in risk-adjusted mortality rates during the US early commercial experience. Transcatheter Valve Therapy Registry analyses using this model will support research, feedback reporting, and the identification of factors associated with quality.

Background— Little is known about whether enrollment versus nonenrollment in Medicare’s prescription drug plan (Part D) is associated with better outcomes after acute myocardial infarction (AMI). Methods and Results— Using Medicare records linked to Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With The Guidelines, we identified 59 149 Medicare beneficiaries (age ≥65 years) discharged after AMI between January 2007 and December 2010. We described trends in Medicare Part D enrollment, and compared the following 30-day and 1-year outcomes: all-cause death, all-cause readmissions, and major adverse cardiac events (a composite of all-cause death or readmission for AMI or stroke) between Part D enrollees and nonenrollees, after adjustment for patient and hospital factors. From 2007 to 2010, 29 264 (49.5%) patients with AMI enrolled in Medicare were also participating in Part D by hospital discharge. All-cause 30-day death was more common among enrollees versus nonenrollees (4.0% versus 3.3%), but this difference was not statistically significant after multivariable adjustment (adjusted hazard ratio, 1.06 [95% confidence interval, 0.97–1.17]). Enrollees also had higher unadjusted risks of 30-day all-cause readmissions or major adverse cardiac events, and 1-year mortality, all-cause readmissions, or major adverse cardiac events, but these were attenuated after multivariable adjustment. Adherence to key secondary prevention medications (statins, β-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and P2Y 12 antagonists) remained low (range, 55%–64%) at 1 year post discharge among Part D enrollees. Conclusions— Only half of Medicare-insured patients with AMI were enrolled in Part D by hospital discharge, and their 30-day and 1-year adjusted outcomes did not differ substantially from nonenrollees. There remain opportunities for improvement in medication adherence among patients with prescription drug coverage.

Background: Inability to resume employment after acute myocardial infarction (MI) has important implications for patients. We sought to assess the prevalence of and outcomes associated with adverse change in employment after MI in a national US cohort. Methods and Results: The TRANSLATE-ACS study (Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome) assessed employment status at baseline and 1 year among 9319 patients with MI (mean age, 60.8 years; SD, 11.3; 27.3% women) enrolled at 233 US hospitals. We defined adverse change in employment as patients working at baseline but working less or not working at 1-year post-MI. In multivariable models, we assessed factors associated with adverse change in employment and its association with patient-reported depression, health status, persistence to evidence-based medications prescribed at discharge, and financial hardship affording medications. Half of the patients (51%; n=4730) were employed at the time of MI. By 1 year, 10% (n=492) of these reported an adverse change in employment, with 3% (n=143) working less and 7% (n=349) no longer working (only 27 of 349 reported retirement). Factors significantly associated with adverse change in employment included a number of unplanned readmissions, postdischarge bleeding complications, hypertension, and smoking. At 1 year, patients with an adverse change in employment were more likely to report depression (Patient Health Questionnaire 2 score >3: 27.4% versus 16.7%), lower health status (mean EuroQoL visual analogue scale: 73 [SD, 17.8] versus 78 [SD, 14.8]), and moderate-extreme financial hardship with medication costs (41.0% versus 28.4%; all P Conclusions: Patients who experienced an adverse change in employment after MI reported lower quality of life, increased depression, and more difficulty affording medications. These results underscore the need for interventions to address this patient-centered outcome and its health impact. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01088503.

Background: There are limited treatment options for patients with HFpEF, with guidelines focusing on diuresis and management of associated cardiovascular conditions. In the TOPCAT trial, treatment with spironolactone in patients with HFpEF compared to placebo did not significantly decrease the incidence of the composite primary outcome, but the incidence of heart failure (HF) hospitalization was significantly lower. The impact of the TOPCAT results on mineralocorticoid antagonists (MRA) prescribing rates is unknown. We analyzed discharge prescribing rates of MRAs in the Get With The Guidelines-Heart Failure (GWTG-HF) registry to assess for practice changes following dissemination of TOPCAT results in 2013. Methods: All patients recorded in GWTG-HF with LVEF ≥ 50% and discharged between January 2009 and December 2016 were included in the study. Data were summarized by calendar year quarters (Q). The TOPCAT trial results were first presented in November 2013, so patients were dichotomized into those discharged before TOPCAT (2009Q1 through 2013Q3) and those after TOPCAT (2013Q4 through 2016Q4). Discharge prescribing rates for MRAs, beta blockers, ACE inhibitors, and ARBs were assessed for overall trends and change in prescribing rates after 2013Q3 by segmented regression. Results: Of 142,201 HFpEF patients included in the study, 18,581 (13.1%) were prescribed a MRA at discharge. Throughout the study period, MRA prescribing steadily increased (2009Q1 = 11.3%; 2016Q4 = 14.8%), without significant change in overall trend following announcement of TOPCAT results (p=0.17) (Figure 1). Discharge prescribing rates were largely stable for beta blockers but with a statistically significant change in trend after TOPCAT (2009Q1 = 82.8%; 2016Q4 = 80.5%; p < 0.0001), while prescribing rates for ACE/ARB decreased significantly throughout the study period without change in trend following TOPCAT (2009Q1 = 74.7%; 2016Q4 = 53.7%; p = 0.58). Conclusions: The prescribing rates for MRAs in HFpEF at hospital discharge modestly increased over time, with little discernible influence of TOPCAT. These findings suggest there has been gradual, modest MRA adoption in the absence of other therapeutic options and highlight the need for further trials on the efficacy and safety of MRAs in HFpEF.

Background: Low patient participation in clinical research undermines the generalizability of findings. Conducting informed consent by video rather than a traditional text format may enhance the appeal of research and break down barriers to participation. Methods: The Patient and Provider Assessment of Lipid Management (PALM) Registry enrolled patients at U.S. cardiology, endocrinology, and primary care clinics to evaluate cholesterol management practices. PALM investigators developed an iPad-based video informed consent tool that included video segments totaling 8 minutes which patients navigated though a “game-ified” interface. At sites whose IRB did not approve the video tool, participants read a 6-page text consent form on the iPad. Characteristics of sites and site activation times were compared between sites that did and did not use the video consent tool using Pearson’s chi-square test for categorical variables and Wilcoxon’s signed rank test for continuous variables. Results: Of 140 sites that enrolled 7904 patients in PALM, 60 (42.9%) used the video informed consent tool. Compared with sites using text consent, sites using the video consent tool were more often rural (16.7 vs. 3.8%, p = 0.01) and used a central IRB (91.7 vs. 80.0%, p = 0.06). Sites using video consent enrolled a greater proportion of patients who were ≥ 75 years old (27.5 vs. 23.6%, p < 0.001) or non-white (17.7 vs. 14.2%, p < 0.001). Sites using video consent had shorter times from site approach to first patient enrollment ( Figure ). Median (IQR) enrollment was 33 (12, 98) patients at sites using video consent versus 24 (12, 86) at sites using text consent only (p = 0.54); there was also no significant difference in median weekly enrollment rate (2.9 [1.1, 7.5] vs. 2.8 [1.3, 6.6], p = 0.73). Conclusions: In this early experience with video consent in a multicenter registry, availability of video informed consent was associated with greater enrollment of older and non-white patients, faster speed to first patient enrolled, and numerically but not significantly more rapid enrollment compared with text informed consent.

Background— There is significant variation in the delivery of evidence-based care for patients with heart failure (HF), but there is limited evidence defining the best methods to improve the quality of care. Methods and Results— We performed a cluster-randomized trial of personalized site performance feedback at 147 hospitals participating in the Get With The Guidelines-Heart Failure quality improvement program from October 2009 to March 2011. The intervention provided sites with specific data on their heart failure achievement and quality measures in addition to the usual Get With The Guidelines-Heart Failure tools. The primary outcome for our trial was improvement in site composite quality of care score. Overall, 73 hospitals (n=33 886 patients) received the intervention, whereas 74 hospitals (n=37 943 patients) did not. One year after the intervention, both the intervention and control arms had a similar mean change in percentage points in their composite quality score (absolute change, +0.31 [SE, 1.51] versus +3.18 [SE, 1.68] in control; P =0.21). Similarly, none of the individual achievement measures or quality measures improved more at intervention versus control hospitals. Conclusions— Our site-based intervention, which included personalized site feedback on adherence to quality metrics, was not able to elicit more quality improvement beyond that already associated with participation in the Get With The Guidelines-Heart Failure program. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00979264.

Background— Novel oral anticoagulants (NOACs) have been shown to be at least as good as warfarin for preventing stroke or transient ischemic attack in patients with atrial fibrillation, yet diffusion of these therapies and patterns of use among atrial fibrillation patients with ischemic stroke and transient ischemic attack have not been well characterized. Methods and Results— Using data from Get With The Guidelines-Stroke, we identified a cohort of 61 655 atrial fibrillation patients with ischemic stroke or transient ischemic attack hospitalized between October 2010 and September 2012 and discharged on warfarin or NOAC (either dabigatran or rivaroxaban). Multivariable logistic regression was used to identify factors associated with NOAC versus warfarin therapy. In our study population, warfarin was prescribed to 88.9%, dabigatran to 9.6%, and rivaroxaban to 1.5%. NOAC use increased from 0.04% to a 16% to 17% plateau during the study period, although anticoagulation rates among eligible patients did not change appreciably (93.7% versus 94.1% from first quarter 2011 to second quarter 2012), suggesting a trend of switching from warfarin to NOACs rather than increased rates of anticoagulation among eligible patients. Several bleeding risk factors and CHA 2 DS 2 -VASc scores were lower among those discharged on NOAC versus warfarin therapy (47.9% versus 40.9% with CHA 2 DS 2 -VASc ≤5, P 2 DS 2 -VASc). Conclusions— NOACs have had modest but growing uptake over time among atrial fibrillation patients hospitalized with stroke or transient ischemic attack and are prescribed to patients with lower stroke risk compared with warfarin.

Background— Divorce is a major life stressor that can have economic, emotional, and physical health consequences. However, the cumulative association between divorce and risks for acute myocardial infarction (AMI) is unknown. This study investigated the association between lifetime exposure to divorce and the incidence of AMI in US adults. Methods and Results— We used nationally representative data from a prospective cohort of ever-married adults aged 45 to 80 years (n=15 827) who were followed biennially from 1992 to 2010. Approximately 14% of men and 19% of women were divorced at baseline and more than one third of the cohort had ≥1 divorce in their lifetime. In 200 524 person-years of follow-up, 8% (n=1211) of the cohort had an AMI and age-specific rates of AMI were consistently higher in those who were divorced compared with those who were continuously married ( P Conclusions— Divorce is a significant risk factor for AMI. The risks associated with multiple divorces are especially high in women and are not reduced with remarriage.

Background— Antiarrhythmic drugs (AADs) are used to reduce the frequency, severity, and duration of atrial fibrillation (AF) events, which should reduce hospitalizations; however, little is known about the associations between different AADs and hospitalization—particularly among younger AF patients without structural heart disease. Methods and Results— Using MarketScan® claims data, we identified AF patients without coronary artery disease or heart failure who received their first AAD prescription (amiodarone, sotalol, dronedarone, or Class Ic) within 14 days post-first AF encounter. The primary outcome was time from first AAD prescription to AF hospitalization, and secondary outcomes included time to cardiovascular and all-cause hospitalizations. We used inverse probability-weighted estimators to adjust for differences in treatment allocation in the Cox proportional hazards model for each outcome. Among 8562 AF patients with a median age of 56 years (interquartile range 49, 61), risk of AF hospitalization was greater with dronedarone than Class Ic (hazard ratio [HR] 1.59; 95% confidence interval 1.13–2.24), amiodarone (HR 2.63; 1.77–3.89), and sotalol (HR 1.72; 1.17–2.54), but lower with amiodarone versus Class Ic (HR 0.68; 0.57–0.80) and sotalol (HR 0.63; 0.53–0.75). Risk of cardiovascular hospitalization was lower with amiodarone than Class Ic (HR 0.80; 0.70–0.92), but not non-AF cardiovascular hospitalization (HR 1.26; 1.01–1.57). There was no difference in all-cause hospitalization between amiodarone, Class Ic, and sotalol. Conclusions— Differences in hospitalization rates were found between AADs in younger AF patients without structural heart disease. Amiodarone had the lowest risk of AF hospitalization and dronedarone had the greatest risk. Additional research is needed to better understand associations between AADs and hospitalization risk.

Background— The safety of intravenous thrombolysis in ischemic stroke (IS) patients with chronic kidney disease (CKD) is uncertain. We assessed whether CKD is associated with bleeding complications after intravenous tissue-type plasminogen activator administration to patients with IS. Methods and Results— Data were analyzed from 44 410 patients with IS treated with intravenous tissue-type plasminogen activator in the Get With The Guidelines-Stroke Program. Glomerular filtration rate based on admission serum creatinine was categorized as dichotomous (presence of CKD as Conclusions— Presence of CKD among patients with IS treated with intravenous tissue-type plasminogen activator is associated with higher unadjusted odds of symptomatic intracranial hemorrhage or serious systemic hemorrhage, but this is explained by non-CKD related factors.

The Centers for Cardiovascular Outcomes Research (CCORs) held a meeting to review how cardiovascular outcomes research had evolved in the decade since the National Heart, Lung, and Blood Institute 2004 working group report and to consider future directions. The conference involved representatives from governmental agencies, outcomes research thought leaders, and public and private healthcare partners. The main purposes of this meeting were to (1) advance collaborative high-yield, high-impact outcomes research; (2) identify priorities and barriers to important cardiovascular outcomes research; and (3) define future needs for the field. This report highlights the key topics covered during the meeting, including an examination of the recent history of outcomes research, an evaluation of the current academic climate, and a vision for the future of cardiovascular outcomes research.

Objectives: Patients vary in the degree to which they understand and engage in their health care. We hypothesized that a personalized patient health education tool will promote patient communication and align patient and provider treatment goals in follow-up visits in order to optimize guideline adherence, including evidence-based therapy use and cardiovascular risk factor control, after an acute myocardial infarction (AMI). Methods: We developed a personalized patient education tool that summarized each patient’s status at discharge of secondary prevention risk factors (blood pressure (BP), low density lipoprotein cholesterol (LDL-C) and glycemic control), medication use (aspirin, beta blocker, ACE inhibitor/ARB, statin, P2Y 12 inhibitor), and outpatient treatment goals. Patients were randomized 1:1 to usual care vs. receipt of the education tool within 2 weeks post-discharge (before the outpatient visit). We compared secondary prevention medication use, cardiovascular risk factor control, and awareness of treatment goals between randomized groups at 6 months post-discharge. Results: Among 192 enrolled AMI patients, the median age was 60 years, 42% female, and 35% African American; demographic and clinical characteristics were well balanced between randomized groups. We noted high rates of secondary prevention therapy use at 6 months (Table). By 6 months post-discharge, mean systolic BP decreased by 10 mmHg with 80% of patients Conclusion: Though secondary prevention medication use remains reasonably high at 6 months, achievement of secondary prevention health goals remains suboptimal after a myocardial infarction. Few patients utilized the health tool in discussions with outpatient providers during their follow-up visit which likely explains the lack of outcomes differences between randomized groups. Further work is needed to find effective interventions to engage patients and promote sustained behavioral modification for secondary prevention.

Background: In non-valvular atrial fibrillation (NVAF) patients, those receiving once-daily (QD) versus twice-daily (BID) non vitamin-K antagonist oral anticoagulants (NOACs) may have better medication adherence. The impact on stroke and bleed risk is not known. Objective: To estimate the impact of adherence differences between QD vs BID therapies on bleed and stroke risks in NVAF patients. Methods: The relation between adherence (proportion of days covered [PDC]) for QD vs BID NOACs and one year bleed risk was modeled using claims data from Truven Health Analytics MarketScan databases (7/2012-10/2015). Next, the relation between adherence and bleeding was calibrated to match that seen in the placebo and NOAC arms of previous randomized controlled trials (RCTs). Finally, we used adherence rates for QD (PDC=0.849) and BID (PDC=0.738) cardiovascular medications from a meta-analysis (Coleman et al.). These rates were used in the calibrated model to estimate bleeds. An analogous method was applied to evaluate the impact of QD vs BID adherence on stroke risk. Results: The relation between PDC and risks of bleed and stroke was modeled using claims data (N=65,022) and calibrated using RCTs. In the calibrated model, compared with BID dosing, QD dosing was associated with 81 fewer strokes (34% reduction) and 14 more bleeds (6% more) per 10,000 patients/year (Figure). Conclusion: Among NVAF patients, better adherence to QD dosing was associated with a significantly lower stroke risk of QD but similar risk of bleed.

Background: Pragmatic clinical trial designs have proposed the use of claims data to ascertain clinical events. However, little is known about the accuracy of medical claims diagnosis in identifying events. Methods: Administrative claims were obtained for all rehospitalizations occurring within 12 months of index acute myocardial infarction (MI) in those enrolled in the TRANSLATE-ACS study. Outcome events (recurrent myocardial infarction [MI], stroke, and hospitalized bleeding) were identified based on all diagnosis and procedure codes in these claims. These clinical events were also independently adjudicated by physicians based on medical record review. The cumulative 1-year incidences for each outcome were compared when identified by administrative claims vs. physician adjudication. Kappa statistics assessed the accuracy of claims-identified events using physician adjudication as the gold standard. Results: Among 12,351 MI patients, the cumulative 1-year incidence of events identified by administrative claims were 4.3% for MI, 0.9% for stroke, and 5.0% for bleeding. Incidence rates based on physician adjudication of medical records were 4.7% for MI, 0.9% for stroke, and 5.4% for bleeding. Agreement between claims-identified and physician-adjudicated events was modest for MI and stroke events: kappa=0.76 and 0.55, respectively. In contrast, agreement was poor between claims-identified and physician-adjudicated bleeding events: kappa=0.24 for any hospitalized bleeding event and 0.15 for GUSTO moderate-severe bleeding. Conclusion: Event rates at 1 year were lower for MI, stroke and bleeding when using administrative claims to identify events in comparison with physician adjudication. Administrative claims diagnoses are modestly accurate in identifying recurrent MI and stroke admissions but have limited accuracy in identifying bleeding events, which suggests that an alternative approach is needed to ensure good safety surveillance in cardiovascular studies.

Objective: Diabetes is a common among patients with atrial fibrillation (AF). However, little is known on the impact of diabetes on symptoms, health status, care and outcomes among AF patients. We assessed whether symptoms, health status, care and outcomes differ between AF patients with and without diabetes. Methods: This observational cohort study included 9,749 patients with AF from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation registry, a prospective, nationwide, multicenter outpatient registry of patients with incident and prevalent AF enrolled at 174 sites between June 2010 and August 2011. The outcomes were symptoms, health status, and AF treatment, as well as 2-year risks of death, readmission, thrombomebolic events, heart failure (HF) and AF progression. Results: Among AF patients; those with diabetes (29.5%) were younger and more likely to have hypertension, chronic kidney disease, HF, coronary heart disease, and stroke. Patients with diabetes had a lower Atrial Fibrillation Effects on Quality of Life score (80.6 [IQR: 62.5 - 92.6] vs. 82.4 [IQR: 67.6 -93.5]; P = 0.025), but a higher CHA 2 DS 2 -VASc score (5 [IQR: 4 - 6] vs. 4 [2 - 5]; P P Conclusions: Among patients with AF, diabetes was associated with worse AF symptoms and lower quality of life, as well an increased risk of death and hospitalizations, but not with the risk of thromboembolic or bleeding events.

Background: Adherence to oral anticoagulant (OAC) agents is important for patients with non-valvular atrial fibrillation (NVAF) to prevent potentially severe adverse events. Objectives: To compare real-world adherence rates for rivaroxaban vs other oral anticoagulant agents (apixaban, dabigatran, and warfarin) among patients with NVAF using claims-based data. Methods: Healthcare claims from the IMS Health Real-World Data Adjudicated Claims database (01/2011-06/2015) were used to assess 6 month adherence rates defined as the percentage of patients with proportion of days covered (PDC) ≥0.8 and ≥0.9. Patients were included if they had ≥2 dispensings of rivaroxaban, apixaban, dabigatran, or warfarin at least 180 days apart (the first was termed as the index date), had > 60 days of supply, had ≥ 6 months of pre-index eligibility, had ≥ 1 AF diagnosis pre-index or at index date, and without valvular involvement. A logistic regression model was used to evaluate adherence to therapy adjusting for sociodemographic and clinical characteristics, insurance type, index month and year, previous OAC use, and mental-health risk factors for non-adherence (e.g., mental disorders, bipolar). Results: A total of 13,645 rivaroxaban, 6,304 apixaban, 3,360 dabigatran, and 13,366 warfarin patients were identified. A significantly higher proportion of rivaroxaban users were adherent to therapy (PDC ≥ 0.8 at 6 months vs apixaban, dabigatran, and warfarin users; Table). After adjustment, the proportion of patients adherent to therapy remained significantly higher for rivaroxaban users vs apixaban (absolute difference [AD]: 5.8%), dabigatran (AD: 9.5%), and warfarin users (AD: 13.6%; all P Conclusion: Among NVAF patients, rivaroxaban was associated with significantly higher adherence rates relative to other OACs, whether using a PDC of ≥0.8 or ≥0.9, which could translate into improved patient outcomes and lower healthcare costs.

Background: Medication adherence rates decline over time, especially after the first dispensing. Comparing adherence rates for medications that have been on the market for differing period of time may distort real differences in medication adherence. Other analysis factors such as minimum number of dispensing criteria and Pharmacy Quality Alliance (PQA) adherence measures can also affect adherence measurement. Objectives: To use one real world example (rivaroxaban vs apixaban) in non-valvular atrial fibrillation (NVAF) patients to quantify the impact of adjusting for imbalances in follow-up periods, minimum number of dispensing, and use of the PQA adherence measure. Methods: Using IMS Health Real-World Data Adjudicated Claims and Truven MarketScan claims databases, we included adult patients with ≥1 rivaroxaban or apixaban dispensing (index date), ≥1 year of pre-index eligibility, ≥1 AF diagnosis pre-index, newly initiated on oral anticoagulant therapy, and no valvular involvement. Adherence was evaluated using proportion of days covered (PDC) ≥0.8 for cohorts with (1) unbalanced follow-up (2) balanced follow-up (by matching on month and year of follow-up since fill-date) (3) ≥2 rivaroxaban or apixaban dispensings and a balanced follow-up, and using (4) the PQA adherence measure. Results: Rivaroxaban users had significantly longer mean (SD) follow-up than apixaban (408 [300] versus 254 [196] days, respectively). While apixaban users appeared to be more adherent in unadjusted analyses, this finding was reversed after 1) adjusting for unbalanced follow-up 2) excluding single-time users; and 3) applying the PQA-endorsed adherence measure (Figure). Similar results were found using the Truven databases. Conclusion: Comparisons of the adherence rates among medications need to account for the period of time each have been on the market, number of dispensing and PQA measures. Retrospective analyses of adherence that do not adjust for such differences could produce spurious findings.

Introduction: Patient understanding of available therapies for atrial fibrillation (AF) is foundational to shared medical decision making and long term medication adherence. Yet, there is a paucity of data regarding the extent to which patients newly diagnosed with AF in routine community practice understand their options. Hypotheses: 1) Understanding of warfarin, novel oral anticoagulants (NOAC), rhythm control therapy, cardioversion and radio frequency ablation changes little from baseline to 6 months and 2) treatment rates at 6 months are associated with patient understanding of therapies at baseline. Methods: We analyzed survey data from SATELLITE, a substudy of new-onset AF patients enrolled at 56 US sites participating in the ORBIT-AF registry. Patients were surveyed at the baseline and 6 month follow up clinic visit using Likert scales. Agreement between time points was assessed with the McNemar test, and the relationship between understanding and treatment was assessed only for the subset not on treatment at baseline. Results: Of 1000 patients enrolled in SATELLITE, 506 had 6-month survey data (data collection is continuing). Among these, the median age was 69.0 years (IQR 63.0 - 76.0) and 93.7% (474 of 506) were white. There was evidence of improvement in the self-reported understanding of warfarin and NOACs from baseline to 6 months, but not for rhythm control, ablation or cardioversion. The proportion reporting high understanding improved significantly for warfarin (p Conclusions: Patients with new-onset AF had improved self-reported understanding of some treatment options over the first 6-months from diagnosis; however, factors other than patient understanding may influence AF treatments received at 6 months. Patient understanding of AF treatments remains suboptimal at 6 months, and our results suggest a need for ongoing patient education.

Background: Intensive risk factor modification significantly improves outcomes for patients with diabetes and cardiovascular disease (CVD). However, the degree to which secondary prevention treatment targets are achieved in international clinical practice is unknown. Methods: Attainment of 5 secondary prevention targets—aspirin use, lipid control (low-density lipoprotein cholesterol (LDL-C) Results: Overall, 29.9% of patients with diabetes and CVD had all 5 secondary prevention measures at target. North America had the highest proportion (41.2%), whereas Western Europe, Eastern Europe, and Latin America had proportions of approximately 25%. The likelihood of having individual prevention components at target also varied by region: compared with North America, individuals in all other regions were less likely to have blood pressure at goal, and individuals in Eastern Europe and Latin America were less likely to have LDL-C at target or to be on statin therapy (see Figure). Overall, blood pressure control (57.9%) had the lowest overall attainment while non-smoking status had the highest (89%). Conclusions: On a global scale, significant opportunities exist to improve the quality of cardiovascular secondary prevention care among patients with diabetes and CVD, which in turn could lead to reduced risk of downstream cardiovascular events.

Background— Prior studies demonstrated that patients with ST-segment–elevation myocardial infarction presenting during off-hours (weeknights, weekends, and holidays) have slower reperfusion times. Recent nationwide initiatives have emphasized 24/7 quality care in ST-segment–elevation myocardial infarction. It remains unclear whether patients presenting off-hours versus on-hours receive similar quality care in contemporary practice. Methods and Results— Using Acute Coronary Treatment and Intervention Outcomes Network-Get With The Guidelines (ACTION-GWTG) database, we examined ST-segment–elevation myocardial infarction performance measures in patients presenting off-hours (n=27 270) versus on-hours (n=15 972; January 2007 to September 2010) at 447 US centers. Key quality measures assessed were aspirin use within first 24 hours, door-to-balloon time, door-to-ECG time, and door-to-needle time. In-hospital risk-adjusted all-cause mortality was calculated. Baseline demographic and clinical characteristics were similar. Aspirin use within 24 hours approached 99% in both groups. Among patients undergoing primary percutaneous coronary intervention (n=41 979; 97.1%), median door-to-balloon times were 56 versus 72 minutes ( P P P =0.09) and door-to-needle time ≤30 minutes (62.3% versus 58.7%; P =0.44) between on-hours versus off-hours. Although in-hospital all-cause mortality was similar (4.2%) in both groups, the risk-adjusted all-cause mortality was higher for patients presenting off-hours (odds ratio, 1.13; 95% confidence interval, 1.02–1.26). Conclusions— In contemporary community practice, achievement of quality performance measures in patients presenting with ST-segment–elevation myocardial infarction was high, regardless of time of presentation. Door-to-balloon time was, however, slightly delayed (by an average of 16 minutes), and risk-adjusted in-hospital mortality was 13% higher in patients presenting off-hours.

Background— Angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) initiated after myocardial infarction (MI) reduce mortality and are American College of Cardiology/American Heart Association guideline recommended. Yet the extent to which ACEI/ARB therapy is applied in patients with acute coronary syndrome at hospital discharge is unclear. Methods and Results— We performed an observational analysis of 80 241 patients admitted with an acute coronary syndrome and discharged home from 311 US hospitals participating in the Get With the Guidelines-Coronary Artery Disease Program from January 2005 to December 2009. Among the 60 847 patients with an American College of Cardiology/American Heart Association class I indication (left ventricular dysfunction or medical history of heart failure, hypertension, diabetes mellitus, or chronic kidney disease), 49 682 (81.7%) received ACEI/ARB with an increase in the rate of treatment over the study period (76.7%–84.6%; adjusted odds ratio, 1.17; 95% confidence interval, 1.10–1.24; P Conclusions— Results from this large US national registry suggest that 1 in 5 eligible patients hospitalized for acute coronary syndrome failed to receive American College of Cardiology/American Heart Association class I guideline-recommended ACEI/ARB therapy, and the use varies by patient factors. In particular, the low likelihood of ACEI/ARB after coronary artery bypass grafting surgery or in patients with renal insufficiency raises concern. These findings highlight an unmet need in this population and provide an incentive for additional quality improvement efforts.

Background— Despite the widespread availability of effective and affordable therapies, hypertension remains this country’s most significant modifiable cardiovascular risk factor. Approximately 30% to 50% of individuals with hypertension currently fail to reach guideline-recommended target blood pressure (BP) goals. Although multiple interventions have been proposed to affect better hypertension control, the integration of multiple elements in a community-based program has not been evaluated to date. Methods and Results— We created a broadly inclusive community-based initiative to control hypertension called Check It, Change It: The Durham Blood Pressure Challenge (CICI). We enrolled ≈2000 participants with hypertension in 8 ambulatory clinics across Durham County, NC. The CICI program engaged individuals by providing them with tools for self-monitoring and tied this information to their caregivers via a web-based portal (the American Heart Association’s Heart360, a remote BP monitoring system). Additionally, the CICI facilitated clinical intervention of high-risk individuals using physician assistants and community health coaches. The primary outcome will be a change in BP during the 6 months postenrollment in the program, which will be compared with concurrent and historical control populations of nonparticipants. Conclusions— We think that this integrated and tiered approach will lead to improved BP control within 6 months. If successful, the CICI program has the potential to enhance community-level BP control.

Background— The benefits of medication adherence to control cardiovascular disease (CVD) are well defined, yet multiple studies have identified poor adherence. The influence of life chaos on medication adherence is unknown. Because this is a novel application of an instrument, our preliminary objective was to understand patient factors associated with chaos. The main objective was to evaluate the extent to which an instrument designed to measure life chaos is associated with CVD-medication nonadherence. Methods and Results— Using baseline data from an ongoing randomized trial to improve postmyocardial infarction (MI) management, multivariable logistic regression identified the association between life chaos and CVD-medication nonadherence. Patients had hypertension and a myocardial infarction in the past 3 years (n=406). Nearly 43% reported CVD-medication nonadherence in the past month. In simple linear regression, the following were associated with higher life chaos: medication nonadherence (β=1.86; 95% confidence interval [CI], 0.96–2.76), female sex (β=1.22; 95% CI [0.22–2.24]), minority race (β=1.72; 95% CI [0.78–2.66]), having less than high school education (β=2.05; 95% CI [0.71–3.39]), low health literacy (β=2.06; 95% CI [0.86–3.26]), and inadequate financial status (β=1.93; 95% CI [0.87–3.00]). Being married (β=−2.09, 95% CI [−3.03 to −1.15]) was associated with lower life chaos. As chaos quartile increased, patients exhibited more nonadherence. In logistic regression, adjusting for sex, race, marital status, employment, education, health literacy, and financial status, a 1-unit life chaos increase was associated with a 7% increase (odds ratio, 1.07; 95% CI [1.02–1.12]) in odds of reporting medication nonadherence. Conclusions— Our results suggest that life chaos may be an important determinant of medication adherence. Life chaos screenings could identify those at risk for nonadherence. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT000901277

Background— Cardiogenic shock is a deadly complication of an acute myocardial infarction (MI). We sought to characterize differences in patient features, treatments, and outcomes of cardiogenic shock by MI classification: ST–segment-elevation MI (STEMI) versus non–ST-segment elevation MI (NSTEMI). Methods and Results— We compared differences in care by the shock status of 235 541 patients with STEMI and NSTEMI treated at 392 US hospitals from 2007 to 2011. Cardiogenic shock occurred in 12.2% of patients with STEMI versus 4.3% of patients with NSTEMI. Compared with STEMI shock, NSTEMI shock was more likely in patients who were older and predominantly women; had diabetes mellitus, hypertension, previous heart failure, MI, or peripheral arterial disease; and who received coronary artery bypass grafting (11.6% versus 21.2%; P P P value Conclusions— Cardiogenic shock is associated with high mortality in patients with STEMI and NSTEMI. However, urgent revascularization is more commonly pursued in patients with STEMI presenting with shock than in patients with NSTEMI. More research is needed to improve the outcomes for patients with MI presenting with shock, particularly those presenting with NSTEMI.

Background— Substantial efforts over the past decade have increased rates of intravenous tissue plasminogen activator (tPA) use in the United States. We sought to determine changes in patient characteristics and rates of tPA use over time among hospitalized acute ischemic stroke (AIS) patients. Methods and Results— We analyzed all AIS patients (n=1 093 895) and those arriving ≤2 hours and treated with tPA ≤3 hours after onset (n=50 798) from 2003 to 2011 in the American Heart Association’s Get with the Guideline–Stroke (GWTG–Stroke). Categorical data were analyzed by Pearson χ 2 and continuous data by Wilcoxon test. Intravenous tPA use ≤3 hours after onset increased from 4.0% to 7.0% in all AIS admissions and 42.6% to 77.0% in AIS patients arriving ≤2 hours and fully eligible for tPA ( P 85 years, nonwhite, and with milder strokes (National Institutes of Health Stroke Scale 0–4). Door-to-image time (median 24 versus 20 minutes) and door-to-tPA time (median 81 versus 72 minutes) also improved, with ≈65% of tPA-treated patients getting brain imaging ≤25 minutes after arrival. Multivariable analysis showed that with each additional calendar year, the odds that an eligible patient would receive tPA increased by 1.37-fold, adjusting for other covariates. Conclusions— The frequency of IV tPA use among all AIS patients, regardless of contraindications, nearly doubled from 2003 to 2011. Treatment with tPA has expanded to include more patients with mild deficits, nonwhite race/ethnicity, and oldest old age.

Background— Patients with atrial fibrillation (AF) at the highest stroke risk derive the largest benefit from oral anticoagulation (OAC). Those with the highest stroke risk have been paradoxically less likely to receive OAC. This study assessed the association between stroke and bleeding risk on rates of OAC. Methods and Results— We analyzed OAC use among 10 098 patients with AF from 174 community-based outpatient practices enrolled in 2010–2011 in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). OAC was defined as warfarin or dabigatran use at study enrollment. Stroke and bleeding risk were calculated using congestive heart failure, hypertension, age, diabetes mellitus, prior stroke (CHADS 2 ), and anticoagulation and risk factors in AF (ATRIA) scores, respectively. The mean subject age was 73 years; 58% were men. Overall, 76% of patients received OAC (71% warfarin and 5% dabigatran). The use of OAC increased among those with higher CHADS 2 scores, from 53% for CHADS 2 =0 to 80% for CHADS 2 ≥2 ( P P 2 scores ( P =0.021). Among those with low bleeding risk, use of OAC increased significantly with increasing stroke risk. Among those with high bleeding risk, CHADS 2 stroke risk had a smaller impact on use of OAC. Conclusions— In community-based outpatients with AF, use of OAC was high and driven by not only predominantly stroke but also bleeding risk. Stroke risk significantly affects OAC use among those with low bleeding risk, whereas those with high bleeding risk demonstrate consistently lower use of OAC regardless of stroke risk.

Background— Early invasive management is recommended for patients with non–ST-segment elevation myocardial infarction (MI), but the incidence of long-term outcomes after early catheterization among older patients and the relationship of revascularization procedures with outcomes in this population have not been described. Methods and Results— Using data from the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines (CRUSADE) registry, we linked 19 336 older patients (≥65 years) with non–ST-segment elevation MI found to have significant coronary disease during catheterization and who survived through 30 days posthospital discharge to Medicare/Medicaid data. All-cause mortality, readmission for MI, readmission for stroke, and use of repeat revascularization procedures were tracked for a median of 1181 days. Outcome comparisons were stratified by use of percutaneous coronary intervention (PCI; n=11 766, 60.8%) or coronary artery bypass grafting (n=3515, 18.2%) performed during the index hospitalization and through 30 days postdischarge, as well as by medical management without revascularization (n=4055, 21.0%). During follow-up, ≈17% of patients underwent PCI (most commonly in patients initially treated with PCI), and only 3% of patients underwent coronary artery bypass grafting. Compared with an unadjusted long-term mortality cumulative incidence through 5 years of 50% in the medical management group, mortality was lower in the PCI group (33.5%; adjusted hazard ratio, 0.75; 95% confidence interval, 0.70–0.79) and lowest in the coronary artery bypass grafting group (24.2%; adjusted hazard ratio, 0.52; 95% confidence interval, 0.47–0.57; P Conclusions— Older patients with non–ST-segment elevation MI with significant coronary disease face high long-term risks for mortality and nonfatal cardiovascular outcomes after early catheterization that differ by type of revascularization procedure performed. These findings can help guide the design of studies evaluating long-term therapies among elderly post-MI patients.

Background— Patients with diabetes mellitus (DM) are at high risk for mortality after myocardial infarction (MI). Despite an overall trend of reduced mortality after MI, the mortality gap between MI patients with and without DM did not decrease over time in previous analyses. We assessed recent trends in hospital mortality for patients with MI according to DM status. Methods and Results— We analyzed data from the National Registry of Myocardial Infarction, a contemporary registry of MI patients treated in 1964 hospitals, representing approximately one fourth of all US acute care hospitals. The study comprised 1734431 MI patients enrolled from 1994 to 2006, including 502315 (29%) with DM. Crude hospital mortality decreased in all patients between 1994 and 2006 but remained higher in patients with DM compared with those without DM throughout the study. The absolute difference in mortality between patients with and without DM significantly narrowed over time, from 15.6% versus 11.5% in 1994 to 8.0% versus 6.8% in 2006 ( P P P Conclusions— The hospital mortality gap between MI patients with and without DM narrowed significantly from 1994 to 2006, with the greatest improvement observed in women with DM.

Background: The 2013 ACC/AHA cholesterol guidelines recommend high intensity statin use for all post-myocardial infarction (MI) patients, instead of treating to a low density lipoprotein cholesterol (LDL-C) goal on follow-up lipid testing. We examined whether high intensity statin use was common in U.S. practice prior to these guideline updates. Methods: We linked the ACTION Registry-GWTG to Medicare data and evaluated 11,046 post-MI patients aged ≥65 years discharged alive on a statin from 347 hospitals between 2007 and 2009. Rates and dosing of lipid therapy as well as follow-up lipid testing within 90 days after discharge were studied. Multivariable logistic regression was used to evaluate the association of lipid testing with 1-year statin use and intensity. Results: Only 21% of MI patients were discharged on a high intensity statin. By 90 days post-MI, 44% (n=4,884) of patients underwent lipid testing. Among patients discharged on low/moderate intensity statins, 43% underwent lipid testing within the next 90 days, and 49% of patients discharged on high intensity statins received lipid testing within 90 days. Rates of lipid testing did not differ substantially between patients with LDL-C ≥100 mg/dL vs. Conclusion: Prior to the 2013 ACC/AHA cholesterol guideline updates, only 1 in 5 MI patients were discharged on high intensity statin therapy. Although follow-up lipid testing was associated with both higher rates of statin persistence to one year and increased likelihood of statin intensification, it was performed in only a minority of patients. The new cholesterol guidelines may promote more aggressive lipid management and cardiovascular risk reduction by eliminating treatment dependence on follow-up lipid testing.

Background: Prior ATPIII lipid guidelines recommended statin therapy for patients with clinical ASCVD to achieve low density lipoprotein cholesterol (LDL-C) targets, while the 2013 ACC/AHA lipid guidelines recommend high-intensity statin therapy for all ASCVD patients. How closely these recommendations are followed in routine clinical practice is unknown. Methods: We evaluated statin use, intensity, and LDL-C values in 1,483 patients with ASCVD (coronary heart disease, cerebrovascular disease, and peripheral arterial disease) enrolled and seen serially at 62 geographically dispersed US cardiology and primary care clinics in the Patient and Provider Assessment of Lipid Management (PALM) Registry between May - September 2015. Factors associated with high intensity statin use (atorvastatin ≥40 mg or rosuvastatin ≥20 mg daily) and LDL-C Results: Of 1,483 ASCVD patients, 86.2% were on a statin, but only 31.4% were on a high-intensity statin. Overall, 64.0% had an LDL-C Discussion: Substantial gaps in care remain for secondary prevention of ASCVD despite simplified recommendations. While the majority of patients with ASCVD in community practice are on a statin, only one-third are on high intensity statins and over two-thirds have LDL ≥70 mg/dL.

Background: Antithrombotic therapies are known to prevent thromboembolic events and stroke for patients with atrial fibrillation (AF). Despite this, it is unclear in contemporary practice what percentage of AF patients presenting with acute ischemic stroke (AIS) receive antithrombotic therapy prior to stroke and how pre-stroke antithrombotic therapy affects stroke severity, particularly in the era of non-vitamin K antagonist oral anticoagulants (NOACs). Methods: We analyzed data from 1625 Get With The Guidelines-Stroke hospitals between October 2012 and March 2015. Multivariable logistic regression was performed to evaluate the association between antithrombotic therapy and stroke severity according to NIHSS. Results: Of 103,327AIS patients with pre-stroke AF, 28,583 (28%) were not on any home antithrombotics prior to their stroke, and another 30,149 (29%) were receiving aspirin alone; followed by warfarin alone (18,532, 18%) with only a quarter (4705/18,532) in the therapeutic range, aspirin and warfarin (7130, 7%), and NOACs alone (5803, 6%) ( Figure ). Even among patients with a CHA2DS2-VASc score≥2, only one third of them (34,145/99,807) were receiving some form of oral anticoagulant. Stroke severity was associated with home antithrombotic use ( Figure ). Compared with those receiving aspirin alone, warfarin with INR≥2 (adjusted odds ratio [aOR], 0.72, 95% CI 0.66-0.79), aspirin and warfarin (aOR 0.83, 95% CI 0.77-0.90), NOACs alone (aOR 0.83, 95% CI 0.77-0.91), NOACs with aspirin or clopidogrel (aOR 0.69, 95% 0.60-0.79), aspirin and clopidogrel (aOR 0.90, 95% CI 0.83-0.99), or triple antithrombotic therapy (aOR 0.64, 95% 0.49-0.84) were associated with a lower likelihood of severe stroke (NIHSS≥16). In contrast, patients subtherapeutic (INR Conclusions: A majority of AF patients presenting with AIS are not on guideline recommended anticoagulation or are not therapeutic on their anticoagulation. Even when strokes occurred on therapeutic warfarin or a NOAC, the strokes were less severe. These findings highlight the huge opportunities to further improve proper use of oral anticoagulants in eligible AF patients.

Background: The longitudinal success of the heart failure (HF) patient with a left ventricular assist device (LVAD) depends on medications to maintain the device, such as antithrombotic agents to prevent pump thrombosis and antihypertensives to reduce stroke risk. However, the role of traditional, evidence-based HF medications for patients with concurrent LVAD support is not well known. This study aimed to determine use, temporal trends, and factors associated with prescription of HF medications at discharge among patients with advanced HF with and without LVADs, and to examine patient and hospital-level factors associated with HF medication prescription among LVAD recipients. Methods: We conducted a retrospective, observational analysis of 4,580 advanced HF patients from 215 hospitals participating in the Get With The Guidelines-Heart Failure registry from January 2009 to March 2015. We examined patterns of HF medication use at hospital discharge among patients with an in-hospital (n=258) or prior (n=326) LVAD implant, and those with advanced HF without an LVAD, as defined by a reduced left ventricular ejection fraction and intravenous inotrope or vasopressin antagonist receipt (n=3,996). Results: For beta-blocker and angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACE/ARB), discharge prescriptions were 58.9% and 53.5% for new LVAD recipients, 62.9% and 51.4% for prior LVAD recipients, and 78.7% and 60.7% for patients without LVAD support, respectively (p Conclusion: Traditional HF therapies are commonly prescribed to LVAD recipients, although less frequently than to advanced HF patients without LVAD support. Aldosterone antagonists are prescribed increasingly to LVAD patients. Further research is needed on the optimal medical regimen for patients with LVADs.

Background: Compared with clopidogrel, ticagrelor and prasugrel are more potent and faster-acting antiplatelet agents that have been associated with a greater reduction in thrombotic cardiovascular events in patients with acute myocardial infarction (AMI). We examined contemporary patterns of P2Y12 inhibitor selection both early (within 24 h of admission) and at discharge among AMI patients captured by a large national registry. Methods: Patients in the ACTION Registry® -GWTG™ who presented with AMI from October 2013 through December 2014 were included in the study (167,455 patients from 622 sites). Among these patients, we evaluated the temporal trends in early use (within 24 h of admission) and discharge prescription of antiplatelet agents and used logistic regression to identify factors associated with P2Y12 inhibitor selection at discharge. Results: Early ticagrelor use increased significantly over time from 11.8% to 16.4% (STEMI 19.6% to 27.6%; NSTEMI 6.8% to 9.5%; p Conclusions: Our contemporary dataset shows a modest but significant increase in use of ticagrelor early and at discharge, with simultaneous decline in the use of clopidogrel and prasugrel in patients presenting with AMI.

Background: The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) survey has recently been validated to measure the impact of atrial fibrillation on patients’ quality of life, but a clinically important difference (CID) in AFEQT score has not been defined. Knowing the CID is needed to interpret the meaningfulness of differences between treatments in clinical trials; or patient populations for quality assessment. Objectives: To calculate CID values in AFEQT in the ORBIT registry. Methods: ORBIT-AF is a US-based outpatient AF registry that measured disease-specific QoL with the AFEQT tool (score range= 0 (worst) to 100) at baseline and at 1 year follow-up. Two anchor-based methods were used to relate changes in AFEQT to clinically important differences in the more established European Heart Rhythm Association (EHRA) measure of functional status. Ranging from 1 (no symptoms) to 4 (disabling), a change of 1 EHRA class was defined as an important change in the anchor. Both the mean change and receiver operating characteristics (ROC) methods were then used to identify CIDs in AFEQT at 1 year follow-up. This was done for both improvement and worsening on the anchor. The mean change method defines a CID as the mean change in AFEQT score among patients with a 1 EHRA class change. The ROC method identifies a CID as the point on the ROC curve that best discriminates patients who experienced an important change in the anchor (≥ 1 EHRA class change) from those who experienced no change. Results: AFEQT was assessed in 2008 AF patients at baseline and 1347 patients at 1 year from 99 US sites participating in ORBIT-AF. CIDs and 95% confidence intervals (CI) corresponding to an improvement in EHRA for the mean change method were 5.4 (3.6, 7.2) AFEQT points and 1.9 (0.4, 9.3) AFEQT points for the ROC method. CIDs corresponding to worsening in EHRA for the mean change method were -4.2 (-6.9,-1.5) AFEQT points and -7.4 (-13.9,-4.6) AFEQT points for the ROC method. Conclusions: Changes in AFEQT as small as 2 points may be clinically relevant, although CIDs vary depending on the method of calculation. The variability suggests identifying a single universal CID to assess improvement in quality of life in AF patients may not be ideal and improvement may relate to the nature of a patient’s symptoms and their baseline level of activity.

Background— It is unclear to what extent cardiovascular health disparities exist and can be modified among sexes, racial/ethnic groups, and geographic regions in US hospitals. Methods and Results— We conducted a cohort study of 49 358 patients aged 65 years and older, admitted to 366 US hospitals from 2003 to 2009 as part of the Get With The Guidelines—Coronary Artery Disease registry linked with Medicare inpatient data. We examined mortality disparities of sex, race/ethnicity, and geographic region with 3-year mortality. The mediator was defined as receiving optimal quality of care. Logistic regression with generalized estimating equations and mediation analysis were used. Compared with men, women were less likely to receive optimal care (odds ratio=0.92; 95% confidence interval: 0.88–0.95; P P =0.05, P for interaction=0.04). Approximately 69% of the sex disparity may potentially be reduced by providing optimal quality of care to women. Quality of care did not differ across racial/ethnic groups or geographic regions. Blacks were more likely to die than whites (odds ratio=1.33; 95% confidence interval: 1.21–1.46; P Conclusions— Women were less likely than men to receive optimal care at discharge. The observed sex disparity in mortality could potentially be reduced by providing equitable and optimal care. In contrast, the higher mortality observed in black patients could not be accounted for by differences in the quality of care measured in this study.

Background— Clinical guidelines recommend similar medical therapy for patients with ST-segment elevation myocardial infarction (STEMI) and non–ST-segment elevation MI (NSTEMI). Methods and Results— Using the Get with the Guidelines–Coronary Artery Disease registry (GWTG–CAD), we analyzed data including 72 352 patients (48 966, NSTEMI; 23 386, STEMI) from 237 US sites between May 1, 2006 and March 21, 2010. Performance and quality measures were compared between NSTEMI and STEMI patients. NSTEMI patients were older and had a higher rate of medical comorbidities compared with STEMI patients, including prior coronary artery disease (38.5% versus 24.7%; P P P P 100 mg/dL 96.8% versus 91.0% (AOR, 1.85; 95% CI, 1.61–2.13). STEMI patients were also more likely to receive β-blockers within 24 hours of hospital arrival 93.9% versus 90.8% (AOR, 1.57; 95% CI, 1.37–1.79) and the following discharge medications: angiotensin-converting enzyme inhibitors or angiotensin receptor blocking agents 85.3% versus 77.4% (AOR, 1.62; 95% CI, 1.51–1.75), clopidogrel 85.6% versus 67.0% (AOR, 2.42; 95% CI, 2.23–2.61) or lipid-lowering medications 94.8% versus 88.0% (AOR, 1.71; 95% CI, 1.56–1.86). Conclusions— Among hospitals participating in GWTG–CAD, adherence with guideline-based medical therapy was high for patients with both STEMI and NSTEMI. Yet, there is still room for further improvement, particularly in the care of NSTEMI patients.

Background— The benefits of intravenous tissue-plasminogen activator (tPA) in acute ischemic stroke are time-dependent. Emergency medical services (EMS) hospital prenotification of an incoming patient with potential stroke may provide a means of reducing evaluation and treatment times and improving treatment rates; yet, available data are limited. Methods and Results— We examined 371 988 patients with acute ischemic stroke transported by EMS and enrolled in Get With The Guidelines–Stroke from April 1, 2003, to March 31, 2011. Prenotification occurred in 249 197 (67.0%) of EMS-transported patients. Among eligible patients arriving by 2 hours, patients with EMS prenotification were more likely to be treated with tPA within 3 hours (82.8% versus 79.2%, absolute difference +3.5%, P P P P P Conclusions— EMS hospital prenotification is associated with improved evaluation, timelier stroke treatment, and more eligible patients treated with tPA. These results support the need for initiatives targeted at increasing EMS prenotification rates as a mechanism from improving quality of care and outcomes in stroke.

Background— Several studies that used claims and registry data have reported that 40% to 80% of patients eligible for an implantable cardioverter defibrillator (ICD) fail to receive one in clinical practice, and the rates are especially high among women and blacks. The extent and documented reasons for nonuse of ICDs among patients with left ventricular systolic dysfunction are unknown. Methods and Results— Using hospital claims and clinical data, we identified patients hospitalized with a heart failure diagnosis and left ventricular ejection fraction ≤30% between January 1, 2007, and August 30, 2007, at a tertiary-care center. Using claims data, we determined placement of an ICD or cardiac resynchronization therapy with defibrillation device at any time up to 1 year after hospitalization. Medical records for patients without an ICD were abstracted to determine reasons for nonuse. Patients with an ICD were compared with patients without an ICD and also with patients without an ICD who did not have any contraindication for an ICD as identified through chart abstraction. Of the 542 potentially eligible patients identified, 224 (41%) did not have an ICD. In the initial adjusted analysis, female sex (odds ratio=1.90; 95% CI, 1.28 to 2.81) and increasing age (odds ratio=1.07; 95% CI, 1.04 to 1.11) were associated with a higher likelihood of not having an ICD. After detailed chart review, of the 224 patients without an ICD, 117 (52%) were ineligible for the device and 38 (17%) patients refused the device, resulting in only 69 (13%) patients eligible for an ICD who failed to receive one. In this subsequent adjusted analysis, remaining factors associated with a higher likelihood of not having an ICD were absence of ventricular arrhythmias (odds ratio=4.93; 95% CI, 2.56 to 9.50), noncardiology hospital service (odds ratio=3.73; 95% CI, 1.98 to 7.04), and lack of health insurance (odds ratio=3.10; 95% CI, 1.48 to 6.46). Conclusions— On the basis of a detailed chart review, the true rate of ICD underuse may be substantially lower than previous estimates. In addition, after accounting for ICD eligibility criteria, patient sex and age disparities in ICD therapy were no longer present.

Background— Secondary prevention by risk factor modification improves patient outcomes, yet it is often not achieved in clinical practice. Reasons for failure stem from challenges of prioritizing risk factor reduction and engaging patients in changing their behaviors. We hypothesize that a novel telemedicine intervention with tailored patient education could improve cardiovascular risk factors. Methods— To evaluate this intervention, we propose enrolling 450 patients with a recent myocardial infarction and hypertension into a 3-arm randomized, controlled trial. The first arm (n=150) will receive home blood pressure (BP) monitors plus a nurse-delivered, telephone-based tailored patient education intervention and will be enrolled into HealthVault, a Microsoft electronic health record platform. The second arm (n=150) will also receive BP monitors plus a tailored patient education intervention and be enrolled in HeartVault. However, the patient education intervention will be delivered by a Web-based program and will cover topics identical to those in the nurse-delivered intervention. Both arms will be compared with a control group receiving standard care (n=150). All participants will have an in-person assessment at baseline and at completion of the study, including standardized measurements of BP, LDL cholesterol, and glycosylated hemoglobin (in diabetic subjects). The study design will allow assessment of a telephone-based, nurse-administered disease management program versus standard care. The main outcome of interest is the reduction in systolic BP in each intervention group compared with the control group at 12 months. Secondary outcomes assessed will include reductions in LDL cholesterol, body weight, and glycosylated hemoglobin, as well as adherence to evidence-based therapies and improvement in health behaviors. Conclusion— If successful in optimizing BP control, managing other coronary heart disease risk factors, and demonstrating a lower cost, the Web-based disease management tool has the potential to enhance coronary artery disease management, quality of care, and ultimately, patient outcomes. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00901277.

Background— Administrative claims data are used routinely for risk adjustment and hospital profiling for heart failure outcomes. As clinical data become more readily available, the incremental value of adding clinical data to claims-based models of mortality and readmission is unclear. Methods and Results— We linked heart failure hospitalizations from the Get With The Guidelines–Heart Failure registry with Medicare claims data for patients discharged between January 1, 2004, and December 31, 2006. We evaluated the performance of claims-only and claims-clinical regression models for 30-day mortality and readmission, and compared hospital rankings from both models. There were 25 766 patients from 308 hospitals in the mortality analysis, and 24 163 patients from 307 hospitals in the readmission analysis. The claims-clinical mortality model (area under the curve [AUC], 0.761; generalized R 2 =0.172) had better fit than the claims-only mortality model (AUC, 0.718; R 2 =0.113). The claims-only readmission model (AUC, 0.587; R 2 =0.025) and the claims-clinical readmission model (AUC, 0.599; R 2 =0.031) had similar performance. Among hospitals ranked as top or bottom performers by the claims-only mortality model, 12% were not ranked similarly by the claims-clinical model. For the claims-only readmission model, 3% of top or bottom performers were not ranked similarly by the claims-clinical model. Conclusions— Adding clinical data to claims data for heart failure hospitalizations significantly improved prediction of mortality, and shifted mortality performance rankings for a substantial proportion of hospitals. Clinical data did not meaningfully improve the discrimination of the readmission model, and had little effect on performance rankings.

Background— Efforts to improve quality of care for patients with acute myocardial infarction (AMI) are a national priority. To date, there have been few studies that have prospectively evaluated hospital quality improvement (QI) interventions. Methods and Results— Using hospitals in the National Cardiovascular Data Registry (NCDR) ACTION Registry–GWTG, a cluster randomized trial of the effectiveness of targeted performance feedback to facilitate process improvement for AMI care will be conducted. ACTION Registry–GWTG hospitals with a minimum of 50 AMI patients per 2 quarters are eligible for randomization. The control arm receives standard performance feedback reports, and the intervention arm receives standard performance feedback reports in addition to a supplemental report on the “top 3” centrally identified, hospital-specific performance gaps. The primary outcome will be improvement in a composite of all metrics, and the secondary outcome will be improvement in the targeted metrics. At study inception in January 2009, 149 sites were randomized: 76 to the intervention arm, and 73 to the control arm. Intervention and control sites were well balanced in terms of baseline performance, center characteristics, and AMI volume (≈70 patients per quarter). The intervention phase will continue for 5 feedback cycles, each containing 2 quarters of data feedback over 18 months. A final trial outcome report will follow. Conclusions— This randomized trial will evaluate a novel hospital-level QI intervention of targeted performance feedback for AMI, thereby demonstrating the effective use of national registries for QI and furthering our understanding of effective QI methods. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00952250.

Background— Stroke results in substantial death and disability. To address this burden, Get With The Guideline (GWTG)-Stroke was developed to facilitate the measurement, tracking, and improvement in quality of care and outcomes for acute stroke and transient ischemic attack (TIA) patients in the United States. Methods and Results— We analyzed the characteristics, performance measures, and in-hospital outcomes in the first 1 000 000 acute ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, and TIA admissions from 1392 hospitals that participated in the GWTG-Stroke Program 2003 to 2009. Patients were 53.5% women, 73.3% white, and with mean age of 70.1±14.9 years. There were 601 599 (60.2%) ischemic strokes, 108 671 (10.9%) intracerebral hemorrhages, 34 945 (3.5%) subarachnoid hemorrhages, 26 977 (2.7%) strokes not classified, and 227 788 (22.8%) TIAs. Performance measures showed small to moderate differences by cerebrovascular event type. In-hospital mortality rate was highest among intracerebral hemorrhage (25.0%) and subarachnoid hemorrhage (20.4%), and intermediate in ischemic stroke (5.5%) patients and lowest among TIA patients (0.3%). Significant improvements over time from 2003 to 2009 in quality of care were observed: all-or-none measure, 44.0% versus 84.3% (+40.3%, P P Conclusions— With more than 1 million patients enrolled, GWTG-Stroke represents an integrated stroke and TIA registry that supports national surveillance, innovative research, and sustained quality improvement efforts facilitating evidence-based stroke/TIA care.