Publications by authors named "Tracy Y Wang"

303 Publications

Trends in Patient Characteristics and COVID-19 In-Hospital Mortality in the United States During the COVID-19 Pandemic.

JAMA Netw Open 2021 May 3;4(5):e218828. Epub 2021 May 3.

Division of Cardiology, Department of Medicine, University of Washington, Seattle.

Importance: In-hospital mortality rates from COVID-19 are high but appear to be decreasing for selected locations in the United States. It is not known whether this is because of changes in the characteristics of patients being admitted.

Objective: To describe changing in-hospital mortality rates over time after accounting for individual patient characteristics.

Design, Setting, And Participants: This was a retrospective cohort study of 20 736 adults with a diagnosis of COVID-19 who were included in the US American Heart Association COVID-19 Cardiovascular Disease Registry and admitted to 107 acute care hospitals in 31 states from March through November 2020. A multiple mixed-effects logistic regression was then used to estimate the odds of in-hospital death adjusted for patient age, sex, body mass index, and medical history as well as vital signs, use of supplemental oxygen, presence of pulmonary infiltrates at admission, and hospital site.

Main Outcomes And Measures: In-hospital death adjusted for exposures for 4 periods in 2020.

Results: The registry included 20 736 patients hospitalized with COVID-19 from March through November 2020 (9524 women [45.9%]; mean [SD] age, 61.2 [17.9] years); 3271 patients (15.8%) died in the hospital. Mortality rates were 19.1% in March and April, 11.9% in May and June, 11.0% in July and August, and 10.8% in September through November. Compared with March and April, the adjusted odds ratios for in-hospital death were significantly lower in May and June (odds ratio, 0.66; 95% CI, 0.58-0.76; P < .001), July and August (odds ratio, 0.58; 95% CI, 0.49-0.69; P < .001), and September through November (odds ratio, 0.59; 95% CI, 0.47-0.73).

Conclusions And Relevance: In this cohort study, high rates of in-hospital COVID-19 mortality among registry patients in March and April 2020 decreased by more than one-third by June and remained near that rate through November. This difference in mortality rates between the months of March and April and later months persisted even after adjusting for age, sex, medical history, and COVID-19 disease severity and did not appear to be associated with changes in the characteristics of patients being admitted.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.8828DOI Listing
May 2021

Harnessing Mobile Health Technology for Secondary Cardiovascular Disease Prevention in Older Adults: A Scientific Statement From the American Heart Association.

Circ Cardiovasc Qual Outcomes 2021 Apr 1:HCQ0000000000000103. Epub 2021 Apr 1.

Secondary prevention of cardiovascular disease (CVD), the leading cause of morbidity and mortality, is critical to improving health outcomes and quality of life in our aging population. As mobile health (mHealth) technology gains universal leverage and popularity, it is becoming more user-friendly for older adults and an adjunct to manage CVD risk and improve overall cardiovascular health. With the rapid advances in mHealth technology and increasing technological engagement of older adults, a comprehensive understanding of the current literature and knowledge of gaps and barriers surrounding the impact of mHealth on secondary CVD prevention is essential. After a systematic review of the literature, 26 studies that used mHealth for secondary CVD prevention focusing on lifestyle behavior change and medication adherence in cohorts with a mean age of ≥60 years were identified. Improvements in health behaviors and medication adherence were observed, particularly when there was a short message service (ie, texting) component involved. Although mobile technologies are becoming more mainstream and are starting to blend more seamlessly with standard health care, there are still distinct barriers that limit implementation particularly in older adults, including affordability, usability, privacy, and security issues. Furthermore, studies on the type of mHealth that is the most effective for older adults with longer study duration are essential as the field continues to grow. As our population ages, identifying and implementing effective, widely accepted, cost-effective, and time-efficient mHealth interventions to improve CVD health in a vulnerable demographic group should be a top health priority.
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http://dx.doi.org/10.1161/HCQ.0000000000000103DOI Listing
April 2021

Electronic Health Record Integration of Predictive Analytics to Select High-Risk Stable Patients With Non-ST-Segment-Elevation Myocardial Infarction for Intensive Care Unit Admission.

Circ Cardiovasc Qual Outcomes 2021 Apr 24;14(4):e007602. Epub 2021 Mar 24.

Cardiovascular Medicine Division, Penn Cardiovascular Outcomes, Quality and Evaluative Research Center, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia (A.C.F.).

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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.007602DOI Listing
April 2021

Sex disparities in patients with symptomatic severe aortic stenosis.

Am Heart J 2021 Mar 17;237:116-126. Epub 2021 Mar 17.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address:

Background: We evaluated whether there is equitable distribution across sexes of treatment and outcomes for aortic valve replacement (AVR), via surgical (SAVR) or transcatheter (TAVR) methods, in symptomatic severe aortic stenosis (ssAS) patients.

Methods: Using de-identified data, we identified 43,822 patients with ssAS (2008-2016). Multivariate competing risk models were used to determine the likelihood of any AVR, while accounting for the competing risk of death. Association between sex and 1-year mortality, stratified by AVR status, was evaluated using multivariate Cox regression models with AVR as a time-dependent variable.

Results: Among patients with ssAS, 20,986 (47.9%) were female. Females were older (median age 81 vs. 78, P<0.001), more likely to have body mass index <20 (8.5% vs. 3.5%), and home oxygen use (4.4% vs. 3.4%, P<0001 for all). Overall, 12,129 (27.7%) patients underwent AVR for ssAS. Females were less likely to undergo AVR compared with males (24.1% vs. 31.0%, adjusted hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.77-0.83), but when treated, were more likely to undergo TAVR (37.9% vs. 30.9%, adjusted HR 1.21, 95% CI 1.15-1.27). Untreated females and males had similarly high rates of mortality at 1 year (31.1% vs. 31.3%, adjusted HR 0.98, 95% CI 0.94-1.03). Among those undergoing AVR, females had significantly higher mortality (10.2% vs. 9.4%, adjusted HR 1.24, 95% CI 1.10-1.41), driven by increased SAVR-associated mortality (9.0% vs. 7.6%, adjusted HR 1.43, 95% CI 1.21-1.69).

Conclusions: Treatment rates for ssAS patients remain suboptimal with disparities in female treatment.
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http://dx.doi.org/10.1016/j.ahj.2021.01.021DOI Listing
March 2021

Evolution of Clinical Thinking and Practice Regarding Aspirin: What Has Changed and Why?

Am J Cardiol 2021 04;144 Suppl 1:S10-S14

Duke Clinical Research Institute, Duke University, Durham, North Carolina.

Aspirin (ASA) is the original antiplatelet agent. Its routine use, long unquestioned for both primary and secondary prevention in cardiovascular disease, is under increasing scrutiny as the risk:benefit balance for ASA becomes less clear and other disease- and risk-modifying approaches are validated. It can be viewed as a significant advance in evidence-based medicine that the use of an inexpensive, readily available, long-validated therapy is being questioned in large, rigorous trials. In this overview we present the important questions surrounding a more informed approach to ASA therapy: duration of therapy, assessment of net clinical benefit, and timing of start and stop strategies. We also consider potential explanations for "breakthrough" thrombosis when patients are on ASA therapy. Other manuscripts in this Supplement address the specifics of primary prevention, secondary prevention, triple oral antithrombotic therapy, and the future of ASA in cardiovascular medicine.
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http://dx.doi.org/10.1016/j.amjcard.2020.12.021DOI Listing
April 2021

Patient-Perceived Versus Actual Risk of Cardiovascular Disease and Associated Willingness to Consider and Use Prevention Therapy.

Circ Cardiovasc Qual Outcomes 2021 Jan 13;14(1):e006548. Epub 2021 Jan 13.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.M.N., T.Y.W., S.L., X.M., Z.L., E.D.P.).

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, =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%, <0.01). Patients' perceptions of their risk relative-to-peers were slightly correlated with standardized risk percentiles (ρ=0.19, <0.01), although most had overly optimistic views of how risk compared with their peers. Increasing perceived risk was not associated with current statin use (=0.18) but was associated with willingness to consider future prevention therapy (<0.01). Perceived risk relative-to-peers was associated with increased prevalent statin use (risk ratio 1.04 per category increase [95% CI, 1.02-1.06]) and reported willingness for prevention therapy (risk ratio 1.11 [95% CI, 1.07-1.16]).

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.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.006548DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855929PMC
January 2021

Difference in Medication Adherence Between Patients Prescribed a 30-Day Versus 90-Day Supply After Acute Myocardial Infarction.

J Am Heart Assoc 2021 Jan 21;10(1):e016215. Epub 2020 Dec 21.

Duke Clinical Research Institute Durham NC.

Background Evidence-based medication adherence rates after a myocardial infarction are low. We hypothesized that 90-day prescriptions are underused and may lead to higher evidence-based medication adherence compared with 30-day fills. Methods and Results We examined patients with myocardial infarction treated with percutaneous coronary intervention between 2011 and 2015 in the National Cardiovascular Data Registry. Linking to Symphony Health pharmacy data, we described the prevalence of patients filling 30-day versus 90-day prescriptions of statins, β-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and P2Y inhibitors after discharge. We compared 12-month medication adherence rates by evidence-based medication class and prescription days' supply and rates of medication switches and dosing changes. Among 353 259 patients with myocardial infarction treated with percutaneous coronary intervention, 90-day evidence-based medication fill rates were low: 13.0% (statins), 12.3% (β-blockers), 14.6% (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers), and 9.7% (P2Y inhibitors). Patients filling 90-day prescriptions were more likely older (median 69 versus 62 years) with a history of prior myocardial infarction (25.0% versus 17.9%) or percutaneous coronary intervention (30.3% versus 19.5%; <0.01 for all) than patients filling 30-day prescriptions. The 12-month adherence rates were higher for patients who filled 90-day versus 30-day supplies: statins, 83.1% versus 75.3%; β-blockers, 72.7% versus 62.9%; angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, 71.1% versus 60.9%; and P2Y inhibitors, 78.5% versus 66.6% (<0.01 for all). Medication switches and dosing changes within 12 months were infrequent for patients filling 30-day prescriptions-14.7% and 0.3% for 30-day P2Y inhibitor fills versus 6.3% and 0.2% for 90-day fills, respectively. Conclusions Patients who filled 90-day prescriptions had higher adherence and infrequent medication changes within 1 year after discharge. Ninety-day prescription strategies should be encouraged to improve post-myocardial infarction medication adherence.
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http://dx.doi.org/10.1161/JAHA.119.016215DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955468PMC
January 2021

Racial and Ethnic Differences in Presentation and Outcomes for Patients Hospitalized with COVID-19: Findings from the American Heart Association's COVID-19 Cardiovascular Disease Registry.

Circulation 2020 Nov 17. Epub 2020 Nov 17.

Duke Clinical Research Institute, Duke University, Durham NC.

The COVID-19 pandemic has exposed longstanding racial/ethnic inequities in health risks and outcomes in the U.S.. We sought to identify racial/ethnic differences in presentation and outcomes for patients hospitalized with COVID-19. The American Heart Association COVID-19 Cardiovascular Disease Registry is a retrospective observational registry capturing consecutive patients hospitalized with COVID-19. We present data on the first 7,868 patients by race/ethnicity treated at 88 hospitals across the US between 01/17/2020 and 7/22/2020. The primary outcome was in-hospital mortality; secondary outcomes included major adverse cardiovascular events (MACE: death, myocardial infarction, stroke, heart failure) and COVID-19 cardiorespiratory ordinal severity score (worst to best: death, cardiac arrest, mechanical ventilation with mechanical circulatory support, mechanical ventilation with vasopressors/inotrope support, mechanical ventilation without hemodynamic support, and hospitalization without any of the above). Multivariable logistic regression analyses were performed to assess the relationship between race/ethnicity and each outcome adjusting for differences in sociodemographic, clinical, and presentation features, and accounting for clustering by hospital. Among 7,868 patients hospitalized with COVID-19, 33.0% were Hispanic, 25.5% were non-Hispanic Black, 6.3% were Asian, and 35.2% were non-Hispanic White. Hispanic and Black patients were younger than non-Hispanic White and Asian patients and were more likely to be uninsured. Black patients had the highest prevalence of obesity, hypertension, and diabetes. Black patients also had the highest rates of mechanical ventilation (23.2%) and renal replacement therapy (6.6%) but the lowest rates of remdesivir use (6.1%). Overall mortality was 18.4% with 53% of all deaths occurring in Black and Hispanic patients. The adjusted odds ratios (ORs) for mortality were 0.93 (95% confidence interval [CI] 0.76-1.14) for Black patients, 0.90 (95% CI 0.73-1.11) for Hispanic patients, and 1.31 (95% CI 0.96-1.80) for Asian patients compared with non-Hispanic White patients. The median OR across hospitals was 1.99 (95% CI 1.74-2.48). Results were similar for MACE. Asian patients had the highest COVID-19 cardiorespiratory severity at presentation (adjusted OR 1.48, 95% CI 1.16-1.90). Although in-hospital mortality and MACE did not differ by race/ethnicity after adjustment, Black and Hispanic patients bore a greater burden of mortality and morbidity due to their disproportionate representation among COVID-19 hospitalizations.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.052278DOI Listing
November 2020

Association between intensive care unit utilization for patients with non-ST-segment elevation myocardial infarction and patient experience.

Am Heart J 2021 01 10;231:32-35. Epub 2020 Oct 10.

Division of Cardiology and Duke Clinical Research Institute, Duke University, Durham, NC.

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.
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http://dx.doi.org/10.1016/j.ahj.2020.09.014DOI Listing
January 2021

Comparative Trends in Percutaneous Coronary Intervention in Japan and the United States, 2013 to 2017.

J Am Coll Cardiol 2020 09;76(11):1328-1340

Japanese Association of Cardiovascular Intervention and Therapeutics, Tokyo, Japan.

Background: Adoption of the results of large-scale randomized controlled trials in percutaneous coronary intervention (PCI) may differ internationally, yet few studies have described the potential variations in PCI practice patterns.

Objectives: Using representative national registries, we compared temporal trends in procedural volume, patient characteristics, pre-procedural testing, procedural characteristics, and quality metrics in the United States and Japan.

Methods: The National Cardiovascular Data Registry CathPCI was used to describe care in the United States, and the J-PCI was used to assess practice patterns in Japan (numbers of participating hospitals: 1,752 in the United States and 1,108 in Japan). Both registries were summarized between 2013 and 2017.

Results: PCI volume increased by 15.8% in the United States from 550,872 in 2013 to 637,650 in 2017, primarily because of an increase in nonelective PCIs (p for trend <0.001). In Japan, the volume of PCIs increased by 36%, from 181,750 in 2013 to 247,274 in 2017, primarily because of an increase in elective PCIs (p for trend <0.001). The proportion of PCI cases for elective conditions was >2-fold greater in Japan (72.7%) than in the United States (33.8%; p < 0.001). Overall, the ratio of nonelective PCI (vs. elective PCI; 27.3% vs. 66.2%; p < 0.001) and the performance of noninvasive stress testing in patients with stable disease (15.2% vs. 55.3%; p < 0.001) was lower in Japan than in the United States. Computed tomography angiography was more commonly used in Japan (22.3% vs. 2.0%; p < 0.001).

Conclusions: Elective PCI is more than twice as common in Japan as in the United States in contemporary practice. Computed tomography angiography is much more frequently used pre-procedurally in Japan than in the United States.
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http://dx.doi.org/10.1016/j.jacc.2020.07.037DOI Listing
September 2020

Time to End "Manels" in Clinical Trial Leadership.

JAMA Intern Med 2020 10;180(10):1383-1384

Division of Cardiology, University of California, San Francisco.

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http://dx.doi.org/10.1001/jamainternmed.2020.2489DOI Listing
October 2020

Racial Differences in the Use of Aortic Valve Replacement for Treatment of Symptomatic Severe Aortic Valve Stenosis in the Transcatheter Aortic Valve Replacement Era.

J Am Heart Assoc 2020 08 11;9(16):e015879. Epub 2020 Aug 11.

Duke University School of Medicine Durham NC.

Background Aortic valve replacement (AVR) is a life-saving treatment for patients with symptomatic severe aortic valve stenosis. We sought to determine whether transcatheter AVR has resulted in a more equitable treatment rate by race in the United States. Methods and Results A total of 32 853 patients with symptomatic severe aortic valve stenosis were retrospectively identified via Optum's deidentified electronic health records database (2007-2017). AVR rates in non-Hispanic Black and White patients were assessed in the year after diagnosis. Multivariate Fine-Gray hazards models were used to evaluate the likelihood of AVR by race, with adjustment for patient factors and the managing cardiologist. Time-trend and 1-year symptomatic severe aortic valve stenosis survival analyses were also performed. From 2011 to 2016, the rate of AVR increased from 20.1% to 37.1%. Overall, Black individuals were less likely than Whites to receive AVR (22.9% versus 31.0%; unadjusted hazard ratio [HR], 0.70; 95% CI, 0.62-0.79; fully adjusted HR, 0.76; 95% CI, 0.67-0.85). Yet, during 2015 to 2016, AVR racial differences were attenuated (29.5% versus 35.2%; adjusted HR, 0.86; 95% CI, 0.74-1.02) because of greater uptake of transcatheter AVR in Blacks than Whites (53.4% of AVRs versus 47.3%; =0.128). Untreated patients had significantly higher 1-year mortality than those treated (adjusted HR, 0.57; 95% CI, 0.53-0.61), which was consistent by race (interaction value=0.52). Conclusions Although transcatheter AVR has increased the use of AVR in the United States, treatment rates remain low. Black patients with symptomatic severe aortic valve stenosis were less likely than White patients to receive AVR, yet these differences have recently narrowed.
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http://dx.doi.org/10.1161/JAHA.119.015879DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7660794PMC
August 2020

Setting Expectations for Clinical Research During the COVID-19 Pandemic.

JAMA Intern Med 2020 10;180(10):1400-1401

Associate Editor, JAMA Internal Medicine.

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http://dx.doi.org/10.1001/jamainternmed.2020.2882DOI Listing
October 2020

Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve.

Am Heart J 2020 09 25;227:91-99. Epub 2020 Jun 25.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.

Vitamin K antagonists are the only approved oral anticoagulants for long-term prophylaxis against valve thrombosis and thromboembolism in patients with a mechanical heart valve. Despite the proven efficacy and safety of anticoagulation with the oral direct factor Xa inhibitor apixaban compared with warfarin in high-risk populations including subjects with atrial fibrillation or with venous thromboembolism, it remains unknown whether patients with a mechanical heart valve can be safely managed with apixaban. The On-X Aortic Heart Valve and On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft may have lower rates of valve thrombosis and thromboembolism than conventional bileaflet and tilting disc valves due its unique pyrolytic carbon composition and flared inlet design. DESIGN: PROACT Xa is a randomized, multicenter, open-label, active-controlled trial comparing apixaban with warfarin in patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft. The study will randomize approximately 1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3 months prior. Patients will be randomized 1:1 to receiving apixaban 5 mg twice daily or warfarin with a target international normalized ratio of 2.0-3.0. The last randomized participant will be followed for at least 2 years. The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding. Assuming the primary outcome occurs in warfarin-anticoagulated patients at a rate of 1.75%/patient-year, the study has more than 90% power to assess noninferiority of apixaban treatment with an absolute noninferiority margin of 1.75%/patient-year. A second co-primary analysis is to compare the hazard rate for the apixaban arm to twice the objective performance criterion for thromboembolism and valve thrombosis, that is, 3.4%/patient-year. SUMMARY: PROACT Xa will determine whether patients with an On-X Aortic Heart Valve can be anticoagulated with apixaban as an alternative to warfarin.
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http://dx.doi.org/10.1016/j.ahj.2020.06.014DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7484170PMC
September 2020

Improving Cardiovascular Drug and Device Development and Evidence Through Patient-Centered Research and Clinical Trials: A Call to Action From the Value in Healthcare Initiative's Partnering With Regulators Learning Collaborative.

Circ Cardiovasc Qual Outcomes 2020 07 20;13(7):e006606. Epub 2020 Jul 20.

American Heart Association, Dallas, TX (N.B.).

The pipeline of new cardiovascular drugs is relatively limited compared with many other clinical areas. Challenges causing lagging drug innovation include the duration and expense of cardiovascular clinical trials needed for regulatory evaluation and approvals, which generally must demonstrate noninferiority to existing standards of care and measure longer-term outcomes. By comparison, there has been substantial progress in cardiovascular device innovation. There has also been progress in cardiovascular trial participation equity in recent years, especially among women, due in part to important efforts by Food and Drug Administration, National Institutes of Health, American Heart Association, and others. Yet women and especially racial and ethnic minority populations remain underrepresented in cardiovascular trials, indicating much work ahead to continue recent success. Given these challenges and opportunities, the multistakeholder Partnering with Regulators Learning Collaborative of the Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University, identified how to improve the evidence generation process for cardiovascular drugs and devices. Drawing on a series of meetings, literature reviews, and analyses of regulatory options, the Collaborative makes recommendations across four identified areas for improvement. First, we offer strategies to enhance patient engagement in trial design, convenient participation, and meaningful end points and outcomes to improve patient recruitment and retention (major expenses in clinical trials). Second, new digital technologies expand the potential for real-world evidence to streamline data collection and reduce cost and time of trials. However, technical challenges must be overcome to routinely leverage real-world data, including standardizing data, managing data quality, understanding data comparability, and ensuring real-world evidence does not worsen inequities. Third, as trials are driven by evidence needs of regulators and payers, we recommend ways to improve their collaboration in trial design to streamline and standardize efficient and innovative trials, reducing costs and delays. Finally, we discuss creative ways to expand the minuscule proportion of sites involved in cardiovascular evidence generation and medical product development. These actions, paired with continued policy research into better ways to pay for and equitably develop therapies, will help reduce the cost and complexity of drug and device research, development, and trials.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.006606DOI Listing
July 2020

Streamlining and Reimagining Prior Authorization Under Value-Based Contracts: A Call to Action From the Value in Healthcare Initiative's Prior Authorization Learning Collaborative.

Circ Cardiovasc Qual Outcomes 2020 07 20;13(7):e006564. Epub 2020 Jul 20.

American Heart Association, Dallas, TX (N.B.).

Utilization management strategies, including prior authorization, are commonly used to facilitate safe and guideline-adherent provision of new, individualized, and potentially costly cardiovascular therapies. However, as currently deployed, these approaches encumber multiple stakeholders. Patients are discouraged by barriers to appropriate access; clinicians are frustrated by the time, money, and resources required for prior authorizations, the frequent rejections, and the perception of being excluded from the decision-making process; and payers are weary of the intensive effort to design and administer increasingly complex prior authorization systems to balance value and appropriate use of these treatments. These issues highlight an opportunity to collectively reimagine utilization management as a transparent and collaborative system. This would benefit the entire healthcare ecosystem, especially in light of the shift to value-based payment. This article describes the efforts and vision of the multistakeholder Prior Authorization Learning Collaborative of the Value in Healthcare Initiative, a partnership between the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University. We outline how healthcare organizations can take greater utilization management responsibility under value-based contracting, especially under different state policies and local contexts. Even with reduced payer-mandated prior authorization in these arrangements, payers and healthcare organizations will have a continued shared need for utilization management. We present options for streamlining these programs, such as gold carding and electronic and automated prior authorization processes. Throughout the article, we weave in examples from cardiovascular care when possible. Although reimagining prior authorization requires collective action by all stakeholders, it may significantly reduce administrative burden for clinicians and payers while improving outcomes for patients.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.006564DOI Listing
July 2020

Implications of ST Changes During Normal Echocardiography-Reply.

JAMA Intern Med 2020 09;180(9):1257-1258

Duke University Medical Center, Durham, North Carolina.

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http://dx.doi.org/10.1001/jamainternmed.2020.1844DOI Listing
September 2020

American Heart Association COVID-19 CVD Registry Powered by Get With The Guidelines.

Circ Cardiovasc Qual Outcomes 2020 08 17;13(8):e006967. Epub 2020 Jun 17.

UT Southwestern Medical Center, Dallas, TX (S.R.D., J.A.d.L.).

Background: In response to the public health emergency created by the coronavirus disease 2019 (COVID-19) pandemic, American Heart Association volunteers and staff aimed to rapidly develop and launch a resource for the medical and research community to expedite scientific advancement through shared learning, quality improvement, and research. In <4 weeks after it was first announced on April 3, 2020, AHA's COVID-19 CVD Registry powered by Get With The Guidelines received its first clinical records.

Methods And Results: Participating hospitals are enrolling consecutive hospitalized patients with active COVID-19 disease, regardless of CVD status. This hospital quality improvement program will allow participating hospitals and health systems to evaluate patient-level data including mortality rates, intensive care unit bed days, and ventilator days from individual review of electronic medical records of sequential adult patients with active COVID-19 infection. Participating sites can leverage these data for onsite, rapid quality improvement, and benchmarking versus other institutions. After 9 weeks, >130 sites have enrolled in the program and >4000 records have been abstracted in the national dataset. Additionally, the aggregate dataset will be a valuable data resource for the medical research community.

Conclusions: The AHA COVID-19 CVD Registry will support greater understanding of the impact of COVID-19 on cardiovascular disease and will inform best practices for evaluation and management of patients with COVID-19.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.120.006967DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7577517PMC
August 2020

Beliefs, risk perceptions, and lipid management among patients with and without diabetes: Results from the PALM registry.

Am Heart J 2020 07 30;225:88-96. Epub 2020 Apr 30.

Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC.

Intensive lipid management is critical to reduce cardiovascular (CV) risk for patients with diabetes mellitus (DM).

Methods: We performed an observational study of 7628 patients with (n = 2943) and without DM (n = 4685), enrolled in the Provider Assessment of Lipid Management (PALM) registry and treated at 140 outpatient clinics across the United States in 2015. Patient self-estimated CV risk, patient-perceived statin benefit and risk, observed statin therapy use and dosing were assessed.

Results: Patients with DM were more likely to believe that their CV risk was elevated compared with patients without DM (39.1% vs 29.3%, P < .001). Patients with DM were more likely to receive a statin (74.2% vs 63.5%, P < .001) but less likely to be treated with guideline-recommended statin intensity (36.5% vs 46.9%, P < .001), driven by the low proportion (16.5%) of high risk (ASCVD risk ≥7.5%) primary prevention DM patients treated with a high intensity statin. Patients with DM treated with guideline-recommended statin intensity were more likely to believe they were at high CV risk (44.9% vs 38.4%, P = .005) and that statins can reduce this risk (41.1% vs 35.6%, P = .02), compared with patients treated with lower than guideline-recommended statin intensity. Compared with patients with an elevated HgbA1c, patients with well-controlled DM were no more likely to be on a statin (77.9% vs 79.3%, P = .43).

Conclusions: In this nationwide study, the majority of patients with DM were treated with lower than guideline-recommended statin intensity. Patient education and engagement may help providers improve lipid therapy for these high-risk patients.
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http://dx.doi.org/10.1016/j.ahj.2020.04.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7539544PMC
July 2020

Copayment Reduction Voucher Utilization and Associations With Medication Persistence and Clinical Outcomes: Findings From the ARTEMIS Trial.

Circ Cardiovasc Qual Outcomes 2020 05 12;13(5):e006182. Epub 2020 May 12.

Division of Cardiology (E.D.P., T.Y.W.), Duke University, Durham, NC.

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 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 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 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 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 =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 =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.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.006182DOI Listing
May 2020

Performance of Hospitals When Assessing Disease-Based Mortality Compared With Procedural Mortality for Patients With Acute Myocardial Infarction.

JAMA Cardiol 2020 07;5(7):765-772

Cardiovascular Division, Hospital of the University of Pennsylvania, Philadelphia.

Importance: Quality of percutaneous coronary intervention (PCI) is commonly assessed by risk-adjusted mortality. However, this metric may result in procedural risk aversion, especially for high-risk patients.

Objective: To determine correlation and reclassification between hospital-level disease-specific mortality and PCI procedural mortality among patients with acute myocardial infarction (AMI).

Design, Setting, And Participants: This hospital-level observational cross-sectional multicenter analysis included hospitals participating in the Chest Pain-MI Registry, which enrolled consecutive adult patients admitted with a diagnosis of type I non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI), and hospitals in the CathPCI Registry, which enrolled consecutive adult patients treated with PCI with an indication of NSTEMI or STEMI, between April 1, 2011, and December 31, 2017.

Exposures: Inclusion into the National Cardiovascular Data Registry Chest Pain-MI and CathPCI registries.

Main Outcomes And Measures: For each hospital in each registry, a disease-based excess mortality ratio (EMR-D) for AMI was calculated, which represents a risk-adjusted observed to expected rate of mortality for AMI as a disease using the Chest Pain-MI Registry, and a procedure-based excess mortality ratio (EMR-P) for PCI was calculated using the CathPCI Registry.

Results: A subset of 625 sites participated in both registries, with a final count of 776 890 patients from the Chest Pain-MI Registry (509 576 men [65.6%]; 620 981 white [80.0%]; and median age, 64 years [interquartile range, 55-74 years]) and 853 386 patients from the CathPCI Registry (582 701 men [68.3%]; 691 236 white [81.0%]; and median age, 63 years [interquartile range, 54-73 years]). Among the 625 linked hospitals, the Spearman rank correlation coefficient between EMR-D and EMR-P produced a ρ of 0.53 (95% CI, 0.47-0.58), suggesting moderate correlation. Among the highest-performing tertile for disease-based risk-adjusted mortality, 90 of 208 sites (43.3%) were classified into a lower category for procedural risk-adjusted mortality. Among the lowest-performing tertile for disease-based risk-adjusted mortality, 92 of 208 sites (44.2%) were classified into a higher category for procedural risk-adjusted mortality. Bland-Altman plots for the overall linked cohort demonstrate a mean difference between EMR-P and EMR-D of 0.49% (95% CI, -1.61% to 2.58%; P < .001), with procedural mortality higher than disease-based mortality. However, among patients with AMI complicated by cardiogenic shock or cardiac arrest, the mean difference between EMR-P and EMR-D was -0.64% (95% CI, -4.41% to 3.12%; P < .001), with procedural mortality lower than disease-based mortality.

Conclusions And Relevance: This study suggests that, for hospitals treating patients with AMI, there is only a moderate correlation between procedural outcomes and disease-based outcomes. Nearly half of hospitals in the highest tertile of performance for PCI performance were reclassified into a lower performance tertile when judged by disease-based metrics. Higher rates of mortality were observed when using disease-based metrics compared with procedural metrics when assessing patients with cardiogenic shock and/or cardiac arrest, signifying what appears to be potential risk avoidance among this highest-risk subset of patients.
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http://dx.doi.org/10.1001/jamacardio.2020.0753DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7191472PMC
July 2020

Lowering Dietary Sodium Intake-Implementing and Studying the Effectiveness of Public Health Interventions.

Authors:
Tracy Y Wang

JAMA Intern Med 2020 06;180(6):887

Duke University, Duke Clinical Research Institute, Durham, North Carolina.

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http://dx.doi.org/10.1001/jamainternmed.2020.0909DOI Listing
June 2020

Use of Low-Density Lipoprotein-Lowering Therapies Before and After PCSK9 Inhibitor Initiation.

J Am Heart Assoc 2020 05 24;9(9):e014347. Epub 2020 Apr 24.

Duke Clinical Research Institute Durham NC.

Background Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are used to reduce low-density lipoprotein (LDL) cholesterol. PCSK9i use after initiation, as well as persistence with or alterations to other LDL-lowering therapy after PCSK9i initiation, is not well understood. Methods and Results We conducted a retrospective study of alirocumab or evolocumab (PCSK9i) new users from July 2015 to December 2017 in the MarketScan Early View database of US commercial insurance beneficiaries. We determined the prevalence of PCSK9i interruption (≥30-day gap in supply) and LDL-lowering therapy use in the year after PCSK9i initiation. The average age of 6151 patients initiating PCSK9i therapy was 63 years, 44.4% were women, and 76.8% had atherosclerotic cardiovascular disease. Overall, 52.2% (95% CI, 50.8%-53.7%) of patients had an interruption in PCSK9i therapy in the first year after treatment initiation and 62.5% remained on PCSK9i therapy at 1-year postinitiation. Also, 27.7% of patients were taking a statin at the time of PCSK9i initiation, with only 22.4% on statin therapy at 1 year after PCSK9i initiation. Ezetimibe use decreased from 20.9% at the time of PCSK9i initiation to 12.0% a year later. By 1 year after PCSK9i initiation, 44.0% of patients had experienced an interruption in all LDL-lowering therapies, and 26.6% were no longer on any LDL-lowering therapies. Conclusions After PCSK9i initiation, statins were often discontinued, whereas more than half of patients experienced an interruption in PCSK9i therapy. These results suggest that many new PCSK9i users may remain at high risk for cardiovascular events because of interruptions in LDL-lowering therapy.
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http://dx.doi.org/10.1161/JAHA.119.014347DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7428552PMC
May 2020

Impact of a Copayment Reduction Intervention on Medication Persistence and Cardiovascular Events in Hospitals With and Without Prior Medication Financial Assistance Programs.

J Am Heart Assoc 2020 04 17;9(8):e014975. Epub 2020 Apr 17.

Duke University Durham NC.

Background Hospitals commonly provide a short-term supply of free P2Y inhibitors at discharge after myocardial infarction, but it is unclear if these programs improve medication persistence and outcomes. The ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) trial randomized hospitals to usual care versus waived P2Y inhibitor copayment costs for 1-year post-myocardial infarction. Whether the impact of this intervention differed between hospitals with and without pre-existing medication assistance programs is unknown. Methods and Results In this post hoc analysis of the ARTEMIS trial, we examined the associations of pre-study free medication programs and the randomized copayment voucher intervention with P2Y inhibitor persistence (measured by pharmacy fills and patient report) and major adverse cardiovascular events using logistic regression models including a propensity score. Among 262 hospitals, 129 (49%) offered pre-study free medication assistance. One-year P2Y inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively). The randomized copayment voucher intervention improved persistence, assessed by pharmacy fills, in both hospitals with (53.6% versus 44.0%, adjusted odds ratio 1.45, 95% CI, 1.20-1.75) and without (59.0% versus 48.3%, adjusted odds ratio 1.46, 95% CI, 1.25-1.70) free medication programs (=0.71). Differences in patient-reported persistence were not significant after adjustment. Conclusions While hospitals commonly report the ability to provide free short-term P2Y inhibitors, we did not find association of this with medication persistence or major adverse cardiovascular events among patients with insurance coverage for prescription medication enrolled in the ARTEMIS trial. An intervention that provided copayment assistance vouchers for 1 year was successful in improving medication persistence in hospitals with and without pre-existing short-term medication programs. Registration URL: https://www.clini​caltr​ials.gov/. Unique identifier: NCT02406677.
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http://dx.doi.org/10.1161/JAHA.119.014975DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7428537PMC
April 2020

Association Between Intensive Care Unit Usage and Long-Term Medication Adherence, Mortality, and Readmission Among Initially Stable Patients With Non-ST-Segment-Elevation Myocardial Infarction.

J Am Heart Assoc 2020 03 15;9(6):e015179. Epub 2020 Mar 15.

ivision of Cardiology and Duke Clinical Research Institute Duke University Durham NC.

Background Hospitals in the United States vary in their use of intensive care units (ICUs) for hemodynamically stable patients with non-ST-segment-elevation myocardial infarction (NSTEMI). The association between ICU use and long-term outcomes after NSTEMI is unknown. Methods and Results Using data from the National Cardiovascular Data Registry linked to Medicare claims, we identified 65 256 NSTEMI patients aged ≥ 65 years without cardiogenic shock or cardiac arrest on presentation between 2011 and 2014. We compared 1-year medication non-adherence, cardiovascular readmission, and mortality across hospitals by ICU use using multivariable regression models. Among 520 hospitals, 154 (29.6%) were high ICU users (>70% of stable NSTEMI patients admitted to ICU), 270 (51.9%) were intermediate (30%-70%), and 196 (37.7%) were low (<30%). Compared with low ICU usage hospitals, no differences were observed in the risks of 1-year medication non-adherence (adjusted odds ratio 1.08, 95% CI, 0.97-1.21), mortality (adjusted hazard ratio 1.06, 95% CI, 0.98-1.15), and cardiovascular readmission (adjusted hazard ratio 0.99, 95% CI, 0.95-1.04) at high usage hospitals. Patients hospitalized at intermediate ICU usage hospitals had lower rates of evidence-based therapy and diagnostic catheterization within 24 hours of hospital arrival, and higher risks of 1-year mortality (adjusted hazard ratio 1.07, 95% CI, 1.02-1.12) and medication non-adherence (adjusted odds ratio 1.09, 95% CI, 1.02-1.15) compared with low ICU usage hospitals. Conclusions Routine ICU use is unlikely to be beneficial for hemodynamically stable NSTEMI patients; medication adherence, long-term mortality, and cardiovascular readmission did not differ for high ICU usage hospitals compared with hospitals with low ICU usage rates.
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http://dx.doi.org/10.1161/JAHA.119.015179DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335514PMC
March 2020

Agreement and Accuracy of Medication Persistence Identified by Patient Self-report vs Pharmacy Fill: A Secondary Analysis of the Cluster Randomized ARTEMIS Trial.

JAMA Cardiol 2020 05;5(5):532-539

Department of Medicine, Duke University, Durham, North Carolina.

Importance: Pharmacy fill data are increasingly accessible to clinicians and researchers to evaluate longitudinal medication persistence beyond patient self-report.

Objective: To assess the agreement and accuracy of patient-reported and pharmacy fill-based medication persistence.

Design, Setting, And Participants: This post hoc analysis of the cluster randomized clinical trial ARTEMIS (Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) enrolled patients at 287 US hospitals (131 randomized to intervention and 156 to usual care) from June 5, 2015, to September 30, 2016, with 1-year follow-up and blinded adjudication of major adverse cardiovascular events. In total, 8373 patients with myocardial infarction and measurement of P2Y12 inhibitor persistence by both patient self-report and pharmacy data were included. Serum P2Y12 inhibitor drug levels were measured for 944 randomly selected patients. Data were analyzed from May 2018 to November 2019.

Interventions: Patients treated at intervention-arm hospitals received study vouchers to offset copayments at each P2Y12 inhibitor fill for 1 year after myocardial infarction.

Main Outcomes And Measures: Nonpersistence was defined as a gap of 30 days or more in P2Y12 inhibitor use (patient report) or supply (pharmacy fill) and as serum P2Y12 inhibitor levels below the lower limit of quantification (drug level). Among patients in the intervention arm, a "criterion standard" definition of nonpersistence was a gap of 30 days or more in P2Y12 inhibitor use by both voucher use and pharmacy fill. Major adverse cardiovascular events were defined as adjudicated death, recurrent myocardial infarction, or stroke.

Results: Of 8373 patients included in this analysis, the median age was 62 years (interquartile range, 54-70 years), 5664 were men (67.7%), and 990 (11.8%) self-reported as nonwhite race/ethnicity. One-year estimates of medication nonpersistence rates were higher using pharmacy fills (4042 patients [48.3%]) compared with patient self-report (1277 patients [15.3%]). Overall, 4185 patients (50.0%) were persistent by both pharmacy fill data and patient report, 1131 patients (13.5%) were nonpersistent by both, and 3057 patients (36.5%) were discordant. By application of the criterion standard definition, the 1-year nonpersistence rate was 1184 of 3703 patients (32.0%); 892 of 3318 patients (26.9%) in the intervention arm who self-reported persistence were found to be nonpersistent, and 303 of 1487 patients (20.4%) classified as nonpersistent by pharmacy fill data were actually persistent. Agreement between serum P2Y12 inhibitor drug levels and either patient-reported (κ = 0.11-0.23) or fill-based (κ = 0.00-0.19) persistence was poor. Patients who were nonpersistent by both pharmacy fill data and self-report had the highest 1-year major adverse cardiac event rate (18.3%; 95% CI, 16.0%-20.6%) compared with that for discordant patients (9.7%; 8.7%-10.8%) or concordantly persistent patients (8.2%; 95% CI, 7.4%-9.0%).

Conclusions And Relevance: Patient report overestimated medication persistence rates, and pharmacy fill data underestimated medication persistence rates. Patients who are nonpersistent by both methods have the worst clinical outcomes and should be prioritized for interventions that improve medication-taking behavior.

Trial Registration: ClinicalTrials.gov Identifier: NCT02406677.
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http://dx.doi.org/10.1001/jamacardio.2020.0125DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7057174PMC
May 2020

Long-Term Outcomes and Associations With Major Adverse Limb Events After Peripheral Artery Revascularization.

J Am Coll Cardiol 2020 02;75(5):498-508

Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado; CPC Clinical Research, Aurora, Colorado.

Background: Long-term cardiovascular and limb outcomes after revascularization for peripheral artery disease and, in particular, prognosis after post-procedure major adverse limb events (MALE) are not well-studied.

Objectives: This study sought to describe outcomes after peripheral revascularization and assess relationships between post-procedure MALE hospitalization and subsequent events.

Methods: Patients undergoing peripheral artery revascularization between January 1, 2009, and September 30, 2015, in the Premier Healthcare Database were examined for the co-primary outcomes of interest, composite myocardial infarction (MI) or stroke and composite major amputation or peripheral revascularization. Multivariable adjusted Cox proportional hazards models with post-procedure MALE hospitalization included as a time-dependent covariate were developed to estimate hazard ratios for outcomes.

Results: Among 393,017 revascularized patients followed for a median of 2.7 years (interquartile range: 1.3 to 4.4 years), the cumulative incidence of MI or stroke was 9.8% and that of major amputation or peripheral revascularization was 41.9%. A total of 50,750 patients (12.9%) had at least 1 post-procedure MALE hospitalization. In time-dependent covariate adjusted models, post-procedure MALE hospitalization was associated with greater risk of subsequent MI or stroke (hazard ratio: 1.34; 95% confidence interval: 1.28 to 1.40) and major amputation or peripheral revascularization (hazard ratio: 8.13; 95% confidence interval: 7.96 to 8.29). After peripheral revascularization with or without post-procedure MALE hospitalization, risk of limb events increased rapidly post-procedure and more slowly after the first year, whereas cardiac risk increased steadily during follow-up.

Conclusions: Revascularized peripheral artery disease patients face earlier limb and later cardiovascular ischemic risk that is heightened among patients with post-procedure MALE hospitalization. Increased provider awareness of these long-term risks may guide efforts to improve post-procedural outcomes.
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http://dx.doi.org/10.1016/j.jacc.2019.11.050DOI Listing
February 2020

Implications of Abnormal Exercise Electrocardiography With Normal Stress Echocardiography.

JAMA Intern Med 2020 04;180(4):494-502

Department of Medicine, Division of Cardiology, Yale School of Medicine, New Haven, Connecticut.

Importance: Patients with abnormal (positive) exercise electrocardiography, but normal stress echocardiography (+ECG/-Echo) are commonly encountered in clinical practice; however, the prognostic significance of this discordant result is unclear.

Objective: To determine whether patients with +ECG/-Echo have a higher rate of adverse clinical events and a poorer prognosis than patients with negative exercise ECG and normal stress Echo imaging (-ECG/-Echo).

Design, Setting, And Participants: Between January 1, 2000, and February 28, 2014, a total of 47 944 consecutive patients without known coronary artery disease who underwent exercise stress Echo at Duke University Medical Center were evaluated for inclusion in this observational cohort study. Data analysis was conducted from January 1, 2000, to December 31, 2016.

Interventions/exposures: Patients were categorized as having -ECG/-Echo, +ECG/-Echo, or +Echo (-ECG/+Echo and +ECG/+Echo).

Main Outcomes And Measures: The primary outcome was a composite end point of death, myocardial infarction, hospitalization for unstable angina, and coronary revascularization. Secondary outcomes included individual adverse events and downstream testing.

Results: After excluding submaximal tests and nondiagnostic ECG or stress imaging results, 15 077 patients (mean [SD] age, 52 [13] years; 6228 [41.3%] men) were classified by stress test results. Of these, 12 893 patients (85.5%) had -ECG/-Echo, 1286 patients (8.5%) had +ECG/-Echo, and 898 patients (6.0%) had +Echo. Through a median follow-up of 7.3 (interquartile range, 4.4-10.0) years, the composite end point occurred in 794 patients with -ECG/-Echo (8.5%), 142 patients with +ECG/-Echo (14.6%), and 297 patients with +Echo (37.4%). Death occurred in 425 patients with -ECG/-Echo (4.8%), 50 patients with +ECG/-Echo (5.9%), and 70 patients with +Echo (11.2%). Myocardial infarction occurred in 195 patients with -ECG/-Echo (2.2%), 31 patients with +ECG/-Echo (3.6%), and 59 patients with +Echo (8.7%). The addition of stress ECG findings to clinical and exercise data yielded incremental prognostic value. Patients with -ECG/-Echo imaging results had the least downstream testing (2.3%), followed by +ECG/-Echo (12.8%), and +Echo (33.6%) (P < .001).

Conclusions And Relevance: The presence of +ECG results with normal stress Echo imaging may identify a population of patients who are at slightly increased risk for adverse cardiac events, which was not previously recognized. Further study is needed to determine whether these patients will benefit from intensification of medical management.
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http://dx.doi.org/10.1001/jamainternmed.2019.6958DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990669PMC
April 2020

Patient and hospital characteristics associated with ticagrelor uptake in acute MI: An analysis of the Chest Pain-MI Registry.

Int J Cardiol 2020 04 15;304:14-20. Epub 2020 Jan 15.

Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, CT, United States of America; Section of Cardiovascular Medicine, Yale University, New Haven, CT, United States of America. Electronic address:

Background: ACC/AHA guidelines support the use of the P2Y inhibitors clopidogrel, prasugrel, or ticagrelor in acute myocardial infarction (AMI). Little is known about trends in P2Y inhibitor selection over time.

Methods: Multicenter, longitudinal analysis of patients and hospitals in the National Cardiovascular Data Registry (NCDR) Chest Pain - MI Registry from the third quarter of 2013 to the first quarter of 2017.

Results: A total of 362,354 AMI patients treated at 801 hospitals were included in our analysis. Ticagrelor use increased over time, from 6.1% in 2013 to 33.7% in 2017, with corresponding reductions in the use of clopidogrel and prasugrel (p < 0.001 for all trends). In multivariable models, patients of white race, with private insurance, or STEMI were more likely to receive ticagrelor (p < 0.05 for all). Hospitals in the highest quartile of ticagrelor uptake had use rates ranging from 29% to 88%, and were more likely to have the lowest volume of MI patients. The correlation between prasugrel and ticagrelor adoption was weakly positive (correlation coefficient: 0.15, p = 0.004); hospitals with the lowest early adoption of prasugrel started with the lowest rate of ticagrelor use and had the slowest rate of increase in ticagrelor use.

Conclusions: There has been a rapid increase in use of ticagrelor since its approval by the FDA and both patient and hospital characteristics were associated with variation in its adoption and utilization. Further examination of the characteristics associated with the rapid adoption of new evidence may provide insights about improving health system performance.
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http://dx.doi.org/10.1016/j.ijcard.2020.01.029DOI Listing
April 2020

Temporal Trends in Racial Differences in 30-Day Readmission and Mortality Rates After Acute Myocardial Infarction Among Medicare Beneficiaries.

JAMA Cardiol 2020 02;5(2):136-145

Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas.

Importance: The association of the Hospital Readmission Reduction Program (HRRP) with reductions in racial disparities in 30-day outcomes for myocardial infarction (MI), is unknown, including whether this varies by HRRP hospital penalty status.

Objective: To assess temporal trends in 30-day readmission and mortality rates among black and nonblack patients discharged after hospitalization for acute MI at low-performing and high-performing hospitals, as defined by readmission penalty status after HRRP implementation.

Design, Setting, And Participants: This observational cohort analysis used data from the multicenter National Cardiovascular Data Registry Chest Pain-MI Registry centers that were subject to the first cycle of HRRP, between January 1, 2008, and November 30, 2016. All patients hospitalized with MI who were included in National Cardiovascular Data Registry Chest Pain-MI Registry were included in the analysis. Data were analyzed from April 2018 to September 2019.

Exposures: Hospital performance category and race (black compared with nonblack patients). Centers were classified as high performing or low performing based on the excess readmission ratio (predicted to expected 30-day risk adjusted readmission rate) for MI during the first HRRP cycle (in October 2012).

Main Outcomes And Measures: Thirty-day all-cause readmission and mortality rates.

Results: Among 753 hospitals that treated 155 397 patients with acute MI (of whom 11 280 [7.3%] were black), 399 hospitals (53.0%) were high performing. Thirty-day readmission rates declined over time in both black and nonblack patients (annualized 30-day readmission rate: 17.9% vs 20.8%). Black (compared with nonblack) race was associated with higher unadjusted odds of 30-day readmission in both low-performing and high-performing centers (odds ratios: before HRRP: low-performing hospitals, 1.14 [95% CI, 1.03-1.26]; P = .01; high-performing hospitals, 1.17 [95% CI, 1.04-1.32]; P = .01; after HRRP: low-performing hospitals, 1.23 [95% CI, 1.13-1.34]; P < .001; high-performing hospitals, 1.25 [95% CI, 1.12-1.39]; P < .001). However, these racial differences were not significant after adjustment for patient characteristics. The 30-day mortality rates declined significantly over time in nonblack patients, with stable (nonsignificant) temporal trends among black patients. Adjusted associations between race and 30-day mortality showed that 30-day mortality rates were significantly lower among black (compared with nonblack) patients in the low-performing hospitals (odds ratios: pre-HRRP, 0.79 [95% CI, 0.63-0.97]; P = .03; post-HRRP, 0.80 [95% CI, 0.68-0.95]; P = .01) but not in high-performing hospitals. Finally, the association between race and 30-day outcomes did not vary after the HRRP period began in either high-performing or low-performing hospitals.

Conclusions And Relevance: In this analysis, 30-day readmission rates among patients with MI declined over time for both black and nonblack patients. Differences in race-specific 30-day readmission rates persisted but appeared to be attributable to patient-level factors. The 30-day mortality rates have declined for nonblack patients and remained stable among black patients. Implementation of the HRRP was not associated with improvement or worsening of racial disparities in readmission and mortality rates.
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http://dx.doi.org/10.1001/jamacardio.2019.4845DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990949PMC
February 2020