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Recent data suggest direct oral anticoagulants are as safe and efficacious as warfarin among select patients with valvular heart disease and atrial fibrillation (AF). However, real-world treatment patterns of AF stroke prophylaxis in the setting of valvular AF are currently unknown. Accordingly, using the prospective, ambulatory National Cardiovascular Data Registry Practice Innovation and Clinical Excellence (PINNACLE) Registry, we sought to characterize overall use, temporal trends in use, and the extent of practice-level variation in the use of any direct oral anticoagulant and warfarin among patients with valvular AF from January 1, 2013, to March 31, 2019.

Background Rheumatic heart disease (RHD) is a neglected disease affecting 33 million people, mainly in low and middle income countries. Yet very few large trials or registries have been conducted in this population. The INVICTUS program of research in RHD consists of a randomized-controlled trial (RCT) of 4500 patients comparing rivaroxaban with vitamin K antagonists (VKA) in patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry. This paper describes the rationale, design, organization and baseline characteristics of the RCT and a summary of the design of the registry and its sub-study. Patients with RHD and AF are considered to be at high risk of embolic strokes, and oral anticoagulation with VKAs is recommended for stroke prevention. But the quality of anticoagulation with VKA is poor in developing countries. A drug which does not require monitoring, and which is safe and effective for preventing stroke in patients with valvular AF, would fulfill a major unmet need. Methods The INVestIgation of rheumatiC AF Treatment Using VKAs, rivaroxaban or aspirin Studies (INVICTUS-VKA) trial is an international, multicentre, randomized, open-label, parallel group trial, testing whether rivaroxaban 20 mg given once daily is non-inferior (or superior) to VKA in patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm2, left atrial spontaneous echo-contrast or thrombus, or a CHA2DS2VASc score ≥2). The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding. The trial has enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America. The Registry plans to enroll an additional 17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years. The pregnancy sub-study will document the clinical course of pregnant women with RHD. Conclusion INVICTUS is the largest program of clinical research focused on a neglected cardiovascular disease and will provide new information on the clinical course of patients with RHD, and approaches to anticoagulation in those with concomitant AF.

Statin use remains suboptimal in patients with atherosclerotic cardiovascular disease (ASCVD). We assessed if the frequency of visits with primary care providers (PCPs) is associated with higher use of evidence-based statin prescriptions and adherence among patients with ASCVD.We identified patients with ASCVD aged ≥18 years receiving care in 130 facilities and associated community-based outpatient clinics in the entire Veterans Affairs Health Care System between October 1, 2013 and September 30, 2014. Patients were divided into frequent PCP visitors (annual PCP visits ≥ median number of PCP visits for the entire cohort) and infrequent PCP visitors (annual PCP visitsmedian number of patient visits). We assessed any- and high-intensity statin prescription as well as statin adherence which was defined by proportion of days covered (PDC).We included 1,249,061 patients with ASCVD (mean age was 71.9 years; 98.0% male). Median number of annual PCP visits was 3. Approximately 80.1% patients were on statins with 23.8% on high-intensity statins. Mean PDC was 0.715 ± 0.336 with 58.3% patients with PDC ≥0.8. Frequent PCP visitors had higher frequency of statin use (82.2% vs 77.4%), high-intensity statin use (26.4% vs 20.3%), and statin adherence (mean PDC 0.73 vs 0.68; P .01) compared to infrequent PCP visitors. After adjusting for covariates, frequent PCP visits was associated with greater odds of being on any statin, high intensity statin, and higher statin adherence.Frequent visits with PCPs is associated with a higher likelihood of any statin use, high intensity statin use, and statin adherence. Further research endeavors are needed to understand the reasons behind these associations.

Statins are a cornerstone guideline-directed medical therapy for secondary prevention of ischemic heart disease (IHD). However, recent temporal trends and disparities in statin utilization for IHD have not been well characterized.This retrospective analysis included data from outpatient adult visits with IHD from the National Ambulatory Medical Care Survey (NAMCS) between January 2006 and December 2018. We examined the trends and predictors of statin utilization in outpatient adult visits with IHD.Between 2006 and 2018, we identified a total of 542,704,112 weighted adult ambulatory visits with IHD and of those 46.6% were using or prescribed statin. Middle age (50-74 years) (adjusted odds ratio [aOR] 1.65, 95% confidence interval [CI] 1.28-2.13 P.001) and old age (≥75 years) (aOR = 1.66, CI 1.26-2.19, P.001) compared to young age (18-49 years), and male sex (aOR = 1.35, CI 1.23-1.48, P.001) were associated with greater likelihood of statin utilization, whereas visits with non-Hispanic (NH) Black patients (aOR = 0.75, CI 0.61-0.91, P = .005) and Hispanic patients (aOR = 0.74, CI 0.60-0.92, P = .006) were associated with decreased likelihood of statin utilization compared to NH White patient visits. Compared with private insurance, statin utilization was nominally lower in Medicare (aOR = 0.91, CI 0.80-1.02, P = .112), Medicaid (aOR = 0.78, CI 0.59-1.02, P = .072) and self-pay/no charge (aOR = 0.72, CI 0.48-1.09, P = .122) visits, however did not reach statistical significance. There was no significant uptake in statin utilization from 2006 (44.1%) to 2018 (46.2%) (P = .549).Substantial gaps remain in statin utilization for patients with IHD, with no significant improvement in use between 2006 and 2018. Persistent disparities in statin prescription remain, with the largest treatment gaps among younger patients, women, and racial/ethnic minorities (NH Blacks and Hispanics).

This study using data from the Veterans Affairs (VA) administrative and clinical dataset examined determinants of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) use among patients with concomitant atherosclerotic cardiovascular disease (ASCVD) and diabetes mellitus. The aim of the present analysis was to identify barriers and facilitators associated with SGLT-2i in a real-world contemporary patient population in order to improve utilization of these guideline-directed agents.

BACKGROUND: There is a need to identify and test low cost approaches for cardiovascular disease (CVD) risk reduction that can enable health systems to achieve such a strategy. OBJECTIVE: Community health workers (CHWs) are an integral part of health-care delivery system in lower income countries. Our aim was to assess impact of CHW based interventions in reducing CVD risk factors in rural households in India. METHODS: We performed an open-label cluster-randomized trial in 28 villages in 3 states of India with the household as a unit of randomization. Households with individuals at intermediate to high CVD risk were randomized to intervention and control groups. In the intervention group, trained CHWs delivered risk-reduction advice and monitored risk factors during 6 household visits over 12 months. Households in the non-intervention group received usual care. Primary outcomes were a reduction in systolic BP (SBP) and adherence to prescribed BP lowering drugs. RESULTS: We randomized 2312 households (3261 participants at intermediate or high risk) to intervention (1172 households) and control (1140 households). At baseline prevalence of tobacco use (48.5%) and hypertension (34.7%) were high. At 12 months, there was significant decline in SBP (mmHg) from baseline in both groups-controls 130.3±21 to 128.3±15; intervention 130.3±21 to 127.6±15 (p

Background Influenza is associated with an increase in the risk of cardiac and other vascular events. Observational data and small randomized trials suggest that influenza vaccination may reduce such adverse vascular events. Research Design and Methods In a randomized controlled trial patients with heart failure are randomized to receive either inactivated influenza vaccine or placebo annually for 3 years. Patients aged ≥18 years with a clinical diagnosis of heart failure and NYHA functional class II, III and IV are eligible. Five thousand patients from 10 countries where influenza vaccination is not common (Asia, the Middle East, and Africa) have been enrolled. The primary outcome is a composite of the following: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria. Analyses will be based on comparing event rates between influenza vaccine and control groups and will include time to event, rate comparisons using Poisson methods, and logistic regression. The analysis will be conducted by intention to treat i.e. patients will be analyzed in the group in which they were assigned. Multivariable secondary analyses to assess whether variables such as age, sex, seasonality modify the benefits of vaccination are also planned for the primary outcome. Conclusion This is the largest randomized trial to test if influenza vaccine compared to control reduces adverse vascular events in high risk individuals. Trial registration number Clinicaltrials.gov NCT02762851

Aims The goal of the global congestive heart failure (G-CHF) registry is to collect comparative international data on heart failure characteristics, management and outcomes; and to better understand the determinants that impact the clinical course of heart failure. Methods G-CHF is a multi-center, prospective cohort study of adult patients with a new or prior clinical diagnosis of heart failure. We have enrolled 23,047 participants from 257 centers in 40 countries from eight major geographic regions of the world, with recruitment ongoing. Approximately 4000 participants will also participate in sub-studies to assess frailty, comorbidity, diet, barriers to care, biomarkers, and planned detailed echocardiographic analyses. Follow up is planned for a period of 5 years. The primary outcome is cause-specific mortality. Key secondary outcomes include hospitalizations, quality of life, major cardiovascular and non-cardiovascular outcomes. 31.9% of participants were enrolled as inpatients. Thus far, mean age of the cohort at baseline is 63.1 years, and 60.8% are male. Participants most commonly have heart failure with reduced ejection fraction (53.6%), followed by preserved ejection fraction (24.2%), and mid-range ejection fraction (20.6%). The most common causes of heart failure are ischemic (37.8%), followed by hypertensive (20.0%), idiopathic (15.1%), and valvular disease (8.8%). Conclusion G-CHF will provide a greater understanding of the characteristics of the global heart failure population, variations in its management, clinical outcomes, and what continues to impact morbidity and mortality in this high-risk population.

Sudden cardiac death in the young (SCDY) spans gender, race, ethnicity, and socioeconomic class. The loss of any pediatric patient is a matter of national and international public health concern, and focused efforts should be aimed at preventing these burdensome tragedies. Prepared by members of the Cardiac Safety Research Consortium, this White Paper summarizes and reports the dialogue at the second Think Tank related to the issues and the proposed solutions for the development of a national resource for screening and prevention of SCDY. This Think Tank, sponsored by the Cardiac Safety Research Consortium and the United States Food and Drug Administration, convened on February 18, 2016, in Miami, FL, to identify and resolve the barriers that prevent early identification of patients at risk for SCDY. All potential stakeholders including national and international experts from industry, medicine, academics, engineering, and community advocacy leaders had an opportunity to share ideas and collaborate.

Background The 2013 American College of Cardiology (ACC)/American Heart Association (AHA) cholesterol guideline recommends statin treatment based on patients' predicted atherosclerotic cardiovascular disease (ASCVD) risk. Whether clinician-reported guideline adoption translates to implementation into practice is unknown. Objectives We aimed to compare clinician lipid management in hypothetical scenarios versus observed practice. Methods The PALM Registry asked 774 clinicians how they would treat 4 hypothetical scenarios of primary prevention patients with: (1) diabetes; (2) high 10-year ASCVD risk (≥7.5%) with high low-density lipoprotein cholesterol (LDL-C; ≥130 mg/dL); (3) low 10-year ASCVD risk ( Results In primary prevention scenarios, 85% of clinicians reported they would prescribe a statin to a diabetic patient and 93% to a high-risk/high LDL-C patient (both indicated by guidelines), while 40% would prescribe statins to a low-risk/high LDL-C patient. In clinical practice, statin prescription rates were 68% for diabetic patients, 40% for high-risk/high LDL-C patients, and 50% for low-risk/high LDL-C patients. Agreement between hypothetical and observed practice was 64%, 39%, and 52% for patients with diabetes, high-risk/high LDL-C, and low-risk/high LDL-C, respectively. Among patients with persistently high LDL-C despite high-intensity statin treatment, 55% of providers reported they would add a non-statin lipid-lowering medication, while only 22% of patients were so treated. Conclusions While the majority of clinicians report adoption of the 2013 ACC/AHA guideline recommendations, observed lipid management decisions in practice are frequently discordant.

8 p., BACKGROUND: It is hypothesized that in individuals without clinical cardiovascular disease (CVD), but at increased CVD risk, a 50% to 60% reduction in CVD risk could be achieved using fixed dose combination (FDC) therapy (usually comprised of multiple blood-pressure agents and a statin [with or without aspirin]) in a single "polypill". However, the impact of a polypill in preventing clinical CV events has not been evaluated in a large randomized controlled trial. METHODS: TIPS-3 is a 2x2x2 factorial randomized controlled trial that will examine the effect of a FDC polypill on major CV outcomes in a primary prevention population. This study aims to determine whether the Polycap (comprised of atenolol, ramipril, hydrochlorothiazide, and a statin) reduces CV events in persons without a history of CVD, but who are at least at intermediate CVD risk. Additional interventions in the factorial design of the study will compare the effect of (1) aspirin versus placebo on CV events (and cancer), (2) vitamin D versus placebo on the risk of fractures, and (3) the combined effect of aspirin and the Polycap on CV events. RESULTS: The study has randomized 5713 participants across 9 countries. Mean age of the study population is 63.9 years, and 53% are female. Mean INTERHEART risk score is 16.8, which is consistent with a study population at intermediate CVD risk. CONCLUSION: Results of the TIP-3 study will be key to determining the appropriateness of FDC therapy as a strategy in the global prevention of CVD.