COVID-19 may negatively impact the prognosis of patients with chronic HFrEF and vice versa.
This study included 2 parallel analyses of patients in the United States who were in the TriNetX health ...database and who underwent polymerase chain reaction testing for SARS-CoV-2 as an inpatient or outpatient between January and September of 2020. Analysis A included patients with positive tests for COVID-19 and compared patients with histories of worsening heart failure with reduced ejection fraction (HFrEF) (hospitalization due to heart failure (HF) or IV diuretic use during the prior 12 months), HFrEF without worsening, and no prior HF. Analysis B included patients with histories of HFrEF and compared patients with positive vs negative COVID-19 tests. Outcomes included mortality and worsening HF. In both analyses, prespecified subgroup analyses were stratified by inpatient vs outpatient settings of the COVID-19 tests.
In Analysis A, of 99,052 patients with positive COVID-19 tests, 514 (0.5%) and 524 (0.5%) patients had histories of worsening HFrEF and HFrEF without worsening, respectively. After adjustment, compared to patients without HF, worsening HFrEF (risk ratio RR 1.42, 95% CI 1.10–1.83; P< 0.001) and HFrEF without worsening (RR 1.33, 95% CI 0.96–1.84; P= 0.06) were associated with higher 30-day mortality rates. Excess risk of mortality tended to be pronounced in patients initially diagnosed with COVID-19 as outpatients (P for interaction, 0.12 and 0.006, respectively). In Analysis B, of 14,838 patients with HFrEF tested for COVID-19, 1038 (7.0%) had positive tests. After adjustment, testing positive was associated with excess 30-day mortality risk (RR 1.67, 95% CI 1.38–2.02; P< 0.001) and worsening HF (RR 1.33, 95% CI 1.17–1.51; P< 0.001). Mortality risk was nominally more pronounced among patients presenting as outpatients (P for interaction 0.07).
In this large cohort of patients tested for COVID-19, among patients testing positive, a history of HFrEF with or without worsening was associated with excess mortality rates, particularly among patients diagnosed with COVID-19 as outpatients. Among patients with established HFrEF, compared with testing negative, testing positive for COVID-19 was independently associated with higher risk of death and worsening HF.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Although a worsening heart failure event (WHFE) is associated with poor outcomes in patients with heart failure with reduced ejection fraction (HFrEF), it is unclear how guideline-directed medical ...therapy (GDMT) is used in this population compared to those without WHFEs. This study evaluated treatment patterns in patients with HFrEF, both with and without WHFEs.
A retrospective study using 100% Medicare Fee-For-Service claims identified beneficiaries with HFrEF, stratified by those with and without WHFEs (defined as hospitalization due to HF or outpatient intravenous diuretic use). The use of GDMT for HFrEF before and after WHFEs and adherence were assessed in patients who were prescribed and initiated GDMT. Logistic regression identified patients’ characteristics associated with medication nonadherence.
Of 353,642 patients with HFrEF, 31.4% had a WHFE. Although there was no overall change in the treatment trajectory of patients without WHFEs, GDMT use in patients with WHFEs intensified within the first 3 months of a WHFE, but the intensification was not sustained in subsequent months. From 0–3 months pre-WHFE to 0–3 months post-WHFE, the proportion of patients receiving dual (41%–48%) and triple-therapy (4%–12%) increased, followed by a decline to pre-WHFE rates. The 1-year adherence rates for those with and without WHFEs were 67.9% vs 73.3% for beta-blockers; 59.1% vs 70.9% for angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists; 53.9% vs 61.3% for angiotensin receptor-neprilysin inhibitors; and 49.2% vs 59.3% for mineralocorticoid receptor antagonists. WHFE, age < 65 years, Black race, asthma, chronic kidney disease, and depression were associated with nonadherence to medications. Asians and Hispanics were less adherent to some medication classes.
This study demonstrated underuse of GDMT for patients with HFrEF with or without WHFEs. Although there was a treatment escalation within 3 months following WHFE, it was not sustained thereafter.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Patients with heart failure with reduced ejection fraction (HFrEF) and worsening HF events (WHFE) represent a distinct subset of patients with a substantial comorbidity burden, greater potential for ...intolerance to medical therapy, and high risk of subsequent death, hospitalization and excessive healthcare costs. Although multiple therapies have been shown to be efficacious and safe in this high-risk population, there are limited real-world data regarding factors that impact clinical decision-making when initiating or modifying therapy. Likewise, prior analyses of US clinical practice support major gaps in medical therapy for HFrEF and few medication changes during longitudinal follow-up, yet granular data on reasons why clinicians do not initiate or up-titrate guideline-directed medication are lacking.
We designed the CHART-HF study, an observational study of approximately 1,500 patients comparing patients with and without WHFE (WHFE defined as receipt of intravenous diuretics in the inpatient, outpatient, or emergency department setting) who had an index outpatient visit in the US between 2017 and 2019. Patient-level data on clinical characteristics, clinical outcomes, and therapy will be collected from 2 data sources: a single integrated health system, and a national panel of cardiologists. Furthermore, clinician-reported rationale for treatment decisions and the factors prioritized with selection and optimization of therapies in real-world practice will be obtained. To characterize elements of clinician decision-making not documented in the medical record, the panel of cardiologists will review records of patients seen under their care to explicitly note their primary reason for initiating, discontinuing, and titrating medications specific medications, as well as the reason for not making changes to each medication during the outpatient visit.
Results from CHART-HF have the potential to detail real-world US practice patterns regarding care of patients with HFrEF with versus without a recent WHFE, to examine clinician-reported reasons for use and non-use of guideline-directed medical therapy, and to characterize the magnitude and nature of clinical inertia toward evidence-based medication changes for HFrEF.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Aims
While glycemic control is key in effective type 2 diabetes mellitus management, many patients fail to reach their individualized glycemic goal. This analysis aimed to describe a real-world ...picture of diabetes management: individualized hemoglobin A
1c
(HbA
1c
) goals, rate of goal attainment, HbA
1c
at each line of therapy, and patient awareness of their glycemic goal. Secondly, we aimed to understand physician satisfaction with HbA
1c
amongst patients aware vs. those unaware of HbA
1c
goal.
Methods
Analysis of physicians and the next ten consulting patients with type 2 diabetes mellitus conducted in Europe and the USA including medical record data abstraction/assessment by physicians, a patient-reported survey and a physician survey. Patients were diagnosed for 3 months or more with a known current and target HbA
1c
. For the sub-analysis assessment of patient awareness of HbA
1c
goal, in addition to the above, these patients had to have completed a patient-reported questionnaire and answer the question on awareness of HbA
1c
goal.
Results
A total of 730 physicians provided data on 8794 patients with type 2 diabetes mellitus; 5331 patients were eligible for this analysis. Overall, mean (standard deviation, SD) individualized HbA
1c
goal was 6.8% (0.68%). Of eligible patients, 39.1% met their HbA
1c
goal; of 60.9% of patients not reaching their HbA
1c
goal, the mean distance from individualized HbA
1c
goal was 0.9% (SD 1.0%). Physicians progressed patients’ antihyperglycemic therapy when HbA
1c
was 8% or higher. Among 2560 patients who were included in the sub-analysis assessing the effect of patient awareness of their HbA
1c
goal on multiple parameters, 70.5% were aware of their HbA
1c
goal; mean HbA
1c
goal was 6.8% (0.7%) and current mean HbA
1c
value 7.1% (1.2%). A total of 949 patients in the sub-analysis (39.2%) achieved their goal; achieving HbA
1c
goal was not related to knowledge of goal. Patients aware of their HbA
1c
goal were slightly more adherent to their antihyperglycemic medication. They also were prescribed more antihyperglycemic agents, more often on a later therapy line receiving a GLP-1 receptor agonist, SGLT2i, or insulin, and more often tested their blood glucose levels than patients who were unaware. Physicians were not satisfied with the current blood glucose level of one third of their patients, believing that more of those who were aware of their HbA
1c
goal could achieve better glucose control (32.4% of aware vs. 28.2% of unaware patients;
p
= 0.003).
Conclusions
Our results showed that the proportion of patients with type 2 diabetes mellitus achieving their goals for glycemic control was suboptimal when compared to current guideline criteria, with only about 40% of patients achieving their individualized HbA
1c
goal. Treatment intensification was often delayed until HbA
1c
was 8% and higher. Patients aware of their HbA
1c
goal were slightly more adherent to their antihyperglycemic medication; however, awareness of HbA
1c
goal did not enhance goal attainment. This highlights the need for a holistic approach to diabetes management, involving patient education, and patient–physician communication and partnership.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Abstract only
Background:
In January 2021, vericiguat was approved by US FDA to reduce the risk of cardiovascular death and HF hospitalization following a recent worsening HF event based on results ...of the VICTORIA trial. Limited data are available characterizing generalizability to US clinical practice.
Methods:
We studied patients hospitalized with HF with reduced ejection fraction (HFrEF) <45% across 525 sites in the Get With The Guidelines (GWTG)-HF registry between January 2014 - December 2020. We excluded patients who left against medical advice, transferred to an acute care facility or to hospice care, or had missing critical data elements. We applied approximate FDA label criteria (excluding eGFR<15 mL/min/1.73 m
2
, dialysis, or heart transplantation or mechanical circulatory support) and eligibility criteria of the VICTORIA trial to the GWTG-HF sample.
Results:
Among 241,057 patients with EF<45% in GWTG-HF, 221,730 (92%) could be candidates for vericiguat under the FDA label and 92,249 (38%) would have been eligible for VICTORIA. The most frequent reason for ineligibility in the FDA label was eGFR<15 mL/min/1.73 m
2
(n=13,747; 5.7%). Sex, race, and clinical characteristics were generally similar between GWTG-HF registry participants, FDA label candidates, and VICTORIA trial eligible patients (
Table
). Among patients age ≥65 years linked to Medicare, 12-month mortality, HF hospitalization, and all-cause hospitalization were similar across the three groups.
Conclusions:
These data from a large US hospitalized HF registry suggest that more than 9 out of 10 patients hospitalized for HFrEF may be candidates for vericiguat based on the FDA label. Patients meeting and not meeting VICTORIA trial eligibility criteria had similar characteristics and outcomes, supporting generalizability of the FDA label and the VICTORIA trial to US practice. Medicare beneficiaries hospitalized for HFrEF and eligible for vericiguat face high post-discharge mortality and readmission rates.
Cardiovascular disease is the most common cause of mortality and morbidity in the world, but the pharmaceutical industry's willingness to invest in this field has declined because of the many ...challenges involved with bringing new cardiovascular drugs to market, including late-stage failures, escalating regulatory requirements, bureaucracy of the clinical trial business enterprise, and limited patient access after approval. This contrasts with the remaining burden of cardiovascular disease in Europe and in the world. Thus, clinical cardiovascular research needs to adapt to address the impact of these challenges in order to ensure development of new cardiovascular medicines.
The present paper is the outcome of a two-day workshop held by the Cardiovascular Round Table of the European Society of Cardiology. We propose strategies to improve development of effective new cardiovascular therapies. These can include (i) the use of biomarkers to describe patients who will benefit from new therapies more precisely, achieving better human target validation; (ii) targeted, mechanism-based approaches to drug development for defined populations; (iii) the use of information technology to simplify data collection and follow-up in clinical trials; (iv) streamlining adverse event collection and reducing monitoring; (v) extended patent protection or limited rapid approval of new agents to motivate investment in early phase development; and (vi) collecting data needed for health technology assessment continuously throughout the drug development process (before and after approval) to minimize delays in patient access. Collaboration across industry, academia, regulators, and payers will be necessary to enact change and to unlock the existing potential for cardiovascular clinical drug development.
A coordinated effort involving academia, regulators, industry, and payors will help to foster better and more effective conduct of clinical cardiovascular trials, supporting earlier availability of innovative therapies and better management of cardiovascular diseases.
Evidence from clinical trials suggest that newer antihyperglycemic agents (AHAs) have a better clinical profile at a higher dose. However, the utilization of the different doses in the real world is ...not well known. This study aimed to assess the dose utilization of the 2 newer classes of AHAs using the 2018 Adelphi T2DM Disease Specific Programme, a survey involving 730 physicians and 8794 patients in the U.S. and Europe. The analysis included 1612 patients on sodium glucose cotransporter 2 inhibitors (SGLT2i) and 1073 patients on glucagon like peptide-1 receptor agonist (GLP-1RA), either monotherapy or combined therapy. Dose cut points for SGLT2i drugs were based on doses utilized in cardiovascular outcomes trials (at a compound level, Table 1). There is no standard cut point on dosing in GLP-1RA, therefore a conservative approach was applied (see Table for details). Analyses were performed at class level. SGLT2i drugs were more likely to be prescribed at a high dose (85.7%) to patients who were slightly younger than those receiving a lower dose (57.1 vs. 58.9 years). GLP-1RA were prescribed at high dose in 63.2% of the patients. Mean BMI was higher in patients receiving high dose of a GLP-1 receptor agonist.
Disclosure
D. Lautsch: Employee; Self; Merck & Co., Inc. E. McLeod: Employee; Self; Pfizer Inc. Stock/Shareholder; Self; Pfizer Inc. T. Wang: Employee; Spouse/Partner; Janssen Pharmaceuticals, Inc. Employee; Self; Merck & Co., Inc. C.D. Gonzalez: Employee; Self; Merck & Co., Inc. S. Rajpathak: Employee; Self; Menarini Group. S. Malkani: None. J. Jackson: None. G. Milligan: None. V. Higgins: None.
Funding
Merck Sharp & Dohme Corp; Pfizer Inc.
To explore the associations between social determinants of health and patient-centred outcomes among adults with chronic heart failure with reduced ejection fraction.
Cross-sectional online ...self-report survey.
A survey assessing social determinants of health (demographics, socio-economic position, affordability of care and social support) and patient-centred outcomes, including the Kansas City Cardiomyopathy Questionnaire-12 and validated measures of medication adherence, treatment satisfaction, treatment burden and mental health, was completed by 512 adults with chronic heart failure with a reduced ejection fraction between 06 March and 29 June 2020. Multivariable analyses included linear and logistic regression.
Female gender, having a care partner, and being offered financial assistance with medications were associated with worse health status, while perceiving medication as affordable and being married were associated with better health status. Females and having Medicaid, dual Medicaid/Medicare or no medical insurance were associated with a higher likelihood of depression, and non-white race/ethnicity was associated with less depression. Medication adherence was lower in patients having a care partner and offered financial assistance. Patients being offered financial and medication management assistance were more likely to be overwhelmed by the treatment burden, whereas those having some college education were less so.
Social determinants of health are associated with patients' disease-specific health status, mental health and treatment satisfaction and burden. These findings underscore the importance of assessing social determinants of health in clinical practice and the need for developing and testing novel strategies to determine whether they improve patients' health.
The relationship between social determinants of health- and patient-centred outcomes was assessed; affordability of care and social support factors were most strongly associated with outcomes for patients with chronic heart failure and reduced ejection fraction, underscoring the importance of assessing social determinants of health in routine clinical care.
Social determinants of health data could potentially inform care delivery for patients with heart failure and reduced ejection fraction by helping to identify those who require additional support to manage their symptoms, access care and adhere to treatment. Social support and affordability of treatment were associated with most patient-centred outcomes, suggesting these factors may provide clinicians with an indicator of a patient's level of general well-being that could be assessed during routine follow-up care.
This research followed the STROBE checklist for cross-sectional studies.
Adults who have heart failure with reduced ejection fraction that consented to participate in the study provided the data used for all analyses reported on in the manuscript. Service users, caregivers or members of the public had no involvement in the study.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK, VSZLJ
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