Abstract only
Introduction:
Right Heart Catheterization (RHC) is the gold standard diagnostic test to confirm Pulmonary Arterial Hypertension (PAH). However, not all patients receive a RHC to confirm ...diagnosis.
Hypothesis:
This study analyzed a real-world PAH dataset to understand factors predictive of RHC being used to confirm diagnosis.
Methods:
Data were analyzed from the 2022 Adelphi PAH Disease Specific Programme™ containing physician-provided patient information for PAH patients in the US, France, Germany, Italy, Spain, UK and Japan. As our outcome (RHC at diagnosis) is binary, logistic regression was used behind LASSO for 113 covariates (predictors). LASSO regression inputs many covariates, only those associated with the outcome are presented. Each covariate is tested individually and against all others. In LASSO an odds ratio (OR) is generated. An OR > 1 or more indicates a predictor is associated with a higher likelihood of RHC at diagnosis, an OR < 1 indicates a lower likelihood. RHC at diagnosis was physician-confirmed from patient records.
Results:
A total of 529 PAH patients with complete data for all covariates were analyzed. Mean age was 55 and 51% were female. Overall, 75% received a RHC at diagnosis. Patient refusal (34%) and deemed unnecessary by managing physician due to other testing (29%) were the most frequently cited reasons for lack of RHC. Of the 113 initial predictors, 24 were considered important in predicting RHC (
Figure 1
). The leading predictors for RHC at diagnosis were patients classified as functional class (FC) III, those experiencing symptoms of dyspnea, palpitations and cyanosis, and those diagnosed at an accredited expert pulmonary hypertension (PH) center.
Conclusions:
Results indicate that RHC is more likely to be used for patients presenting with a higher FC, key PAH symptoms and diagnosed at PH expert centers. Further emphasis should be placed on RHC at diagnosis particularly within non-specialist settings to help achieve accurate diagnosis.
The American Diabetes Association (ADA) guidelines recommend A1C testing schedules for patients with type 2 diabetes; however, level of real-world guideline adherence remains unclear. The current ...study evaluated A1C testing frequency and its association with glycemic control and cardiovascular outcomes.
A retrospective study was conducted utilizing Aetna's Enterprise Data Warehouse. Adult patients with a medical claim for type 2 diabetes in 2017 (index date) were included. Patients had continuous enrollment through December 2019 and ≥1 reported A1C measurement from 2017 to 2019. Follow-up was up to 36 months post-index date.
Of the 112,572 eligible patients, 50.0% were female and median age was 70 years; 32.9% of patients with controlled baseline A1C (<8%, 64 mmol/mol) received less than the 2 tests/year recommended by the ADA, while 60.6% of patients with uncontrolled baseline A1C received less than the quarterly testing recommended by the ADA. More frequent testing was associated with age (65-75 years), uncontrolled baseline A1C and presence of comorbidities. In separate multivariable models, 2-3 A1C tests/year were associated with greater likelihood of A1C < 8% (64 mmol/mol) vs. <2 tests/year (OR = 1.07, 95% confidence interval CI 1.02-1.12), while >3 tests/year was associated with a modestly increased risk of cardiovascular events vs. <2 tests/year (OR = 1.08, 95% CI 1.01-1.15).
A large proportion of type 2 diabetes patients were not tested per guideline recommendations. The relationship between A1C testing frequency and glycemic control was inconsistent, though there was a significant association between more frequent testing and experiencing a CV event.
Background: Metformin is the first line treatment for type 2 diabetes mellitus. Sodium glucose cotransporter 2 inhibitors (SGLT2i) are a novel class of oral antidiabetic agents. We aimed to ...understand factors associated with attaining the HbA1c threshold of <8% in the United States.
Methods: Observational, retrospective cohort study in adult type 2 diabetes mellitus patients from IQVIA EMR database. Observation period was June 2015 to June 2018. Patients needed to initiate SGLT2i and metformin without other antihyperglycemic agents. The impact of sociodemographic factors on achievement of HbA1c <8% was tested using multivariable logistic regression with backward stepwise selection using SAS 9.4.
Results: Of 3491 patients in the final cohort, 2176 (62.3%) achieved HbA1c <8%. The remaining patients had a median distance to goal of 1.1% (IQR 0.5-2.3%). Mean age was 56.5 year. 52.6% were male. Black patients had lower odds to attain HbA1c <8% than white patients OR 0.69 (0.57, 0.85), while patients <65 years of age had non relevant higher odds OR 1.01 (1.01, 1.02), Table 1.
Conclusion: In the real world in the U.S., 62% of patients treated with metformin and an SGLT2i had an HbA1c <8%. Black patients had lower odds to attain this threshold.
Disclosure
D. Lautsch: Employee; Self; Merck & Co., Inc. L. Yang: Employee; Self; Merck & Co., Inc. S. Rajpathak: Employee; Self; Menarini Group. N. Bansal: None. N. Kathe: None.
Funding
Merck & Co., Inc.
DYSIS II ACS was a longitudinal, observational study in 3867 patients from 18 countries. They were being hospitalized after suffering an acute coronary syndrome. Evaluations were performed at the ...time of admission and again 120±15 days following the date of admission (the follow-up time point). 2521 patients were on active lipid lowering treatment (LLT) at admission. Mean atorvastatin dose was 22mg per day and 2.7% received ezetimibe in combination with a statin. At discharge from hospital, 3767 patients received LLT expressed as a mean atorvastatin dose of 36mg per day with 4.8% receiving ezetimibe on top of a statin. After 120 days, intensity in lipid lowering treatment was reduced to 32mg per day with 4.9% of the patients receiving ezetimibe and a statin. Of note, during this 4-month follow up period, only 32% of all patients received laboratory lipid testing. 37% attained the low density lipoprotein cholesterol (LDL-C) target value of <70mg/dl after 120 days. There are differences in the therapy administered as well as in the switch strategies when comparing the data from the respective countries studied.
Only one in three patients achieved the LDL-C target value following only marginal improvements in atorvastatin dose or combination therapy after an ACS event.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract only
Introduction:
Select centers have published local experiences with outpatient (OP) intravenous (IV) diuretic clinics to treat worsening heart failure (HF) and prevent hospitalization. ...Little is known regarding widespread use of this care strategy in contemporary US practice, including the potential impact of the COVID-19 pandemic.
Methods:
Inpatient (IP) and OP claims from Optum (April 2018-March 2021) were utilized to identify instances where patients with HF with reduced ejection fraction (HFrEF) received ≥1 administration of IV diuretic. Episodes of care were categorized into hierarchical mutually exclusive groups defined by intensity of care setting, including IP hospitalization, critical care (without IP hospitalization), emergency department (without IP hospitalization), observation unit, nursing facility, and outpatient clinic. Analyses were stratified across pre-pandemic (4/2018-3/2019, 4/2019-3/2020) and COVID-19 pandemic periods (4/2020-3/2021).
Results:
Among 302,397 patients with HFrEF, 56,213 (19%) patients received IV diuretic therapy during the study period, accounting for 94,865 total IV diuretic episodes. Of patients receiving IV diuretics, 44% were female and 20% were Black. Among 85,827 (90%) IV diuretic episodes with available data on location of care, 14% were outpatient clinic visits, 60% were IP hospitalizations, and 21% were ED visits. Critical care, observation unit, and nursing facility locations each constituted ~1-2% of IV diuretic episodes. The proportion of outpatient IV diuretic visits and the overall distribution of IV diuretic episodes was similar over time, spanning the pre-pandemic and COVID-19 pandemic periods
(Figure)
.
Conclusions:
In this cohort of US patients with HFrEF, approximately 1 in 7 care episodes involving IV diuretic therapy occurred in outpatient clinic. The relative proportion of outpatient IV diuretic visits did not meaningfully change during the first year of the COVID-19 pandemic.
Abstract Background and aims There is an inconsistency between international guidelines on lipid-lowering treatment regarding whether to pursue LDL-C treatment targets or to focus on the intensity of ...treatment. While either approach is attractive, there is no recent global data on actual LDL-C values, treatment targets attained, and the intensity of treatment in statin-treated patients. We aimed to determine and compare the extent of treatment target attainment globally using standardized data collection. Methods Analyses were based on the Dyslipidemia International Study (DYSIS), a cross-sectional study documenting statin-treated outpatients throughout 30 countries worldwide (across Europe, the Middle East, Canada, Africa, and Asia). Patients were classified as being at very high, high, or non-high cardiovascular risk based on the 2011 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines. Results Data were available for a total of 57,885 patients with a median LDL-C value of 98.2 mg/dl (IQR: 76.6, 125.7 mg/dl). Overall, only 26.8% of patients were documented to have attained their risk-based target LDL-C level. Of the 76% of patients who were classified as being at very high risk, only 21.7% attained their LDL-C goal. Globally, the median distance to target was 33.0 mg/dl, ranging from 18.8 to 42.1 mg/dl across countries. We calculated that a further LDL-C reduction of just 10 mg/dl would result in an 11% increase in the proportion of very-high-risk and high-risk patients attaining their target level (9% for non-high risk patients). Conclusions In spite of statin therapy, LDL-C values were high, with a substantial distance to target that was even more pronounced in (very) high risk patients. These results call for the optimization of existing treatment strategies and a collaborative effort to improve the impact of treatment guidance on clinical practice.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, PNG, SAZU, SBCE, SBJE, UL, UM, UPUK, ZRSKP
Objective
Given the high economic burden of disease among adult patients with chronic heart failure with reduced ejection fraction (HFrEF) following a worsening heart failure event in the US, this ...study aimed to estimate the cost effectiveness of vericiguat plus prior standard-of-care therapies (PSoCT) versus PSoCT alone from a US Medicare perspective.
Methods
A four-state Markov model (alive prior to heart failure hospitalization, alive during heart failure hospitalization, alive post-heart failure hospitalization, and death) was developed to predict clinical and economic outcomes, based on the results of the VICTORIA trial, in which patients with chronic HFrEF following a worsening heart failure were randomized to placebo or vericiguat, in addition to PSoCT, which consisted of β-blockers, renin-angiotensin-aldosterone inhibitors, mineralocorticoid receptor antagonists, and the angiotensin receptor–neprilysin inhibitor sacubitril/valsartan. Risks of heart failure hospitalization and cardiovascular mortality were based on multivariable regression models derived from VICTORIA data. Utilities were derived from VICTORIA EQ-5D data and the literature. Costs included drug acquisition, heart failure hospitalization, routine care, and terminal care. Primary outcomes included heart failure hospitalization, cardiovascular mortality, life-years, quality-adjusted life-years (QALYs), and incremental costs per QALY gained over a 30-year lifetime horizon, discounted at 3.0% annually.
Results
For the VICTORIA overall intent-to-treat population, compared with PSoCT, vericiguat plus PSoCT resulted in 19 fewer heart failure hospitalizations and 13 fewer cardiovascular deaths per 1000 patients, as well as 0.28 QALY gained per patient at an incremental cost of $23,322, leading to $82,448 per QALY gained.
Conclusions
Based on the results of VICTORIA, patients treated with vericiguat had lower rates of heart failure hospitalization and cardiovascular death. The addition of vericiguat to PSoCT was estimated to increase QALYs and to be cost effective at a willingness-to-pay threshold of $100,000 per QALY gained.
Full text
Available for:
CEKLJ, 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 Introduction: COVID-19 may negatively impact prognosis for patients with chronic HFrEF, and vice versa. However, large-scale data characterizing the interplay of COVID-19 and HFrEF on ...clinical outcomes are scarce. Methods: We examined the TriNetX health database from January 2020-September 2020 to conduct 2 analyses. Analysis A excluded patients with HFpEF and included patients with a positive inpatient or outpatient test for COVID-19, with a 3-way comparison of patients 1) without prior HF, 2) HFrEF without recent worsening HF event (WHFE) (i.e., no HF hospitalization or outpatient IV diuretic within prior 1 year), and 3) worsening HFrEF (i.e., HF hospitalization or outpatient IV diuretic within prior 1 year). Outcomes included mortality at 30 days and composite all-cause mortality or hospitalization following COVID-19 test. Analysis B included patients with HFrEF who underwent PCR testing for COVID-19, and compared patients with a positive versus negative test. Outcomes were mortality at 30 days and worsening HF (i.e., HF hospitalization or outpatient IV diuretic use). Results: In analysis A, 98,014 (99%) patients had no prior HF, 524 (0.5%) had HFrEF without WHFE, and 514 (0.5%) had worsening HFrEF. After adjustment for confounders, compared with patients without HF, worsening HFrEF was independently associated with excess mortality (p<0.01), whereas HFrEF without WHFE was not statistically significant (p=0.06) (Table) . In analysis B, 1,038 (7%) had a positive test for COVID-19 and 13,800 (93%) had only negative tests. After adjustment, testing positive for COVID-19 was independently associated with mortality and worsening HF (all p<0.01). Conclusions: In this US population of ambulatory and hospitalized patients, after accounting for confounders, worsening HFrEF was independently associated with excess mortality after COVID-19 infection. Among patients with HFrEF, COVID-19 infection was associated with higher risk of death and worsening HF events.
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