Circulation-Cardiovascular Quality and Outcomes最新文献

Background: Despite the growing number of nonstatin lipid-lowering treatments (NS-LLTs), data are lacking on how patients value their various features and outcomes. Study objectives were to quantify patients' preferences across levels of efficacy, treatment regimens, side effects, and out-of-pocket costs of NS-LLTs and compare approaches with framing treatment efficacy.

Methods: A discrete choice experiment survey was administered to US adults aged ≥40 years with medical claims indicating statin use and atherosclerotic cardiovascular disease. Each participant was administered 12 sets of experimentally designed pairs of add-on NS-LLT profiles that varied in efficacy, administration regimen, injection-site reaction, joint pain, out-of-pocket cost, and a no-additional treatment option. Random-parameter logit models were used to estimate preference weights, and tradeoffs across attributes were reported as willingness-to-pay estimates.

Results: A total of 1193 participants completed the survey (36% female; 90% White; mean age, 68.2±9.7 years). Across treatment features assessed, out-of-pocket cost ranging from $0 to $200 per month was the most important factor. All else being equal, a daily oral dosing regimen was the most preferred regimen. Among injectable regimens, participants preferred dosing every 6 months versus every 2 weeks (P<0.001) or every month (P<0.001). Efficacy presented as 25% to 60% reductions in LDL-C (low-density lipoprotein-cholesterol) levels was valued greater than equivalent reductions in 5-year cardiovascular risks. Among those reporting annual household incomes <$150 000 (93.5%), the average maximum willingness to pay for an add-on NS-LLT as a daily, oral medication without side effects ranged from $131 to $175 per month with efficacy framed as a 25% reduction in LDL-C levels versus $89 to $124 with efficacy framed as corresponding reductions in 5-year cardiovascular risk.

Conclusions: Among treatment features assessed, out-of-pocket costs were the primary factor driving choices. Those opting for an add-on NS-LLT were willing to trade off additional efficacy for less frequent injections or a daily oral medication.

Background: Sleep and physical activity (PA) are important lifestyle-related behaviors that impact cardiometabolic health. This study investigated the joint associations of daily step count and sleep patterns (regularity and duration) with cardiometabolic biomarkers in adults.

Methods: We conducted a cross-sectional study using pooled data from the Prospective PA, Sitting, and Sleep Consortium, comprising 6 cohorts across Europe and Australia with thigh-worn accelerometry data collected between 2011 and 2021. The sleep regularity index, a metric that quantifies day-to-day sleep consistency, sleep duration (h/d), and steps (per day), was derived from the accelerometer data and categorized based on tertiles and sleep duration guidelines. We used multivariate generalized linear models to examine joint associations of sleep patterns and total daily step count with individual cardiometabolic biomarkers, including body mass index, waist circumference, total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, HbA1c (glycated hemoglobin), and a composite cardiometabolic health score (mean of the 6 standardized biomarker Z scores).

Results: The sample included 11 903 adults with a mean±SD age of 54.7±9.5 years, 54.9% female, a sleep regularity index of 78.7±10.4, and 10 206.4±3442.2 daily steps. Lower PA (<8475 steps/d) combined with either lower sleep regularity (sleep regularity index <75.9) or short sleep duration (<7 h/d) was associated with the least favorable composite cardiometabolic health. The corresponding Z scores (95% CI) were 0.34 (0.30-0.38) and 0.26 (0.22-0.31) compared with those with optimal sleep (sleep regularity index >84.5 or 7-8 h/d) and high step count (>11 553 steps/d). The combination of low sleep regularity and low daily steps was associated with higher body mass index (2.92 [2.61-3.24] kg/m²), waist circumference (8.58 [7.78-9.38] cm), total cholesterol (0.15 [0.07-0.23] mmol/L), and lower HDL levels (0.17 [0.14-0.2] mmol/L), regardless of sleep duration. The combination of short sleep and low step count had the strongest unfavorable associations for body mass index (2.31 [1.98-2.65] kg/m²) and waist circumference (7.01 [6.15-7.87] cm).

Conclusions: Our findings suggest that the potential deleterious associations of irregular or insufficient sleep with cardiometabolic health outcomes may be exaggerated by lower daily PA. Investigation of the prospective joint association of sleep patterns and PA with cardiometabolic health may be warranted.

Background: There are multiple risk assessment models (RAMs) for venous thromboembolism prophylaxis, but it is unknown whether they increase appropriate prophylaxis.

Methods: To determine the impact of a RAM embedded in the electronic health record, we conducted a stepped-wedge hospital-level cluster-randomized trial conducted from October 1, 2017 to February 28, 2019 at 10 Cleveland Clinic hospitals. We included consecutive general medical patients aged 18 years or older. Patients were excluded if they had a contraindication to prophylaxis, including anticoagulation for another condition, acute bleeding, or comfort-only care. A RAM was embedded in the general admission order set and physicians were encouraged to use it. The decisions to use the RAM and act on the results were reserved to the treating physician. The primary outcome was the percentage of patients receiving appropriate prophylaxis (high-risk patients with pharmacological thromboprophylaxis plus low-risk patients without prophylaxis) within 48 hours of hospitalization. Secondary outcomes included total patients receiving prophylaxis, venous thromboembolism among high-risk patients at 14 and 45 days, major bleeding, heparin-induced thrombocytopenia, and length of stay. Mixed-effects models were used to analyze the study outcomes.

Results: A total of 26 506 patients (mean age, 61; 52% female; 73% White) were analyzed, including 11 134 before and 15 406 after implementation of the RAM. After implementation, the RAM was used for 24% of patients, and the percentage of patients receiving appropriate prophylaxis increased from 43.1% to 48.8% (adjusted odds ratio, 1.11 [1.00-1.23]), while overall prophylaxis use decreased from 73.5% to 65.2% (adjusted odds ratio, 0.87 [0.78-0.97]). Rates of venous thromboembolism among high-risk patients (adjusted odds ratio, 0.72 [0.38-1.36]), rates of bleeding and heparin-induced thrombocytopenia (adjusted odds ratio, 0.19 [0.02-1.47]), and length of stay were unchanged.

Conclusions: Implementation of a RAM for venous thromboembolism increased appropriate prophylaxis use, but the RAM was used for a minority of patients.

Registration: URL: https://www.clinicaltrials.gov/study/NCT03243708?term=nct03243708&rank=1; Unique identifier: NCT03243708.

Background: Compared with the 2003 Seventh Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) guideline, the 2017 American College of Cardiology and American Heart Association guideline (ACC/AHA 2017) expanded hypertension diagnostic criteria to blood pressure (BP) ≥130/80 mm Hg and intensified treatment goals to <130/80 mm Hg. The cost-effectiveness of ACC/AHA 2017 guideline treatment has not been quantified.

Methods: We used the Cardiovascular Disease (CVD) Policy Model to simulate hypertension treatment according to ACC/AHA 2017 compared with JNC7 in untreated US adults aged 35 to 79 years. Outcomes were projected over 10 years and included CVD events and deaths, quality-adjusted life-years (QALYs), and total health care costs (ie, costs of antihypertensive treatment and costs of health care utilization for cardiovascular and noncardiovascular care, regardless of payer). Cost-effectiveness was calculated from a health care sector perspective as incremental health care costs divided by incremental QALYs.

Results: Under ACC/AHA 2017, 4.9 million more US adults are indicated for treatment and 14.9 million are recommended more intensive treatment goals compared with JNC7. Over 10 years, ACC/AHA 2017 versus JNC7 treatment would cost $48 300 per QALY gained ($38 300/QALY in men; $65 200/QALY in women). Overall, 34% of CVD events prevented by ACC/AHA 2017 versus JNC7 would be from expanded diagnosis (at $120 900/QALY gained), and 66% from intensified BP treatment goals (at $18 900/QALY gained). Cost-effectiveness improved with a longer time horizon ($17 600 per QALY gained at 30 years) and when generic drug costs were assumed in place of median US drug costs ($27 900 per QALY gained in 10 years). ACC/AHA 2017 is cost-saving in adults with BP ≥140/90 mm Hg and prior CVD or 10-year CVD risk ≥10%.

Conclusions: Initiating hypertension treatment according to the ACC/AHA 2017 guideline in untreated US adults is cost-effective compared with JNC7 at 10 years. Prioritizing low-cost generic medicines and intensive BP treatment of high-CVD-risk adults with BP ≥140/90 mm Hg returns the most value.

Background: Mortality due to ischemic heart disease (IHD) has declined in countries with high socioeconomic development. Whether these declines extend to other settings, and whether socioeconomic development influences IHD mortality among men and women differently, is unknown.

Methods: We obtained annual data on sex-specific IHD mortality rates for countries/territories in the GBD study (Global Burden of Disease) from 1980 to 2021. The sociodemographic index (SI), a measure of socioeconomic development, was retrieved for each country/territory. Age-adjusted IHD mortality rates were modeled as a smooth function of sex, year, and SI.

Results: From 1980 to 2021, IHD mortality rates did not decrease in low SI settings for men or women. In contrast, mortality rates relative to 1980 declined by >25% in average SI settings (age-adjusted mortality per 100 000, 153-107 for women and 218-161 for men) and >50% in high SI settings (age-adjusted mortality per 100 000, 162-69 for women and 258-114 for men). Comparing the 20th versus 80th percentile of SI in 2021 (corresponding to lower versus higher socioeconomic development), mortality rates were 81% higher for men and 111% higher for women living in socioeconomically deprived settings (P for difference by sex: 0.01), although absolute differences were larger in men. The association of low SI with higher IHD mortality was especially pronounced for mortality attributable to environmental/occupational risk factors (eg, particulate matter air pollution, lead exposure, and extremes of temperature), with mortality rates being 174% higher among women and 199% higher among men.

Conclusions: Across the past 4 decades, low socioeconomic development was associated with no improvement in IHD mortality rates for men or women, in contrast to the large reductions observed in settings with high socioeconomic development. In contemporary settings, socioeconomic deprivation is associated with larger relative excess mortality in women and larger absolute excess mortality in men.

Background: One-time atrial fibrillation (AF) screening trials in older adults have produced mixed results. In a secondary analysis of the VITAL-AF trial, we aimed to identify a subset of people in whom such screening is effective, using effect-based and risk-based approaches.

Methods: The VITAL-AF trial was a cluster-randomized trial of 1-time, 30-second single-lead ECG screening during primary care visits. It enrolled adults aged ≥65 years in 16 Massachusetts General Hospital primary care practices (2018-2019). In this secondary analysis, we tested 2 approaches to identify subgroups where screening is effective. First, we developed an effect-based model using T-learner, a causal inference approach that estimates screening effects by separately training 2 predictive models-one for screening and one for usual care-and then compares their predictions for each individual. Second, we used a validated AF risk model (Cohorts for Heart and Aging Research in Genomic Epidemiology AF) to test for heterogeneous screening effectiveness. We assessed AF screening effectiveness by quartile of predicted effect and predicted AF risk and determined their correlation.

Results: The study included 29 656 participants (mean±SD age 74±7 years, 59% women). In the highest quartile of predicted screening effect, AF diagnosis rates were higher in the screening versus the usual care group (4.00 versus 2.88 per 100 person-years, rate difference 1.12 [95% CI, 0.11-2.13] per 100 person-years). In the highest quartile of predicted AF risk, AF diagnosis rates were also higher in the screening versus the usual care group (5.55 versus 4.23 per 100 person-years, rate difference 1.32 [95% CI, 0.14-2.50] per 100 person-years). Predicted screening effect and predicted AF risk were weakly correlated (Spearman correlation coefficient, 0.23).

Conclusions: One-time screening was associated with increased AF diagnoses in the top quartile of both predicted screening effect and predicted AF risk. Because predicted effect and risk were only weakly correlated, future AF screening efforts should include both high-effect and high-risk individuals.