A scoping review of direct oral anticoagulant ambulatory management practices.

Models of care for managing direct oral anticoagulant (DOAC) therapy are evolving. Little is known of what services are provided by anticoagulation managements services (AMS) for DOACs, or what necessitates comprehensive DOAC management and what differentiates it from usual care. The purpose of this scoping review was to describe services, management, or monitoring of DOACs distinct from prescriber-managed or usual care of DOACs. This scoping review reported followed the 2018 Preferred Reporting Items for Systematic Review and Meta-Analyses extension for scoping reviews (PRISMA-ScR). We searched PubMed, CINAHL, and EMBASE from inception to November 2020 to identify articles of interest. No language restriction was applied. Articles were included if they provided a description of DOAC management services, and described longitudinal anticoagulation follow-up that occurred in ambulatory care, community, or outpatient-related settings. Data was extracted from a total of 23 articles. The specific types of DOAC management interventions provided varied across the included studies. Nearly all studies described some form of DOAC therapy appropriateness assessment. Other common interventions included assessments of DOAC therapy compliance, adverse event triage and management, assessment of DOAC dosing appropriateness, periprocedural management of DOAC therapy, educational interventions, and renal function monitoring. A variety of DOAC management interventions were identified, but additional studies are needed to help health systems decide whether specific interventions performed by dedicated services are preferred over the usual care provided by clinicians prescribing DOAC therapy.

Factors associated with antihypertensive monotherapy among US adults with treated hypertension and uncontrolled blood pressure overall and by race/ethnicity, National Health and Nutrition Examination Survey 2013-2018.

BACKGROUND: Treating hypertension with antihypertensive medications combinations, rather than one medication (ie, monotherapy), is underused in the United States, particularly in certain race/ethnic groups. Identifying factors associated with monotherapy use despite uncontrolled blood pressure (BP) overall and within race/ethnic groups may elucidate intervention targets in under-treated populations. METHODS: Cross-sectional analysis of National Health and Nutrition Examination Surveys (NHANES; 2013-2014 through 2017-2018). We included participants age ≥20 years with hypertension, taking at least one antihypertensive medication, and uncontrolled BP (systolic BP [SBP] ≥ 140 mmHg or diastolic BP [DBP] ≥ 90 mmHg). Demographic, clinical, and healthcare-access factors associated with antihypertensive monotherapy were determined using multivariable-adjusted Poisson regression. RESULTS: Among 1,597 participants with hypertension and uncontrolled BP, age- and sex- adjusted prevalence of monotherapy was 42.6% overall, 45.4% among non-Hispanic White, 31.9% among non-Hispanic Black, 39.6% among Hispanic, and 50.9% among non-Hispanic Asian adults. Overall, higher SBP was associated with higher monotherapy use, while older age, having a healthcare visit in the previous year, higher body mass index, and having heart failure were associated with lower monotherapy use. CONCLUSION: Clinical and healthcare-access factors, including a healthcare visit within the previous year and co-morbid conditions were associated with a higher likelihood of combination antihypertensive therapy.

Cost-Effectiveness of Intensive versus Standard Blood-Pressure Control.

BACKGROUND: In the Systolic Blood Pressure Intervention Trial (SPRINT), adults at high risk for cardiovascular disease who received intensive systolic blood-pressure control (target, <120 mm Hg) had significantly lower rates of death and cardiovascular disease events than did those who received standard control (target, <140 mm Hg). On the basis of these data, we wanted to determine the lifetime health benefits and health care costs associated with intensive control versus standard control. METHODS: We used a microsimulation model to apply SPRINT treatment effects and health care costs from national sources to a hypothetical cohort of SPRINT-eligible adults. The model projected lifetime costs of treatment and monitoring in patients with hypertension, cardiovascular disease events and subsequent treatment costs, treatment-related risks of serious adverse events and subsequent costs, and quality-adjusted life-years (QALYs) for intensive control versus standard control of systolic blood pressure. RESULTS: We determined that the mean number of QALYs would be 0.27 higher among patients who received intensive control than among those who received standard control and would cost approximately $47,000 more per QALY gained if there were a reduction in adherence and treatment effects after 5 years; the cost would be approximately $28,000 more per QALY gained if the treatment effects persisted for the remaining lifetime of the patient. Most simulation results indicated that intensive treatment would be cost-effective (51 to 79% below the willingness-to-pay threshold of $50,000 per QALY and 76 to 93% below the threshold of $100,000 per QALY), regardless of whether treatment effects were reduced after 5 years or persisted for the remaining lifetime. CONCLUSIONS: In this simulation study, intensive systolic blood-pressure control prevented cardiovascular disease events and prolonged life and did so at levels below common willingness-to-pay thresholds per QALY, regardless of whether benefits were reduced after 5 years or persisted for the patient's remaining lifetime. (Funded by the National Heart, Lung, and Blood Institute and others; SPRINT ClinicalTrials.gov number, NCT01206062 .).

Fixed-Dose Combination Medications for Treating Hypertension: A Review of Effectiveness, Safety, and Challenges.

PURPOSE OF REVIEW: To summarize the recent evidence on the effectiveness and safety of antihypertensive fixed-dose combination (FDC) medications, and to describe the facilitators and barriers to implementing FDCs in US clinical practice. RECENT FINDINGS: Recent clinical practice guidelines include FDC use for treating high BP. Clinical trials in recent years support the use of antihypertensive FDCs including low-dose triple- and quadruple-therapy FDCs. Initiating a low-to-standard dose dual-therapy FDCs showed better BP control than initiating treatment with a standard-dose monotherapy, and triple-therapy FDCs produced better BP control rates than dual-therapy FDCs. Retrospective cohort studies showed that FDCs are associated with increased medication adherence, reduced clinical inertia, decreased time to BP control, and improved cardiovascular outcomes. We further discussed barriers and facilitators of wider implementation of antihypertensive FDCs in clinical practice. FDC treatment for hypertension is not commonly used despite historical and recent data which support the effectiveness, safety, and benefits of FDCs. Simplified and protocolized treatment algorithms, team-based care, shared decision-making principles are crucial to successful utilization and implementation of FDC in clinical practice.

Diagnostic Accuracy and Time-Saving Effects of Point-of-Care Ultrasonography in Patients With Small Bowel Obstruction: A Prospective Study.

STUDY OBJECTIVE: We evaluate the accuracy of point-of-care ultrasonography compared with computed tomographic (CT) scan and assess the potential time-saving effect of point-of-care ultrasonography in diagnosing small bowel obstruction. METHODS: This was a prospective observational study of a convenience sample of patients with suspected small bowel obstruction in an academic emergency department (ED). Physician sonographers were blinded to clinical data, laboratory results, and CT scan findings. Point-of-care ultrasonographic findings of small bowel obstruction was the primary outcome, defined as bowel-loop diameter greater than or equal to 25 mm with abnormal peristalsis. Maximum bowel dilatation, visible peristalsis, interluminal free fluid, and bowel wall thickness were evaluated. Time to completion of imaging results was abstracted from the medical records for each imaging modality. RESULTS: The study included 125 patients (median age 54.0 years [interquartile range 43 to 63 years]; 46% men), of whom 32 (25.6%) had small bowel obstruction, and 9 (7.2%) underwent surgery for it. Overall, the sensitivity of point-of-care ultrasonography for small bowel obstruction was 87.5% (95% confidence interval 71.0% to 96.5%), and specificity was 75.3% (95% confidence interval 65.2% to 83.6%). The area under the receiver operating characteristic curve to accurately predict small bowel obstruction was 0.74 (95% confidence interval 0.66 to 0.82). Results were similar across evaluated subgroups, including physician training level. The average time to obtain a CT scan report was 3 hours, 42 minutes; obtaining an abdominal radiograph took 1 hour, 38 minutes; and the mean elapsed time to complete point-of-care ultrasonography was 11 minutes. CONCLUSION: In ED patients with suspected small bowel obstruction, point-of-care ultrasonography has a reasonably high accuracy in diagnosing small bowel obstruction compared with CT scan, and may substantially decrease the time to diagnosis.

The role of clinical pharmacy anticoagulation services in direct oral anticoagulant monitoring.

The role of dedicated anticoagulation management services (AMS) for patients receiving direct oral anticoagulant (DOAC) therapy is unclear. The objective of our study was to describe DOAC management in patients who were and were not managed by an AMS. We conducted a retrospective cohort study among patients with atrial fibrillation at the University of Utah Health (UUH) who received DOAC therapy between January 2013 and June 2016. Patients in the AMS group were managed by a pharmacist-led AMS whereas those in the non-AMS group were managed by other providers. The number and type of provider encounters and interventions related to DOAC therapy and a composite endpoint of thromboembolism, bleeding, and all-cause mortality were recorded. Overall, 90 and 370 patients were managed in the AMS and non-AMS groups, respectively. AMS group patients had greater chronic disease burden as measured by the Charlson comorbidity index. AMS group patients had more frequent DOAC-related encounters than non-AMS group patients but both groups had similar DOAC therapy intervention rates. Over half of patients in the AMS group received potentially duplicative interventions from their regular clinicians. The composite endpoint occurred in 18.9% and 13.5% of AMS and non-AMS group patients, respectively (p = 0.29). Patients managed by AMS providers were more complex and had more frequent encounters regarding their DOAC therapy than those managed by non-AMS providers. However, there was evidence of duplicative DOAC therapy management efforts. No difference between AMS and non-AMS groups in the composite clinical endpoint was detected.

Development of a nomogram to predict small bowel obstruction using point-of-care ultrasound in the emergency department.

OBJECTIVE: Early diagnostic prediction in patients with small bowel obstruction (SBO) can improve time to definitive management and disposition in the emergency department. We sought to develop a nomogram to leverage point-of-care ultrasound (POCUS) and maximize accuracy of prediction of SBO diagnosis. METHODS: Using data from a prospective cohort of 125 patients with suspected SBO who were evaluated with POCUS in the ED, we developed a nomogram integrating age, gender, comorbidities, prior abdominal surgery, physician's pre-test probability, and POCUS findings to determine post-test risk of SBO. The primary outcome was to develop a nomogram to allow calculating output probabilities for predictive models using POCUS findings. The discriminative ability of the nomogram was tested using a C-statistics, calibration plots, and receiver operating characteristic curves. RESULTS: The derivation cohort included 125 patients with a median age of 54 years who underwent POCUS for a suspected SBO. One-fourth of the patients (25.6% [32/125]) had SBO. Using a retrospective stepwise selection of clinically important variables with the POCUS results, the final nomogram incorporated four relevant factors for the prediction of SBO: small bowel diameter (odds ratio [OR] per 1 mm increase, 1.10; 95% CI, 1.03-1.17; P = 0.001), positive free intraperitoneal fluid between bowel loops (OR, 8.19; 95% CI, 2.62-25.62; P < 0.001), clinician's moderate (OR, 5.94; 95% CI, 0.83-42.57; P = 0.08) or high pretest probability (OR, 11.26; 95% CI, 1.44-88.25; P = 0.02), and patient age (OR per 1 year increase, 1.03; 95% CI, 1.00 to1.07; P = 0.08).The discriminative ability and calibration of the nomogram revealed good predictive ability as indicated by the C-statistic of 0.89 for the SBO diagnosis. CONCLUSION: A unique nomogram incorporating patient age, physician pretest probability of SBO, and POCUS measurements of small bowel diameter and the presence of free intraperitoneal fluid between bowel loops was developed to accurately predict the diagnosis of SBO in the emergency department. The nomogram should be externally validated in a novel cohort of patients at risk for SBO to better assess predictability and generalizability.

Cost-Effectiveness and Challenges of Implementing Intensive Blood Pressure Goals and Team-Based Care.

PURPOSE OF REVIEW: Review the effectiveness, cost-effectiveness, and implementation challenges of intensive blood pressure (BP) control and team-based care initiatives. RECENT FINDINGS: Intensive BP control is an effective and cost-effective intervention; yet, implementation in routine clinical practice is challenging. Several models of team-based care for hypertension management have been shown to be more effective than usual care to control BP. Additional research is needed to determine the cost-effectiveness of team-based care models relative to one another and as they relate to implementing intensive BP goals. As a focus of healthcare shifts to value (i.e., cost, effectiveness, and patient preferences), formal cost-effectiveness analyses will inform which team-based initiatives hold the highest value in different healthcare settings with different populations and needs. Several challenges, including clinical inertia, financial investment, and billing restrictions for pharmacist-delivered services, will need to be addressed in order to improve public health through intensive BP control and team-based care.

Durable lesion formation while avoiding esophageal injury during ablation of atrial fibrillation: Lessons learned from late gadolinium MR imaging.

INTRODUCTION: Adequate catheter/atrial tissue contact is critical for lesion formation during radiofrequency (RF) ablation of atrial fibrillation (AF). Late gadolinium enhancement magnetic resonance imaging (LGE-MRI) is a unique tool for the evaluation of lesion formation and detection of acute esophageal injury. METHODS: LGE-MRIs were obtained prior, within 24 hours of, and at 115 ± 62 days after first AF ablation in 36 patients. The Visitag module of CARTO3 was used to collect contact force (CF) and duration from a CF sensing ablation catheter for each registered ablation point. The minimum CF resulting in permanent lesions was determined. Esophageal enhancement detected by acute LGE-MRI was classified as mild, moderate, and severe. The CF resulting in esophageal enhancement was determined. RESULTS: A total of 4,642 registered ablation tags at 50 W power were analyzed. The mean RF duration (5.9 ± 3.7 vs. 5.6 ± 3.2 seconds, P < 0.05), CF (11.5 ± 5.6 vs. 10.9 ± 5.4 g, P < 0.001), and force time integral (FTI) (67.3 ± 54.5 vs. 62.2 ± 52.7 gs, P < 0.01) were significantly higher between ablation tags with and without associated LGE-MRI detected scar. The mean CF (15.7 ± 6.1 vs. 12.6 ± 5.9 g, P < 0.05, n  =  17 patients) in areas of esophageal enhancement was greater than areas without. CONCLUSION: Left atrial short duration ablation lesions with a CF greater than 12 g are more likely to be associated with permanent lesion formation. Ablating on top of the esophagus, CF less than 15 g would help minimize esophageal wall injury.

Glucagon-like peptide-1 receptor agonist and sodium-glucose cotransporter 2 inhibitor use among adults with diabetes mellitus by cardiovascular-kidney disease risk: National Health and Nutrition Examination Surveys, 2015-2020.

Objective: Glucagon-like peptide-1 receptor agonists (GLP1-RAs) and sodium-glucose cotransporter 2 inhibitors (SGLT2Is) lower adverse cardiac and kidney events among high-risk patients with diabetes mellitus (DM) and are now guideline-recommended as first-line therapy alongside metformin. However, the adoption of these new treatments from 2015 to 2020 among the highest-risk adults with DM remains unclear. Methods: We performed a cross-sectional analysis of the National Health and Nutrition Examination Surveys (NHANES) 2015-2020 to estimate the use of GLP1-RAs and SGLT2Is among adults with DM overall and by level of cardiovascular and kidney risk (CKR). We defined high CKR by history of atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), heart failure, or age ≥55 years with at least 2 ASCVD risk factors (i.e., obesity, hypertension, hyperlipidemia, or current smoker). Results: Overall, 2,432 participants with DM (mean age 60.6 years, 46.8 % female, 58.8 % Non-Hispanic White) were included, of which 1,869 and 563 were with and without high CKR, respectively. Participants with vs. without high CKR were more likely to be older, have higher systolic blood pressure, lower estimated glomerular filtration rate, use oral antidiabetic agents, and have health insurance. Overall, the weighted prevalence of GLP1-RA or SGLT2I was 9.0 % (95 % confidence interval [CI] 6.9-11.0): 4.8 % (95 % CI 3.6-6.1) took GLP1-RAs, and 5.1 % (95 % CI 3.3-7.0) took SGLT2Is. Use of GLP1-RAs or SGLT2Is did not differ between participants with vs. without high CKR (adjusted prevalence ratio [aPR] 1.00; 95 % CI 0.98-1.02). Participants with ASCVD were more likely to be on a GLP1-RA or SGLT2I (aPR 1.28; 95 % CI 1.25-1.31), while adults with CKD were less likely (aPR 0.84; 95 % CI 0.82-0.86). Conclusion: Among US adults with DM, GLP1-RA and SGLT2I use was low regardless of CKR. Data since 2020 analyzing the utilization of GLP1-RAs and SGLT2Is among high-CKR patients with DM is needed to identify implementation strategies for increased utilization.

Association Between Self-Reported Medication Adherence and Therapeutic Inertia in Hypertension: A Secondary Analysis of SPRINT (Systolic Blood Pressure Intervention Trial).

BACKGROUND: Therapeutic inertia (TI), failure to intensify antihypertensive medication when blood pressure (BP) is above goal, remains prevalent in hypertension management. The degree to which self-reported antihypertensive adherence is associated with TI with intensive BP goals remains unclear. METHODS AND RESULTS: Cross-sectional analysis was performed of the 12-month visit of participants in the intensive arm of SPRINT (Systolic Blood Pressure Intervention Trial), which randomized adults to intensive (<120 mm Hg) versus standard (<140 mm Hg) systolic BP goals. TI was defined as no increase in antihypertensive regimen intensity score, which incorporates medication number and dose, when systolic BP is ≥120 mm Hg. Self-reported adherence was assessed using the 8-Item Morisky Medication Adherence Scale (MMAS-8) and categorized as low (MMAS-8 score <6), medium (MMAS-8 score 6 to <8), and high (MMAS-8 score 8). Poisson regressions estimated prevalence ratios (PRs) and 95% CIs for TI associated with MMAS-8. Among 1009 intensive arm participants with systolic BP >120 mm Hg at the 12-month visit (mean age, 69.6 years; 35.2% female, 28.8% non-Hispanic Black), TI occurred in 50.8% of participants. Participants with low adherence (versus high) were younger and more likely to be non-Hispanic Black or smokers. The prevalence of TI among patients with low, medium, and high adherence was 45.0%, 53.5%, and 50.4%, respectively. After adjustment, neither low nor medium adherence (versus high) were associated with TI (PR, 1.11 [95% CI, 0.87-1.42]; PR, 1.08 [95% CI, 0.84-1.38], respectively). CONCLUSIONS: Although clinician uncertainty about adherence is often cited as a reason for why antihypertensive intensification is withheld when above BP goals, we observed no evidence of an association between self-reported adherence and TI.

Effectiveness of Hypertension Management Strategies in SPRINT-Eligible US Adults: A Simulation Study.

BACKGROUND: Despite reducing cardiovascular disease (CVD) events and death in SPRINT (Systolic Blood Pressure Intervention Trial), intensive systolic blood pressure goals have not been adopted in the United States. This study aimed to simulate the potential long-term impact of 4 hypertension management strategies in SPRINT-eligible US adults. METHODS AND RESULTS: The validated Blood Pressure Control-Cardiovascular Disease Policy Model, a discrete event simulation of hypertension care processes (ie, visit frequency, blood pressure [BP] measurement accuracy, medication intensification, and medication adherence) and CVD outcomes, was populated with 25 000 SPRINT-eligible US adults. Four hypertension management strategies were simulated: (1) usual care targeting BP <140/90 mm Hg (Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure usual care), (2) intensive care per the SPRINT protocol targeting BP <120/90 mm Hg (SPRINT intensive), (3) usual care targeting guideline-recommended BP <130/80 mm Hg (American College of Cardiology/American Heart Association usual care), and (4) team-based care added to usual care and targeting BP <130/80 mm Hg. Relative to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure usual care, among the 18.1 million SPRINT-eligible US adults, an estimated 138 100 total CVD events could be prevented per year with SPRINT intensive, 33 900 with American College of Cardiology/American Heart Association usual care, and 89 100 with team-based care. Compared with the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure usual care, SPRINT intensive care was projected to increase treatment-related serious adverse events by 77 600 per year, American College of Cardiology/American Heart Association usual care by 33 300, and team-based care by 27 200. CONCLUSIONS: As BP control has declined in recent years, health systems must prioritize hypertension management and invest in effective strategies. Adding team-based care to usual care may be a pragmatic way to manage risk in this high-CVD-risk population.

Single-Pill Combination Product Availability of the Antihypertensive Regimens Used for Intensive Systolic Blood Pressure Treatment in the Systolic Blood Pressure Intervention Trial.

BACKGROUND: Single-pill combination (SPC) antihypertensive products improve blood pressure control and medication adherence among patients with hypertension. It is unknown to what degree commercially available SPC products could be used to target an intensive systolic blood pressure goal of <120 mm Hg. METHODS: This cross-sectional analysis included participants randomized to the intensive treatment arm (goal systolic blood pressure <120 mm Hg) of the Systolic Blood Pressure Intervention Trial (SPRINT) using ≥2 antihypertensive medication classes at the 12-month postrandomization visit. Antihypertensive medication data were collected using pill bottle review by research coordinators, and regimens were categorized by the unique combinations of antihypertensive classes. We calculated the proportion of regimens used, which are commercially available as one of the 7 SPC class combinations in the United States as of January 2023. RESULTS: Among the 3833 SPRINT intensive arm participants included (median age, 67.0 years; 35.5% female), participants were using 219 unique antihypertensive regimens. The 7 regimens for which there are class-equivalent SPC products were used by 40.3% of participants. Only 3.2% of all medication class regimens used are available as a class-equivalent SPC product (7/219). There are no SPC products available with 4 or more medication classes, which were used by 1060 participants (27.7%). CONCLUSIONS: Most SPRINT participants in the intensive arm used an antihypertensive medication regimen, which is not commercially available as a class equivalent SPC product. To achieve the SPRINT results in real-world settings, maximize the potential benefit of SPCs, and reduce pill burden, improvements in the product landscape are needed. REGISTRATION: URL: https://www. CLINICALTRIALS: gov/ct2/show/NCT01206062; Unique identifier: NCT01206062.

New Users of Angiotensin II Receptor Blocker-Versus Angiotensin-Converting Enzyme Inhibitor-Based Antihypertensive Medication Regimens and Cardiovascular Disease Events: A Secondary Analysis of ACCORD-BP and SPRINT.

BACKGROUND Angiotensin II receptor blockers (ARBs) and angiotensin-converting enzyme inhibitors (ACEIs) block distinct components of the renin-angiotensin system. Whether this translates into differential effects on cardiovascular disease events remains unclear. METHODS AND RESULTS We used the ACCORD-BP (Action to Control Cardiovascular Risk in Diabetes-Blood Pressure) trial and the SPRINT (Systolic Blood Pressure Intervention Trial) to emulate target trials of new users of ARBs versus ACEIs on cardiovascular disease events (primary outcome) and death (secondary outcome). We estimated marginal cause-specific hazard ratios (HRs) and treatment-specific cumulative incidence functions with inverse probability of treatment weights. We identified 3298 new users of ARBs or ACEIs (ACCORD-BP: 374 ARB versus 884 ACEI; SPRINT: 727 ARB versus 1313 ACEI). For participants initiating ARBs versus ACEIs, the inverse probability of treatment weight rate of the primary outcome was 3.2 versus 3.5 per 100 person-years in ACCORD-BP (HR, 0.91 [95% CI, 0.63-1.31]) and 1.8 versus 2.2 per 100 person-years in SPRINT (HR, 0.81 [95% CI, 0.56-1.18]). There were no appreciable differences in pooled analyses, except that ARBs versus ACEIs were associated with a lower death rate (HR, 0.56 [95% CI, 0.37-0.85]). ARBs were associated with a lower rate of the primary outcome among subgroups of male versus female participants, non-Hispanic Black versus non-Hispanic White participants, and those randomly assigned to standard versus intensive blood pressure (Pinteraction: <0.01, 0.05, and <0.01, respectively). CONCLUSIONS In this secondary analysis of ACCORD-BP and SPRINT, new users of ARB- versus ACEI-based antihypertensive medication regimens experienced similar cardiovascular disease events rates, with important subgroup differences and lower rates of death overall. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01206062, NCT00000620.

Antihypertensive Medication Regimens Used by US Adults With Hypertension and the Potential for Fixed-Dose Combination Products: The National Health and Nutrition Examination Surveys 2015 to 2020.

Background Fixed-dose combination (FDC) antihypertensive products improve blood pressure control and adherence among patients with hypertension. It is unknown to what degree commercially available FDC products meet the current hypertension management prescription patterns in the United States. Methods and Results This cross-sectional analysis of the National Health and Nutrition Examination Surveys 2015 to March 2020 included participants with hypertension taking ≥2 antihypertensive medications (N=2451). After constructing each participant's regimen according to antihypertensive classes used, we estimated the extent to which the 7 class-level FDC regimens available in the United States as of January 2023 would match the regimens used. Among a weighted population of 34.1 million US adults (mean age, 66.0 years; 52.8% women; 69.1% non-Hispanic White race and ethnicity), the proportions using 2, 3, 4, and ≥5 antihypertensive classes were 60.6%, 28.2%, 9.1%, and 1.6%, respectively. The 7 FDC regimens were among 189 total regimens used (3.7%), and 39.2% of the population used one of the FDC regimens (95% CI, 35.5%-43.0%; 13.4 million US adults); 60.8% of the population (95% CI, 57.0%-64.5%; 20.7 million US adults) were using a regimen not available as a class-equivalent FDC product. Conclusions Three in 5 US adults with hypertension taking ≥2 antihypertensive classes are using a regimen that is not commercially available as a class-equivalent FDC product as of January 2023. To maximize the potential benefit of FDCs to improve medication adherence (and thus blood pressure control) among patients taking multiple antihypertensive medications, use of FDC-compatible regimens and improvements in the product landscape are needed.

Prevalence of Statin Use for Primary Prevention of Atherosclerotic Cardiovascular Disease by Race, Ethnicity, and 10-Year Disease Risk in the US: National Health and Nutrition Examination Surveys, 2013 to March 2020.

Importance: The burden of atherosclerotic cardiovascular disease (ASCVD) in the US is higher among Black and Hispanic vs White adults. Inclusion of race in guidance for statin indication may lead to decreased disparities in statin use. Objective: To evaluate prevalence of primary prevention statin use by race and ethnicity according to 10-year ASCVD risk. Design, Setting, and Participants: This serial, cross-sectional analysis performed in May 2022 used data from the National Health and Nutrition Examination Survey, a nationally representative sample of health status in the US, from 2013 to March 2020 (limited cycle due to the COVID-19 pandemic), to evaluate statin use for primary prevention of ASCVD and to estimate 10-year ASCVD risk. Participants aged 40 to 75 years without ASCVD, diabetes, low-density lipoprotein cholesterol levels 190 mg/dL or greater, and with data on medication use were included. Exposures: Self-identified race and ethnicity (Asian, Black, Hispanic, and White) and 10-year ASCVD risk category (5%-<7.5%, 7.5%-<20%, ≥20%). Main Outcomes and Measures: Prevalence of statin use, defined as identification of statin use on pill bottle review. Results: A total of 3417 participants representing 39.4 million US adults after applying sampling weights (mean [SD] age, 61.8 [8.0] years; 1289 women [weighted percentage, 37.8%] and 2128 men [weighted percentage, 62.2%]; 329 Asian [weighted percentage, 4.2%], 1032 Black [weighted percentage, 12.7%], 786 Hispanic [weighted percentage, 10.1%], and 1270 White [weighted percentage, 73.0%]) were included. Compared with White participants, statin use was lower in Black and Hispanic participants and comparable among Asian participants in the overall cohort (Asian, 25.5%; Black, 20.0%; Hispanic, 15.4%; White, 27.9%) and within ASCVD risk strata. Within each race and ethnicity group, a graded increase in statin use was observed across increasing ASCVD risk strata. Statin use was low in the highest risk stratum overall with significantly lower rates of use among Black (23.8%; prevalence ratio [PR], 0.90; 95% CI, 0.82-0.98 vs White) and Hispanic participants (23.9%; PR, 0.90; 95% CI, 0.81-0.99 vs White). Among other factors, routine health care access and health insurance were significantly associated with higher statin use in Black, Hispanic, and White adults. Prevalence of statin use did not meaningfully change over time by race and ethnicity or by ASCVD risk stratum. Conclusions and Relevance: In this study, statin use for primary prevention of ASCVD was low among all race and ethnicity groups regardless of ASCVD risk, with the lowest use occurring among Black and Hispanic adults. Improvements in access to care may promote equitable use of primary prevention statins in Black and Hispanic adults.

Association of Direct Oral Anticoagulation Management Strategies With Clinical Outcomes for Adults With Atrial Fibrillation.

Importance: Anticoagulation management services (AMSs; ie, warfarin clinics) have evolved to include patients treated with direct oral anticoagulants (DOACs), but it is unknown whether DOAC therapy management services improve outcomes for patients with atrial fibrillation (AF). Objective: To compare outcomes associated with 3 DOAC care models for preventing adverse anticoagulation-related outcomes among patients with AF. Design, Setting, and Participants: This retrospective cohort study included 44 746 adult patients with a diagnosis of AF who initiated oral anticoagulation (DOAC or warfarin) between August 1, 2016, and December 31, 2019, in 3 Kaiser Permanente (KP) regions. Statistical analysis was conducted from August 2021 through May 2023. Exposures: Each KP region used an AMS to manage warfarin but used distinct approaches to DOAC care: (1) usual care (UC) by the prescribing clinician, (2) UC plus an automated population management tool (PMT), or (3) pharmacist-managed AMS care. Propensity scores and inverse probability of treatment weights (IPTWs) were estimated. Direct oral anticoagulant care models were first indirectly compared using warfarin as a common comparator within each region and then directly compared across regions. Main Outcomes and Measures: Patients were followed up until the first occurrence of an outcome (composite of thromboembolic stroke, intracranial hemorrhage, other major bleeding, or death), discontinuation of KP membership, or December 31, 2020. Results: Overall, 44 746 patients were included: 6182 in the UC care model (3297 DOAC; 2885 warfarin), 33 625 in the UC plus PMT care model (21 891 DOAC; 11 734 warfarin), and 4939 in the AMS care model (2089 DOAC; 2850 warfarin). Baseline characteristics (mean [SD] age, 73.1 [10.6] years, 56.1% male, 67.2% non-Hispanic White, median CHA2DS2-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes, stroke, vascular disease, age 65-74 years, female sex] score of 3 [IQR, 2-5]) were well balanced after IPTW. Over a median follow-up of 2 years, patients who received the UC plus PMT or AMS care model did not have significantly better outcomes than those who received UC. The incidence rate of the composite outcome was 5.4% per year for DOAC and 9.1% per year for warfarin for those in the UC group, 6.1% per year for DOAC and 10.5% per year for those in the UC plus PMT group, and 5.1% per year for DOAC and 8.0% per year for those in the AMS group. The IPTW-adjusted hazard ratios (HRs) for the composite outcome comparing DOAC vs warfarin were 0.91 (95% CI, 0.79-1.05) in the UC group, 0.85 (95% CI, 0.79-0.90) in the UC plus PMT group, and 0.84 (95% CI, 0.72-0.99) in the AMS group (P = .62 for heterogeneity across care models). When directly comparing patients receiving DOAC, the IPTW-adjusted HR was 1.06 (95% CI, 0.85-1.34) for the UC plus PMT group vs the UC group and 0.85 (95% CI, 0.71-1.02) for the AMS group vs the UC group. Conclusions and Relevance: This cohort study did not find appreciably better outcomes for patients receiving DOAC who were managed by either a UC plus PMT or AMS care model compared with UC.

Antihypertensive Medication Regimens Used in the Systolic Blood Pressure Intervention Trial.

BACKGROUND: Describing the antihypertensive medication regimens used in the SPRINT (Systolic Blood Pressure Intervention Trial) would contextualize the standard and intensive systolic blood pressure (SBP) interventions and may inform future implementation efforts to achieve population-wide intensive SBP goals. METHODS: We included SPRINT participants with complete medication data at the prerandomization and 12-month visits. Regimens were categorized by antihypertensive medication class. Analyses were stratified by treatment group (standard goal SBP <140 mm Hg versus intensive goal SBP <120 mm Hg). RESULTS: Among 7860 participants (83.7% of 9361 randomized), the median number of classes used at the prerandomization visit was 2.0 and 2.0 in the standard and intensive groups (P=0.559). At 12-months, the median number of classes used was 3.0 and 2.0 in the intensive and standard groups (P<0.001). Prerandomization, angiotensin-converting enzyme inhibitor (ACE), or angiotensin-II receptor blocker (ARB) monotherapy was the most common regimen in the intensive and standard groups (12.6% versus 12.2%). At 12-months, ACE/ARB monotherapy was still the most common regimen among standard group participants (14.7%) and was used by 5.3% of intensive group participants. Multidrug regimens used by the intensive and standard participants at 12 months were as follows: an ACE/ARB with thiazide (12.2% and 7.9%); an ACE/ARB with calcium channel blocker (6.2% and 6.8%); an ACE/ARB, thiazide, and calcium channel blocker (11.4% and 4.3%); and an ACE/ARB, thiazide, calcium channel blocker, and beta-blocker (6.5% and 1.2%). CONCLUSIONS: SPRINT investigators favored combining ACEs or ARBs, thiazide diuretics, and calcium channel blockers to target SBP <120 mm Hg, compared to ACE/ARB monotherapy to target SBP <140 mm Hg. REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT01206062.

Identifying Patients for Intensive Blood Pressure Treatment Based on Cognitive Benefit: A Secondary Analysis of the SPRINT Randomized Clinical Trial.

Importance: Intensive vs standard treatment to lower systolic blood pressure (SBP) reduces risk of mild cognitive impairment (MCI) or dementia; however, the magnitude of cognitive benefit likely varies among patients. Objective: To estimate the magnitude of cognitive benefit of intensive vs standard systolic BP (SBP) treatment. Design, Setting, and Participants: In this ad hoc secondary analysis of the Systolic Blood Pressure Intervention Trial (SPRINT), 9361 randomized clinical trial participants 50 years or older with high cardiovascular risk but without a history of diabetes, stroke, or dementia were followed up. The SPRINT trial was conducted between November 1, 2010, and August 31, 2016, and the present analysis was completed on October 31, 2022. Intervention: Systolic blood pressure treatment to an intensive (<120 mm Hg) vs standard (<140 mm Hg) target. Main Outcomes and Measures: The primary outcome was a composite of adjudicated probable dementia or amnestic MCI. Results: A total of 7918 SPRINT participants were included in the analysis; 3989 were in the intensive treatment group (mean [SD] age, 67.9 [9.2] years; 2570 [64.4%] men; 1212 [30.4%] non-Hispanic Black) and 3929 were in the standard treatment group (mean [SD] age, 67.9 [9.4] years; 2570 [65.4%] men; 1249 [31.8%] non-Hispanic Black). Over a median follow-up of 4.13 (IQR, 3.50-5.88) years, there were 765 and 828 primary outcome events in the intensive treatment group and standard treatment group, respectively. Older age (hazard ratio [HR] per 1 SD, 1.87 [95% CI, 1.78-1.96]), Medicare enrollment (HR per 1 SD, 1.42 [95% CI, 1.35-1.49]), and higher baseline serum creatinine level (HR per 1 SD, 1.24 [95% CI, 1.19-1.29]) were associated with higher risk of the primary outcome, while better baseline cognitive functioning (HR per 1 SD, 0.43 [95% CI, 0.41-0.44]) and active employment status (HR per 1 SD, 0.44 [95% CI, 0.42-0.46]) were associated with lower risk of the primary outcome. Risk of the primary outcome by treatment goal was estimated accurately based on similar projected and observed absolute risk differences (C statistic = 0.79). Higher baseline risk for the primary outcome was associated with greater benefit (ie, larger absolute reduction of probable dementia or amnestic MCI) of intensive vs standard treatment across the full range of estimated baseline risk. Conclusions and Relevance: In this secondary analysis of the SPRINT trial, participants with higher baseline projected risk of probable dementia or amnestic MCI gained greater absolute cognitive benefit from intensive vs standard SBP treatment in a monotonic fashion. Trial Registration: ClinicalTrials.gov Identifier: NCT01206062.

Cost-Effectiveness of Masked Hypertension Screening and Treatment in US Adults With Suspected Masked Hypertension: A Simulation Study.

BACKGROUND: Recent US blood pressure (BP) guidelines recommend using ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM) to screen adults for masked hypertension. However, limited evidence exists of the expected long-term effects of screening for and treating masked hypertension. METHODS: We estimated the lifetime health and economic outcomes of screening for and treating masked hypertension using the Cardiovascular Disease (CVD) Policy Model, a validated microsimulation model. We simulated a cohort of 100,000 US adults aged ≥20 years with suspected masked hypertension (i.e., office BP 120-129/<80 mm Hg, not taking antihypertensive medications, without CVD history). We compared usual care only (i.e., no screening), usual care plus ABPM, and usual care plus HBPM. We projected total direct healthcare costs (2021 USD), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. Future costs and QALYs were discounted 3% annually. Secondary outcomes included CVD events and serious adverse events. RESULTS: Relative to usual care, adding masked hypertension screening and treatment with ABPM and HBPM was projected to prevent 14.3 and 20.5 CVD events per 100,000 person-years, increase the proportion experiencing any treatment-related serious adverse events by 2.7 and 5.1 percentage points, and increase mean total costs by $1,076 and $1,046, respectively. Compared with usual care, adding ABPM was estimated to cost $85,164/QALY gained. HBPM resulted in lower QALYs than usual care due to increased treatment-related adverse events and pill-taking disutility. CONCLUSIONS: The results from our simulation study suggest screening with ABPM and treating masked hypertension is cost-effective in US adults with suspected masked hypertension.