Importance Bridging the low-density lipoprotein cholesterol (LDL-C) care gap in patients with established atherosclerotic cardiovascular disease (ASCVD) is challenging. Few quality improvement (QI) interventions have successfully improved patient care. Objective To evaluate the impact of a digitally enabled, multifaceted, QI intervention on the control of LDL-C concentration in patients with ASCVD. Design, Setting and Participants This was a pragmatic, 2-arm, cluster randomized clinical trial. A total of 28 clusters (public or private outpatient clinics) in Brazil were randomized to receive a digitally enabled QI intervention or routine practice (control). Adult patients (≥18 years) with established ASCVD were enrolled between November 2023 and December 2024 and followed up for 6 months. Intervention The intervention comprised a structured, digitally enabled QI strategy integrating previsit screening, electronic clinical decision support algorithms, audit and feedback mechanisms, and targeted clinician and patient engagement tools embedded within routine workflows to support lipid monitoring, treatment intensification, and adherence. Main Outcomes and Measures The primary outcome was mean LDL-C level at 6 months. Secondary outcomes included relative LDL-C change, achievement of LDL-C targets (<50 mg/dL and ≥50% reduction; to convert to millimoles per liter, multiply by 0.0259), and prescription of lipid-lowering therapies. All analyses were performed following the intention-to-treat principle and accounted for the cluster design by using a generalized estimating equations model. Results Among 1465 enrolled patients (mean [SD] age, 62.3 [10.1] years; 894 male [61.0%]; 714 intervention; 751 control), mean (SD) LDL-C concentration at 6 months was 76.3 (37.5) mg/dL in the intervention group and 85.6 (37.1) mg/dL in the control group. The adjusted mean difference was −6.62 mg/dL (95% CI, −11.11 to −2.13 mg/dL; P = .004). Patients in the intervention group were more likely to achieve an LDL-C concentration less than 50 mg/dL (23.5% vs 13.4%; odds ratio, 1.86; 95% CI, 1.30-2.65) and a 50% or greater reduction in LDL-C concentration (18.6% vs 13.4%; odds ratio, 1.76; 95% CI, 1.27-2.43). Prescription of intensive and combination lipid-lowering therapy was significantly higher in the intervention group. No significant differences in major cardiovascular events were observed. Conclusions and Relevance In this pragmatic cluster randomized clinical trial, a digitally enabled, multifaceted strategy produced modest LDL-C reduction and increased treatment intensification among patients with ASCVD. However, a proportion of patients had LDL-C levels that remained above recommended LDL-C targets, underscoring that the strategy tested was only partially effective in eliminating the residual care gap. Trial Registration ClinicalTrials.gov Identifier: NCT05622929
Importance:Home blood pressure monitoring (HBPM) is essential and universally recommended for hypertension management, but patterns of real-world patient engagement with HBPM have not been studied and remain largely unknown. Objective:To evaluate patient engagement with HBPM in a remote hypertension management program. Design, Setting, and Participants:This retrospective cohort study analyzing prospectively collected program data was conducted within a remote hypertension management program at a large academic health care system, Mass General Brigham, in Boston, Massachusetts. Data were collected from from September 2018 to June 2022. Adults with uncontrolled hypertension enrolled in the program were eligible for inclusion. Data analyses were conducted from February to April 2025. Interventions:Patients received free automated HBPM devices, education, and ongoing personalized support from health care navigators via telephone and messaging, with algorithm-guided medication titration. Main Outcomes and Measures:The primary outcome was engagement at baseline. Weekly HBPM frequency was categorized as no engagement (0 measurements), low engagement (1-11 measurements/week), intermediate engagement (12-23 measurements/week), and high engagement (24-28 measurements/week). Results:A total of 3390 patients were enrolled in the remote hypertension program; median (IQR) patient age was 61 (52-69) years, with 1958 (57.8%) female patients. Mean (SD) systolic BP at baseline was 143 (13) mm Hg, and most patients had comorbidities, including 1369 patients (40.4%) with atherosclerotic cardiovascular disease and 996 (29.4%) with diabetes. At baseline, 1107 patients (32.7%) had no engagement, 484 (14.3%) had low engagement, 618 (18.2%) had intermediate engagement, and 1181 (34.8%) had high engagement. Conclusions and Relevance:In this cohort study of a remote hypertension management program, patient engagement with HBPM was suboptimal despite free devices, education, and personalized support with a navigator. To support optimal HBPM, innovative methods of BP monitoring that are more convenient and less burdensome for patients may enhance engagement and improve hypertension management outcomes.
ABSTRACT Objective Remote interventions leveraging team‐based care may ameliorate persistent gaps in obesity medication implementation, but prospective studies are lacking. In this paper, the design, enrollment, and implementation of a remote intervention for obesity medications are described. Methods The Supplementary Anti‐Obesity Medication Integration into a Longitudinal Obesity (SAIL) study is a fully remote program with pharmacist‐ and navigator‐led obesity medication implementation. Individuals with body mass index (BMI)‐defined overweight or obesity receiving a digital lifestyle intervention were recruited for participation in SAIL via a survey. Effectiveness outcomes included obesity medication prescription and body weight change at 6 months. Focus groups were conducted with study staff after program completion to identify implementation barriers and solutions. Results Between June 2023 and September 2024, 200 patients responded to the survey, of which 99 were eligible. Of these, 75 enrolled in SAIL (mean age, 50 ± 12 years; 83% women; mean BMI 36 ± 6 kg/m 2 ). Focus groups identified multiple implementation challenges and opportunities, including medication access, insurance coverage, and patient education. Addressing misinformation, frequent patient engagement, and program flexibility emerged as unique strengths of SAIL. Conclusions The final results of SAIL will inform the effectiveness of remote, algorithm‐driven, navigator‐ and pharmacist‐led programs for obesity medication prescription and management.
Importance:Bridging the low-density lipoprotein cholesterol (LDL-C) care gap in patients with established atherosclerotic cardiovascular disease (ASCVD) is challenging. Few quality improvement (QI) interventions have successfully improved patient care. Objective:To evaluate the impact of a digitally enabled, multifaceted, QI intervention on the control of LDL-C concentration in patients with ASCVD. Design, Setting and Participants:This was a pragmatic, 2-arm, cluster randomized clinical trial. A total of 28 clusters (public or private outpatient clinics) in Brazil were randomized to receive a digitally enabled QI intervention or routine practice (control). Adult patients (≥18 years) with established ASCVD were enrolled between November 2023 and December 2024 and followed up for 6 months. Intervention:The intervention comprised a structured, digitally enabled QI strategy integrating previsit screening, electronic clinical decision support algorithms, audit and feedback mechanisms, and targeted clinician and patient engagement tools embedded within routine workflows to support lipid monitoring, treatment intensification, and adherence. Main Outcomes and Measures:The primary outcome was mean LDL-C level at 6 months. Secondary outcomes included relative LDL-C change, achievement of LDL-C targets (<50 mg/dL and ≥50% reduction; to convert to millimoles per liter, multiply by 0.0259), and prescription of lipid-lowering therapies. All analyses were performed following the intention-to-treat principle and accounted for the cluster design by using a generalized estimating equations model. Results:Among 1465 enrolled patients (mean [SD] age, 62.3 [10.1] years; 894 male [61.0%]; 714 intervention; 751 control), mean (SD) LDL-C concentration at 6 months was 76.3 (37.5) mg/dL in the intervention group and 85.6 (37.1) mg/dL in the control group. The adjusted mean difference was -6.62 mg/dL (95% CI, -11.11 to -2.13 mg/dL; P = .004). Patients in the intervention group were more likely to achieve an LDL-C concentration less than 50 mg/dL (23.5% vs 13.4%; odds ratio, 1.86; 95% CI, 1.30-2.65) and a 50% or greater reduction in LDL-C concentration (18.6% vs 13.4%; odds ratio, 1.76; 95% CI, 1.27-2.43). Prescription of intensive and combination lipid-lowering therapy was significantly higher in the intervention group. No significant differences in major cardiovascular events were observed. Conclusions and Relevance:In this pragmatic cluster randomized clinical trial, a digitally enabled, multifaceted strategy produced modest LDL-C reduction and increased treatment intensification among patients with ASCVD. However, a proportion of patients had LDL-C levels that remained above recommended LDL-C targets, underscoring that the strategy tested was only partially effective in eliminating the residual care gap. Trial Registration:ClinicalTrials.gov Identifier: NCT05622929.
BACKGROUND:Sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1 RA) reduce cardiovascular and kidney risk in patients with type 2 diabetes (T2D), yet real-world use remains suboptimal. Remote care models offer a promising approach to improve access; there is limited data on the safety of and adverse events (AEs) associated with prescribing and titrating these therapies through a protocol-driven remote management program. METHODS:The DRIVE trial was a pragmatic, randomized clinical trial evaluating the safety of a remote disease management program that initiated SGLT2i and/or GLP1 RA in patients with T2D and elevated cardiovascular or kidney risk. Participants were enrolled at a large integrated health care system in Massachusetts between March 2021 and December 2022. Participants were randomized to 1 of 2 implementation strategies: a sequential approach (two months of education first followed by medication initiation) or a bundled approach (simultaneous education and medication initiation). Nonclinical navigators and clinical pharmacists, supervised by physicians, oversaw medication initiation and monitoring under a collaborative drug therapy management agreement and protocol that included algorithms for initiation and titration of SGLT2i and GLP1 RA, as well as adjustment of concurrent glucose-lowering medications to reduce the risk of hypoglycemia Safety outcomes were collected through chart review and patient report, including targeted AEs, hospitalizations, emergency department visits, and urgent care visits. Targeted AEs were prospectively collected over the first 6 months after enrollment: for SGLT2i initiators, symptoms of genital mycotic infection, urinary tract infection, or volume depletion; for GLP 1 RA initiators, nausea, vomiting, diarrhea, and abdominal pain. Hospitalizations, emergency department visits, and urgent care visits over the first 6 months after enrollment were retrospectively collected through electronic health record review. RESULTS:Of 200 participants enrolled, 106 (53%) initiated SGLT2i (n = 68) or GLP1 RA (n = 40). Among SGLT2i users, 29.4% reported an AE, most commonly genital mycotic infections (10.3%) and symptoms of volume depletion (11.8%); 10.3% discontinued due to AEs. Among GLP1 RA users, 55.0% experienced AEs, predominantly gastrointestinal; 10.0% discontinued due to AEs. No severe hypoglycemia, emergency department visits, or hospitalizations occurred. CONCLUSIONS:A remote, pharmacist- and navigator-led program safely initiated SGLT2i and GLP1 RA in a high-risk T2D population, with AE rates comparable to clinical trials and high persistence. These findings support the feasibility of remote prescribing with appropriate clinical oversight and structured AE management. TRIAL REGISTRATION:Registry: ClinicalTrials.gov; URL: https://clinicaltrials.gov/study/NCT06046560; unique identifier: NCT06046560.
Background and aims:Cardiovascular disease remains a significant global health burden. Bempedoic acid is a novel, oral adenosine triphosphate-citrate lyase inhibitor that lowers low-density lipoprotein cholesterol (LDL-C). While randomized controlled trials (RCTs) have established its efficacy and safety, evidence from real-world clinical practice is needed. Methods:A systematic literature review (SLR) was conducted to identify studies reporting real-world use of bempedoic acid as monotherapy, in fixed dose combination with ezetimibe, or in combination with any other lipid lowering therapy (LLT). MEDLINE, EMBASE, and Cochrane Library were searched from inception to February 19, 2025. Two reviewers independently screened studies, with discrepancies resolved by a third. Data extraction and validation were conducted, and the risk of bias assessed using the Newcastle-Ottawa Scale. Results:Of 269 records, 28 reports on 22 unique studies met the eligibility criteria. Most studies evaluated LDL-C changes from baseline after initiation of bempedoic acid; one pragmatic randomized trial was identified. Bempedoic acid achieved LDL-C reductions of 15% to 39% when added to maximally tolerated statins, 22% to 38% in statin intolerant cohorts, and 18% to 42% in mixed statin intolerant cohorts. Safety data was limited; treatment discontinuation ranged from 9% to 36%, with higher rates in cohorts with greater statin-intolerance. Discussion:This SLR shows bempedoic acid, with or without other LLTs, achieves a minimum of approximately 20% LDL-C reductions, consistent with RCTs. Data suggests it may be effective as an adjunct to statins and as an oral alternative for statin-intolerant patients.
This study aimed to assess the relationship between coronary CT angiography detected coronary artery disease (CAD) and long-term cardiovascular outcomes among individuals with and without diabetes mellitus (DM). A retrospective cohort study of patients undergoing CCTA at two medical centers between 2006 and 2024. Patients with prior CAD, advanced kidney disease, or malignancy were excluded. DM was defined by diagnostic codes or elevated hemoglobin A1c. CCTA findings were categorized as no CAD, nonobstructive CAD (1–49
BACKGROUND AND AIMS:Randomized trials demonstrated that in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) direct oral anticoagulants (DOAC) and a P2Y12 inhibitor reduce bleeding compared with vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT) with no increase in ischemic risk; however, important gaps in knowledge remain, limiting certainty and generalizability of these findings. METHODS:In this patient-level meta-analysis of randomized trials evaluating antithrombotic strategies in patients with AF undergoing PCI, Cox proportional hazard models, stratified by trial, were used to estimate hazard ratios and 95% confidence intervals (HR, 95%CI). The primary efficacy and safety outcomes were the composite of cardiovascular death, myocardial infarction, or stroke, and TIMI major bleeding, respectively. The study was registered in PROSPERO (CRD420251130025). RESULTS:Six trials (10,634 patients) comparing DOAC plus P2Y12 inhibitor (4,083), VKA plus single antiplatelet therapy (SAPT, 1,247), VKA plus DAPT (3,715), and DOAC plus DAPT (1,589) were included. The transition from DAPT to SAPT was recommended at 1 (1-3) and 3 (1-7) days in the DOAC plus P2Y12 inhibitor and VKA plus SAPT groups, respectively. At 1 year, the risk of the primary efficacy outcome did not differ across the antithrombotic strategies (reference group: VKA plus DAPT; DOAC plus P2Y12 inhibitor: HR 1.16, 95%CI 0.97-1.41; VKA plus SAPT: 1.14, 0.85-1.54, DOAC plus DAPT: 0.99, 0.75-1.30), without any statistically significant interaction between treatment effects and all prespecified subgroups, including age, sex, bleeding risk, and thrombotic risk. However, 14-day landmark analysis showed an increased risk of myocardial infarction and definite/probable stent thrombosis in patients receiving DOAC plus P2Y12 inhibitor or VKA plus SAPT in the early phase after PCI. DOAC plus P2Y12 inhibitor reduced the risk of the primary safety outcome compared with VKA plus DAPT (0.48, 0.38- 0.65) and VKA plus SAPT (0.62, 0.40-0.97); only a borderline reduction was observed compared to DOAC plus DAPT (0.66, 0.44-1.01). DOAC plus P2Y12 inhibitor reduced intracranial hemorrhage compared with VKA plus DAPT (0.21, 0.07-0.64). CONCLUSIONS:In patients with AF undergoing PCI, the risk of cardiovascular death, myocardial infarction, or stroke did not significantly differ according to whether patients received a DOAC or VKA, whereas a modest increase in risk with single compared with dual antiplatelet therapy cannot be excluded, given the higher risk of early coronary events. DOACs compared with VKAs reduced the risk of bleeding across all severity grades, including intracranial hemorrhage, whereas omission of a second antiplatelet agent reduced the risk of TIMI major or minor bleeding.
Background and Aims Large-scale genome-wide association studies have identified common genetic variants that predict the risk of peripheral artery disease (PAD). This study assessed whether a polygenic risk score (PRS) is associated with PAD and the incidence of major adverse limb events (MALE) independent of clinical risk factors in patients with established cardiometabolic disease. Methods A genetic analysis was performed, pooling individual patient-level data from six TIMI trials. The association of a recently validated PAD PRS with prevalent PAD and the incidence of MALE (acute limb ischaemia, chronic limb-threatening ischaemia, major amputation, or peripheral revascularization) was assessed. Results A total of 68 816 patients were included in this analysis, with a median follow-up of 2.6 years. Of these, 5986 (8.7%) had known PAD at baseline. After adjusting for clinical risk factors, a higher PAD PRS was independently associated with a 15% greater odds of prevalent PAD (adjusted odds ratio per 1-SD: 1.15 [95% confidence interval 1.12-1.18], P < .0001), a magnitude of risk as strong as established clinical risk factors. A total of 577 patients experienced MALE during follow-up. A higher PAD PRS was associated with a 30% increased risk of MALE (adjusted hazard ratio per 1-SD: 1.30 [1.19-1.42], P < .0001). Adding the PAD PRS to clinical risk factors resulted in a statistically significant but modest improvement in discrimination (area under the curve went from 0.651 to 0.662 P < .0001). Conclusions In a broad spectrum of patients with cardiometabolic disease, the PAD PRS is associated with an increased risk of PAD and the incidence of MALE beyond clinical risk factors; however, the improvement in discrimination was statistically significant but clinically modest.
BACKGROUND:Despite overwhelming evidence of clinical benefit for patients with heart failure (HF), the uptake of guideline-directed medical therapies (GDMT) has been slow. Collaborative approaches are critically needed to improve alignment between evidence and clinical practice. Many strategies proposed to improve GDMT implementation have been either ineffective or too resource-intensive to implement at scale across different practice contexts. Furthermore, most existing approaches focus primarily on patients with HF and reduced EF, despite growing evidence for effective pharmacologic therapy in those with HF and mildly reduced or preserved ejection fraction (HFpEF). HYPOTHESIS:Based on this experience, we designed the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure (COPILOT-HF) study (NCT05734690). METHODS:This is a pragmatic, randomized, open-label intervention trial to compare a comprehensive, remote, navigator-led, algorithm-driven strategy for optimization of GDMT prescribing in patients with HF across the full spectrum of ejection fraction with a control intervention focused on patient and provider education regarding the importance of GDMT optimization. RESULTS:The primary efficacy endpoint of the study is the proportion of patients receiving optimal HF treatment at 3 months. Additional outcomes of interest include the proportion of patients with optimal HF therapy at 6 months and 12 months as well as health resource utilization, including hospitalizations and deaths. CONCLUSIONS:COPILOT-HF will evaluate the effectiveness of an early implementation of a remote pharmacist-led medication titration strategy across the HF spectrum.
BACKGROUND:The 2022 American Heart Association/American College of Cardiology/Heart Failure Society of America heart failure (HF) classification incorporates cardiac biomarkers to identify early risk of HF. The HF stages may also guide the prognosis and management of cardiovascular and kidney-related events. METHODS:SCORED (Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk) was a randomized trial in diabetes with kidney disease comparing sotagliflozin versus placebo on cardiovascular death, HF hospitalizations, and urgent HF visits. SCORED participants were grouped by HF stage post hoc. Stage A: no HF, normal biomarkers (NT-proBNP [N-terminal pro-B-type natriuretic peptide] <125 pg/mL; high sensitivity cardiac troponin T [hs-cTnT] <14 ng/L), and normal cardiac structure/function. Stage B (pre-HF): no HF but elevated NT-proBNP, hs-cTnT, or abnormal cardiac structure/function. Stage C/D: symptomatic HF. End points include the primary composite (cardiovascular death and HF-related events), major adverse cardiovascular events, and kidney-related composites (≥50% decline in estimated glomerular filtration rate, kidney failure, or kidney death). Using competing-risk proportional hazards models, we examined the association between HF stage and these end points, and the effect of sotagliflozin versus placebo by HF stage. RESULTS:There were 741 patients (7%) in stage A, 6560 (62%) in stage B (pre-HF), and 3283 (31%) in stage C/D (established HF). The median NT-proBNP and hs-cTnT increased with HF stage. Increasing HF stage was associated with a 2- to 4-fold increase in the primary outcome/major adverse cardiovascular events in the placebo group. The kidney-specific composite was 5-fold higher in stage B (pre-HF) versus stage A but similar in stages B and C/D. The effect of sotagliflozin versus placebo was similar, irrespective of HF stage (primary outcome: hazard ratio, 0.74 [95% CI, 0.63-0.88]; Pinteraction=1.00), with higher absolute benefit in each HF stage (P-trendIRR=0.002). The absolute benefit for the kidney-specific end point was comparable for stages B and C/D. CONCLUSIONS:Increasing HF stage is associated with a higher risk of HF, major adverse cardiovascular events, and kidney events. Asymptomatic stage B (pre-HF) increased cardiovascular and renal events by >2- and 5-fold, respectively. The benefits of sotagliflozin are consistent, irrespective of HF stage.
Background/Synopsis Homozygous familial hypercholesterolemia (HoFH), an ultra-rare inherited condition, affects the low-density lipoprotein (LDL) receptor pathway - and is associated with very high levels of LDL-cholesterol (LDL-C). HoFH leads to early-onset atherosclerotic cardiovascular disease and a reduced life expectancy. Lomitapide is an oral selective inhibitor of microsomal triglyceride transfer protein approved as an adjunctive therapy for HoFH. The Lomitapide Observational Worldwide Evaluation Registry (LOWER) is a global, long-term, prospective, observational registry established to monitor the real-world effectiveness and safety of lomitapide. Objective/Purpose To evaluate the long-term effectiveness and safety of lomitapide in patients with HoFH. Methods LOWER is a registry study of the long-term safety and effectiveness of lomitapide in clinical practice across sites in the US, Europe, Canada, Argentina, and Taiwan. Enrolment began in March 2014 and data collection will continue for 10 years from enrolment of the 300th patient. Results As of February 2023, 226 patients (43.4% male) were enrolled in LOWER, with a mean ±SD [range] age of 51.4 ±15.1 [18–83] years and baseline LDL-C level of 237.1 ±105.4 [71–632] mg/dL. Post-lomitapide data were available for 223 patients (98.7%); mean lomitapide [range] exposure was 38.5 [0.3–118.1] months, with 78.9% receiving lomitapide for ≥12 months and 25.6% for 5–<10 years. Lomitapide doses ranged from 2.5–50 mg/day and the global mean dose was 13.0 mg/day (17.4 mg/day in patients treated in Europe). Figure shows LDL-C reductions from baseline in the full analysis set and in patients who remained on treatment; 68.6% of patients enrolled in LOWER experienced a reduction in LDL-C by ≥50% from baseline. At any time after lomitapide initiation, 73.1% (n=163) patients achieved an LDL-C level <100 mg/dL and 47.1% (n=105) achieved <70 mg/dL. The most common events of special interest (ESI) were gastrointestinal and hepatic in nature. During nine years follow-up, hepatic steatosis was reported in 6.3% of patients (n=14). Asymptomatic elevated aminotransferase levels ≥3–<5x and ≥5x the upper limit of normal were observed in 15.0% and 6.5% of patients, respectively. Conclusions Data from the LOWER registry support the sustained lipid-lowering effect and safety of lomitapide, with ∼50% patients achieving LDL-C <70 mg/dL at some point during follow-up. ESIs in this large cohort were consistent with the known safety profile of lomitapide.
BACKGROUND:Remote hypertension management programs have emerged as potential solutions to improve poor rates of blood pressure (BP) control. The Continual Versus Occasional Blood Pressure (COOL-BP) Study investigated the feasibility and efficacy of using a cuffless wrist BP monitor in a remote hypertension (HTN) program. METHODS:COOL-BP was a prospective single-arm study within a larger HTN management program at Mass General Brigham (MGB). Participants had uncontrolled HTN, were already engaged in the MGB Remote Hypertension Program, and used a smartphone. The study involved patients wearing the Aktiia cuffless wrist BP monitor and performing traditional home BP monitoring (HBPM). The primary endpoint was the correlation of BP measurements between devices. Secondary endpoints included concordance between HBPM and cuffless pressures following a medication titration, and patient satisfaction with the cuffless device. RESULTS:We enrolled 38 patients, of whom 25 provided BP data on overlapping dates with both devices. There was moderate correlation between average nonsimultaneous daytime BPs within the same time periods (r = 0.57, 95% CI: 0.39-0.71 for systolic BP [P < 0.001]; r = 0.64, 95% CI: 0.48-0.76, for diastolic BP [P < 0.001]). The concordance of systolic BP changes detected by the two devices post medication titration was 87.5%. Most patients (91%) preferred the cuffless device, citing ease of use and convenience. CONCLUSIONS:Cuffless BP devices demonstrate promise in enhancing patient compliance and effectiveness in HTN management. Their integration into clinical practice could offer a more patient-friendly and reliable approach to BP monitoring, though more research is needed to establish their utility in large populations.
Background Translating evidence into clinical practice in the management of established atherosclerotic cardiovascular disease patients is challenging. Few quality improvement interventions have successfully improved patient care. Objectives The main objectives are to evaluate the impact of a digitally enabled multifaceted quality improvement (QI) intervention on the control of LDL-cholesterol (LDL-C) in atherosclerotic cardiovascular disease (ASCVD). Design We designed a pragmatic 2-arm cluster randomized trial involving 28 clusters (outpatient clinics from public or private hospitals or private practices). Clusters are randomized to receive a digitally enabled multifaceted QI intervention or to routine practice (control). The QI intervention includes reminders, electronic clinical decision support algorithms, audit and feedback reports, and distribution of educational materials to health care providers, as well as electronic educational materials and app-based tools for drug adherence control, lipid profile control, and communication to participants. The primary endpoint is the LDL-C at 06 months after the intervention period. All analyses are performed following the intentionto-treat principle and take the cluster design into consideration by using individual-level regression modeling (generalized Summary If proven effective, this low-cost, digitally enabled multifaceted QI intervention would be highly useful in promoting optimal LDL-C control in ASCVD patients.
BACKGROUND: Hypertension is a major cardiovascular risk factor, yet traditional care often results in suboptimal blood pressure (BP) control at the population level. We implemented a remote hypertension management program that monitored home BP and titrated medications per algorithm. This study assessed the program’s long-term effects by examining participants’ office BP up to 42 months post-enrollment. METHODS: Participants of the remote hypertension program were categorized into 4 groups: (1) enrolled-maintenance (achieved goal home BP of ≤130/80 mm Hg), (2) enrolled–early exit (left before achieving goal BP), (3) education-only (lifestyle modifications and medications compliance), and (4) white coat hypertension group (high office BP but normal home BP). Office BP readings of participants were collected up to 42 months post-enrollment. A linear mixed-effects regression model estimated mean BP levels and studied factors associated with above-goal systolic BP in the maintenance group. RESULTS: Office BP readings from 3601 participants (mean age, 61±11 years; 57% female; 60% white; 52% atherosclerotic cardiovascular disease) were extracted from electronic health records and analyzed. All groups sustained office BP below their qualifying values ( P <0.001) over 42 months. In the maintenance group, 89.7% of participants maintained systolic BP at goal, compared with 63.5% in the early exit group, 69.4% in the education-only group, and 90.7% in the white coat hypertension group. Age >50 years was associated with above-goal systolic BP in the maintenance group. CONCLUSIONS: Participants who achieved BP control through the remote hypertension program maintained goal systolic BP in 90% of cases up to 42 months post-enrollment. These findings highlight the long-term benefits of remote, intensive management programs for effective hypertension control.
BACKGROUND:The prevalence, chronicity and clinical impact of type 2 diabetes (T2D) defines this disease state as a critical determinant in morbidity and mortality, as encountered by individuals, health care systems, and public health in general. The need to understand and optimize T2D identification and management is now further heightened by the advent of medications with established cardiovascular (CV) and kidney benefits in such patients, namely sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RA). Prescription rates for these agents have remained low despite guidelines incorporating and emphasizing their use. Better understanding T2D disease and management patterns, including percentage of patients meeting guideline indications, is necessary to address undertreatment, improve patient management, and enable better strategies. We evaluated such issues, including eligibility for and utilization of SGLT2i and GLP-1 RA, in a large health system caring for over 1.5 million patients annually. METHODS:The electronic health record (EHR) at a large health network in the Northeastern United States was queried to identify patients 18 years of age or older with T2D and at least 1 hemoglobin A1c (HbA1c) between January 1, 2020 and January 1, 2023, examining those with T2D and 1) atherosclerotic CV disease (ASCVD), 2) an estimated 10-year ASCVD risk score ≥ 10% without known ASCVD, 3) heart failure (HF), and/or 4) chronic kidney disease (CKD) based on EHR listed comorbidities. Demographics, medications, comorbidities, and indications for SGLT2i and/or GLP-1 RA therapy were assessed by 1 or more of the 4 indications above as outlined in society guidelines. RESULTS:Of the 147,338 patients who met inclusion criteria, 47% were female, 28% were non-white, and 14% with a non-English language preference. Of those, 121,508 (83%) had an indication for either SGLT2i or GLP-1 RA based on guideline recommendations: 17% were prescribed an SGLT2i, 22% were prescribed GLP-1 RA, and 6% of patients were prescribed both medications. Only 33% of all eligible patients were prescribed therapy. Of patients eligible for either an SGLT2i or GLP-1 RA therapy not currently receiving either therapy, 49% had 10-year ASCVD risk ≥ 10% without known ASCVD, 42% had ASCVD, 52% had CKD, and 14% had HF. CONCLUSIONS:More than 4 out of 5 patients with T2D had a CV or kidney indication for either SGLT2i or GLP-1 RA. However, uptake of SGLT2i/GLP-1 RA in these high-risk populations remains low (just 32%) across this health network. Future studies are needed to identify better strategies to overcome provider, patient, and system-level barriers to the uptake and dissemination of guideline-concordant T2D therapies.