{"title":"GENETICALLY PREDICTED LIPOPROTEIN(A) IS ASSOCIATED WITH CORONARY ARTERY PLAQUE SEVERITY INDEPENDENT OF LOW-DENSITY LIPOPROTEIN CHOLESTEROL","authors":"","doi":"10.1016/j.ajpc.2024.100757","DOIUrl":"10.1016/j.ajpc.2024.100757","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>ASCVD/CVD Risk Factors</div></div><div><h3>Background</h3><div>Elevated Lipoprotein(a) [Lp(a)] is a causal risk factor for atherosclerotic cardiovascular disease, but mechanisms are debated. The role of Lp(a) in atherogenesis has been questioned by prior small studies showing a lack of association with markers of atherosclerosis, including carotid intima media thickness and coronary artery calcification. Some have hypothesized that the association between Lp(a) and atherosclerosis may depend on low-density lipoprotein cholesterol (LDL-C).</div></div><div><h3>Methods</h3><div>We examined participants of the Million Veteran Program who have undergone an invasive angiogram. The primary exposure was genetically predicted Lp(a), estimated by a validated polygenic score consisting of 43 single nucleotide variants at the LPA locus. The primary outcome was coronary artery plaque severity, categorized as normal, non-obstructive disease, 1-vessel disease, 2-vessel disease, and 3-vessel or left main disease. Multivariable multinomial regression was used to assess the association between genetically predicted Lp(a) and coronary plaque severity, independent of age, sex, LDL-C, lipid-lowering therapy, hypertension, diabetes, tobacco use, and genetic principal components. Similar logistic regression models were used to assess the overall risk for obstructive plaque. Odds ratios were calculated per 1 standard deviation increase in predicted Lp(a) and by comparing the top 20% to bottom 80%.</div></div><div><h3>Results</h3><div>Among 18,927 adults of genetically inferred European ancestry (mean age 66 years; 96.8% male), we observed significant associations between genetically predicted Lp(a) and all categories of obstructive plaque. The association was borderline significant for non-obstructive plaque. We observed a consistent pattern of increasing effect sizes for increasingly severe categories of atherosclerosis (Figure [A]). Participants with genetically predicted high Lp(a) were at significantly increased risk for obstructive plaque across LDL-C levels (Figure [B]).</div></div><div><h3>Conclusions</h3><div>Genetically predicted Lp(a) is positively associated with coronary plaque severity independent of LDL-C, consistent with Lp(a) promoting atherogenesis. However, Lp(a) may contribute more to plaque progression towards obstructive disease than to plaque initiation. Our findings suggest that Lp(a) reduction could protect against the development of obstructive coronary plaque beyond what might be achieved by LDL-C reduction alone.</div></div>","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":null,"pages":null},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"LONG-TERM EFFICACY OF EVINACUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA: RESULTS FROM SUBGROUP ANALYSES","authors":"","doi":"10.1016/j.ajpc.2024.100801","DOIUrl":"10.1016/j.ajpc.2024.100801","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>Pharmacologic Therapy</div></div><div><h3>Background</h3><div>Homozygous familial hypercholesterolemia (HoFH) is a rare genetic disorder characterized by severely elevated low-density lipoprotein cholesterol (LDL-C) and increased risk of early-onset atherosclerotic cardiovascular disease. Despite treatment with multiple lipid-lowering therapies (LLTs), most patients with HoFH do not attain guideline-recommended LDL-C treatment goals. In a phase 3 trial (NCT03409744), evinacumab, an angiopoietin-like 3 inhibitor, substantially reduced mean LDL-C by 43.6% from baseline to Week 24. Here, we report on the long-term LDL-C lowering efficacy of evinacumab analyzed by patient subgroups from the open-label treatment period (OLTP) of this phase 3 trial.</div></div><div><h3>Methods</h3><div>This single-arm, open-label, phase 3 study (NCT03409744) comprised patients with HoFH aged ≥12 years who were evinacumab-naïve or had previously received evinacumab in other trials. The study included a run-in period (≤10 weeks), a screening period (2 weeks), an OLTP (≤192 weeks), and a follow-up period (24 weeks). In the OLTP, all patients received intravenous evinacumab 15 mg/kg every 4 weeks alongside optimized LLT.</div></div><div><h3>Results</h3><div>Overall, 116 patients were enrolled with a mean (standard deviation [SD]) age of 38.8 (15.9) years. The proportion of male and female patients was similar (50.9% vs 49.1%, respectively). Most patients were White (69.0%) or Asian (10.3%). At baseline, mean (SD) LDL-C was 261.0 (160.1) mg/dL. Evinacumab reduced mean (SD) LDL-C from baseline to Week 96 by 57.6% (16.7%), 36.4% (54.6%), and 38.0% (52.9%) in patients <18 years of age, patients ≥18 years of age, and overall, respectively. Among female and male patients, mean (SD) LDL-C reduction from baseline to Week 96 was 48.8% (32.3%) and 30.5% (62.6%), respectively. Mean (SD) LDL-C reduction from baseline to Week 96 was 43.1% (36.9%) in patients with null-null variants in either the low-density lipoprotein receptor (LDLR) gene or the low-density lipoprotein receptor adapter protein 1 (LDLRAP1) gene; mean (SD) LDL-C reduction was 35.1% (62.4%) in patients with non-null variants in LDLR or LDLRAP1. From baseline to Week 96, reductions in LDL-C with evinacumab were observed irrespective of background LLT (Figure).</div></div><div><h3>Conclusions</h3><div>In patients with HoFH, evinacumab showed substantial and sustained LDL-C reduction irrespective of age, sex, LDLR genotype, and background LLT.</div></div>","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":null,"pages":null},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"HOW CAN WE UTILIZE DIGITAL MEDIA FOR ASCVD PREVENTION? A RANDOMIZED CONTROLLED TRIAL","authors":"","doi":"10.1016/j.ajpc.2024.100803","DOIUrl":"10.1016/j.ajpc.2024.100803","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>CVD Prevention – Primary and Secondary</div></div><div><h3>Background</h3><div>The growing complexity of cardiology, higher patient volumes, and increasing administrative/charting demands pose challenges for providers to spend valuable clinic time on educating patients sufficiently about Atherosclerotic Cardiovascular Disease (ASCVD). We performed a prospective randomized controlled trial to determine if using an animated video in the clinical setting to educate patients about cardiac anatomy and pathophysiology is an effective method of ASCVD prevention.</div></div><div><h3>Methods</h3><div>This study took place in a busy cardiology clinic within a teaching hospital in New York City. Patients with traditional risk factors for ASCVD were asked to participate if they were >18 years, and understood English or Spanish. Willing participants were randomized to either the intervention or control, “usual-care”, cohort. Both cohorts were asked to complete a pre-visit questionnaire regarding coronary artery disease (CAD), physical activity, and patient satisfaction before their scheduled clinical encounter. Only the intervention cohort was then shown a novel, 3.5-minute animated video via tablet that illustrates anatomy and pathophysiology of CAD. Next, all participants completed their clinical encounter with their cardiologist, and finally were asked to complete a post-visit questionnaire which was identical to the pre-visit version.</div></div><div><h3>Results</h3><div>A total of 48 participants were enrolled in this study, 23 in the control (usual care) cohort and 25 in the intervention cohort. Baseline demographic characteristics are summarized in Table 1. The average score on the 5-point Likert scale of the pre-visit questionnaire for the intervention cohort was 3.81, and post-visit improved to 4.64 (average change of 0.96 points, p=0.003). The average score of the pre-visit questionnaire for the control cohort was 3.68, and post-visit score was 3.73 (average change of 0.05 points, p=0.19).</div><div>Results:</div></div><div><h3>Conclusions</h3><div>This pilot study demonstrates that digital media, in conjunction with the clinical encounter, is more effective in bolstering peoples’ knowledge of ASCVD risk, improving attitudes towards their provider and increasing patient satisfaction, compared to usual care. The positive results suggest the need for more prospective studies to evaluate the efficacy of utilizing digital media to deliver patient education and prevent cardiovascular disease.</div></div>","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":null,"pages":null},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"FIRST PRESENTATION OF CARDIOVASCULAR DISEASE IN PREVIOUSLY HEALTHY INDIVIDUALS: THE MULTI-ETHNIC STUDY OF ATHEROSCLEROSIS","authors":"","doi":"10.1016/j.ajpc.2024.100746","DOIUrl":"10.1016/j.ajpc.2024.100746","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>ASCVD/CVD Risk Assessment</div></div><div><h3>Background</h3><div>The initial presentation of atherosclerotic cardiovascular disease (ASCVD) may be a severe, sometimes fatal outcome, and there is need for improved understanding and identification of ASCVD in asymptomatic individuals.</div></div><div><h3>Methods</h3><div>Using data from 6,779 participants the Multi-Ethnic Study of Atherosclerosis (MESA) without known cardiovascular disease, we evaluated the association between traditional risk factors and coronary artery calcium (CAC) with first ASCVD event (angina, stroke, myocardial infarction [MI], or death/resuscitated cardiac arrest [RCA]) in cox proportional hazards models.</div></div><div><h3>Results</h3><div>Overall, 1037 participants (15.3%) experienced a first ASCVD event over median follow-up of 15.8 years. The most common first presentation was death/RCA (27.7%). Those with CAC>0 were significantly more likely to present with angina than those with CAC=0 (26.% vs 13.0%, overall p<0.001). Black (35.6%) and Chinese (28.7%) individuals were more likely to present with death/RCA than White individuals (24.8%, overall p=0.011) and Black (25.7%) and Hispanic (29.3%) individuals were more likely to present with stroke than White (21.7%, p<0.001 overall) individuals. Women were more likely to present with death/RCA than men (29.8 vs 26.3%, overall p<0.001). Age, systolic blood pressure, diabetes, and smoking were significantly associated with a first presentation of death/RCA, while female sex and HDL-C were inversely associated. CAC (ln-transformed) was also significantly associated with first presentation of death/RCA (HR 1.15, 95% CI 1.10-1.22) and improved risk prediction when added to the Pooled Cohort Equations (continuous NRI 0.6081, 95% CI 0.4971-0.7141).</div></div><div><h3>Conclusions</h3><div>In previously asymptomatic individuals, the most common initial presentation of ASCVD was death/resuscitated cardiac arrest. In addition to traditional risk factors, CAC was associated with an initial presentation of death/RCA, and improved risk prediction for death/RCA when added to traditional risk factors. These findings suggest CAC scoring may help to identify individuals at risk for death or resuscitated cardiac arrest as a first presentation of ASCVD.</div></div>","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":null,"pages":null},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"DEMYSTIFYING BAG3 CARDIOMYOPATHY","authors":"","doi":"10.1016/j.ajpc.2024.100789","DOIUrl":"10.1016/j.ajpc.2024.100789","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>Heart Failure</div></div><div><h3>Case Presentation</h3><div>A 56-year-old male with progressive exertional dyspnea and ankle edema was evaluated in the cardiology office. The patient had no overt traditional cardiac risk factors. ECG showed sinus rhythm and a right bundle branch block. The echocardiogram showed an LVEF of 45-50% and a severely dilated LV measuring 7.2 cm at end-diastole, with an abnormal global longitudinal strain (GLS) (11.6%) and apical and mid-wall sparing. Ischemic workup was negative. Genetic testing revealed a pathogenic variant in BAG3 (p.Glu471Argfs*95). His father and two siblings were also carriers of the same variant. He was treated with beta-blockers, angiotensin-neprilysin inhibitor, mineralocorticoid receptor antagonist, and an SGLT2 inhibitor. Frequent runs of non-sustained ventricular tachycardia prompted primary prevention implantable cardioverter defibrillator placement. Close follow-up was arranged, given the high risk for deterioration and progressive heart failure.</div></div><div><h3>Background</h3><div>The cause of dilated cardiomyopathy (DCM) can be determined in approximately 40% of cases due to genetic testing now being widely available. BAG3 mutations account for 2-5% of DCM cases; BAG 3 gene encodes a protein crucial for maintaining the structure and function of cardiomyocytes. Mutations in BAG3 disrupt its normal function, leading to myofibrillar disarray and systolic dysfunction.</div></div><div><h3>Conclusions</h3><div>The BAG3 mutation, in this case, resulted in a premature translational stop of the BAG3 gene, disrupting the last 105 amino acids of the BAG3 protein. Inheritance follows an autosomal dominant pattern, and penetrance is 40%. Left ventricular global longitudinal strain (GLS) may inform outcomes beyond LVEF in patients with heart failure and reduced ejection fraction. Currently, preliminary research involving gene therapy in animal models shows that replenishing normal levels of BAG3 may have salutary effects. However, essential questions remain on how it can be implemented effectively in human subjects.</div></div>","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":null,"pages":null},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"PERSISTENT ATRIAL FIBRILLATION AFTER CATHETER ABLATION IN HUMAN IMMUNODEFICIENCY VIRUS TYPE‐1 POSITIVE PATIENTS","authors":"","doi":"10.1016/j.ajpc.2024.100805","DOIUrl":"10.1016/j.ajpc.2024.100805","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>Other: Electrophysiology</div></div><div><h3>Case Presentation</h3><div>A 35-year-old African-American male with medical history of HIV-1 infection on 800 mg Darunavir, 150 mg Cobicistat, 200 mg Emtricitabine, and 10 mg Tenofovir Alafenamide presented with the complain of palpitations and sweating. He reported resting tachycardia, 120-140 beats per minute, from his smartwatch. Upon arrival, 12-lead electrocardiogram showed atrial flutter with variable A-V block. Patient's troponin I was <0.01 ng/ml. Subsequently, he underwent transesophageal echocardiogram and was successfully cardioverted to sinus rhythm with one dose of 200 joules of synchronized cardioversion. After multidisciplinary management, patient was discharged on Sotalol 80 mg twice a day and Dabigatran 150 mg twice a day. 45 days after initial presentation, patient underwent successful outpatient atrial flutter ablation. 65 days status post ablation, he again presented and was admitted due to atrial fibrillation with premature ventricular complexes. Currently, patient remains on rate control with anticoagulation treatment and frequent outpatient surveillance. Since the last incidence, no inpatient hospitalizations have been reported.</div></div><div><h3>Background</h3><div>Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. It is due to abnormal electrical activity within the atria of the heart, causing them to fibrillate. This arrhythmia may be paroxysmal (less than seven days) or persistent (more than seven days) (1). Researcher studies have found that Human Immunodeficiency Virus (HIV)-positive patients had an incidence of 18.2 AF diagnoses per thousand person-years, compared to 8.9 in patients without HIV (2). Non-pulmonary vein triggers are highly prevalent in HIV-positive AF patients and the mid- and long-term arrhythmia recurrence was observed to be mostly driven by those triggers (3). We present a patient who represents part of the growing study population of young HIV-1 positive male associated with arrhythmia recurrence.</div></div><div><h3>Conclusions</h3><div>The prothrombotic nature of HIV infection is well-documented (4). It is believed that HIV-1 infection elevates stroke risk via systemic mechanisms such as low-grade inflammation and heightened oxidative stress, or through direct cardiac toxicity potentially leading to AF (5). A key consideration in the treatment of atrial fibrillation in patients with HIV‐1 who are in combination antiretroviral therapy (ART), is the significant impact these drugs have on liver enzymes like CYP2C9 and CYP3A4 (6). These enzymes are crucial for metabolizing numerous medications, including various oral anticoagulants (6). Given this, there is a strong likelihood of interactions between vitamin K antagonists and ART, particularly with protease inhibitors (PIs) or non‐nucleoside reverse transcriptase inhibitors (NNRTIs) (7).</div><div>Additionally, ART regimens containing PIs with or","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":null,"pages":null},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"SEX-BASED DIFFERENCES IN AORTIC VALVE CALCIUM AND THE RISK FOR AORTIC STENOSIS","authors":"","doi":"10.1016/j.ajpc.2024.100734","DOIUrl":"10.1016/j.ajpc.2024.100734","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>Novel Biomarkers</div></div><div><h3>Background</h3><div>Aortic valve calcification (AVC) is the primary underlying process leading to aortic stenosis (AS). In general, women have lower AVC scores compared to men of the same age and the AVC score threshold for severe AS is lower for women. It remains unknown if the long-term risk of AS differs between sexes with similar AVC scores. We aimed to assess the association between AVC and the risk for clinically significant AS stratified by sex using the Multi-Ethnic Study of Atherosclerosis (MESA).</div></div><div><h3>Methods</h3><div>We included 6,812 MESA participants free of cardiovascular disease with AVC measured at Visit 1 using non-contrast cardiac CT. AVC was examined as a continuous (logarithmically transformed, ln (AVC+1)) and categorical variable (0, 1-99, 100-299, ≥300 AU). Incident long-term AS was adjudicated using standard clinical criteria with a median follow up of 16 years. The primary outcome was incident moderate or severe AS. The association between AVC and AS was examined by calculating absolute event rates per 1,000 person-years, and multivariable adjusted Cox Proportional hazards regression.</div></div><div><h3>Results</h3><div>Among those with AVC >0, women were older (71.7 years vs. 69.8 years, p = 0.01) and generally had a higher risk factor burden. There were 65 cases of incident AS for women and 75 for men. There was a similar absolute event rate for incident AS for women and men across the AVC categories. AVC as a continuous variable was strongly associated with an increased risk for incident aortic stenosis for both women (HR 1.91, 95% CI 1.68-2.16) and men (HR 2.13, 95% CI 1.88-2.41). There was no interaction between AVC, as a continuous variable, and sex (p = 0.31) for the association with AS. The adjusted hazard for severe AS was similar across AVC categories for women and men with HR estimates 134.9 (95% CI 45.1-403.9) for women with AVC ≥300 and 132.8 (95% CI 6.2-274.9) for men with AVC ≥300 (Table 1).</div></div><div><h3>Conclusions</h3><div>The association of AVC with the long-term risk for incident AS was similar for women versus men. These findings further emphasize the utility of AVC as a prognostic marker for incident AS.</div></div>","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":null,"pages":null},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"IMPROVEMENT IN HEART FAILURE NAVIGATOR CONSULTATION - A QUALITY IMPROVEMENT INITIATIVE","authors":"","doi":"10.1016/j.ajpc.2024.100791","DOIUrl":"10.1016/j.ajpc.2024.100791","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>Heart Failure</div></div><div><h3>Background</h3><div>Heart failure (HF) has the highest 30-day rehospitalization rate among medical and surgical conditions. Data shows that HF patients who suffer from a 30-day readmission have worse prognosis at 6-month follow-up. Implementing educational interventions to improve outcome of adherence in HF patients has shown to reduce readmission rates by >15%. Although the means to implement such educational interventions are available, this resource appears grossly underutilized. Preliminary analysis showed that < 15% of patients admitted to advanced heart care with an ICD 10 diagnosis of acute heart failure exacerbation currently to receive an order for HF Navigator consultation.</div></div><div><h3>Methods</h3><div>The number of heart failure navigator consults placed on the advanced heart care unit in relation to primary diagnosis of acute heart failure exacerbation was measured. The baseline, measured over several weeks prior to implementation of intervention, was measured to be <15%. Plan-Do-Study-Act (PDSA) Cycles were run. The cycles entailed: 1st Provider reeducation that ANY HF admission warrants HF Navigator consultation, 2nd Implementation of a widget making it accessible to follow up if consultation happened, 3rd order set for HF was enforced , which entailed the heart failure navigator order, 4th Distribution of reminder posters, post it's, and emails, 5th Distribution of questionnaire evaluating the main cause of lack of adherence to orders, serving as reminder to utilize the order, 6th educational meeting with the HF Navigator. 7th Information technology guided interventions are currently pending.</div></div><div><h3>Results</h3><div>The following number of orders for heart failure navigator consultation were noted after each PDSA cycle:1st 16%, 2nd 16%, 3rd 33 %, 4th 39 %, 5th 26%, 6th 50% (Figure 1).</div></div><div><h3>Conclusions</h3><div>Sustained and relevant change requires ongoing education, and improved workflow with utilization of order sets, which equal integrated clinical pathways. Ultimately, information technology support is needed to implement reflex orders, and clinical pathway tools, based on diagnosis, to ensure evidence based healthcare and optimal patient care. Advancements in electronic medical record systems with application of clinical pathways will improve human error and in the long-term safe patient suffering and hospital dollars.</div></div>","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":null,"pages":null},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"EVALUATING TOUR006 IN PARTICIPANTS WITH CHRONIC KIDNEY DISEASE AND ELEVATED HS-CRP: RATIONALE AND DESIGN OF THE TRANQUILITY PHASE 2 STUDY","authors":"","doi":"10.1016/j.ajpc.2024.100778","DOIUrl":"10.1016/j.ajpc.2024.100778","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>Pharmacologic Therapy</div></div><div><h3>Background</h3><div>Subgroups of patients with atherosclerotic cardiovascular disease (ASCVD) remain at very high risk of major adverse cardiovascular and limb events despite lifestyle modification and intensive pharmacological management including antiplatelet drugs, antihypertensive therapy, and LDL-lowering medications. Converging evidence from human genetic studies, prospective cohort studies, and mechanistic studies as well as results of canakinumab and colchicine cardiovascular outcome trials support the therapeutic potential of IL-6 pathway inhibition to lower the risk of ASCVD independent of traditional risk factors. TOUR006 is a fully human, high-affinity monoclonal antibody against the IL-6 cytokine. In prior Phase 1/2 studies, TOUR006 administered to patients with high-grade inflammatory autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and systemic lupus erythematosus achieved rapid and durable reductions in C-reactive protein (CRP), the key downstream pharmacodynamic (PD) biomarker of IL-6 activity, as assessed by the high-sensitivity (hs) assay. A pharmacokinetic (PK)/PD model was developed from these data, and simulations in virtual patients showed significant reductions in hs-CRP with both monthly and quarterly dosing of TOUR006. The objective of this Phase 2 study is to characterize the hs-CRP-lowering effect, safety, tolerability, and PK of TOUR006 in patients with chronic kidney disease (CKD) and elevated hs-CRP. The CKD population was selected for this trial because of the high prevalence of elevated hs-CRP as well as evidence supporting a significant role of IL-6 pathway activation in driving ASCVD risk among patients with CKD.</div></div><div><h3>Methods</h3><div>TRANQUILITY is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, US-based trial enrolling approximately 120 patients with CKD stage 3 or 4 and hs-CRP≥2 and <15 mg/L. Participants will be stratified by CKD stage and randomized to subcutaneous TOUR006 50 mg quarterly, 25 mg quarterly, 15 mg monthly, or placebo (Figure). The primary PD endpoint is change in hs-CRP; additional biomarkers include IL-6, lipoprotein(a), oxidized LDL, and fibrinogen. Treatment and follow-up periods are 180 days and 185 days, respectively.</div></div><div><h3>Conclusions</h3><div>TRANQUILITY, an ongoing trial with anticipated primary completion in May 2025, will assess the safety, tolerability, PK, and hs-CRP-lowering effect of TOUR006 and inform the dosing regimen and design of future Phase 3 cardiovascular studies in high-risk patients.</div></div>","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":null,"pages":null},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"EXAMINING URBAN AND RURAL PHARMACY AVAILABILITY IN MINNESOTA FROM 2009 TO 2020","authors":"","doi":"10.1016/j.ajpc.2024.100821","DOIUrl":"10.1016/j.ajpc.2024.100821","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>ASCVD/CVD in Special Populations</div></div><div><h3>Background</h3><div>Cardiovascular disease (CVD) is the leading cause of death in the United States. Controlling CVD risk factors is key to treatment and prevention. However, medication adherence is difficult when pharmacies are difficult to access. This study aims to characterize pharmacy access by geographic region in Minnesota from 2009 to 2020.</div></div><div><h3>Methods</h3><div>Pharmacy lists for 2009 and 2020 were obtained from the Minnesota Board of Pharmacy. Pharmacies were geocoded and labeled with a rural-urban community area (RUCA) code. Geographic areas were divided into 3 RUCA areas: urban, large rural city/town, small/isolated rural town. Each pharmacy was designated as a chain, supermarket-based, independent, or associated with a health system. We evaluated pharmacy hours, count and density for each geographic area by year, and the proportion of pharmacy types in all geographic locations.</div></div><div><h3>Results</h3><div>A total of 1,010 pharmacies were open in 2009 and 916 pharmacies in 2020. Pharmacy density (n/100,000 resident) decreased over time for all geographic areas: urban from 17.0 to 13.9, large rural from 24.1 to 21.1, and small rural from 25.6 to 24.2. Pharmacy types also changed over time. While chain pharmacies accounted for nearly half of pharmacies in both 2009 and 2020, independent pharmacies decreased over time in all regions (Figure 1). Supermarket and health system pharmacies represented a stable or increasing share of all pharmacies although the absolute number of pharmacies decreased everywhere except in small rural towns.</div><div>Supermarket pharmacies had the best access; >95% were open after 6pm and had open hours on the weekend. Chain pharmacies had similarly high accessibility in the urban regions, but were less accessible in large rural city (65% extended hours, 87% open weekends) and small town (23% extended hours, 66% open weekends) regions (Table 1). Independent pharmacies tended to be open on weekends, but were less likely to have extended hours.</div></div><div><h3>Conclusions</h3><div>Pharmacy access decreased across the state of Minnesota from 2009 to 2020, especially for independent pharmacies. Residents of less populated areas had fewer options for pharmacy use outside of regular business hours.</div></div>","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":null,"pages":null},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142423109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}