Incidence Of Cardiovascular Death Research Articles

Long-term outcomes in hospitalized heart failure patients in China: results from the China National Heart Failure (CN-HF) registry study

Abstract Background There is a paucity of data on the long-term outcomes of heart failure (HF) patients in China. We aimed to investigate the incidence of cardiovascular (CV) death or rehospitalization due to worsening HF (WHF) and other outcomes among different subtypes of patients with chronic HF in China. Methods Data from the China National HF registry (CN-HF) during the period 1 February 2013–31 October 2015 were analyzed. Patients were categorized into three groups based on their left ventricular ejection fraction (LVEF): HF with reduced ejection fraction (HFrEF, LVEF≤40%), HF with mildly reduced ejection fraction (HFmrEF, LVEF 41%–49%), and HF with preserved ejection fraction (HFpEF, LVEF≥50%). Rates and risk of CV death or HF rehospitalization and other outcomes including all-cause mortality in each group were calculated and compared. Results In total 7171 patients (mean age 69.6 years, 59.5% male) with HF were enrolled across 45 centers in China. At discharge, ACEIs/ARBs, β-blockers and MRA were prescribed in 57.3%, 50.8% and 54.5% HF patients totally. The overall incidence of the primary outcome (CV death or HF rehospitalization) was 8.9%, 16.1%, and 23.5% at 6, 12, and 24 months post-discharge, respectively. Significantly higher rates of the primary outcome, all-cause mortality, and HF re-hospitalization were observed in patients with HFrEF and HFmrEF compared with those with HFpEF at 6, 12, and 24 months (P < 0.05). The incidence of CV death was similar across all LVEF subgroups. Conclusions Compared to patients with HFpEF, incidence of death or rehospitalization were higher among patients with HFrEF or HFmrEF in China. Optimal follow-up and management of HF both inside and outside of the hospital should be highlighted and put into practice.Primary outcome according to LVEFAll-cause death and rehospitalization

Effect of the longitudinal change in anemia status on clinical outcomes for patients with nonvalvular atrial fibrillation: analysis from the Hokuriku-Plus AF registry

Abstract Background Anemia is a common comorbidity in older patients with heart failure (HF)1 and atrial fibrillation (AF)2, associated with an increased risk of adverse events. This study evaluated the prognostic effects of longitudinal changes in anemia status on clinical outcomes in patients with AF, as limited data are available on this aspect. Methods and Results We prospectively evaluated data of 1,388 patients with AF obtained from the Hokuriku-Plus AF registry (1,010 men, 72.3±9.7 years) and recorded the incidence of cardiovascular death (CVD), HF, thromboembolism, and major bleeding. Finally, 1,233 patients with AF with baseline and first year of follow up hemoglobin levels were evaluated. Patients were categorized into 3 groups based on the longitudinal changes in 1-year anemia status: AF without anemia (group 1), AF with improved anemia (group 2), and AF with sustained or new-onset anemia (group 3). During 1–5-year follow up, the incidences of CVD, HF, thromboembolism, and major bleeding were significantly higher in patients with AF and anemia than in those without (Figure1). Additionally, the incidence of CVD or HF was significantly higher in group 3 than in groups 1 and 2 (Figure 2). Multivariate analysis revealed no anemia or improvement from anemia in 1 year as an independent predictor for reducing CVD and HF. Conclusions Recovery from anemia may be associated with a favorable clinical course in AF.

Ultra-processed food consumption and risk of cardiovascular mortality in Australia: preliminary results from prospective observational study

Abstract Background/Introduction A large proportion of the Australian population emigrated from countries where traditional dietary patterns are protective of cardiovascular health. Yet, recent evidence suggests that 42% of a modern Australian diet's total energy intake is comprised of ultra-processed foods. This is concerning as previous meta-analyses and umbrella reviews based on population studies have found an association between ultra-processed food consumption and adverse health outcomes, including cardiovascular disease and mortality. However, this has yet to be explored in an Australian population. Purpose To determine the association between ultra-processed food consumption and the risk of cardiovascular mortality in an Australian cohort. Methods Prospective data from the Melbourne Collaborative Cohort Study (MCCS; n = 38054) were analysed. UPF consumption at baseline (1990 to 1994) was assessed in accordance with the NOVA food classification system using data from a 121-item food frequency questionnaire. Energy-adjusted ultra-processed food consumption was then categorised into quartiles. Cardiovascular mortality was obtained through data linkage with national and local registries up to 2015 and 2019, respectively. This was done using the International Classification of Diseases (ICD) codes (390-459 and I00-I99). Unadjusted and adjusted multivariate logistic regression models were fitted to estimate associations between ultra-processed food consumption (exposure) and cardiovascular mortality (outcome). Results A total of 4,242 incident cardiovascular deaths occurred (2,272 for males and 1,970 for females) during the follow-up period. After adjusting for sociodemographic characteristics and lifestyle and health-related behaviours, higher UPF consumption was associated with a higher risk of cardiovascular mortality (aOR high (quartile 4) vs. low (quartile 1) category = 1.26, 95%CIs 1.14 to 1.39, ptrend < 0.001). Conclusion(s) In this large prospective cohort of Australian adults, higher ultra-processed food consumption was associated with an increased risk of cardiovascular mortality. These findings support previous research and guidelines recommending the reduction of ultra-processed food consumption as part of a heart-healthy diet.

Long-Term Risk of Cardiovascular Death in Patients With Mildly Reduced Ejection Fraction After Acute Myocardial Infarction: A Multicenter, Prospective Registry Study.

The prognostic implication of mildly reduced ejection fraction (mrEF) after acute myocardial infarction has not been clearly demonstrated. We investigated the long-term risk of cardiovascular death and its predictors in patients with mrEF following acute myocardial infarction. A total of 18 668 patients who presented with acute myocardial infarction were included in 2 prospective, multicenter registries. The incidence of adverse cardiovascular events according to the left ventricular ejection fraction (EF) strata at index admission were evaluated. A score system consisting of clinical variables were developed to predict long-term cardiovascular death in the mrEF group. There were 2548 patients with reduced EF (EF ≤40%), 4266 patients with mrEF (EF 41%-49%), and 11 854 patients with preserved EF (EF ≥50%). During a median follow-up period of 37.9 months, the cardiovascular death rate was 22.3% in the reduced EF group, 10.3% in the mrEF group, and 7.3% in the preserved EF group (P<0.001). In the mrEF group, age>65 years, hypertension, stroke, severe renal insufficiency, and Killip class ≥3 were independent predictors for cardiovascular death. Presence of >2 predictors best discriminated the high-risk patients for cardiovascular death with an area under the curve of 0.746. Incidence of cardiovascular death in the high-risk mrEF group was comparable with the rEF group, while it was lower in the low-risk mrEF group than in the pEF group. Patients with mrEF after acute myocardial infarction had a modest risk of cardiovascular death. Clinical predictors could help discriminate a high-risk subpopulation with cardiovascular death risks comparable with those in the reduced EF group.

One-month DAPT after biodegradable-polymer everolimus-eluting stent implantation in patients at high-bleeding risk: an individual patient data pooled analysis of the SENIOR and POEM trials.

Dual antiplatelet therapy (DAPT) can be shortened up to 1 month in high-bleeding risk (HBR) patients receiving a contemporary biodegradable-polymer sirolimus-eluting stent. We aimed to summarize the evidence on a similar DAPT regimen after biodegradable-polymer everolimus-eluting stent (EES) implantation in patients at HBR. We pooled the individual participant data from the available trials evaluating this strategy, namely, the SENIOR and the POEM trials. Inclusion criteria were ≥1 biodegradable-polymer EES implantation and ≤1-month duration of DAPT. The primary endpoint was the 1-year composite of cardiovascular death, myocardial infarction, or stroke. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) type 3-5 bleeding. Landmark analyses were performed at 1 month, the time point for intended DAPT interruption. We included 766 participants (age 77.5 ± 8.2 years, women 31.9%), 323 from the SENIOR and 443 from the POEM trial. The primary endpoint occurred in 45 participants (6.0%; 95% confidence interval [CI], 4.3-7.7%) through 1 year of follow-up, with 21 (2.8%; 95% CI, 1.6-3.9%) events during the first month and 24 (3.4%; 95% CI, 2.0-4.7%) thereafter. The incidences of cardiovascular death, myocardial infarction, and stroke were 2.2% (95% CI, 0.36-2.50%), 3.1% (95% CI, 1.8-4.3%), and 1.2% (95% CI, 0.4-2.0%), respectively. BARC type 3-5 bleeding ocuurred in 1.1% (95% CI, 0.3-1.8%) at 1 month and 2.9% (95% CI, 1.6-4.1%) at 1 year. HBR patients receiving biodegradable-polymer EES had few ischemic and bleeding events when given 1 month of DAPT. One-month DAPT after biodegradable-polymer EES implantation seems safe in patients at HBR.

Effect of dapagliflozin on uric acid in patients with chronic heart failure and hyperuricemia

BACKGROUND Patients with chronic heart failure (CHF) frequently develop hyperuricemia, an elevated serum uric acid level, associated with adverse outcomes. Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, demonstrates reduction in cardiovascular mortality and hospitalization in patients with CHF and ejection fraction (HFrEF), irrespective of diabetes. However, dapagliflozin’s effect on the uric acid levels in patients with CHF and hyperuricemia remain unclear. AIM To investigate the effects of dapagliflozin on uric acid levels in CHF patients with hyperuricemia. METHODS We conducted a randomized, double-blind, placebo-controlled trial in 200 patients with CHF and hyperuricemia, with HFrEF and serum uric acid levels ≥ 7 mg/dL (≥ 416 μmol/L). The participants were randomly assigned to receive a daily dose of 10 mg dapagliflozin or placebo for 24 months. The primary endpoint was the change in serum uric acid level from baseline to 24 months. Secondary endpoints included changes in left ventricular ejection fraction (LVEF), N-terminal pro-B-type natriuretic peptide (NT-proBNP), and quality of life (QoL) scores, as well as the incidence of cardiovascular death and hospitalization for heart failure. RESULTS At 24 months, dapagliflozin significantly reduced serum uric acid levels by 1.2 mg/dL (71 μmol/L) compared with placebo (95%CI: -1.5 to -0.9; P &lt; 0.001). Dapagliflozin also significantly improved LVEF by 3.5% (95%CI: 2.1-4.9; P &lt; 0.001), NT-proBNP by 25% (95%CI: 18-32; P &lt; 0.001), and QoL scores by 10 points (95%CI: 7-13; P &lt; 0.001) and reduced the risk of cardiovascular death and hospitalization for heart failure by 35% (95%CI: 15–50; P = 0.002) compared with the placebo. Adverse events were similar between the two groups, except for a higher rate of genital infections in the dapagliflozin group (10% vs 2%, P = 0.01). CONCLUSION Dapagliflozin significantly lowered serum uric acid levels and improved the clinical outcomes in patients with CHF and hyperuricemia. Therefore, dapagliflozin may be a useful therapeutic option for this high-risk population.

Effect of Reconstituted Human Apolipoprotein A-I on Recurrent Ischemic Events in Survivors of Acute MI

BackgroundThe AEGIS-II trial hypothesized that CSL112, an intravenous formulation of human apoA-I, would lower the risk of plaque disruption, decreasing the risk of recurrent events such as myocardial infarction (MI) among high-risk patients with MI. ObjectivesThis exploratory analysis evaluates the effect of CSL112 therapy on the incidence of cardiovascular (CV) death and recurrent MI. MethodsThe AEGIS-II trial was an international, multicenter, randomized, double-blind, placebo-controlled trial that randomized 18,219 high-risk acute MI patients to 4 weekly infusions of apoA-I (6 g CSL112) or placebo. ResultsThe incidence of the composite of CV death and type 1 MI was 11% to 16% lower in the CSL112 group over the study period (HR: 0.84; 95% CI: 0.7-1.0; P = 0.056 at day 90; HR: 0.86; 95% CI: 0.74-0.99; P = 0.048 at day 180; and HR: 0.89; 95% CI: 0.79-1.01; P = 0.07 at day 365). Similarly, the incidence of CV death or any MI was numerically lower in CSL112-treated patients throughout the follow-up period (HR: 0.92; 95% CI: 0.80-1.05 at day 90, HR: 0.89; 95% CI: 0.79-0.996 at day 180, HR: 0.91; 95% CI: 0.83-1.01 at day 365). The effect of CSL112 treatment on MI was predominantly observed for type 1 MI and type 4b (MI due to stent thrombosis). ConclusionsAlthough CSL112 did not significantly reduce the occurrence of the primary study endpoints, patients treated with CSL112 infusions had numerically lower rates of CV death and MI, type-1 MI, and stent thrombosis–related MI compared with placebo. These findings could suggest a role of apoA-I in reducing subsequent plaque disruption events via enhanced cholesterol efflux. Further prospective data would be needed to confirm these observations.

Clinical Background and Coronary Artery Lesions Characteristics in Japanese Patients With Acute Coronary Syndrome Suffering Major Bleeding.

Background: Although the clinical factors that predict major bleeding in Western patients with acute coronary syndrome (ACS) are becoming elucidated, they have not been fully investigated, especially coronary lesion characteristics, in a Japanese population. Methods and Results: ACS patients (n=1,840) were divided into a "bleeding group" and a "no-bleeding group," according to whether they had major bleeding during the 2-year follow-up period, to investigate the prognostic effect of bleeding and the predictive factors of bleeding. Among them, patients who underwent primary percutaneous coronary intervention with optical coherence tomography (OCT) guidance (n=958) were examined to identify the effect of coronary lesion characteristics on bleeding. Of the 1,840 enrolled patients, 124 (6.7%) experienced major bleeding during the 2-year follow-up period. Incidence of cardiovascular death during the 2-year follow-up period was significantly higher among patients with major bleeding (26.4% vs. 8.5%, P=0.001). OCT examination showed that disrupted fibrous cap (DFC: 68% vs. 48%, P=0.014) and calcified plaque (63% vs. 42%, P=0.011) were more prevalent in the bleeding group. DFC was a predictor of major bleeding in the multivariate Cox proportional hazards analyses (hazard ratio 2.135 [95% confidence interval 1.070-4.263], P<0.001). Conclusions: ACS patients with major bleeding had poorer cardiac outcomes. Advanced atherosclerosis at the culprit lesion influences the higher incidence of major bleeding in ACS patients.

Outcome after primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction complicated by cardiogenic shock

BackgroundPrimary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS) may reduce the risk of subsequent cardiovascular events but remains challenging. The study aim was to evaluate the clinical characteristics and long-term outcomes of patients undergoing primary PCI for STEMI with CS. MethodsWe conducted an observational cohort study of patients with STEMI who underwent primary PCI between April 2004 and December 2017 at Juntendo University Shizuoka Hospital. The primary outcome was cardiovascular death (CVD) during the median 3-year follow-up. We performed a landmark analysis for the incidence of CVD from 0 day to 1 year and from 1 to 10 years. ResultsAmong the 1758 STEMI patients in the cohort, 212 (12.1 %) patients with CS showed significantly higher 30-day CVD rate on admission than those without (26.4 % vs 2.9 %). Landmark Kaplan–Meier analysis showed that CVD from day 0 to year 1 was significantly higher in the patients with CS (log-rank p < 0.0001). Multivariate Cox regression analysis showed that CS was significantly associated with higher cardiovascular mortality (adjusted hazard ratio, 11.8; 95%confidence intervals, 7.78–18.1; p < 0.0001), but the mortality rates from 1 to 10 years were comparable (log-rank p = 0.68). ConclusionThe cardiovascular 1-year mortality rate for patients with STEMI was higher for those with CS on admission than without, but the mortality rates of >1 year were comparable. Surviving the early phase is essential for patients with STEMI and CS to improve long-term outcomes.

Serum 5'-Nucleotidase as a Novel Predictor of Adverse Clinical Outcomes after Percutaneous Coronary Intervention in Patients with Coronary Artery Disease.

The correlation between -Nucleotidase ( -NT) and the clinical outcomes in coronary artery disease (CAD) patients following percutaneous coronary intervention (PCI) is not clear. This study aims to clarify this relationship. The PRACTICE study enrolled 15,250 patients between December 2016 and October 2021. After filtering out those without -NT data, a total of 6555 patients were analyzed with a median follow-up of 24 months. Based on the receiver operating characteristic (ROC) curve analysis, a -NT level of 5.57 U/L was selected as the optimal cutoff value. All research samples were divided into high-value ( 5.57 U/L, n = 2346) and low-value groups ( 5.57 U/L, n = 4209). Key clinical outcomes included all-cause death (ACD), cardiovascular death (CD), major adverse cardiovascular events (MACE), and major adverse cardiovascular and cerebrovascular events (MACCE). After separating patients into high and low value groups, multivariate Cox regression analysis was used to correct for potential confounding variables. Finally, risk ratios and their 95% confidence intervals (CIs) were calculated. During the follow-up period, 129 instances of ACD were recorded-49 cases (1.2%) in the low-value group and 80 cases (3.4%) in the high-value group. Similarly, 102 CDs occurred, including 42 low-value group cases (1.0%) and 60 high-value group cases (2.6%). A total of 363 MACE occurred, including 198 low-value group cases (4.7%) and 165 high-value group cases (7%). A total of 397 cases of MACCE occurred, including 227 low-value group cases (5.4%) and 170 high-value group cases (7.2%). As serum -NT increased, the incidence of ACD, CD, MACE and MACCE increased. After multivariate Cox regression, high -NT levels were linked with a 1.63-fold increase in ACD risk (hazard ratio [HR] = 2.630, 95% CI: [1.770-3.908], p 0.001) when compared to low -NT patients. Similarly, the risk of CD, MACE, and MACCE increased by 1.298-fold (HR = 2.298, 95% CI: [1.477-3.573], p 0.001), 41% (HR = 1.410, 95% CI: [1.124-1.768], p = 0.003) and 30.5% (HR = 1.305, 95% CI: [1.049-1.623], p = 0.017), respectively. high serum -NT levels were independently correlated with adverse clinical outcomes in CAD patients following PCI, affirming its potential as a prognostic indicator.

Sleep apnoea is associated with long-term cardiovascular outcomes in patients undergoing coronary artery bypass grafting

Abstract Background Sleep apnoea is highly prevalent in patients undergoing coronary artery bypass grafting (CABG), and is associated with poorer peri-operative outcomes. However, whether sleep apnoea is associated with long-term cardiovascular outcomes remain unknown. Purpose We aimed to examine the relationship between sleep apnoea and long-term major adverse cardiac and cerebrovascular events (MACCE) in patients undergoing non-urgent CABG. MACCE was a composite endpoint that comprised cardiovascular mortality, non-fatal myocardial infarction, no-fatal stroke, and unplanned revascularisation. Methods This was a prospective cohort study with five years follow-up. Between 2013 and 2018, a total of 1007 patients referred to a tertiary cardiac centre for non-emergent CABG were recruited. All the participants underwent an overnight sleep study using an FDA-approved portable diagnostic device. Sleep apnoea was diagnosed when the apnoea-hypopnoea index was ≥15 events per hour. The clinical team involved in patient care was independent of the research project and blinded to the sleep study results. Results The sleep apnoea (n=513 patients, 50.9%) and non-sleep apnoea groups did not differ in terms of surgical complexity, based on the number of bypass grafts and the estimated blood loss. Fourteen patients died, including nine in the sleep apnoea and five in the non-sleep apnoea group. At an average follow-up of 4.8 years, the overall cohort had 221 patients (21.8%) experienced the four-component MACCE. This included 59 cardiovascular deaths (5.9%), 85 non-fatal myocardial infarctions (8.4%) , 90 non-fatal strokes (8.9%), and 71 unplanned revascularizations (7.1%). Compared with the non-sleep apnoea group, the sleep apnoea group experienced a higher crude incidence of MACCE (estimated 5-year incidence, 24.6% vs 17.2%, p=0.011). For the individual components, the incidence of cardiovascular death (6.6% vs 4.1%, p=0.071), non-fatal myocardial infarction (9.2% vs 7.7%, p=0.02), and non-fatal stroke (9.6% vs 8.3%, p=0.41) was higher in the sleep apnoea than the non-sleep apnoea group. The incidence of unplanned revascularizations was similar between the two groups (7.0% vs 7.1%, p=0.96). The Kaplan-Meier survival curve is shown in Figure 1. In the Cox regression analysis, sleep apnoea was associated with a higher incidence of MACCE (unadjusted Hazard Ratio [HR]=1.41, 95% Confidence Interval [CI]: 1.08 - 1.85, p=0.011). After adjustment for the effects of age, gender, body mass index, left ventricular ejection fraction, diabetes mellitus, hypertension, chronic kidney disease, and excessive daytime sleepiness, sleep apnoea was independently associated with MACCE (adjusted HR: 1.32; 95% CI: 1.01-1.73; p=0.041). Conclusion To the best of our knowledge, this is the first report showing that in patients undergoing an non-urgent CABG, sleep apnoea was independently associated with a 30% higher risk of MACCE over a long-term follow-up period.

Abstract 18319: Regional Disparities in the Cardiovascular Deaths Among Sarcoidosis Patients: A CDC-Wonder Database Analysis From 2005-2020

Background: Sarcoidosis can manifest as “Cardiovascular Death (CVD)” in undiagnosed patients. Regional Impact and Disparities In CVDs among sarcoidosis have not been identified. Methods: We analyzed data from the Centers for Disease Control and Prevention WONDER (Wide-Ranging Online Data for Epidemiologic Research) database from January 2005, to December 2020. All deaths related to CVS were included from 4 different regions. Data for deaths related to sarcoidosis and CVD were obtained by querying “Sarcoidosis” using ICD 10th Revision code “D86”. Rates per year for trends and disparities were calculated using cumulative CVD. Results: A total of 8211 CVD from 2005-2020 were identified among sarcoid patients- 1666, (20.2%) in north east, 1,697 (20.64%) in midwest, 3,684 (44.81%) in south and 1,164, (14.15%) in west . The CVDs occurred mostly in the ages(55-74) in the northeast, (45-74) in the Midwest, (35-84) in the south and (45-84) in the west. Incidence of cardiovascular death among females with sarcoid was greater than males in all regions .(12.03% vs 8.25% in northeast , 12.65% vs 8.02% in midwest , 8.12 %vs 6.05% in west , 27.13%v/s 17.73% in south ). The South showed a significantly higher population of blacks suffering from CVD (31.3% blacks vs 12.61% whites) whereas in other regions , the rates were comparable. The most common cause of CV death was found to be cardiac arrest (28.8 %) in the north east, cardiomyopathy(27.09%) in the midwest , cardiac arrhythmias (17.13%) in the west and conduction disorders (52.17%) in the south. An increasing trend of CVD was recorded in the south with an increase in rates from 42.5% in 2005 to 45% in 2020. Conclusion: Incidence of CVD related to sarcoidosis is highest in the south and females had higher mortality in all regions. Pulmonary hypertension, cardiac arrest and CHF were the major causes of CVD.

Abstract 15947: Cracking the Code of Cardiovascular Risk: Cardiac Troponin I vs. T in Community Dwelling Adults. Is Specificity at Stake?

Introduction. High sensitive cardiac troponin I and T (hs-cTnI and T) are detectable in most adults. Several studies have identified that hs-cTnI and T perform differently for long-term prediction of incident myocardial infarction (MI). Furthermore, in adults with myopathies, hs-cTnT can lose cardiovascular (CV) specificity which may be more relevant to MI prediction vs heart failure (HF) and CV death (CVD). We hypothesized that a meta-analysis of ambulatory adult studies would demonstrate hs-cTnI is a superior predictor of incident MI, but similar for HF and CVD. Methods. Research articles on hs-cTnI or T for longitudinal outcomes in ambulatory adults were screened from PubMed, EMBASE, and Web of Science inclusive of incident MI, HF or CVD and reporting hazard ratios (HR) and 95% confidence intervals (CI) for hs-cTn on a continuous log scale. Two reviewers evaluated the studies for inclusion, removing overlapping populations and extracting the most adjusted model HR. Pooled effect sizes were calculated with a random-effects model, and heterogeneity was assessed using the I 2 statistic. Subgroup analyses based on hs-cTn type were conducted. Results. A total of 3092 studies were screened and 44 met inclusion criteria. There were 109,553, 80,597, and 141,389 participants for HF, MI, and CVD with hs-cTnI measured, and 90,012, 81,259, and 73,977 participants for HF, MI, and CVD with hs-cTnT measured with a mean age of 61 ± 10 years and a median follow-up of 2.1 – 20 years. The pooled effect size estimate (HR) for HF, MI and CVD was 1.57(1.47, 1.66), 1.27(1.18, 1.37) and 1.41(1.32, 1.50) respectively. Subgroup analyses showed similar HR values for HF (I: 1.49 (1.37, 1.62) and T: 1.64 (1.51, 1.78)), MI (Figure) and CVD (I: 1.32 (1.21, 1.44) and T: 1.49 (1.36, 1.63)). Conclusion. hs-cTnI and T are prognostically similar for incident MI, as well as HF and CVD in ambulatory adults, suggesting similar cardiac specificity, though substantial heterogeneity exists between individual studies.

Abstract 13727: Cost-Effectiveness of Sotagliflozin in Heart Failure Patients With Preserved and Reduced Ejection Fractions—Results From the SOLOIST-WHF

Background: SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) showed patients with diabetes and recent worsening heart failure (HF), sotagliflozin initiated before or shortly after discharge lowered incident cardiovascular deaths, hospitalizations, and HF urgent visits. In this study, we evaluated the cost-effectiveness of sotagliflozin in all patients and those with preserved (HFpEF ≥50%) and reduced (HFrEF &lt;50%) ejection fraction. Methods: We ran a Markov microsimulation model based on treatment effects from SOLOIST-WHF, healthcare costs and utilities from national sources, and estimated net costs for sotagliflozin of $434 (range from $407 to $612) monthly, to calculate projected lifetime healthcare costs, HF and CVD events, survival, and quality-adjusted life-years (QALYs) for sotagliflozin vs placebo in SOLOIST-WHF eligible patients from a payer perspective. Outcome measured as the incremental cost-effectiveness ratio (ICER), incremental costs / QALYs gained. Sensitivity analyses assessed and quantified uncertainties. Results: Over a lifetime, sotagliflozin compared to placebo added 0.39 QALYs (4.43 vs. 4.04 QALYs) and 0.64 life-years (7.12 vs. 6.48) at an incremental cost of $29,449 (95% uncertainty interval (UI): $26,610-$32,528) for an ICER of $75,510 per QALY gained (UI: $55,640-$98,300). In HFpEF patients, sotagliflozin compared to placebo added 0.43 QALYs (4.53 vs. 4.10 QALYs) and 0.68 life-years (7.14 vs. 6.46) at an incremental cost of $26,615 (UI: $23,376-$29,694) for an ICER of $61,488 per QALY gained (UI: $41,618-$84,280). In HRrEF patients, sotagliflozin added 0.37 QALYs (4.33 vs. 3.96 QALYs) and 0.63 life-years (7.09 vs. 6.46) at an incremental cost of $30,012 (UI: $26,773-$33,251) for an ICER of $77,996 per QALY gained (UI: $58,126-$100,780). The benefit of sotagliflozin in QALY mainly results from the decrease in CVD deaths. Findings were sensitive to drug cost and number of readmissions. Conclusions: This study demonstrates that sotagliflozin priced from $407 to $612 per month is a clinically and economically favorable medication in patients with diabetes, recent worsening heart failure, with both preserved and reduced ejection fraction.

Time Trends of Etiology, Treatment, and Long-Term Outcomes Among Patients with Left Ventricular Thrombus.

Recommendations for drug treatment of left ventricular thrombus (LVT) are based on the ST-segment elevation myocardial infarction (STEMI) guidelines; however, the etiology of LVT has changed. Due to the lack of evidence regarding LVT treatment in the heart failure population, current heart failure guidelines do not cover LVT treatment. We sought to review the etiology of LVT and changes in antithrombotic therapy over the previous 12 years and explore the impact of anticoagulation treatment from a single center's experience. From January 2009 to June 2021, we studied 1675 patients with a discharge diagnosis of LVT at a single center to investigate the clinical characteristics, incidence of all-cause death, cardiovascular death, ischemic stroke, major adverse cardiac and cerebrovascular events (MACCE), systemic embolism (SE), and major bleeding events. Patients were divided into an anticoagulant group and a non-anticoagulant group according to whether they received oral anticoagulant therapy at discharge. The study included 909 patients (anticoagulation, 510; no anticoagulation, 399). While overall antiplatelet therapy dramatically decreased, more patients with LVT received oral anticoagulation in 2021 (74.0%) than in 2009 (29.6%). In addition, more than half of the patients had heart failure with reduced ejection fraction (HFrEF) each year. The all-cause mortality was 17.3% during 3.8 years of follow-up. The incidences of cardiovascular death, stroke, MACCE, SE, and major bleeding were 16.0%, 3.3%, 19.8%, 5.1%, and 1.7%, respectively. The anticoagulation group had a significantly higher proportion of dilated cardiomyopathy than the non-anticoagulation group (24.7% vs. 5.5%, p 0.001), and a lower LVEF (34.0 vs. 41.0, p 0.001). The anticoagulation group also had a higher probability of adverse events on long-term follow-up (p 0.05). A multivariable competing risk regression model found no significant difference in all six endpoints between the groups (all p 0.05). Similar results were found by matched and weighted data analysis. Diabetes mellitus (hazard ratio (HR), 1.42; 95% confidence interval (CI), 1.04-1.93; p = 0.027), renal insufficiency (HR, 2.36; 95% CI, 1.60-3.50; p 0.001), history of previous stroke (HR, 1.60; 95% CI, 1.13-2.29; p = 0.009), and HFrEF (HR, 2.54; 95% CI, 1.78-3.64; p 0.001) were predictors of increased risk of MACCE. Heart failure, rather than acute myocardial infarction, is currently the primary cause of LVT. A trend towards better prognosis in the no anticoagulation group was noted. Multivariable, matching and weighting analysis showed no improvement in prognosis with anticoagulant therapy. Our study does not negate the efficacy of anticoagulation but suggests the need to strengthen the management of anticoagulation in order to achieve better efficacy.

Indian Real-world Evidence of Rivaroxaban Use in Coronary Artery Disease – A Prospective Observational Cohort Study (IN-RECORD): Study Design and Baseline Characteristics

Abstract Background: Antiplatelet therapy (APT) is the cornerstone for cardiovascular (CV) prevention in patients with coronary artery disease (CAD). However, there is potential for greater effectiveness in vascular prevention for patients with stable CAD or peripheral artery disease (PAD) through the use of rivaroxaban alone or in combination with aspirin, surpassing the benefits offered by aspirin alone. Materials and Methods: INdian Real world EvidenCe Of Rivaroxaban use in coronary artery Disease – A prospective observational cohort study (IN-RECORD) study is designed as a prospective, observational study. The objective of this study is to compare the real-world effectiveness and safety of rivaroxaban in combination with APT (dual pathway inhibition therapy [DPIT]) versus dual APT (DAPT) in Indian patients with CAD and peripheral arterial disease (PAD). The study will encompass multiple clinical sites across the Indian geography. The study’s primary outcome is the comparison of net clinical benefit between the two groups which is defined as the composite of effectiveness (reduction in incidence of CV death, stroke, and myocardial infarction [MI]) and safety (life-threatening or fatal bleeding). Results: From June 2021 to December 2022, we enrolled 374 patients from the participating sites from India. We enrolled 225 and 149 patients in the DAPT and DPIT groups, respectively. The mean observed age and weight at the baseline were 63.05 ± 10.09 years and 64.15 ± 11.43 kg, respectively. There was a male preponderance observed in the enrolled patients (males: 86.63%, females: 13.37%). The most frequent comorbidity observed in CAD patients was hypertension, followed by diabetes and MI. At baseline, a significant percentage of patients were taking antiplatelet medications besides aspirin. Conclusion: IN-RECORD will provide information on the efficacy and safety of rivaroxaban in combination with APT versus APT in the Indian patient population in real-life clinical scenario.

BASELINE REMNANT CHOLESTEROL MODIFIES THE EFFECT OF INTENSIVE BLOOD PRESSURE CONTROL ON CARDIOVASCULAR OUTCOMES IN PATIENTS WITH TYPE 2 DIABETES: THE ACCORD-BP TRIAL

Objective: The equivocal benefit of intensive blood pressure lowering in patients with diabetes may be partially due to the neglected residual cardiovascular risk. However, it remains uncertain whether residual cholesterol (RC) level affect the benefit of intensive blood pressure lowering in patients with diabetes. We aimed to determine whether the treatment difference of intensive versus standard blood pressure therapy on risk of cardiovascular events (CVD) in the ACCORD-BP trial depended on baseline RC level. Design and method: Participants in the ACCORD-BP trail were divided into two groups based on baseline RC levels (low RC: &lt; 31 mg/dL and high RC: 31mg/dL and higher). We report the primary outcomes identical to those used in the original ACCORD trial, which included nonfatal myocardial infarction, nonfatal stroke, and/or incident cardiovascular death. Adjusted hazard ratios (aHR) with 95% confidence intervals (CI) estimated from stratified Cox regression models were used to quantify the association between intensive therapy and incident CVD for the 2 different baseline RC groups. Results: The incident rate was significantly lower in the intensive-therapy group as compared with standard-therapy group in the low RC group (log-rank P = 0.029) but not in the high RC group (log-rank P = 0.74). Compared with standard therapy, intensive therapy was associated with a lower risk of incident CVD among participants with low RC (aHR: 0.71; 95% CI: 0.53 to 0.94), but not among participants with high RC (aHR: 1.04; 95% CI: 0.80 to 1.35). The same pattern was observed for nonfatal stroke (aHR [95% CI] in participants with low RC: 0.48 [0.25-0.93]; aHR [95% CI] in participants with high RC: 0.76 [0.41-1.41]). Subgroup analyses revealed that the protective effect of intensive therapy against CVD events among the low RC group was not influenced by sex, previous CVD at baseline, assignment to intensive glycemic control, systolic or diastolic blood pressure at baseline, and baseline low-density lipoprotein cholesterol levels. Conclusions: Intensive blood pressure lowering therapy was effective at preventing incident CVD events in the ACCORD-BP trial participants with low baseline RC level but not in those with high RC level.

WATCH-DM risk score predicts the prognosis of diabetic phenotype patients with heart failure and preserved ejection fraction

BackgroundHeart failure with preserved ejection fraction (HFpEF) is a heterogeneous syndrome. Diabetes may identify an essential phenotype that significantly affects the prognosis of these patients. The WATCH-DM risk score has been validated for predicting the risk of heart failure in outpatients with type 2 diabetes mellitus (T2DM), but its ability to predict clinical outcomes in HFpEF patients with T2DM is unknown. We aimed to assess whether this risk score could predict the prognosis of diabetic phenotype patients with heart failure and preserved ejection fraction. MethodsWe enrolled retrospectively 414 patients with HFpEF (70.03 ± 8.654 years, 58.70% female), including 203 (49.03%) type 2 diabetics. Diabetic HFpEF patients were stratified by baseline WATCH-DM risk score. ResultsDiabetic HFpEF patients exhibited a trend toward more concentric remodeling/hypertrophy than nondiabetic HFpEF patients. When analyzed as a continuous variable, per 1-point increase in the WATCH-DM risk score was associated with increased risks of all-cause death (HR 1.181), cardiovascular death (HR 1.239), any hospitalization (HR 1.082), and HF hospitalization (HR 1.097). The AUC for the WATCH-DM risk score in predicting incident cardiovascular death (0.7061, 95% CI 0.6329–0.7792) was higher than that of all-cause death, any hospitalization, or HF hospitalization. ConclusionsAs a high-risk phenotype for heart failure, diabetic HFpEF necessitates early risk stratification and specific treatment. To the best of our knowledge, the current study is the first to demonstrate that the WATCH-DM score predicts poor outcomes in diabetic HFpEF patients. Its convenience may allow for quick risk assessments in busy clinical settings.

A Systematic Review and Meta-Analysis of the Incidence and Risk Factors for Major Adverse Cardiovascular Events in Patients with Unrepaired Abdominal Aortic Aneurysms

Major adverse cardiovascular events (MACE), including myocardial infarction (MI), stroke and cardiovascular death, cause substantial morbidity and mortality. This review assessed the incidence rate of MACE and the association with modifiable risk factors (diabetes, hypertension) and medication use (aspirin, statins) in patients with unrepaired abdominal aortic aneurysm (AAA). Electronic databases were searched systematically for observational studies reporting the incidence of MI, stroke or cardiovascular death in patients with unrepaired AAAs. The primary outcome was cardiovascular death reported as an incidence rate (events per 100 person-years (PY)). Fourteen studies, including 69,579 participants with a mean follow-up time of 5.4 years, were included. Meta-analysis revealed the overall incidence of cardiovascular death, MI and stroke of 2.31 per 100 PY (95% CI, 1.63-3.26; I2 = 98%), 1.65 per 100 PY (95% CI, 1.01-2.69, I2 = 88%) and 0.89 per 100 PY (95% CI, 0.53-1.48, I2 = 87.0%), respectively. The mean rates of statin and aspirin prescriptions were 58.1% and 53.5%, respectively. In conclusion, there is a substantial incidence of MACE in patients with unrepaired AAA, but the prescription of preventative medication is suboptimal. Greater emphasis should be placed on secondary prevention in this population.

Impact of gender on mid-term prognosis of patients undergoing coronary artery bypass grafting.

We evaluated the impact of sex on mid-term prognosis in patients who underwent coronary artery bypass grafting (CABG). Data on gender differences in current management or clinical outcomes after CABG are controversial, and there have been limited data focusing on them. This was a retrospective and prospective, single-center, observational study. Between January 2001 and December 2017, 6613 patients who underwent CABG were enrolled from an institutional registry of Samsung Medical Center, Seoul, Korea (Clinicaltrials.gov, NCT03870815) and divided into two groups according to sex (female group, n = 1679 vs. male group, n = 4934). The primary outcome was cardiovascular death or myocardial infarction (MI) at 5 years. Propensity score matching analysis was performed to reduce confounding factors. During a mean follow-up duration of 54 months, a total of 252 cardiovascular death or MIs occurred (female, 78 [7.5%] vs. male, 174 [5.7%]). Multivariate analysis revealed no significant difference in the incidence of cardiovascular death or MI at 5 years between female and male groups (hazard ratio [HR] 1.05; 95% confidence interval [CI] 0.78 to 1.41; p = 0.735). After propensity score matching, the incidence of cardiovascular death or MI was still similar between the two groups (HR 1.08; 95% CI 0.76 to 1.54; p = 0.666). The similarity of long-term outcomes between the two groups was consistent across various subgroups. There was also no significant difference in the risk of 5-year cardiovascular death or MI between males and females according to age (pre- and postmenopausal status) (p for interaction = 0.437). After adjusting for baseline differences, sex does not appear to influence long-term risk of cardiovascular death or MI in patients undergoing CABG. NCT03870815.