Composite Of All-cause Mortality Research Articles

TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and complex or multivessel coronary disease (TCW): an international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial

Patients with severe aortic stenosis present frequently (∼50%) with concomitant obstructive coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as the preferred treatment. Transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) represent a valid treatment alternative. We aimed to test the non-inferiority of FFR-guided PCI plus TAVI versus SAVR plus CABG in patients with severe aortic stenosis and complex coronary artery disease. This international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial was conducted at 18 tertiary medical centres across Europe. Patients (aged ≥70 years) with severe aortic stenosis and complex coronary artery disease, deemed feasible for percutaneous or surgical treatment according to the on-site Heart Team, were randomly assigned (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG according to a computer-generated sequence with random permuted blocks sizes stratified by site. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularisation, valve reintervention, and life-threatening or disabling bleeding at 1 year post-treatment. The trial was powered for non-inferiority (with a margin of 15%) and if met, for superiority. The primary and safety analyses were done per an intention-to-treat principle. This trial is registered with ClinicalTrials.gov (NCT03424941) and is closed. Between May 31, 2018, and June 30, 2023, 172 patients were enrolled, of whom 91 were assigned to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age of patients was 76·5 years (SD 3·9). 118 (69%) of 172 patients were male and 54 (31%) patients were female. FFR-guided PCI plus TAVI resulted in favourable outcomes for the primary endpoint (four [4%] of 91 patients) versus SAVR plus CABG (17 [23%] of 77 patients; risk difference -18·5 [90% CI -27·8 to -9·7]), which was below the 15% prespecified non-inferiority margin (pnon-inferiority<0·001). FFR-guided PCI plus TAVI was superior to SAVR plus CABG (hazard ratio 0·17 [95% CI 0·06-0·51]; psuperiority<0·001), which was driven mainly by all-cause mortality (none [0%] of 91 patients vs seven (10%) of 77 patients; p=0·0025) and life-threatening bleeding (two [2%] vs nine [12%]; p=0·010). The TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment. Isala Heart Centre and Medtronic.

External Validation of COAPT Risk Score in Patients Undergoing Transcatheter Edge-To-Edge Repair of Severe, Functional Mitral Regurgitation: a Multicenter, Observational Italian-Polish Study

COAPT Risk Score predicts the risk of death or hospitalization for heart failure (HFH) within 2 years after transcatheter edge-to-edge repair (TEER) of mitral regurgitation (MR) using MitraClip device. We performed an international validation of the Score in patients undergoing TEER in Italian and Polish cardiology centers. Patients with severe, functional MR who underwent TEER with MitraClip between March 2012 and July 2023 were included. Patients were categorized as COAPT eligible or COAPT non-eligible based on the COAPT trial criteria. Clinical data were collected from medical records and COAPT Risk Score was calculated for each patient. The primary endpoint was a composite of all-cause mortality and HFH at 2-year follow-up. Among 344 patients, 218 (63%) were COAPT eligible and 126 (37%) COAPT non-eligible. Higher COAPT Score correlated with increased risk of primary endpoint in the overall population (p<0.001), COAPT eligible (p=0.020) and COAPT non-eligible group (p=0.042). COAPT Score had poor predictive value for the primary endpoint in every group (AUC ≤0.61 for all). It performed better among lower-risk patients (<4 points), compared to higher-risk patients (≥4 points) (AUC 0.658 vs. AUC 0.523). COAPT Score was independently associated with an increased risk of primary endpoint in patients with <4 points (adjusted HR 1.338, 95% CI 1.031-1.737, p=0.028), but not those with higher Score values. In conclusion, COAPT Risk Score has poor performance in COAPT-eligible and -non-eligible patients with severe FMR. The Score performance depends on the patient baseline risk, with better accuracy in lower-risk patients.

The Impact of Multiarterial Grafting in Patients with Left Ventricular Dysfunction.

Coronary artery bypass grafting (CABG) is one of the revascularization modalities available in patients with left ventricular dysfunction (LVD). Multiple arterial grafting (MAG) is associated with improved long-term outcomes. Data on the benefits of MAG in patients with LVD are limited. We examined the effect of MAG on outcomes across the spectrum of left ventricle (LV) function. Retrospective cohort study of patients undergoing isolated CABG (January 1, 2009, to October 1, 2021). Patients were grouped according to revascularization strategy (single vs. MAG). The primary outcome was a composite of all-cause mortality, cerebrovascular accident, myocardial infarction, and repeat revascularization (major adverse cardiac and cerebrovascular events [MACCE]). The cumulative incidence of MACCE was plotted using Kaplan-Meier curves. Results were stratified according to LV function (<30%, 30-50%, >50%). Our cohort included 4,763 patients; 1,976 (41.4%) underwent single arterial grafting (SAG), and 2,787 (58.6%) underwent MAG; 3,976 (83.4%) were male with a median age of 64 (interquartile range [IQR] 57-71) years. Distribution of LV function was 2,539 (53.3%) with an ejection fraction (EF) >50%, 1,828 (38.3%) with an EF of 30-50%, and 396 (8.3%) with an EF <30%. Median follow-up time was 64 (37-102) months. Cumulative incidence of MACCE at 72 months was 28.7% in the MAG and 30.3% in the SAG group. Stratified by LV function, the hazard ratio for MACCE at 160 months was 0.71 (95% CI 0.54-0.93), 0.78 (95% CI 0.68-0.9), and 0.95 (95% CI 0.83-1.09) for LV function <30%, 30-50%, >50%, respectively, with no significant interaction between MAG and LV function. MAG is associated with improved outcomes following CABG across the spectrum of LV function.

Abstract 4139177: Five-Year Clinical Outcomes of Balloon-Expandable versus Self-Expanding Transcatheter Aortic Valve Replacement in Patients with Small Aortic Annulus

Introduction: Self-expanding transcatheter aortic valves (SEV) have reportedly better hemodynamic outcomes, and similar clinical outcomes compared to balloon-expanding valves (BEV) at 1 year in patients with a small aortic annulus based on results from the SMART trial. Head-to-head comparison of long-term clinical outcomes, however, is lacking. Objectives: To compare the long-term (5 years) echocardiographic and cardiovascular outcomes in BEV versus SEV in patients with small aortic annulus undergoing transcatheter aortic valve replacement (TAVR). Methodology: The RESOLVE registry included consecutive patients who underwent TAVR and survived up to 30 days at Cedars-Sinai Medical Center with either BEV or SEV from 2015 to 2020, with clinical variables obtained from the STS/TVT registry. CT core lab analysis identified patients with a small aortic annulus (&lt;430 mm 2 ), who were systematically followed up with clinical exams and echocardiography until December 2023. The primary outcome was a composite of all-cause mortality, stroke or transient ischemic attack, or heart failure hospitalization at 5 years. Results: Out of 1392 patients, a total of 423 met criteria for small aortic annulus (345 BEV, 78 SEV), with a median follow-up of 5 years (4-6 years). There were no significant differences in baseline sociodemographic and clinical characteristics between the BEV and SEV groups. (Figure 1) The post-TAVR invasive aortic valve mean gradient were similar in both groups [Median (IQR): BEV:3(1-5.8), SEV: 3.4(0.4-6.6), p 0.58], while echocardiographic gradients were higher in BEV group [Median (IQR): BEV:12 (9-15), SEV:8(6-11), p&lt;0.001)].There was no significant difference in primary outcome at 5 years in Cox multivariable regression analysis (HR:1.21, 95% CI 0.81-1.82, p 0.33) (Figure 2). There were no significant differences in other clinical endpoints at 5 years, although patients with SEV had lower echocardiographic gradients and higher indexed effective orifice area. (Figure 2-3) Conclusion: Post-TAVR invasive aortic valve gradients were similar between BEV and SEV, despite higher echocardiographic transaortic gradients in BEV patients. We found no significant difference in 5-year clinical outcomes between patients who received TAVR with BEV or SEV.

Abstract 4115684: Outcomes Associated with Remote Monitoring without In-person Evaluations for Patients with Cardiovascular Implantable Electronic Devices

Introduction: Traditionally, patients with cardiovascular implantable electronic devices (CIEDs: pacemakers and implantable cardioverter-defibrillators) attend in-person visits at least annually, paired with remote monitoring (RM). Because similar data are obtained through RM and in-person visits, it is unclear whether routine in-person visits are necessary. Two small trials conducted outside the U.S. found no difference in clinical outcomes without routine in-person visits for patients engaged in RM, but their generalizability is uncertain. Research Aim: To determine whether routine visits for CIED care are associated with major adverse cardiac events (MACE) among patients in the U.S.’ largest public integrated health system, the Veterans Health Administration (VHA). Methods: We classified Veterans who received their CIED care within VHA and sent ≥1 RM transmission between 7/1/20-6/30/21 into one of three groups based on type of clinical encounters for CIED care: (1) any in-person, (2) virtual-only (telephone and/or videoconference), or (3) no in-person or virtual visits. Data were obtained from the VHA National Cardiac Device Surveillance Program and Corporate Data Warehouse. The primary outcome was MACE, a composite of all-cause mortality, stroke, and cardiac hospitalization, between 7/1/21-6/30/22. We performed multivariable logistic regression, adjusting for patient and device characteristics. Results: Of 40,366 patients, 27,298 (68%) had at least one in-person visit, 9,268 (23%) had only virtual visits, and 3,800 (9%) had neither. Mean age was 73 years, 97% were male, and 37% lived in rural areas. There were 6522 (23.9%) MACE events among patients who had in-person visits, 2116 (22.8%) among those who had only virtual visits, and 947 (24.9%) among those who had no visits. After multivariable adjustment, there was no significant association between encounter type and MACE [odds ratio 0.93 (95% CI: 0.85-1.01) for patients who had any in-person or virtual visits compared to those without]. Conclusion: Among patients engaged in RM, the odds of MACE was similar regardless of whether patients had in-person or virtual visits versus no visits. Although there could be unmeasured confounding, these results suggest routine in-person or virtual visits may no longer be necessary for CIED care with RM. Patients, clinicians, and healthcare systems could benefit by reducing low-value visits and re-focusing resources on visits that yield actionable interventions.

Associations of SGLT2i with Cardiorenal Outcomes Among Diabetics with Prostate Cancer on Hormone Therapy.

Studies have reported associations between prostate cancer, type II diabetes mellitus (T2DM), and cardiovascular disease in the context of treatment with hormone therapy (HT). This study aimed to assess the role of Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in preventing adverse cardiovascular and renal outcomes in diabetics with prostate cancer. Patients ≥ 18years of age with T2DM and prostate cancer who received HT between August 1, 2013, and August 31, 2021, were identified using the TriNetX research network. Patients were divided into two cohorts based on treatment with SGLT2i or alternative antidiabetic therapies. The primary outcome was the composite of all-cause mortality, new-onset heart failure (HF), acute myocardial infarction (MI), and peripheral artery disease over 2years from HT initiation. After propensity score matching, 2155 patients remained in each cohort. The primary composite outcome occurred in 218 patients (16.1%) in the SGLT2i cohort versus 355 patients (26.3%) in the non-SGLT2i cohort (OR 0.539, 95% CI 0.446-0.651; p < 0.001). Furthermore, SGLT2i were associated with significantly lower odds of HF, HF exacerbation, peripheral artery disease, atrial fibrillation/flutter, cardiac arrest, need for renal replacement therapy, overall emergency room visits/hospitalizations, and all-cause mortality. Use of SGLT2i for the treatment of T2DM among patients with prostate cancer on HT is associated with favorable cardiovascular, renal, and all-cause mortality outcomes. This observation supports the hypothesis that a therapeutically relevant link exists between HT and cardiovascular disease in the context of prostate cancer.

Preventive catheter ablation for ventricular arrhythmias in patients with end-stage heart failure referred for heart transplantation evaluation: Rationale for and design of the CASTLE-VT trial.

Timely referrals for transplantation and left ventricular assist device (LVAD) play a key role in favourable outcomes in patients with advanced heart failure (HF). Cardiovascular mortality, driven by sudden cardiac death, is the main reason for dying while waiting for heart transplantation (HTx). The purpose of the Preventive Catheter Ablation for ventricular arrhythmiaS in patients with end-sTage heart faiLure rEferred for heart transplantation eValuaTion (CASTLE-VT) trial is to test the hypothesis that prophylactic catheter ablation of arrhythmogenic ventricular scar tissue will reduce mortality, need for LVAD implantation, and urgent HTx in patients with end-stage HF related to ischaemic cardiomyopathy (ICM). CASTLE-VT is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for HTx evaluation and diagnosed with ICM. Ablation will be performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. The primary endpoint is the composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation. The main secondary study endpoints are all-cause mortality, cardiovascular mortality, incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, quality of life, time to first ICD therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, left ventricular function, and exercise tolerance. CASTLE-VT will randomize 160 patients with a follow-up period of 2 years. CASTLE-VT will determine whether prophylactic catheter ablation of arrhythmogenic ventricular scar tissue reduces mortality in patients with end-stage HF who are referred for HTx evaluation.

1-Year Outcomes of Transcatheter AorticValve Replacement Using a Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valve.

Mid-term comparative data for the self-expanding ACURATE neo2 transcatheter heart valve and the balloon-expandable SAPIEN 3 Ultra are lacking. The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement of these 2 valves. A total of 2,106 patients from 3 centers (neo2, n=1,166; Ultra, n=940) undergoing transfemoral transcatheter aortic valve replacement were analyzed retrospectively. The primary endpoint was the composite of all-cause mortality, stroke, and rehospitalization at 1 year. Secondary endpoints were the individual components of the primary endpoint at 1 year. To adjust for baseline differences, nearest neighbor propensity score matching was used. After matching (702 pairs), baseline characteristics were similar between groups. Device success was more common in the neo2 group (87.5% vs 82.3%; P=0.007), irrespective of matching. DP mean after the procedure was higher for Ultra (13mmHg [Q1-Q3: 10-15mmHg] vs 8mmHg [Q1-Q3: 6-11] mmHg; P< 0.001). Rates of paravalvular leakage, device embolization, and multiple valve implantations were more common in the neo2 arm, whereas major cardiac structural complications and major vascular complications occurred more frequently in the Ultra group. All other in-hospital complication rates were similar between the 2 groups. At 1 year, the cumulative incidence of the primary endpoint (14.1% for neo2 vs 14.5% for Ultra; P=0.819) was similar between the groups. Likewise, the individual components showed no difference between the groups. Despite differing immediate results, the outcomes at 1 year, including the composite of all-causemortality, stroke, or hospitalization, were similar for neo2 and Ultra transcatheter heart valves.

Incremental Prognostic Value of Left Ventricular and Left Atrial Strain in Moderate Aortic Stenosis.

Patients with moderate aortic stenosis (AS) show a poor prognosis if they have high-risk features. We investigated the incremental prognostic value of left ventricular (LV) and left atrial (LA) strain in patients with moderate AS. In a cohort of 923 patients with moderate AS (median age 74 years, men 55%, aortic valve area 1.18 [IQR 1.08-1.30] cm2, mean pressure gradient 25 [IQR 23-30] mmHg), LV global longitudinal strain (LV-GLS) and LA reservoir strain (LARS), were measured using speckle-tracking echocardiography. Absolute values of myocardial strain were used. The primary endpoint was a composite of all-cause mortality and heart failure hospitalization.During a median of 5.9 years, the primary endpoint occurred in 186 patients (20.2%). The median LV-GLS and LARS were 17.7% (IQR 14.8-19.7) and 24.5% (IQR 18.7-29.3). LV-GLS (adjusted HR 0.92, 95% CI 0.87-0.97) and LARS (adjusted HR 0.97, 95% CI 0.95-0.99) were significant predictors of the primary outcome, independent of clinical and echocardiographic variables including LV ejection fraction. Notably, the prognostic value of LV-GLS was stronger than that of LARS, remaining significant after further adjustment for LARS. LV-GLS<17% and LARS<22% were identified as optimal cutoffs for the primary outcome. Patients with both reduced LV-GLS and LARS had the worst outcome (log-rank p<0.001). LV-GLS<17% and LARS<22% had incremental prognostic value on top of other clinical and echocardiographic variables. In moderate AS, reduced LV-GLS and LARS have incremental prognostic value, and can refine risk stratification to identify high-risk patients.

Differences between MINOCA and type 2 myocardial infarction: An ITALIAN observational study

BackgroundMyocardial infarction with non-obstructive coronary arteries (MINOCA) and type 2 myocardial infarction (MI), both presenting as non-ST-elevation MI (NSTEMI), are often grouped together due to overlapping symptoms. The aim of our study is to compare their characteristics and prognosis to distinguish between them. MethodsAmong 7815 patients with NSTEMI who underwent coronary angiography between 2005 and 2022 we identified 538 patients with diagnosis of MINOCA (n = 301; 3,9 %) and type 2 MI (n = 237; 3 %). The outcome was a composite of all-cause mortality, non-fatal MI, hospitalisation for heart failure (HF) and transitory ischemic attack or non-fatal stroke. ResultsThe mean age of the entire cohort was 68 (11.5) years, with women being the most frequently represented group (65 %). Comparing the sub-cohorts, MINOCA patients were younger (66.3 (11.7) Vs. 70.6 (11) years, p < 0.01), and less likely to have typical cardiovascular risk than type 2 MI patients.At multivariable analysis different clinical (age, heart rate, typical chest pain, palpitations, postmenopausal status), and instrumental (cardiac rhythm, ST-segment changes, diastolic dysfunction, hypo/akinesia with non-coronary distribution) variables were independent predictors of MINOCA with AUC of 0.83 [95 % CI, 0.78–0.88], p < 0.01 at ROC analysis.At a median follow-up of 61 (IQR 34–100) months, MINOCA patients had significantly lower rate of the composite endpoint compared to type 2 MI (20 % Vs. 32 %, p < 0.01). ConclusionsMINOCA cohort was associated with different characteristics compared to type 2 MI and had a better prognosis despite the number of events was not negligible.

Impact of discharge checklist on guideline-directed medical therapy and mid-term prognosis in heart failure.

Despite the proven benefit of the guideline-directed medical therapy (GDMT), it remains underutilized in patients hospitalized with acute heart failure (HF). We aimed to evaluate the impact of the discharge checklist on GDMT installation and the prognosis of HF patients. This study was a single-center, observational study that included all patients admitted for HF from March 2021 to February 2023. The data were retrieved from electronic medical records and discharge checklists. A comparison was conducted between the checklist group and the non-checklist group. The primary endpoint was a composite of all-cause mortality or readmission for HF within 6 months. The checklist was completed for 537 patients (checklist group) and not for 187 patients (non-checklist group). The proportion of patients to whom two or more components of GDMT were prescribed was significantly higher in the checklist group than in the non-checklist group (59.6% vs 42.2%, p < 0.001). The checklist group exhibited a significantly lower primary outcome compared to the non-checklist group (27.4% vs. 36.4%, HR 0.73, 95% CI 0.55-0.98, p = 0.036). The effect of the checklist was more prominent in HF with reduced ejection fraction (HR 0.51, 95% CI 0.34-0.77, p = 0.001) than in HF with mildly-reduced and preserved ejection fraction (HR 0.91, 95% CI 0.58-1.42, p = 0.676) (p for interaction = 0.06). The implementation of the discharge checklist was associated with an improvement in GDMT prescription and an improved prognosis in patients with HF with reduced ejection fraction.

Impact of Alcohol Consumption on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention.

Background/Objectives: The impact of alcohol consumption and its restriction on clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) remains elusive. We aimed to investigate the clinical outcomes in drinkers undergoing PCI. Methods: We included 77,409 patients who underwent PCI and a health check-up within one year of the PCI using a nationwide prospective database from the Korean National Health Insurance System. Primary outcomes were major adverse cardiovascular and cerebrovascular events (MACCE), a composite of all-cause mortality, myocardial infarction, coronary revascularization, and stroke. Patients were classified as non-drinkers, within-the-guideline (≤1 standard drink in women and ≤2 in men), and above-the-guideline drinkers based on drinking status at the first health check-up after PCI. Results: During a 4.0-year follow-up duration, MACCE incidence was 19.7% (n = 15,214) (4689 [6.1%] deaths, 1916 [2.5%] MI, 2033 [2.6%] strokes, and 10,086 [13.0%] revascularizations). Both within-the-guideline- (aHR [95%CI], 0.843 [0.773-0.919]) and above-the-guideline drinkers (0.829 [0.784-0.876]) had a lower MACCE risk than the non-drinkers. A characteristic J-curve relationship was observed between the frequency or body weight-adjusted alcohol consumption and MACCE risk, with the lowest risk in the once-per-week and a mild amount per body weight (≤0.33 g/kg/week) group. Drinking habits after PCI were associated with a lower risk of adverse cardiovascular outcomes; those who continued to drink before and after PCI had the lowest risk. Conclusions: Alcohol consumption was associated with a lower risk of adverse outcomes in patients undergoing PCI. Further studies with longer-term follow-up are warranted.

Incidence, characteristics, and prognostic impact of cancers in patients with atrial fibrillation: a report from the GLORIA-AF registry

Abstract Background Cancers and atrial fibrillation (AF) are all aging-related diseases. Coexistence of the two conditions makes management complex due to increased risk of both thromboembolism and bleeding. Purpose The aim of the present study was to analyze the incidence and prognostic impact of cancers in patients with AF in the GLORIA-AF registry. Methods GLORIA-AF registry is a prospective multi-centered international multi-centered AF cohort studies. We characterized these patients according to the presence or absence of a cancer diagnosis when enrolled. The primary endpoints were all-cause mortality, cardiovascular mortality, and major bleeding; the secondary endpoints were major adverse cardiovascular events (MACEs) including all-cause mortality, stroke, and major bleeding. Results The prevalence of cancers was 9.7%. The mean CHA2DS2-VASc and HAS-BLED scores in cancer patients were higher than in non-cancer patients (mean CHA2DS2-VASc 3.5 vs. 3.2, P&amp;lt;0.001; mean HAS-BLED score 1.6 vs. 1.3, P&amp;lt;0.001). Patients with cancers had higher oral anticoagulant use than non-cancer patients (84.4% vs. 81.0%, P&amp;lt;0.001) and were more likely to receive NOACs (58.4% vs. 54.0%, P&amp;lt;0.001). During a mean follow up period of 3 years, AF patients with cancers had significantly higher all-cause mortality (15.0% vs. 8.3%, P&amp;lt;0.001), major bleeding rate (5.3% vs. 3.1%, P&amp;lt;0.001), the composite of all-cause mortality, stroke, and major bleeding (20.0% vs. 12.0%, P&amp;lt;0.001), and composite of all-cause mortality, thromboembolism, and major bleeding than non-cancer patients (21.0% vs. 12.0%, P&amp;lt;0.001), but nonsignificant differences in cardiovascular mortality (3.6% vs. 3.1%, P=0.2), any stroke, transient ischemic attack, or non-central nervous system embolism (3.2% vs. 2.7%, P=0.1), and OAC discontinuation (29.0% vs. 28%, P=0.2). Among the cancers, hematological cancer was associated the highest risk of all-cause mortality (HR=3.7, 95%CI 2.69-5.0, P&amp;lt;0.001) while respiratory cancer was associated the highest risk of major bleeding (HR=2.62, 95%CI 1.24-5.5, P=0.011). After multivariable adjustment, cancer was independently associated with increased risk of all-cause mortality (HR=1.30, 95%CI 1.05-1.62, P=0.018), composite of all-cause mortality, stroke, and major bleeding (HR=1.32, 95%CI 1.04-1.68, P=0.022), and composite of all-cause mortality, thromboembolism, and major bleeding (HR=1.29, 95%CI 1.04-1.60, P=0.022), but the risk of major bleeding was nonsignificantly different (HR=1.16, 95%CI 0.71-1.87, P=0.6). Conclusions Cancer is a common comorbidity in patients with AF and is independently associated with increased risk of poor outcomes including all-cause mortality and MACEs. However, cancer did not increase the risk of cardiovascular mortality, major bleeding, and discontinuation of OAC. Cancer in patients with AF should receive appropriate treatments for the cancer itself and appropriate OAC, although strategies may vary between different cancers.Distribution of caners in GLORIA-AFKaplan-Meier curves for the outcomes

Hemoglobin/creatinine ratio as long- term prognostic marker in acute coronary syndromes: a praise registry study

Abstract Introduction Anemia and renal impairment are key determinants of adverse outcomes in patients with acute coronary syndrome (ACS). The hemoglobin/creatinine (Hb/Cr) ratio, a simple and universally accessible index that combines these two factors, was found to predict adverse outcomes in patients with cardiovascular disease. There is limited evidence on the performance of the Hb/Cr ratio in predicting long-term adverse outcomes in the specific setting of ACS. Purpose To evaluate the long-term prognostic impact of the Hb/Cr ratio in patients with ACS. Methods Out of the 23,270 ACS patients enrolled in the international PRAISE registry between 2003 and 2019, 3.465 were excluded due to missing data and 19.805 were included in this analysis. The primary endpoint was all-cause mortality at one year follow-up. Secondary endpoints were major bleeding and the composite of all-cause mortality or reinfarction at one year follow-up. A cut-point analysis according to Liu’s method was run to evaluate the best discriminative value of the Hb/Cr ratio for the prediction of all-cause mortality. Results The cut-point analysis showed that a cut-off value of 13.79 represented the most discriminative in predicting all-cause mortality at one year (CI 13.35–14.23; AUC 0.66), and that mortality increased exponentially when the ratio was &amp;lt;12.4. On the basis of this discriminative value, we divided our population into low vs. high Hb/Cr groups. The former included 5,874 (29.7%) patients, while the latter included 13,931 (70.3%). Patients in the low Hb/Cr group were older, more frequently female, and had a higher prevalence of cardiovascular risk factors, comorbidities, and history of coronary artery disease. Conversely, patients in the high Hb/Cr group were mostly men and more frequently admitted with a STEMI diagnosis. One year post-discharge from ACS, all-cause mortality (8.3% vs. 2.3%; p &amp;lt; 0.001), major bleeding (5.4% vs. 2.2%; p &amp;lt; 0.001) and the composite of all-cause mortality or reinfarction (11.6% vs. 4.7%; p &amp;lt; 0.001) were significantly higher in the low Hb/Cr group. Bivariate regression analysis showed that Hb/Cr ratio was inversely associated with all-cause mortality (OR 0.85; CI 0.84 – 0.86; p &amp;lt; 0.0001), major bleeding (OR 0.91; CI 0.89-0.92; p &amp;lt; 0.0001), and the composite of all-cause mortality or reinfarction (OR 0.89; CI 0.88-0.90; p &amp;lt; 0.0001). This association held strongly true even after an extensive adjustment for several covariates, including cardiovascular risk factors, comorbidities, and discharge medical therapy: all-cause mortality (OR 0.95; CI 0.92 – 0.97; p &amp;lt; 0.0001), major bleeding (OR 0.92; CI 0.89-0.95; p &amp;lt; 0.0001), composite of all-cause mortality or reinfarction (OR 0.96; CI 0.94-0.98; p &amp;lt; 0.0001). Conclusions HB/Cr ratio appears to be inversely associated with long-term adverse outcomes among ACS patients. Further research is warranted before routinely considering this index in clinical practice.

Clinical outcomes according to residual cholesterol and inflammatory risk in patients undergoing PCI

Abstract Background Elevated concentrations of low-density lipoprotein cholesterol (LDL-c) and low grade vascular inflammation, commonly quantified using high-sensitivity C-reactive protein (hsCRP), have been demonstrated to be causal in the development of atherosclerotic disease. Whilst recent large-scale trials have investigated the relative impact of LDL-c and inflammation on cardiovascular outcomes, there is a scarcity of data in real-world patients undergoing percutaneous coronary intervention (PCI). Purpose To investigate the relative drivers of residual risk in patients with established statin treatment undergoing PCI in a contemporary large-scale cohort. Methods From January 2012 to February 2020 patients undergoing PCI at a tertiary center were included for current analysis. Patients were categorized into 4 subgroups according to different combinations of LDL-c and hsCRP concentrations at baseline: no residual cholesterol or inflammatory risk (LDL-c &amp;lt;70 mg/dL + hsCRP &amp;lt;2 mg/L), residual cholesterol risk (LDL-c ≥70 mg/dL + hsCRP &amp;lt;2 mg/L), residual inflammatory risk (LDL-c &amp;lt;70 mg/dL + hsCRP ≥2 mg/L), and combined residual cholesterol and inflammatory risk (LDL-c ≥70 mg/dL + hsCRP ≥2 mg/L). Individuals who presented with acute myocardial infarction, neoplastic disease and hsCRP concentrations &amp;gt;10 mg/l were excluded. The outcome of interest was major adverse cardiac events (MACE - composite of all-cause mortality, myocardial infarction, or stroke). A univariable cox regression model was calculated. Results Overall, 10,845 patients were included. In total, 3,210 patients displayed neither cholesterol nor inflammatory risk and 3,059 individuals had elevated cholesterol risk only. In 1,839 patients an inflammatory risk was noted, whilst 2,737 patients presented with combined cholesterol and inflammatory risk. Kaplan-Meier curves for 1-year follow-up are displayed in Figure 1. Patients with residual inflammatory risk had the highest event rate of the composite endpoint (5.2%), followed by patients with combined residual risk (3.5%), individuals with residual cholesterol risk (2.3%) and persons with neither cholesterol nor inflammatory risk (2.4%; p&amp;lt;0.0001 for log rank test across all groups). An association with MACE was solely documented for patients with residual inflammatory risk (HR: 2.09, 95% CI: 1.52 - 2.88; p&amp;lt;.001), and also borderline significant for combined cholesterol and inflammatory risk (HR: 1.41, 95% CI: 1.03 - 1.95; p=0.034), whilst this was not the case for patients with elevated cholesterol risk only (see Figure 2). Conclusion In a contemporary real-world cohort of statin treated patients undergoing PCI, inflammation irrespective of LDL-c concentrations was the driver for adverse cardiovascular outcomes. This data might be helpful to further define target populations for both intensified lipid-lowering as well as anti-inflammatory treatment approaches.

One-year clinical outcome of aspirin-free prasugrel monotherapy following stent implantation in patients with chronic coronary syndrome: insight from ASET-JAPAN study

Abstract Background Single antiplatelet therapy with a potent P2Y12 inhibitor without aspirin after coronary stent implantation may provide an adequate balance between ischemic and bleeding risks in selected patients. The 3-month follow-up of the Acetyl-Salicylic Elimination Trial (ASET)-Japan pilot study demonstrated the feasibility and safety of Prasugrel monotherapy without aspirin after successful percutaneous coronary intervention (PCI) in selected patients with chronic coronary syndrome (CCS). Purpose The current study aimed to evaluate the 1-year clinical outcome in the ASET-Japan. Methods The ASET-Japan pilot study was designed to demonstrate the feasibility and safety of the approved dose of prasugrel monotherapy in Japan without aspirin after optimal PCI with a platinum-chromium everolimus-eluting stent in CCS population. After successful procedure, all patients were treated with a locally approved maintenance dose of 3.75 mg/day of Prasugrel monotherapy up to 3-month. After 3-month, the choice of antiplatelet therapy was left to the discretion of the investigators. Patients were followed up to 1 year. The target lesion-related endpoint was a composite of cardiac death, spontaneous target-vessel myocardial infarction (MI) &amp;gt;48 h after the index PCI or clinical-driven target lesion revascularisation. Patient-Oriented Composite Endpoint (POCE) was defined as a composite of all cause mortality, any stroke, any MI and any revascularisation. Spontaneous MI was defined according to Forth universal definition. The event rate was estimated by the Kaplan-Meier method. The event was adjudicated by an independent clinical event committee. Results A total of 208 patients were enrolled in the study. The average anatomical SYNTAX score was 7.96 (±4.6). After procedure, prasugrel monotherapy was immediately initiated. After 3-month, Prasugrel monotherapy was continued in 88.6% up to 1-year. Aspirin monotherapy was prescribed to 10 patients (5.0%), while 6 patients (3.0%) were on DAPT at 1-year. All-cause mortality rate was 1.49%, with no occurrence of cardiovascular death. Revascularisation occurred in 4.0% (n=8) with no occurrence of TLR, while one patient (0.5%) underwent a clinical driven target vessel revascularisation. In summary, 7 out of 8 revascularisations were non-target vessel revascularisation (6 clinically-driven non-TVR). Spontaneous non TV-MI occured in 0.5% (n=1) of patients. There was no definite/probable stent thrombosis up to 1 year. The target lesion related endpoint rate at 1-year was 0%, whereas 1-year POCE rate was 7.0% (n=14). Conclusion Discontinuation of Aspirin and Prasugrel monotherapy at a low maintenance dose of 3.75 mg/day following an angiographically successful stent deployment was feasible and safe in selected patients with CCS and low SYNTAX score. This safety profile is confirmed at 1 year while the investigators, in their large majority and at their own discretion, had maintained the prasugrel treatment.

ABLE-SCORE: a simplified risk score for major adverse cardiovascular outcomes in patients with left ventricular noncompaction

Abstract Background Left ventricular noncompaction (LVNC) is a heterogeneous entity with life-threatening complications and variable prognosis [1,2]. However, there are limited prediction models available to identify individuals at high risk of adverse outcomes, and the current risk score in LVNC is comparatively complex for clinical practice [3,4]. Purpose To develop and validate a simplified risk score to predict major adverse cardiovascular events (MACE) in LVNC. Methods This multicenter longitudinal cohort study consecutively enrolled morphologically diagnosed LVNC patients between January 2009 and December 2020 at a single national-level medical center (derivation cohort n=300; internal validation cohort n=129), and between January 2014 and December 2022 at two national-level medical centers (external validation cohort n=95). The derivation/internal validation cohorts and the multicenter external validation cohort were followed annually until December 2022 and December 2023, respectively. MACE was defined as a composite of all-cause mortality, heart transplantation/left ventricular assist device implantation, cardiac resynchronization therapy, malignant ventricular arrhythmia, and thromboembolism. A simplified risk score, the ABLE-SCORE, was developed based on independent risk factors for MACE in the multivariable Cox regression predictive model, and underwent both internal and external validation to confirm its discrimination (Harrell’s C-index), calibration (calibration plots), and clinical applicability (decision curve analysis). Results A total of 524 LVNC patients (43.5 ± 16.6 years, 65.8% male) were included in the study. At the end of the follow-up, 97 (32.3%), 38 (29.5%), and 20 (21.1%) individuals in the derivation, internal validation, and external validation cohort experienced at least one endpoint of MACE. The ABLE-SCORE was established using four easily accessible clinical variables: age at diagnosis, N-terminal pro-brain natriuretic peptide levels, left atrium enlargement and left ventricular ejection fraction≤40% measured by echocardiography. The risk score showed excellent performance in discrimination, with Harrell’s C-index of 0.821 (95%CI 0.772-0.869), 0.786 (95%CI 0.703-0.869), and 0.750 (95%CI 0.644-0.856) in the derivation, internal validation, and external validation cohort, respectively. Calibration plots of the three datasets suggested accurate agreement between the predicted and observed 5-year risk of MACE in LVNC. According to decision curve analysis, the ABLE-SCORE displayed greater net benefit than the currently existing risk score for MACE in LVNC [3], indicating its strength in clinical applicability. Conclusions Derived from readily available laboratory and echocardiographic variables, a simplified and efficient risk score for MACE was developed and validated using a large LVNC cohort, making it a reliable and convenient tool for the risk stratification and clinical management of patients with LVNC.Development of the ABLE-SCOREValidation of the ABLE-SCORE

Comparative outcomes of drug-coated balloon angioplasty versus second-generation drug-eluting stent for in-stent restenosis: a real-world data analysis

Abstract Background Coronary in-stent restenosis (ISR) poses a significant challenge in interventional cardiology, with optimal treatment strategies being the subject of ongoing debate. Current clinical guidelines offer a choice between drug-coated balloon angioplasty (DCB) and repeat stenting with second-generation drug-eluting stents (DES), each with distinct implications for long-term patient outcomes. Purpose The aim of this study is to compare 1-year outcomes between DCB angioplasty and second-generation DES in the treatment of ISR. Longitudinal real-world data are used from the OBSERVABLE database, which comprises German health claims data between 2012 and 2021. Methods A total of 10,440 ISR individuals undergoing DCB or DES intervention were identified. After exclusion of bare-metal stents, first generation stents and non-DCBs, 3,810 propensity score-matched individuals remained. The primary outcome was the composite of all-cause mortality and myocardial infraction (MI). Secondary outcomes included all-cause death, MI, and bleeding as a safety outcome. Results At 1-year follow-up, the primary outcome of all-cause mortality and MI was observed in 246 individuals (12.9%) in the DES group, compared with 201 individuals (10.6%) in the DCB group (HR, 1.27; 95% CI, 1.06-1.53). Sensitivity analysis confirmed the robustness of these findings. Secondary outcomes revealed higher all-cause mortality in the DES group (7.9%) compared to the DCB group (6.3%) (HR, 1.31; 95% CI, 1.03-1.66), with no difference in MI. Bleeding events were comparable between the two treatments, with 244 individuals (12.8%) in the DES group and 206 individuals (10.8%) in the DCB group (HR, 1.17; 95% CI, 0.89-1.53). Conclusion This real-world data analysis demonstrated a higher incidence of the primary composite endpoint of all-cause mortality and MI within one year, after treatment with DES compared to DCB. Our results support prior findings about the safety profile of repeated DES implantation and strengthen DCB as a potential superior alternative to DES in ISR management.

Rivaroxaban or warfarin in atrial fibrillation and coronary stent implantation in real-world patients involving chronic kidney disease (REWRAPS): 5-year follow-up study

Abstract Background Recent guidelines recommended either non vitamin K antagonist oral anticoagulants (NOAC) or vitamin K oral anticoagulant (VKA) one year after coronary stenting in patients with atrial-fibrillation (AF). However, whether NOAC is still superior to VKA at 5-years in patients involving chronic kidney disease (CKD) with AF and coronary stenting &amp;gt;1-year remains unclear. Methods In a multicenter, prospective, non-randomized registry, 493 patients were treated with either rivaroxaban or warfarin, while the majority (66.3%) of them had CKD. The primary efficacy endpoint was major adverse cardiac and cerebral events (MACCE). The primary safety endpoint was major bleeding (Bleeding Academic Research Consortium [BARC] 3 and 5). Net adverse clinical events (NACE) were defined as the composite of all-cause mortality and major bleeding. Both crude and propensity score matched (PSM) analyses were performed. P &amp;lt;0.05 was considered as statistically significant. Results At a median follow-up of 4.8 years MACCE rates did not differ between rivaroxaban and warfarin in 486 patients with crude-analysis (23.0% versus 29.0%, hazard-ratio [HR], 0.79; 95% confidence interval [CI], 0.55 to 1.11; P=0.17), while in 316 patients with PSM-analysis rivaroxaban met non-inferiority criteria to warfarin (HR, 0.86; 95% CI, 0.56 to 1.33; p=0.020 for non-inferiority). Rivaroxaban was associated with lower major bleeding risk compared with warfarin (6.5% versus 12.6%; HR, 0.50; 95% CI, 0.27 to 0.91; P=0.025) at crude analyses, which was no longer significant at PSM analyses (5.7% versus 10.8%; HR, 0.53; 95% CI, 0.24 to 1.19; P=0.12). However, NACE rates were significantly lower in rivaroxaban compared to warfarin at both crude (19.0% versus 35.7%; HR, 0.50; 95% CI, 0.35 to 0.72; P=0.0002) and PSM-analyses (19.6% versus 31.0%; HR, 0.63; 95% CI, 0.40 to 0.98; P=0.043), respectively. Conclusions Rivaroxaban did not differ from warfarin for efficacy endpoints of MACCE but was associated with lower NACE rates (i.e. all-cause mortality and major bleeding) in AF and coronary stent in real-world patients having CKD at 5-year follow-up (NCT02024230).

Arrhythmogenic right ventricular cardiomyopathy: the importance of biventricular strain in risk-stratification

Abstract Background Despite Arrhythmogenic right ventricular cardiomyopathy (ARVC) being a predominant right ventricle (RV) disease, concomitant left ventricle (LV) involvement has been recognized. ARVC diagnosis is made through the RV-centric 2010 Task Force Criteria (TFC), but previous studies already suggested the use of echocardiographic strain measures to better depict RV and LV dysfunction in these patients. No data however is available on the additional value of combining biventricular strain in ARVC for risk stratification. Purpose To assess the prognostic value of measuring both LV global longitudinal strain (GLS) and RV free wall strain (FWLS) analysis in patients with ARVC. Methods A total of 204 patients who met the TFC for the ARVC spectrum were included. Patients were categorized based on a cut-off of -18% for strain impairment in both ventricles. The end-point was a composite of all-cause mortality, arrhythmic events, ICD therapy and heart failure events. Results Patients (age 41 ± 17 years, 55% males) were divided into impaired (n=33), discordant (either RV or LV impaired, n=70), and normal (n=101) strain groups (Fig. 1A). Definite and borderline ARVC were diagnosed in 78% and 39%, respectively, at the time of first available echocardiography. During a follow-up of 87 [24-136] months, 60 (29%) experienced the combined outcome, and a significant difference in event-free survival was observed (p&amp;lt;0.001) between the 3 groups (Fig. 1B). In the multivariate analysis (Fig. 2), the strain grouping remained associated with outcome (p=0.040) after adjusting for age, gender, history of syncope and definite ARVC diagnosis, which were also significantly associated with the endpoint at the univariate analysis. A sub-analysis including only definite and borderline ARVC patients confirmed that the strain grouping was an independent predictor of the composite endpoint (p=0.027). Conclusion Biventricular involvement by strain analysis has additional prognostic value in ARVC patients and outcome is worse for those with both RV and LV involvement.Strain groups and Kaplan Meier curvesMultivariate analysis