Incidence Of Primary Endpoint Research Articles

The impact of high-intensity statin on 3-year clinical outcomes in elderly acute myocardial infarction patients underwent percutaneous coronary intervention with drug-eluting stents

Abstract Background There is limited data on role of high-intensity statin for secondary prevention in elderly acute myocardial infarction (AMI) patients above 75 years old. Therefore, this study aimed to show the impact of high-intensity statin on 3-year clinical outcomes in elderly AMI patients (>75 years) underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Methods Among the 13,104 patients included in the Korea AMI registry (KAMIR)-National Institutes of Health (NIH), the elderly patients (>75 years, n=2063) were divided into three groups according to statin treatment at discharge; the high-intensity statin group (n=521), the low/moderate-intensity statin group (n=1419), and the no statin group (n=123). The primary endpoint was 3-year composite of cardiac death and recurrent myocardial infarction (MI). Results During the 3-year clinical follow-up, the cumulative incidence of primary endpoint in the high-intensity statin group was similar to that of the low/moderate-intensity statin group (11.5% versus 12.5%; adjusted hazard ratio [aHR]: 1.053; 95% confidence interval [CI]: 0.780-1.423; P=0.739) and was significantly lower than that of the no statin group after adjustment (11.5% versus 22.0%; aHR: 2.433; 95% CI: 1.377-4.298; P=0.002). The incidences of major adverse cardiac events (MACE), target lesion failure (TLF), target vessel failure (TVF), procedure free cardiac events (PFCE), total death, cardiac death, and re-hospitalization due to heart failure (HF) in the high-intensity statin group were significantly lower than those of the no statin group after adjustment. However, the incidences of primary endpoint and other clinical events in the high-intensity statin group were similar to those of the low/moderate-intensity statin group. Conclusions In elderly AMI patients (>75 years) underwent PCI with DES, high-intensity statin was associated with significantly reduced 3-year major clinical outcomes than no statin therapy group. This clinical benefit was similar to low/moderate-intensity statin therapy.

Comparison of the effects of pre-dilatation with conventional versus larger balloon sizes on clinical outcomes in transcatheter aortic valve implantation with self-expandable valves

Abstract Background Transcatheter aortic valve implantation (TAVI) is considered an established treatment option for patients with severe aortic stenosis. When implanting self-expandable valve, pre-dilatation is often necessary to facilitate optimal transcatheter heart valve (THV) deployment. Traditionally, balloon sizes chosen for pre-dilatation are smaller than the minimum annulus diameter. Insufficient pre-dilatation can result in under-expansion of the THV, necessitating post-dilatation, and can increase the risk of complications. However, this conventional approach may not always yield the best outcomes, prompting a reassessment of balloon sizing strategies to improve procedural success and patient outcomes. Purpose The aim of this study was to investigate the impact on procedural outcomes of using larger balloons, sized less than the mean annulus diameter, for pre-dilatation compared to the traditional practice of using balloons sized less than the minimum annulus diameter during the implantation of self-expandable valves. Methods We analyzed 785 patients who underwent TAVI with self-expandable valve with pre-dilatation out of a consecutive 3880 cases at 6 centers from 2010 to 2023 (Figure 1). Among them, we divided the patients into two groups: those who underwent pre-dilation with balloons smaller than the minimum annulus diameter defined as the Conventional-size group and those who underwent pre-dilatation with balloons smaller than the mean annulus diameter defined as the Large-size group. The primary endpoint of this study was procedural success, stroke and need for permanent pacemaker implantation as designated by the VARC-3criteria. Results Of patients (69% female; mean age 84.9), there were 563 (71.7%) patients in the Conventional-size group and 222 (28.2%) patients in the Large-size group. There was no annulus rupture in either group. The incidence of post-dilatation was significantly higher in the Conventional-size group than in the Large-size group (109 of 563 [19.4%] vs. 23 of 222 [10.3%], p=0.001) (Figure 2). There was no significant difference in the incidence of primary endpoints (all p > 0.05). In post-echocardiographic outcomes, there was no significant difference in effective orifice area, mean pressure gradient, patients-prosthesis mismatch, or paravalvular leakage between the groups (P > 0.05). Conclusions This study demonstrates that a large-size strategy using a balloon smaller than the mean annulus diameter in the deployment of self-expandable valves is safe and may avoid the need for post-dilatation compared to the traditional strategy using a balloon smaller than the smallest diameter.

Safety and efficacy of transcatheter aortic valve implantation (TAVI) for pure aortic regurgitation; a systematic review and meta-analysis

Abstract Background Although Transcatheter Aortic Valve Implantation (TAVI) has gained ground in the management of severe aortic stenosis (AS), evidence about its safety and efficacy for patients with pure native aortic regurgitation (AR) remains limited. Purpose The aim of the study is to systematically review and summarize available data regarding the safety and the outcomes of TAVI in pure AR. Methods This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 1, 2024, for studies assessing the characteristics and outcomes of patients undergoing TAVI for pure AR. Primary endpoint of our systematic review and meta-analysis is the in-hospital, 30-days and 1-year mortality rates. Secondary endpoints comprised in-hospital stroke, major bleeding, and permanent pacemaker implantation (PPM) implantation. Endpoint definitions followed the Valve Academic Research Consortium 2 criteria. The cumulative incidence of primary and secondary endpoints and the corresponding 95% confidence intervals (CI) were estimated. A random effects model (DerSimonian-Laird) was used to account for heterogeneity among the included studies. Results Our meta-analysis included a total of 22 studies and 6,710 patients undergoing TAVI for pure-AR. Our analysis showed that patients undergoing TAVI for pure AR had 3.4% (95% CI: 2%-4.7%), 7.9% (95% CI: 5.2%-10.6%) and 15.5% (95% CI: 9.9%-21.2%) in-hospital, 30-days and 1-year all-cause mortality. In-hospital stroke occurred in 1.9% (95% CI: 1.5%-2.2%) of the patients, while 4.9% (95% CI: 3.3%-6.6%) of the patients suffered from major bleeding events. Finally, considering the PPM implantation rates, patients had a 10.7% (95% CI: 7.4%-13.9%) in-hospital incidence. Conclusion Our systematic review and meta-analysis shows a promising safety profile for TAVI treating pure AR. It demonstrated relatively low in-hospital, 30-days and 1-year mortality incidence, comparable to the TAVI treating severe AS, according to the existing literature. Taking into consideration that TAVI for pure-AR might be the only therapeutic option for an increasing number of patients, further studies are needed to further assess the safety and efficacy of the procedure.TAVI for pure AR mortality rates

Safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with previous TAVI; a systematic review and meta-analysis

Abstract Background Transcatheter Aortic Valve Implantation (TAVI) has gained ground in the management of severe aortic stenosis, even in low-surgical risk patients. However, TAVI prostheses, like bioprostheses, have a finite lifetime; thus, TAVI in patients with previous TAVI (TAVI-in-TAVI) rates are radically increased. Although data regarding TAVI indicate low mortality and stroke rates within the first year, TAVI-in-TAVI is less studied. Purpose The aim of the study is to systematically review and summarize available data regarding the safety and the outcomes of TAVI-in-TAVI. Methods This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 10, 2024, for studies assessing the characteristics and outcomes of patients undergoing TAVI-in-TAVI. Primary endpoint of our systematic review and meta-analysis is the in-hospital, 30-days and 1-year mortality rates. Secondary endpoints comprised in-hospital, 30-days and 1-year stroke rates, in-hospital vascular complications, conversion to surgery, coronary compression or obstruction, and perforation with or without tamponade, and in-hospital and 30-days permanent pacemaker implantation (PPM) implantation. Endpoint definitions followed the Valve Academic Research Consortium 3 criteria. The cumulative incidence of primary and secondary endpoints and the corresponding 95% confidence intervals (CI) were estimated. A random effects model (DerSimonian-Laird) was used to account for heterogeneity among the included studies. Results Our meta-analysis included a total of 5 studies and 2,145 patients undergoing TAVI-in-TAVI, 72.9% (N=1,564) of whom were treated with a balloon-expandable valve. Our analysis showed that patients undergoing TAVI-in-TAVI had 3.7% (95% CI: 1.6%-5.9%), 3.9% (95% CI: 3%-4.7%) and 12.5% (95% CI: 11%-14%) in-hospital, 30-days and 1-year all-cause mortality, while stroke occurred in 1.8% (95% CI: 1.2%-2.4%), 2.1% (95% CI: 1.4%-2.9%) and 3% (95% CI: 2.3%-3.8%) of the patients in-hospital, 30-days and 1-year, respectively. Notalby, conversion to surgery, coronary compression/obstruction and perforation with or without tamponade occurred in <1% of the patients, while 6.1% (95% CI: 2.2%-9.9%) of the patients had vascular complications during the procedure. Considering the PPM implantation rates, patients had a 1.8% (95% CI: 1.2%-2.4%) for in-hospital and a 6.8% (95% CI: 5.2%-8.3%) for 30-days incidence. Conclusion Our systematic review and meta-analysis is the first to present that TAVI-in-TAVI has an acceptable safety profile with relatively low in-hospital, 30-days and 1-year mortality and stroke rates, comparable to the native-valve-TAVI. Taking into consideration that TAVI-in-TAVI might be the only therapeutic approach for an increasing number of patients, further studies are warranted to further assess its safety and efficacy and to provide additional procedural techniques.TAVI-in-TAVI mortality rates

Safety and Effectiveness of Concomitant iGlarLixi and SGLT-2i Use in People with T2D During Ramadan Fasting: A SoliRam Study Sub-analysis.

The aim of this work was to assess the safety and effectiveness of concomitant iGlarLixi and sodium-glucose co-transporter-2 inhibitors (SGLT-2i) use in adults with type 2 diabetes (T2D) who fasted during Ramadan. Of the 420 eligible participants from the SoliRam study, 174 were using SGLT-2i in addition to iGlarLixi and 246 were not using SGLT-2i, referred to as SGLT-2i user and non-user, respectively. The primary endpoint was the proportion of participants experiencing ≥ 1 severe and/or symptomatic documented (< 70mg/dl [< 3.9mmol/l]) hypoglycemia. More than 50% of participants in both groups were male. The mean weight, glycated hemoglobin (HbA1c), and fasting plasma glucose (FPG) were similar in both groups. Approximately half of participants in the SGLT-2i-user group and ~ 25% participants in the SGLT-2i-non-user group were on two oral anti-hyperglycemic drugs (OADs), whereas ~ 20% in the SGLT-2i-user group and ~ 1% of participants in the SGLT-2i-non-user group were on three OADs in addition to iGlarLixi. Around 35% and 55% of participants in the SGLT-2i-user and SGLT-2i-non-user groups, respectively, were taking concurrent sulphonylureas. About 97% of participants in both groups were able to fast for ≥ 25days. The incidence of primary endpoint was low in both groups; SGLT-2i user: 0.6%, 4.2%, and 0.6% and SGLT-2i-non-user: 1.3%, 0.9% and 0% during pre-Ramadan, Ramadan, and post-Ramadan period, respectively. The incidence of severe and/or symptomatic documented (< 54mg/dl [< 3.0mmol/l]) hypoglycemia events was also low throughout the study, including during Ramadan. No severe hypoglycemia occurred during Ramadan in either group. Improvements in HbA1c and FPG, with a small reduction in weight, were observed from pre- to post-Ramadan in both groups. No serious adverse event was reported in either group. Concomitant iGlarLixi and SGLT-2i therapy with or without other OADs was demonstrated to be safe in adults with T2D during Ramadan fast, with a low risk of hypoglycemia and improvements in glycemic outcomes.

Prevalence and Prognostic Implications of Changes in Tricuspid Regurgitation Severity in Acute Heart Failure

BackgroundTricuspid regurgitation (TR), prevalent in acute heart failure (AHF), has a poor prognosis; however, the dynamics of TR severity during hospitalization and its prognostic implications remain unclear. We investigated TR dynamism during hospitalization and its prognostic impact in AHF. Methods and ResultsThis is a post hoc analysis of a prospective multicenter study of patients with AHF who underwent echocardiographic TR severity evaluation at admission and before discharge. The primary end point was a combined of 1-year all-cause mortality and HF rehospitalization after discharge. Among 1079 participants, TR severity changed dynamically, with 60.3% of those with moderate TR and 29.6% of those with severe TR at admission being diagnosed as no or mild TR at discharge. In 3 groups stratified by changes in TR severity, the persistent TR groups had a higher incidence of the primary end point than the resolution and absence groups. In adjusted analyses, the persistent group (hazard ratio, 1.37; 95% confidence interval, 1.04–1.80), but not the resolution group (hazard ratio, 1.07; 95% confidence interval, 0.79–1.44), had a higher primary end point incidence than the absence group. ConclusionsTR severity at admission in patients with AHF can change dynamically and is associated with subsequent prognosis. Significant TR that remains even after decongestive therapy might be a target for further treatment in hospitalized patients with AHF.

Application of a Novel Mitral Valvuloplasty Strategy in Children with Mitral Regurgitation.

To retrospectively analyze the clinical efficacy of an innovative mitral valvuloplasty strategy in the treatment of mitral regurgitation in children. From January 2018 to December 2022, 140 patients undergoing surgical treatment for mitral regurgitation in our hospital were enrolled. Ninety patients underwent three-step standardized pediatric mitral valvuloplasty (group A) and 50 patients underwent simple annuloplasty (group B). The incidence of primary and secondary study endpoint was compared between the two groups, and the independent risk factors for the primary study endpoint were determined. Our primary study endpoint was a composite endpoint of postoperative functional mitral failure, postoperative heart failure, transplantation, and/or mortality. Secondary end points were defined as perioperative complications. During the follow-up period, there was no all-cause death. Primary endpoint events occurred in 22 patients, including 12 patients in group A and 10 patients in group B. There was no significant difference in the incidence of primary and secondary endpoint events between the two groups. Multivariate Cox proportional hazards regression analysis showed that younger age and residual mitral regurgitation at discharge were independent risk factors for the primary endpoint events, while type of MV repair was not an independent risk factor. Subgroup analysis based on age showed that primary endpoint events occurred in 4 patients in group A and 7 patients in group B in patients < 1year old. The incidence of primary endpoint events in group A was lower than that in group B (6.06% vs. 20.59%, P = 0.041). In patients ≥ 1year old, the primary endpoint event occurred in 8 cases in group A and 3 cases in group B. There was no significant difference in the incidence of primary endpoint events between groups A and B (33.33% vs. 18.75%, P = 0.312). The degree of mitral regurgitation at discharge was significantly improved compared with that before operation in both groups (P < 0.001), and the degree of mitral regurgitation at the last follow-up was not significantly worse than that at discharge (P = 0.090). The mid-term results of mitral valvuloplasty for mitral regurgitation in children are encouraging. The perioperative recovery and postoperative outcomes of three-step standardized mitral valvuloplasty in children are not inferior to those of annuloplasty alone. Three-step standardized pediatric mitral valvuloplasty has better postoperative outcomes than simple mitral annuloplasty, especially for patients younger than 1year old. Children with residual mitral regurgitation at discharge should be followed up regularly to be alert to the occurrence of poor prognosis.

Gender-specific aspects of long-term CryoPVI efficacy

Abstract Background While a gender-specific influence has been demonstrated for many cardiovascular interventions, no prospective data is yet available for cryoballoon pulmonary vein isolation (CryoPVI). Methods We prospectively analyzed consecutive AF patients who underwent a first CryoPVI in a single-center cohort between 2018 and 2023. We stratified patients regarding gender into two groups. CryoPVI was performed in a standardized procedure. Foollow-up was performed at 3, 6, 12, 18, 24 and 36 months after CryoPVI. Efficacy endpoint was the occurrence of symptomatic atrial arrhythmia while major inguinal complications, phrenic nerve injury, stroke or death were considered safety endpoints. Periprocedural parameters were observed. Results During the study period 1180 patients underwent CryoPVI. Of these, 511 patients were female (43.3%). Female patients were significantly older (72.1 vs 67.3 years; p&amp;lt;0.001); had higher CHADS-VASc (3.4 vs 2.3; p&amp;lt;0.0001) and left ventricular ejection fraction (55.7 vs 53.9 p=0.001). There were no differences regarding AF phenotype (persistent AF 40.7% vs 59.3% p=0.17). The incidence of primary efficacy endpoint after 36 months was significantly higher in female patients (48.9% vs. 42.5%, p=0.0064). Safety endpoints occurred in form of phrenic nerve injury in one female patient (0.2%), one stroke in both groups (female 0.2% vs male 0.1%) and three major inguinal complications in both groups (female 0.6% vs male 0.4%). Conclusion In female patients CryoPVI is equally safe but less effective. The reason for the different therapeutic success remains unclear but should be considered for an individualized approach.

Impact of early atrial arrhythmia recurrence on long-term CryoPVI success

Abstract Background According to current guidelines, the occurrence of atrial fibrillation (AF) recurrence within the first 90 days after pulmonary vein isolation (PVI) should not indicate re-do procedures. Accordingly, a 90-day blanking period is usually accepted. However, data suggests that early atrial arrhythmia relapses during the blanking period have an impact on the efficacy. The optimal period for indicating a re-ablation therefore remains unclear. Methods We prospectively analyzed consecutive AF patients who underwent cryoballoon PVI (CryoPVI) in a single-center cohort between 2018 and 2023. We divided patients into four groups according to arrhythmia recurrence (recurrence between 0-30 days, recurrence between 30-60 days, recurrence between 60-90 days and no recurrence within the first 90 days). CryoPVI was performed in a standardized procedure. At 3, 6, 12, 18, 24 and 36 months after CryoPVI follow up was performed. Efficacy endpoint was the occurrence of symptomatic atrial arrhythmia relapse. Results During the study period 1179 patients underwent a first CryoPVI. Of these, 84 patients (7.1%) had atrial arrhythmia relapse between 0-30 days, 38 patients (3.2%) had atrial arrhythmia relapse between 30-60 days, and 38 patients (3.2%) had a relapse between 60-90 days. Overall, 1019 (86.4%) patients didn’t have an atrial arrhythmia relapse between 0-90 days after CryoPVI. Primary efficacy endpoint incidence after 36 months was significantly higher in patients who experienced atrial arrhythmia relapse within the first 90 days (between 0-30 days 62.5% vs. between 30-60 days 70.1% vs. between 60-90 days 77.9% vs. no recurrence ≤ 90 days 41.6%, p&amp;lt;0.0001). Conclusion Atrial arrhythmia relapse within the first 90 days is associated with a reduced long-term efficacy of CryoPVI. Re-ablation should be indicated regardless of the time of recurrence.

The Prognostic Role of Global Longitudinal Strain and NT-proBNP in Heart Failure Patients Receiving Cardiac Resynchronization Therapy.

We aimed to evaluate whether baseline GLS (global longitudinal strain), NT-proBNP, and changes in these after cardiac resynchronization therapy (CRT) can predict long-term clinical outcomes and the echocardiographic-based response to CRT (defined by 15% relative reduction in left ventricular end-systolic volume). We enrolled 143 patients with stable ischemic heart failure (HF) undergoing CRT-D implantation. NT-proBNP and echocardiography were obtained before and 6 months after. The patients were followed up (median: 58 months) for HF-related deaths and/or HF hospitalizations (primary endpoint) or HF-related deaths (secondary endpoint). A total of 84 patients achieved the primary and 53 the secondary endpoint, while 104 patients were considered CRT responders and 39 non-responders. At baseline, event-free patients had higher absolute GLS values (p < 0.001) and lower NT-proBNP serum levels (p < 0001) than those achieving the primary endpoint. A similar pattern was observed in favor of CRT responders vs. non-responders. On Cox regression analysis, baseline absolute GLS value (HR = 0.77; 95% CI, 0.51-1.91; p = 0.002) was beneficially associated with lower primary endpoint incidence, while baseline NT-proBNP levels (HR = 1.55; 95% CI, 1.43-2.01; p = 0.002) and diabetes presence (HR = 1.27; 95% CI, 1.12-1.98; p = 0.003) were related to higher primary endpoint incidence. In HF patients undergoing CRT-D, baseline GLS and NT-proBNP concentrations may serve as prognostic factors, while they may predict the echocardiographic-based response to CRT.

Gender differences in the development of heart failure after acute coronary syndrome: Insight from the CORALYS registry

BackgroundImpact of gender on heart remodeling after acute coronary syndrome (ACS) and consequently on development of heart failure (HF) remains to be elucidated. MethodsCORALYS is a multicenter, retrospective, observational registry enrolling consecutive patients admitted for ACS and treated with percutaneous coronary intervention. HF hospitalization was the primary endpoint while all-cause mortality and the composite endpoint of incidence of first HF hospitalization and cardiovascular mortality were the secondary ones. ResultsAmong 14,699 patients enrolled in CORALYS registry, 4578 (31%) were women and 10,121 (69%) males. Women were older, had more frequently hypertension and diabetes and less frequently smoking habit. History of myocardial infarction (MI), STEMI at admission and multivessel disease were less common in women. After median follow up of 2.9 ± 1.8 years, women had higher incidence of primary and secondary endpoints and female sex was an independent predictor of HF hospitalization (HR 1.26;1.05–1.50; p = 0.011) and cardiovascular death/HF hospitalization (HR 1.18;1.02–1.37; p = 0.022). At multivariable analysis women and men share as predictors of HF diabetes, history of cancer, chronic kidney disease, atrial fibrillation, complete revascularization and left ventricular ejection fraction. Chronic obstructive pulmonary disease (HR 2.34;1.70–3.22, p < 0.001) and diuretics treatment (HR 1.61;1.27–2.04, p < 0.001) were predictor of HF in men, while history of previous MI (HR 1.46;1.08–1.97, p = 0.015) and treatment with inhibitors of renin-angiotensin system (HR 0.69;0,49–0.96 all 95% CI, p = 0.030) in women. ConclusionsWomen are at increased risk of HF after ACS and gender seems to be an outcome-modifier of the relationship between a variable and primary outcome.

Long-term clinical outcomes of hemodialysis patients with acute coronary syndrome undergoing primary percutaneous coronary intervention

Abstract Background Number of hemodialysis (HD) patients, especially those with diabetic nephropathy (DN) has increased all over the world. It is well known that the leading cause of death in HD patients is cardiovascular event, however, little is known regarding the long-term clinical outcomes of hemodialysis (HD) patients with acute coronary syndrome (ACS) undergoing primary percutaneous coronary intervention (pPCI) in the current real-world setting. Purpose We aimed to characterize and clarify the long-term clinical outcome of HD patients with ACS undergoing pPCI. Method: Consecutive 531 patients (70.3±13.0 yrs, male 75.5%, 51 HD patients, 9.6% ) with ACS undergoing pPCI in our hospital from 2015 to 2019 were enrolled. The primary endpoint of the present study was the composite outcomes; all-cause death, any unplanned PCI after ACS, heart failure (HF) admission, major bleeding, non-fatal myocardial infarction (MI), non-fatal stroke, and stent thrombosis. Event rate in the studied subjects was stratified with the log-rank test. Result Incidence of the primary endpoint during the median follow-up period of 1515 days in HD patients was significantly higher than non-HD patients (94.1% in HD vs. 61.6% in non-HD; p&amp;lt;0.01, Figure 1). In HD patients, all-cause death, any unplanned PCI, HF hospitalization, and non-fatal MI were significantly more prevalent (52.9% in HD vs. 24.4% in non-HD; p&amp;lt;0.01, 52.9% in HD vs. 16.9% in non-HD; p&amp;lt;0.01, 19.6% in HD vs. 6.5% in non-HD; p&amp;lt;0.01, and 7.8% in HD and 2.1% in non-HD; p=0.04, respectively, Table 1). Incidence of major bleeding, non-fatal stroke and ST were comparable between the two groups (11.8% in HD vs. 7.3% in non-HD; p=0.27, 3.9% in HD vs. 2.7% in non-HD; P=0.64, and 0% in HD vs. 0.4% in non-HD, P=1.0, respectively). In the HD patients, incidence of primary endpoint in DN was similar compared with non-HD patients (93.9% in DN vs. 94.4% in non-DN; p=0.4). Incidence of primary endpoint in patients with HD duration longer than or equal to 6 years was also comparable to those in patients with HD duration less than 6 years (92.6% vs. 95.8%, p=0.09), however, 180-day primary endpoint in the former group was significantly higher than the latter group (66.7% vs 29.2%, P&amp;lt;0.01) due to all-cause death and major bleeding. Conclusion HD patients with ACS undergoing pPCI have extremely worse clinical outcomes with more all-cause death, any unplanned PCI, HF admission, and non-fatal MI even in the current pPCI era. In the long-term, diabetic nephropathy and longer HD years had no significant impact on the clinical outcomes, however those with longer HD years have an extremely poor prognosis in a short-term.

Ticagrelor versus Clopidogrel in diabetes patients afflicted with acute coronary syndrome stratified by renal function

Abstract Background Ticagrelor has been recommended in place of clopidogrel as part of dual antiplatelet therapy (DAPT) in diabetic patients with acute coronary syndrome (ACS). Chronic kidney disease (CKD) patients also have a worse prognosis in the setting of ACS, but the safety and efficacy data for the use of P2Y12 inhibitors in moderate to severe CKD patients (eGFR &amp;lt;60 mL/min/1.73m2) are insufficient. Purpose There has been limited data on the outcome of prescribing ticagrelor compared to clopidogrel in ACS-DM patients with chronic kidney disease (CKD). Methods This prospective, nationwide, multi-center, observational study, the Acute Coronary Syndrome-Diabetes Mellitus Registry (ACS-DM Registry) was compiled from consecutive patients between October 1, 2013 and September 30, 2016. The primary end point was repeated revascularisation and the composite outcome was CV death, repeat revascularisation and CV-related readmission, was stratified by renal function stages. The Cox proportional hazards models and propensity score models were applied to six-months, one-year, and two-year post ACS, respectively. Results There were 539 patients with moderate to severe CKD or on dialysis identified from ACS-DM Registry. There were 451 patients eligible for inclusion criteria of which 116 patients were taking ticagrelor and 335 patients were taking clopidogrel. At our two-year follow-up, the unadjusted incidence of primary end point resulted higher in Ticagrelor group (HR 2.09, 95% CI 1.37-3.18, p = 0.001). After adjustment, ticagrelor also had poor primary end point event and composite outcome as compared to clopidogrel (HR 2.24, 95% CI 1.36-3.68, p = 0.002; HR 1.63, 95% CI 1.06-2.48, p = 0.024, respectively). In regards to the repeated revascularisation issue, the clopidogrel was preferable within the eGFR strata (CKD stage III: HR 2.53, 95% CI 1.32-4.84, CKD stage IV: 1.06 (0.09-12.51), CKD stage V: 1.91 (0.80-4.59), P for interaction=0.684). Conclusions Cardiovascular benefits associated with ticagrelor may not be as significant as in the landmark trial. Our results show that patients taking ticagrelor was associated with increased CV events as compared to clopidogrel in ACS-DM patients with stage III-V CKD.propensity score matchingForest plots

The prognostic value of atrial fibrillation in patients with cardiac sarcoidosis

Abstract Background/Introduction The prognostic value of the presence of atrial fibrillation (AF) at the time of diagnosis in patients with cardiac sarcoidosis (CS) is unknown. Purpose The aim of this study is to investigate the association between the presence of AF at the time of diagnosis of CS and prognosis. Methods This study is a post-hoc analysis of ILLUMINATE-CS (Illustration of the Management and Prognosis of Japanese Patients With Cardiac Sarcoidosis), a multicenter, retrospective, and observational study that evaluated the clinical characteristics and prognosis of cardiac sarcoidosis. The primary endpoint was the combined endpoint of all-cause death and heart failure hospitalization. Results After excluding 32 patients with missing data about the presence of AF, 480 patients with CS (61.6±11.4 years, 36% men) diagnosed according to current guidelines were analyzed, and 86 primary endpoints were observed during a median follow-up period of 3.3 (interquartile range, 1.8-6.0) years. Patients with AF were associated with older age, higher levels of brain natriuretic peptide (BNP), and the prevalence of heart failure admission compared to those without AF. Kaplan-Meier curve analysis indicated that AF was significantly associated with a high incidence of primary endpoints (log-rank P=0.002), and this association was retained even after adjusting for known risk factors including log-transformed BNP and left ventiricular ejection fraction (LVEF) (hazard ratio, 2.10 [95% CI, 1.16-3.82]; P=0.015). Conclusion The presence of atrial fibrillation at the time of diagnosis in patients with cardiac sarcoidosis is independently associated with adverse events.

Prevalence and prognostic value of atrial fibrillation in patients with cardiac sarcoidosis.

The prognostic value of the presence of atrial fibrillation (AF) in patients at the time of cardiac sarcoidosis (CS) diagnosis is unknown. This study aimed to investigate the association between AF at the time of CS diagnosis and patient prognosis. This study is a post-hoc analysis of Illustration of the Management and Prognosis of Japanese Patients with CS, a multicentre, retrospective observational study that evaluated the clinical characteristics and prognosis of patients with CS. The primary endpoint was the combined endpoint of all-cause death and hospitalization due to heart failure. After excluding patients with missing data about AF status, 445 patients (62 ± 11 years, 36% males) diagnosed with CS according to the Japanese current diagnostic guideline were analysed. Compared to patients without AF, patients with AF (n = 46, 10%) had higher levels of brain natriuretic peptide and a higher prevalence of heart failure hospitalizations. During a median follow-up period of 3.2 years (interquartile range, 1.7-5.8 years), 80 primary endpoints were observed. Kaplan-Meier curve analysis indicated that concomitant AF at the time of diagnosis was significantly associated with a high incidence of primary endpoints (log-rank P = 0.002). This association was retained after adjusting for known risk factors including log-transformed brain natriuretic peptide levels and left ventricular ejection fractions [hazard ratio, 1.96 (95% confidence interval, 1.05-3.65); P = 0.035]. The presence of AF at the time of CS diagnosis is associated with higher incidence of all-cause death and heart failure hospitalization.

Prognosis of Older Adult Patients Suffering from Atrial Fibrillation and Hypokalemia.

To examine the effects of hypokalemia on the prognosis of older adult patients with atrial fibrillation (AF). We enrolled 794 older adult patients ≥ 75 years suffering from AF, and divided them into two groups according to the inclusion and exclusion criteria: Group 1, (hypokalemia group), 246 cases, serum K+<3.5 mmol/L; Group 2, (normal blood potassium group), 548 cases, 3.5mmol/L≤serum K+<5.5 mmol/L. The two groups of patients were followed for 70 months to observe the occurrence of clinical events. The primary endpoint was cardiovascular death and the secondary endpoint was all-cause death. The median follow-up time was 15.00 months. In terms of baseline profile characteristics, serum creatinine levels were significantly lower in Group 1 than in Group 2 patients (P=0.002). In terms of the relationship between hypokalemia and clinical outcomes, Kaplan-Meier survival analysis revealed that the incidence of clinical primary endpoint in Group 1 was significantly higher than that in Group 2 (P < 0.001), and the incidence of the secondary endpoint did not differ significantly between the two groups (P> 005). Based on multivariate Cox regression risk model analysis, coronary heart disease, hemoglobin content, serum uric acid and usage of anticoagulant drugs were the independent variables related to the primary endpoint of cardiovascular death (all P< 0.01). The incidence of hypokalemia in older adult patients with AF was 30.98%. Hypokalemia was closely related to the cardiovascular death, and coronary heart disease, hemoglobin content, serum uric acid level, and usage of anticoagulant drugs were the independent risk factors for the primary endpoint event.

De Ritis Ratio is Associated with Contrast-Associated Acute Kidney Injury Prediction and Long-Term Clinical Outcomes in Patients Undergoing Emergency Percutaneous Coronary Intervention.

Contrast-associated acute kidney injury (CA-AKI) is a familiar complication following percutaneous coronary intervention (PCI). The present study evaluated the predictive value of the De Ritis ratio for CA-AKI and its association with long-term clinical outcomes in patients undergoing emergency PCI. Overall, 546 patients were included in this study. The De Ritis ratio was calculated by aspartate aminotransferase/alanine aminotransferase activity. The De Ritis ratios in the CA-AKI patients were significantly higher than the non-CA-AKI patients [3.74 (2.32, 4.90) vs 1.61 (1.02, 2.53); P < .001]. The De Ritis ratio was an independent risk factor for CA-AKI [odds ratio, 2.243; 95% confidence interval (CI), 1.823-2.759; P < .001]. The area under the ROC curve was .813 (95% CI, .763-.862; P < .001), and the sensitivity and specificity were 67.0% and 82.4%, respectively, when the optimum cut-off value was 2.97. Furthermore, patients in the high De Ritis ratio group (≥1.76) had a significantly greater incidence of primary endpoints [26.7% (73/273) vs 13.2% (36/273); P < .001], and the high De Ritis ratio was an independent predictor for primary endpoints (hazard ratio, 1.888, 95% CI, 1.235-2.887; P = .003). In conclusion, the De Ritis Ratio is associated with CA-AKI prediction and long-term clinical outcomes in patients undergoing emergency PCI.

The value of cardiac MRI in the risk stratification in patients with hypertrophic cardiomyopathy

Objective: To explore the value of cardiac magnetic resonance imaging (CMR) in the risk stratification of hypertrophic cardiomyopathy (HCM). Methods: HCM patients who underwent CMR examination in Fuwai Hospital between March 2012 and May 2013 were retrospectively enrolled. Baseline clinical and CMR data were collected and patient follow-up was performed using telephone contact and medical record. The primary composite endpoint was sudden cardiac death (SCD) or and equivalent event. The secondary composite endpoint was all-cause death and heart transplant. Patients were divided into SCD and non-SCD groups. Cox regression was used to explore risk factors of adverse events. Receiver operating characteristic (ROC) curve analysis was used to assess the performance and the optimal cut-off of late gadolinium enhancement percentage (LGE%) for the prediction of endpoints. Kaplan-Meier and log-rank tests were used to compare survival differences between groups. Results: A total of 442 patients were enrolled. Mean age was (48.5±12.4) years and 143(32.4%) were female. At (7.6±2.5) years of follow-up, 30 (6.8%) patients met the primary endpoint including 23 SCD and 7 SCD equivalent events, and 36 (8.1%) patients met the secondary endpoint including 33 all-cause death and 3 heart transplant. In multivariate Cox regression, syncope(HR=4.531, 95%CI 2.033-10.099, P<0.001), LGE% (HR=1.075, 95%CI 1.032-1.120, P=0.001) and left ventricular ejection fraction (LVEF) (HR=0.956, 95%CI 0.923-0.991, P=0.013) were independent risk factors for primary endpoint; Age (HR=1.032, 95%CI 1.001-1.064, P=0.046), atrial fibrillation (HR=2.977, 95%CI 1.446-6.131, P=0.003),LGE% (HR=1.075, 95%CI 1.035-1.116, P<0.001) and LVEF (HR=0.968, 95%CI 0.937-1.000, P=0.047) were independent risk factors for secondary endpoint. ROC curve showed the optimal LGE% cut-offs were 5.1% and 5.8% for the prediction of primary and secondary endpoint, respectively. Patients were further divided into LGE%=0, 0<LGE%<5%, 5%≤LGE%<15% and LGE%≥15% groups. There were significant survival differences between these 4 groups whether for primary endpoint or secondary endpoint (all P<0.001) and the accumulated incidence of primary endpoint was 1.2% (2/161), 2.2% (2/89), 10.5% (16/152) and 25.0% (10/40), respectively. Conclusion: LGE is an independent risk factor for SCD events as well as all-cause death and heart transplant. LGE is of important value in the risk stratification in patients with HCM.

P252 THE TREATMENT WITH BETA–BLOCKERS AFTER MYOCARDIAL INFARCTION WITHOUT REDUCED EJECTION FRACTION (REBOOT) TRIAL, 2023 UPDATES

Abstract Introduction The role of beta blockers (BB) post–myocardial infarction (MI) in patients without reduced ejection fraction in the era of invasive management is controversial results from observational studies have led to opposite results. Methods REBOOT is an independent multinational pragmatic, controlled, randomized, open–label, with blinded endpoint adjudication clinical trial. The study is testing the benefits of BB maintenance therapy in post–MI patients (either with or without ST segment elevation) discharged with LVEF &amp;gt;40%. Patients ≥18 years old undergoing invasive management during admission and without history of heart failure (HF) are eligible to participate. At discharge, they are 1:1 randomized to either receive BB (agent and dose chosen by the treating physician) or no BB therapy. The primary endpoint is a composite of all–cause death, nonfatal re–MI, or heart failure hospitalization over a minimum follow–up period of 2.75 years (minimum 2 years, maximum 3 years). Events are adjudicated by a blinded committee. Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC) is the sponsor of the trial and the coordinator of Spanish Centers while Istituto di Ricerche Farmacologiche Mario Negri IRCCS coordinates the Italian participating network. Hospital admission for COVID–19 were also recorded since June 2020. Results The study is currently ongoing and 29 Italian centers are still actively recruiting. A sample size of 8468 pts (728 events) was estimated to provide a power of 85% to detect a RRR of 20% (incidence of primary endpoint in control 10%) and assuming 5% withdrawals. More than 75 Spanish and 35 Italian centers recruited patients. The first patients have been included in Spain in October 2018, in Italy in January 2019. On December 31st 2022, the number of enrolled patients by Italian centers was 1685. The top three Italian enrollers at the moment are: Ospedale G. da Saliceto –Piacenza (483 pts), Ospedale S. Luigi Gonzaga – Orbassano (183 pts) and A.O San’Anna and San Sebastiano – Caserta (170 pts). The patient enrollment rate was almost stable during all the study periods with a slight decrease during COVID pandemic outbreaks. The Italian REBOOT Network goal is to include 1800 patients by April 2023. The first results will become available by the end of 2025. Conclusion The REBOOT, with other ongoing trials, will provide robust evidence to guide the prescription of BB to patients discharged after MI without reduced LVEF.

Favorable Prognosis in Patients with Recovered Pulmonary Hypertension after TAVI: An Analysis of the LAPLACE-TAVI Registry.

Pulmonary hypertension (PH) is a common complication of aortic stenosis (AS). Despite the established association between PH and poor outcomes in patients with AS, the prognostic implication of a change in PH after transcatheter aortic valve implantation (TAVI) has been rarely evaluated. This study analyzed a prospective multi-center TAVI registry database involving six Japanese centers and used the transtricuspid pressure gradient (TRPG) obtained by echocardiography to estimate pulmonary artery systolic pressure. The participants (n = 2056) were first divided into two groups by TRPG before TAVI, a PH (-) group (TRPG &lt; 30 mmHg) (n = 1407, 61.9%) and a PH (+) group (TRPG ≥ 30 mmHg) (n = 649, 28.6%). Next, by TRPG after (4.1 ± 5.3 days) TAVI, the PH (+) group was further subdivided into two groups, Recovered PH (TRPG &lt; 30 mmHg, n = 253) and Persistent PH (TRPG after TAVI ≥ 30 mmHg, n = 396). The median follow-up duration was 1.8 years. The primary and secondary endpoints were the composite and each of cardiovascular (CV) death and heart failure hospitalization, respectively. Unadjusted Kaplan-Meier estimates with log-rank comparisons showed significantly higher cumulative incidences of primary and secondary endpoints in the Persistent PH group compared to other groups. Moreover, adjusted multivariate Cox-proportional hazard analyses showed that a decreased (-10 mmHg) TRPG after TAVI was linearly associated with a reduced risk of the primary endpoint (hazard ratio (HR): 0.76, 95% confidence interval (CI): 0.64-0.90, p = 0.0020). The findings in the present study indicate that the recovery of PH may partly contributes to the prognostic benefit of TAVI procedure in patients with AS and elevated pulmonary artery systolic pressure.