Incidence Of Primary Endpoint Research Articles

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<0.001); had higher CHADS-VASc (3.4 vs 2.3; p<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<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.

289 DIAGNOSTIC PATHWAY OF PATIENTS WITH CHRONIC CORONARY SYNDROME AFTER THE ISCHEMIA TRIAL PUBLICATION

Abstract Introduction Patients with chronic coronary syndrome (CCS) can initially undergo an invasive (i.e., early referral to invasive coronary angiography [ICA]) or a conservative (i.e., anatomical or functional testing before ICA) management. The ISCHEMIA trial showed no difference between these two strategies in CCS patients with moderate-to-severe ischemia. The aim of our study was to assess whether the results of the ISCHEMIA trial impacted on the management of CCS patients. Methods Trends in the management of patients with CCS in our centre, according to the ISCHEMIA trial publication date, were analyzed and patients categorized into pre-ISCHEMIA (before March 2020) and post-ISCHEMIA (from July 2020 to February 2022) groups, with an in-between blanking period of three months. The primary outcome was incidence of referral to ICA by coronary computed tomography angiography (CCTA). Secondary objectives included the incidence ischemia test-referred ICA, incidence of CCTA-referred ICA and subsequent percutaneous coronary intervention (PCI), incidence of ischemia test-referred ICA and subsequent PCI and incidence of CCTA-referred ICA without subsequent PCI. Differences between the pre-specified subpopulations (age ≥75 years, diabetes, chronic kidney disease [CKD], peripheral arterial disease [PAD], gender male, unstable angina, active smoking status, body mass index [BMI] &amp;gt;30, hypertension, family history of coronary artery disease [CAD], atrial fibrillation [AF], prior percutaneous coronary intervention [PCI], prior coronary artery bypass grafting [CABG]) and the general population of the study were tested using a regression analysis. Results A total of 2,365 patients were included, 487 (20.6%) and 1,878 (79.4%) in the pre-ISCHEMIA and post-ISCHEMIA groups, respectively. There were no notable between-group differences in baseline characteristics. The primary outcome occurred more frequently in the post-ISCHEMIA group (73.5% vs. 32.5%; p&amp;lt;0.01). Compared to pre-ISCHEMIA, the post-ISCHEMIA group displayed less referrals to ICA by ischemia testing (31.6% vs. 52.5%; p&amp;lt;0.01) and more ICA referrals by CCTA with subsequent PCI (8.3% vs. 12.0%; p&amp;lt;0.01). There were no within-group differences in ischemia test-referred ICA and PCI, and CCTA-referred ICA without subsequent PCI. A regression analysis between the primary endpoint incidence in the general population compared to the incidence in the pre-specified subpopulations showed no significant difference in the p values for interaction. Conclusions In the first two years from publication, the ISCHEMIA trial significantly impacted on the decision-making algorithm for patients with CCS, increasing referral to ICA by CCTA and diminishing ICAs indicated by an ischemia test.

Efficacy of guideline-directed medical treatment in heart failure with mildly reduced ejection fraction.

Heart failure with mildly reduced ejection fraction (HFmrEF) has received increasing attention following the publication of the latest ESC guidelines in 2021. However, it remains unclear whether patients with HFmrEF could benefit from guideline-directed medical treatment (GDMT), referring the combination of ACEI/ARB/ARNI, β-blockers, and MRAs, which are recommended for those with reduced ejection fraction. This study explored the efficacy of GDMT in HFmrEF patients. This was a retrospective cohort study of HFmrEF patients admitted to The First Affiliated Hospital of Dalian Medical University between 1 September 2015 and 30 November 2019. Propensity score matching (1:2) between patients receiving triple-drug therapy (TT) and non-triple therapy (NTT) based on age and sex was performed. The primary outcome was all cause death, cardiac death, rehospitalization from any cause, and rehospitalization due to worsening heart failure. Of the 906 patients enrolled in the matched cohort (TT group, n=302; NTT group, N=604), 653 (72.08%) were male, and mean age was 61.1±11.92. Survival analysis suggested that TT group experienced a significantly lower incidence of prespecified primary endpoints than NTT group. Multivariable Cox regression showed that TT group had a lower risk of all-cause mortality (HR 0.656, 95% CI 0.447-0.961, P=0.030), cardiac death (HR 0.599, 95% CI 0.380-0.946, P=0.028), any-cause rehospitalization (HR 0.687, 95% CI 0.541-0.872, P=0.002), and heart failure rehospitalization (HR 0.732, 95% CI 0.565-0.948, P=0.018). In patients with HFmrEF, combined use of neurohormonal antagonists produces remarkable effects in reducing the occurrence of the primary outcome of rehospitalization and death. Thus, the treatment of HFmrEF should be categorized as HFrEF due to the similar benefit of neurohormonal blocking therapy in HFrEF and HFmrEF.

The Prognostic Value of B-Type Natriuretic Peptide in Patients With Cardiac Sarcoidosis Without Heart Failure: Insights From ILLUMINATE-CS.

Background The prognostic role of BNP (B-type natriuretic peptide) in patients with cardiac sarcoidosis without evident heart failure is unknown. Methods and Results This 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. We analyzed patients with cardiac sarcoidosis without evident heart failure at the time of diagnosis. The association between baseline BNP levels and prognosis was investigated. The primary end point was the combined end point of all-cause death, heart failure hospitalization, and fatal ventricular arrhythmia. In total, 238 patients (61.0±11.1 years, 37% men) were analyzed, and 61 primary end points were observed during a median follow-up period of 3.0 (interquartile range, 1.7-5.8) years. Patients with high BNP (BNP above the median value of BNP) were older and had a lower renal function and left ventricular ejection fraction than those with low BNP values. Kaplan-Meier curve analysis indicated that high BNP levels were significantly associated with a high incidence of primary end points (log-rank P=0.004), and this association was retained even in multivariable Cox regression (hazard ratio, 2.06 [95% CI, 1.19-3.55]; P=0.010). Log-transformed BNP as a continuous variable was associated with the primary end point (hazard ratio, 2.12 [95% CI, 1.31-3.43]; P=0.002). Conclusions High baseline BNP level was an independent predictor of future adverse events in patients with cardiac sarcoidosis without heart failure at the time of diagnosis. Registration URL: https://www.umin.ac.jp/english/; Unique Identifier: UMIN-CTR: UMIN000034974.

Contrast volume and in-hospital outcomes of dialysis patients undergoing percutaneous coronary intervention

Toxicity resulting from retained contrast media may cause adverse cardiovascular outcomes (e.g., heart failure and cardiogenic shock) for dialysis patients. However, the association between the administered contrast volume and outcomes of dialysis patients after percutaneous coronary intervention (PCI) has not been sufficiently investigated. We evaluated 953 consecutive dialysis patients (age, 67.9 ± 9.9 years; 30.1% with acute coronary syndrome) who underwent PCI between September 2008 and March 2019. Patients were divided into two groups: those with a contrast volume ≥ 200 ml and those with a contrast volume < 200 ml. The cutoff was 200 ml because 100 ml increment of contrast volume is known to raise the risk of acute kidney injury, and 200 ml is more than the average volume used at most PCI centers. The primary endpoint was a composite of in-hospital death, post-PCI cardiogenic shock and post-PCI heart failure. A multivariable logistic regression model and smooth spline curve were constructed to assess the association between contrast volume and the primary endpoint. The median contrast volume was 157 ml (interquartile range, 115–210 ml). The overall primary endpoint incidence was 6.8% (N = 65). A contrast volume ≥ 200 ml was associated with a higher risk of the primary endpoint (odds ratio 2.91; 95% confidence interval 1.42–6.05; P = 0.004). The smooth spline curve demonstrated a linear relationship between the contrast volume and primary endpoint. In conclusions, the contrast volume was associated with adverse in-hospital outcomes of dialysis patients undergoing PCI. Attention should be focused on the contrast volume used for dialysis patients undergoing PCI.

Solve the post-operative subdural pneumatosis of chronic subdural hematoma: A novel active bone hole drainage system

BackgroundPost-operative subdural pneumatosis (PSP) is commonly encountered after the chronic subdural hematoma (CSDH) surgery which currently lacks effective methods to avoid the condition. This study invented an active bone hole drainage system to change the venting technique with the aim of comparing post-operative efficacy and prognosis to traditional drilling and drainage.MethodsWe conducted a randomized controlled trial between January 2020 and January 2021. A total of 86 patients undergoing surgery were assessed for eligibility, with 50 patients randomly assigned to the control group (received drilling and drainage) and 36 patients to the test group (received modified surgery). The 6-month follow-up was done after surgery. CSDH recurrence and post-operative hematoma re-increasement were the primary endpoints. The data from the two groups were compared and analyzed. This study was registered with the Chinese Clinical Trials Register (ChiCTR2200057158), and had ethics committee approval and patient consent.ResultsThe incidence of PSP in the test group (0%, 0/30)was lower than the control group (93.88%, 46/49) (P < 0.001). The brain non-expansion rates 3 days/weeks/months after surgery of the test group were 59.25 [49.62, 76.97], 52.10 [42.88, 72.45], and 29.45 [23.40, 36.95] respectively, which were lower than the control group which were 78.60 [69.50, 94.70], 73.10 [60.70, 87.40], and 61.70 [51.50, 78.30], respectively (P < 0.001). The ADL scores a week/month/3/6 months after surgery of the test group were 100.00 [60.00, 100.00], 100.00 [85.00, 100.00], 100.00 [100.00, 100.00], 100.00 [100.00, 100.00], which were better than the control group's 60.00 [60.00, 80.00], 75.00 [60.00, 100.00], 100.00 [60.00, 100.00], 100.00 [60.00, 100.00] (P < 0.05). The incidence of primary endpoints in the test group (10%, 3/30) was lower than the control group (34.69%, 17/49) (P < 0.05).ConclusionsCompared to drilling and drainage, the modified surgery with the active bone hole drainage system significantly reduced the incidence of PSP and primary endpoints and improved the post-operative efficacy and prognosis.Clinical trial registrationIdentifier: ChiCTR2200057158.

CPAP for secondary cardiovascular prevention in obstructive sleep apnoea patients: not only one moon, but many stars.

While continuous positive airway pressure (CPAP) therapy has a strong evidence base for the treatment of obstructive sleep apnoea (OSA), its impact on cardiovascular comorbidity remains unclear. This journal club reviews three recent randomised controlled trials aimed to evaluate the impact of CPAP therapy in secondary prevention of cerebrovascular and coronary heart disease (SAVE trial), comorbid coronary heart disease (RICCADSA trial) and in patients admitted with acute coronary syndrome (ISAACC trial). All three trials included patients with moderate-to-severe OSA and excluded patients with severe daytime sleepiness. When CPAP was compared with usual care, they all reported no difference in a similar primary composite end-point including death from cardiovascular disease, cardiac events, and strokes. These trials faced the same methodological challenges, including a low primary end-point incidence, the exclusion of sleepy patients, and a low CPAP adherence. Therefore, caution must be taken when broadening their results to the wider OSA population. Although randomised controlled trials provide a high level of evidence, they may not be sufficient to capture the diversity of OSA. Large-scale, real-world data may be able to provide a more rounded and generalisable picture of the effects of routine clinical use of CPAP on cardiovascular morbimortality.

Clinical Prognosis in Patients with Heart Failure and Reduced Left Ventricular Ejection Fraction after Myocardial Revascularization on the Background of Taking SGLT2 Inhibitors

The aim. To evaluate clinical and prognostic effects of sodium-glucose co-transporter 2 (SGLT2) inhibitors on primary (progression of heart failure, rehospitalization) and secondary endpoints (death from cardiovascular disease and from all causes) in patients with heart failure with reduced ejection fraction (HFrEF) within 8 months after percutaneous coronary intervention (PCI).&#x0D; Materials and methods. In a one-center study on the basis of the Ukrainian Children’s Cardiac Center, Clinic for Adults we analyzed the data for drug and interventional treatment of 166 patients with coronary artery disease and reduced left ventricular ejection fraction (LVEF) (&lt;40%), who underwent PCI in the last 8 months. Among the 166 patients studied, 86 (51.8%) patients received SGLT2 inhibitors as an adjunct to the standard baseline therapy, and 80 (48.2%) patients did not receive SGLT2 inhibitors after PCI.&#x0D; Results and discussion. The primary combined outcome was observed in 10 patients (6.02%) in the group of patients taking SGLT2 inhibitors and 35 patients (21.08%) without addition of SGLT2 inhibitors (hazard ratio 0.72; 95% CI, 0.65-0.85; p &lt;0.001). The incidence of the secondary combined result was lower in the group receiving SGLT2 inhibitors than in the comparison group (risk ratio, 0.85; 95% CI, 0.75-0.95; p &lt;0.001).&#x0D; Conclusions. The use of SGLT2 inhibitors in addition to the standard therapу provided a 72% reduction in the relative risk, estimated by the incidence of primary combined endpoint in particular, hospitalization due to the heart failure decompensation by 34% in the same group, and the secondary endpoint by 50%. The advantage of SGLT2 inhibitors over the standard therapy in the effect on the primary endpoint did not depend on the complete or incomplete myocardial revascularization by PCI in patients over an 8-month follow-up period. SGLT2 inhibitors use in patients after PCI with reduced left ventricular systolic function over the 8-month follow-up period led to regression of angina according to the KCCQ-TSS questionnaire, decreased functional class according to the New York classification, and increased LVEF.