Aims In persistent atrial fibrillation (AF), low-voltage areas (LVAs) in the left atrium are considered arrhythmogenic. Although substrate ablation targeting LVAs may reduce AF recurrence, its effect on broader clinical outcomes remains unclear, and procedural risks must be considered. This study aims to compare hierarchical clinical outcomes between pulmonary vein isolation (PVI) alone and PVI plus LVA ablation in patients with persistent AF and LVAs using a win ratio analysis.Methods and results This was a post hoc sub-analysis of the SUPPRESS-AF trial, including 341 patients with LVAs out of 1364 randomized. Patients received either PVI alone (n = 171) or PVI with LVA ablation (n = 170). Hierarchical outcomes were analysed in order of clinical importance: all-cause death, symptomatic stroke, AF recurrence, bleeding, and periprocedural complications. Win ratio analysis was used for comparison. Baseline characteristics were balanced between groups. The PVI plus LVA group had longer procedure times and higher energy delivery. The win ratio analysis showed no significant difference between groups (win ratio: 1.01, 95% confidence interval: 0.73-1.39, P = 0.940). The PVI-alone group had numerically fewer adverse events, while the LVA ablation group showed a numerical reduction in AF recurrence. Subgroup analyses showed consistent findings.Conclusion In patients with persistent AF and LVAs, LVA ablation added to PVI did not improve hierarchical clinical outcomes and prolonged procedures. Routine use of current LVA ablation strategies is not supported, though targeted substrate modification may warrant further research.Registration UMIN-CTR, https://www.umin.ac.jp/ctry. UMIN000035940.
Introduction: Cancer patients are at risk for acute kidney injury (AKI) due to anticancer agents, tumor lysis syndrome, sepsis, and contrast-induced nephropathy. Renal replacement therapy (RRT) is associated with longer hospital stays, higher healthcare costs, and significant healthcare resource consumption. Therefore, early detection of severe AKI requiring RRT and the implementation of preventive measures are crucial. We comprehensively evaluated the associations with RRT by cancer site among Japanese cancer patients undergoing treatment through use of Hospital-Based Cancer Registry (HBCR) data linked to administrative data in a multicenter cohort study. Methods: Patients were classified into three groups based on the timing of RRT after the initiation of cancer treatment: acute phase (≤30 days), post-acute phase (after 30 days), and no RRT. The hazard ratios (HRs) and subdistribution HRs for RRT incidence were evaluated by cancer site (colon, lung, stomach, liver, kidney, esophagus, pancreas, and hematologic malignancies) using Cox proportional hazards and Fine-Gray competing-risk models adjusted for patient characteristics, comorbidities, and diuretic use. The 1-year cumulative incidence of RRT was also calculated. Results: A total of 230,850 patients were analyzed. Among them, 386 patients received RRT at ≤30 days after cancer treatment initiation (acute phase), 479 patients received RRT at >30 days (post-acute phase), and 229,985 patients did not receive RRT. In the Cox proportional hazards regression model, the HRs for RRT were significantly higher in the acute phase among patients with colorectal cancer (HR: 1.72, p < 0.001), liver cancer (HR: 1.80, p = 0.006), kidney cancer (HR: 2.49, p < 0.001), and hematologic malignancies (HR: 4.06, p < 0.001) when compared according to cancer site. In the post-acute phase, only hematologic malignancies showed a significantly increased HR for RRT (HR: 2.65, p < 0.001). The 1-year cumulative incidence of RRT among all patients was 0.413%. Conclusion: The risk of RRT after cancer treatment was increased during the acute phase in patients with colorectal, liver, and kidney cancer and those with hematologic malignancies. Patients with hematologic malignancies always had a higher HR for RRT, but the HR was particularly high in the acute phase.
Background The potential value of low-voltage area (LVA) ablation for persistent atrial fibrillation (AF) has been suggested. However, its efficacy determinants remain unclear. We investigated the impact of diabetes on the outcomes of LVA ablation in patients with persistent AF.Methods This post hoc subanalysis of the multicenter randomized controlled trial SUPPRESS-AF (Efficacy and Safety of Low-Voltage-Guided Ablation for Recurrence Prevention Compared With Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation) included patients with persistent AF undergoing initial ablation. Following pulmonary vein isolation (PVI), patients with LVAs were randomized to PVI+LVA-ablation or PVI alone. We compared recurrence-free survival between patients with and without diabetes. The primary end point was freedom from AF/atrial tachycardia recurrence.Results Of 1347 patients with persistent AF, 343 (25.5%) had left atrial LVAs. The nondiabetic group comprised 264 patients (136 and 128 in the PVI-alone and PVI+LVA-ablation arms, respectively), and the diabetic group comprised 77 patients (35 and 42 in each arm, respectively). No significant difference was observed in LVA extent between the groups. Overall recurrence rates were also similar (44% versus 42%; P=0.658). In the nondiabetic group, the PVI+LVA-ablation arm showed significantly lower recurrence rates compared with the PVI-alone arm (35% versus 49%; P=0.018). Conversely, patients with diabetes exhibited higher recurrence rates in the PVI+LVA-ablation arm compared with those in the PVI-alone arm (48% versus 40%; P=0.290). A significant interaction was observed between diabetes status and LVA ablation efficacy (P for interaction=0.041).Conclusions In this exploratory post hoc analysis, LVA ablation may benefit patients without diabetes, whereas no clear benefit, and a possible signal of futility, was observed in patients with diabetes.
ABSTRACT Background Left atrial low‐voltage areas (LVAs) represent an arrhythmogenic substrate in atrial fibrillation (AF). LVA‐targeted ablation is increasingly used as an adjunct to pulmonary vein isolation (PVI), yet outcomes vary across randomized trials, potentially due to differences in ablation strategy. We performed a meta‐analysis to evaluate the effectiveness of LVA‐targeted ablation added to PVI and to assess whether treatment effects differ between LVA isolation and LVA homogenization strategies. Methods Following PRISMA, we systematically searched PubMed and CENTRAL for randomized controlled trials (RCTs). Eligible studies enrolled patients with any AF type undergoing voltage mapping and compared PVI plus LVA‐targeted ablation (PVI + LVA) with PVI alone. The primary outcome was AF/atrial tachyarrhythmia recurrence during follow‐up, as defined in each trial. Odds ratios (ORs) with 95% confidence intervals (CIs) were pooled using a random‐effects model. Subgroup analyses were performed according to the predominant LVA strategy (isolation vs. homogenization). Results Six RCTs involving 1565 patients (PVI + LVA, n = 780; PVI alone, n = 785) were included. Overall, PVI + LVA reduced recurrence compared with PVI alone (OR 0.72; 95% CI 0.54–0.96). In strategy‐specific analyses, LVA isolation was associated with a significant reduction in recurrence (OR 0.57; 95% CI 0.38–0.87), whereas LVA homogenization showed a smaller and non‐significant effect (OR 0.85; 95% CI 0.59–1.24). Between‐strategy heterogeneity was substantial ( I 2 = 90.4%). Conclusions In RCTs of AF ablation, adding LVA‐targeted ablation to PVI reduced arrhythmia recurrence. The treatment effect appeared more pronounced with LVA isolation than with homogenization; however, these strategy‐specific findings should be considered exploratory and require confirmation in future randomized studies.
BACKGROUND:In persistent atrial fibrillation (AF), the incremental benefit of adjunctive low-voltage area (LVA) ablation beyond pulmonary vein isolation (PVI) remains inconsistent. OBJECTIVE:To examine whether a simple clinical score characterizes treatment-effect heterogeneity of adjunctive LVA ablation among patients with mapped LVA > 5 cm2 and to perform an exploratory supportive analysis in an independent randomized cohort. METHODS:In this post-hoc analysis of SUPPRESS-AF, which included patients with persistent AF and mapped LVA > 5 cm2 after PVI, four variables-age ≥ 75 years, left atrial diameter > 44 mm, estimated glomerular filtration rate < 60 mL/min/1.73 m2, and absence of diabetes-were combined into the ALID score (0-4). Patients were stratified into low (0-1), intermediate (2), and high (3-4) score groups. Because EARNEST-PVI did not use LVA-guided ablation or select patients based on mapped LVA, it was analyzed as an exploratory supportive cohort rather than as an external validation cohort. RESULTS:In SUPPRESS-AF (n = 336), a significant treatment-by-score interaction was observed (P < 0.001). Adjunctive LVA ablation was associated with increased recurrence in the low-score stratum (HR 3.92; 95% CI 1.50-10.20) and reduced recurrence in the high-score stratum (HR 0.48; 95% CI 0.26-0.86). In EARNEST-PVI (n = 494), a qualitatively similar interaction pattern was observed for additional ablation beyond PVI (interaction P = 0.029), although the ablation strategy differed from LVA-guided ablation. CONCLUSIONS:Among patients with persistent AF and mapped LVA >5 cm2, the ALID score identified heterogeneity in response to adjunctive LVA ablation. These hypothesis-generating findings require prospective validation before clinical implementation.
BACKGROUND:Continuous anticoagulation guided by the CHA2DS2-VASc score is standard for atrial fibrillation (AF) but does not reflect real-time AF occurrence. We evaluated an Apple Watch-guided event-triggered anticoagulation strategy that adjusts direct oral anticoagulant (DOAC) use according to smartwatch detection. METHODS AND RESULTS:This multicenter prospective single-arm study enrolled postablation patients in sinus rhythm who were taking DOACs and had a CHA2DS2-VASc score ≤3. Apple Watch monitoring continued for 360 days. If no AF occurred during Days 1-30, anticoagulation was stopped on Day 31; thereafter, Apple Watch notification or electrocardiogram (ECG) evidence of AF prompted DOAC resumption through Day 360. Of 54 enrolled patients enrolled in the study, 50 comprised the analysis population (mean age 63 years; 10% female; median CHA2DS2-VASc score 2). Across 15,865 person-days, Apple Watch guidance reduced DOAC exposure by 94.6% compared with continuous anticoagulation. Reductions were similar for patients with CHA2DS2-VASc scores of 2-3 and 0-1 (95.0% and 94.0%, respectively; P=0.818). No deaths, strokes, systemic thromboembolic events, or bleeding events were observed. One device malfunction prevented ECG acquisition. CONCLUSIONS:In this cohort, Apple Watch-guided event-triggered anticoagulation markedly reduced DOAC exposure without thromboembolic events. Given the limited sample size and low baseline thromboembolic risk, these safety findings should be interpreted cautiously. Results were similar in the prespecified analysis restricted to patients with CHA2DS2-VASc scores of 2-3, the group for whom postablation anticoagulation decisions are most clinically relevant.
BACKGROUND:Incomplete low-voltage area (LVA) ablation may confound evaluation of its true efficacy in persistent atrial fibrillation (AF). This post hoc subanalysis of the multicenter randomized SUPPRESS-AF trial assessed the impact of complete LVA ablation. METHODS AND RESULTS:Patients with persistent AF and a left atrial (LA) LVA ≥5 cm2after pulmonary vein isolation were randomized to LVA ablation or no additional ablation. The primary endpoint was freedom from AF or atrial tachycardia recurrence, assessed by 24-h Holter and twice-daily electrocardiogram recordings. Outcomes were compared among 3 groups: no LVA ablation; complete LVA ablation; and incomplete LVA ablation. Among 341 patients, 170 underwent LVA ablation, including 37 with incomplete. LVA size was significantly larger in the incomplete than complete ablation group (22.0 vs. 12.2 cm2; P<0.001). Incomplete LVA ablation was not associated with increased arrhythmia recurrence. Arrhythmia-free survival did not differ significantly between the complete and no LVA ablation groups (hazard ratio [HR] 0.80; 95% confidence interval [CI] 0.56-1.13), including after propensity score matching (HR 0.76; 95% CI 0.51-1.15). However, a trend towards greater benefit of complete LVA ablation was observed with increasing LA diameter (Pinteraction=0.099). CONCLUSIONS:Leaving LVA ablation incomplete to avoid complications appears reasonable. Although complete LVA ablation showed no overall superiority, LA enlargement may represent a clinically relevant factor for patient stratification.
Background Although low-voltage area (LVA) ablation has been proposed as a substrate-modification strategy, it may also facilitate atrial tachycardia (AT), making it difficult to distinguish the effects of underlying substrate from those of adjunctive ablation. Objective To evaluate whether adjunctive LVA ablation is associated with post-protocol AT inducibility and whether inducibility is associated with clinical AT recurrence in a randomized cohort. Methods This post hoc analysis included patients from the SUPPRESS-AF randomized trial comparing pulmonary vein isolation (PVI) alone with PVI plus LVA ablation (PVI+LVA-ABL) in persistent atrial fibrillation with LVAs ≥5 cm2. After completion of the assigned ablation strategy, AT inducibility was assessed by atrial burst pacing. The primary analysis compared post-protocol AT inducibility between groups, and induced AT characteristics were compared descriptively. A secondary analysis examined the association between AT inducibility and clinical AT recurrence. Results Among 341 patients, AT was inducible in 38 (11%). AT inducibility was more frequent after PVI+LVA-ABL than after PVI alone (16% vs 6%, P = 0.005). Reentrant AT was the predominant pattern, with a numerically higher frequency after PVI+LVA-ABL. During 1-year follow-up, clinical AT recurrence occurred in 35 patients. Despite a 79% acute procedural success rate for induced AT ablation, AT inducibility was associated with AT recurrence in multivariable competing-risk analysis (subdistribution hazard ratio 2.23, 95% confidence interval 1.02–4.91). Conclusion In this randomized cohort with comparable LVA burden, adjunctive LVA ablation was associated with more frequent induced ATs compared with PVI alone. Post-protocol AT inducibility was associated with clinical AT recurrence.
Background Larger low‐voltage areas (LVAs) in the left atrium are associated with increased arrhythmia recurrence after atrial fibrillation (AF) ablation. The benefit of adjunctive LVA ablation may therefore depend on substrate extent. This study examined the efficacy of LVA ablation across a spectrum of LVA sizes in persistent AF. Methods The SUPPRESS‐AF (Efficacy and Safety of Left Atrial Low‐Voltage Area Guided Ablation for Recurrence Prevention Compared to Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation) trial screened 1364 patients undergoing initial ablation for persistent AF, of whom 342 with left atrial LVAs (≥5 cm2) were randomized to pulmonary vein isolation with or without adjunctive LVA ablation. In the 341 analyzed patients, LVA size was categorized as small (<10 cm2, n=106), moderate (≥10 to <20 cm2, n=127), or extensive (≥20 cm2, n=108). The primary end point was recurrence of AF or atrial tachycardia within 1 year without antiarrhythmic drugs. Treatment effects across LVA sizes were evaluated using a Cox model with restricted cubic splines. Results AF/atrial tachycardia recurrence rates were similar between the pulmonary vein isolation+LVA ablation and pulmonary vein isolation‐alone groups in patients with small (38.5% versus 29.6%; P=0.28) and moderate LVA sizes (40.6% versus 53.5%; P=0.15). However, adjunctive LVA ablation significantly reduced recurrence in patients with extensive LVAs (34.7% versus 57.6%; P=0.029; interaction P=0.054), driven mainly by lower AF recurrence (18.4% versus 42.4%, P=0.008). Spline analysis indicated a greater treatment benefit with increasing LVA size, reaching significance around 20 cm2. Conclusions The efficacy of adjunctive LVA ablation increased with substrate size, with a significant benefit observed in patients with extensive LVAs. These findings support a substrate size–guided ablation strategy to optimize rhythm outcomes in persistent AF. Registration URL: https://www.umin.ac.jp/ctr; Identifier: UMIN000035940.
BACKGROUND: Coronary bifurcation lesions remain one of the most challenging lesions. In particular, satisfactory clinical outcomes have not yet been achieved for side branches. The use of drug-coated balloons (DCBs) has demonstrated acceptable clinical outcomes in native coronary arteries. This study aimed to evaluate the efficacy and safety of additional DCB inflation in the side branches of bifurcation lesions. METHODS: The OCVC-BIF study was conducted as a multicenter, randomized, open-label trial. Patients with bifurcation lesions scheduled for drug-eluting stent (DES) implantation in the main vessel followed by kissing balloon inflation were enrolled in the study. The patients were randomized to receive either additional dilatation of the side branch using a DCB after DES implantation with kissing balloon inflation (DCB group) or only DES implantation with kissing balloon inflation using conventional balloons (non-DCB group). The primary end point was restenosis of the side branch, assessed using scheduled coronary angiography at 9 months or symptom-driven coronary angiography during the 1-year follow-up. Restenosis was defined as ≥50% stenosis of the side branch, determined using 3-dimensional bifurcation quantitative coronary angiography. The key secondary end points included major adverse cardiac events at 12 months, which were defined as a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization, and stent thrombosis. RESULTS: In total, 299 patients were randomized into the DCB (151 patients) and non-DCB (148 patients) groups between October 2019 and September 2024. Serial 3-dimensional bifurcation quantitative coronary angiography evaluation was performed in 262 (87.6%) patients. The restenosis rate was lower in the DCB group than that in the non-DCB group (8.1% versus 18.3%, P =0.012). However, the incidence of major adverse cardiac events at 12 months was similar between them (10.1% versus 12.4%, P =0.58). CONCLUSIONS: Additional DCB inflation in the side branch after main-vessel DES implantation with kissing balloon inflation decreases restenosis in the side branch in the treatment of bifurcation lesions. REGISTRATION: URL: xxxx; Unique identifier: jRCTs052200077.
BACKGROUND:In heart failure with preserved ejection fraction (HFpEF), the relationship between N-terminal pro-brain natriuretic peptide (NT-proBNP) levels and echocardiographic parameters and the influence of atrial fibrillation (AF) on the relationship remain poorly understood. METHODS:This study analyzed data from the Prospective mUlticenteR obServational stUdy of patIenTs with HFpEF (PURSUIT HFpEF). Patients hospitalized for acute decompensated HF with a left ventricular ejection fraction (LVEF) ≥ 50% were included. The association between longitudinal NT-proBNP levels and echocardiographic parameters was assessed using linear mixed-effects models, with further stratification by AF status. RESULTS:Of 1238 enrolled patients (median age 83[77, 87] years; 551[45%] male), 617 patients with longitudinal NT-proBNP data available (407 without AF, 210 with AF) were analyzed. In patients without AF, even after covariates adjusted, NT-proBNP levels were positively associated with left ventricular diastolic diameter (β-coefficient: 1.878 ± 0.736, P < 0.001), left ventricular mass index (β-coefficient: 1.467 ± 0.280, P < 0.001), left atrial volume index (β-coefficient: 0.795 ± 0.232, P < 0.001), E/e' (β-coefficient: 1.041 ± 0.214, P < 0.001), and tricuspid regurgitation pressure gradient (TRPG) (β-coefficient: 0.849 ± 0.261, P < 0.001). Conversely, left ventricular ejection fraction was negatively associated (β-coefficient: -1.632 ± 0.607, P < 0.001). However, in patients with AF, most of these parameters except for E/e', TRPG, and interventricular septal thickness at end-diastole had no correlation with NT-proBNP levels. CONCLUSIONS:In HFpEF patients without AF, longitudinal NT-proBNP levels were broadly associated with both structural and functional echocardiographic parameters. Whereas, patients with AF showed limited associations. Notably, E/e' and TRPG remained associated with NT-proBNP irrespective of AF status. TRIAL REGISTRATION:UMIN-CTR ID: UMIN000021831.
Abstract Aims Atrial fibrillation (AF) is a heterogeneous syndrome. We aimed to assess whether latent class analysis (LCA) can identify phenotypes that stratify prognosis and predict differential responses to catheter ablation strategies. Methods We first developed an LCA-based phenotyping model using the DIRECT-Extend registry (N = 7,512), a pooled AF cohort of patients receiving anticoagulation therapy. Patients with echocardiographic data (N = 2,741) were classified into latent clusters based on 16 clinical, laboratory, and echocardiographic variables. This phenotypic classification was then applied to the randomized EARNEST-PVI trial to evaluate whether the effectiveness of ablation strategies—pulmonary vein isolation (PVI) alone versus PVI plus extensive ablation (PVI-plus)—varied across phenotypes. Results In the DIRECT-Extend registry, three phenotypes were identified: Phenotype 1 (N = 1,565; “Low comorbidity”), Phenotype 2 (N = 981; “Cardiomyopathy & CKD”), and Phenotype 3 (N = 195; “Inflammatory-enriched AF”). Over a median 600 days, the primary endpoint -a composite of all-cause death, acute myocardial infarction, any stroke and major bleeding differed across phenotypes (log-rank p < 0.001). In EARNEST-PVI, patients were stratified into Phenotype 1 (n = 328), Phenotype 2 (n = 139), and Phenotype 3 (n = 30) according to the classification model. AF recurrence was significantly lower in the PVI-plus group compared to the PVI-alone group in phenotype 1 (log-rank p = 0.013), whereas there was no significant difference in Phenotypes 2 and 3. Conclusions LCA identified distinct AF phenotypes associated with prognoses. These phenotypes may also provide insights into heterogeneity in response to ablation strategies. This phenotyping approach may support risk stratification and individualized AF management.
Background: In patients with persistent atrial fibrillation (AF), extensive ablation for substrate modification, such as linear ablation or complex fractionated atrial electrogram ablation in addition to pulmonary vein isolation (PVI) remains controversial. Previous studies investigating extensive ablation have demonstrated its varying efficacy, suggesting the possible heterogeneity of its efficacy. Aging is a major risk factor for AF and is associated with atrial remodeling. We aimed to compare the efficacy and safety of the extensive ablation strategy compared with PVI alone strategy between young and elderly patients. Methods: This study is a post-hoc analysis of the multicenter, randomized controlled, noninferiority trial investigating the efficacy and safety of PVI-only (PVI-alone arm) compared with extensive ablation (PVI-plus arm) in patients with persistent AF (EARNEST-PVI trial). We divided the overall population into 2 groups based on age and assessed treatment effects. Results: In the young group (age <65 years, N = 206), there was no significant difference in the recurrence rate between the PVI-alone group and PVI-plus group [hazard ratio (HR): 1.00, 95 % CI: 0.57-1.73, p = 0.987], whereas the recurrence rate was significantly lower in the PVI-plus group compared to the PVI-alone group in the elderly group (age >= 65 years, N = 291) (HR: 0.47, 95 % CI: 0.29-0.76, p = 0.0021) (p for interaction = 0.0446). There were no fatal procedural complications. Conclusion: In patients with persistent AF, the extensive ablation strategy was more effective than the PVI-alone strategy in elderly patients, while the effectiveness of both approaches was comparable in young patients. Trial registration: URL: https://clinicaltrials.gov; Unique identifier: NCT03514693. URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022454 Unique ID issued by UMIN: UMIN000019449. (c) 2024 Japanese College of Cardiology. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
AIMS:Malnutrition and inflammation are associated with poor outcomes with heart failure (HF). As a marker integrating inflammation and nutritional status, the advanced lung cancer inflammation index (ALI), calculated by body mass index × serum albumin level / neutrophil-to-lymphocyte ratio, has been developed for the prognosis of several diseases including HF. The aim of this study is to investigate the prognostic value of ALI in elderly multimorbid HF patients with HF with preserved ejection fraction (HFpEF). METHODS:The study utilized data from the Prospective mUlticenteR obServational stUdy of patIenTs with Heart Failure with preserved Ejection Fraction (PURSUIT-HFpEF). Patients with acute decompensated HF and left ventricular ejection fraction ≥50% were included. ALI levels were calculated from discharge data. The primary endpoint was all-cause death. RESULTS:A total of 1238 patients [83 (77, 87) years, 555 (45%) male] were enrolled, with 1121 analysed for prognostic value of ALI. In the multivariable Cox model, ALI was significantly associated with the primary endpoint [adjusted hazard ratio (HR) for log-transformed ALI: 0.50, 95% confidence interval (CI): 0.34-0.75, P = 0.001]. ALI appears to enhance the prognostic value of the MAGGIC risk score [net reclassification improvement (NRI) = 46% (95% CI: 28%-65%), P < 0.001; integrated discrimination improvement (IDI) = 4.6% (95% CI: 2.8%-6.5%), P < 0.001], the geriatric nutritional risk index [NRI = 16% (95% CI: -3% to 35%), P = 0.103; IDI = 2.0% (95% CI: 0.8%-3.1%), P < 0.001] and C-reactive protein [NRI = 39% (95% CI: 20%-58%), P < 0.001; IDI = 4.8% (95% CI: 2.9%-6.6%), P < 0.001]. CONCLUSIONS:Low ALI levels were significantly associated with poor prognosis in elderly multimorbid HFpEF patients. ALI might complement existing risk indices for prognostic assessment.
BACKGROUND:Although several clinical trials have suggested the usefulness of drug-coated balloons (DCB) for side-branch lesions, their efficacy and safety have not yet been established. METHODS AND STUDY DESIGN:The Osaka Cardiovascular Conference (OCVC) will conduct a multicenter, randomized, open-label, controlled trial aiming to examine whether additional DCB treatment for the side branch after main vessel stenting followed by kissing balloon inflation (KBI) is superior to only KBI by conventional balloons in PCI patients with coronary bifurcation lesions. The primary endpoint is restenosis of side branches documented by scheduled or symptom-driven coronary angiography during 9-month follow-up period after the index PCI. The key secondary endpoints include major adverse cardiac event which consists of cardiac death, myocardial infarction, target lesion revascularization, and stent thrombosis, and optical coherence tomography findings. A total of 300 patients will be enrolled and followed up to 1 year. SUMMARY:The OCVC-BIF trial is a randomized controlled trial designed to assess whether additional DCB treatment for side branch is superior to only KBI by conventional balloons in patients with coronary bifurcation lesions undergoing PCI with main vessel stenting.
Background Growth differentiation factor 15 (GDF15) is a cytokine responding to oxidative stress and inflammation, and it regulates appetite and energy balance. The association between GDF15 and clinical factors and its prognostic value in elderly multimorbid patients with heart failure with preserved ejection fraction (HFpEF) have not been well unknown.Methods This exploratory analysis is part of the Prospective mUlticenteR obServational stUdy of patIenTs with Heart Failure with preserved Ejection Fraction study (N=1231), an ongoing, prospective, multicentre observational study of acute decompensated HFpEF (UMIN000021831). A predefined subcohort of 212 patients underwent multi-biomarker testing. Of these, we analysed 181 patients with available GDF15 data. The primary endpoint was a composite of all-cause death and hospitalisation for HF.Results In this analysis population, the median age was 81 (75–85) years, with 48% male patients. GDF15 significantly correlated with cardiac burden, anaemia, renal dysfunction and inflammation. Notably, poor nutritional status was significantly associated with GDF15. GDF15 was linked to poor prognosis in this elderly multimorbid cohort with HFpEF (adjusted HR for log-transformed GDF15: 13.67, 95% CI: 2.78 to 67.22, p=0.001). Furthermore, GDF15 added significant incremental value to the MAGGIC risk score (net reclassification improvement=0.4955 (95% CI: 0.1367 to 0.8543), p=0.007; integrated discrimination improvement=0.0278 (95% CI: 0.0013 to 0.0543), p=0.040).Conclusions GDF15 was associated with anaemia, inflammation, renal dysfunction, cardiac burden and malnutrition. It demonstrated prognostic value in elderly multimorbid HFpEF patients, suggesting its potential role as a complementary marker for the prognostic risk assessment of HFpEF patients.Trial registration number UMIN-CTR ID: UMIN000021831.
BACKGROUND:Primary percutaneous coronary intervention is the preferred treatment for acute myocardial infarction. However, in patients with chronic kidney disease (CKD), the use of contrast media can exacerbate renal dysfunction, often necessitating alternative strategies. The impact of CKD on acute myocardial infarction prognosis, particularly in the context of percutaneous coronary intervention, is not fully understood. METHODS AND RESULTS:This study utilized real-world registry data from the OACIS (Osaka Acute Coronary Insufficiency Study) to evaluate prognosis across different CKD grades, including advanced CKD and hemodialysis. From a database of 12 093 patients with acute myocardial infarction, we identified 8411 patients with renal function data at admission (a median follow-up period of 1765 days). These patients were classified into 8 CKD categories based on estimated glomerular filtration rate (eGFR); G1 (eGFR≥90 mL/min per 1.73 m2): n=1122, G2 (90>eGFR ≥60 mL/min per 1.73 m2): n=3588, G3a (60>eGFR≥45 mL/min per 1.73 m2): n=1923, G3b (45>eGFR≥30 mL/min per 1.73 m2): n=1030, G4: (30>eGFR≥15 mL/min per 1.73 m2): n=473, G5a: (15>eGFR≥8 mL/min per 1.73m2): n=80, G5b: (eGFR<8 mL/min per 1.73 m2): n=53 and hemodialysis: n=142. Percutaneous coronary intervention rates declined with advancing CKD, reaching the lowest in G5a (80.3%) but increasing again in G5b and hemodialysis groups (≈90%). Thirty-day all-cause mortality rates increased with CKD severity, with a notable reduction in G5b (9.4%) before rising again in patients with hemodialysis (16.9%). Long-term data showed a progressive worsening of prognosis with advanced CKD, culminating in the poorest outcomes among patients with hemodialysis. CONCLUSIONS:This study demonstrated differential impacts of CKD severity on short- and long-term clinical outcomes in the context of patients with acute myocardial infarction.