Background: No previous studies have evaluated the effect of an aspirin-free strategy for patients undergoing staged percutaneous coronary intervention (PCI).

Methods and Results: We conducted a post hoc subgroup analysis in patients undergoing staged PCI within 1 month in STOPDAPT-3 (n=6,002), which randomly compared prasugrel monotherapy with dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome or high bleeding risk. The co-primary endpoints were major bleeding (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month. There were 814 patients undergoing staged PCI within 1 month (no-aspirin group, n=401; DAPT group, n=413). The median interval from randomization to the first staged PCI was 8 (interquartile range 5–13) days. More than 90% of the patients received assigned antiplatelet agents at all staged PCI procedures. The effect of no-aspirin relative to DAPT was not different for the co-primary bleeding (3.74% vs. 1.94%; HR 1.94; 95% CI 0.82–4.57) and cardiovascular (3.49% vs. 2.42%; HR 1.44; 95% CI 0.64–3.25) endpoints. The no-aspirin group compared with the DAPT group had a numerically higher incidence of the co-primary cardiovascular endpoint, which occurred after the first staged PCI procedure (2.49% vs. 1.21%; HR 2.07; 95% CI 0.71–6.05).

Conclusions: An aspirin-free prasugrel monotherapy relative to DAPT had numerically higher risks of cardiovascular and major bleeding events in patients undergoing staged PCI at 1 month.

Background: The cardio-ankle vascular index (CAVI) is an important marker of arterial stiffness, providing a blood pressure-independent assessment of vascular function. However, the clinical significance of low CAVI values remains unclear. Some connective tissue diseases are associated with aortic diseases due to intrinsic arterial wall abnormalities and may exhibit low CAVI values. This study aimed to investigate whether low CAVI is associated with these connective tissue diseases and succeeding aortic diseases.

Methods and Results: This was a single-center, retrospective observational study conducted at Juntendo University Hospital. A total of 17,364 patients aged 20–80 years who underwent arterial stiffness analysis using CAVI were included. Low CAVI was defined as the lowest 2.5 percentile within each sex- and age-specific distribution. The prevalences of aortic diseases (dissection and/or aneurysm) and Marfan syndrome were similar between the between the low CAVI and normal CAVI groups (aortic disease, 3.99% vs. 3.99%, P>0.99; Marfan syndrome, 0.04% vs. 0.07%, P>0.99, for the low and normal CAVI group, respectively).

Conclusions: This study found no evidence that patients with low CAVI had an increased prevalence of aortic dissection, aortic aneurysm, or Marfan syndrome. Further studies are needed to clarify the clinical implications of low CAVI in vascular diseases.

Background: Data on cardiac rehabilitation (CR) outcomes in patients with cardiovascular disease (CVD), frailty, and multimorbidity in post-acute settings are limited. This study aimed to evaluate the feasibility and efficacy of individualized, multidisciplinary CR in convalescent rehabilitation hospitals (cRHs).

Methods and Results: This multicenter, prospective, observational study included 72 consecutive patients transferred from acute care hospitals. Personalized CR programs were implemented in cRHs. Primary outcomes were changes in the Barthel Index (BI) and functional independence measure (FIM) scores. Secondary outcomes included assessments of physical and cognitive function, and nutritional status. Mean participant age was 78.6±11.8 years. Prior to admission, 51.4% experienced acute decompensated heart failure (ADHF). The average length of stay was 59.5±39.2 days. BI and FIM scores improved from admission to discharge. The following parameters improved: Short Physical Performance Battery, knee extensor strength, comfortable gait speed, 6-min walk distance, New York Heart Association classification, and cognitive function (Mini-Mental State Examination). Discharge dispositions included 53 (73.6%) home discharges, and 19 (26.4%) outpatient CR post-discharges. Patients with post-ADHF and patients with other conditions both showed functional improvements, but ∆BI and ∆FIM were lower in the post-ADHF group.

Conclusions: Tailored multidisciplinary CR in cRHs effectively improves daily living activities and physical and cognitive outcomes in patients with CVD with complex conditions. Expanded use of these hospitals may help address clinical challenges.

Background: Serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) values after initiating sacubitril/valsartan (Sac/Val) are considered a favorable prognostic factor in patients with heart failure (HF). However the relationship between the trajectory of repeated NT-proBNP measurements and cardiovascular events after Sac/Val remains uncertain.

Methods and Results: A Japanese nationwide multicenter study enrolled 995 patients who were prescribed Sac/Val from August 2020 to August 2021. Of them, 434 patients who had a complete set of NT-proBNP measurements were divided into 3 groups: sustained-responder group (n=129), with ≥10% reduction in NT-proBNP at 1 month and further ≥10% reduction at 3 months; transient-responder group (n=161), with ≥10% reduction at 1 month but not at 3 months; and non-responder group (n=144), without ≥10% reduction at 1 month. There were no significant differences in the mean Sac/Val dose at each measurement point among the 3 groups. During a median follow-up of 456 (interquartile range: 371–549) days, the primary endpoint, which was either cardiovascular death or hospitalization for HF, occurred in 78 patients. Kaplan-Meier analysis revealed that the sustained-responder group had a significantly higher event-free survival rate among the 3 groups (Log-rank P<0.001).

Conclusions: Repeated NT-proBNP monitoring and the pattern of the NT-proBNP trajectory after Sac/Val may be helpful in optimizing HF therapy and understanding the prognosis of HF.

Background: Transthyretin amyloid cardiomyopathy (ATTR-CM) is increasingly recognized as a major cause of heart failure in elderly patients with left ventricular hypertrophy. Although tafamidis was approved in 2019 following the ATTR-ACT study, its real-world survival impact in community settings remains unclear.

Methods and Results: This retrospective study analyzed 117 patients diagnosed with ATTR-CM at a single center from 2015 to 2024, with 75 receiving tafamidis and 42 untreated. Among the 83 patients who underwent genetic testing, all had the wild-type genotype. ATTR-CM diagnoses increased significantly after the advent of ^{99 m}Tc-pyrophosphate scintigraphy and tafamidis. Kaplan-Meier analysis showed significantly longer survival in tafamidis-treated patients. Multivariate analysis identified New York Heart Association (NYHA) functional class, left ventricular wall thickness, N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels, and tafamidis treatment as independent survival predictors. Tafamidis treatment was associated with significantly improved survival in patients who were younger, had a less advanced NYHA functional class, and lower levels of NT-proBNP and troponin T. In contrast, its survival benefits were marginal in patients with older age, higher NYHA functional class, elevated NT-proBNP levels, and increased troponin T levels.

Conclusions: In this real-world cohort, tafamidis treatment was significantly associated with better survival in ATTR-CM patients, particularly when initiated in the early stage. Therefore, early detection and timely initiation of treatment are critical for optimizing clinical outcomes in this increasingly recognized condition.

Background: Dapagliflozin is clinically beneficial in heart failure (HF). However, how these clinical benefits translate into economic burden reduction is unclear. With IMPLICATION HF, we projected the reductions in HF events and costs that would result from dapagliflozin use in Japan using a cost offset model.

Methods and Results: The modeled population comprised symptomatic HF patients from the DAPA-HF and DELIVER trials. We compared the event incidences and associated costs between HF treatment with and without dapagliflozin, using the prevalence, event rates, and event costs of HF in Japan from published literature, as well as the treatment effects of dapagliflozin from the pooled meta-analysis of DAPA-HF and DELIVER. The cumulative number of events (HF hospitalization [hHF], cardiovascular [CV] death, and all-cause death) and associated costs (hHF, CV death, total) were projected. Cost offsets were calculated according to the difference in event-related costs between HF treatment with and without dapagliflozin. Dapagliflozin was estimated to prevent 63,770 hHF events (number needed to treat [NNT] 20), 11,613 CV deaths (NNT 108), and 16,141 all-cause deaths (NNT 78), as well as reducing hHF and CV death costs by JPY62.7 billion and JPY16.6 billion, totaling JPY79.3 billion over 1 year in Japan. The sensitivity analyses corroborated these findings.

Conclusions: The addition of dapagliflozin to HF treatment is projected to provide economic benefits to the Japanese healthcare system.

Background: Persistent left ventricular hypertrophy (LVH) after surgical aortic valve replacement (SAVR) for aortic stenosis (AS) worsens prognosis. We investigated predictors of LVH regression 1 year after SAVR in AS patients, including patient-prosthesis mismatch (PPM) and valvuloarterial impedance (Zva).

Methods and Results: We retrospectively studied 175 patients who underwent SAVR for AS at Jichi Medical University between 2014 and 2019. Echocardiography was performed at preoperative baseline, 1-week postoperative, and 1-year postoperative. The left ventricular mass index (LVMI) regression rate (RR) was defined as the difference between baseline LVMI and 1-year LVMI divided by baseline LVMI. Patients were divided into 2 groups based on their median LVMI RR as follows: (1) a poor LVH regression (PR-LVH) group with values below the median LVMI RR; and (2) a good LVH regression (GR-LVH) group with values above the median LVMI RR. The median LVMI RR was 25.4%. There were 88 (50.3%) patients in the PR-LVH group. In the multivariable analysis, 1-week postoperative Zva (odds ratio [OR] 2.777; 95% confidence interval [CI] 1.584–4.869; P<0.001) and baseline LVMI per 10-unit increment (OR 0.974; 95% CI 0.960–0.988; P=0.001) were independent predictors of PR-LVH. The receiver operating characteristic curve analysis identified Zva ≥3.5 mmHg/mL/m²as a cut-off value associated with PR-LVH.

Conclusions: One-week postoperative Zva was a better predictor of improved LVH at 1 year after SAVR than PPM.

Background: The effect of Intensified Multifactorial treatments on coronary atherosclerosis in PAtients with Coronary artery disease and Type 2 Diabetes Mellitus (IMPACT-DM) trial was designed to investigate the effects of intensified multifactorial treatments (IMT) on coronary plaque progression in patients with coronary artery disease (CAD) and diabetes.

Methods and Results: In this prospective, randomized, open-label, parallel assignment, multicenter study, eligible patients with diabetes who underwent successful percutaneous coronary intervention in culprit lesions are randomly assigned to receive either IMT or guideline-oriented standard treatments (Control) for 18 months. The IMT are managed according to strict target goals and step-by-step medical treatment protocols based on modern medical treatments. Target goals in IMT and Control groups are set to hemoglobin A1c <6.2% vs. <7.0%; low-density lipoprotein cholesterol <55 mg/dL for any type of CAD vs. <70 mg/dL for acute coronary syndrome, or <100 mg/dL for stable CAD; and blood pressure <120/80 mmHg vs. <130/80 mmHg, respectively. Non-culprit lesions are evaluated using intravascular ultrasound (IVUS) at post-procedure and 18 months follow up. The primary endpoint is absolute changes in percent plaque volumes in non-culprit lesions as assessed using IVUS from post-procedure to 18 months.

Conclusions: The IMPACT-DM trial will clarify the clinical benefits of IMT on non-culprit coronary plaques in patients with diabetes undergoing successful PCI in culprit lesions.