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In this updated expert consensus document, the methods for the quantitative measurement and morphologic assessment of optical coherence tomography (OCT) / optical frequency domain imaging images (OFDI) are briefly summarized. The focus is on the clinical application and the clinical evidence of OCT / OFDI to guide percutaneous coronary interventions., Competing Interests: Declarations. Conflicts of interest: Dr. Takashi Kubo received lecture fees from Abbott Vascular, Terumo and Boston Scientific Corporation. Dr. Gaku Nakazawa received lecture fees from Abbott Vascular Terumo and Boston Scientific Corporation. Dr. Yoshio Kobayashi received research grant from Abbott Vascular Terumo and Boston Scientific Corporation. Dr. Kozuma received lecture fees from Abbott Vascular, Medtronic and Boston Scientific Corporation, as well as a scholarship fund from Abbott Medical Japan. Dr. Akasaka is a medical advisor of Terumo Corporation. Human rights statement: This article does not contain any studies with human participants or animals performed by any of the authors. Informed consent: Informed consent was not obtained in the study because this article does not contain any studies with human participants., (© 2024. The Author(s).)

Intravascular ultrasound (IVUS) provides precise anatomic information in coronary arteries including quantitative measurements and morphological assessment. To standardize the IVUS analysis in the current era, this updated expert consensus document summarizes the methods of measurements and assessment of IVUS images and the clinical evidence of IVUS use in percutaneous coronary intervention., (© 2025. The Author(s).)

The efficacy and safety of percutaneous coronary intervention (PCI) for coronary artery disease has been established, and approximately 250,000 PCI procedures are performed annually in Japan. However, various complications including life-threatening complications can occur during PCI. Although several bailout procedures have been proposed to address complications during PCI, it is critically important for operators to manage each complication in real catheter rooms with confidence even in emergent situations. Standard bailout methods including specific techniques should be clarified as algorithms and shared with inexperienced operators as well as experienced operators. The Task Force of the Japanese Society for Cardiovascular Intervention and Therapeutics (CVIT) has developed the expert consensus document on bailout algorithms for complications in PCI., (© 2024. The Author(s).)

Introduction : Direct oral anticoagulants (DOACs) are frequently used to prevent embolism in atrial fibrillation. Gastrointestinal bleeding is frequent, but its drug-specific characteristics remain unclear. This study examined the frequency and characteristics of gastrointestinal bleeding in patients with nonvalvular atrial fibrillation for different DOACs. Methods : The present study included 978 patients receiving treatment with DOACs for nonvalvular atrial fibrillation between 2011 and 2018 and examined the frequencies of clinically significant events including major cardiovascular and cerebrovascular events, hemorrhagic events, or death during the first 5 years of prescription. Gastrointestinal bleeding was evaluated for the frequency, source and severity of gastrointestinal bleeding by DOAC type. Results : The median age of subjects was 73 years (interquartile range, 65-80 years), and 622 (64%) were male. The overall observation period was 2499 person-years. During this period, 102 (4.1/100 person-years) major cardiovascular events and 107 (4.3/100 person-years) clinically significant bleeding were reported, including 60 cases (2.4/100 person-years) of gastrointestinal bleeding and 37 cases (1.5/100 person-years) of all-cause mortality. Gastrointestinal bleeding accounted for more than half of all bleeding events among DOAC users, and bleeding from the lower gastrointestinal tract was more common than that from the upper gastrointestinal tract, particularly with dabigatran. No significant difference was seen in the rate of gastrointestinal bleeding by drug type. Peptic ulcer accounted for half of the events of upper gastrointestinal bleeding, all of which were severe. Conclusions : Gastrointestinal bleeding is frequent among patients taking DOACs, especially from the lower alimentary tract. The tendency was more pronounced with dabigatran. In the upper gastrointestinal tract, severe peptic ulcer bleeding is common and requires caution.

Background: Mavacamten, a cardiac myosin inhibitor, significantly improved symptoms and cardiac function vs. placebo in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in EXPLORER-HCM. However, the efficacy and safety profiles of mavacamten in Japanese patients are unclear., Methods and Results: HORIZON-HCM is a Phase 3 single-arm study in Japanese patients with symptomatic obstructive HCM. The mavacamten starting dose was 2.5 mg; individualized dose titration occurred in Weeks 6-20 based on Valsalva left ventricular outflow tract (LVOT) gradient and resting left ventricular ejection fraction (LVEF). Overall, 38 patients were treated; 36 completed the 30-week primary treatment analysis period. Clinically significant improvements in postexercise LVOT gradient were observed after 30 weeks of treatment (mean change from baseline -60.7 mmHg). Improvements in N-terminal pro B-type natriuretic peptide, New York Heart Association class, and Kansas City Cardiomyopathy Questionnaire-23 Clinical Summary Score were observed over 30 weeks, and mean LVEF was ≥74% at all visits. Treatment-emergent adverse events (TEAEs) and serious TEAEs were reported in 63.2% and 7.9% of patients, respectively; none resulted in treatment discontinuation. One patient experienced a transient asymptomatic reduction in LVEF to <50%. No deaths occurred during the study., Conclusions: In Japanese patients with obstructive HCM, mavacamten was associated with similar improvements in LVOT gradients, cardiac biomarkers, and symptoms to those observed in EXPLORER-HCM. Treatment was well tolerated with no new safety concerns.

The aminopeptidase, endoplasmic reticulum aminopeptidase 1 (ERAP1), trims peptides for loading into major histocompatibility complex class I (MHC class I), and loss of this activity has broad effects on the MHC class I peptidome. Here, we investigated the impact of targeting ERAP1 in immune checkpoint blockade (ICB), as MHC class I interactions mediate both activating and inhibitory functions in antitumor immunity. Loss of ERAP sensitized mouse tumor models to ICB, and this sensitivity depended on CD8 + T cells and natural killer (NK) cells. In vivo suppression screens revealed that Erap1 deletion inactivated the inhibitory NKG2A-HLA-E checkpoint, which requires presentation of a restricted set of invariant epitopes (VL9) on HLA-E. Loss of ERAP altered the HLA-E peptidome, preventing NKG2A engagement. In humans, ERAP1 and ERAP2 showed functional redundancy for the processing and presentation of VL9, and loss of both inactivated the NKG2A checkpoint in cancer cells. Thus, loss of ERAP phenocopies the inhibition of the NKG2A-HLA-E pathway and represents an attractive approach to inhibit this critical checkpoint., Competing Interests: Declaration of interests This manuscript is the result of a collaborative effort between the Broad Institute and Calico Life Sciences, LLC and was supported by funding from Calico Life Sciences, LLC. K.J.F., M.M.S., M.C., N.O., F.E.M., A.F., D.S., and F.A.H. are current employees of Calico Life Science, LLC. S.K. was an employee of Broad Institute at the time she contributed to the work and is a current employee of Genentech. M.F.P. was an employee of Calico Life Sciences at the time he contributed to the work and is a current employee of TenSixteen Bio. W.S. was an employee of Calico Life Sciences at the time she contributed to the work. A.I.-V. was an employee of the Broad Institute at the time he contributed to the work and is a current employee of Monte Rosa Therapeutics. T.G.R.D. was an employee of the Broad Institute at the time he contributed to the work and is a current employee of Tessera Therapeutics. T.A. was an employee of the Broad Institute at the time she contributed to the work and is a current employee of ZS. T.B.S. was an employee of the Broad Institute at the time he contributed to the work and is a current employee of Johnson & Johnson Innovative Medicine. R.T.M. has received speaking or consulting fees from Bristol Myers Squibb, Gilead Sciences, Kumquat Biosciences, and Immunai Therapeutics and has equity ownership in OncoRev, LLC. Calico Life Sciences, LLC and the Broad Institute participated in the interpretation of data, review, and approval of the publication., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) leads to transient platelet activation and hypercoagulation status, resulting in thrombocytopenia., Aims: This study investigated the associations of coagulation/fibrinolysis status after transfemoral TAVI with valve type, post-TAVI thrombocytopenia, and complication of TAVI., Methods: Thrombin-antithrombin complex (TAT) and fibrin/fibrinogen degradation product (FDP) levels were measured before and 1 h, 1 day, and 2 days after TAVI. A percentage drop in platelet count (DPC) was determined from the pre- and lowest post-procedural values., Results: SAPIEN 3 (S3) was implanted in 158 patients and Evolut PRO/PRO+ (Evolut) in 117. Both TAT and FDP increased after TAVI. Pre-TAVI balloon dilatation was generally performed on patients undergoing implantation with Evolut. Peak TAT was then stratified into 4 quartiles (Q1 to Q4). Of all 275 study patients, 69 patients reached ultra-hypercoagulation status (Q4). S3, TAVI without pre-balloon dilatation, DPC and bleeding complications were significantly associated with the ultra-hypercoagulation status after TAVI. TAT was significantly greater 1 h after S3 implantation than Evolut (median [IQR], 43.1 [34.1-59.6] vs. 31.0 [25.0-40.4] ng/mL; p < 0.001). In contrast, FDP levels did not differ between the two at any measurement point. The difference in DPC among the peak TAT quartiles was statistically significant (p < 0.001). The occurrence of bleeding complications was significantly higher in the group with ultra-hypercoagulation status (5.8% vs. 1.0%, p = 0.036)., Conclusions: The increase in coagulation status and post-TAVI thrombocytopenia were significantly greater after S3 implantation. Ultra-hypercoagulation after TAVI was related to bleeding complications., (© 2024 Wiley Periodicals LLC.)

In patients with acute myocardial infarction (MI), heart failure (HF) is one of the most common complications that is associated with a significant burden of mortality and healthcare resources. The clinical benefits of key HF drugs, the so-called "4 pillars" or "fantastic 4", namely β-blockers, mineralocorticoid receptor antagonists, angiotensin receptor-neprilysin inhibitor, and sodium-glucose cotransporter 2 inhibitors, have been established in patients with HF with reduced ejection fraction, whereas the effects of these drugs are not comprehensively appreciated in patients with acute MI. This review summarizes current evidence on pharmacological and device-based interventions for preventing HF after acute MI.

Primary Percutaneous Coronary Intervention (PCI) has significantly contributed to reducing the mortality of patients with ST-segment elevation myocardial infarction (STEMI) even in cardiogenic shock and is now the standard of care in most of Japanese institutions. The Task Force on Primary PCI of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) proposed an expert consensus document for the management of acute myocardial infarction (AMI) focusing on procedural aspects of primary PCI in 2018 and updated in 2022. Recently, the European Society of Cardiology (ESC) published the guidelines for the management of acute coronary syndrome in 2023. Major new updates in the 2023 ESC guideline include: (1) intravascular imaging should be considered to guide PCI (Class IIa); (2) timing of complete revascularization; (3) antiplatelet therapy in patient with high-bleeding risk. Reflecting rapid advances in the field, the Task Force on Primary PCI of the CVIT group has now proposed an updated expert consensus document for the management of ACS focusing on procedural aspects of primary PCI in 2024 version., (© 2024. The Author(s).)

Percutaneous coronary intervention for left main coronary artery disease (LM-PCI) represents a high-risk yet life-saving procedure that has evolved significantly over the years. This review outlines the current state-of-the-art practices for LM-PCI in Japan in detail, emphasizing the integration of coronary physiology and intracoronary imaging alongside with evidence-based standardized technique using latest drug-eluting stents. These advancements enable precise lesion assessment, stent sizing, and optimal deployment, thereby enhancing procedural safety and efficacy. Despite discrepancies between current guidelines favoring coronary artery bypass grafting and real-world practice trends towards increased LM-PCI adoption, particularly in elderly populations with multiple comorbidities, careful patient selection and procedural planning are critical. Future perspectives include further refining LM-PCI through conducting randomized controlled trials integrating advanced techniques and addressing the issue of ostial left circumflex lesions and nationwide standardization of medical care for LM disease., (© 2024. The Author(s) under exclusive licence to Japanese Association of Cardiovascular Intervention and Therapeutics.)

Because of its superior safety profile and improved outcomes, trans-radial percutaneous coronary intervention (TRI) has become the preferred access in percutaneous coronary intervention (PCI) of native coronary disease. This study investigated the impact of TRI on in-hospital outcomes after PCI for coronary artery bypass graft vessels (GV-PCI). We analyzed patients who underwent GV-PCI in 2019-2022 from the Japanese nationwide registry. Patients were categorized into the TRI and trans-femoral PCI (TFI) groups. We assessed the association between TRI and in-hospital outcomes. The primary outcome was a composite of in-hospital death and major bleeding. In this study, 2,295 patients were analyzed.. The primary outcomes occurred in 29 patients (1.3%), including 17 deaths (0.7%). Major bleeding occurred in 12 patients (0.5%), and access site bleeding in 7 patients (0.3%). The TRI group (n = 1,521) showed lower crude rates of the primary outcome (0.9% vs 1.9%, p = 0.039), major bleeding (0.3% vs 1.0%, p = 0.027), and access site bleeding (0.1% vs 0.6%, p = 0.047) compared with the TFI group (n = 774). Univariable logistic regression demonstrated a significant association of TRI with reduced primary outcome (odd ratio [OR] 0.47, 95% confidence interval [CI] 0.22 to 0.98), major bleeding (OR 0.25, 95% CI 0.07 to 0.80), and access site bleeding (OR 0.20, 95% CI 0.03 to 0.94). In the multivariable analysis, TRI was still significantly associated with a decrease in major bleeding events (OR 0.29, 95% CI 0.07 to 0.93). In conclusion, the use of TRI was associated with a reduction in bleeding events when referenced to TFI in the context of GV-PCI., Competing Interests: Declaration of competing interest Dr. Kohsaka reports a relationship with Bristol-Myers Squibb, Pfizer, Novartis, and AstraZeneca that includes: funding grants and speaking and lecture fees. Dr. Ishii reports a relationship with Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Kowa, Novartis, Nippon Boehringer Ingelheim, Otsuka Pharma, Pfizer, Mochida Pharma, and Tanabe Mitsubishi that includes: speaking and lecture fees. Dr. Amano reports a relationship with Astellas Pharma, AstraZeneca, Bayer, Daiichi Sankyo, and Bristol-Myers Squibb that includes: speaking and lecture fees. The remaining authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Gender disparity remains a significant global concern in interventional cardiology, and there is a lack of extensive research examining the outcomes of percutaneous coronary interventions (PCIs) performed by female interventionalists., Objectives: The aim of this study was to examine the practice patterns and outcomes of PCIs conducted by female interventionalists in Japan., Methods: This retrospective observational study analyzed data from the Japanese Percutaneous Coronary Intervention registry between January 2019 and December 2021. The primary endpoint was in-hospital mortality and the secondary endpoint was the success rate of PCIs., Results: A total of 447 female operators (7.3% of all operators) performed 35,211 PCIs (5.3%) during the study period. Female doctors treated a higher percentage of patients with ST-segment elevation myocardial infarction compared with their male counterparts (20.2% vs 17.7%; P  = 0.001), whereas male doctors were more likely to perform PCIs for left main disease (4.9% vs 5.9%; P  < 0.001) and lesions treated with rotational atherectomy (3.5% vs 4.9%; P  < 0.001). The success rate of PCIs was higher for female interventionalists (97.8% vs 97.2%; P  < 0.001). After conducting a risk-adjusted analysis, we found no significant difference in in-hospital mortality (adjusted OR: 0.896; 95% CI: 0.78-1.03; P  = 0.12), or procedural complications associated with the operator's gender., Conclusions: Overall, female operators exhibited outcomes similar to their male counterparts in terms of adjusted procedural outcomes, and higher crude success rate in certain subgroups. These findings emphasize gender disparities and stress the need to increase gender diversity in interventional cardiology., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Background: Although technological improvements in intravascular ultrasound (IVUS) may reduce technical failures in endovascular therapy (EVT), perioperative complications (POCs) associated with IVUS use may increase., Aims: This study investigated the impact of IVUS on periprocedural outcomes in symptomatic lower-extremity artery disease (LEAD) patients undergoing EVT., Methods: This study evaluated 28,088 symptomatic LEAD patients who underwent EVT between January 2021 and December 2021 using a prospective nationwide registry in Japan. Outcome measures included periprocedural outcomes, including technical failure and POCs. To compare outcomes with and without IVUS use, propensity score matching analysis was performed for overall and for each arterial region (aortoiliac [AI], femoropopliteal [FP], and infrapopliteal [IP] arteries) using a binary logistic regression model., Results: IVUS was used in 75%, 72%, and 37% of AI, FP, and IP lesions, respectively. After propensity matching extraction, the IVUS group had a tendency of lower technical failure rate than the non-IVUS group, although not statistically different (3.9% vs. 5.4%, p = 0.054), without an increase in the POC rate (1.8% vs. 1.6%, p = 0.54). Regarding the per-regional analysis, the technical failure rate of FP-EVT was significantly lower in the IVUS group (3.1% vs. 4.2%, p = 0.006), whereas those of AI-EVT (2.2% vs. 3.1%, p = 0.12) and IP-EVT (6.8% vs. 6.1%, p = 0.37) were not significantly different between the two groups. Furthermore, IVUS did not increase the POC rate for any region (AI-EVT: 1.3% vs. 1.3%, p = 1.00; FP-EVT: 1.8% vs. 1.7%, p = 0.75; and IP-EVT: 2.0% vs. 1.7%, p = 0.56)., Conclusion: The current study revealed that IVUS did not increase the POCs and technical failure for overall lesions but reduced the incidence of FP-EVT technical failure., (© 2024 Wiley Periodicals LLC.)

Background: Severe aortic valve stenosis (AS) and atrial fibrillation (AF) are risk factors of hemodynamic instability in heart failure (HF) management due to low cardiac output, respectively. Therefore, the treatment of HF due to severe AS complicated with AF is anticipated to be difficult. Tolvaptan, a vasopressin V2 receptor inhibitor, is effective in controlling acute decompensated heart failure (ADHF) with hemodynamic stability. However, its clinical efficacy against ADHF caused by AS with AF remains to be determined., Methods: Clinical information (from September 2014 to December 2017) of 59 patients diagnosed with ADHF due to severe AS (20 patients with AF; 39 patients with sinus rhythm [SR]) was obtained from the LOHAS registry. The registry collected data from seven hospitals and assessed the short-term effects of tolvaptan in patients hospitalized for ADHF with severe AS. We attempted to identify clinical differences from baseline up to 4 days, comparing patients with AF (AF group) versus those with SR (SR group)., Results: There were no significant differences between the groups in age (83.7 ± 4.5 vs. 85.8 ± 6.9 years, respectively; p = 0.11) and aortic valve area (0.60 [0.46-0.73] vs. 0.56 [0.37-0.70] cm 2 , respectively; p = 0.50). However, left atrial volume was larger (104 [85-126] vs. 87 [64-103] mL, respectively; p < 0.01), whereas stroke volume was lower (51.6 ± 14.8 vs. 59.0 ± 18.7 mL, respectively; p = 0.08) in the AF group versus the SR group. Body weight decreased daily from baseline up to day 4 in both groups (from 55.4 to 53.2 kg [p < 0.01] and from 53.5 to 51.0 kg [p < 0.01], respectively) without change in heart rate. Notably, the systolic blood pressure decreased slightly in the AF group after 2 days of treatment with tolvaptan., Conclusions: Short-term treatment with tolvaptan improved HF in patients hospitalized for severe AS, regardless of the presence of AF or SR. After achieving sufficient diuresis, a slight decrease in blood pressure was observed in the AF group, suggesting an appropriate timeframe for safe and effective use of tolvaptan., (© 2024. Springer Nature Japan KK, part of Springer Nature.)

Background: Women with acute myocardial infarction (AMI) often present a worse risk profile and experience a higher rate of in-hospital mortality than men. However, sex differences in post-discharge prognoses remain inadequately investigated. We examined the impact of sex on 1-year post-discharge outcomes in patients with AMI undergoing percutaneous coronary intervention., Methods and results: We extracted patient-level data for the period January 2017-December 2018 from the J-PCI OUTCOME Registry, endorsed by the Japanese Association of Cardiovascular Intervention and Therapeutics. One-year all-cause and cardiovascular mortality and major adverse cardiovascular events were compared between men and women. In all, 29,856 AMI patients were studied, with 6,996 (23.4%) being women. Women were significantly older and had a higher prevalence of comorbidities than men. Crude all-cause mortality was significantly higher among women than men (7.5% vs. 5.4% [P<0.001] for ST-elevation myocardial infarction [STEMI]; 7.0% vs. 5.2% [P=0.006] for non-STEMI). These sex-related differences in post-discharge outcomes were attenuated after stratification by age. Multivariate analysis demonstrated an increase in all-cause mortality in both sexes with increasing age and advanced-stage chronic kidney disease (CKD)., Conclusions: Within this nationwide cohort, women had worse clinical outcomes following AMI than men. However, these sex-related differences in outcomes diminished after adjusting for age. In addition, CKD was significantly associated with all-cause mortality in both sexes.

Non-culprit lesion-related coronary events are a significant concern in patients with coronary artery disease (CAD) undergoing coronary intervention. Since several studies using intra-coronary imaging modalities have reported a high prevalence of vulnerable plaques in non-culprit lesions at the initial coronary event, the immediate stabilization of these plaques by intensive pharmacological regimens may contribute to the reduction in the adverse events. Although current treatment guidelines recommend the titration of statin and other drugs to attain the treatment goal of low-density lipoprotein cholesterol (LDL-C) level in patients with CAD, the early prescription of strong LDL-C lowering drugs with more intensive regimen may further reduce the incidence of recurrent cardiovascular events. In fact, several studies with intensive regimen have demonstrated a higher percentage of patients with the attainment of LDL-C treatment goal in the early phase following discharge. In addition to many imaging studies showing plaque stabilization by LDL-C lowering drugs, several recent reports have shown the efficacy of early statin and proprotein convertase subtilisin/kexin type 9 inhibitors on the immediate stabilization of non-culprit coronary plaques. To raise awareness regarding this important concept of immediate plaque stabilization and subsequent reduction in the incidence of recurrent coronary events, the term 'Drug Intervention' has been introduced and gradually applied in the clinical field, although a clear definition is lacking. The main target of this concept is patients with acute coronary syndrome as a higher prevalence of vulnerable plaques in non-culprit lesions in addition to the worse clinical outcomes has been reported in recent imaging studies. In this article, we discuss the backgrounds and the concept of drug intervention., (© 2024. The Author(s) under exclusive licence to Japanese Association of Cardiovascular Intervention and Therapeutics.)

Background: The slow-flow phenomenon is associated with worse clinical outcomes after percutaneous coronary intervention (PCI), so our goal for this study was to see how predictive how near-infrared spectroscopy (NIRS) could be., Methods and results: We enrolled 179 lesions from 152 patients who had de novo coronary stent implantation guided by NIRS-intravascular ultrasound (IVUS) (male: 69.1%, mean age: 74.3±11.5 years, acute coronary syndrome: 65.1%, diabetes: 42.1%). NIRS automatically determined the maximum 4-mm lipid core burden index (maxLCBI 4 mm ) value at pre- and post-PCI procedures. The slow-flow phenomenon was defined as the deterioration of TIMI (Thrombolysis in Myocardial Infarction) flows on angiography during the PCI procedure in the absence of mechanical obstruction. The slow-flow phenomenon occurred in 13 (7.3%) lesions, and the slow-flow phenomenon group had a significantly higher maxLCBI 4 mm (740±147 vs. 471±223, P<0.001). The best maxLCBI 4 mm cutoff point in both acute and chronic coronary syndrome was 578 and 480, with sensitivity of 100%, for predicting the slow-flow phenomenon. In the receiver-operating characteristics analysis, the area under the curve for acute and chronic coronary syndrome was 0.849 and 0.851, respectively., Conclusions: The results of this study support the utility of NIRS-IVUS-guided PCI for the prediction of the slow-flow phenomenon.

Background: The 1-year clinical outcomes of the Absorb GT1 Japan post-market surveillance (PMS) suggested that an appropriate intracoronary imaging-guided bioresorbable vascular scaffold (BVS) implantation technique may reduce the risk of target lesion failure (TLF) and scaffold thrombosis (ST) associated with the Absorb GT1 BVS. The long-term outcomes through 5 years are now available., Methods and results: This study enrolled 135 consecutive patients (n=139 lesions) with ischemic heart disease in whom percutaneous coronary intervention (PCI) with the Absorb GT1 BVS was attempted. Adequate lesion preparation, imaging-guided appropriate sizing, and high-pressure post-dilatation using a non-compliant balloon were strongly encouraged. All patients had at least 1 Absorb GT1 successfully implanted at the index procedure. Intracoronary imaging was performed in all patients (optical coherence tomography: 127/139 [91.4%] lesions) and adherence to the implantation technique recommendations was excellent: predilatation, 100% (139/139) lesions; post-dilatation, 98.6% (137/139) lesions; mean (±SD) post-dilatation pressure, 18.8±3.5 atm. At 5 years, the follow-up rate was 87.4% (118/135). No definite/probable ST was reported through 5 years. The cumulative TLF rate was 5.1% (6/118), including 2 cardiac deaths, 1 target vessel-attributable myocardial infarction, and 3 ischemia-driven target lesion revascularizations., Conclusions: Appropriate intracoronary imaging-guided BVS implantation, including the proactive use of pre- and post-balloon dilatation during implantation may be beneficial, reducing the risk of TLF and ST through 5 years.

Background: Cardiac arrest is a serious complication of acute myocardial infarction. The implementation of contemporary approaches to acute myocardial infarction management, including urgent revascularization procedures, has led to significant improvements in short-term outcomes. However, the extent of post-discharge mortality in patients experiencing cardiac arrest during acute myocardial infarction remains uncertain. This study aimed to determine the post-discharge outcomes of patients with cardiac arrest., Methods: We analysed data from the J-PCI OUTCOME registry, a Japanese prospectively planed, observational, multicentre, national registry of percutaneous coronary intervention involving consecutive patients from 172 institutions who underwent percutaneous coronary intervention and were discharged. Patients who underwent percutaneous coronary intervention for acute myocardial infarction between January 2017 and December 2018 and survived for 30 days were included. Mortality in patients with and without cardiac arrest from 30 days to 1 year after percutaneous coronary intervention for acute myocardial infarction was compared., Results: Of the 26,909 patients who survived for 30 days after percutaneous coronary intervention for acute myocardial infarction, 1,567 (5.8%) had cardiac arrest at the onset of acute myocardial infarction. Patients with cardiac arrest were younger and more likely to be males than patients without cardiac arrest. The 1-year all-cause mortality was significantly higher in patients with cardiac arrest than in those without (11.9% vs. 2.8%, p  < 0.001) for all age groups. Multivariable analysis showed that cardiac arrest was an independent predictor of all-cause long-term mortality (hazard ratio: 2.94; 95% confidence interval: 2.29-3.76)., Conclusions: Patients with acute myocardial infarction and concomitant cardiac arrest have a worse prognosis for up to 1 year after percutaneous coronary intervention than patients without cardiac arrest., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ‘Dr. Kohsaka has received speaker fees from Bristol-Myers Squibb and Pfizer and has received institutional research grant support from Novartis and AstraZeneca. Dr. Ishii received lecture fees from Astellas Pharma, AstraZeneca, Bayer Pharmaceutical Co., Ltd., Chugai Pharma, Inc., Daiichi Sankyo, and MSD K. K. Dr. Amano received lecture fees from Astellas Pharma, AstraZeneca, Bayer, Daiichi Sankyo, and Bristol-Myers Squibb. The remaining authors have no conflicts of interest to declare’., (© 2024 The Authors.)

Background: Subungual melanoma (SUM) is a rare tumor with historically poor outcomes. Thus, the benefit of proximal versus distal amputation in SUM remains unclear., Methods: We performed a retrospective review of our prospectively-maintained institutional melanoma database, including SUM and non-subungual acral melanoma (AM) patients who underwent sentinel lymph node biopsy (SLNB) between 1999 and 2022. All SUMs had distal joint or proximal amputations. Primary endpoints were overall survival (OS) and recurrence free survival (RFS). Kaplan-Meier estimates, and Cox univariate and multivariate analyses were performed. Tests were repeated on propensity score matched (PSM) populations in a 2:1 ratio., Results: 123 patients underwent resection with SLNB for SUM (n ​= ​27) and AM (n ​= ​96). Median follow-up was 9.2 years. Unadjusted median OS was 149.1 months for AM and 198.1 months for SUM. In the PSM comparison, median OS and RFS remained comparable between SUM and AM (149.5 months versus 198.1 months; p ​= ​0.612). Sentinel node positivity was associated with significantly worse overall survival outcome (Hazard Ratio 5.49; CI (1.59-18.97), p ​= ​0.007). In the PSM population, male sex was also associated with a significant hazard of death (HR 3.00, CI (1.03-8.71), p ​= ​0.043). Proximal amputations were associated with significantly worse OS (p ​< ​0.002) and RFS (p ​< ​0.01) compared to distal amputations in SUM., Conclusion: SUM was well-treated with distal amputations, and had better OS and RFS compared to SUM treated with proximal amputations. Sentinel lymph node status is an important prognostic factor for SUMs and AMs. SUMs can be treated similarly to AMs with comparably good long-term outcomes., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to declare that are relevant to the content of this article., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Intraoperative carcinoid crisis is typically sudden onset of profound hypotension during operations on patients with neuroendocrine tumors. The crisis was thought to be due to massive release of hormones, and perioperative octreotide was recommended as a prophylaxis against the crisis and as first-line treatment. Recent studies show that octreotide does not prevent the crisis and that no massive release of hormones occurs. Therefore, the authors hypothesized that octreotide is not effective for treating the crisis., Methods: A prospective carcinoid anesthesia database was analyzed for occurrences of crisis. Outcomes were compared between protocols when first-line therapy was bolus octreotide and when it was vasopressors without octreotide. Significance was determined by Student's t test, the Mann-Whitney U test, and Fisher's exact test., Results: Among operations performed with octreotide as first-line treatment (n = 150), crisis occurred for 45 (30 %) patients, the median crisis duration was 6 min, 12 (27 %) patients had crises longer than 10 min, 42 patients (93 %) required subsequent vasopressor administration to resolve the crisis, and 3 (2 %) operations were aborted. Among operations performed with vasopressors as the first-line treatment (n = 195), crisis occurred for 49 (25 %) patients (p = 0.31), the median crisis duration was 3 min (p < 0.001), and no crisis lasted longer than 10 min (p = 0.001). Patients treated with vasopressors were less likely to have multiple crises and had a shorter total time in crisis, a shorter anesthesia time, and no aborted operations (p < 0.05 for all)., Conclusions: First-line octreotide was ineffective treatment for carcinoid crisis, with patients requiring vasopressors to resolve the crisis, and many crises lasting longer than 10 min. First-line vasopressor treatment resulted in significantly shorter crisis durations, fewer crises and aborted operations, and shorter anesthesia times. Vasopressors should be used as first-line treatment for intraoperative crisis, and treatment guidelines should be changed., (© 2024. Society of Surgical Oncology.)

Invasive functional coronary angiography (FCA), an angiography-derived physiological index of the functional significance of coronary obstruction, is a novel physiological assessment tool for coronary obstruction that does not require the utilization of a pressure wire. This technology enables operators to rapidly evaluate the functional relevance of coronary stenoses during and even after angiography while reducing the burden of cost and complication risks related to the pressure wire. FCA can be used for treatment decision-making for revascularization, strategy planning for percutaneous coronary intervention, and procedure optimization. Currently, various software-computing FCAs are available worldwide, with unique features in their computation algorithms and functions. With the emerging application of this novel technology in various clinical scenarios, the Japanese Association of Cardiovascular Intervention and Therapeutics task force was created to outline expert consensus on the clinical use of FCA. This consensus document advocates optimal clinical applications of FCA according to currently available evidence while summarizing the concept, history, limitations, and future perspectives of FCA along with globally available software., (© 2024. The Author(s).)

Competing Interests: Conflicts of Interest A.K. received remuneration from Abbott Medical Japan as proctor for MitraClip. All other authors declare no conflicts of interest.

Background: The geographical disparity in the pathophysiological pattern of coronary artery disease (CAD) among patients undergoing percutaneous coronary intervention (PCI) is unknown., Objectives: To elucidate the geographical variance in the pathophysiological characteristics of CAD., Methods: Physiological indices derived from angiography-based fractional flow reserve pullbacks from patients with chronic coronary syndrome enrolled in the ASET Japan (n = 206) and ASET Brazil (n = 201) studies, which shared the same eligibility criteria, were analysed. The pathophysiological patterns of CAD were characterised using Murray law-based quantitative flow ratio (μQFR)-derived indices acquired from pre-PCI angiograms. The diffuseness of CAD was defined by the μQFR pullback pressure gradient index., Results: Significant functional stenoses pre-PCI (μQFR ≤0.80) were more frequent in ASET Japan compared to ASET Brazil (89.9% vs. 67.5%, p < 0.001), as were rates of a post-PCI μQFR <0.91 (22.1% vs. 12.9%, p = 0.013). In the multivariable analysis, pre-procedural μQFR and diffuse disease were independent factors for predicting a post-PCI μQFR <0.91, which contributed to the different rates of post-PCI μQFR ≥0.91 between the studies. Among vessels with a post-PCI μQFR <0.91, a consistent diffuse pattern of CAD pre- and post-PCI occurred in 78.3% and 76.7% of patients in ASET Japan and Brazil, respectively; only 6.3% (Japan) and 10.0% (Brazil) of vessels had a major residual gradient. Independent risk factors for diffuse disease were diabetes mellitus in ASET Japan, and age and male gender in Brazil., Conclusions: There was geographic disparity in pre-procedural angiography-based pathophysiological characteristics. The combined pre-procedural physiological assessment of vessel μQFR and diffuseness of CAD may potentially identify patients who will benefit most from PCI., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Quality indicators (QIs) have been developed to improve and standardize care quality in percutaneous coronary intervention (PCI). In Japan, consecutive PCI procedures are registered in a nationwide database (the Japanese Percutaneous Coronary Intervention registry), which introduces a benchmarking system for comparing individual institutional performance against the national average., Objectives: The aim of this study was to assess the impact of the benchmarking system implementation on QI improvement at the hospital level., Methods: A total of 734,264 PCIs were conducted at 1,194 institutions between January 2019 and December 2021. In January 2018, a web-based benchmarking system encompassing 7 QIs for PCI at the institutional level, including door-to-balloon time and rate of transradial intervention, was introduced. The process by which institutions tracked their QIs was centrally monitored., Results: During the 3-year study period, the benchmarking system was reviewed at least once at 742 institutions (62.1%) (median 4 times; Q1-Q3: 2-7 times). The institutions that reviewed their records had higher PCI volumes. Among these institutions, although door-to-balloon time was not directly associated, the proportion of transradial intervention increased by 2.3% in the system review group during the initial year compared with 0.7% in their counterparts. However, in the subsequent year, the association between system reviews and QI improvement was attenuated., Conclusions: The implementation of a benchmarking system, reviewed by participating institutions in Japan, was partially associated with improved QIs during the first year; however, this improvement was attenuated in the subsequent year, highlighting the need for further efforts to develop effective and sustainable interventions to enhance care quality in PCI., Competing Interests: This study was supported by a grant from the Chiba Foundation for Health Promotion and Disease Prevention and the Health and Labor Sciences Research Grants (21FA1015). Dr Inohara is an employee of Eli Lilly Japan. Dr Kohsaka has received investigator-initiated grants from Novartis and AstraZeneca; and has received lecture fees from Bristol Myers Squibb. Dr Kumamaru has received consultation fee from EPS Corporation; has received speaker fee from Chugai Pharmaceutical; and is affiliated with the Department of Health Quality Assessment at the University of Tokyo, a social collaboration department supported by the National Clinical Database, Johnson & Johnson, Nipro Corporation, and Intuitive Surgical Sàrl. Dr Ishii has received lecture fees from AstraZeneca, Bayer Pharmaceutical, Boehringer Ingelheim Japan, Bristol Myers Squibb, Daiichi-Sankyo, Merck Sharpe & Dohme, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Novartis Japan, and Pfizer Japan. Dr Amano has received lecture fees from Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, and Daiichi-Sankyo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Intravascular ultrasound (IVUS) provides precise anatomic information in coronary arteries including quantitative measurements and morphological assessment. To standardize the IVUS analysis in the current era, this updated expert consensus document summarizes the methods of measurements and assessment of IVUS images and the clinical evidence of IVUS use in percutaneous coronary intervention., (© 2023. The Author(s).)

The Agent device consists of a semi-compliant balloon catheter, which is coated with a therapeutic low-dose formulation of paclitaxel (2 µg/mm 2 ) blended with an inactive excipient acetyl-tri-n-butyl citrate (ATBC). AGENT Japan SV is a randomized controlled study that enrolled 150 patients from 14 Japanese sites treated with Agent or SeQuent Please paclitaxel-coated balloon. This study also includes a single-arm substudy evaluating the safety and effectiveness of Agent in patients with in-stent restenosis (ISR). Patients with a single de novo native lesion (lesion length ≤ 28 mm and reference diameter ≥ 2.00 to  < 3.00 mm) were randomized 2:1 to receive either Agent (n = 101) or SeQuent Please (n = 49). The ISR substudy enrolled 30 patients with lesion length ≤ 28 mm and reference diameter ≥ 2.00 to  ≤ 4.00 mm. In the SV RCT, target lesion failure (TLF) at 1 year occurred in four patients treated with Agent (4.0%) versus one patient with SeQuent Please (2.0%; P = 1.00). None of the patients in either treatment arm died. There were no significant differences in the rates of myocardial infarction, target lesion revascularization and target lesion thrombosis through 1 year. In the ISR substudy, the 1-year rates of TLF and target lesion thrombosis were 6.7% and 0.0%, respectively. These data support the safety and effectiveness of the Agent paclitaxel-coated balloon in patients with small vessels and ISR., (© 2023. The Author(s).)

Background: Even with intracoronary imaging-guided stent optimisation, suboptimal haemodynamic outcomes post-percutaneous coronary intervention (PCI) can be related to residual lesions in non-stented segments. Preprocedural assessment of pathophysiological coronary artery disease (CAD) patterns could help predict the physiological response to PCI., Aims: The aim of this study was to assess the relationship between preprocedural pathophysiological haemodynamic patterns and intracoronary imaging findings, as well as their association with physiological outcomes immediately post-PCI., Methods: Data from 206 patients with chronic coronary syndrome enrolled in the ASET-JAPAN study were analysed. Pathophysiological CAD patterns were characterised using Murray law-based quantitative flow ratio (μQFR)-derived indices acquired from pre-PCI angiograms. The diffuseness of CAD was defined by the pullback pressure gradient (PPG) index. Intracoronary imaging in stented segments after stent optimisation was also analysed., Results: In the multivariable analysis, diffuse disease - defined by the pre-PCI μQFR-PPG index - was an independent factor for predicting a post-PCI μQFR <0.91 (per 0.1 decrease of PPG index, odds ratio 1.57, 95% confidence interval: 1.07-2.34; p=0.022), whereas the stent expansion index (EI) was not associated with a suboptimal post-PCI μQFR. Among vessels with an EI ≥80% and post-PCI μQFR <0.91, 84.0% of those vessels had a diffuse pattern preprocedure. There was no significant difference in EI between vessels with diffuse disease and those with focal disease. The average plaque burden in the stented segment was significantly larger in vessels with a preprocedural diffuse CAD pattern., Conclusions: A physiological diffuse pattern preprocedure was an independent factor in predicting unfavourable immediate haemodynamic outcomes post-PCI, even after stent optimisation using intracoronary imaging. Preprocedural assessment of CAD patterns could identify patients who are likely to exhibit superior immediate haemodynamic outcomes following PCI.

Background: The ASET (Acetyl-Salicylic Elimination Trial) pilot studies recently investigated P2Y 12 inhibitor monotherapy without aspirin immediately after percutaneous coronary intervention (PCI) in Brazil and Japan., Objectives: This comparative analysis of the 2 ASET pilot studies aimed to summarize clinical outcomes and assess geographic and ethnic differences in baseline demographics and procedures., Methods: Patients undergoing successful platinum-chromium everolimus-eluting stent implantation for chronic coronary syndrome were included. Following the index PCI, patients received prasugrel monotherapy with a maintenance dose of 10 mg/day in Brazil and 3.75 mg/day in Japan. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding at up to 3 months., Results: Of 409 enrollments, 3-month follow-up was completed in 406 patients. Mean age was 64.3 ± 8.4 years, and 73% were men. Overall, post-TIMI flow grade 3 was achieved in 99.8%. Intravascular imaging for poststent optimization was used in 16.8% and 99.6% of treated lesions in Brazil and Japan, respectively. The primary ischemic and bleeding endpoints occurred in the same patient (0.2%). No stent thrombosis events occurred., Conclusions: Prasugrel monotherapy following PCI was safe and feasible in selected low-risk chronic coronary syndrome patients after optimal platinum-chromium everolimus-eluting stent implantation regardless of the ethnic and geographic differences in baseline demographics, procedures, and prasugrel dosage. Randomized controlled trials will be needed to compare P2Y 12 inhibitor monotherapy without aspirin with the current standard of care., Competing Interests: Dr Masuda has received a grant from Terumo Corporation outside the submitted work. Medical. Dr Tanabe has received honoraria from Boston Scientific and Daiichi-Sankyo. Dr Muramatsu has received honoraria from Boston Scientific Japan and Daiichi-Sankyo. Dr Ozaki has received a research grant from Takeda Pharma Ltd, Daiichi-Sankyo Company Ltd, and Terumo Corporation. Dr Kotoku has received a grant for studying overseas from the Fukuda Foundation for Medical Technology. Dr Kozuma has received honorarium for lectures and advisory board from Daiichi-Sankyo and Boston Scientific. Drs Serruys and Onuma have reported institutional grants from Heartflow Inc and GE. Dr Serruys has reported consultancy for Xeltis, SMT, Philips, Novartis, and Merillife outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Background: Temporal trends in the management of acute coronary syndrome complicated with cardiogenic shock after the revision of guideline recommendations for intra-aortic balloon pump (IABP) use and the approval of the Impella require further investigation, because their impact remains uncertain., Methods and Results: Using the Japanese Percutaneous Coronary Intervention (J-PCI) registry database from 2019 to 2021, we identified 12 171 patients undergoing percutaneous coronary intervention for acute coronary syndrome complicated with cardiogenic shock under mechanical circulatory support. The patients were stratified into 3 groups: (1) IABP alone, (2) Impella, and (3) venoarterial extracorporeal membrane oxygenation (VA-ECMO); the VA-ECMO group was further stratified into (3a) VA-ECMO alone, (3b) VA-ECMO in combination with IABP, and (3c) VA-ECMO in combination with Impella. The quarterly prevalence and outcomes were reported. The use of IABP alone decreased significantly from 63.5% in the first quarter of 2019 to 58.3% in the fourth quarter of 2021 ( P for trend=0.01). Among 4245 patients requiring VA-ECMO, the use of VA-ECMO in combination with IABP decreased significantly from 78.7% to 67.3%, whereas the use of VA-ECMO in combination with Impella increased significantly from 4.2% to 17.0% ( P for trend <0.001 for both). After adjusting for the confounders, the risk difference in the fourth quarter of 2021 relative to the first quarter of 2019 for in-hospital mortality was not significant (adjusted odds ratio, 0.84 [95% CI, 0.69-1.01])., Conclusions: Our study revealed substantial changes in the use of different mechanical circulatory support modalities in acute coronary syndrome complicated with cardiogenic shock, but they did not significantly improve the outcomes.

Objectives: We sought to investigate the 1-year outcomes, including all-cause and cardiovascular mortality, major adverse cardiovascular events (MACEs), and major bleeding, of patients undergoing percutaneous coronary intervention (PCI) with or without the revived directional coronary atherectomy (DCA) catheter in a Japanese nationwide registry., Background: Clinical data regarding the midterm outcomes of patients undergoing PCI with DCA are scarce in contemporary real-world practice., Methods: We analyzed the data of 74,764 patients who underwent PCI at 179 hospitals from January 2017 to December 2018. The baseline characteristics and 1-year outcomes of patients with stable coronary artery disease or unstable angina who underwent PCI with or without DCA were assessed., Results: Overall, 431 patients (0.6%) underwent PCI with DCA. Patients in the DCA group were younger and predominantly male, with fewer comorbidities than patients in the non-DCA group. Stentless PCI with DCA following additional drug-coated balloon (DCB) angioplasty was the dominant strategy in the DCA group (43.6%). One-year outcomes, including all-cause mortality (1.2% in the DCA group vs. 2.5% in the non-DCA group, respectively, p = 0.075), cardiovascular death (0.9% vs. 1.0%, p = 0.69), MACEs (1.9% vs. 1.8%, p = 0.96), and nonfatal major bleeding requiring readmission (1.2% vs. 1.4%, p = 0.62), were comparable between the two groups. In the DCA group, 1-year outcomes were comparable, regardless of whether the stent or DCB was used., Conclusions: One-year clinical outcomes after PCI with DCA in patients with stable coronary artery disease or unstable angina are acceptable, regardless of stent use., (© 2023 Wiley Periodicals LLC.)

Background: Intracoronary imaging improves clinical outcomes after stenting of complex coronary bifurcation lesions (CBLs), but the impact of Medina classification-based CBL distribution on outcomes of imaging-guided bifurcation stenting is unclear., Methods: In this integrated analysis of four previous studies, in which all CBLs were treated with drug-eluting stents under intravascular ultrasound or optical coherence tomography guidance, the distribution of 763 CBLs was assessed using angiographic Medina classification. Major adverse cardiac events (MACE), including target lesion revascularization (TLR), myocardial infarction, stent thrombosis, and cardiac death, were investigated at 1-year follow-up., Results: The most and least prevalent Medina subtypes were 0-1-0 (27.9 %) and 0-0-1 lesions (2.8 %). The most and least frequent MACE/TLR rates were 18.2 %/18.2 % for 0-0-1 lesions and 4.1 %/2.8 % for 0-1-0 lesions. Risks were higher for 0-0-1 lesions than for 0-1-0 lesions for both MACE (hazard ratio [HR]: 4.04, 95 % confidence interval [CI]: 1.21-13.45, p = 0.02) and TLR (HR: 6.19, 95 % CI: 1.69-22.74, p = 0.006). MACE rates were similar for true and non-true CBLs excluding 0-0-1 lesions (8.2 % and 5.9 %, HR 1.54, 95 % CI: 0.86-2.77, p = 0.15), while MACE (HR: 3.25, 95 % CI: 1.10-9.63, p = 0.03) and TLR (HR: 4.24, 95 % CI: 1.38-12.96, p = 0.01) risks were higher for 0-0-1 lesions., Conclusions: This integrated analysis of imaging-guided bifurcation stenting demonstrated similar clinical outcomes in true and non-true CBLs, except for 0-0-1 lesions, which had a significantly higher risk of MACE/TLR., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Y. Murasato has received speaker fees from Abbott Medical, Medtronic, Terumo, and Kaneka. N. Suzuki has received speaker fees from Abbott Medical, Actelion Pharmaceuticals, Astellas, Astellas-Amgen, Bayer Healthcare Pharmaceuticals, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Nipro, Otsuka, Sanofi and Toa Eiyo. T. Okamura and J. Shite have received honoraria for technical consulting from Abbott Medical. K. Kozuma received lecture fees from Boston Scientific, Abbott Medical, Medtronic, Otsuka, Takeda, Daiichi-Sankyo, Amgen, Novartis, Behringer, Bayer, Life Science Institute, Mochida, and Zeon Medical, and research grants from Boston Scientific and Abbott Medical. The other authors have no conflicts of interest to declare., (© 2023 The Author(s).)

Aims: Transradial intervention (TRI) for percutaneous coronary intervention (PCI) is used to reduce periprocedural complications. However, its effectiveness and safety for patients on dialysis are not well established. We aimed to investigate the association of TRI with in-hospital complications in dialysis patients undergoing PCI., Methods and Results: We included 44 462 patients on dialysis who underwent PCI using Japanese nationwide PCI registry data (2019-21) regardless of acute or chronic coronary syndrome. Patients were categorized based on access site: TRI, transfemoral intervention (TFI). Periprocedural access site bleeding complication requiring transfusion was the primary outcome and in-hospital death, and other periprocedural complications were the secondary outcomes. Matched weighted analysis was performed for TRI and TFI. Here, 8267 (18.6%) underwent TRI, and 36 195 (81.4%) underwent TFI. Patients who received TRI were older and had lower rates of comorbidities than those who received TFI. Access site bleeding rate and in-hospital death were significantly lower in the TRI group (0.1% vs. 0.7%, P < 0.001; 1.8% vs. 3.2%, P < 0.001, respectively). After adjustment, TRI was associated with a lower risk of access site bleeding (odds ratio [OR] [95% confidence interval (CI)]: 0.19 [0.099-0.38]; P < 0.001) and in-hospital death (OR [95% CI]: 0.79 [0.65-0.96]; P = 0.02). Other periprocedural complications between TRI and TFI were not significantly different., Conclusion: In patients undergoing dialysis and PCI, TRI had a lower risk of access site bleeding and in-hospital death than TFI. This suggests that TRI may be safer for this patient population., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background The prevalence of traditional atherosclerotic risk factors (TARFs) and their association with clinical profiles or mortality in percutaneous coronary intervention remain unclear. Methods and Results The study analyzed 559 452 patients who underwent initial percutaneous coronary intervention between 2012 and 2019 in Japan. TARFs were defined as male sex, hypertension, dyslipidemia, diabetes, smoking, and chronic kidney disease. We calculated the relative importance according to R 2 and machine learning models to assess the impact of TARFs on clinical profile and in-hospital mortality. The relative contribution (RC) of each TARF was defined as the average percentage of the relative importance calculated from these models. The age-specific prevalence of TARFs, except for chronic kidney disease, formed an inverted U-shape with significantly different peaks and percentages. In the logistic regression model and relative risk model, smoking was most strongly associated with acute myocardial infarction (adjusted odds ratio [OR], 1.62 [95% CI, 1.60-1.64]; RC, 47.1%) and premature coronary artery disease (adjusted unstandardized beta coefficient, 2.68 [95% CI, 2.65-2.71], RC, 42.2%). Diabetes was most strongly associated with multivessel disease (adjusted unstandardized beta coefficient, 0.068 [95% CI, 0.066-0.070], RC, 59.4%). The absence of dyslipidemia was most strongly associated with presentation of cardiogenic shock (adjusted OR, 0.62 [95% CI, 0.61-0.64], RC, 34.2%) and in-hospital mortality (adjusted OR, 0.44 [95% CI, 0.41-0.46], RC, 39.8%). These specific associations were consistently observed regardless of adjustment or stratification by age. Conclusions Our analysis showed a significant variation in the age-specific prevalence of TARFs. Further, their contribution to clinical profiles and mortality also varied widely.

Background The prognostic impact of optical coherence tomography-diagnosed culprit lesion morphology in acute coronary syndrome (ACS) has not been systematically examined in real-world settings. Methods and Results This investigator-initiated, prospective, multicenter, observational study was conducted at 22 Japanese hospitals to identify the prevalence of underlying ACS causes (plaque rupture [PR], plaque erosion [PE], and calcified nodules [CN]) and their impact on clinical outcomes. Patients with ACS diagnosed within 24 hours of symptom onset undergoing emergency percutaneous coronary intervention were enrolled. Optical coherence tomography-guided percutaneous coronary intervention recipients were assessed for underlying ACS causes and followed up for major adverse cardiac events (cardiovascular death, myocardial infarction, heart failure, or ischemia-driven revascularization) at 1 year. Of 1702 patients with ACS, 702 (40.7%) underwent optical coherence tomography-guided percutaneous coronary intervention for analysis. PR, PE, and CN prevalence was 59.1%, 25.6%, and 4.0%, respectively. One-year major adverse cardiac events occurred most frequently in patients with CN (32.1%), followed by PR (12.4%) and PE (6.2%) (log-rank P <0.0001), primarily driven by increased cardiovascular death (CN, 25.0%; PR, 0.7%; PE, 1.1%; log-rank P <0.0001) and heart failure trend (CN, 7.1%; PR, 6.8%; PE, 2.2%; log-rank P <0.075). On multivariate Cox regression analysis, the underlying ACS cause was associated with 1-year major adverse cardiac events (CN [hazard ratio (HR), 4.49 [95% CI, 1.35-14.89], P =0.014]; PR (HR, 2.18 [95% CI, 1.05-4.53], P =0.036]; PE as reference). Conclusions Despite being the least common, CN was a clinically significant underlying ACS cause, associated with the highest future major adverse cardiac events risk, followed by PR and PE. Future studies should evaluate the possibility of ACS underlying cause-based optical coherence tomography-guided optimization.

Background: The optimal revascularization strategy in patients with multivessel disease and intermediate SYNTAX score (SS) has not been fully elucidated. This study aimed to investigate the clinical outcomes of optimal intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) stratified by SS., Methods: This was a substudy of the OPTIVUS-Complex PCI study Multivessel Cohort, which aimed to meet the prespecified criteria for optimal stent expansion after IVUS-guided PCI. A total of 1,005 patients were divided into 3 groups according to SS: low, ≤22; intermediate, 23 to 32; and high, ≥33. The primary end points were major adverse cardiac and cerebrovascular events (MACCE) defined as a composite of death, myocardial infarction, stroke, or coronary revascularization., Results: The cumulative 1-year incidence of the primary end point was significantly higher in patients with high SS than in those with intermediate or low SS (25.0%, 10.9%, and 9.5%, respectively; p = 0.003). This difference was mainly caused by the incidence of coronary revascularization. In the multivariable Cox proportional hazards models, the excess risk of patients with high versus low SS remained significant for the primary end point (hazard ratio 3.19, 95% confidence interval 1.65 to 6.16, p <0.001), whereas the excess risk of patients with intermediate versus low SS was no longer significant (hazard ratio 1.20, 95% confidence interval 0.72 to 2.01, p = 0.46)., Conclusions: After IVUS-guided multivessel PCI, patients with intermediate SS had a similar 1-year risk of MACCE to that of patients with low SS, whereas patients with high SS had a higher 1-year risk of MACCE than those with low SS., Competing Interests: Declaration of Competing Interest Dr. Hibi reports funding grants from Abbott; lecturer fees from Abbott Medical, Daiichi Sankyo, and Medtronic; research grants from the Research Institute for Production Development and Japan Medical Device Corporation; and scholarship funds from Abbott Medical and Nipro. Dr. Morimoto reports lecturer fees from AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Japan Lifeline, Kowa, Toray, and Tsumura; manuscript fees from Bristol-Myers Squibb and Kowa; and participation on the advisory boards of Novartis and Teijin. Dr. Tanabe reports honoraria from Abbott Medical, Boston Scientific, Japan Lifeline, Medtronic, OrbusNeich, and Terumo. Dr. Kimura reports research grants from Abbott Medical and Boston Scientific; honoraria from Abbott Medical, Boston Scientific, Daiichi Sankyo, Sanofi, and Terumo; and participation on the advisory boards of Abbott Medical, Boston Scientific, and Sanofi. The remaining authors declare no conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Recent studies suggested short-term mortality after transcatheter edge-to-edge repair (TEER) was comparable between men and women. However, the gender-specific prognostic difference in the long-term follow-up after TEER is still unknown. To evaluate the impact of gender on long-term mortality after TEER for functional mitral regurgitation (FMR) using multicenter registry data. We retrospectively analyzed 1,233 patients (male 60.3%) who underwent TEER for FMR at 24 centers. The impact of gender on all-cause death and hospitalization for heart failure (HF) after TEER was evaluated using multivariate regression analysis and propensity score (PS) matching methods. During the 2-year follow-up, 207 all-cause death and 263 hospitalizations for HF were observed after TEER for FMR. Men had a significantly higher incidence of all-cause death than women (18.6% vs 14.1%, log-rank p = 0.03). After adjustment by multivariate Cox regression and PS matching, the male gender was significantly associated with a higher incidence of all-cause mortality after TEER than the female gender (hazard ratio 2.11, 95% confidence interval 1.42 to 3.14 in multivariate Cox regression; hazard ratio 1.89, 95% confidence interval 1.03 to 3.48 in PS matching). The gender-specific prognostic difference was even more pronounced after 1-year of TEER. On the contrary, there was no gender-related difference in hospitalization for HF after TEER. In conclusion, women with FMR had a better prognosis after TEER than men, whereas this was not observed in hospitalization for HF. This result might indicate that women with FMR are more likely to benefit from TEER., Competing Interests: Declaration of Competing Interest Drs. Hioki and Asami received honoraria for a lecture from Abbott Medical. Drs. Yamamoto, Watanabe, Kataoka, Kubo, Izumo, Mizuno, Nakajima, and Shirai are clinical proctors of transcatheter edge-to-edge repair for Abbott Medical. Dr. Saji is a clinical proctor of transcatheter edge-to-edge repair for Abbott Medical and received a consultant fee from Abbott Medical. Dr. Ohno is the advisor of Abbott Medical and received consultant and speaker fees from Abbott Medical. Dr. Yamaguchi is a clinical proctor of transcatheter edge-to-edge repair for Abbott Medical and received a lecture fee and a scholarship donation from Abbott Medical. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Recent studies showed that preoperative functional assessment with fractional flow reserve (FFR) could predict a long-term patency of arterial bypass grafts in patients with coronary artery bypass grafting (CABG). Quantitative flow ratio (QFR) is a novel angiography-based approach to estimate FFR. This study aimed to investigate whether preoperative QFR could discriminate arterial bypass function at 1 year after surgery. The PRIDE-METAL registry was a prospective, multicenter observational study that enrolled 54 patients with multivessel coronary artery disease. By protocol, left coronary stenoses were revascularized by CABG with arterial grafts, whereas right coronary stenoses were treated with coronary stenting. Follow-up angiography at 1 year after surgery was scheduled to assess arterial graft patency. QFR was performed using index angiography by certified analysts, blinded to bypass graft function. The primary end point of this sub-study was the discriminative ability of QFR for arterial graft function, as assessed by receiver-operating characteristic curve. Among 54 patients enrolled in the PRIDE-METAL registry, index and follow-up angiography was available in 41 patients with 97 anastomoses. QFR were analyzed in 35 patients (71 anastomoses) with an analyzability of 85.5% (71/83). Five bypass grafts were found to be non-functional at 1 year. The diagnostic performance of QFR was substantial (area under the curve: 0.89; 95% confidence interval: 0.83 to 0.96) with an optimal cutoff of 0.76 to predict functionality of bypass grafts. Preoperative QFR is highly discriminative for predicting postoperative arterial graft function.Trial registration: Clinical.gov reference: NCT02894255., (© 2023. The Author(s) under exclusive licence to Japanese Association of Cardiovascular Intervention and Therapeutics.)

Background: New-generation drug-eluting stents (DES) achieved technological innovations and reported clinical advantages as compared with first-generation DES in clinical trials with 3-5 years follow-up. However, detailed clinical outcome data in very long-term follow-up is still scarce., Objectives: To evaluate 10-year clinical outcomes after first- and new-generation DES implantation., Methods: In this extende follow-up study of the RESET, which is a largest randomized trial comparing everolimus-eluting stent (EES) with Sirolimus-eluting stent (SES), the study population consisted of 2892 patients from 84 centers. The primary efficacy and safety endpoints were target lesion revascularization (TLR) and a composite of death or myocardial infarction (MI), respectively. Complete 10-year follow-up was achieved in 87.9% of patients., Results: Cumulative 10-year incidences of TLR and non-TLR were not significantly different between EES and SES (13.9% vs. 15.7%, Log-rank p = 0.20, and 33.4% vs. 31.3%, Log-rank p = 0.30). The cumulative 10-year incidence of death/MI was also not significantly different between the groups (32.5% vs. 34.4%, Log-rank p = 0.18). Cumulative 10-year incidence of definite stent thrombosis was numerically lower in EES than in SES (1.0% vs. 1.7%, Log-rank p = 0.16). The lower risk of EES relative to SES was significant for a composite endpoint of target lesion failure (TLF: 19.6% vs. 24.9%, Log-rank p = 0.001) and target vessel failure (TVF: 26.7% vs. 31.4%, Log-rank p = 0.006)., Conclusion: During 10-year of follow-up, the risks for primary efficacy and safety endpoints were not significantly different between new-generation EES and first-generation SES, although EES compared with SES was associated with a lower risk for composite endpoints such as TLF and TVF., (© 2023 Wiley Periodicals LLC.)

Competing Interests: A. Kataoka and Y. Watanabe received remuneration from Abbott Medical Japan as proctors for MitraClip. The other authors have no conflicts of interest to declare.

Competing Interests: Y. Watanabe is aclinical proctor of transfemoral TAV for Edwards Lifesciences and Medtronic. The other authors have no conflicts of interest to declare.

Background: The impact of coronary bifurcation angle (BA) on incomplete stent apposition (ISA) after crossover stenting followed by side branch (SB) intervention has not been established., Methods: A total of 100 crossover stentings randomly treated with proximal optimization technique followed by short balloon dilation in the SB (POT-SBD group, 48 patients) and final kissing balloon technique (KBT group, 52 patients) were analyzed in the PROPOT trial. Major ISA with maximum distance > 400 μm and its location was determined using optical coherence tomography before SB intervention and at the final procedure. The BA was defined as the angle between the distal main vessel and SB. Optimal POT was determined when the difference in stent volume index between the proximal and distal bifurcation was greater than the median value (0.86 mm 3 /mm) before SB intervention., Result: Major ISA was more frequently observed in the POT-SBD than in the KBT group (35% versus 17%, p < 0.05). In the POT-SBD group, worsening ISA after SBD was prominent at the distal bifurcation. The BA was an independent predictor of major ISA (odds ratio 1.04, 95% confidence interval 1.00-1.07, p < 0.05) with a cut-off value of 59.5° (p < 0.05). However, the cases treated with optimal POT in the short BA (<60°) indicated the lowest incidence of major ISA. In the KBT group, BA had no significant impact., Conclusion: A wide BA has a potential risk for the occurrence of major ISA after POT followed by SBD in coronary bifurcation stenting., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Author(s).)

The party balloon inflation maneuver increases intrathoracic pressure, decreases venous return, and after release enhances venous return to the right atrium more effectively than does the conventional Valsalva maneuver. Therefore, it shows potential for more effective detection of right-to-left shunts in patients with a patent foramen ovale. ( Level of Difficulty: Intermediate. )., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2023 The Authors.)

Background: There are no randomised trials reporting clinical outcomes of biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at 10 years., Aims: We aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES., Methods: The randomised NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT) was originally designed to evaluate the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at 1 year and the primary safety endpoint of death or myocardial infarction (MI) at 3 years. In this extended follow-up study, clinical outcomes were compared from 1 year after stent implantation up to 10 years between patients with BP-BES and DP-EES., Results: From May to October 2011, NEXT enrolled a total of 3,241 patients from 98 centres in Japan. The current study population consisted of 2,417 patients (1,204 patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58). TLR occurred in 15.9% of patients in the BP-BES group and in 14.1% of the DP-EES group (HR 1.12, 95% CI: 0.90-1.40; p=0.32). In a landmark analysis at 1 year, the cumulative incidences of death or MI and TLR were not significantly different between the 2 groups., Conclusions: The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1 year and up to 10 years after stent implantation.

Purpose: Our objective was to evaluate the feasibility of performing endovascular therapy (EVT) for aortoiliac artery disease using transradial approach (TRA) as compared to transfemoral approach (TFA)., Methods: We analyzed 9671 cases with symptomatic lower extremity artery disease due to aortoiliac occlusive disease (AIOD) treated using EVT from a Japanese Nationwide EVT Registry between January and December 2021. We compared the baseline characteristics, procedural information, and 30-day outcomes of patients who received EVT only via TRA (n=863 [16.9%]) and those only via TFA (n=4255 [83.1%]) by using propensity score (PS) matching, after excluding those who required regular dialysis, those who underwent hybrid surgeries, and those who received EVT through 2 or more approach sites., Results: After matching, the final study population consisted of 862 matched patients with similar baseline characteristics in each group. Technical success rate was comparable between the 2 groups (99.3% vs. 99.3%, p>0.99). No significant differences were observed with respect to the composite of all-cause death within 48 hours after EVT and post-procedural complications within 30 days, including severe bleeding that required transfusion, revascularization procedures, urgent surgeries, cerebral infarction, and major limb amputation (0.2% vs. 0.7%, p=0.29). Transradial approach was associated with shorter operation time (85 vs. 90 minutes, p=0.016), but longer fluoroscopy time (26 vs. 20 minutes, p<0.001) and higher contrast agent volume (80 vs. 75 mL, p<0.001)., Conclusion: After PS matching, TRA showed the comparable rates of successful EVT and 30-day complications in patients with AIOD compared to TFA. Transradial approach was found to be safe and be a viable alternative of TFA for the treatment of AIOD., Clinical Impact: The efficacy of transradial approach (TRA) is established in percutaneous coronary intervention; however, its safety and feasibility are unclear in endovascular therapy (EVT). We analyzed 9,671 cases with symptomatic aortoiliac occlusive disease treated using EVT from a Nationwide Registry to compare the 30-day outcomes of those who received EVT only via TRA (n = 863 [16.9%]and those only via TFA (n=4,255 [83.1%]) by using propensity score matching. Technical success rate (99.3% vs. 99.3%, p > 0.99) and 30-day complications (0.2% vs. 0.7%, p = 0.29) were comparable between the two groups. EVT via TRA could be performed safely.

Background: The impact of shorter door-to-balloon (DTB time on long-term outcomes in ST-segment elevation myocardial infarction (STEMI treated with primary percutaneous coronary intervention (PPCI has not been fully elucidated., Methods: We investigated 3283 consecutive patients with acute myocardial infarction selected from a prospective, nationwide, multicenter registry (J-MINUET database comprising 28 institutions in Japan between July 2012 and March 2014. Among the study population, we analyzed 1639 STEMI patients who had PPCI within 12 h of onset. Patients were stratified into four groups (DTB time < 45 min, 45-60 min, 61-90 min, >90 min. The primary endpoint was a composite of all-cause death, non-fatal MI, non-fatal stroke, cardiac failure, and urgent revascularization for unstable angina up to 3 years. We performed landmark analysis for incidence of the primary endpoint from 31 days to 3 years among the four groups., Results: The primary endpoint rate from 31 days to 3 years increased significantly and time-dependently with DTB time (10.2 % vs. 15.3 % vs. 16.2 % vs. 19.3 %, respectively; log-rank p = 0.0129. Higher logarithm-transformed DTB time was associated with greater risk of a primary endpoint from 31 days to 3 years, and the increased number of adverse long-term clinical outcomes persisted even after adjusting for other independent variables., Conclusion: Shorter DTB time was associated with better long-term clinical outcomes in STEMI patients treated with PPCI in contemporary clinical practice. Further efforts to shorten DTB time are recommended to improve long-term clinical outcomes in STEMI patients., Trial Registration: UMIN Unique trial Number: UMIN000010037., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Yukio Ozaki has received several research grants from Bayer Yakuhin, Ltd., Research Institute for Production Development, Daiichi-Sankyo Co., Ltd., and Dainippon Sumitomo Co., Ltd. Kazuo Kimura has received honoraria from AstraZeneca, Toa Eiyo Ltd., MSD K.K., Bayer Yakuhin, Ltd., and Daiichi-Sankyo Co., Ltd., and has received several research grants from MSD K.K., Daiichi-Sankyo Co., Ltd., Ono Pharmaceutical Co., Pfizer Japan Inc., Bayer Yakuhin Ltd., Takeda Pharmaceutical Co., Ltd., Boehringer Ingelheim Japan, Tanabe Mitsubishi, and Astellas Pharma Inc. Wataru Shimizu has received honoraria from Daiichi-Sankyo Co., Ltd., Boehringer Ingelheim Japan, Bayer Yakuhin Ltd., Bristol, and Ono Pharmaceutical Co., and has received several research grants from Daiichi-Sankyo Co., Ltd., Boehringer Ingelheim Japan, Ono Pharmaceutical Co., Otsuka Pharmaceutical Co., Eisai Co., Mitsubishi Tanabe Pharma Co., Asterllas Pharma Inc., and St Jude Medical. Yoshihiko Saito has received honoraria from Otsuka Pharmaceutical Co., Ltd., Kowa Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., and Novartis Pharma K.K., and has received several research grants from Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., Ono Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Eisai Co., Ltd., ZERIA Pharmaceutical Co., Ltd., Shionogi & Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Dainippon Sumitomo Pharma Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Astellas Pharma Inc., Daiichi Sankyo Co., Ltd., and Boston Scientific Japan K.K. Toshiaki Mano has received a research grant from Abbot Vascular Japan. Kengo Tanabe has received honoraria from Abbot Vascular Japan, Mitsubishi Tanabe Pharma Co., and Daiichi Sankyo Co., Ltd. and has received several research grants from Kaneka and Terumo. Kenichi Tsujita has received honoraria from Amgen Astellas Bio Pharma K.K., Bayer Yakuhin, Ltd., Daiichi Sankyo Co., Ltd., MSD K.K., and Sanofi K.K., and has received several research grants from AstraZeneca K.K., Astellas Pharma Inc., Bayer Yakuhin, Ltd., Boehringer Ingelheim Japan, Boston Scientific Japan K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Kowa Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., MSD K.K., Pfizer Japan Inc., Sanofi K.K., Shionogi & Co., Ltd., and Takeda Pharmaceutical Co., Ltd. Masaharu Ishihara has received honoraria from Bayer Yakuhin Ltd., MSD K.K., Astra Zeneca, and Astellas Pharma Inc. and has received several research grants from Abbott Vascular Japan, Boston Scientific Japan K.K., Sanofi K.K., MSD K.K., Astellas Pharma Inc., Bayer Yakuhin Ltd., Pfizer, Daiichi Sankyo Co., Ltd., MID, and Goodman. No funders played any role in this study., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)