Rationale and Design of Prospective, Multicenter, Double-Arm Clinical Trial to Investigate the Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus (TOP-HFPEF Trial).

Background: Recent large clinical trials have revealed that sodium-glucose cotransporter 2 (SGLT2) inhibitors improve cardiovascular outcomes not only in patients with heart failure with reduced ejection fraction, but also in patients with heart failure with mildly reduced or preserved ejection fraction (HFpEF). However, the effect of SGLT2 inhibitors on left ventricular (LV) diastolic function is still controversial.

Methods And Results: The TOP-HFPEF trial (Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus) is a multicenter, double-arm, open-label, confirmatory, investigator-initiated clinical study to investigate the effect of SGLT2 inhibitor on LV diastolic function in patients with HFpEF and type 2 diabetes mellitus.

Efficacy of azilsartan on left ventricular diastolic dysfunction compared with candesartan: J-TASTE randomized controlled trial.

Characterized by ventricular and vascular stiffness, heart failure with preserved ejection fraction (HFpEF) has led to high morbidity and mortality. As azilsartan is an angiotensin receptor blocker with the highest myocardial and vascular affinities, azilsartan may improve the left ventricular (LV) diastolic function in patients with hypertension and either HFpEF or HF with mildly reduced ejection fraction (HFmrEF) more than candesartan. In this randomized, open-label trial, we randomly assigned 193 hypertensive patients with HF and LV ejection fraction ≥ 45% to 20 mg of azilsartan (n = 95) or 8 mg of candesartan (n = 98), once daily for 48 weeks.

Usefulness of transpedal intervention for inferior epigastric artery bleeding following catheter ablation: a case report.

Background: Cardiovascular interventions may result in access-site complication, including inferior epigastric artery (IEA) bleeding. The IEA injury is generally treated through surgery and transcatheter embolization; however, additional complications should be avoided in the bailout procedure. Here, we present a case of catheter ablation complicated by IEA haemorrhage that we managed by transcatheter embolization using a transpedal intervention (TPI).

Effects of ipragliflozin on left ventricular diastolic function in patients with type 2 diabetes and heart failure with preserved ejection fraction: The EXCEED randomized controlled multicenter study.

Aim: We carried out a randomized controlled trial using ipragliflozin. We analyzed changes in diastolic function using echocardiography in patients with type 2 diabetes and heart failure with preserved ejection fraction.

Methods: We carried out an open-label, multicenter, randomized, two-arm interventional trial.

A Randomized Trial of Home Blood-Pressure Reduction by Alcohol Guidance During Outpatient Visits: OSAKE Study.

Background: To evaluate the effectiveness of the nurse-led alcohol guidance to control home blood pressure (HBP) in the morning among male patients with hypertension during outpatient visits.

Methods: We enrolled 53 male patients with an HBP of ≥135/85 mm Hg with excessive drinking (alcohol ≥210 g/week or ≥60 g/day habitually) among outpatients in a randomized trial. Patients were assigned to a nurse-led alcohol guidance intervention or to the control.

Late peri-stent contrast staining appearance due to rupture of atherogenic neointima following drug-eluting stent.

The development of peri-stent contrast staining (PSS) after coronary intervention with implantation of a stent is observed in approximately 1-3% of patients treated with drug-eluting stent. Although the cumulative incidences of late in-stent restenosis and stent thrombosis are significantly higher in lesions with PSS than in those without the finding, the mechanisms for the development of PSS have not yet been fully elucidated. In this report, we describe a case of rapid development of PSS with ulcer formation caused by rupture of atherogenic neointima, which was observed by serial optical coherence tomography examinations over 6 months.

Acute myocardial infarction in a patient with uncorrected tetralogy of Fallot accompanied by coronary artery ectasia: A case report.

A 63-year-old male with a medical history of uncorrected tetralogy of Fallot (TOF) presented to our hospital due to acute myocardial infarction (AMI). Emergency coronary angiography (CAG) was performed and it showed a severe thrombotic stenosis in the middle right coronary artery (RCA) and total thrombotic occlusion of the posterior descending branch of the RCA. Subsequently, percutaneous coronary artery intervention (PCI) under the guidance of intravascular ultrasound (IVUS) was performed.

Successful percutaneous removal of dislodged ring-marker of optical coherence tomography catheter using the twisted wire technique with a guide-extension catheter: A case report.

An 81-year-old male with diabetes and hypertension was admitted to our hospital due to chest pain on exertion. Coronary angiography revealed a severe stenosis at the middle of right coronary artery (RCA). We performed percutaneous coronary intervention under the guidance of optical coherence tomography (OCT) to the lesion in the middle RCA.

Influence of caffeine intake on intravenous adenosine-induced fractional flow reserve.

Background: This study evaluated whether caffeine abstention is required before fractional flow reserve (FFR) measurement by intravenous adenosine triphosphate (ATP) administration in Japanese patients.

Methods: This study was a subanalysis of a previously published study and a total of 208 intermediate lesions that underwent FFR measurements were enrolled for this analysis. Hyperemia was induced by continuous intravenous ATP infusion at 150 μg/kg/min (IVATP150) and 210 μg/kg/min (IVATP210), and by intracoronary administration of nicorandil 2 mg (ICNIC2mg) as a reference standard.

Short- and mid-term influence of drug-coated stent implantation on structural and functional vascular healing response: An optical coherence tomography and acetylcholine testing study.

Objective: This study investigated the effect of a drug-coated stent (DCS) that has a novel microporous abluminal surface without a polymer on 1-month and 1-year functional and morphological healing response as assessed using acetylcholine (Ach) testing and optical coherence tomography (OCT).

Background: DCS is expected to induce favorable morphological and physiological arterial healing after its implantation.

Methods: A total of 11 patients who underwent vascular response examinations 1-month and 1-year after the index PCI with DCS implantation were enrolled.

Effect of neointimal tissue morphology on vascular response to balloon angioplasty in lesions with in-stent restenosis after drug-eluting stent deployment: an optical coherence tomography analysis.

This study aimed to evaluate the vascular response to balloon angioplasty for drug-eluting stent (DES) in-stent restenosis (ISR) lesions based on our novel optical coherence tomography (OCT) classification to establish the optimal treatment strategy for ISR lesions after DES implantation. A total of 104 ISR lesions after DES implantation were imaged by OCT and categorized into the following six patterns: type I-homogeneous high-intensity tissue, type II-heterogeneous tissue with signal attenuation, type III-speckled heterogeneous tissue, type IV-mixed tissue containing poorly delineated region with invisible strut, type V-mixed tissue containing sharply delineated low-intensity region, and type VI-bright protruding tissue with an irregular surface. Serial volumetric OCT analysis was performed before and after balloon dilation to evaluate the vascular response to balloon angioplasty.

Impact of optical coherence tomography-derived neointimal tissue morphology on development of very late in-stent restenosis.

Objectives: This study evaluated the progression of very late in-stent restenosis (VL-ISR) by analyzing four serial coronary angiography (CAG) images and its correlation with neointimal tissue characterization of the VL-ISR lesions on optical coherence tomography (OCT).

Background: Recently, VL-ISR is occasionally observed beyond a few years after drug-eluting stents (DESs) implantation.

Methods: This study analyzed 50 VL-ISR lesions after DES in which 4 serial CAGs over a period of 2 years, including at baseline procedure, 9 months after baseline procedure, 12 months before VL-ISR, and at the time of VL-ISR, were performed.

Genetic factors associated with elevation of uric acid after treatment with thiazide-like diuretic in patients with essential hypertension.

We investigated changes in blood pressure (BP) and metabolic adverse effects, especially elevation of uric acid (UA), after treatment with a thiazide-like diuretic (TD) in patients with essential hypertension. Furthermore, the role of genetic factors in the elevation of UA by TD was assessed by a 500 K SNP DNA microarray. The subjects included 126 hypertensive patients (57 women and 69 men, mean age 59 ± 12 years) who registered for the GEANE (Gene Evaluation for ANtihypertensive Effects) study.

Utility and Validity of Intracoronary Administration of Nicorandil Alone for the Measurement of Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis.

Background: Intracoronary (IC) administration of nicorandil has been proposed as an alternative choice of hyperemic agent for fractional flow reserve (FFR) measurements. This study evaluated the utility and validity of IC nicorandil administration alone to induce maximal hyperemia.

Methods and results: Two-hundred-seven patients with coronary artery disease listed for coronary angiography with FFR were prospectively enrolled.

Optical coherence tomography characteristics of in-stent restenosis after drug-eluting stent implantation: a novel classification and its clinical significance.

This study aimed to establish a novel classification of in-stent restenosis (ISR) morphological characteristics after drug-eluting stent (DES) implantation as visualized by optical coherence tomography (OCT) and determine its clinical significance. A total of 133 lesions with intrastent restenosis after DES implantation were imaged by OCT. Neointimal tissue characteristics were categorized according to the classical classification as either homogeneous, heterogeneous, or layered.

Evaluation of repeated progression of native coronary artery stenosis by optical frequency domain imaging in a patient with essential thrombocytosis.

Essential thrombocytosis (ET) is a myeloproliferative disorder with abnormal proliferation of the megakaryocytes and is manifested clinically by the overproduction of dysfunctional platelets, leading to thrombus formation. Therefore, the accurate evaluation of the morphological features for coronary stenosis and initiation of appropriate treatment may be life-saving for ET patients. In this report, we describe a case of the rapid development of repeated stenosis in the native coronary artery in an ET patient, and optical frequency domain imaging confirmed the etiology of the stenoses.

Vascular response to biolimus A-9 eluting stent in patients with shorter and prolonged dual antiplatelet therapy: optical coherence tomography sub-study of the NIPPON trial.

Dual antiplatelet therapy (DAPT) with thienopyridine and aspirin is the standard care for the prevention of stent thrombosis. However, the optimal duration and effect of the duration of DAPT on intra-stent thrombus (IS-Th) formation are unknown. The NIPPON study (Nobori Dual Antiplatelet Therapy as Appropriate Duration) was an open label, randomized multicenter, assessor-blinded, trial designed to demonstrate the non-inferiority of shorter (6-month) DAPT to prolonged (18-month) DAPT, after biolimus A9 eluting stent implantation in 3773 patients at 130 sites in Japan.

Accuracy of J-CTO Score Derived From Computed Tomography Versus Angiography to Predict Successful Percutaneous Coronary Intervention.

Objectives: The aim of this study was to compare the ability of conventional versus computed tomography angiography (CTA) to predict procedural success and 30-min wire crossing rates in percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) lesions.

Background: Coronary CTA can be used to assess the morphology of CTO lesions.

Methods: We examined 205 consecutive patients (218 CTO lesions) who underwent coronary CTA pre-PCI.

Simultaneous occurrence of spontaneous coronary artery dissections of the left anterior descending and right coronary arteries in acute myocardial infarction.

Spontaneous coronary artery dissection (SCAD) is a rare and often fatal cause of ischemic heart disease that occurs predominantly in young or middle-aged patients who are otherwise healthy. Therefore, the accurate diagnosis of SCAD and initiation of appropriate treatment may be life-saving. Although recent case reports have described patients with SCAD who exhibited multiple coronary dissections in addition to the culprit lesion, the authors could not determine whether the multiple dissections occurred simultaneously or at different times.

A multidirectional approach to risk assessment in patients with three-vessel coronary artery disease undergoing percutaneous intervention.

Background: The SYNTAX score (SS) and Clinical SYNTAX score (CSS) have demonstrated utility as risk-stratifying tools following percutaneous coronary intervention (PCI). However, useful determinants for predicting hard clinical events (HCE: death, nonfatal myocardial infarction, and stroke) in the setting of routinely-performed-angiographic follow-up have yet to be elucidated.

Methods And Results: We retrospectively examined the clinical outcomes of 252 three-vessel disease (TVD) patients following PCI.

Indications and outcomes of excimer laser coronary atherectomy: Efficacy and safety for thrombotic lesions-The ULTRAMAN registry.

Background: Excimer laser coronary atherectomy (ELCA) recently became available in Japan, but ELCA's effectiveness and safety are not clear.

Methods And Results: We enrolled consecutive patients who underwent ELCA and were registered in the Utility of Laser for Transcatheter Atherectomy-Multicenter Analysis around Naniwa (ULTRAMAN) registry comprising six Japanese medical centers around Naniwa in Japan with patients registered from April 2006 to June 2015. We evaluated the catheter sizes used and compared the success rate, thrombolysis in myocardial infarction (TIMI) flow, blush score, and complications between the rich-thrombus (RT) group [acute coronary syndrome (ACS) and saphenous vein graft (SVG)] and the poor-thrombus (PT) group [in-stent restenosis (ISR), chronic total occlusion (CTO), calcification, and long or bifurcation (L&B) lesions].

Cardiovascular events occur independently of high on-aspirin platelet reactivity and residual COX-1 activity in stable cardiovascular patients.

Several studies have indicated that approximately 25 % of patients treated with aspirin exhibit high on-treatment platelet reactivity (HTPR), which is potentially associated with cardiovascular events (CVEs). However, this association is still controversial, since the mechanisms by which HTPR contributes to CVEs remain unclear and a no standardised definition of HTPR has been established. To determine whether HTPR is associated with CVE recurrence and what type of assay would best predict CVE recurrence, we conducted a multicentre prospective cohort study of 592 stable cardiovascular outpatients treated with aspirin monotherapy for secondary prevention.

Changes in left ventricular relaxation after azelnidipine treatment in hypertensive patients with diabetes: subanalysis of a prospective single-arm multicentre study.

Objectives: We previously demonstrated that a calcium channel blocker, azelnidipine, improves left ventricular relaxation in patients with hypertension and diastolic dysfunction in a multicentre, Clinical impact of Azelnidipine on Left VentricuLar diastolic function and OutComes in patients with hypertension (CALVLOC) trial. The objectives of the present subanalysis were to investigate the differences in diastolic function in hypertensive patients with and without diabetes, and the efficacy of azelnidipine on diastolic function among them.

Design: Subanalysis of a prospective single-arm multicentre study.