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. The participants are randomly assigned (1:1) to the tofogliflozin group (20 mg once daily) or the control group (administration or continuation of antidiabetic drugs other than SGLT2 inhibitors). The estimated number of patients to be enrolled in this trial is 90 in total (45 in each group). The participants are followed up for 52 weeks with tofogliflozin or control drugs. The primary endpoint is the change in E/e' assessed by echocardiography from the baseline to the end of this study (52 weeks). This trial will also evaluate the effects of tofogliflozin on cardiovascular events, biomarkers, other echocardiographic parameters, the occurrence of atrial fibrillation, and renal function. CONCLUSIONS: The TOP-HFPEF trial will clarify the efficacy of an SGLT2 inhibitor, tofogliflozin, 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. After the initiation of treatment, changes in the doses of the study drugs were permitted based on the patient's conditions, including blood pressure (median dose at 48 weeks: azilsartan 20.0 mg/day, candesartan 8.0 mg/day). The primary endpoint was the baseline-adjusted change in the ratio of peak early diastolic transmitral flow velocity (E) to early diastolic mitral annular velocity (e') (E/e'). Adjusted least-squares mean (LSM) change in E/e' was - 0.8 (95% confidence interval [CI] - 1.49 to - 0.04) in the azilsartan group and 0.2 (95% CI - 0.49 to 0.94) in the candesartan group, providing the LSM differences of - 1.0 (95% CI - 2.01 to 0.03, P = 0.057). The median change in left atrial volume index was - 2.7 mL/m2 with azilsartan vs 1.4 mL/m2 with candesartan (P = 0.091). The frequency of adverse events related to hypotension and hyperkalemia did not differ between the groups. The current study did not provide strong evidence that azilsartan improves LV diastolic dysfunction, and further confirmatory study is required.

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). Case summary: A 58-year-old man underwent catheter ablation for symptomatic paroxysmal atrial fibrillation. Pulmonary vein isolation was performed uneventfully via catheterization of the right femoral artery and vein access. After the procedure, he complained of persistent abdominal pain and had a palpable mass in the lower right abdomen. Computed tomography angiography (CTA) revealed a haematoma in the right rectus abdominis with signs of active bleeding from a branch of the right IEA. We performed transcatheter arterial embolization through a TPI to stop bleeding and avoid further complication. No leakage of contrast media was detected after embolization using a microcoil and the abdominal pain improved. We did not observe any serious intraprocedural complications. Discussion: Catheter ablation procedures may be complicated by access-site complications such as active bleeding. Arterial embolization is a feasible treatment approach to control the resulting haemorrhage. Embolization through the transpedal route (TPI) could be an effective bailout technique in the setting of emergent transcatheter arterial embolization to achieve haemostasis and avoid further complication.

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 total of eligible 68 participants were randomly assigned into two groups (ipragliflozin group n = 36; conventional treatment group n = 32). Primary end-points were the change in E/e' and e'. Secondary end-points were other parameters of echocardiography, plasma NT-proBNP level, New York Heart Association class, hemoglobin A1c and blood pressure. RESULTS: After 24 weeks of follow up, E/e' decreased in both groups (ipragliflozin: 11.0 vs 10.4; conventional treatment 10.5 vs 10.1; multivariate-adjusted P = 0.95). There were no significant differences in the amount of change in E/e', e', echocardiography parameters, plasma NT-proBNP level, New York Heart Association class, hemoglobin A1c and blood pressure between the two groups. In the subgroup analysis, ipragliflozin treatment decreased in left ventricular mass index in patients aged ≥70 years and also decreased in NT-proBNP levels in patients with baseline NT-proBNP ≥400 pg/mL. CONCLUSIONS: In this randomized controlled study carried out in patients with type 2 diabetes and heart failure with preserved ejection fraction, 24-week ipragliflozin treatment did not improve left ventricular diastolic function compared with conventional treatment. As the subgroup, ipragliflozin treatment decreased in left ventricular mass index in participants aged ≥70 years. Geriatr Gerontol Int 2022; 22: 298-304.

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. The primary outcomes were the mean HBP of 5 consecutive days at 6 months and alcohol consumption. RESULTS: Twenty-eight and 25 patients were randomized to intervention and control groups, respectively (mean age; 62.7 years old and 64.5, respectively). At baseline, the groups were well balanced across most characteristics. At 6 months, the mean HBP was 131/82 mm Hg in the intervention group vs. 145/87 mm Hg in the control group (SBP <0.001, DBP = 0.09). An HBP level of less than 135/85 mm Hg was achieved among 55.6% of the participants in the intervention group vs. 16.7% in the control group (P = 0.004). The alcohol consumption at 6 months was 256 ± 206 g/w vs. 413 ± 260 g/w, respectively (P = 0.020). CONCLUSIONS: We confirmed the effectiveness of the nurse-led alcohol guidance to control the HBP in male patients with hypertension during outpatient visits. PUBLIC TRIALS REGISTRY NUMBER: UMIN000017454 (UMIN Clinical Trials Registry).

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. Protrusion of the stent-jailed underlying necrotic core toward the lumen by the contracting force might have resulted in formation of atherogenic neointima within the stent. Subsequently, rupture of this necrotic core induced by iatrogenic neointimal injury due to balloon dilation and dissolution of the accumulated necrotic core may have resulted in PSS formation 6 months after the procedure. These findings may be helpful for consideration of etiology and therapeutic strategy for lesions with PSS. .

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. He was discharged on the 14th day in stable condition. Nine months after the PCI procedure, coronary computed tomography angiography was performed for follow-up, which revealed tetralogy of Fallot and complete resolution of the thrombus and ectasic coronary artery without stenosis. When he was 70 years old, he was transferred to our hospital because of recurrent AMI. As emergency CAG showed total thrombotic occlusion of the middle RCA, IVUS-guided PCI was performed. We experienced a very rare case of AMI in an adult patient with uncorrected TOF accompanied by coronary artery ectasia (CAE). To the best of our knowledge, this is the first case of AMI in an adult patient with uncorrected TOF accompanied by CAE. .

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. The vascular response was evaluated by the functional response test by acetylcholine infusion, the morphological response test by OCT. RESULTS: Although 94.5% of the DCS struts were covered by homogeneous smooth neointima at 1 month, the percentage of neointimal coverage increased to 98.5% at 1 year (p = .02). Conversely, the proportion of uncovered struts and malapposed struts at 1 year were 1.2 and 0.7%, respectively. Furthermore, the coronary vasomotor response to incremental doses of Ach were impaired especially in the distal segments at each period, although the responses to Ach at 10-6 mol/L in the distal segment tended to improve over time from baseline to 1 month and 1 year later (-19 ± 20%, -9 ± 17%, and -5 ± 14%, respectively; p = .27). CONCLUSIONS: The morphological assessment of DCS with OCT revealed a high degree of strut coverage and apposition at 4 weeks after implantation. The impaired endothelium-dependent vasomotor response tended to improve chronologically from baseline to 1 month and 1 year later.

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. After balloon dilations, a drug-eluting stent was deployed to the lesion. Then, OCT examination was performed. At that time, fluoroscopy revealed a foreign body over the 0.014-inch guidewire in the distal RCA, which was the ring-marker of OCT catheter. As RCA blood flow was well preserved, percutaneous removal of the dislodged ring-marker was immediately attempted. At first, we tried to remove the dislodged ring-marker with the guide-extension catheter trapping technique. However, it failed and advanced balloon catheter made the dislodged ring-marker migrate more distally. Therefore, we tried the twisted wire technique with the guide-extension catheter and finally the dislodged ring-marker was removed with it. To the best of our knowledge, this is the first case report of a successful percutaneous removal of a dislodged ring-marker of OCT catheter using the twisted wire technique with a guide-extension catheter. .

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. After balloon dilation, the minimal decrease in neointimal volume was noted in type I lesions and maximal in type III lesions. In contrast, the increase in stent volume was significantly more in type I lesions than others. Neointimal tissue characterization by OCT allows us to provide useful information about the vascular response to balloon dilation, which can influence the therapeutic strategy for DES ISR lesions.

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. Neointimal tissue characteristics by OCT were categorized as homogeneous, heterogeneous with invisible strut (Type I), heterogeneous with visible strut (Type II), speckled (Type III), or heterogeneous with sharply delineated border (Type IV). RESULTS: From the development process, 23 VL-ISRs (46%) were categorized as rapid progression and 27 (54%) as gradual progression. The five categories of neointimal tissue composition significantly differed between lesions with rapid and gradual progression. Homogeneous neointima and Type IV heterogeneous neointima were observed only in lesions with gradual progression. Moreover, most Type I heterogeneous neointima was identified in lesions with gradual progression. Instead, main neointimal tissue components of lesions with rapid progression were Type II (43%) and Type III (43%) heterogeneous neointima. CONCLUSION: The progression rate of in-stent atherosclerotic changes is gradual, whereas organized thrombus could be associated with an increased risk of rapid neointimal growth. The two types of stenosis progression provide a new insight into the mechanism of VL-ISR development after DES implantation.

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. Then all tissues were also classified into six types as follows: homogeneous high-intensity tissue (type I), heterogeneous tissue with signal attenuation (type II), speckled heterogeneous tissue (type III), heterogeneous tissue containing poorly delineated region with invisible strut (type IV), heterogeneous tissue containing sharply delineated low-intensity region (type V), or bright protruding tissue with an irregular surface (type VI). The kappa value for interobserver agreement between the two observers was higher in the modified classification than in the classical classification (0.97 and 0.72, respectively). Most lesions classified as type V and VI were likely to be identified in patients on hemodialysis and located at the ostial right coronary artery. The duration from stent implantation to ISR was significantly longer in types IV and VI than in others. The incidence of stent fracture was significantly higher in types I and IV. This new modified classification enabled us to classify most ISR lesions easily with higher reproducibility. The clinical significance of neointimal restenotic tissue classification by OCT became clear while using the modified classification.

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. After one month of the nontreatment period, TD, indapamide, angiotensin II receptor antagonist valsartan, and Ca channel blocker amlodipine were administered to all patients for 3 months each in a randomized crossover manner. BP, renal function, serum UA level, and electrolytes were measured at baseline and at the end of each treatment period. Single nucleotide polymorphisms (SNPs) associated with UA elevation after treatment with indapamide were investigated by a genome-wide association study (GWAS). Indapamide significantly decreased both office and home BP levels. Treatment with indapamide also significantly reduced the estimated glomerular filtration rate and serum potassium and increased serum UA. Patients whose UA level increased more than 1 mg/dl showed significantly higher baseline office SBP and plasma glucose and showed greater decline in renal function compared with those who showed less UA increase (<1 mg/dl). Some SNPs strongly associated with an increase in UA after treatment with indapamide were identified. This study is the first report on SNPs associated with UA elevation after TD treatment. This information may be useful for the prevention of adverse effects after treatment with TD.

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. FFR was measured after (1) IC administration of nicorandil 2 mg (ICNIC2 mg); (2) continuous intravenous (IV) adenosine triphosphatase (ATP) infusion at 150 µg/kg/min (IVATP150); (3) IV ATP infusion at 210 µg/kg/min (IVATP210); (4) IC administration of 0.5 mg nicorandil during IVATP150 (ICNIC0.5 mg+IVATP150); (5) IC administration of 1 mg nicorandil during IVATP150 (ICNIC1 mg+IVATP150); and (6) IC administration of 2 mg nicorandil during IVATP150 (ICNIC2 mg+IVATP150). The average FFR values and the rate of achieving maximum hyperemia after ICNIC2 mg, IVATP150, IVATP210, ICNIC0.5 mg+IVATP150, ICNIC1 mg+IVATP150, and ICNIC2 mg+IVATP150 were 0.85±0.08, 0.89±0.08, 0.85±0.09, 0.84±0.08, 0.83±0.08, 0.83±0.08 (P<0.01), and 92%, 54%, 91%, 96%, 99%, 99% (P<0.01), respectively. The incidence of systolic aortic pressure drop, chest discomfort, and transient atrioventricular block increased in a dose-dependent manner after IV ATP infusion, but almost no adverse effects were observed after ICNIC2 mg. CONCLUSIONS: ICNIC2 mg produced a more pronounced hyperemia than continuous IV ATP, and might be the preferred method for assessment of FFR.

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. These findings may be helpful for consideration of etiology and therapeutic strategy for thrombotic complications in ET patients. .

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. Among them, 101 patients were randomly allocated for an optical coherence tomography (OCT) sub-study to assess the difference of local IS-Th formation between the two groups. In addition to standard OCT parameters, the number of IS-Th formed was counted in each target stent at 8 months. Baseline patient characteristics were not different between the 6- and 18-month groups. IS-Th was detected in 9.8% of the cases and the presence of IS-Th was not significantly different between the two groups (10.9% in 6-month vs. 9.1% in 12-month, P = 0.76). Furthermore, the number of IS-Th formed was not significantly different between the two groups. This OCT sub-study was in line with the main NIPPON study which demonstrated the non-inferiority of 6-month DAPT to 18-month DAPT. Shorter DAPT duration did not promote progressive IS-Th formation at the mid-term time point.

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. The J-CTO (Multicenter CTO Registry of Japan) score (the sum of the following 5 binary parameters: blunt proximal cap, calcification, bending >45°, and length of occluded segment >20 mm plus previously failed PCI attempt) was calculated using both CTA and conventional coronary angiography and compared. RESULTS: The median patient age was 69 years (interquartile range: 62 to 75 years), 82.4% were male, and a retrograde approach was attempted in 72 (33.0%) cases. The procedural success rate of the CTO-PCI procedures was 82.6%, and 29.4% of cases achieved 30-min wire crossing. The areas under the curve of the CTA-derived J-CTO score for predicting procedural success and 30-min wire crossing were significantly greater than those derived from conventional angiography (0.855 vs. 0.698; p < 0.001 for procedural success and 0.812 vs. 0.692; p < 0.001, for 30-min wire crossing). In addition, the areas under the curve of CTA-derived evaluations of calcification, bending, and occlusion length were significantly higher than those of derived from angiography for predicting procedural success. CONCLUSIONS: The CTA-derived J-CTO score was a more useful predictor of both procedural success and 30-min wire crossing than the J-CTO score derived from conventional angiography.

Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation.

OBJECTIVES: The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the noninferiority of short-term versus long-term dual antiplatelet therapy (DAPT) in patients with implantation of the Nobori drug-eluting stent (DES) (Terumo, Tokyo, Japan), which has a biodegradable abluminal coating. BACKGROUND: The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear. METHODS: The subjects were 3,773 patients with stable or acute coronary syndromes undergoing Nobori stent implantation. They were randomized 1:1 to receive DAPT for 6 or 18 months. The primary endpoint was net adverse clinical and cerebrovascular events (NACCE) (all-cause mortality, myocardial infarction, stroke, and major bleeding) from 6 to 18 months after stenting. Intention-to-treat analysis was performed in 3,307 patients who were followed for at least 6 months. RESULTS: NACCE occurred in 34 patients (2.1%) receiving short-term DAPT and 24 patients (1.5%) receiving long-term DAPT (difference 0.6%, 95% confidence interval [CI]: 1.5 to 0.3). Because the lower limit of the 95% CI was inside the specified margin of -2%, noninferiority of short-term DAPT was confirmed. Mortality was 1.0% with short-term DAPT versus 0.4% with long-term DAPT, whereas myocardial infarction was 0.2% versus 0.1%, and major bleeding was 0.7% versus 0.7%, respectively. The estimated probability of NACCE was lower in the long-term DAPT group (hazard ratio: 1.44, 95% CI: 0.86 to 2.43). CONCLUSIONS: Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227).

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. In this report, we describe a case involving the simultaneous occurrence of multiple SCADs in the right coronary artery and left anterior descending artery. Intravascular ultrasound helped us to confirm the diagnosis of multiple SCADs, confirm their simultaneous occurrence, and navigate the guidewire into the true lumen. .