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Aim We aimed to validate the subjective and qualitative angioscopic findings by the objective and quantitative near-infrared spectroscopic (NIRS) assessment to compensate each other's drawbacks. Methods This is a single-center prospective observational study. Patients undergoing a planned follow-up coronary angiography after percutaneous coronary intervention were prospectively enrolled from January 2018 to April 2019. The major three vessels were examined by NIRS-intravascular ultrasound, followed by coronary angioscopic evaluation. Yellow color grade on angioscopy was classified into four grades (0, white; 1, slight yellow; 2, yellow; and 3, intensive yellow) at a location of maximal lipid core burden index over 4 mm [LCBI (4)] on NIRS in each vessel. Results A total of 95 lesions in 44 patients (72.6±6.7 years, 75% male) were analyzed. LCBI (4) was significantly different among different yellow color grades by coronary angioscopy (ANOVA, p＜0.001). Positive correlation was found between angioscopic yellow color grade and LCBI (4) (beta coefficient 164.8, 95% confidence interval 122.9-206.7; p＜0.001). The best cutoff value of LCBI (4) to predict the presence of yellow plaque (yellow color grade ≥ 2) was 448 (sensitivity 79.3%, specificity 69.7%, C-statistic 0.800, 95% confidence interval 0.713-0.887, p＜0.001). Conclusion The qualitative angioscopic assessment was objectively validated by the quantitative NIRS evaluation, which would be helpful for the reinterpretation of the existing evidences of both imaging modalities.

Background Infective endocarditis (IE) lesions rarely exist only in the endocardium, except on the valves. Such lesions are usually treated with the same strategy used to treat valvular IE. Depending on the causative organisms and degree of intracardiac structure destruction, it might be cured with conservative treatment consisting of antibiotics alone. Case summary A 38-year-old woman had a continuous high fever. Echocardiography revealed a vegetation located on the endocardial side of the posterior wall of the left atrium, from the valve ring on the side of the posteromedial scallop, which was exposed to a mitral regurgitation jet. Mural endocarditis caused by methicillin-sensitive Staphylococcus aureus (MSSA) was diagnosed based on blood cultures. Splenic infarction developed despite various types of appropriate antibiotics. The vegetations increased in size over time to >10 mm. The patient underwent surgical resection and had an uneventful post-operative course. There was no evidence of exacerbation or recurrence during the post-operative outpatient follow-up visits. Discussion Even in cases of isolated mural endocarditis, infections caused by MSSA that are resistant to multiple antibiotics can be challenging to manage with antibiotics alone. Specifically, for cases of MSSA IE that show resistance to various antibiotics, early consideration should be given to surgical intervention as part of the treatment process.

Background Aortogenic embolism is one of the causes of embolic stroke of undetermined source, which can be difficult to diagnose. Methods We present the case of a 74‐year‐old male patient with a history of Bentall surgery and thoracic endovascular aortic repair who was transported to our hospital with sudden‐onset right‐sided hemiplegia and total aphasia. Magnetic resonance imaging revealed an acute left middle cerebral artery occlusion. Subsequently, an emergency mechanical thrombectomy was performed, through which the left middle cerebral artery was partially reperfused. We immediately investigated the aorta using an angioscopy. Results The angioscopy revealed a thrombus attached to an artificial blood vessel of the aorta close to the origin of the left common carotid artery. Because no other source of the embolus could be identified using electrocardiography or ultrasound, we diagnosed an aortogenic cerebral infarction by combining these findings with the pathological findings of the collected thrombus. Conclusions This is the first report that aortogenic cerebral infarction could be diagnosed using an angioscopy immediately after a cerebral artery thrombectomy.

Evidence on the efficacy and safety of low-dose direct oral anticoagulant (DOAC) in older patients with nonvalvular atrial fibrillation is still scarce. We conducted a single-center prospective registry of patients with nonvalvular atrial fibrillation treated with DOACs: the DIRECT registry (n = 2,216; follow-up, 407 ± 388 days, UMIN000033283). The whole population was divided into 2 groups: the older group (age ≥80 years, n = 548) versus the younger group (age80 years, n = 1,668). Primary safety and efficacy end points were major bleeding according to the International Society on Thrombosis and Haemostasis criteria, and stroke or systemic embolism (SSE), respectively. Effects of known risk factors and low-dose DOAC on major bleeding and SSE were assessed using a multivariable Cox proportional hazards model. In the older group, low-dose DOAC was associated with lower bleeding events (hazard ratio 0.279, 95% confidence interval 0.087 to 0.892, p = 0.031) but was not associated with increased SSE (p = 0.894). In the younger group, low-dose DOAC was neither associated with risk of major bleeding nor SSE (both p 0.05). In conclusion, in older patients, low-dose DOAC was associated with reduced risk of major bleeding without compromising its efficacy.

Peripartum cardiomyopathy (PPCM) is a left ventricular systolic dysfunction associated with heart failure (HF) in late-term pregnancy or peripartum. A 29-year-old pregnant woman with no history of cardiac disease noted lower extremity edema around 34 weeks' gestation with significant weight gain. She delivered twins via caesarean section, and the edema regressed postpartum. On postpartum day 4, however, she experienced difficulty breathing at night and was diagnosed with HF owing to PPCM. HF treatment along with cabergoline was initiated. With low prolactin blood levels, her symptoms and cardiac function improved over time. This case demonstrated the usefulness of anti-prolactin therapy with cabergoline in PPCM.

In the drug-eluting stent era, stent thrombosis is uncommon but still a life-threatening complication after percutaneous coronary intervention. There are several types of risk factors associated with stent thrombosis, which could work synergistically to produce thrombus. We report the case of subacute stent thrombosis. A 66-year-old male was hospitalized due to ST-segment elevation myocardial infarction and received emergency percutaneous coronary intervention to the obtuse marginal branch and the posterolateral artery. Five days later, he complained of chest pain. Emergency coronary angiography was performed and revealed stent thromboses in both the obtuse marginal branch and the posterolateral artery. Remarkably, in this case, stent thromboses occurred in the obtuse marginal branch and the posterolateral artery simultaneously. Finally, we overcame this situation by stenting to the main branch of left circumflex artery. We speculated the precise mechanism of simultaneously occurring two subacute stent thromboses through multiple intracoronary imaging modalities. In this case, we hypothesized that the combination of the protrusion of obtuse marginal branch stent to the main branch of left circumflex artery, blood flow turbulence due to the ulcer, and relatively high thrombogenicity of acute coronary syndrome lesion synergistically generated the thrombus.

The vessel healing process after implantation of biodegradable polymer (BP) and durable polymer (DP) everolimus-eluting stent (EES) in ST-elevation myocardial infarction (STEMI) lesions remains unclear.Methods and Results: We conducted a multicenter prospective randomized controlled trial to compare early (2 weeks) and mid-term (12 months) vascular responses after implantation of BP-EES vs. DP-EES in STEMI patients. In this prespecified subanalysis, serial coronary angioscopy (CAS) analysis was performed in 15 stents in the BP-EES arm (n=10 patients) and 14 stents in the DP-EES arm (n=10 patients). At the 2-week follow-up, there was no significant difference in the estimated marginal means of the neointimal coverage grade (primary endpoint) between the 2 arms (mean [±SE] 0.00±0.00 in both arms; P0.999). There were no significant differences between the BP-EES and DP-EES groups in the yellow color grade (1.046±0.106 vs. 0.844±0.114, respectively; P=0.201) or the presence of thrombus (77.8% vs. 88.8%, respectively; P=0.205). At 12 months, competent strut coverage, defined as yellow color grade ≤1, no thrombus, and a neointimal coverage grade ≥1 was achieved more frequently in the BP-EES than DP-EES arm (85.2% vs. 53.1%; adjusted odds ratio 2.11 [95% confidence interval 1.26-3.53]; P=0.023).Neointimal coverage 2 weeks after implantation of BP-EES and DP-EES in STEMI lesions was comparable on CAS evaluation. However, at 1 year, BP-EES was independently associated with competent strut coverage.

Background An association between uric acid (UA) and cardiovascular diseases, including heart failure (HF), has been reported. However, whether UA is a causal risk factor for HF is controversial. In particular, the prognostic value of lowering UA in patients with HF with preserved ejection fraction (HFpEF) is unclear. Methods and Results We enrolled patients with HFpEF from the PURSUIT‐HFpEF (Prospective Multicenter Observational Study of Patients With Heart Failure With Preserved Ejection Fraction) registry. We investigated whether UA was correlated with the composite events, including all‐cause mortality and HF rehospitalization, in patients with hyperuricemia and HFpEF (UA >7.0 mg/dL). Additionally, we evaluated whether lowering UA for 1 year (≥1.0 mg/dL) in them reduced mortality or HF rehospitalization. We finally analyzed 464 patients with hyperuricemia. In multivariable Cox regression analysis, UA was an independent determinant of composite death and rehospitalization (hazard ratio [HR], 1.15 [95% CI, 1.03–1.27], P =0.015). We divided them into groups with severe and mild hyperuricemia according to median estimated value of serum UA (8.3 mg/dL). Cox proportional hazards models revealed the incidence of all‐cause mortality was significantly higher in the group with severe hyperuricemia than in the group with mild hyperuricemia (HR, 1.73 [95% CI, 1.19–2.25], P =0.004). The incidence of all‐cause mortality was significantly decreased in the group with lowering UA compared with the group with nonlowering UA (HR, 1.71 [95% CI, 1.02–2.86], P =0.041). The incidence of urate‐lowering therapy tended to be higher in the group with lowering UA than in the group with nonlowering UA (34.9% versus 24.6%, P =0.06). Conclusions UA is a predictor for the composite of all‐cause death and HF rehospitalization in patients with hyperuricemia and HFpEF. In these patients, lowering UA, including the use of urate‐lowering therapy, may improve prognosis.

BACKGROUND In-stent restenosis (ISR), especially for neoatherosclerosis, is still a major problem of percutaneous coronary intervention (PCI) even in the drug-eluting stent (DES) era. AIMS The purpose of this study was to investigate the impact of neoatherosclerosis on prognosis after PCI for ISR. METHODS Between March 2009 and December 2017, 313 ISR lesions in patients undergoing an OCT-guided PCI in five hospitals were retrospectively enrolled. Neoatherosclerosis was defined as a lipid neointima or calcified neointima. We examined the association between neoatherosclerosis and the clinically driven target lesion revascularisation (CD-TLR) rates. RESULTS In 313 ISR lesions, 64 lesions (20.4%) had bare metal stents and 241 lesions (77.0%) had drug-eluting stents (DES). Among them, 47.0% of lesions (147 lesions) had neoatherosclerosis. A multivariate logistic regression analysis demonstrated that eGFR (odds ratio [OR] 0.986, 95% confidence interval [CI]: 0.974-0.998; p=0.023), the time from PCI to the ISR (OR 1.13, 95% CI: 1.06-1.22; p

Aims Frailty is associated with prognosis of cardiovascular diseases. However, the significance of frailty in patients with heart failure with preserved ejection fraction (HFpEF) remains to be elucidated. The purpose of this study was to examine the prognostic significance of the Clinical Frailty Scale (CFS) in real‐world patients with HFpEF using data from a prospective multicentre observational study of patients with HFpEF (PURSUIT‐HFpEF study). Method and Results We classified 842 patients with HFpEF enrolled in the PURSUIT‐HFpEF study into two groups using CFS. The registry enrolled patients hospitalized with a diagnosis of decompensated heart failure. Median age was 82 [interquartile range: 77, 87], and 45% of the patients were male. Of 842 patients, 406 were classified as high CFS (CFS ≥ 4, 48%) and 436 as low CFS (CFS ≤ 3, 52%). The primary endpoint was the composite of all‐cause mortality and heart failure admission. Secondary endpoints were all‐cause mortality and heart failure admission. Patients with high CFS were older (85 vs. 79 years, P

Aims: The feasibility of offline optical coherence tomography (OCT) guidance in bifurcation (with either two-dimensional or three-dimensional images) and its potential benefits have been demonstrated in retrospective studies; however, these have not yet been investigated prospectively. The aim of this trial is to determine the superiority of online three-dimensional optical frequency domain imaging (3D-OFDI)- guided stenting to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition (ISA) at the bifurcation segment. Methods and results: The OPTIMUM trial is a randomised, superiority, multicentre clinical trial. The primary endpoint of this trial is the post-procedural percentage of malapposed struts assessed by OFDI in the main branch bifurcation region after final kissing balloon dilatation (FKBD). A total of 106 patients will be randomly allocated to either 3D-OFDI guidance or angiography guidance PCI. Bifurcation lesions will be treated with a provisional single-stent strategy using the Ultimaster sirolimus-eluting stent. Patients randomised to the 3D-OFDI guidance arm will undergo OFDI assessment in the main branch (MV) after rewiring into the jailed side branch following stent implantation, while in the angiography guidance arm re-crossing of a wire into the side branch will be performed using conventional fluoroscopic/angiographic guidance. In patients in the 3D-OFDI guidance arm, if the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm the re-crossing position. The proximal optimisation technique and FKBD are mandatory in this trial. The study will provide a 90% power to show superiority of 3D-OFDI guidance PCI compared with angiography-guided PCI. Conclusions: The OPTIMUM trial will be the first prospective, randomised trial to evaluate the efficacy and safety of online 3D-OFDI-guided PCI in bifurcation lesions. ClinicalTrials.gov Identifier: NCT02972489.

Background Modification of arrhythmogenic substrates with extensive ablation comprising linear and/or complex fractional atrial electrogram ablation in addition to pulmonary vein isolation (PVI‐plus) can theoretically reduce the recurrence of atrial fibrillation. The DR‐FLASH score (score based on diabetes mellitus, renal dysfunction, persistent form of atrial fibrillation, left atrialdiameter >45 mm, age >65 years, female sex, and hypertension) is reportedly useful for identifying patients with arrhythmogenic substrates. We hypothesized that, in patients with persistent atrial fibrillation, the DR‐FLASH score can be used to classify patients into those who require PVI‐plus and those for whom a PVI‐only strategy is sufficient. Methods and Results This study is a post hoc subanalysis of the a multicenter, randomized controlled, noninferiority trial investigating efficacy and safety of pulmonary vein isolation alone for recurrence prevention compared with extensive ablation in patients with persistent atrial fibrillation (EARNEST‐PVI trial). This analysis focuses on the relationship between DR‐FLASH score and the efficacy of different ablation strategies. We divided the population into 2 groups based on a DR‐FLASH score of 3 points. A total of 469 patients were analyzed. Among those with a DR‐FLASH score >3 (N=279), the event rate of atrial arrhythmia recurrence was significantly lower in the PVI‐plus arm than in the PVI‐only arm (hazard ratio [HR], 0.45 [95% CI, 0.28–0.72]; P P =0.795). There was significant interaction between patients with a DR‐FLASH score >3 and DR‐FLASH score ≤3 ( P value for interaction=0.020). Conclusions The DR‐FLASH score is a useful tool for deciding the catheter ablation strategy for patients with persistent atrial fibrillation. Registration URL: https://clinicaltrials.gov ; Unique identifier: NCT03514693.

Background The respiratory tract is the most commonly affected organ system in sarcoidosis. Purely extrapulmonary sarcoidosis is rare. There have been no reports of extrapulmonary sarcoidosis with lesions only in the heart and guts. Case summary A 19-year-old male was admitted for chest symptoms accompanied by remarkably elevated troponin T and creatinine kinase levels. Electrocardiogram (ECG) showed sinus rhythm with a right bundle branch block, broad ST segment elevation, and abnormal Q waves. Endoscopic biopsy revealed granuloma formation in the transverse colon. Based on multimodal imaging, we made a clinical diagnosis of extrapulmonary sarcoidosis involving only the heart and guts. One year of immunosuppressive therapy with prednisolone resolved the inflammation in the guts but not in the heart. He experienced runs of sustained ventricular tachycardia with loss of consciousness and was admitted to our hospital again. The addition of methotrexate markedly reduced cardiac accumulation of fluorodeoxyglucose. No life-threatening ventricular arrhythmias have been recorded afterwards. Discussion This unusual case of cardiac sarcoidosis not only involved rare lesions only in the heart and guts but also presented with ST elevation on ECG. This case suggests that the gastrointestinal tract is a site of effective antigen capture outside of the respiratory tract that can affect the heart.

Although embolic stroke accounts for most cerebral infarction, examinations to identify the embolic source have been insufficient. Nonobstructive general angioscopy (NOGA) has developed to allow the detailed observation of atheromatous changes of the aorta.The purpose of this study was to clarify the importance of the aortogenic mechanism in the development of ischemic stroke.We examined 114 consecutive patients whose aorta was observed by NOGA and who subsequently underwent brain magnetic resonance imaging to detect ischemic stroke lesions. In the evaluation of the aorta, the presence and location of spontaneously ruptured aortic plaque (SRAP) were determined. The aorta was observed from the origin to the arch (proximal aorta [PAo]) and the proximal descending aorta.Forty-nine of 114 patients had SRAP observed by NOGA. Among these, 24 had SRAP in the PAo, and 43 had SRAP in the descending aorta. Thirty-three patients had ischemic stroke lesions, including 6 with a clinical neurologic deficit. The frequency at which SRAP was detected in these patients was significantly higher in comparison to 81 patients without ischemic stroke (69% vs 33%;In the treatment of ischemic stroke, attention should be paid to SRAP, especially that in the PAo. (STROKE-NOGA [SponTaneously Ruptured aOrtic plaques as a potential cause of embolic stroKEs visualized by Non-Obstructive General Angioscopy] Study; UMIN000034588).

The present study aimed to assess the associations between dosing of DOACs and outcomes in patients with non-valvular atrial fibrillation (NVAF). Direct oral anticoagulants (DOACs) require dose adjustment according to patient or clinical factors for patients with NVAF. We conducted a single-center prospective registry of NVAF patients with DOACs: DIRECT registry (UMIN000033283). In the present analysis, we categorized the patients (n = 2,216) into 5 groups: appropriate standard-dose (n = 907, 40.9%), appropriate low-dose (n = 833, 37.6%), overdose (n = 117, 5.3%), underdose (n = 338, 15.3%), and contraindication (n = 21, 0.9%). The efficacy endpoints were major adverse cardiovascular event (MACE: a composite of all-cause death, myocardial infarction, and stroke/systemic embolism) and its individual components. The safety end points were adverse bleeding events including clinically significant bleeding, major bleeding, and gastro-intestinal bleeding. All NVAF patients treated with DOACs in our institution from 2011 to 2017 were enrolled (71.6 ± 10.8 years, 36.4% female, follow-up duration: 407.2 ± 388.3 days). Appropriate low-dose group were older, more likely female, had a higher CHADS2 and ORBIT scores than the other groups. MACE (7.4%) and clinically significant bleeding (26.2%) occurred most frequently in the appropriate low-dose group. However, after adjustment for various confounders, appropriate dose reduction of DOAC showed 35.4% risk reduction of clinically significant bleeding (adjusted hazard ratio 0.646, 95% CI [0.469 to 0.890], p = 0.007) with no impairment of efficacy end points. In the real-world Asian clinical practice, four fifths of the NVAF patients received appropriate dose of DOACs. Appropriate dose reduction was associated with decrease in clinically significant bleeding and no significant impairment in efficacy end points.

A 76-year-old man developed repeated fulminant myocarditis in a short period, and immunosuppressive therapy was remarkably effective. A pathologic evaluation showed that inflammatory cells had infiltrated the myocardium. Not only invasion of inflammatory cells but also the formation of lymphoid follicle was noted. Chronic myocardial inflammation was proven, but cardiac sarcoidosis was negative according to the results of various examinations. This is the first report of recurrent autoimmune myocarditis with a lymphoid follicle in the myocardium. These findings may suggest a novel pathogenesis of myocarditis.

Background: Little is known about factors associated with elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) at the convalescent stage and their effects on 1-year outcomes in patients with heart failure with preserved ejection fraction (HFpEF). Methods and Results: This study included 469 patients with HFpEF. Elevated NT-proBNP was defined as the highest quartile. The first 3 quartiles (Q1-Q3) were combined together for comparison with the fourth quartile (Q4). Median NT-proBNP concentrations in Q1-Q3 and Q4 were 669 and 3,504 pg/mL, respectively. Multivariate logistic regression analysis revealed that low albumin (odds ratio [OR] 2.44; 95% confidence interval [CI] 1.35-4.39; P=0.003), low estimated glomerular filtration rate (OR 5.83; 95% CI 3.46-9.83; P

Background Non-obstructive general angioscopy is a powerful modality for detecting areas in the aorta with vulnerable plaque, which are difficult to visualize using conventional diagnostic tools such as computed tomography (CT). The aim of the present study was to clarify the efficacy and usefulness of aortic angioscopy in patients with chronic type B aortic dissection scheduled for thoracic endovascular repair (TEVAR). Methods Ten patients with chronic type B aortic dissection who underwent elective TEVAR were enrolled. Before starting the stent graft procedure, the aortic intima was observed by use of non-obstructive general angioscopy. Based on those findings, the range of the stent graft position was confirmed. Results In all patients, observations of the aortic intima with non-obstructive general angioscopy from a point just proximal of the descending aorta to the iliac artery were successful. At the proximal site, an entry site or ulcer-like projection was detected in all patients, while a small intimal tear or entry, or an irregular intima surface with a salmon-pink color were seen in some cases. In contrast, preoperative CT did not detect any such findings in the same locations. After confirming the position of the abnormal intima, we determined the position of the distal end of the stent graft. No complications considered to be related to aortic angioscopy were noted. Conclusions Non-obstructive general angioscopy is useful for observing the condition of the aortic intima, revealing abnormal conditions, and confirming a normal aortic intima in patients with chronic type B aortic dissection. This modality may play an important role in determining the precise position of a stent graft for a TEVAR procedure.

The early and mid-term arterial healing profile of biodegradable polymer-coated everolimus-eluting stents (BP-EES) is unclear, especially in ST-segment elevation myocardial infarction (STEMI) culprit lesions. This study aimed to compare early- and mid-term arterial healing between durable polymer-coated everolimus-eluting stents (DP-EES) and BP-EES in STEMI patients. In a prospective, multicenter, non-inferiority trial, STEMI patients were randomized to receive BP-EES (n = 60) or DP-EES (n = 60). The primary endpoint of this study was the mean percentage of covered struts (%covered struts) on FD-OCT 2 weeks post-PCI. Key secondary endpoints included the percentage of uncovered struts, frequency of abnormal intra-stent tissue, and percentage of malapposed struts by FD-OCT 2 weeks and 12 months post-PCI. They underwent serial frequency-domain optical coherence tomography (FD-OCT) evaluations immediately after percutaneous coronary intervention, and at 2 weeks and at 12 months after the procedure. The primary endpoint of %covered struts at 2 weeks was 71.4% in BP-EES and 72.3% in DP-EES [risk difference - 0.94%, lower limit of one-sided 95% confidence interval (CI) - 5.6; P

Background Stent thrombosis (ST) remains a significant medical issue. In particular, longer‐term mortality and clinical predictors after ST occurrence have yet to be elucidated. Methods and Results This was a multicenter, retrospective, observational study. A total of 187 definite ST cases from January 2008 to December 2017 were enrolled, and the long‐term clinical outcomes were investigated. The primary outcome measure was the cumulative mortality after ST occurrence. In addition, independent predictors of mortality were assessed. Among the stent types causing ST, bare‐metal stent, first‐generation drug‐eluting stent, second‐generation drug‐eluting stent, and third‐generation drug‐eluting stent comprised 31.0%, 19.3%, 36.9%, and 6.4% of cases, respectively. Median duration from stent implantation to ST was 680.5 (interquartile range, 33.8–2450.5) days. Cumulative mortality was 14.6%, 17.4%, 21.2%, 24.4%, and 33.8% at 1, 2, 3, 5 and 10 years, respectively. The cumulative mortality did not significantly differ by type of stent, and mortality of late ST was higher than that of early ST and very late ST; however, it did not reach statistical significance after the multivariate analysis. Independent predictors of mortality were hemodialysis (hazard ratio [HR], 7.80; 95% CI, 3.07–19.81; P P =0.008), culprit lesions in the left coronary artery (HR, 2.77; 95% CI, 1.10–6.96; P =0.030), and peak creatine kinase (HR, 1.017; 95% CI, 1.011–1.022; P Conclusions The 10‐year cumulative mortality after ST reached 33.8%. Close follow‐up is thus mandatory for patients with ST, especially with hemodialysis, culprit lesions in the left main trunk and left coronary artery, and high peak creatine kinase.

In patients with multivessel disease (MVD), functional information on lesions improves the prognostic capability of the SYNTAX score. Quantitative flow ratio (QFR®) is an angiography-derived fractional flow reserve (FFR) that does not require a pressure wire or pharmacological hyperemia. We aimed to investigate the feasibility of QFR-based patient information in Heart Teams' discussions to determine the optimal revascularization strategy for patients with MVD. We hypothesized that there is an acceptable agreement between treatment recommendations based on the QFR approach and recommendation based on the FFR approach. The DECISION QFR study is a prospective, multicenter, randomized controlled trial that will include patients with MVD who require revascularization. Two Heart Teams comprising cardiologists and cardiac surgeons will be randomized to select a revascularization strategy (percutaneous coronary intervention or coronary artery bypass graft) according to patient information either based on QFR or on FFR. All 260 patients will be assessed by both teams with reference to the anatomical and functional SYNTAX score/SYNTAX score II 2020 derived from the allocated physiological index (QFR or FFR). The primary endpoint of the trial is the level of agreement between the treatment recommendations of both teams, assessed using Cohen's κ. As of March 2022, the patient enrollment has been completed and 230 patients have been discussed in both Heart Teams. The current trial will indicate the usefulness of QFR, which enables a wireless multivessel physiological interrogation, in the discussions of Heart Teams to determine the optimal revascularization strategy for MVD.

Background Non-anastomotic thoracic aortic graft rupture is extremely rare and difficult to diagnose. Non-obstructive general angioscopy can help monitor the aortic intima and detect the locations of abnormal findings, while aortic angioscopy can detect vulnerable plaques in the aorta, which are difficult to visualize using conventional diagnostic methods. Herein, we report the case of a patient with non-anastomotic thoracic aortic graft rupture diagnosed using non-obstructive aortic angioscopy. Case presentation An 85-year-old man who had undergone total arch replacement 5 years prior complained of chest pain. Emergent contrast-enhanced computed tomography (CT) revealed an intra-mediastinal hematoma around the vascular graft of the ascending aorta and angiography revealed pooling of contrast medium on the dorsal side of the vascular graft. We suspected extravasation of the thoracic vascular graft. Aortic angioscopic examination revealed a red vascular graft defect that matched extravasation at the contralateral level of the prosthetic left common carotid artery branch. Subsequently, non-anastomotic thoracic aortic graft rupture was diagnosed. The patient underwent a two-debranching thoracic endovascular aortic repair (Zone 0) with a right subclavian artery-left common carotid artery-left subclavian artery bypass. Postoperative angiography revealed disappearance of the extravasation from the graft rupture site, patent grafted vessels with flow, and no endoleak. Follow-up CT at 6 months postoperatively showed no extravasation. Conclusions To our knowledge, this is the first report of non-anastomotic thoracic aortic graft rupture detected using non-obstructive aortic angioscopy. Aortic angioscopy can help establish a definitive diagnosis in patients with aortic graft rupture.

IntroductionThe optimal antithrombotic strategy for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) is uncertain. For patients with non-AF, many trials are now evaluating short 1-month dual antiplatelet therapy. In patients with AF undergoing PCI, in contrast, short dual therapy (P2Y12 inhibitor +direct oral anticoagulant (DOAC)) has not yet been evaluated.Methods and analysisThe OPTIMA-AF trial (OPTIMAl antiplatelet therapy in combination with direct oral anticoagulants in patients with non-valvular Atrial Fibrillation undergoing percutaneous coronary intervention with everolimus-eluting stent) is an investigator-initiated, open-label, nationwide, multicentre, prospective, randomised controlled trial. The primary objective is to compare the efficacy and safety of short dual therapy (1-month DOAC +P2Y12 inhibitor followed by DOAC monotherapy) against long dual therapy (12-month DOAC +P2Y12 inhibitor followed by DOAC monotherapy) in the treatment of AF subjects undergoing PCI. The primary efficacy endpoint is a composite of death or thromboembolic events (myocardial infarction, definite stent thrombosis, stroke or systemic embolism) at 365 days; and the primary safety endpoint is bleeding (International Society on Thrombosis and Haemostasis major or clinically relevant non-major bleeding) at 365 days. This trial is intended to show the non-inferiority of short dual therapy versus long dual therapy in terms of the primary efficacy endpoint and show superiority in terms of the primary safety endpoint. A total of 1090 subjects will be randomised in a 1:1 ratio at approximately 60 sites.Ethics and disseminationThis study received approval from the Certified Review Board of Osaka University (a certified research ethics committee by the Japanese Clinical Research Act). The findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberJapan Registry of Clinical Trials: jRCTs051190053; Pre-results.

ObjectivesThe severity of diastolic dysfunction is assessed using a combination of several indices of left atrial (LA) volume overload and LA pressure overload. We aimed to clarify which overload is more associated with the prognosis in patients with heart failure and preserved ejection fraction (HFpEF).SettingA prospective, multicenter observational registry of collaborating hospitals in Osaka, Japan.ParticipantsWe enrolled hospitalised patients with HFpEF showing sinus rhythm (men, 79; women, 113). Blood tests and transthoracic echocardiography were performed before discharge. The ratio of diastolic elastance (Ed) to arterial elastance (Ea) was used as a relative index of LA pressure overload.Primary outcome measuresAll-cause mortality and admission for heart failure were evaluated at >1 year after discharge.ResultsIn the multivariable Cox regression analysis, Ed/Ea, but not LA volume index, was significantly associated with all-cause mortality or admission for heart failure (HR 2.034, 95% CI 1.059 to 3.907, p=0.032), independent of age, sex, and the serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level. In patients with a higher NT-proBNP level, the effect of higher Ed/Ea on prognosis was prominent (p=0.015).ConclusionsEd/Ea, an index of LA pressure overload, was significantly associated with the prognosis in elderly patients with HFpEF showing sinus rhythm.Trial registration numberUMIN000021831.

We aimed to quantitatively assess a possible difference of the neointimal quality between biodegradable polymer- (BP-) and durable polymer drug-eluting stents (DP-DESs). We conducted a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful OCT examination at planned 3-month follow-up after DES implantation were analyzed. Study population was divided into 2 groups, BP-DES versus DP-DES groups. We evaluated standard OCT variables, coverage percent, and the quantitative light property values including light intensity, attenuation, and backscatter. We performed OCT analyses of 121 lesions in 98 patients (BP-DES 55 lesions in 51 patients vs. DP-DES 66 lesions in DP-DES 53 patients). Lesion and procedural characteristics were overall well-balanced between both groups. At 3-month follow-up, neointimal thickness (BP-DES 49.3 [38.2, 57.7] µm versus DP-DES 54.7 [45.1, 70.7] µm, p = 0.059) and coverage percent (BP-DES 94.5 [89.8, 97.0]% vs. DP-DES 95.8 [91.1, 98.1]%, p = 0.083) did not significantly differ. Light intensity of superficial neointima in the BP-DES was lower than that in the DP-DES, whereas that of deep neointima did not differ between both groups. Both superficial and deep neointima of the BP-DES presented significantly lower light attenuation and backscatter than those of the DP-DES did. Almost complete coverage at 3 months in both contemporary BP- and DP-DES would support the ultra-short DAPT strategy in the upcoming decade. Nevertheless, there was a significant difference in the neointimal characteristics on OCT light property 3 months after BP- versus DP-DES implantation. Trial Registration UMIN000033009.

Clinical outcomes of the real-world Asian nonvalvular atrial fibrillation (NVAF) patients treated with DOAC and the incremental bleeding risk of add-on antiplatelet therapy to direct oral anticoagulants (DOACs) are still to be investigated. We conducted a single-center prospective observational registry of NVAF patients treated with DOACs: the DIRECT registry (UMIN000033283). All patients with NVAF (N = 2216) who were users of dabigatran (N = 648), rivaroxaban (N = 538), apixaban (N = 599), or edoxaban (N = 431) from June 2011 to November 2017 were enrolled (71.6 ± 10.8 years, 36.4% female, follow-up duration: 407.2 ± 388.3 days). No add-on antiplatelet agent was prescribed to 1,739 patients, while single and dual antiplatelet therapy (SAPT and DAPT) in combination with DOAC were prescribed to 411 and 66 patients, respectively. The primary safety endpoint was any bleeding which was defined as a composite of major bleeding according to the International Society on Thrombosis and Hemostasis criteria and clinically relevant non-major bleeding. Patients treated with add-on antiplatelet agents irrespective of SAPT or DAPT had a higher any-bleeding risk than those without (hazard ratio: 1.42; 95% confidence interval 1.16-1.74, p = 0.001). Multivariate adjusted hazard of add-on antiplatelet therapy was not statistically significant (hazard ratio: 1.20; 95% confidence interval 0.94-1.53, p = 0.147). In conclusion, NVAF patients treated with antiplatelet agents and DOAC had a significantly higher bleeding risk than those using DOAC only. However, after adjustment of patients' background, add-on antiplatelet therapy to DOAC itself did not influence to a bleeding risk.

The purpose of this study was to evaluate the vessel healing status 3 months after stent implantation of bioresorbable-polymer drug-eluting stents (BP-DESs) in comparison with durable-polymer DESs (DP-DESs) by angioscopy. Study design was a single-center all-comer prospective cohort study: the RESTORE registry (UMIN000033009). All patients who received successful angioscopic examination at planned 3-month follow-up after the DES implantation in the native coronary artery were enrolled. We evaluated main, maximum, minimum strut coverage grades and coverage heterogeneity score defined as a difference between maximum and minimum coverage grades. All lesions were divided into three segments: proximal, mid, and distal segments. A total of 108 patients (66.6 ± 10 years) with 124 lesions were analyzed (BP-DES 57 patients 61 lesions 226 segments vs. DP-DES 57 patients 63 lesions 203 segments; six patients had both BP-DES and DP-DES). Patient and lesion demographics, procedural characteristics were well balanced. Main coverage grade (mean ± standard error; 1.08 ± 0.02 vs. 1.05 ± 0.03, p = 0.354) and minimum coverage grade (1.00 ± 0.00 vs. 1.00 ± 0.00, p > 0.999) were not significantly different between BP-DES and DP-DES groups. Maximum coverage grade was significantly higher in the BP-DES than in the DP-DES (1.45 ± 0.04 vs. 1.35 ± 0.04, p = 0.049). Coverage heterogeneity score did not differ between BP-DES and DP-DES groups (1.05 ± 0.07 vs. 0.90 ± 0.07, p = 0.162). At 3-month follow-up, the current BP-DES had higher maximum stent coverage than the contemporary DP-DES, while main and minimum coverage grades and heterogeneity of the neointimal coverage were comparable. Further prospective randomized trials should be conducted to evaluate the clinical significance of the present imaging results.

BACKGROUND Although diastolic dysfunction is important pathophysiology in heart failure with preserved ejection fraction (HFpEF), its prognostic impact in HFpEF patients, including those with atrial fibrillation (AF), remains to be elucidated.Methods and Results:We included the data for 863 patients (321 patients with AF) registered in a prospective multicenter observational study of patients with HFpEF. Patients were divided into 3 groups according to the 2016 ASE/EACVI recommendations. The primary endpoint was a composite of all-cause death or HF rehospitalization. Median age was 83 years, and 55.5% were female. 196 (22.7%) were classified with normal diastolic function (ND), 253 (29.3%) with indeterminate (ID) and 414 (48.0%) with diastolic dysfunction (DD). The primary endpoint occurred more frequently in patients with DD than in those with ND or ID (log-rank P

Background Percutaneous coronary intervention with drug-coated balloon (DCB) angioplasty is one of the standard treatments for lesions with in-stent restenosis (ISR). However, the efficacy of additional excimer laser coronary angioplasty (ELCA) for ISR lesions prior to DCB angioplasty has not been elucidated. The aims of this study were to elucidate the efficacy of ELCA prior to DCB treatment for ISR and the difference in effectiveness by lesion morphology. Methods This was a multicenter, retrospective observational study. We enrolled 208 ISR lesions from 204 patients which were treated with DCB angioplasty under optical coherence tomography (OCT) guidance. We compared the acute gain evaluated by quantitative coronary angiography and clinically driven target lesion revascularization (CD-TLR) between the ELCA (+) (47 lesions) and ELCA (−) (161 lesions) groups. Results The acute gain was significantly larger in the ELCA (+) group (1.51 ± 0.47 mm versus 1.29 ± 0.52 mm, P = 0.012). Even after adjustment for comorbidities, the ELCA had a significant impact on the acute gain (coefficient 0.24 [95% confidence interval 0.067–0.41]). In addition, the ELCA usage was significantly associated with larger acute gain in lesions with a homogeneous pattern, although there was no association between ELCA and either the heterogeneous pattern or neoatherosclerosis. The freedom from CD-TLR was not different between the ELCA (−) and ELCA (+) groups (hazard ratio 0.53 [0.24–1.18]). Conclusions ELCA had a significant impact on the larger acute gain in ISR lesions, especially may did in those with a homogenous pattern, while it did not impact CD-TLR significantly.

An 80-year-old man presented to our hospital complaining of loss of appetite. During the medical examination, he developed variant angina accompanied with heart failure. Oral calcium channel blocker therapy controlled his variant angina, but medical management of heart failure became increasingly difficult due to gradually increasing pericardial effusion, and pericardiocentesis leading to the diagnosis of effusive-constrictive pericarditis (ECP). Here, we report a rare case of idiopathic pericarditis caused variant angina with already having endothelial dysfunction and eventually developed ECP.

Background: The association between direct oral anticoagulant (DOAC) dose and clinical outcomes when used with antiplatelets still remains to be investigated. Methods and Results: We conducted a prospective registry of non-valvular atrial fibrillation (AF) patients with DOAC: the DIRECT registry (n=2,216; follow-up, 407±388 days). We analyzed patients taking standard dose (n=907) and off-label reduced dose (n=338) DOAC in this sub-analysis. These patients were further stratified by add-on antiplatelets. Because DOAC dose was not randomly selected, potential confounding factors were eliminated through a propensity score-matching technique. The primary endpoint was clinically significant bleeding. The secondary endpoint was major adverse cardiovascular events (MACE; composite of all-cause death, all myocardial infarction, and stroke/systemic embolism). In patients with DOAC only/DOAC+antiplatelets, we successfully matched 212/62 patients who received off-label reduced dose DOAC with 212/62 standard dose patients. Off-label DOAC dose reduction did not have a significant impact on bleeding (HR, 1.123; 95% CI: 0.730–1.728, P=0.596) or MACE (HR, 1.107; 95% CI: 0.463–2.648, P=0.819) in patients with DOAC only, whereas in patients with add-on antiplatelets, off-label dose reduction significantly reduced bleeding (HR, 0.429; 95% CI: 0.212–0.868, P=0.019) without increasing MACE (HR, 2.205; 95% CI: 0.424–11.477, P=0.348). Conclusions: Reduced DOAC dose in combination with antiplatelet agents was associated with fewer bleeding complications than standard-dose therapy with no reduction in efficacy.

Background: Sex-related difference in non-valvular atrial fibrillation (NVAF) patients treated with direct oral anticoagulants (DOACs) is still to be investigated. We aimed to investigate sex difference in patient characteristics and clinical outcomes of the NVAF patients treated with DOAC in the real-world Japanese clinical practice. Methods and results: We conducted a single-center prospective observational registry of NVAF patients treated with DOACs: the DIRECT registry (women, N = 806; men, N = 1410; follow-up duration, 407 ± 388 days). In the present study, all patients were stratified by sex. Women had significantly higher age, lower body weight, lower hemoglobin, lower creatinine clearance, and a higher bleeding risk estimate (ORBIT score) and higher thromboembolic risk estimates (CHADS2 score and CHA2DS2VAS score) than men. Albeit the different bleeding risk estimates by the ORBIT score between both sexes, the Kaplan–Meier estimates of bleeding events were similar between both sexes (Log-rank test P = 0.152 for clinically significant bleeding, and P = 0.122 for major bleeding). The Kaplan–Meier estimated 2 year rate of stroke/systemic embolism was higher in women than in men (4.9 ± 1.3% vs. 2.3 ± 0.6%, Log-rank test P = 0.048). Conclusions: Our real-world study of patients treated with DOAC showed that Japanese women experienced comparable bleeding events as compared to men despite the higher bleeding risk estimates. The higher thromboembolic risk estimates in women than in men translated into the higher thromboembolic event rates. Clinical trials identifier: UMIN000033283

We aimed to assess a possible difference of the neointimal coverage status and its quality after implantation of the current-generation metallic stents in patients with acute coronary syndrome (ACS) vs. stable coronary lesions (non-ACS). We comprehensively analyzed three prospective single-center observational studies RESTORE (UMIN000033009), HEAL-BioFreedom (UMIN000029692), and HEAL-BioFreedom ACS (UMIN000034769). All patients who received successful optical coherence tomography (OCT) examination at planned 3-month follow-up after stent implantation were analyzed. Study population was divided into two groups, ACS vs. non-ACS groups. We evaluated standard OCT variables, coverage percent, and the quantitative light property values including light intensity, attenuation, and backscatter of neointima. A total of 177 lesions from 154 patients (ACS 44 lesions vs. non-ACS 133 lesions) were analyzed. At 3-month follow-up, coverage percent (ACS 91.5 +/- 9.5% vs. non-ACS 91.8 +/- 9.0%, P = 0.722) and neointimal thickness (ACS 59.5 +/- 32.3 mu m vs. non-ACS 58.2 +/- 32.3 mu m, P = 0.760) did not significantly differ. Light property values were similar between both groups (light intensity 159.29 +/- 72.20 vs. 159.45 +/- 63.78, P = 0.654; light attenuation 0.88 +/- 0.26 vs. 0.87 +/- 0.24 m(-1), P = 0.988; backscatter 4.86 +/- 0.58 vs. 4.83 +/- 0.57, P = 0.812). The similarity of the neointimal quality in ACS and non-ACS patients was consistent across the 6 different types of current-generation metallic stents (P for interaction > 0.05). Our findings suggested the comparable neointimal characteristics 3 months after implantation of the current-generation metallic stents in patients with ACS and stable coronary lesions by quantitative OCT methodology.

Background Non-obstructive general angioscopy (NOGA) can be used to diagnose aortic atherosclerotic plaques. We examine the association between the number of aortic plaques detected by NOGA and the risk of subsequent cardiovascular events. Methods The Evaluation of AtheroScleroTic and rupture events by Non-Obstructive General Angioscopy (EAST-NOGA) was a prospective cohort study of patients with suspected coronary artery disease who underwent NOGA. Results Of the 577 patients who underwent NOGA, 532 (92%) completed the follow-up (median follow-up: 13 months, interquartile range: 12-16). The median number of plaques per person was 6 (interquartile range: 3-12), and 567 (98%) had at least one aortic plaque. During the 13-month follow-up, 38 (7.1%) patients had a primary composite endpoint [including cardiovascular death, myocardial infarction, stroke, peripheral artery disease (PAD), or worsening renal function], which was significantly associated with chronic kidney disease, a history of PAD, a lower hemoglobin level, and large numbers of aortic plaques [11 (5-17) vs. 6 (2-11), p = 0.003]. A receiver operating characteristic curve analysis for the number of aortic plaques predicting composite endpoints revealed that the cut-off value of aortic plaques was 12. After multivariate adjustment, the presence of ≥12 aortic plaques remained a significant predictor for composite endpoint events (hazard ratio 2.53, 95% confidence interval 1.26-5.04, p = 0.010). Conclusions The number of aortic plaques detected by NOGA may predict subsequent clinical events.

Background: Although aortogenic stroke is recognized as one of the embolic strokes, examinations to identify the embolic source has been insufficient. Recently, non-obstructive general angioscopy (NOGA) has developed to be applied to observe atheromatous change of aorta. NOGA can help visualize the in vivo surface of aorta and plaques in detail. Methods: We examined the 114 consecutive patients whose aorta was observed by NOGA and ischemic stroke lesions were searched by brain MRI. The evaluation of the aortic observation by NOGA was defined as the presence and location of spontaneous ruptured aortic plaque (SRAP). The ascending aorta and arch were defined as proximal aorta (PAo), which ranges from the origin of the aorta to the left subclavian artery. The segment from the left subclavian artery to the height of the 5th thoracic vertebra was defined as the proximal descending aorta (DAo). Findings: Forty-nine of 114 patients included in the study had SRAP observed by NOGA. Of those, 24 patients had SRAP in PAo, and 43 had SRAP in DAo. Patients with ischemic stroke had a significantly higher frequency of SRAP detection than those without ischemic stroke (69% vs. 33%, p

The relationship between general obesity or abdominal obesity (abdominal circumference of ≥85 cm in men and ≥ 90 cm in women) and the heart-to-mediastinum ratio (HMR), a measure of cardiac sympathetic innervation, on cardiac iodine-123-metaiodobenzylguanidine scintigraphy (MIBG) in patients with heart failure with preserved ejection fraction (HFpEF) has not been clarified. A total of 239 HFpEF patients with both MIBG and abdominal circumference data were examined. We divided these patients into those with abdominal obesity and those without it. In the cardiac MIBG study, early phase image was acquired 15–20 min after injection, and late phase image was acquired 3 h after the early phase. A HMR obtained from a low-energy type collimator was converted to that obtained by a medium-energy type collimator. Early and late HMRs were significantly lower in those with abdominal obesity, although washout rates were not significantly different. The incidence of patients with early and late HMRs

Background: The risks of bleeding and cardiovascular events in high bleeding risk (HBR) Japanese patients undergoing percutaneous coronary intervention (PCI) while receiving single-antiplatelet therapy (SAPT) remains unknown. We aimed to evaluate the frequency of bleeding and cardiovascular events associated with prasugrel monotherapy after short-term dual-antiplatelet therapy (DAPT) in Japanese HBR patients after PCI. Methods and Results: The PENDULUM mono study was a multicenter, non-interventional, prospective registry (n=1,173). The primary endpoint was the cumulative incidence of clinically relevant bleeding (CRB; Bleeding Academic Research Consortium types 2, 3, and 5) from 1 to 12 months after PCI. Secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE). The proportion of patients who received prasugrel monotherapy at 12 months after PCI was 79.7%, and no cases of stent thrombosis were observed among these patients. The cumulative incidence of CRB was 3.2% from 1 to 12 months after PCI; that of MACCE was 3.8%. Severe anemia, chronic kidney disease, oral anticoagulant use at discharge, and heart failure were significantly associated with CRB. Conclusions: Among HBR patients undergoing PCI who were not suitable for concomitant aspirin and were scheduled for prasugrel monotherapy, most patients were on prasugrel monotherapy after DAPT. Cumulative incidences of CRB and MACCE after periprocedural period were 3.2% and 3.8%, respectively, and no cases of stent thrombosis were reported. SAPT might be a suitable alternative to DAPT.

Background Diabetes mellitus (DM) is a strong risk factor for major cardiac and cerebrovascular events. In particular, coronary artery disease with DM is often complicated with complex lesions. Drug-eluting stents (DES) are mainly used for these lesions, and dual-antiplatelet therapy (DAPT) has been used to prevent stent thrombosis. Early arterial healing after DES implantation may enable short DAPT strategy. However, the impact of DM on the arterial healing in the early phase has not been elucidated to date. Purpose We evaluated the arterial healing in the early phase after DES implantation using coronary angioscopy (CAS) and compared the findings between DM and non-DM patients. Methods This study was a multicenter retrospective observational study. We analyzed CAS findings of 337 lesions from 270 patients which were evaluated 3 to 5 months after DES implantation. Patients were divided into two groups: DM (149 lesions in 118 patients) versus non-DM groups (188 lesions in 152 patients). We assessed neointimal coverage (NIC) grades (maximum, minimum and dominant), thrombus adhesion and maximum yellow color of plaque underneath the stent. NIC was graded as follows: grade 0, stent struts were not covered; grade 1, stent struts were covered by thin layer; grade 2, stent struts were buried under neointima. Yellow color was graded as follows: grade 0, white; grade 1, light yellow; grade 2, yellow; grade 3, intensive yellow. Results Minimum NIC coverage grade was lower in DM group than in non-DM group (P=0.002, Figure), while maximum and dominant NIC coverage grades were similar between them (P=0.94 and P=0.59, respectively). Thrombus adhesion (44.3% versus 38.8%, P=0.32) and maximum yellow color grade (P=0.78) were also similar between DM and non-DM groups. Even after the adjustment by the confounding factors such as follow-up duration and primary disease of acute coronary syndrome, DM was an independent factor predicting grade 0 of minimum NIC (odds ratio [OR] 1.83 [95% confidence interval 1.11–3.03], P=0.019). Conclusion DM patients showed less covered struts than non-DM patients 3 to 5 months after DES implantation, suggesting that the recent ultra-short DAPT strategy might not be easily applicable to DM patients. Minimum neointimal coverage grade Funding Acknowledgement Type of funding source: None

Background Early arterial healing after drug-eluting stent (DES) implantation may enable short dual-antiplatelet therapy (DAPT) strategy. The impact of diabetes mellitus (DM) on this healing has not been elucidated. We used coronary angioscopy (CAS) to compare intravascular status of DM and non-DM patients in the early phase after DES implantation. Methods This study was a multicenter retrospective observational study. We analyzed CAS findings of 337 lesions from 270 patients evaluated 3–5 months after DES implantation. We divided the lesion into two groups: DM (n = 149) and non-DM (n = 188). We assessed neointimal coverage (NIC) grades (dominant, maximum and minimum), thrombus adhesion and maximum yellow color grade. NIC was graded as follows: grade 0, stent struts were not covered; grade 1, stent struts were covered by thin layer; grade 2, stent struts were buried under neointima. Yellow color was graded as grade 0, white; grade 1, light yellow; grade 2, yellow; grade 3, intensive yellow. Results Minimum NIC grade was significantly lower in DM than in non-DM groups (p = 0.002), whereas dominant and maximum NIC grades were similar between them (p = 0.59 and p = 0.94, respectively), as were thrombus adhesion (44.3% vs. 38.8%, p = 0.32) and maximum yellow color grade (p = 0.78). A multivariate analysis demonstrated that DM was an independent predictor of minimum NIC of grade 0 (odds ratio: 2.14, 95% confidence interval: 1.19–3.86, p = 0.011). Conclusions DM patients showed more uncovered struts than non-DM patients 3–5 months after DES implantation, suggesting that the recent ultra-short DAPT strategy might not be easily applied to DM patients.