Flower technique-A bailout technique to retrieve disrupted balloon catheters and stents.

We report two case series in which we encountered the difficulties to retrieve disrupted devices during percutaneous coronary intervention and endovascular treatment. The broken devices were successfully and safely retrieved by the "flower technique" that creates multiple cut and slit in the tip of the guiding catheter. This technique can be easily and safely applied in situations where a balloon catheter or stent has been disrupted and device entrapment has occurred, as the technique simply involves manually placing multiple cuts or slits in the tip of the guiding catheter. Transcatheter interventionists should be familiar with this technique because it can be bailout from device entrapment without additional cost or clinical experience.

Prasugrel Monotherapy After Percutaneous Coronary Intervention for Chronic Coronary Syndrome: Insights From ASET Pilot Studies.

Background: The ASET (Acetyl-Salicylic Elimination Trial) pilot studies recently investigated P2Y12 inhibitor monotherapy without aspirin immediately after percutaneous coronary intervention (PCI) in Brazil and Japan. Objectives: This comparative analysis of the 2 ASET pilot studies aimed to summarize clinical outcomes and assess geographic and ethnic differences in baseline demographics and procedures. Methods: Patients undergoing successful platinum-chromium everolimus-eluting stent implantation for chronic coronary syndrome were included. Following the index PCI, patients received prasugrel monotherapy with a maintenance dose of 10 mg/day in Brazil and 3.75 mg/day in Japan. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding at up to 3 months. Results: Of 409 enrollments, 3-month follow-up was completed in 406 patients. Mean age was 64.3 ± 8.4 years, and 73% were men. Overall, post-TIMI flow grade 3 was achieved in 99.8%. Intravascular imaging for poststent optimization was used in 16.8% and 99.6% of treated lesions in Brazil and Japan, respectively. The primary ischemic and bleeding endpoints occurred in the same patient (0.2%). No stent thrombosis events occurred. Conclusions: Prasugrel monotherapy following PCI was safe and feasible in selected low-risk chronic coronary syndrome patients after optimal platinum-chromium everolimus-eluting stent implantation regardless of the ethnic and geographic differences in baseline demographics, procedures, and prasugrel dosage. Randomized controlled trials will be needed to compare P2Y12 inhibitor monotherapy without aspirin with the current standard of care.

Inhalation of gaseous hypochlorous acid and its effect on human respiratory epithelial cells in laboratory model systems.

During the disinfection of indoor spaces using gaseous hypochlorous acid (HOCl(g)), inhalation is the most common route of exposure for humans. In this study, an artificial human respiratory tract model was exposed to 12-140 ppb HOCl(g) at an aspiration flow rate of 800 mL/s for 15 h in a 1 m3 chamber. The respiratory tract model was equipped with 5th order bronchi and all gas-contact parts were made of silicone rubber with no other chlorine-consuming substances. The concentration of HOCl(g) reaching the lung pseudo-space was approximately 47.4% of the HOCl(g) concentrations in the chamber and was calculated to be very close to zero when the chamber concentration was less than 20.5 ppb. The disappearance of HOCl(g) during inhalation is likely due to the adsorption of HOCl(g) on the gas-contact silicone rubber surfaces. The cytotoxicity of HOCl(g) on respiratory epithelial cells was also examined using human air-liquid-interface airway tissue models. Human nasal epithelium and bronchiolar epithelium were exposed to 100 ppb and 500 ppb HOCl(g) for 8 h and 5 d, respectively. No significant effects of HOCl(g) on cell viability and ciliary activity were observed in any cell type, indicating that low concentrations of HOCl(g）, less than 500 ppb, had no cytotoxic effect.

Comparison between optical coherence tomography-guided and intravascular ultrasound-guided primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.

Objective: To examine the clinical outcomes of optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). Methods: We retrospectively investigated 533 consecutive patients who underwent primary PCI for STEMI between June 2016 and December 2020. The primary endpoint was a target lesion failure (TLF; defined as a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization). Propensity score (PS) matching was performed to allow direct comparison of OCT-guided and intravascular ultrasound (IVUS)-guided PCI. Results: Patients in the OCT group (n=166) were younger than those in the IVUS group (n=367) and had a significantly higher left ventricular ejection fraction and estimated glomerular filtration rate. Killip class IV and left main stem disease were more common in the IVUS group. The median peak creatine kinase level was comparable between the two groups (1953 U/L vs 1603 U/L). A significantly larger amount of contrast was used in the OCT group (200 mL vs 165 mL; p<0.001). The cumulative incidence of TLF during a median follow-up of 2.2 years did not differ significantly between OCT and IVUS groups (9.6% vs 13.6%; p=0.221) but cardiac mortality was significantly higher in the IVUS group (8.7% vs 3.6%; p=0.047). After PS matching (n=161 in each group), there was no significant between-group difference in TLF or any other clinical outcome measures. Conclusions: OCT-guided PCI demonstrated clinical outcomes in patients with STEMI that were comparable to those of IVUS-guided PCI despite considerable differences in background characteristics.

Assessment of the renal angina index in patients hospitalized in a cardiac intensive care unit.

The renal angina index (RAI) is a validated scoring tool for predicting acute kidney injury (AKI). We investigated the efficacy of the RAI in 2436 heterogeneous patients (mean age, 70 years) treated in cardiac intensive care units (CICUs). The RAI was calculated from creatinine and patient condition scores. AKI was diagnosed by the Kidney Disease: Improving Global Outcome criteria. The primary and secondary endpoints were the development of severe AKI and all-cause mortality, respectively. Four hundred thirty-three patients developed AKI, 87 of them severe. In multivariate analyses, the RAI was a significant independent predictor of severe AKI. During the 12-month follow-up period, 210 patients suffered all-cause death. Elevated RAI was independently associated with all-cause mortality, as was NT-proBNP (p < 0.001). The RAI is a potent predictor not only of severe AKI but also of adverse outcomes and substantially improved the 12-month risk stratification of patients hospitalized in CICUs.

Geographic disparity of pathophysiological coronary artery disease characteristics: Insights from ASET trials.

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

Clinical Outcomes Based on Coronary Computed Tomography-Derived Fractional Flow Reserve and Plaque Characterization.

BACKGROUND: Coronary computed tomography angiography (CTA) followed by computed tomography angiography-derived fractional flow reserve (FFRCT) is now commonly used for the management of chronic coronary syndrome (CCS). CTA-verified high-risk plaque (HRP) characteristics have also been reported to be associated with a greater likelihood of adverse cardiac events but have not been used for management decisions. OBJECTIVES: The aim of this study was to evaluate clinical outcomes based on a combination of point-of-care computed tomography angiography-derived fractional flow reserve (POC-FFRCT) and the presence of HRP in CCS patients initially treated medically or with revascularization based on invasive coronary angiography findings. METHODS: CTA was performed as the initial test in 5,483 patients presenting with CCS between September 2015 and December 2020 followed by invasive coronary angiography and revascularization as necessary. POC-FFRCT assessment and HRP characterization were obtained subsequently in 745 consecutive patients. We investigated how HRP and POC-FFRCT, which were not available during the original clinical decision making, correlated with the endpoint defined as a composite of cardiac death, acute coronary syndrome, and a need for unplanned revascularization. RESULTS: Cardiac events occurred in 20 patients (2.7%) during a median follow-up of 744 days. The event rate was significantly higher in patients with POC-FFRCT <0.80 compared with POC-FFRCT ≥0.8 (5.4 vs 0.5 per 100 vessel years; log-rank P < 0.0001) and in patients with HRP compared to those without HRP (3.6 vs 0.8 per 100 vessel years; log-rank P = 0.0001). POC-FFRCT <0.80 and the presence of HRP were the independent predictors of cardiac events (HR: 16.67; 95% CI: 2.63-105.39; P = 0.002) compared with POC-FFRCT ≥0.8 and absent HRP. For the vessels with POC-FFRCT <0.80 and HRP, a significantly higher rate of adverse events was observed in patients who did not undergo revascularization compared with those revascularized (16.4 vs 1.4 per 100 vessel years; log-rank P = 0.006). CONCLUSIONS: POC-FFRCT <0.80 and the presence of HRP were the independent predictors of cardiac events, and revascularization of HRP lesions with abnormal POC-FFRCT was associated with a lower event rate.

Coronary computed tomography angiographic detection of in-stent restenosis via deep learning reconstruction: a feasibility study.

OBJECTIVES: Evaluation of in-stent restenosis (ISR), especially for small stents, remains challenging during computed tomography (CT) angiography. We used deep learning reconstruction to quantify stent strut thickness and lumen vessel diameter at the stent and compared it with values obtained using conventional reconstruction strategies. METHODS: We examined 166 stents in 85 consecutive patients who underwent CT and invasive coronary angiography (ICA) within 3 months of each other from 2019-2021 after percutaneous coronary intervention with coronary stent placement. The presence of ISR was defined as percent diameter stenosis ≥ 50% on ICA. We compared a super-resolution deep learning reconstruction, Precise IQ Engine (PIQE), and a model-based iterative reconstruction, Forward projected model-based Iterative Reconstruction SoluTion (FIRST). All images were reconstructed using PIQE and FIRST and assessed by two blinded cardiovascular radiographers. RESULTS: PIQE had a larger full width at half maximum of the lumen and smaller strut than FIRST. The image quality score in PIQE was higher than that in FIRST (4.2 ± 1.1 versus 2.7 ± 1.2, p < 0.05). In addition, the specificity and accuracy of ISR detection were better in PIQE than in FIRST (p < 0.05 for both), with particularly pronounced differences for stent diameters < 3.0 mm. CONCLUSION: PIQE provides superior image quality and diagnostic accuracy for ISR, even with stents measuring < 3.0 mm in diameter. CLINICAL RELEVANCE STATEMENT: With improvements in the diagnostic accuracy of in-stent stenosis, CT angiography could become a gatekeeper for ICA in post-stenting cases, obviating ICA in many patients after recent stenting with infrequent ISR and allowing non-invasive ISR detection in the late phase. KEY POINTS: • Despite CT technology advancements, evaluating in-stent stenosis severity, especially in small-diameter stents, remains challenging. • Compared with conventional methods, the Precise IQ Engine uses deep learning to improve spatial resolution. • Improved diagnostic accuracy of CT angiography helps avoid invasive coronary angiography after coronary artery stenting.

Clinical impact of non-lying time on hospital-associated functional decline in older patients undergoing transcatheter aortic valve implantation.

The purposes of the present study were: (1) to investigate the relationship between hospital-associated functional decline (HAFD) and non-lying time and (2) to clarify the optimal cut-off value for non-lying time associated with HAFD in older patients undergoing transcatheter aortic valve implantation (TAVI). From January 2021 to December 2022, patients admitted to a university hospital who underwent trans-femoral TAVI were consecutively recruited. We measured short physical performance battery (SPPB) pre and post-TAVI, and non-lying time from post-operative days 3-5. HAFD was defined as at least 1 point decrease in SPPB during pre and post-TAVI. Among 75 patients (47 female, mean age of 84.5 years) enrolled, 14 patients were classified as having HAFD. Non-lying time was significantly shorter in the HAFD group than in the non-HAFD group (371 min vs. 539 min, P < 0.001). Receiver-operating characteristic analysis determined an optimal cut-off value of 477 min for differentiating the patients more likely to experience HAFD (sensitivity, 75%; specificity, 92%; area under the curve, 0.798). The non-lying time could be one of the associated factors of HAFD in older patients with TAVI. Non-lying time of about 480 min (8 h) during hospitalization may be an initial target for preventing HAFD.

Remineralization effects of enamel binding peptide, WGNYAYK, on enamel subsurface demineralization in vitro. Enamel binding peptide, WGNYAYK effect remineralization of enamel.

Objectives: We investigated remineralization effects of enamel binding peptide (EBP), WGNYAYK, on enamel subsurface demineralization in vitro.Methods: Bovine lower incisor crowns were used as subsurface enamel demineralization samples, and changes of EBP binding, remineraliztion rate, hardness and microstructure were investigated. Binding of EBP, remineralization rate, hardness and structural changes were investigated. Fluorescein isothiocyatate (FITC)-labeled EBPs (0.4 mM, 4.0 mM, and 7.0 mM) were applied to the samples for 30 min at 37 °C, with sample surfaces and cross-sections observed by confocal laser scanning microscope (CLSM). Mineralization analysis samples were divided into 4 experimental groups; distilled water (DW), EBP 0.4 mM, EBP 4.0 mM, and EBP 7.0 mM. Mineral density changes were measured by micro-CT with hardness measured by nano-indentation. Samples were also observed by scanning electron microscope (SEM) for surface and longitudinal microstructure. Results: CLSM images indicated that increased fluorescence was observed in the surface layer and up to about 20 µm below the surface layer. The remineralization rate was significantly higher for EBP 7.0 mM compared to DW (p = 0.008). Enamel surface hardness was significantly higher in all EBP groups compared to DW (p < 0.05) and was highest in the 7.0 mM group. SEM images showed obscuring of the superficial columnar structure in the 7.0 mM EBP group, indicating subsurface crystalline structure recovery. Conclusion: The results of this study suggest that EBP binds to demineralized enamel and promotes remineralization.

Preprocedural physiological assessment of coronary disease patterns to predict haemodynamic outcomes post-PCI.

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

Revisiting the History of Odontoma, with Special Reference to Its Original Illustration.

BACKGROUND: Practically every facet of the most common odontogenic tumor, odontoma, has been covered by an extensive volume of literature. However, uncertainty about its precise history has persisted. MATERIALS AND METHODS: The historical evolution of odontoma was traced with reference to the original illustrations that accompanied European and American reports published at the beginning of the 19th century and also at the turn of the century. RESULTS: The prevailing views regarding the first description of odontoma by Oudet of Paris in 1809 and the original designation "odontome" by Broca of Paris in 1867 are not entirely accurate. Before Broca's suggested term, "exostose dentaire" (dental exostosis) and "tumeur dentaire" (dental tumor) proposed by Oudet and Forget of Paris, respectively, were popular terms adopted in France, while in Briatin the terms "warty tooth" and "supernumerary teeth" proposed by Salter and Tomes of London, respectively, were widely coined. The original illustrations of complex odontoma were published by Wedl of Vienna in 1851, and in 1862 Tomes published the first drawing of compound odontoma denticles. Before the advent of diagnostic radiography in the early 1900s, spontaneous exposure or eruption of odontoma followed by secondary infection was very common. In 1887-1888, Bland Sutton of London criticized Broca's monumental research and formulated the first modern classification which, in essence, remains valid today. At that time, large osteomas of the maxilla were inappropriately classified as odontomas by many pathologists because of Bland Sutton's influential view. Interestingly, the first radiographic evidence of odontoma was published by the American oral surgeon Gilmer in 1899. CONCLUSION: In view of their fundamental achievements, the names of Wedl, Salter, Broca and Bland Sutton have been closely associated with the true history of odontoma.

Young age is a key determinant of body weight gain after switching from tenofovir disoproxil fumarate to tenofovir alafenamide in Japanese people living with HIV.

BACKGROUND: Treatment with tenofovir alafenamide fumarate (TAF) is associated with body weight gain. However, little or no information is available on this issue in Asian populations. METHODS: This single-center retrospective study included Japanese people living with HIV (PLWH) who satisfied the following criteria; 1) switching from TDF to TAF after HIV-suppression, 2) follow-up for ≥2 years while on TDF and TAF, and 3) no switching of the third antiretroviral agent. Changes in annual body weight and lipid profiles were compared between the TDF and TAF periods. RESULTS: Of 328 patients, dolutegravir (DTG) was used in 118 PLWH. Overall, no significant difference in weight gain was observed between TDF and TAF (0.76 vs. 0.9 kg/year, p = 0.331). In TAF-period, younger (<50 years of age) group showed significantly greater weight gain than older group (1.03 vs. 0.12 kg/year, p = 0.037). In DTG group, weight gain was larger in TAF-period (0.74 vs. 1.31 kg/year, p = 0.046), especially in younger subgroup (1.43 kg/year) compared with older one (-0.12 kg/year). Multivariate regression analysis showed that TAF was not associated with weight gain (estimates 0.201, p = 0.170) except for DTG group, whereas young age was associated with weight gain in all subjects (estimates -0.033/1 year older, p < 0.001), DTG, RAL, and EFV groups. CONCLUSION: In Japanese PLWH, annual body weight change was comparable in TDF- and TAF-period, while TAF plus DTG correlated with weight gain. Since young age was a key determinant of weight change, careful interpretation is needed for TAF-associated weight gain.

Warthin Tumor of the Parotid Gland: The History of an Eponym.

The eponymous history of Warthin tumor (WT) is a fascinating issue in the field of salivary gland pathology. The late decades of the nineteenth century and the turn of the century saw notable German and French contributions on WT. Especially, the seminal 1910 paper of Albrecht and Arzt of Vienna is the foundation for the current knowledge of WT. It is generally believed that prior to this pioneering study, Hildebrand of Göttingen accurately described the lesion of WT in 1895. However, the historical origins of WT appear to be unsettled, and only a few German pathologists and surgeons are aware that dating back to 1885, the first recognizable reference to WT was that by the renowned German-Swiss pathologist Zahn, whose name is eponymously associated with "Zahn infarct" and "lines of Zahn". Two noted French surgeons with a major interest in pathology, Albarrán in 1885 and Lecéne in 1908, did not contribute to the topic. Since the 1950s, a mostly American group of pathologists and surgeons gradually adopted the term WT to replace the very accurate histologic descriptor "papillary cystadenoma lymphomatosum" coined by Warthin himself in 1929. It is our opinion that from a historical viewpoint, there is no particular reason why this tumor should have been named WT.

Multimodality imaging to identify lipid-rich coronary plaques and predict periprocedural myocardial injury: Association between near-infrared spectroscopy and coronary computed tomography angiography.

Background: This study compares the efficacy of coronary computed tomography angiography (CCTA) and near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS) in patients with significant coronary stenosis for predicting periprocedural myocardial injury during percutaneous coronary intervention (PCI). Methods: We prospectively enrolled 107 patients who underwent CCTA before PCI and performed NIRS-IVUS during PCI. Based on the maximal lipid core burden index for any 4-mm longitudinal segments (maxLCBI4mm) in the culprit lesion, we divided the patients into two groups: lipid-rich plaque (LRP) group (maxLCBI4mm ≥ 400; n = 48) and no-LRP group (maxLCBI4mm < 400; n = 59). Periprocedural myocardial injury was a postprocedural cardiac troponin T (cTnT) elevation of ≥5 times the upper limit of normal. Results: The LRP group had a significantly higher cTnT (p = 0.026), lower CT density (p < 0.001), larger percentage atheroma volume (PAV) by NIRS-IVUS (p = 0.036), and larger remodeling index measured by both CCTA (p = 0.020) and NIRS-IVUS (p < 0.001). A significant negative linear correlation was found between maxLCBI4mm and CT density (rho = -0.552, p < 0.001). Multivariable logistic regression analysis identified maxLCBI4mm [odds ratio (OR): 1.006, p = 0.003] and PAV (OR: 1.125, p = 0.014) as independent predictors of periprocedural myocardial injury, while CT density was not an independent predictor (OR: 0.991, p = 0.22). Conclusion: CCTA and NIRS-IVUS correlated well to identify LRP in culprit lesions. However, NIRS-IVUS was more competent in predicting the risk of periprocedural myocardial injury.

Prasugrel Monotherapy After Percutaneous Coronary Intervention With Biodegradable-Polymer Platinum-Chromium Everolimus Eluting Stent for Japanese Patients With Chronic Coronary Syndrome (ASET-JAPAN).

BACKGROUND: P2Y12 inhibitor monotherapy without aspirin immediately after percutaneous coronary intervention (PCI) has not been tested in East Asian patients, so in this study we aimed to assess the safety and feasibility of reduced dose (3.75 mg/day) prasugrel monotherapy in Japanese patients presenting with chronic coronary syndrome (CCS).Methods and Results: ASET-JAPAN is a prospective, multicenter, single-arm pilot study that completed enrolment of 206 patients from 12 Japanese centers in September 2022. Patients with native de-novo coronary lesions and a SYNTAX score <23 were treated exclusively with biodegradable-polymer platinum-chromium everolimus-eluting stent(s). Patients were loaded with standard dual antiplatelet therapy (DAPT) and following successful PCI and optimal stent deployment, they received low-dose prasugrel (3.75 mg/day) monotherapy for 3 months. The primary ischemic endpoint was a composite of cardiac death, spontaneous target-vessel myocardial infarction, or definite stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5. At 3-month follow-up, there were no primary bleeding or ischemic events, or any stent thrombosis. CONCLUSIONS: This pilot study showed the safety and feasibility of prasugrel monotherapy in selected low-risk Japanese patients with CCS. This "aspirin-free" strategy may be a safe alternative to traditional DAPT following PCI.

Reduced-dose prasugrel monotherapy without aspirin after PCI with the SYNERGY stent in East Asian patients presenting with chronic coronary syndromes or non-ST-elevation acute coronary syndromes: rationale and design of the ASET Japan pilot study.

The Acetyl Salicylic Elimination Trial (ASET) Japan pilot study is a multicentre, single-arm, open-label, proof-of-concept study with a stopping rule based on the occurrence of definite stent thrombosis. This study aims to demonstrate the feasibility and safety of low-dose prasugrel monotherapy following percutaneous coronary intervention (PCI) in Japanese patients presenting with chronic coronary syndromes (CCS) or non-ST-elevation acute coronary syndromes (NSTE-ACS). Four hundred patients with a SYNTAX score <23 requiring PCI due to CCS or NSTE-ACS will be screened and considered eligible for the study. The enrolment is planned in two phases: 1) 200 patients presenting with CCS, followed by 2) 200 patients presenting with NSTE-ACS. After optimal PCI with implantation of a SYNERGY (Boston Scientific) stent, patients will be enrolled and loaded with prasugrel 20 mg, followed by a maintenance dose of prasugrel 3.75 mg once daily without aspirin continued for 3 months in Phase 1 (CCS patients), and for 12 months in Phase 2 (NSTE-ACS patients). After these follow-up periods, prasugrel will be replaced by standard antiplatelet therapy according to local practice. The primary endpoint is a composite of cardiac death, target vessel myocardial infarction, or definite stent thrombosis after the index procedure. The primary bleeding endpoint is any Bleeding Academic Research Consortium type 3 or 5 bleeding occurring within 3 months of the index PCI for CCS patients, or 12 months for NSTE-ACS patients. The ASET Japan study is designed to demonstrate the feasibility and safety of reduced-dose prasugrel monotherapy after PCI in East Asian patients with acute and chronic coronary syndromes.

Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics.

Drug-coated balloon (DCB) technology was developed to deliver the antiproliferative drugs to the vessel wall without leaving any permanent prosthesis or durable polymers. The absence of foreign material can reduce the risk of very late stent failure, improve the ability to perform bypass-graft surgery, and reduce the need for long-term dual antiplatelet therapy, potentially reducing associated bleeding complications. The DCB technology, like the bioresorbable scaffolds, is expected to be a therapeutic approach that facilitates the "leave nothing behind" strategy. Although newer generation drug-eluting stents are the most common therapeutic strategy in modern percutaneous coronary interventions, the use of DCB is steadily increasing in Japan. Currently, the DCB is only indicated for treatment of in-stent restenosis or small vessel lesions (< 3.0 mm), but potential expansion for larger vessels (≥ 3.0 mm) may hasten its use in a wider range of lesions or patients with obstructive coronary artery disease. The task force of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) was convened to describe the expert consensus on DCBs. This document aims to summarize its concept, current clinical evidence, possible indications, technical considerations, and future perspectives.