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Background: Because the clinical benefit of antiplatelet therapy (APT) for patients with nonsignificant coronary artery disease (CAD) remains poorly understood, we evaluated it in patients after fractional flow reserve (FFR)-guided deferral of revascularization., Methods and Results: From the J-CONFIRM (Long-Term Outcomes of Japanese Patients with Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), we investigated 265 patients with deferred lesions who did not require APT for secondary prevention of cardiovascular disease. A 2-year landmark analysis assessed the relationship between APT at 2 years and 5-year major cardiac adverse events (MACE: composite of all-cause death, target vessel-related myocardial infarction, clinically driven target vessel revascularization). Of the 265 patients, 163 (61.5%) received APT. The 5-year MACE did not significantly differ between the APT and non-APT groups after adjustment for baseline clinical characteristics (9.2% vs. 6.9%, inverse probability weighted hazard ratio, 1.40 [95% confidence interval, 0.53-3.69]; P=0.49). There was a marginal interaction between the effect of APT on MACE and FFR values (< or ≥0.84) (P for interaction=0.066)., Conclusions: The 5-year outcomes after FFR-guided deferral of revascularization did not significantly differ between the APT and non-APT groups, suggesting that APT might not be a critical requirement for nonsignificant obstructive CAD patients not requiring APT for secondary prevention of cardiovascular disease., Competing Interests: S.K. receives lecture fees from Abbott Vascular Japan and Boston Scientific Japan; H.M. receives lecture fees from Abbott Vascular Japan, Boston Scientific Japan, and Phillips Japan; Y.K. receives lecture fees from Abbott Vascular Japan and Phillips Japan; Y.S. receives lecture fees from Abbott Vascular Japan and Phillips Japan; T.A. receives lecture fees from Abbott Vascular Japan and Phillips Japan; K.T. is a member of Circulation Journal’s and Circulation Reports’ Editorial Team; N.T. receives lecture fees from Abbott Vascular Japan and Boston Scientific Japan; H.Y. receives lecture fees from Boston Scientific Japan. The other authors report no conflicts., (Copyright © 2024, THE JAPANESE CIRCULATION SOCIETY.)

Background: Standard modifiable cardiovascular risk factors (SMuRFs; hypertension, diabetes mellitus, dyslipidemia, and smoking) are widely recognized as risk factors for coronary artery disease. However, the associations between absence of SMuRFs and long-term clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients are unclear., Methods: Consecutive STEMI patients who underwent primary percutaneous coronary intervention (PCI) between 1999 and 2015 were retrospectively analyzed. The primary endpoint was up to 5-year all-cause mortality. Clinical characteristics and outcomes were compared between patients with at least one of the SMuRFs and those without any SMuRFs., Results: Of 1963 STEMI patients, 126 (6.4 %) did not have any SMuRFs. Patients without SMuRFs were significantly older, had lower body mass index, and were more likely to be female. During a median follow-up period of 4.9 years, the cumulative incidence of death was significantly higher in patients without SMuRFs than in those with SMuRFs (log-rank p < 0.0001). Landmark analysis showed that patients without SMuRFs had higher mortality within 30 days of STEMI onset (log-rank p = 0.0045) and >30 days after STEMI onset (log-rank p = 0.0004). Multivariable Cox hazards analysis showed that absence of SMuRFs was associated with a higher risk of mortality (hazard ratio, 1.59; 95 % confidence interval, 1.14-2.21; p = 0.006)., Conclusions: Of STEMI patients undergoing primary PCI, patients without any SMuRFs had higher mortality than those with at least one of the SMuRFs. Patients without any SMuRFs have a poor prognosis and require more attention., Competing Interests: Declaration of competing interest The authors declare that there is no conflict of interest., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Purpose: To explore the potential of quantitative parameters of the hydrogel spacer distribution as predictors for separating the rectum from the planning target volume (PTV) in linear-accelerator-based stereotactic body radiotherapy (SBRT) for prostate cancer., Methods: Fifty-five patients underwent insertion of a hydrogel spacer and were divided into groups 1 and 2 of the PTV separated from and overlapping with the rectum, respectively. Prescribed doses of 36.25-45 Gy in five fractions were delivered to the PTV. The spacer cover ratio (SCR) and hydrogel-implant quality score (HIQS) were calculated., Results: Dosimetric and quantitative parameters of the hydrogel spacer distribution were compared between the two groups. For PTV, D 99% in group 1 (n = 29) was significantly higher than that in group 2 (n = 26), and D max , D 0.03cc , D 1cc , and D 10% for the rectum were significantly lower in group 1 than in group 2. The SCR for prostate (89.5 ± 12.2%) in group 1 was significantly higher (p < 0.05) than that in group 2 (74.7 ± 10.3%). In contrast, the HIQS values did not show a significant difference between the groups. An area under the curve of 0.822 (95% confidence interval, 0.708-0.936) for the SCR was obtained with a cutoff of 93.6%, sensitivity of 62.1%, and specificity of 100%., Conclusions: The SCR seems promising to predict the separation of the rectum from the PTV in linear-accelerator-based SBRT for prostate cancer., (© 2024 The Authors. Journal of Applied Clinical Medical Physics is published by Wiley Periodicals, Inc. on behalf of The American Association of Physicists in Medicine.)

The Breast Cancer Clinical Practice Guidelines, organized by the Japanese Breast Cancer Society (JBCS), were published in 2022. We present the English version of the Radiation Therapy (RT) section of the guidelines. The JBCS formed a task force to update the 2018 version of the JBCS Clinical Practice Guidelines. The Background Questions (BQs) contain the standard treatments for breast cancer in clinical practice, whereas the Clinical Questions (CQs) address daily clinical questions that remain controversial. Future Research Questions (FRQs) explore the subjects that are considered important issues, despite there being insufficient data for inclusion as CQs. The task force selected the 12 BQs, 8 CQs, and 6 FRQs for the RT section. For each CQ, systematic literature reviews and meta-analyses were conducted according to the Minds Manual for Guideline Development 2020, version 3.0. The recommendations, strength of recommendation, and strength of evidence for each CQ were determined based on systematic reviews and meta-analyses, and finalized by voting at the recommendation decision meeting., (© 2024. The Author(s).)

The purpose of this study was to determine the maximum tolerated dose (MTD) for stereotactic body radiation therapy (SBRT) in the treatment of non-metastatic prostate cancer. This study was a phase 1 dose escalation trial conducted in Japan. Patients with histologically proven prostate cancer without lymph nodes or distant metastases were enrolled. The prescribed doses were 42.5, 45, or 47.5 Gy in five fractions. Dose-limiting toxicity (DLT) was defined as grade (G) 3+ gastrointestinal or genitourinary toxicity within 180 days after SBRT completion, and a 6 plus 6 design was used as the method of dose escalation. A total of 16 patients were enrolled, with 6 in the 42.5 Gy group and 10 in the 45 Gy group. No DLT was observed in the 42.5 Gy group. In the 45 Gy group, one patient experienced G3 rectal hemorrhage, and another had G4 rectal perforation, leading to the determination of 42.5 Gy as the MTD. None of the patients experienced biochemical recurrence or death during the follow-up period. We concluded that SBRT for non-metastatic prostate cancer at 42.5 Gy in five fractions could be safely performed, but a total dose of 45 Gy increased severe toxicity.

Background: Since the complication of diabetes mellitus (DM) is a risk for adverse cardiovascular outcomes in patients with coronary artery disease (CAD), appropriate risk estimation is needed in diabetic patients following percutaneous coronary intervention (PCI). However, there is no useful biomarker to predict outcomes in this population. Although stromal cell derived factor-1α (SDF-1α), a circulating chemokine, was shown to have cardioprotective roles, the prognostic impact of SDF-1α in diabetic patients with CAD is yet to be fully elucidated. Moreover, roles of SDF-1α isoforms in outcome prediction remain unclear. Therefore, this study aimed to assess the prognostic implication of three forms of SDF-1α including total, active, and inactive forms of SDF-1α in patients with DM and after PCI., Methods: This single-center retrospective analysis involved consecutive patients with diabetes who underwent PCI for the first time between 2008 and 2018 (n = 849). Primary and secondary outcome measures were all-cause death and the composite of cardiovascular death, non-fatal myocardial infarction, and ischemic stroke (3P-MACE), respectively. For determining plasma levels of SDF-1α, we measured not only total, but also the active type of SDF-1α by ELISA. Inactive isoform of the SDF-1α was calculated by subtracting the active isoform from total SDF-1α., Results: Unadjusted Kaplan-Meier analyses revealed increased risk of both all-cause death and 3P-MACE in patients with elevated levels of inactive SDF-1α. However, plasma levels of total and active SDF-1α were not associated with cumulative incidences of outcome measures. Multivariate Cox hazard analyses repeatedly indicated the 1 higher log-transformed inactive SDF-1α was significantly associated with increased risk of all-cause death (hazard ratio (HR): 2.64, 95% confidence interval (CI): 1.28-5.34, p = 0.008) and 3P-MACE (HR: 2.51, 95% CI: 1.12-5.46, p = 0.02). Moreover, the predictive performance of inactive SDF-1α was higher than that of total SDF-1α (C-statistics of inactive and total SDF-1α for all-cause death: 0.631 vs 0.554, for 3P-MACE: 0.623 vs 0.524, respectively)., Conclusion: The study results indicate that elevated levels of plasma inactive SDF-1α might be a useful indicator of poor long-term outcomes in diabetic patients following PCI., Trial Registration: This study describes a retrospective analysis of a prospective registry database of patients who underwent PCI at Juntendo University Hospital, Tokyo, Japan (Juntendo Physicians' Alliance for Clinical Trials, J-PACT), which is publicly registered (University Medical Information Network Japan-Clinical Trials Registry, UMIN-CTR 000035587)., (© 2024. The Author(s).)

Background: Bleeding rates on dual antiplatelet therapy (DAPT) within 1 month after percutaneous coronary intervention (PCI) remain high in clinical practice, particularly in patients with acute coronary syndrome or high bleeding risk. Aspirin-free strategy might result in lower bleeding early after PCI without increasing cardiovascular events, but its efficacy and safety have not yet been proven in randomized trials., Methods: We randomly assigned 6002 patients with acute coronary syndrome or high bleeding risk just before PCI either to prasugrel (3.75 mg/day) monotherapy or to DAPT with aspirin (81-100 mg/day) and prasugrel (3.75 mg/day) after loading of 20 mg of prasugrel in both groups. The coprimary end points were major bleeding (Bleeding Academic Research Consortium 3 or 5) for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) for noninferiority with a relative 50% margin., Results: The full analysis set population consisted of 5966 patients (no-aspirin group, 2984 patients; DAPT group, 2982 patients; age, 71.6±11.7 years; men, 76.6%; acute coronary syndrome, 75.0%). Within 7 days before randomization, aspirin alone, aspirin with P2Y12 inhibitor, oral anticoagulants, and intravenous heparin infusion were given in 21.3%, 6.4%, 8.9%, and 24.5%, respectively. Adherence to the protocol-specified antiplatelet therapy was 88% in both groups at 1 month. At 1 month, the no-aspirin group was not superior to the DAPT group for the coprimary bleeding end point (4.47% and 4.71%; hazard ratio, 0.95 [95% CI, 0.75-1.20]; P superiority =0.66). The no-aspirin group was noninferior to the DAPT group for the coprimary cardiovascular end point (4.12% and 3.69%; hazard ratio, 1.12 [95% CI, 0.87-1.45]; P non inferiority =0.01). There was no difference in net adverse clinical outcomes and each component of coprimary cardiovascular end point. There was an excess of any unplanned coronary revascularization (1.05% and 0.57%; hazard ratio, 1.83 [95%CI, 1.01-3.30]) and subacute definite or probable stent thrombosis (0.58% and 0.17%; hazard ratio, 3.40 [95% CI, 1.26-9.23]) in the no-aspirin group compared with the DAPT group., Conclusions: The aspirin-free strategy using low-dose prasugrel compared with the DAPT strategy failed to attest superiority for major bleeding within 1 month after PCI but was noninferior for cardiovascular events within 1 month after PCI. However, the aspirin-free strategy was associated with a signal suggesting an excess of coronary events., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111., Competing Interests: Disclosures Dr Natsuaki reports honoraria from Abbott Medical Japan, Daiichi Sankyo, Medtronic, Terumo, Japan Lifeline, Asahi Intecc, Bristol-Myers Squibb, Otsuka, Amgen, Sanofi, Takeda and Bayer. Dr Watanabe reports personal fees from Abbott Medical Japan during the conduct of the study, and personal fees from Daiichi Sankyo, Kowa, Abiomed, Bayer, Pfizer, Bristol-Myers Squibb, and Otsuka, as well, outside the submitted work. Dr Morimoto reports lecturer’s fees from AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Japan Lifeline, Kowa, Pfizer and Tsumura; manuscript fees from Bristol-Myers Squibb and Pfizer; advisory board for Novartis and Teijin. Dr Suwa reports personal fees from Abbott Medical Japan and Daiichi Sankyo outside the submitted work. Dr Ogita reports personal fees from Daiichi Sankyo, Abbott Medical Japan, and Japan Lifeline outside the submitted work. Dr Suzuki reports grants from Abbott Medical Japan during the conduct of the study. Dr Morishima reports honoraria from Abbott Medical Japan and Daiichi Sankyo. Dr Kimura reports grants from Abbott Medical Japan and Boston Scientific and being an advisory board member of Abbott Medical Japan and Terumo Japan. The remaining authors reported no conflicts.

Unresectable, isolated lymph node recurrence after radiotherapy is rare but a candidate for re-irradiation. However, severe toxicity is anticipated. Therefore, this study aimed to explore the efficacy and toxicity of re-irradiation in isolated lymph node recurrence of head and neck lesions. We analyzed 46 patients who received re-irradiation for lymph node recurrence without local progression. The primary tumor sites included the oral cavity in 17 patients, the hypopharynx in 12, the oropharynx in seven, the larynx in three, the nasopharynx in two, and other sites. During a median follow-up time of 10 months, the median survival time was 10.6 months, and the 1-year overall survival rate was 45.5%. The 1-year local control and progression-free survival rates were 49.8% and 39.3%, respectively. According to univariate analysis, age (≥ 65 years), the interval between treatment (≥ 12 months), rN category (rN1), and gross tumor volume (GTV < 25 cm 3 ) were predisposing factors for better survival. In the multivariate analysis, the rN category and interval were identified as statistically significant predictors. Late toxicity grade ≥ 3 occurred in four patients (8.6%). These were all Grade 5 carotid blowout syndrome, which associated with tumor invasion of the carotid artery and/ or high doses administration for the carotid artery. Small-volume rN1 tumor that recur after a longer interval is a feasible candidate for re-irradiation. However, strict patient selection and meticulous care for the carotid are required., (© 2024. The Author(s).)

Background: The relationship between sex differences and long-term outcomes after fractional flow reserve (FFR)- and instantaneous wave-free ratio (iFR)-guided deferral of revascularization has yet to be elucidated. Methods and Results: From the J-CONFIRM registry (long-term outcomes of Japanese patients with deferral of coronary intervention based on FFR in a multicenter registry), this study included 432 lesions from 385 patients (men, 323 lesions in 286 patients; women, 109 lesions in 99 patients) with paired data of FFR and iFR. The primary endpoint was the cumulative 5-year incidence of target vessel failure (TVF), including cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. The median FFR value was lower in men than in women (0.85 [0.81, 0.88] vs. 0.87 [0.83, 0.91], P=0.002), but the iFR value was comparable between men and women (0.94 [0.90, 0.98] vs. 0.93 [0.89, 0.98], P=0.26). The frequency of discordance between FFR and iFR was comparable between men and women (19.5% vs. 23.9%, P=0.34), although with different discordance patterns (P=0.036). The cumulative incidence of 5-year TVF did not differ between men and women after adjustment for baseline characteristics (13.9% vs. 6.9%, adjusted hazard ratio 1.82 [95% confidence interval: 0.44-7.56]; P=0.41). Conclusions: Despite sex differences in the results for physiological indexes, the 5-year TVF in deferred lesions did not differ between men and women after adjustment for baseline characteristics., Competing Interests: S.K. receives lecture fees from Abbott Vascular Japan, Boston Scientific Japan, and Phillips Japan; H.M. serves as advisory board member for Zeon Medical and receives lecture fees from Abbott Vascular Japan, Boston Scientific Japan, and Phillips Japan; Y.K. receives lecture fees from Abbott Vascular Japan and Phillips Japan; Y.S. receives lecture fees from Abbott Vascular Japan and Phillips Japan; T.A. receives lecture fees from Abbott Vascular Japan and Phillips Japan; N.T. serves as advisory board member for Abbott Vascular Japan and Boston Scientific Japan; H.Y. receives lecture fees from Boston Scientific Japan. K.T. is a member of Circulation Reports’ Editorial Team. The other authors report no conflicts., (Copyright © 2024, THE JAPANESE CIRCULATION SOCIETY.)

Purpose: The primary objective is to systematically review primary studies, such as randomized control trials (RCTs), feasibility, exploratory, and case studies; and the secondary objective is to evaluate all secondary articles, such as reviews, guidelines, and editorials, relevant to the use of StrataXRT for the prevention and/or management of radiation dermatitis (RD) in cancer patients., Methods: A literature search was conducted up to February 26, 2023, for articles investigating the use of StrataXRT for the prevention and treatment of RD, in the following databases: Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar. The keywords "StrataXRT", "dermatitis", "radiotherapy", and "radiation" were used to identify relevant articles., Results: Twenty-seven articles from 2018 to 2022 were identified to fulfill the inclusion criteria of this review, of which nine are primary studies and 18 are secondary papers. Significant heterogeneity was observed in the current literature studying the effects of StrataXRT, making it difficult to make cross-trial comparisons. There is a suggestion of the efficacy of StrataXRT in the prevention and treatment of RD., Conclusion: The findings of this review recommend further adequately powered RCTs with robust methodology including patient and clinician assessments to determine the efficacy of StrataXRT in preventing and treating RD. This is essential to improve the quality of life of patients and identify which groups of patients would benefit most from StrataXRT., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

There is a scarcity of studies evaluating statin discontinuation in patients with coronary artery disease in real-world practice. In 11,144 patients who underwent first coronary revascularization and taking statins in the CREDO-Kyoto Registry Cohort-3, we evaluated the incidence of statin discontinuation, defined as stopping statins for at least 2 months. The reasons for statin discontinuation included nonadherence, side effects, worsening co-morbidities, surgery, prescription error, and direction by physicians for other reasons. During a median 6 years of follow-up, the cumulative incidence of statin discontinuation was 6.1% at 1 year, 12.4% at 3 years, 17.4% at 5 years, and 21.4% at 7 years. The major components of the reasons for statin discontinuation were nonadherence, side effects, and worsening co-morbidities. Compared with patients with statin discontinuation because of other reasons, patients with statin discontinuation because of nonadherence more often had younger age, men, acute coronary syndrome, and current smoking; patients with statin discontinuation because of side effects more often had liver cirrhosis; and patients with statin discontinuation because of worsening co-morbidities more often had advanced age and co-morbidities such as malignancy. Statin discontinuation was strongly associated with subsequent mortality (hazard ratio [HR] 3.54; 95% confidence interval [CI] 3.18 to 3.94, p <0.001), which was consistent, regardless of the reasons, except for the small group of patients with prescription error (nonadherence: HR 2.35, 95% CI 1.69 to 3.27, p <0.001; side effects: HR 2.48, 95% CI 1.84 to 3.34, p <0.001; worsening co-morbidities: HR 22.08, 95% CI 18.55 to 26.29, p <0.001). In conclusion, in real-world practice, approximately 1 in 5 patients discontinued statins after coronary revascularization during a median of 6 years of follow-up. Statin discontinuation was associated with subsequent mortality., Competing Interests: Declaration of Competing Interest Dr. Morimoto reports lecturer's fees from Bayer, Daiichi Sankyo, Japan Lifeline, Kyocera, Mitsubishi Tanabe, Novartis, and Toray and manuscript fees from Bristol-Myers Squibb and Kowa and served advisory boards for Asahi Kasei, Boston Scientific, Bristol-Myers Squibb, and Sanofi. Dr. Shiomi reports personal fees from Abbott Vascular, Boston Scientific, and Daiichi Sankyo. Dr. Ehara reports personal fees from Abbott vascular Japan, Bayer, Boehringer Ingelheim (Bristol), Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Edwards Lifescience, Medtronic, Pfizer (New York, NY, United States), Takeda, and Terumo. Dr. Kimura reports personal fees from Abbott Vascular, Abiomed, Astellas, Astellas Amgen BioPharma, AstraZeneca, Bayer, Boston Scientific, Boehringer Ingelheim-Myers Squibb, Chugai Pharmaceutical, Edwards Lifescience, EISAI, Daiichi Sankyo, Interscience, Japan Society for the Promotion of Science, Kowa, Kowa Pharmaceutical, Lifescience, Medical Review, MSD, MSD Life Science Foundation, Mitsubishi Tanabe Pharma, Novartis Pharma, Ono Pharmaceutical, OrbusNeich, Otsuka Pharmaceutical, Pharmaceuticals and Medical Devices Agency, Philips, Public Health Research Foundation, Sanofi, Sumitomo Dainippon Pharma, Takeda Pharmaceutical, Terumo, Toray, and Tsumura. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background Chronic kidney disease (CKD) might influence fractional flow reserve (FFR) value, potentially attenuating its prognostic utility. However, few large-scale data are available regarding clinical outcomes after FFR-guided deferral of revascularization in patients with CKD. Methods and Results From the J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), 1218 patients were divided into 3 groups according to renal function: (1) non-CKD (estimated glomerular filtration rate ≥60 mL/min per 1.73 m 2 ), n=385; (2) CKD (estimated glomerular filtration rate 15-59 mL/min per 1.73 m 2 , n=763); and (3) end-stage renal disease (ESRD) (eGFR <15 mL/min per 1.73 m 2 , n=70). The primary study end point was the cumulative 5-year incidence of target vessel failure (TVF), defined as a composite of cardiac death, target vessel myocardial infarction, and clinical driven target vessel revascularization. Cumulative 5-year incidence of TVF was significantly higher in the ESRD group than in the CKD and non-CKD group, whereas it did not differ between the CKD and non-CKD groups (26.3% versus 11.9% versus 9.5%, P <0.001). Although the 5-year TVF risk increased as the FFR value decreased regardless of renal function, patients with ESRD had a remarkably higher risk of TVF at every FFR value than those with CKD and non-CKD. Conclusions At 5 years, patients with ESRD showed a higher incidence of TVF than patients with CKD and non-CKD, although with similar outcomes between patients with CKD and non-CKD. Patients with ESRD had an excess risk of 5-year TVF at every FFR value compared with those with CKD and non-CKD. Registration URL: https://www.umin.ac.jp; Unique identifier: UMIN000014473.

Floating aortic arch thrombi - blood clots forming in an aorta without aneurysms or atherosclerosis - in a normal aorta are exceedingly rare. The etiology is unknown, and there are no guidelines for appropriate treatment strategies. We report a case of floating aortic arch thrombosis in a patient without coagulopathy that was treated surgically. As the mass could not be identified preoperatively as a tumor or thrombus, synthetic graft replacement was performed, allowing resection of the lesion site. Histopathological examination revealed erosion and fissures in the tunica intima of the aorta, which suggested vessel damage to the tunica intima as the cause., Competing Interests: Disclosure StatementAll authors declare no conflict of interest., (© 2023 The Editorial Committee of Annals of Vascular Diseases.)

Purpose: This systematic review and meta-analysis aimed to evaluate the efficacy of Mepitel film in preventing or treating acute radiation dermatitis (RD) in patients with breast cancer in randomized controlled trials (RCTs)., Methods: Embase, APA PsychInfo, Journals@Ovid Full Text, Ovid MEDLINE, PubMed, and Cochrane Trials were searched until December 12, 2022, to identify RCTs on the use of Mepitel film for preventing or treating acute RD from breast cancer radiotherapy. Per-protocol analysis was used to compare outcomes, calculate pooled effect sizes, odds ratio (OR), and 95% confidence intervals (CI), and to create forest plots using random effects analysis in RevMan 5.4., Results: Three RCTs were included in this review. Mepitel film significantly reduced the incidence of grade 3 RD (OR 0.15 95% CI 0.06, 0.37, p<0.0001) and grade 2 or 3 RD (OR 0.16 95% CI 0.04, 0.65, p=0.01) as scored on either the CTCAE or the RTOG scale. Additionally, Mepitel film significantly reduced RISRAS mean scores assessed by patients and combined researcher and patient (standardized mean difference (SMD) -7.59, 95% CI -14.42, -0.76, p=0.03; SMD -15.36, 95% CI -30.01, -0.71 p=0.04) but not the researcher component of the assessment tool (SMD -17.55, 95% CI -36.94, 1.84, p=0.08)., Conclusion: Mepitel film reduced the incidence of acute RD and improved patient-reported outcomes with minimal side effects, the main one being itchiness. Future research should assess the feasibility of Mepitel film with respect to specific patient-reported outcomes such as health-related quality of life issues associated with its use., (© 2023. Crown.)

Purpose: To evaluate the overall efficacy of StrataXRT, a topical gel dressing, in preventing acute radiation dermatitis (RD) in breast cancer patients undergoing radiotherapy (RT)., Methods: A systematic search was conducted on April 25, 2023 in Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. Randomized controlled trials (RCTs) assessing the effectiveness of StrataXRT in preventing acute RD in breast cancer patients undergoing adjuvant RT to the breast or chest wall with or without regional nodes were included. Pooled incidence odds ratio (OR) and 95% confidence interval (CI) were calculated using a random-effects model, with analysis and forest plots generated in RevMan v5.4., Results: The analysis included three RCTs with a total of 189 patients assessed using per-protocol analysis. Two RCTs compared StrataXRT to standard of care, while the third compared it with Mepitel film and was reported separately. In the former RCTs, the odds ratio (OR) for developing acute grade 3 RD favored StrataXRT at 0.05 (95% CI, 0.01-0.22; P < 0.0001). The OR for developing acute grades 2-3 RD was 0.32 (95% CI, 0.03-3.18; P = 0.33). The RCT comparing StrataXRT with Mepitel film showed insignificant ORs for grade 3 and grades 2-3 RD. One RCT reported significantly lower erythema index (P = 0.008) and melanin index (P = 0.015) in StrataXRT patients. The use of StrataXRT did not raise additional safety concerns., Conclusion: StrataXRT may help prevent severe acute RD in breast cancer RT patients. Further high quality, large-scale studies are needed to confirm these findings., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Recent clinical trials have shown that percutaneous coronary intervention (PCI) for non-culprit lesions (NCLs) reduces the risk of adverse events in patients with ST-segment elevation myocardial infarction (STEMI), but the effect on long-term outcomes remains unclear in acute coronary syndrome (ACS) patients and a real-world clinical setting., Methods: A retrospective observational cohort study of ACS patients who underwent primary PCI between April 2004 and December 2017 at Juntendo University Shizuoka Hospital, Japan, was performed. The primary endpoint was the composite of cardiovascular disease death (CVD death) and non-fatal myocardial infarction (MI) during the mean follow-up period of 2.7 years, and a landmark analysis for the incidence of the primary endpoint from 31 days to 5 years between the multivessel PCI group and the culprit only PCI group was performed. Multivessel PCI was defined as PCI including non-infarct-related coronary arteries within 30 days after the onset of ACS., Results: Of the 1109 ACS patients with multivessel coronary artery disease of the current cohort, multivessel PCI was performed in 364 (33.2 %) patients. The incidence of the primary endpoint from 31 days to 5 years was significantly lower in the multivessel PCI group (4.0 % vs. 9.6 %, log-rank p = 0.0008). Multivariate Cox regression analysis showed that multivessel PCI was significantly associated with fewer cardiovascular events (HR 0.37, 95 % CI 0.19-0.67, p = 0.0008)., Conclusion: In ACS patients with multivessel coronary artery disease, multivessel PCI may reduce the risk of CVD death and non-fatal MI compared to culprit-lesion-only PCI., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Survival information for stereotactic body radiotherapy (SBRT) and surgery for stage I non-small cell lung cancer (NSCLC) was examined., Methods: Stage I NSCLC patients who underwent surgery or SBRT between 2012 and 2016 were retrospectively enrolled in this single-institution study. Using the Kaplan--Meier method and Cox regression model, overall survival (OS) was estimated and compared., Results: Among 538 enrolled patients, compared to the surgery group (443), the SBRT group (95) had more complications (P = 0.01), worse performance status (P = 0.001), and were older (P < 0.001). Three-year OS was 70.5% post SBRT and 90.1% postsurgery. The 3-year cancer-specific survival (CSS) and disease-free survival (DFS) post SBRT and postsurgery were 92.7% vs. 92.3% and 61.1% vs 79.3%, respectively. Three-year locoregional and distant control rates post SBRT and postsurgery were 85.6% vs. 90.1% and 82.5% vs. 86.4%, respectively. Multivariate analysis using the Cox model, including age, T-stage, CCI, and C/T ratio and treatment, showed the surgery group's OS to be significantly superior to that of the SBRT group (HR of SBRT per surgery: 1.90, 95%CI: 1.12-3.21, P = 0.017). No significant differences were observed in rates of adverse events., Conclusion: Although OS was better in the surgery group, no differences in CSS existed. This analysis suggests the need for future studies that compare specific radical surgeries and SBRT in a prospective and randomized setting.

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

Background: Little evidence is available about the long-term safety of fractional flow reserve (FFR)-guided deferral of revascularization in infarct-related artery (IRA) lesions, especially when measuring FFR in the late setting after myocardial infarction (MI). This study aimed to assess the long-term outcomes after deferral of revascularization in IRA lesions based on FFR assessed in the late phase of post-MI., Methods: From the J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), data on 1447 lesions (1263 patients) were divided into 2 groups: the IRA and non-IRA groups. The primary study end point was the cumulative 5-year incidence of target vessel failure (TVF), such as cardiac death, target vessel-related MI, and clinically driven target vessel revascularization., Results: Of the 1447 lesions, 138 (9.5%) were classified into the IRA group. The median duration of FFR measurement was 716 days after MI. The frequency of visual-functional mismatches (ie, FFR >0.80 and percent diameter stenosis ≥50% or FFR ≤0.80 and percent diameter stenosis <50%) was comparable between the IRA and non-IRA groups (31.9% vs 36.3%). The cumulative 5-year incidence of TVF did not differ between the groups (9.2% vs 11.8%; inverse probability-weighted hazard ratio, 1.18, 95% confidence intervals, 0.48-2.91, P = .71). Similar results were observed irrespective of regional wall motion assessed by ultrasonic cardiography and acute MI type., Conclusions: The 5-year TVF rate did not differ between the IRA and non-IRA lesions when deferring revascularization guided by FFR in the late setting of post-MI., (© 2023 The Authors.)

Aim: This study aimed to examine the association between participation in health and frailty check-ups and functional outcomes and mortality, controlling for physical and cognitive function, or self-rated health among Japanese community-dwelling older adults., Methods: A cohort of 5093 participants aged ≥65 years (not disabled or institutionalized), completed the baseline survey in April 2013. Functional outcomes and mortality served as follow-up data from April 2013 to March 2018. However, the data did not include events, such as certified cases for long-term care and death for 12 months from the start of follow-up. We collated data on the use of the annual health check system in 2012 and frailty check-ups using the postal Kihon Checklist in 2013. Cox proportional hazards regression models were used to determine the association between participation in the check-ups, and functional outcomes and mortality, adjusting for potential confounders., Results: Long-term care and mortality risks were significantly lower among those aged <75 years who used health screening than among those who did not, despite adjusting for confounding factors (hazard ratios: 2.1-3.5). In those aged ≥75 years, the risk for long-term care was lower in individuals participating in both health and frailty check-ups and in those who participated in the frailty check-ups only, than in those who did not participate., Conclusions: The association between participation in health and frailty check-ups and adverse health outcomes differed among the age groups, indicating the potential benefit of health and frailty check-ups in older adults. Geriatr Gerontol Int 2023; 23: 348-354., (© 2023 Japan Geriatrics Society.)

Background: The REAL-CAD trial, reported in 2017, demonstrated a significant reduction in cardiovascular events with high-intensity statins in patients with chronic coronary syndrome. However, data are scarce on the use of high-intensity statins in Japanese patients with acute coronary syndrome (ACS)., Methods and results: In STOPDAPT-2 ACS, which exclusively enrolled ACS patients between March 2018 and June 2020, 1,321 (44.2%) patients received high-intensity statins at discharge, whereas of the remaining 1,667 patients, 96.0% were treated with low-dose statins. High-intensity statins were defined as the maximum approved doses of strong statins in Japan. The incidence of the cardiovascular composite endpoint (cardiovascular death, myocardial infarction, definite stent thrombosis, stroke) was significantly lower in patients with than without high-intensity statins (1.44% vs. 2.69% [log-rank P=0.025]; adjusted hazard ratio [aHR] 0.48, 95% confidence interval [CI] 0.24-0.94, P=0.03) and the effect was evident beyond 60 days after the index percutaneous coronary intervention (log-rank P=0.01; aHR 0.38, 95% CI 0.17-0.86, P=0.02). As for the bleeding endpoint, there was no significant difference between the 2 groups (0.99% vs. 0.73% [log-rank P=0.43]; aHR 0.96, 95% CI 0.35-2.60, P=0.93)., Conclusions: The prevalence of high-intensity statins has increased substantially in Japan. The use of the higher doses of statins in ACS patients recommended in the guidelines was associated with a significantly lower risk of the primary cardiovascular composite endpoint compared with lower-dose statins.

This study aimed to examine the efficacy and toxicity of reirradiation in patients with locally recurrent oral, pharyngeal, and laryngeal cancers. We conducted a retrospective, multi-institutional analysis of 129 patients with previously irradiated cancer. The most frequent primary sites were the nasopharynx (43.4%), oral cavity (24.8%), and oropharynx (18.6%). With a median follow-up duration of 10.6 months, the median overall survival was 14.4 months and the 2-year overall survival rate was 40.6%. For each primary site, the 2-year overall survival rates were 32.1%, 34.6%, 30%, 60.8%, and 5.7% for the hypopharynx, oral cavity, larynx, nasopharynx, and oropharynx, respectively. Prognostic factors for overall survival were primary site (nasopharynx versus other sites) and gross tumor volume (GTV) (≤ 25 cm 3 versus > 25 cm 3 ). The 2-year local control rate was 41.2%. Twenty-four patients (18.6%) presented with grade ≥ 3 toxicities, including nine with hemorrhages that led to grade 5 toxicities in seven patients. All nine tumors that caused hemorrhage showed tumor encasement of the carotid ≥ 180 degrees and eight of nine tumors had larger GTV > 25 cm 3 . Reirradiation is a feasible treatment option for small local recurrence of oral, pharyngeal, and laryngeal cancers, with the requirement of a strict eligibility assessment for large tumors with carotid encasement., (© 2023. The Author(s).)

Background: Diabetes was reported to be associated with an impaired response to clopidogrel., Objectives: The aim of this study was to evaluate the safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) in patients with diabetes undergoing percutaneous coronary intervention (PCI)., Methods: A subgroup analysis was conducted on the basis of diabetes in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2) Total Cohort (N = 5,997) (STOPDAPT-2, n = 3,009; STOPDAPT-2 ACS [Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 for the Patients With ACS], n = 2,988), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent implantation. The primary endpoint was a composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) or bleeding (TIMI [Thrombolysis In Myocardial Infarction] major or minor) endpoints at 1 year., Results: There were 2,030 patients with diabetes (33.8%) and 3967 patients without diabetes (66.2%). Regardless of diabetes, the risk of 1-month DAPT relative to 12-month DAPT was not significant for the primary endpoint (diabetes, 3.58% vs 4.12% [HR: 0.87; 95% CI: 0.56-1.37; P = 0.55]; nondiabetes, 2.46% vs 2.49% [HR: 0.99; 95% CI: 0.67-1.48; P = 0.97]; P interaction  = 0.67) and for the cardiovascular endpoint (diabetes, 3.28% vs 3.05% [HR: 1.10; 95% CI: 0.67-1.81; P = 0.70]; nondiabetes, 1.95% vs 1.43% [HR: 1.38; 95% CI: 0.85-2.25; P = 0.20]; P interaction  = 0.52), while it was lower for the bleeding endpoint (diabetes, 0.30% vs 1.50% [HR: 0.20; 95% CI: 0.06-0.68; P = 0.01]; nondiabetes, 0.61% vs 1.21% [HR: 0.51; 95% CI: 0.25-1.01; P = 0.054]; P interaction  = 0.19)., Conclusions: Clopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT reduced major bleeding events without an increase in cardiovascular events regardless of diabetes, although the findings should be considered as hypothesis generating, especially in patients with acute coronary syndrome, because of the inconclusive result in the STOPDAPT-2 ACS trial. (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 [STOPDAPT-2], NCT02619760; Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2 for the Patients With ACS [STOPDAPT-2 ACS], NCT03462498)., Competing Interests: Funding Support and Author Disclosures This work (STOPDAPT-2 and STOPDAPT-2 ACS) was supported by Abbott Vascular Japan. The study sponsor is not involved in the implementation of the study, data collection, event fixation and statistical analysis. However, approval of the study sponsor should be obtained for presentation in scientific meetings and submission of papers. Dr H. Watanabe has received honoraria from Abbott Medical, Abiomed, Bayer, Bristol Myers Squibb, Daiichi Sankyo, Kowa, Pfizer, and Otsuka; and has received support for attending meetings from Abbott Medical. Dr Morimoto has received lecture fees from Bristol Myers Squibb, Daiichi Sankyo, Japan Lifeline, Kowa, Kyocera, Novartis, and Toray; has received manuscript fees from Bristol Myers Squibb and Kowa; and has participated on an advisory board for Sanofi. Dr Natsuaki has received honoraria from Abbott Medical. Dr Ogita has received honoraria from Abbott Medical, Daiichi Sankyo, and Japan Lifeline. Dr Suwa has received honoraria from Abbott Medical and Daiichi Sankyo. Dr Kimura has received research grant support from Abbott Medical and Boston Scientific; has received honoraria from Abbott Medical, Boston Scientific, Daiichi Sankyo, Sanofi, and Terumo; and has participated on advisory boards for Abbott Medical, Boston Scientific, and Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Although cardiac metastasis of malignant tumors has often been reported, undifferentiated uterine sarcoma (UUS) is a rare and aggressive uterine tumor. Thus, little is known of the UUS as a primary site of cardiac metastasis. We report a case of a 66-year-old woman, with a history of uterine myoma for 30 years, who was hospitalized with a large uterine tumor and cardiac masses. Although we investigated cardiac masses using imaging modalities, such as ultrasound, cardiac computer tomography, and magnetic resonance imaging, it was challenging to determine the masses as metastasis or thrombi. Cardiac masses were removed by surgery to assess the tissue characteristics and were later identified as tumors due to their appearance. Then, pathological findings revealed that UUS spreads to the right ventricle. We attempted chemotherapy after surgery; however, the disease progressed very quickly and the patient died on the 49th day of admission. In this report, we described the case of a patient with a difficult diagnosis and rapid disease progression of cardiac metastasis from UUS., Competing Interests: The authors declare that there is no conflict of interest., (Copyright © 2022 Hiroka Sasahara et al.)

Previous studies showed that elevated apolipoprotein A1 (ApoA1) and high-density lipoprotein cholesterol (HDL-C) predicted reduced risk of cardiovascular-related (CV) mortality in patients following percutaneous coronary intervention (PCI). Nevertheless, as the association between ApoA1 and cancer mortality in this population has been rarely addressed, our study aimed to evaluate prognostic impact of ApoA1 on multiple types of cancer mortality after PCI. This is a retrospective analysis of a single-center prospective registry database of patients who underwent PCI between 2000 and 2018. The present study enrolled 3835 patients whose data of serum ApoA1 were available and they were divided into three groups according to the tertiles of the preprocedural level of ApoA1. The outcome measures were total, gastrointestinal, and lung cancer mortalities. The median and range of the follow-up period between the index PCI and latest follow-up were 5.9 and 0-17.8 years, respectively. Consequently, Kaplan-Meier analyses showed significantly higher rates of the cumulative incidences of total, gastrointestinal, and lung cancer mortality in the lowest ApoA1 tertile group compared to those in the highest. In contrast, there were no significant differences in all types of cancer mortality rates in the groups divided by the tertiles of HDL-C. Multivariable Cox proportional hazard regression analysis adjusted by cancer-related prognostic factors, such as smoking status, identified the elevated ApoA1 as an independent predictor of decreased risk of total and gastrointestinal cancer mortalities. Our study demonstrates the prognostic implication of preprocedural ApoA1 for predicting future risk of cancer mortality in patients undergoing PCI., (© 2022 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)

Pancreatic ductal adenocarcinoma (PDAC) is caused by genetic mutations in four genes: KRAS proto-oncogene and GTPase ( KRAS ), tumor protein P53 ( TP53 ), cyclin-dependent kinase inhibitor 2A ( CDKN2A ), and mothers against decapentaplegic homolog 4 ( SMAD4 ), also called the big 4. The changes in tumors are very complex, making their characterization in the early stages challenging. Therefore, the development of innovative therapeutic approaches is desirable. The key to overcoming PDAC is diagnosing it in the early stages. Therefore, recent studies have investigated the multifaced characteristics of PDAC, which includes cancer cell metabolism, mesenchymal cells including cancer-associated fibroblasts and immune cells, and metagenomics, which extend to characterize various biomolecules including RNAs and volatile organic compounds. Various alterations in the KRAS -dependent as well as KRAS -independent pathways are involved in the refractoriness of PDAC. The optimal combination of these new technologies is expected to help treat intractable pancreatic cancer.

This study developed a standoff detection system for Raman spectra in the deep-ultraviolet region to facilitate remote detection of various hazardous materials. Although Raman spectroscopy can distinguish various materials, the measurement of Raman spectra through standoff detection is challenging because of the low scattering cross-section of Raman scattering. The resonance Raman scattering effect in the deep-ultraviolet wavelength region is promising in terms of enhancing the spectral intensity of Raman scattering. A catoptric light receiver system was developed to effectively collect deep-ultraviolet light via a change in the distance from the primary to secondary mirror of the telescope. The experimental results for the standoff detection indicate that the system enables the measurement of the Raman spectrum of SO 2 gas, which was locally present 20 m from the system with a wavelength resolution of 0.15 nm. The gas used in this remote measurement has a relatively simple molecular structure among chemical, biological, radiological, nuclear, and explosive gases. However, the high wavelength resolution of Raman spectroscopy will enable measurement of substances with complex molecular structures, such as bacteria and explosives, without losing the detailed structure of their spectra.

Aims: Guideline-directed medical therapy (GDMT) is essential to prevent future cardiovascular events in chronic coronary syndrome (CCS) patients. However, whether achieving optimal GDMT could improve clinical outcomes in CCS patients with deferred lesions based on fraction flow reserve (FFR) remains thoroughly investigated. We sought to evaluate the association of GDMT adherence with long-term outcomes after FFR-based deferral of revascularization in a real-world registry., Methods and Results: This is a post-hoc analysis of the J-CONFIRM registry (long-term outcomes of Japanese patients with deferral of coronary intervention based on fractional flow reserve in multicentre registry). Optimal GDMT was defined as combining four types of medications: antiplatelet drug, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker, beta-blocker, and statin. After stratifying patients by the number of individual GDMT agents at 2 years, landmark analysis was conducted to assess the relationship between GDMT adherence at 2 years and 5-year major adverse cardiac events (MACEs), defined as a composite of all-cause death, target vessel-related myocardial infarction, clinically driven target vessel revascularization. Compared with the suboptimal GDMT group (continuing ≤3 types of medications, n = 974), the optimal GDMT group (n = 139) showed a lower 5-year incidence of MACE (5.2% vs. 12.4%, P = 0.02). The optimal GDMT was associated with a lower risk of MACE (hazard ratio: 0.41; 95% confidence interval: 0.18 to 0.92; P = 0.03)., Conclusion: Patients with optimal GDMT were associated with better outcomes, suggesting the importance of achieving optimal GDMT on long-term prognosis in CCS patients after FFR-guided deferral of revascularization., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Family caregivers provide long-term, home-based, informal medical care to patients with special healthcare needs. We examined whether informal care involving medical device use is associated with caregiver burden, considering potential risk variables as moderators. Data were collected from March to May 2019 through a Japanese public visiting care system. This system is offered to patients with severe chronic or intractable disease or impairment. After contacting government-certified offices that provide visiting care systems, the offices that agreed to participate invited dyads of patients and caregivers to complete our questionnaire. To focus on new parameters other than the caregiver factor that had been clarified previously, we aimed to analyse the data from patient-caregiver dyads. Using a questionnaire-based cross-sectional design, we asked participants about caregiver and patient characteristics, care types, and caregiver burden using the Zarit Caregiver Burden Interview. Logistic regression analyses were conducted to test the association between caregiver burden and informal medical care. Data from 371 complete patient-caregiver dyads were analysed; 49.3% showed high caregiver burden, and 40.4% were administering at least one informal medical care procedure. Univariate analyses indicated a relationship between high caregiver burden among caregivers who slept less, provided care for longer periods daily, performed medical care procedures and cohabited with patients. Importantly, logistic regression analyses indicated a significant relationship between high caregiver burden and care involving multiple medical procedures (i.e. 4-6 procedures with medical devices; adjusted odds ratio (AOR) = 2.03, 95% confidence intervals (95% CI) = [1.01, 4.09]). In propensity-matched participants (n = 314), results continued to show that multiple medical care procedures were significantly related to high caregiver burden (AOR = 2.19, 95% CI [1.14-4.22]). The effects of non-medical informal care on caregiver burden were moderate. This result suggests that more intensive interventions are required for patients with multiple medical care needs to reduce caregiver burden., (© 2022 John Wiley & Sons Ltd.)

Background: Little evidence is available regarding the long-term outcome in elderly patients after deferral of revascularization based on fractional flow reserve (FFR)., Methods and results: From the J-CONFIRM registry (long-term outcomes of Japanese patients with deferral of coronary intervention based on fractional flow reserve in multicenter registry), 1,262 patients were divided into 2 groups according to age: elderly and younger patients (aged ≥75 or <75 years, respectively). The primary endpoint was the cumulative 5-year incidence of target vessel failure (TVF), defined as a composite of cardiac death, target vessel-related myocardial infarction (TVMI), and clinically driven target vessel revascularization (CDTVR). Cumulative 5-year incidence of TVF was not significantly different between elderly and younger patients (14.3% vs. 10.8%, P=0.12). Cardiac death occurred more frequently in elderly patients than younger patients (4.4% vs. 0.8%, P<0.001), whereas TVMI and CDTVR did not differ between groups (1.3% vs. 0.9%, P=0.80; 10.7% vs. 10.1%, P=0.80, respectively). FFR values in lesions with diameter stenosis <50% were significantly higher in elderly patients than in younger patients (0.88±0.07 vs. 0.85±0.07, P=0.01), whereas this relationship was not observed in those with diameter stenosis ≥50%., Conclusions: Elderly patients had no excess risk of ischemic events related to the deferred coronary lesions by FFR, although FFR values in mild coronary artery stenosis were modestly different between elderly and younger patients.

Background: Hormonal therapy and radiotherapy are conducted concurrently or sequentially after breast cancer surgery. It remains unclear whether concurrent or sequential treatment is safer in terms of lung complications. Using a Japanese nationwide database, this study aimed to compare the occurrence of severe lung complications between concurrent and sequential treatments., Methods: We identified patients who underwent partial mastectomy for stage 0-III breast cancer from July 2010 to March 2020 and received adjuvant hormonal therapy and radiotherapy concurrently (n = 1851) or sequentially (n = 18,429). Two propensity score analyses (1:4 matching and overlap weighting) were conducted to compare hospitalization for radiation pneumonitis and pneumonia within 1 year after surgery, and intensive care unit admission and mortality during the hospitalization. We conducted additional analyses stratified by hormonal drugs (aromatase inhibitors and tamoxifen)., Results: The propensity score-matched analysis showed no significant differences in occurrence of hospitalization for radiation pneumonitis (0.27 vs. 0.58%, p = 0.10) and pneumonia (0.16 vs. 0.58%, p = 0.05) between the concurrent and sequential treatments. The overlap propensity score-weighted analysis also showed no significant differences (0.25 vs. 0.56%, p = 0.08 and 0.15 vs. 0.44%, p = 0.06, respectively). Intensive care unit admission and in-hospital mortality did not differ significantly between the two treatments. The stratified analysis showed similar results., Conclusion: Our propensity score analyses revealed no significant differences in severe lung complications between concurrent and sequential hormonal therapy with radiotherapy following breast cancer surgery, regardless of the type of hormonal drugs. Clinicians can provide concurrent or sequential treatment with equivalent attention to early lung complications., (© 2022. The Author(s), under exclusive licence to The Japanese Breast Cancer Society.)

Background: Prostate cancer is the second most common malignancy worldwide, and the majority of patients are diagnosed with localized disease. We examined patients' quality of life after stereotactic body radiation therapy (SBRT) for prostate cancer., Methods: We included patients who were treated between 2016 and 2020. Inclusion criteria were adenocarcinoma of the prostate; class risk of low, intermediate, and high; and a World Health Organization performance status of 0-2. Quality of life was measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P)., Results: A total of 439 patients were treated with SBRT, with a median age of 73 years old. The median follow-up period was 34 months. FACT-P Trial Outcome Index (p < 0.0001), FACT-General (p = 0.0003), and FACT-P-Total (p < 0.0001) scores declined at 1 month post-SBRT, then recovered and returned to the same level as before treatment at 3-4 months post-SBRT. The decrease in quality of life in the first month was particularly remarkable in patients who received long-term hormone injections (36%). One month after the end of SBRT, about 22% of patients experienced "quite a bit" or more troubling side effects., Conclusions: This study showed longitudinal changes in quality of life by FACT-P after SBRT for prostate cancer. Overall, prostate SBRT was well tolerated., (© 2022. The Author(s).)

Background: Although short-term mortality of acute myocardial infarction (AMI) has decreased dramatically in the past few decades, sudden cardiac arrest remains a serious complication. The aim of the study was to assess the clinical characteristics and predictors of prognosis in AMI patients who experienced out-of-hospital cardiac arrest (OHCA)., Methods: We retrospectively registered consecutive AMI patients who were treated with emergency percutaneous coronary intervention (PCI) between 2004 and 2017. Clinical characteristics and outcomes were compared between patients with OHCA and those without OHCA., Results: Among 2101 AMI patients, 95 (4.7%) presented with OHCA. Younger age (odds ratio [OR]: 0.95; 95% confidence interval [CI]: 0.93-0.97; p < 0.0001), absence of diabetes mellitus (OR, 0.51; 95% CI, 0.30-0.85; p = 0.01) or dyslipidemia (OR, 0.56; 95% CI, 0.36-0.88; p = 0.01), left main trunk (LMT) or left anterior descending artery (LAD) as the culprit lesion (OR, 3.26; 95% CI, 1.99-5.33; p < 0.0001), and renal deficiency (OR, 3.64; 95% CI, 2.27-5.84; p < 0.0001) were significantly associated with incidence of OHCA. Thirty-day mortality was 32.6% in patients with OHCA and 4.5% in those without OHCA. Multivariate logistic analysis revealed LMT or LAD as the culprit lesion (OR, 12.18; 95% CI, 2.27-65.41; p = 0.004), glucose level (OR, 1.01; 95% CI, 1.00-1.01; p = 0.01), and renal deficiency (OR, 3.35; 95% CI, 1.07-10.53; p = 0.04) as independent predictors of 30-day mortality among AMI patients with OHCA., Conclusions: In patients with AMI who underwent emergency PCI, 30-day mortality was six times greater in those having presented initially with OHCA compared with those without OHCA. Younger age, absence of diabetes mellitus or dyslipidemia, LMT or LAD as the culprit lesion, and renal deficiency were independent predictors of OHCA. OHCA patient with higher blood glucose level on admission, LMT or LAD as the culprit lesion, or renal deficiency showed worse clinical outcomes., (© 2022. The Author(s).)

The association between lipoprotein(a) (Lp[a]) levels and cardiovascular disease has been reported. However, it is still uncertain whether Lp(a) concentration could be a residual risk factor for cardiovascular events after acute coronary syndrome (ACS). The aim of the present study is to evaluate the impact of Lp(a) on long-term cardiovascular outcomes in patients with ACS treated with statins. We studied 1,758 consecutive patients with ACS who underwent emergency percutaneous coronary intervention between 2008 and 2017. We finally enrolled 1,131 patients for whom Lp(a) data were available and who were treated with statins at discharge. Patients were divided into 2 groups according to Lp(a) levels (median Lp(a) 15.0 mg/100 ml). The primary end points were major adverse cardiac events (MACEs), composite of all-cause death, and myocardial infarction up to 5 years. Overall, 107 MACEs (9.5%) were identified. The cumulative incidence of MACE was significantly higher in the high Lp(a) group than the low Lp(a) group (log-rank p = 0.01). After adjustment for other cardiovascular risk factors, the high Lp(a) group had a significantly higher risk of MACE (hazard ratio 1.66, 95% confidence interval 1.05 to 2.61, p = 0.03). Multivariate Cox hazard analysis also showed that increasing Lp(a) as a continuous variable was associated with the incidence of MACE (hazard ratio 1.35 per log Lp[a] 1 increase, 95% confidence interval 1.07 to 1.72, p = 0.01). In conclusion, high Lp(a) level is significantly associated with long-term cardiovascular outcomes in patients with ACS treated with statins after primary percutaneous coronary intervention and is likely to be a potential biomarker for residual risk prediction of future clinical events., Competing Interests: Disclosures The authors have no conflicts of interest to declare., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Importance: Clopidogrel monotherapy after short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) has not yet been fully investigated in patients with acute coronary syndrome (ACS)., Objective: To test the hypothesis of noninferiority of 1 to 2 months of DAPT compared with 12 months of DAPT for a composite end point of cardiovascular and bleeding events in patients with ACS., Design, Setting, and Participants: This multicenter, open-label, randomized clinical trial enrolled 4169 patients with ACS who underwent successful PCI using cobalt-chromium everolimus-eluting stents at 96 centers in Japan from December 2015 through June 2020. These data were analyzed from June to July 2021., Interventions: Patients were randomized either to 1 to 2 months of DAPT followed by clopidogrel monotherapy (n = 2078) or to 12 months of DAPT with aspirin and clopidogrel (n = 2091)., Main Outcomes and Measures: The primary end point was a composite of cardiovascular (cardiovascular death, myocardial infarction [MI], any stroke, or definite stent thrombosis) or bleeding (Thrombolysis in MI major or minor bleeding) events at 12 months, with a noninferiority margin of 50% on the hazard ratio (HR) scale. The major secondary end points were cardiovascular and bleeding components of the primary end point., Results: Among 4169 randomized patients, 33 withdrew consent. Of the 4136 included patients, the mean (SD) age was 66.8 (11.9) years, and 856 (21%) were women, 2324 (56%) had ST-segment elevation MI, and 826 (20%) had non-ST-segment elevation MI. A total of 4107 patients (99.3%) completed the 1-year follow-up in June 2021. One to 2 months of DAPT was not noninferior to 12 months of DAPT for the primary end point, which occurred in 65 of 2058 patients (3.2%) in the 1- to 2-month DAPT group and in 58 of 2057 patients (2.8%) in the 12-month DAPT group (absolute difference, 0.37% [95% CI, -0.68% to 1.42%]; HR, 1.14 [95% CI, 0.80-1.62]; P for noninferiority = .06). The major secondary cardiovascular end point occurred in 56 patients (2.8%) in the 1- to 2-month DAPT group and in 38 patients (1.9%) in the 12-month DAPT group (absolute difference, 0.90% [95% CI, -0.02% to 1.82%]; HR, 1.50 [95% CI, 0.99-2.26]). The major secondary bleeding end point occurred in 11 patients (0.5%) in the 1- to 2-month DAPT group and 24 patients (1.2%) in the 12-month DAPT group (absolute difference, -0.63% [95% CI, -1.20% to -0.06%]; HR, 0.46 [95% CI, 0.23-0.94])., Conclusions and Relevance: In patients with ACS with successful PCI, clopidogrel monotherapy after 1 to 2 months of DAPT failed to attest noninferiority to standard 12 months of DAPT for the net clinical benefit with a numerical increase in cardiovascular events despite reduction in bleeding events. The directionally different efficacy and safety outcomes indicate the need for further clinical trials., Trial Registration: ClinicalTrials.gov Identifiers: NCT02619760 and NCT03462498.

Dipeptidyl-peptidase-4 inhibitors (DPP4i) have been the most used antidiabetic medications worldwide due to their good safety profiles and tolerability with a low risk of hypoglycemia, however, large cardiovascular outcome trials (CVOTs) have not shown any significant the prognostic superiority. On the contrary, since observational studies have suggested the effects of DPP4i are enhanced some populations, such as Asians and those who without overweight, their prognostic benefit is still under debate. The aim of this study was thus to assess the prognostic impact of DPP4i in patients with both diabetes and coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) through the insulin-like growth factor-1 (IGF-1) axis, a substrate of DPP4. This single-center analysis involved consecutive Japanese diabetic patients who underwent PCI for the first time between 2008 and 2018 (n = 885). Primary and secondary endpoints were set as cardiovascular (CV) death and the composite of CV death, non-fatal myocardial infarction and ischemic stroke (3P-MACE). Serum levels of IGF-1 and its main binding protein (insulin-like growth factor binding protein-3: IGFBP-3) were measured. In consequences, unadjusted Kaplan-Meier analyses revealed reduced incidences of CV-death and 3P-MACE by DPP4i, which was particularly enhanced in patients who were not overweight (BMI ≤ 25). Multivariate Cox hazard analyses consistently indicated reduced risks of CV death by DPP4i at PCI (hazard ratio (HR) 0.39, 95% confidence interval (CI) 0.16-0.82, p = 0.01) and 3P-MACE (HR 0.47, 95% CI 0.25-0.84, p = 0.01), respectively. Moreover, elevated IGF-1 activity indicated by the IGF-1/IGFBP-3 ratio was associated with decreased risks of both endpoints and it was significantly higher in patients with DPP4i (p < 0.0001). In conclusion, the findings of the present study indicate beneficial effects of DPP4i to improve outcomes in Japanese diabetic patients following PCI, which might be mediated by DPP4-IGF-1 axis., (© 2022. The Author(s).)

We analyzed the efficacy and toxicity following reirradiation for locoregional recurrence of rare head and neck tumors. We retrospectively analyzed 17 patients who had received reirradiation for rare head and neck tumors. Primary tumor sites included nine ears (auditory organ), four salivary glands, and four orbits. The median follow-up time was 13.2 months for surviving patients. The median survival time was 12.6 months with one- and two-year survival rates of 53.1% and 44.3%, respectively. Nine out of 17 patients experienced local failure. The one- and two-year local control rates were 42.4% and 31.8%, respectively. The median survival times were 12.6, 5.3, and 11.0 months for orbit, auditory organ, and salivary glands, respectively. Three patients experienced grade 3 toxicity, including meningitis, brain necrosis, and facial nerve disorders. No grade ≥4 toxicities were observed. Reirradiation of rare head and neck tumors is feasible, with acceptable toxicity., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2022, Yamazaki et al.)

Objectives: The aim of this study was to evaluate the impact of thrombotic risk on the occurrence of cardiovascular events in patients with coronary artery disease with deferred revascularization after fractional flow reserve (FFR) measurements., Background: Deferral of revascularization on the basis of FFR is generally considered to be safe, but after deferral, some patients have cardiovascular events over time., Methods: From J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), 1,263 patients with deferral of revascularization on the basis of FFR were evaluated. The association between thrombotic risk as assessed by CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) thrombotic score and 5-year target vessel failure (TVF) and major adverse cardiac and cerebrovascular events (MACCE) was investigated., Results: FFR and high thrombotic risk (HTR) were associated with increased risk for 5-year TVF (FFR per 0.01-unit decrease: HR: 1.08; 95% CI: 1.05-1.11; P < 0.001; HTR: HR: 2.16; 95% CI: 1.37-3.39; P < 0.001) and MACCE (FFR per 0.01-unit decrease: HR: 1.05; 95% CI: 1.02-1.06; P < 0.001; HTR: HR: 2.11; 95% CI: 1.56-2.84; P = 0.001). Patients with HTR had higher risk for 5-year TVF (HR: 2.30; 95% CI: 1.45-3.66; P < 0.001) and MACCE (HR: 2.34; 95% CI: 1.75-3.13; P < 0.001) than those without HTR, even when they had negative FFR., Conclusions: Assessment of thrombotic risk provides additional prognostic value to FFR in predicting 5-year TVF and MACCE in patients with deferral of revascularization after FFR measurements. (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry; UMIN000014473)., Competing Interests: Funding Support and Author Disclosures This work was supported by Abbott Medical Japan, Phillips Japan, and Boston Scientific Japan. The funders of the study had no role in the study design, data collection, data analysis, interpretation of the data, writing of the report, or decision to submit the paper for publication. Dr Shiono has received lecture fees from Abbott Medical Japan and Phillips Japan. Dr Kuramitsu has received lecture fees from Abbott Medical Japan and Boston Scientific Japan. Dr Matsuo serves as an advisory board member for Zeon Medical; and has received lecture fees from Abbott Medical Japan, Phillips Japan, and Boston Scientific Japan. Dr Kikuta has received lecture fees from Abbott Medical Japan and Phillips Japan. Dr Asano has received lecture fees from Abbott Medical Japan and Phillips Japan. Dr Tanaka serves as advisory board member for Abbott Medical Japan and Boston Scientific Japan. Dr Yokoi has received lecture fees from Boston Scientific Japan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The aim of this study was to clarify the association between intrafractional prostate shift and hydrogel spacer., Methods: Thirty-eight patients who received definitive volumetric modulated arc therapy (VMAT)-stereotactic body radiation therapy (SBRT) for prostate cancer with prostate motion monitoring in our institution in 2018-2019 were retrospectively evaluated. In order to move the rectum away from the prostate, hydrogel spacer (SpaceOAR system, Boston Scientific, Marlborough, the United States) injection was proposed to the patients as an option in case of meeting the indication of use. We monitored intrafractional prostate motion by using a 4-dimensional (4D) transperineal ultrasound device: the Clarity 4D ultrasound system (Elekta AB). The deviation of the prostate was monitored in each direction: superior-inferior, left-right, and anterior-posterior. We also calculated the vector length. The maximum intrafractional displacement (MID) per fraction for each direction was detected and mean of MIDs was calculated per patient. The MIDs in the non-spacer group and the spacer group were compared using the unpaired t-test., Results: We reviewed 33 fractions in eight patients as the spacer group and 148 fractions in 30 patients as the non-spacer group. The superior MID was 0.47 ± 0.07 (mean ± SE) mm versus 0.97 ± 0.24 mm (P = 0.014), the inferior MID was 1.07 ± 0.11 mm versus 1.03 ± 0.25 mm (P = 0.88), the left MID was 0.74 ± 0.08 mm versus 0.87 ± 0.27 mm (P = 0.55), the right MID was 0.67 ± 0.08 mm versus 0.92 ± 0.21 mm (P = 0.17), the anterior MID was 0.45 ± 0.06 mm versus 1.16 ± 0.35 mm (P = 0.0023), and the posterior MID was 1.57 ± 0.17 mm versus 1.37 ± 0.22 mm (P = 0.56) in the non-spacer group and the spacer group, respectively. The max of VL was 2.24 ± 0.19 mm versus 2.89 ± 0.62 mm (P = 0.19), respectively., Conclusions: Our findings suggest that maximum intrafractional prostate motion during VMAT-SBRT was larger in patients with hydrogel spacer injection in the superior and anterior directions. Since this difference seemed not to disturb the dosimetric advantage of the hydrogel spacer, we do not recommend routine avoidance of the hydrogel spacer use., (© 2022. The Author(s).)

Background: Little large-scale data is available about the long-term (beyond 3 years) clinical outcomes after fractional flow reserve (FFR)-based deferral of revascularization in clinical practice. We sought to assess the 5-year outcomes after deferral of revascularization based on FFR., Methods: The J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry) prospectively enrolled 1263 patients with 1447 lesions in whom revascularization was deferred based on FFR from 28 Japanese centers. The primary study end point was the cumulative 5-year incidence of target vessel failure (TVF), including cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization., Results: Five-year follow-up was completed in 92.2% of patients. The 5-year TVF rate was 11.6% in deferred lesions, mainly driven by clinically driven target vessel revascularization (9.8%). Cardiac death and target vessel-related myocardial infarction were 1.9% and 0.95%, respectively. Cumulative 5-year incidence of TVF was similar between the FFR 0.75 to 0.80 and 0.81 to 0.85 groups even after adjustment for baseline characteristics (12.2% versus 13.0%, inverse probability-weighted hazard ratio, 0.86 [95% CI, 0.46-1.60]; P =0.63). Compared with the almost normal FFR (0.86-1.00) group, the significant (<0.75) and borderline (0.75-0.85) FFR groups showed a higher incidence of TVF at 5 years (29.9% versus 12.8% versus 8.6%, P <0.001). Independent predictors of the 5-year TVF were hemodialysis, FFR value, left main coronary artery lesion, prior percutaneous coronary intervention, and male sex., Conclusions: The 5-year TVF rate was 11.6% in deferred lesions, mainly driven by clinically driven target vessel revascularization. Notably, cardiac death and target vessel-related myocardial infarction rarely occurred during the follow-up. Our findings highlight the long-term safety of FFR-based deferral of revascularization in patients with chronic coronary syndrome. Registration: URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000014473.

Background: Patients with end-stage renal disease (ESRD) on chronic hemodialysis who are complicated by coronary artery disease (CAD) are at very high risk of cardiovascular (CV) events and mortality. However, the prognostic benefit of statins, which is firmly established in the general population, is still under debate in this particular population., Methods: As a part of a prospective single-center percutaneous coronary intervention (PCI) registry database, this study included consecutive patients on chronic hemodialysis who underwent PCI for the first time between 2000 and 2016 ( n = 201). Participants were divided into 2 groups by following 2 factors, such as (1) with or without statin, and (2) with or without high LDL-C (> and ≤LDL-C = 93 mg/dL, median) at the time of PCI. The primary endpoint was defined as CV death, and the secondary endpoints included all-cause and non-CV death, and 3 point major cardiovascular adverse events (3P-MACE) which is the composite of CV death, non-fatal myocardial infarction and stroke. The median and range of the follow-up period were 2.8, 0-15.2 years, respectively., Results: Kaplan-Meier analyses showed significantly lower cumulative incidences of primary and secondary endpoints other than non-CV deaths in patients receiving statins. Conversely, no difference was observed when patients were divided by the median LDL-C at the time of PCI ( p = 0.11). Multivariate Cox proportional hazard analysis identified statins as an independent predictor of reduced risk of CV death (Hazard ratio of statin use: 0.43, 95% confidence interval 0.18-0.88, p = 0.02), all-cause death (HR: 0.50, 95%CI 0.29-0.84, p = 0.007) and 3P-MACE (HR: 0.50, 95%CI 0.25-0.93, p = 0.03)., Conclusions: Statins were associated with reduced risk of adverse outcomes in patients with ESRD following PCI.

Red cell distribution width (RDW) has been shown to be an independent risk factor for increased cardiovascular mortality, heart failure, and cardiovascular disease. However, the association between RDW and long-term clinical outcomes in patients with chronic coronary syndrome (CCS) remains uncertain. In this study, a total of 2,881 CCS patients who underwent their first percutaneous coronary intervention (PCI) and who had available data on pre-procedural RDW between 2002 and 2016 were enrolled. Of these, 1,827 without anemia and severe renal dysfunction were divided into quartiles based on their RDW values. The primary endpoint was a composite of all-cause death and non-fatal myocardial infarction. As a result, patients in the higher RDW quartile groups were more likely to be older and have chronic kidney disease. During a median follow-up of 6.2 years, 209 (11.4%) events were identified. Kaplan-Meier curves showed the highest RDW quartile group had a clearly higher incidence of the primary endpoint (log-rank P = 0.0002). The highest RDW group had a significantly higher risk of cardiovascular events compared with the lowest RDW group, even after adjustment for other risk factors (hazard ratio 1.95, 95% confidence interval 1.04-3.67, P = 0.04). Increasing RDW as a continuous variable was also associated with the incidence of the primary endpoint (hazard ratio 1.46 per 1% increase, 95% confidence interval 1.24-1.69, P < 0.0001). In conclusion, this study demonstrated that increased RDW was associated with worse clinical outcomes after elective PCI. Assessing pre-PCI RDW may be useful for risk stratification of CCS.

We evaluated the efficacy and toxicity of reirradiation of nasal cavity or paranasal sinus tumors. We collected and analyzed multi-institutional data of reirradiation cases. Seventy-eight patients with nasal or paranasal sinus tumors underwent reirradiation. The median survival time was 20 months with a medial follow-up of 10.7 months. The 2-year local control and overall survival rates were 43% and 44%, respectively. Tumor volume (≤25 cm 3 ), duration between previous radiotherapy and reirradiation (≤12 months), histology (squamous cell carcinoma), male sex, and lymph node involvement were predisposing factors for poor survival. Distant metastasis was observed in 20 patients (25.6%). Grade ≥ 3 adverse events were observed in 22% of the patients, including five grade 4 (8.6%) cases and one grade 5 (1.2%) case. Tumor location adjacent to the optic pathway was a significant predisposing factor for grade ≥3 visual toxicity. Reirradiation of nasal and paranasal sinus tumors is feasible and effective. However, adverse events, including disease-related toxicities, were significant. Prognostic factors emerge from this study to guide multidisciplinary approaches and clinical trial designs.

The ultra-short dual antiplatelet therapy (DAPT) followed by P2Y 12 inhibitor monotherapy might be promising after percutaneous coronary intervention (PCI). However, CYP2C19 loss-of-function (LOF) alleles have been reported to diminish the effect of clopidogrel, and clopidogrel monotherapy has a concern about the increased ischemic risk for patients with such alleles. STOPDAPT-2 is the multicenter prospective open-label, but adjudicator-blinded randomized control study comparing 1-month DAPT followed by clopidogrel monotherapy with the standard 12-month DAPT after PCI with cobalt-chromium everolimus-eluting stents. Among the participants of STOPDAPT-2, selected patients participated in a substudy of the CYP2C19 gene test. Patients with two CYP2C19*2 or *3 alleles were defined as the poor metabolizer (PM), one allele as the intermediate metabolizer (IM), and no allele as the extensive metabolizer (EM). The primary endpoint was the composite of cardiovascular and bleeding events, as defined in STOPDAPT-2. Among 750 (24.9%) patients with known CYP2C19 genotypes, 129 (17.2%) were PM, 367 (49.0%) were IM, and 254 (33.9%) were EM. The hazard ratios of 1-month DAPT relative to 12-month DAPT for the primary endpoint in PM, IM, and EM strata were 0.66 (95% CI 0.11-3.94), 1.94 (95% CI 0.60-6.31), and 0.21 (95% CI 0.02-1.78), respectively (P interaction = 0.17), and those for cardiovascular composite endpoint were 1.00 (95% CI 0.14-7.10), 6.10 (95% CI 0.75-49.55), and 0.26 (95% CI 0.03-2.34), respectively (P interaction = 0.12). In conclusion, for the selected patients in STOPDAPT-2 trial, CYP2C19 LOF alleles had no significant, consistent interaction with the effect of 1-month DAPT relative to 12-month DAPT for clinical outcomes, although the study was overtly underpowered. TRIAL REGISTRY: STOPDAPT-2 ClinicalTrials.gov number, NCT02619760., (© 2020. Japanese Association of Cardiovascular Intervention and Therapeutics.)

Objective: The radiotherapy utilization rate in Japan is lower than that in other developed countries. This study identified factors associated with the low rate, by conducting an online survey of Japanese cancer survivors., Methods: We reviewed the web survey results of Japanese cancer patients. The survey examined the process of choosing treatments and the actual treatment received. We included respondents whose most engaged-in treatment was either radiotherapy or surgery, dividing them into two groups. We used the chi-square test to compare the patients in the both groups for their impression of the therapy, decision-making approach, and decision to seek second medical opinions (SMOs). To assess the relationship between seeking SMOs, being most engaged in radiotherapy, and feeling satisfied, we used the structural equation modeling (SEM) approach., Results: We included 139 patients in the radiotherapy group and 681 patients in the surgery group. Compared with patients in the surgery group, more patients in the radiotherapy group sought SMOs (19% vs. 28%), shared opinions with their doctor (27% vs. 42%), and were satisfied with their treatment (69% vs. 78%). SEM analysis showed that seeking SMOs contributed to radiotherapy being the most-engaged-in therapy (β = 0.23; P < 0.01), and the treatment contributed to the satisfaction (β = 0.15; P < 0.01)., Conclusion: Patients who underwent radiotherapy felt more satisfied with the treatment than patients who underwent surgery. Perceptions about radiotherapy and SMOs may be a reason for the low utilization of radiotherapy in Japan.

Background: The efficacy of a hydrogel spacer in stereotactic body radiotherapy (SBRT) has not been clarified. We evaluated the safety and efficacy of SBRT in combination with a hydrogel spacer for prostate cancer., Methods: This is a prospective single-center, single-arm phase II study. Prostate cancer patients without lymph node or distant metastasis were eligible. All patients received a hydrogel spacer insertion, followed by SBRT of 36.25 Gy in 5 fractions with volumetric modulated arc therapy. The primary endpoint was physician-assessed acute gastrointestinal (GI) toxicity within 3 months. The secondary endpoints were physician-assessed acute genitourinary (GU) toxicity, patient-reported outcomes evaluated by the EPIC and FACT-P questionnaires, and dosimetric comparison. We used propensity score-matched analyses to compare patients with the hydrogel spacer with those without the spacer. The historical data of the control without a hydrogel spacer was obtained from our hospital's electronic records., Results: Forty patients were enrolled between February 2017 and July 2018. A hydrogel spacer significantly reduced the dose to the rectum. Grade 2 acute GI and GU toxicity occurred in seven (18%) and 17 (44%) patients. The EPIC bowel and urinary summary score declined from the baseline to the first month (P < 0.01, < 0.01), yet it was still significantly lower in the third month (P < 0.01, P = 0.04). For propensity score-matched analyses, no significant differences in acute GI and GU toxicity were observed between the two groups. The EPIC bowel summary score was significantly better in the spacer group at 1 month (82.2 in the spacer group and 68.5 in the control group)., Conclusions: SBRT with a hydrogel spacer had the dosimetric benefits of reducing the rectal doses. The use of the hydrogel spacer did not reduce physician-assessed acute toxicity, but it improved patient-reported acute bowel toxicity., Trial Registration: Trial registration: UMIN-CTR, UMIN000026213. Registered 19 February 2017, https://upload.umin.ac.jp/cgi-open-bin/ctr&#95;e/ctr&#95;view.cgi?recptno=R000029385 .

Long-term clinical outcomes among patients with cardiogenic shock (CS) and heart failure (HF) who survive the early phase of acute myocardial infarction (AMI) remain uncertain. We investigated 3283 consecutive patients with AMI, selected from a prospective, nation-wide multicenter registry (J-MINUET) database comprising 28 institutions in Japan between July 2012 and March 2014. The 3263 eligible patients were divided into the following three groups: CS-/HF- group (n = 2467, 75.6%); CS-/HF+ group (n = 479, 14.7%); and CS+ group (n = 317, 9.7%). The thirty-day mortality rate in CS+ patients was 32.8%, significantly higher than in CS- patients. Among CS+ patients, multivariate logistic regression analysis identified statin use before admission (Odds ratio (OR) 0.32, 95% confidence interval (CI) 0.14-0.66, P = 0.002), renal deficiency (OR 8.72, 95%CI 2.81-38.67, P < 0.0001) and final thrombolysis in myocardial infarction flow grade (OR 0.42, 95%CI 0.18-0.99, P = 0.046) were associated with 30-day mortality. Landmark Kaplan-Meier analysis showed that mortality rates after 30 days were comparable between CS+ and CS-/HF+ groups but were lower in the CS-/HF- group. Multivariate Cox hazard analysis also showed that hazard risk of mortality after 30 days was comparable between the CS+ and CS-/HF+ groups (Hazard ratio (HR) 1.03, 95%CI 0.63-1.68, P = 0.90), and significantly lower in the CS-/HF- group (HR 0.44, 95%CI 0.32-059, P < 0.0001). In conclusion, AMI patients with CS who survived 30 days experienced worse long-term outcomes compared with those without CS up to 3 years. Attention is required for patients who show HF on admission without CS to improve long-term AMI outcomes.

Cardiovascular disease is a major cause of death among travelers, but the clinical characteristics and clinical outcomes of patients who develop acute coronary syndrome (ACS) while traveling have not been assessed. We evaluated 2548 patients with ACS who underwent primary percutaneous coronary intervention (PCI) between 1999 and 2015 and compared the incidences of all-cause and cardiac death during follow-up between travelers and locals. We assessed 192 (7.5%) patients who developed ACS while traveling. These patients were younger and had a higher prevalence of ST-elevation myocardial infarction than local patients. During a median follow-up period of 5.3 years, 632 (24.8%) all-cause deaths were identified, including 310 cardiac deaths (12.2%). Kaplan-Meier analysis revealed that the cumulative incidence of all-cause death was significantly lower among the travelers than locals (P = 0.001, log-rank test). Multivariate Cox hazard analysis revealed that travel was significantly associated with a lower rate of all cause death (hazard ratio, 0.53; 95% confidence interval, 0.33-0.80; P = 0.002). Cardiac mortality did not significantly differ between travelers and locals (P = 0.29). Patients with ACS treated with primary PCI while traveling had more favorable long-term clinical outcomes than local patients. Appropriate initial treatments and secondary preventions might improve the prognosis of travelers.