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Background: Neuromodulation through spinal cord stimulation (SCS) is a therapeutic option for relieving leg pain and improving the chances of limb salvage in patients with intractable chronic limb‐threatening ischemia (CLTI); however, there is no consensus on its indications. Objective: The aim of this study was to assess the clinical outcomes of SCS in patients with intractable leg pain caused by various diseases treated in the department of cardiovascular medicine in Japan. Methods: This was a retrospective study of patients who underwent SCS for pain management. Patients were considered eligible for the therapy if they met the following criteria: (1) intractable leg pain (numerical rating scale [NRS] score of 10), (2) no revascularization option, and (3) no septicemia. Results: Twenty patients (mean age: 77 years; men/women: 11/9) were included in this study. The NRS score of the patients significantly reduced from 10 ± 0 before procedure to 4 ± 3 at discharge (p < 0.001). The clinical response rate of the entire cohort was 65% (13/20) at 17 ± 14 months after implantation; however, patients with intractable CLTI showed a low response rate (45%), whereas those with subacute limb ischemia showed a high response rate (100%). A multivariable regression analysis showed that hemoglobin level was significantly associated with treatment response, even after adjusting for age and sex (p = 0.026). The area under the receiver operating characteristic curve for the correlation between hemoglobin level (cutoff, 11.4 g/dL) and clinical response to SCS was 0.824 (0.619–1). Conclusions: SCS can reduce clinical symptoms in majority of patients with intractable leg pain. Although implantation of an SCS device has been shown to improve microvascular perfusion insufficiency, the correlation between hemoglobin level and the clinical effect of SCS indicates that a preserved microcirculatory vascular bed is essential for the therapy to be effective. [ABSTRACT FROM AUTHOR]

Background: This study aimed to reveal the prevalence of sodium-glucose co-transporter 2 (SGLT2) inhibitor treatment and its association with restenosis risk in patients with diabetes mellitus undergoing endovascular therapy for symptomatic peripheral artery disease. Methods: We used the database of a multicenter prospective study registering patients with symptomatic peripheral artery disease undergoing femoropopliteal drug-coated balloon treatment in Japan. The current analysis included 1058 patients with diabetes mellitus free from end-stage renal disease. The association of clinical characteristics with SGLT2 inhibitor use was investigated using the logistic regression model. The propensity score matching was adopted to compare the primary patency, i.e., freedom from restenosis, after endovascular therapy between patients treated with and without a SGLT2 inhibitor. Results: The proportion of SGLT2 inhibitor treatment at revascularization was 14.8% (95% confidence interval, 12.8–17.1%). Younger age, increased body mass index, and increased hemoglobin A1c levels were independently associated with SGLT2 inhibitor use (all P < 0.05). The proportion of SGLT2 inhibitor reached 38.2% (95% confidence interval, 25.4–52.3%) in patients with the three associated factors. The propensity score-matching analysis demonstrated that primary patency was not different between patients treated with a SGLT2 inhibitor and those without it (72.0% [95% confidence interval, 64.1–80.9%] versus 67.8% [62.7–73.3%] at 2 years; P = 0.45). Conclusions: SGLT2 inhibitors were not rarely used in patients with diabetes mellitus who underwent femoropopliteal endovascular therapy using a drug coated balloon for symptomatic peripheral artery disease in real-world settings. SGLT2 inhibitor treatment was not associated with an increased risk of restenosis. [ABSTRACT FROM AUTHOR]

Introduction: Cilostazol is a selective cyclic inhibitor of the 3-phosphodiesterase type (PDE3) that is recommended to be administered in cases of symptomatic peripheral vascular disease (YEI). It was discovered as a chemical compound in the 1980s, in Takao Nishi laboratory in Japan. Objective: The purpose of the present review was to evaluate the efficacy of cilostazol administration in a YEI with intermittent claudication or moderate to severe lower extremity ischemia. Material and method: A systematic review of the literature was carried out where articles were searched in the international database PubMed. The year 2005 was set as a time limit for the publication date of the articles. The following keywords were used: cilostazol, peripheral arterial disease, revascularization and lower limb. A total of 95 articles were found, of which only 10 were selected for the present study. Results: According to the results of the current review, the use of cilostazol increases the ability to walk, improves the quality of life, reduces the rates of re-narrowing of vessels and stents, reduces the likelihood of amputation and is co-administered with other antiplatelet and anticoagulant agents. Conclusions: Cilostazol administration should be a possible treatment option for symptomatic YEI. Further research is necessary to determine its safety after three years. [ABSTRACT FROM AUTHOR]

Peripheral artery disease (PAD) is commonly caused by atherosclerosis and has an unfavorable prognosis. Complete revascularization (CR) of the coronary artery reduces the risk of major adverse cardiovascular event (MACE) in patients with coronary artery disease (CAD). However, the impact of CR in patients with PAD has not been established to date. Therefore, we evaluated the impact of CR of CAD on the five-year clinical outcomes in patients with PAD. This study was based on a prospective, multicenter, observational registry in Japan. We enrolled 366 patients with PAD undergoing endovascular treatment. The primary endpoint was MACE, defined as a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke. After excluding ineligible patients, 96 and 68 patients received complete revascularization of the coronary artery (CR group) and incomplete revascularization of the coronary artery (ICR group), respectively. Freedom from MACE in the CR group was significantly higher than in the ICR group at 5 years (66.7% vs 46.0%, p < 0.01). Multivariate analysis revealed that CR emerged as an independent predictor of MACE (Hazard ratio: 0.56, 95% confidential interval: 0.34–0.94, p = 0.03). CR of CAD was significantly associated with improved clinical outcomes in patients with PAD undergoing endovascular treatment. [ABSTRACT FROM AUTHOR]

We investigated the clinical impact of hemodialysis on long-term outcomes of bypass surgery in patients with peripheral artery disease. We evaluated 660 consecutive patients who underwent successful bypass surgery (392 hemodialysis and 268 non-hemodialysis). The endpoint was amputation-free survival (AFS). To minimize differences in clinical characteristics between the 2 groups, propensity score matching was performed. The AFS rates for 10-year follow-up were 39.3% and 67.7% in hemodialysis and non-hemodialysis patients [hazard ratio (HR) 2.21, 95% confidence interval (CI) 1.65–3.01, P <.0001]. Cumulative incidence of amputation was higher in the hemodialysis group than in the non-hemodialysis group [(19.4 vs 8.4%, HR 2.15, 95% CI 1.29–3.74, P =.0027). In a matched cohort (n = 210 each), AFS was still lower in the hemodialysis patients (53.1 vs 66.3%, HR 1.94, 95% CI 1.36–2.82, P =.0003). However, there was no significant difference in amputation rate between the groups (10.5 vs 10.6%, HR.97, 95% CI 0.49–1.87, P =.93). In a sub-analysis of patients with critical limb ischemia, similar results were obtained. The 10-year AFS was consistently lower in the hemodialysis group than in the non-hemodialysis group. However, the amputation rate was comparable between the groups when matched for the differences in clinical characteristics. [ABSTRACT FROM AUTHOR]

Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS2°P) is a contemporary risk scoring system for secondary prevention based on nine clinical factors. However, this scoring system has not been validated in other populations. The aim of this study was to validate the TRS2°P in patients with acute myocardial infarction (AMI) treated with primary percutaneous coronary intervention (PCI) in a nationwide registry cohort. Among 3283 consecutive patients with AMI enrolled in the Japanese registry of acute Myocardial INfarction diagnosed by Universal dEfiniTion (J-MINUET), a total of 2611 patients who underwent primary PCI were included in this study. The performance of the TRS2°P to predict major adverse cardiovascular events (MACE) composed of all-cause death, non-fatal MI, and non-fatal stroke up to 3 years in the present cohort was evaluated. The TRS2°P had modest discriminative performance in this J-MINUET cohort with a c-statistic of 0.63, similar to that in the derived cohort (TRA2°P-TIMI50, c-statistic 0.67). A strong graded relationship between the TRS2°P and 3-year cardiovascular event rates was also observed in the J-MINUET cohort. Age ≥ 75 years, Killip ≥ 2, prior stroke, peripheral artery disease, anemia, and non-ST-elevation myocardial infarction were identified as independent factors for the incidence of MACE. The TRS2°P modestly predicted secondary cardiovascular events among patients with AMI treated by primary PCI in a nationwide cohort of Japan. Further studies are needed to develop a novel risk score better predicting secondary cardiovascular events. [ABSTRACT FROM AUTHOR]

Purpose: To present a subgroup analysis of patients from a large real-world study evaluating the safety and effectiveness of the Zilver PTX drug-eluting stent (DES) for treating femoropopliteal in-stent restenosis (ISR).Materials and Methods: This study examined patients enrolled in the Zilver PTX Japan Post-Market Surveillance Study (ClinicalTrials.gov identifier NCT02254837), a prospective, multicenter registry of 904 symptomatic patients with 1082 femoropopliteal lesions treated with the DES at 95 institutions in Japan. Five-year outcomes, including mortality, stent radiography, freedom from target lesion revascularization (TLR), and clinical benefit, were evaluated for 177 patients (mean age 74.2±8.3 years; 118 men) with 204 ISR lesions treated with the Zilver DES. Over half of the patients (108, 61.0%) were diabetic. Mean lesion length was 17.8±10.4 cm, and a third (72, 35.3%) were total occlusions. Outcome measures were all-cause mortality, thrombosis, freedom from TLR, and clinical benefit, defined as freedom from persistent or deteriorating ischemic symptoms.Results: No device-related or procedure-related deaths or paclitaxel-related adverse events were reported. All-cause mortality was 25.1% at 5 years. Stent fracture was observed in 5 stents through 5 years. The 5-year rate of freedom from clinically-driven TLR was 73.4%, and the rate of clinical benefit was 63.6%. Improvement in Rutherford category and ankle-brachial index was sustained through 5 years.Conclusion: The safety and effectiveness of the Zilver PTX stent for the treatment of femoropopliteal ISR lesions demonstrated that this device provides a favorable treatment option in this difficult-to-treat subgroup. [ABSTRACT FROM AUTHOR]

Atherosclerosis is a systemic process. As the population ages, increasingly more patients who undergo coronary revascularization are complicated with peripheral artery disease (PAD). However, the large body of evidence in this area has not been limited to analysis from trial-based data from younger and relatively uncomplicated patients in Western countries. The impact of PAD on the outcomes can differ by patient characteristics, and integrated analysis of large-scale data is necessary. J-PCI is a universal (all-comer) nationwide registration system in Japan, regulated and audited by professional society that controls national board-certification system. For the present study, we extracted data of 894,014 percutaneous coronary intervention (PCI) cases performed between 2014 and 2017 (mean age 70.2 years [standard deviation 11.0]). In-hospital outcomes of PAD and Non-PAD patients were compared. PAD was defined as a previous history of stenosis of peripheral arteries or abdominal aortic aneurysm. Primary outcome was in-hospital mortality, and multivariable modeling was performed. A total of 66,891 patients (8.1%) had PAD. Crude in-hospital mortality rate was higher in this group (0.99% vs. 0.67% in Non-PAD group). PAD was associated with an increased risk of in-hospital mortality (odds ratio [OR] 1.383 [95% confidence interval 1.251–1.528]). However, the impact of PAD differed by kidney condition (OR 1.578 [1.370–1.821] for patients with chronic kidney disease [CKD] and OR 1.234 [1.076–1.416] without CKD: P for interaction 0.005), and by clinical presentation: PAD was not associated with an increased risk of in-hospital mortality in patients undergoing PCI for silent ischemia (OR 1.211 [0.8701–1.685]: P for interaction 0.002). Presence of PAD was independently associated with in-hospital mortality in patients receiving PCI. However, its impact varied substantially by the patient background or indication of the procedure. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the incidence and clinical predictors, including institutional annual case volume, of critical in-hospital complications after endovascular therapy (EVT) for peripheral artery disease (PAD).Materials and Methods: The data were extracted from the nationwide registry of peripheral interventions in Japan [Japanese EVT (J-EVT)] between 2012 and 2017. A total of 92,224 EVT cases either for chronic limb-threatening ischemia (CLTI) or intermittent claudication were included in the analysis. The primary outcome measure was critical in-hospital complications, which were defined as a composite of urgent surgery and in-hospital death within 30 days after EVT. The institutional volume was classified into quartiles. The association of institutional volume, as well as baseline characteristics, with the critical in-hospital complications was explored using a multivariable logistic regression model with multiple imputation for missing data. Results are presented as the adjusted odds ratio (OR) with the 95% confidence intervals (CI).Results: The estimated prevalence of critical in-hospital complications was 0.3% (95% CI 0.3% to 0.4%). The following 10 patient- and limb-related characteristics were identified as independent risk factors for critical in-hospital complications: (1) female sex (OR 1.75, 95% CI 1.36 to 2.25), (2) age ≥75 years (OR 1.60, 95% CI 1.06 to 2.40), (3) CLTI (OR 2.12, 95% CI 1.47 to 3.05), (4) nonambulatory status (OR 1.66, 95% CI 1.23 to 2.24), (5) regular dialysis (OR 1.35, 95% CI 1.02 to 1.77), (6) cerebrovascular disease (OR 1.76, 95% CI 1.33 to 2.33), (7) urgent revascularization (OR 5.10, 95% CI 3.64 to 7.13), (8) aortoiliac TASC II D lesion (OR 3.65, 95% CI 2.51 to 5.33), (9) femoropopliteal TASC II D lesion (OR 1.77, 95% CI 1.24 to 2.52), and (10) infrapopliteal TASC D lesion (OR 1.52, 95% CI 1.08 to 2.13). In addition, the 4th quartile of the institutional volume (≥158 cases/year), but not the 2nd or 3rd quartile, had a significantly and independently lower risk of critical in-hospital complications than the 1st quartile (OR 0.13, 95% CI 0.07 to 0.23).Conclusion: After EVT for symptomatic PAD, 0.3% of the population encountered critical in-hospital complications. A higher institutional volume was significantly associated with a lower risk of critical in-hospital complications. [ABSTRACT FROM AUTHOR]

Purpose: To determine whether limb-based patency (LBP) after infrainguinal revascularization for chronic limb-threatening ischemia (CLTI) is similar between bypass surgery and endovascular therapy (EVT).Materials and Methods: The database for the Surgical Reconstruction vs Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) study was interrogated to identify 130 patients (mean age 73±8 years; 94 men) who underwent bypass surgery and 271 patients (mean age 74±10 years; 178 men) who underwent EVT alone. Skin perfusion pressure (SPP) and the ankle-brachial index (ABI) were measured before the procedure and at 0, 1, and 3 months after revascularization. The outcome measure was hemodynamically evaluated LBP (SPP ≥10 mm Hg or ABI ≥0.1) maintained over the first 3 months after treatment. Any reintervention or major amputation was regarded as loss of LBP. The associations between the revascularization strategy (bypass vs EVT) and between the preoperative characteristics and the study outcome (ie, SPP- or ABI-based LBP), were determined using generalized linear mixed models with a logit link function. Patency rates are presented with the 95% confidence interval (CI).Results: The bypass surgery group had a higher stage of limb severity (WIfI) and anatomic complexity (GLASS) than the EVT group, whereas the EVT group had a higher prevalence of heart failure. Both SPP- and ABI-based LBP rates were higher in the bypass group than in the EVT group. SPP-based LBP rates at 3 months were 73.8% (95% CI 63.4% to 84.2%) in the bypass group and 46.2% (95% CI 38.5% to 53.8%) in the EVT group; the corresponding ABI-based LBP rates were 71.5% (95% CI 61.8% to 81.2%) and 44.0% (95% CI 37.3% to 50.7%).Conclusion: LBP is an important concept in the new global vascular guidelines for assessing the anatomic and hemodynamic status of CLTI patients. The present study found that LBP was significantly lower in the EVT group vs the bypass surgery group. [ABSTRACT FROM AUTHOR]

Background: As Japan has an aging population, elderly patients with multiple complicating comorbidities have increased in number. The purpose of the present study was to examine the 90-day mortality and reoperation rate after emergency amputation of the lower limbs and to clarify patient characteristics and preoperative comorbidities that are risk factors for reoperations.Methods: This retrospective case study was conducted between January 2005 and December 2017. Ninety-one patients with 108 limbs who had undergone emergency amputation of the lower limbs were included in this study. Baseline data, medical comorbidities, surgical procedures and laboratory data including C-reactive protein (CRP), white blood cells (WBC) and hemoglobin A1c (HbA1c) were evaluated. Outcome measurements were mortality, reoperation rate, and factors associated with reoperation in 90 days and any complication after amputation of the lower limbs.Results: The patients (male/female ratio = 64/27) had a mean age of 64.9 years, a mean WBC count of 16,747/μL, a mean CRP value of 15.6 mg/dL, and a mean HbA1c value of 7.5%. The 90-day mortality rate in the study population was 12.1%. The 90-day reoperation rate was 35.2% (32/91) patients with 32.4% (35/108) limbs. The factor significantly associated with reoperation in 90 days was peripheral arterial disease (PAD) (p = 0.022, HR = 2.75), identified with Cox proportional hazards regression analysis. A total of 41.8% (38/91) patients with 40.7% (44/108) limbs experienced postoperative wound complications. The overall rate of medical complications was 18.7% (17/91) patients with 16.7% (18/108) limbs.Conclusions: This study indicates that the 90-day mortality and reoperation rates after emergency amputation of the lower limbs were high. Furthermore, PAD influences the rate of reoperation in 90 days. However, there was no association between laboratory results or diabetes mellitus and reoperation. These findings will have important implications for the treatment of lower leg amputation and prevention of reoperation. [ABSTRACT FROM AUTHOR]

Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy (ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent. [ABSTRACT FROM AUTHOR]

Myocardial infarction with nonobstructive coronary arteries (MINOCA) is a common presentation of acute myocardial infarction (AMI) and has a better prognosis. However, there were few reports on large-scale, high aged population. The aim of this study was to determine the differences in the clinical characteristics and short-term prognosis between MINOCA and myocardial infarction with obstructive coronary artery disease (MI-CAD) using a nationwide administrative database in the super-aging society, Japan. This was an observational study using data of 137,678 AMI patients who underwent angiography between April 2012 through March 2016. Using the international classification of diseases 10th revision, AMI patients were divided into two groups based on the presence or absence of revascularization and coronary atherosclerosis, identifying 123,633 MI-CAD and 14,045 working diagnosis of MINOCA patients. The true MINOCA (n = 13,022) was defined as the MINOCA excluding non-ischemic causes. We assessed in-hospital mortality within 30 days. Both MINOCA groups were typically found in non-obese, non-smoker young females, with a low grade on Killip classification, and non-low ADL status. Compared to MI-CAD, chronic pulmonary diseases, peripheral vascular diseases, liver diseases, renal diseases, and cerebrovascular diseases were more common, whereas diabetes was less common in the MINOCA groups. In-hospital mortality within 30 days was higher in both MINOCA groups than in MI-CAD. Multivariate frailty model identified both MINOCA groups as an independent risk factor for in-hospital mortality. Our large-population study demonstrated that MINOCA was associated with a high risk of in-hospital mortality compared with MI-CAD in the super-aging society. • This study showed the characteristics of MINOCA in the super-aged society. • MINOCA was associated with a higher risk for in-hospital mortality. • The prognosis of MINOCA was heterogeneous due to the diversity of the causes. [ABSTRACT FROM AUTHOR]

Critical limb ischemia represents the advanced stage of peripheral artery disease, a health problem with increasing prevalence. Critical limb ischemia is associated with significant mortality, limb loss, pain, and diminished health-related quality of life. Public awareness and early diagnosis are necessary for an effective treatment with early risk factor modification, smoking cessation, and exercise therapy. Herein, we present an overview of the epidemiology as well as the clinical stages of the disease, and estimate that there are 6.5 million patients with critical limb ischemia in the US, Europe, and Japan based on global population-based studies. At least 75% of these patients, accounting for approximately 4.8 million patients, are amenable to endovascular therapy. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of the study is to report 12-month efficacy and safety results from the subgroup of Japanese patients in the prospective IMPERIAL 2:1 randomized controlled trial (RCT).Methods: The global IMPERIAL RCT was designed to compare performance of the Eluvia Drug-Eluting Vascular Stent System (Boston Scientific, Marlborough, MA, USA) with the Zilver PTX Drug-Eluting Peripheral Stent (Cook Medical, Bloomington, IN, USA) for treatment of femoropopliteal artery lesions. Patients with symptomatic (Rutherford category 2-4) disease were included. Post-procedural technical success was defined as delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% by visual assessment. Twelve-month assessments included primary patency (core laboratory-assessed duplex ultrasound peak systolic velocity ratio ≤ 2.4 in the absence of clinically driven TLR or bypass of the target lesion) and major adverse events (MAEs).Results: Fifty-six patients in the Eluvia group and 28 in the Zilver PTX group were treated at Japanese centers. Mean lesion length was 91.8 ± 38.0 mm for Eluvia and 87.4 ± 41.7 mm for Zilver PTX. Technical success was 100% for both groups. At 12 months, the observed primary patency rate was 90.9% for Eluvia and 84.6% for Zilver PTX. The 12-month MAE rate was 1.8% for Eluvia and 7.7% for Zilver PTX. All MAEs were clinically driven TLRs.Conclusion: The results show excellent vessel patency and a good safety profile up to 1 year in the subgroup of Japanese patients in IMPERIAL treated with Eluvia for femoropopliteal artery disease.Level Of Evidence: Level 3; subgroup analysis of randomized trial.Clinical Trial Registration: ClinicalTrials.gov, identifier NCT02574481. [ABSTRACT FROM AUTHOR]

The concept of angiogenic therapy emerged in the early 1990s. The method employs genes that encode growth factors to promote formation of new vessels and remodeling of collateral vessels. Since the procedure involved in this therapy usually only consists of local injections of vectors, the process is minimally invasive, quick, and simple to perform. However, since the first clinical evidence of the effects of gene therapy with vascular endothelial growth factor (VEGF) was observed in patients with peripheral artery disease, to date only two angiogenic therapy drugs have been approved, one in Russia and another in Japan, which seem a very small number, in view of the large volume of investment made in pre-clinical and clinical studies. After all, can we conclude that angiogenic therapy is a reality? [ABSTRACT FROM AUTHOR]

Purpose: Patient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel.Methods: Data from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the BMS study was limited to 3 years and is complete. Kaplan-Meier analyses assessed mortality. A Cox proportional hazards model identified significant factors related to mortality.Results: In the RCT, there were 336 patients treated with the DES and 143 patients treated with percutaneous transluminal angioplasty (PTA) or BMS. In Japan, there were 904 DES patients and 190 BMS patients. There was no difference in all-cause mortality for the DES compared to PTA/BMS in the RCT (19.1% DES versus 17.1% PTA/BMS through 5 years, p = 0.60) or Japan (15.8% DES versus 15.3% BMS through 3 years, p = 0.89). Cox proportional hazard models revealed that age, tissue loss, and congestive heart failure were significantly associated with mortality in the RCT, and critical limb ischemia, age, renal failure, and gender were significantly associated with mortality in Japan (all p < 0.05). Neither treatment with Zilver PTX (p = 0.46 RCT, p = 0.49 Japan) nor paclitaxel dose (p = 0.86 RCT, p = 0.07 Japan) was associated with mortality.Conclusion: Analyses of the Zilver PTX patient-level data demonstrated no increase in long-term all-cause mortality.Level Of Evidence: Zilver PTX RCT: Level 1, randomized controlled trial; Japan PMS studies: Level 3, post-market surveillance study. [ABSTRACT FROM AUTHOR]

Background: Lower-extremity peripheral artery disease (LE-PAD) and coronary artery disease (CAD) are both pathologically rooted in atherosclerosis, and their shared clinical features regarding the exposure to cardiovascular risk factors have been emphasized. However, comparative data of the two cardiovascular diseases (CVDs) were so far lacking. The purpose of this study was to directly compare the clinical profile between cases undergoing endovascular therapy (EVT) for LE-PAD and those undergoing percutaneous coronary intervention (PCI). Methods: Data were extracted from the nationwide procedural databases of EVT and PCI in Japan (J-EVT and J-PCI) between 2012 and 2017. A total of 1,121,359 cases (103,887 EVT cases for critical limb ischemia [CLI] or intermittent claudication and 1,017,472 PCI cases for acute coronary syndrome [ACS] or stable angina) were analyzed. Heterogeneity in clinical profile between CVDs was evaluated using the C statistic of the logistic regression model for which dependent variable was one CVD versus another, and explanatory variables were clinical profile. When two CVDs were completely discriminated from each other by the developed model, the C statistic (discrimination ability) of the model would be equal to 1, indicating that the two CVDs were completely different in clinical profile. On the other hand, when two CVDs were identical in clinical profile, the developed model would not discriminate them at all, with the C statistic equal to 0.5. Results: Mean age was 73.5 ± 9.3 years in LE-PAD patients versus 70.0 ± 11.2 years in CAD patients (P < 0.001). The prevalence of diabetes mellitus and end-stage renal disease was 1.96- and 6.39-times higher in LE-PAD patients than in CAD patients (both P < 0.001). The higher prevalence was observed irrespective of age group. The exposure to other cardiovascular risk factors and the likelihood of cardiovascular risk clustering also varied between the diseases. The between-disease heterogeneity in patient profile was particularly evident between CLI and ACS, with the C statistic equal to 0.833 (95% CI 0.831–0.836). Conclusions: The current study, an analysis based on nationwide procedural databases, confirmed that patient profiles were not identical but rather considerably different between clinically significant LE-PAD and CAD warranting revascularization. [ABSTRACT FROM AUTHOR]

Background: Recently, coefficients in the equation of cardio-ankle vascular index (CAVI) used in VaSera® device were disclosed. This study aimed to simulate the influence of adjusting the coefficients in the equation of CAVI and also aimed to validate the equation.Methods: The CAVI displayed by VaSera (CAVIvs) and the CAVI estimated (CAVIes) with fixing the coefficients of the middle range of the heart-ankle stiffness parameter β (haβ) in the equation were compared. Moreover, the heart-ankle pulse wave velocity (haPWV) which corresponds to the low cutoff haβ of 7.348 was estimated in various blood pressure patterns to validate the formula.Results: The CAVIvs was clearly lower than CAVIes in the low and the high range of CAVIvs. Moreover, it was virtually impossible to obtain the low cutoff haβ of 7.348 by using typical values of haPWV.Conclusion: The CAVIvs in the high-range of VaSera underestimates the original property of stiffness parameter β. Moreover, there will be also a missing information in the equations introduced in the corresponding article, especially in the calculation formula of CAVIvs from haβ. Therefore, in order to make the best use of the nature of the stiffness parameter β to be used in VaSera, fixing the coefficients or termination of its use should be considered. [ABSTRACT FROM AUTHOR]

Surveillance of cardiovascular Events in Antiplatelet-treated arterioSclerosis Obliterans patients in JapaN (SEASON) is a 2-year, prospective, real-world, registry study conducted in Japan from 2009 to 2013. This post hoc analysis evaluated risk factors for limb ischemia in patients with peripheral arterial disease (PAD) and ankle–brachial index (ABI) <0.90. Vascular events were adjudicated by an Efficacy Endpoint Review Committee. Cox regression identified predictors of limb-specific peripheral vascular events (amputation, development of critical limb ischemia, and acute limb ischemia). Patients (n = 6565) were stratified according to ABI: normal (≥1.0; n = 1300), borderline (0.90 ≤ ABI ≤ 1.0; n = 776), and abnormal (<0.90; n = 4489). Compared to normal ABI, patients with ABI <0.90 had a significantly higher risk of any vascular event, all-cause death, and any limb-specific peripheral vascular event. Risk factors for limb-specific vascular events included history of lower extremity revascularization/amputation (adjusted hazard ratio: 2.18; 95% confidence interval [CI]: 1.49-3.20), chronic kidney disease (2.00; 1.33-3.00), diabetes (1.71; 1.16-2.52), and ABI <0.4 (4.45; 2.62-7.55) or <0.7 (1.78; 1.15-2.76). These findings from a Japanese real-world population confirm the increased vascular risk of patients with PAD and ABI <0.90 and identified risk factors for limb-specific peripheral vascular events. [ABSTRACT FROM AUTHOR]

Although endovascular therapy (EVT) is commonly used in treatment of peripheral artery disease (PAD), severely calcified lesions pose a challenge, in spite of the technical advancement. In this report, we discuss the case of a 74-year-old male with coronary artery disease and end-stage renal disease who presented at our institution with bilateral intermittent claudication. Angiography showed chronic total occlusion (CTO) of the right superficial femoral arteries (SFA). Because the bilateral external iliac arteries demonstrated moderate stenosis, we performed endovascular therapy on the right SFA-CTO using a contralateral approach. With the antegrade wire progressing into the subintimal space, direct distal-SFA puncture was performed and wire externalization was established. However, no devices (minimal balloon, microcatheter, or Crosser system) were able to pass the lesion in antegrade or retrograde manner, even though the child catheter support or needle cracking technique from outside/inside was applied. Therefore, we used a combination of an excimer laser and high-speed rotational atherectomy to overcome the severely calcified lesion. First, the excimer laser catheter (Turbo Elite 0.9 mm) ablated the entry to the CTO; however, it did not pass through completely. Thereafter, the thin microcatheter (Caravel) succeeded in crossing the CTO in an antegrade manner using the BAlloon Deployment using FORcible Manner (BADFORM) technique. After wire-exchange to the Rota-wire, rotational atherectomy (RotaLink Plus 1.5 mm) passed through the CTO. Subsequently, we could dilate the CTO lesion with a conventional balloon followed by bare metal stent deployment. The right ankle-brachial index of the patient improved from being unmeasurable to 0.79, and the intermittent claudication disappeared. This combination therapy, described as the "RASER" technique in coronary section, is accepted for reimbursement. However, these devices in EVT section are considered off-label use in Japan. Therefore, we have to refrain from frequent use of this strategy; however, this method provides an option for severely calcified lesions. [ABSTRACT FROM AUTHOR]

This study investigated the incidence rate and features of vascular adverse events (VAEs) in Japanese patients with chronic myeloid leukemia (CML) who were treated with tyrosine kinase inhibitors (TKIs). The analysis included 369 CML patients in the chronic or accelerated phases, selected from the CML Cooperative Study Group database; 25 events in 23 (6.2%) of these patients were VAEs. At the time of VAE incidence, nine patients were on treatment with imatinib, 12 with nilotinib, three with dasatinib, and one with bosutinib. VAE incidence comprised 13 cases of ischemic heart disease (IHD), eight of cerebral infarction (CI), and four of peripheral arterial occlusive disease (PAOD). IHD incidence rate in the study population was higher than that in the age-matched general population, particularly in nilotinib-treated patients, while CI incidence rate was almost equivalent. Compared with the Suita score, the SCORE chart and the Framingham score risk assessment tools detected more patients with high or very high risk of VAEs. In conclusion, incidence of IHD requires closer monitoring in nilotinib-treated patients. More detailed investigations for determining the most useful tool to predict VAE incidence and long-term analysis of therapy-related VAE cases are needed for improving safety during TKI therapy. [ABSTRACT FROM AUTHOR]

We evaluated whether underweight status is associated with poor prognosis in patients with peripheral artery disease (PAD) with claudication, excluding critical limb ischemia. We identified 441 claudicants hospitalized for cardiovascular disease between 2005 and 2012. Patients were divided into 4 groups according to body mass index (BMI): an underweight group (BMI < 18.5 kg/m2; n = 48), a normal group (BMI = 18.5-25.0 kg/m2; n = 286), an overweight group (BMI = 25.0-30.0 kg/m2; n = 92), and an obese group (BMI ≥ 30.0 kg/m2; n = 15). The mean follow-up period was 3.5 ± 1.9 years. The underweight group had significantly lower levels of hemoglobin, albumin, estimated glomerular filtration rate, triglycerides, and hemoglobin A1c; higher levels of C-reactive protein and B-type natriuretic peptide; and a higher prevalence of hemodialysis. The incidence of all-cause death and cardiovascular death was significantly higher in the underweight group (underweight vs normal, 77.1% vs 33.0%; P < .001 and 43.3% vs 14.4%; P < .001, respectively). In a multivariate Cox analysis, underweight status was an independent predictor of all-cause death (hazard ratio, 2.53; 95% confidence interval, 1.58-4.18; P < .001). Therefore, promoting weight gain, as well as managing cardiovascular disease, may be important for underweight patients with PAD. [ABSTRACT FROM AUTHOR]

Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort.Methods: MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months.Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups.Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort. [ABSTRACT FROM AUTHOR]

Purpose: Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF.Methods: This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF. Outcomes included freedom from target lesion revascularization (TLR) and patency.Results: Of the patients included in this subgroup analysis, 2-year data were available for 209 patients in the CRF group and 453 patients in the non-CRF group. The two groups were similar in terms of lesion length and the frequency of in-stent restenosis. Critical limb ischemia, severe calcification, and diabetes were more common in patients with CRF, whereas total occlusion was more common in patients without CRF. Freedom from TLR rates were 81.4 versus 84.9% (p = 0.24), and patency rates were 70.7 versus 70.3% (p = 0.95) in patients with and without CRF at 2 years, respectively.Conclusion: This is the first comparative study of the DES in femoropopliteal artery lesions in patients with and without CRF. These results indicate that the DES placed in femoropopliteal artery lesions of CRF patients is safe and effective with similar patency and TLR rates to patients without CRF.Level Of Evidence: Level 3, Post-Market Surveillance Study. [ABSTRACT FROM AUTHOR]

Purpose: To investigate whether administering cilostazol after treatment for femoropopliteal in-stent restenosis (ISR) can have a positive impact on recurrent ISR (Re-ISR).Methods: The database of a multicenter, retrospective, observational registry was interrogated to identify 338 consecutive patients (mean age 72.3±8.8 years; 148 men) who underwent endovascular therapy for femoropopliteal ISR in 379 limbs from January 2010 to December 2014. Ninety-seven patients (103 limbs) who received cilostazol after the initial stent implantation procedure were excluded. This left 24 ISR patients (30 limbs) who received cilostazol initially after ISR treatment for comparison with 217 ISR patients (246 limbs) who did not receive the drug. The primary endpoint was 2-year Re-ISR after treatment. The secondary endpoints were recurrent target lesion revascularization (Re-TLR) and reocclusion at 2 years. Restenosis was determined by a peak systolic velocity ratio >2.4 on a duplex scan or >50% stenosis on angiography.Results: The mean follow-up was 23.3±15.5 months. At 2 years, freedom from Re-ISR was significantly higher in the cilostazol group than in the no cilostazol group (48.6% vs 32.4%, p=0.047). However, freedom from Re-TLR and reocclusion between the 2 groups did not differ significantly [64.7% vs 53.8% (p=0.15) and 88.3% vs 73.9% (p=0.11), respectively]. After adjusting for prespecified risk factors, cilostazol administration was a negative predictor of Re-ISR.Conclusion: This small comparative study suggests that administering cilostazol for ISR lesions after femoropopliteal stenting reduces recurrent ISR. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the angiographic dissection patterns after balloon angioplasty for superficial femoral artery (SFA) lesions, the clinical outcome associated with each dissection pattern, and the predictive factors for severe dissection.Methods: A retrospective, multicenter analysis examined 621 patients (mean age 72.8±9.5 years; 414 men) with 748 symptomatic de novo SFA lesions treated with endovascular therapy. Vessel dissection after the initial balloon angioplasty procedure was graded into 7 types according to a modified version of the coronary artery classification types A to F. Severe vessel dissection patterns were defined as type C or higher. Nitinol stent implantation was performed in 555 (74.2%) lesions for residual stenosis >30% or flow-limiting dissection; 193 lesions (25.8%) were treated with balloon angioplasty only. To determine the clinical outcomes associated with each dissection pattern and identify predictive factors for severe dissection, 2-year follow-up data for the 193 lesions treated with balloon angioplasty only were analyzed for primary patency and clinically driven target lesion revascularization (TLR).Results: No dissection was found in 16% (120/748) of lesions, and types A and B dissections were seen in 19% (142/748) and 23% (172/748), respectively. Dissection grades above type C were observed in 42% of cases, most frequently type D (180/748, 24%) and less often type C (37/748, 5%), type E (67/748, 9%), and type F (30/748, 4%). The bailout stent implantation rate increased according to dissection severity. At up to 2 years, the severe dissection group (types C-F) showed a significantly lower patency rate (p<0.001) and higher clinically driven TLR (p<0.001) compared to the nonsevere group (no dissection and types A and B dissections). Severe dissection was a significant risk factor for restenosis, which rose progressively from types C to F. Multivariate analysis identified a small reference vessel diameter <5 mm (p=0.001), lesion length >15 cm (p=0.001), and chronic total occlusion (p<0.001) as independent predictors of severe dissection. In subgroup analysis, vessels with a small reference diameter and TASC II C and D lesions had a higher prevalence of severe dissection.Conclusion: Severe dissection was found in 42% of cases after PTA. A small vessel diameter and/or TASC II C/D lesions were related to a high incidence of dissection. Severe dissection during procedures employing balloon angioplasty only could affect long-term patency. [ABSTRACT FROM AUTHOR]

Purpose: To assess the influence of repeat intervention on the risk of major amputation after infrapopliteal angioplasty for patients with critical limb ischemia (CLI).Methods: A multicenter database of Japanese CLI patients was interrogated to identify patients who underwent balloon angioplasty for isolated infrapopliteal lesions from April 2004 to December 2012. In that time frame, 1298 limbs of 1065 patients (mean age 72±10 years; 739 men) were eligible for this analysis. The prevalence of tissue loss was 76%, with 33% accompanied by infection. The association between repeat intervention and future risk for major amputation was evaluated using a mixed effects logistic regression model. A stratification analysis was also performed with baseline variables. A supplementary analysis compared baseline characteristics between the cases with and without repeat intervention. Hazard ratios (HR) and their 95% confidence intervals (CI) are reported.Results: Median follow-up was 1.2 years (interquartile range 0.4-2.5), during which time 143 (11.0%) limbs had major amputations and 499 (38.4%) underwent repeat intervention. The mixed effects modeling revealed that repeat intervention was significantly associated with future risk for major amputation (unadjusted HR 3.01, 95% CI 2.05 to 4.41, p=0.001). From the stratification analysis, repeat intervention significantly increased future risk of major amputation in cases with regular dialysis (HR 3.35, 95% CI 2.14 to 5.26, p<0.001), whereas it did not in those without dialysis. The supplemental analysis showed that patients with repeat intervention within 1 year had a higher prevalence of nonambulatory status, regular dialysis, tissue loss, and infection at baseline compared to those without repeat intervention for 1 year.Conclusion: In the patients with CLI due to infrapopliteal lesions, the need for repeat intervention increased the risk of future major amputation. However, this correlation was not applicable to nondialysis patients. [ABSTRACT FROM AUTHOR]

Aims: The aim of this study was to examine the associations between possible indices of obesity based on information on weight history and the incidence of microvascular complications.Methods: A cohort of individuals with type 2 diabetes from 59 institutes in Japan was followed for 8years. Patients were classified into three categories according to weight at entrance and past maximum weight: normal (BMI at baseline <25kg/m(2) and maximum BMI <25kg/m(2)), past obesity (BMI at baseline <25kg/m(2) and maximum BMI ≥25kg/m(2)), and current obesity (BMI at baseline ≥25kg/m(2)) groups. The outcomes were diabetic retinopathy and overt nephropathy.Results: BMI at maximum and baseline of the 1809 patients was 26.5±3.5 and 23.1±3.0kg/m(2) (p<0.01), respectively (23.0±1.6 and 20.6±1.9kg/m(2) for normal, 27.4±2.0 and 22.8±1.4kg/m(2) for past obesity, and 30.1±2.9 and 27.0±1.8kg/m(2) for current obesity). The hazard ratios of past and current obesity compared to normal were 1.92 (95% CI, 1.08-3.41; p=0.03) and 2.21 (1.16-4.22; p=0.02), respectively, for overt nephropathy and 1.38 (1.05-1.83; p=0.02) and 1.64 (1.18-2.28; p<0.01), respectively, for diabetic retinopathy after adjustment for confounders.Conclusions: Past obesity as well as current obesity were associated with increased risks of microvascular complications. Further identification of high-risk populations may be possible by classifying normal weight patients by past obesity. [ABSTRACT FROM AUTHOR]

Purpose: To compare optimal balloon angioplasty with nitinol stenting and drug-eluting stent (DES) implantation for femoropopliteal in-stent occlusion (ISO).Methods: A dual center, retrospective study was performed from January 2004 to December 2014 encompassing 110 ISOs after bare nitinol stenting for a femoropopliteal lesion in 100 patients (mean age 72.7±10.1 years; 58 men). These patients underwent optimal balloon angioplasty with implantation of a bare stent (conventional group, n=79) or a DES (n=21). The primary endpoint was recurrent in-stent restenosis (Re-ISR); secondary endpoints were recurrent target lesion revascularization (Re-TLR), reocclusion, and major adverse limb events (MALE). Re-ISR or reocclusion was defined as ISR or occlusion after TLR. Restenosis was defined as a peak systolic velocity ratio >2.4 on a duplex scan or >50% stenosis on angiography. Univariate Cox regression analysis was used to identify any relationships between patient and procedure variables and the occurrence of Re-ISR; the results are presented as the hazard ratio (HR) and the 95% confidence interval (CI).Results: The mean follow-up period was 34.9±27.4 months. At 2 years, Kaplan-Meier estimated freedom from Re-ISR rates were 79.3% in the DES group and 20.2% in the conventional group, respectively (p<0.001). The rates of freedom from Re-TLR, reocclusion, and MALE at 2 years were 85.7%, 85.9%, and 85.7% in the DES group and 27.1%, 42.5%, and 25.3% in the conventional group, respectively (p<0.001, p=0.006, and p<0.001, respectively). Univariate analysis showed only postprocedure stenosis (HR 1.04, 95% CI 1.02 to 1.07, p<0.001) as a predictor of Re-ISR. Postprocedure ABI (HR 0.06, 95% CI 0.01 to 0.30, p<0.001) and DES use (HR 0.20, 95% CI 0.07 to 0.44, p<0.001) were associated with a lower likelihood of developing Re-ISR.Conclusion: In this small comparative study, DES stent implantation gives more favorable outcomes than conventional treatment for ISO after femoropopliteal stenting. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the thus far poorly defined impact of perioperative complications (POCs) on clinical outcomes after endovascular therapy (EVT) of diabetic patients with critical limb ischemia (CLI) due to isolated infrapopliteal lesions. Methods: A multicenter registry of CLI patients was interrogated to identify 780 consecutive diabetic patients (mean age 71 ± 10 years; 553 men) who successfully underwent balloon angioplasty for isolated infrapopliteal lesions. More than half of the population (487 patients) was on dialysis. Independent predictors (logistic regression) and prognostic impact on outcomes (Cox proportional hazards model) of POC (ie, death, myocardial infarction, stroke, pseudoaneurysm, puncture site hemorrhage/hematoma, distal emboli, vascular rupture, transfusion, dialysis, and gastrointestinal hemorrhage) were investigated. Outcomes are presented as the odds ratio (OR) and hazard ratio (HR), respectively, with 95% confidence intervals (CI). Results: POCs occurred in 12.3% (96/780) of the population. Multivariate modeling identified body mass index (BMI) <18.5 kg/m(2) (adjusted OR 1.71, 95% CI 1.01 to 2.89, p=0.047) and tissue loss (adjusted OR 2.43, 95% CI 1.14 to 5.15, p=0.021) as independent predictors of POCs. In a Cox regression model adjusted for baseline clinical characteristics, the occurrence of POCs was independently associated with major adverse limb events (HR 1.87, 95% CI 1.12 to 3.13, p=0.016) but not with mortality or wound healing. In follow-up, freedom from major adverse limb events was higher in the group without POC (85.2%) than with POC (69.7%, p=0.006) at up to 3 years. Conclusion: POCs within 30 days after balloon angioplasty for infrapopliteal disease in diabetics with CLI were more likely to occur in patients with low BMI and tissue loss. POC occurrence was associated with major adverse limb events in follow-up but not with mortality or wound healing. [ABSTRACT FROM AUTHOR]

Purpose: The aims of this study were to investigate the prevalence of peripheral arterial disease (PAD) and specify the patients who are necessary to measure ankle-brachial index (ABI) as a preoperative PAD screening in spine surgery.Methods: A total of 1425 consecutive patients with non-emergency spine surgery underwent a PAD screening using ABI measurement. We reviewed their ABI data, age, smoking status, and co-morbidities including diabetes mellitus (DM), cerebrovascular disease (CVD) and ischemic heart disease (IHD). CT- or MR-angiography was used for a definitive diagnosis of PAD when the ABI was 0.9 or less.Results: Of 1425 patients, 37 patients (2.5%) showed less than 0.9 in ABI; 24 patients (1.6%) were eventually diagnosed as PAD. Of 24 patients with PAD, 22 patients (91.6%) were over 65 years. The prevalence of DM was 58.3% in the PAD group versus 18.7% in the non-PAD group (P < 0.05). Patients with CVD or IHD were more likely to have PAD, but the differences were not significant. Smoking rate was 62.5% in the PAD group versus 42.4% in the non-PAD group (P < 0.05).Conclusions: The current preoperative PAD screening data showed that age over 65 years, DM and smoking habit were the risk factors for PAD development. Based on the current results, we advocate preoperative ABI measurement for over 50-year patients who had co-morbidities and/or smoking habit and all the patients aged 65 years or more. [ABSTRACT FROM AUTHOR]

Purpose: To present a propensity score matching analysis comparing the 1-year outcomes of de novo femoropopliteal lesions treated with drug-eluting stents (DES) or bare nitinol stents (BNS).Methods: A retrospective review was conducted of 452 limbs in 389 patients (mean age 74±8 years; 284 men) treated with DES implantation and 1808 limbs in 1441 patients (mean age 72±9 years; 1023 men) implanted with BNS for de novo femoropopliteal lesions. One-year follow-up data were available on all patients. The primary endpoint was 12-month restenosis assessed by duplex ultrasonography or follow-up angiography within ±2 months. Secondary endpoint was major adverse limb events (MALE) including major amputation, any reintervention, and restenosis.Results: The BNS group was more likely to have current smoking, chronic total occlusion, and poor below-the-knee runoff. The stratification analysis demonstrated that diabetes mellitus (DM) and reference vessel diameter (RVD) had a significant interaction on the association of DES vs BNS implantation with restenosis (interaction p<0.05). Thus, the population was stratified into 4 subgroups (1: -DM, RVD ≥5 mm, 2: +DM, RVD ≥5 mm, 3: -DM, RVD <5 mm, and 4: +DM, RVD <5 mm); the RVD threshold was empirically determined. There were no significant intergroup differences in baseline variables after matching. There was no significant difference in restenosis risk between DES and BNS in the RVD ≥5 mm subgroup regardless of the presence of DM. The DES group had a significantly higher restenosis risk in the RVD <5 mm subgroup regardless of the presence of DM. No significant difference was observed in the risk of major amputation, reintervention, or MALE in any subgroup.Conclusion: These results suggest that a first-generation DES was not superior to a conventional BNS for femoropopliteal lesions. [ABSTRACT FROM AUTHOR]

The article focuses on the predictors for a high trough apixaban level in older patients with atrial fibrillation prescribed with reduced dose of the drug based on an analysis of a registry of patients in Japan. The analysis discovered the relation between reduced dose and bleeding that required hospitalization. Among the independent predictors are female gender, creatinine clearance and heart failure. Also noted is the anti-Xa assay needs of patients with three or more risk factors.

Background: The clinical features of newly diagnosed Japanese patients with Takayasu arteritis and its age or sex specificities are unknown.Methods and Results: We analyzed information from nationwide registration forms submitted by patients with Takayasu arteritis between April 2001 and March 2011 as part of a research program by the Japanese Ministry of Health, Labor and Welfare. Among the 7779 patients who submitted their forms, 1372 newly registered patients with Takayasu arteritis were enrolled; 83.8% were female. The median age at onset was 35 years, which was significantly higher in male patients (median, 43.5 years) than in female patients (median, 34 years; P<0.001). Local symptoms and findings were most commonly observed in the cervicobrachial area, with more complaints in the head or neck than in the upper limbs. Approximately 85% of the patients had vascular involvements in the aortic arch or its major branches; many young female patients had localized lesions. Although male patients had extensive aortic lesions or aneurysms with more complications, localized abdominal lesions were relatively more frequent in male patients with age at onset >40 years than in other age-sex groups. Disease statuses were severe in patients who registered at ≥1 year after onset.Conclusions: The proportions of male patients and patients with elderly onset increased in newly diagnosed patients with Takayasu arteritis. Their clinical and angiographic features differed according to onset age and sex. [ABSTRACT FROM AUTHOR]

Patients on hemodialysis (HD; n = 210) were examined for peripheral arterial disease (PAD) using ankle-brachial index (ABI) and toe-brachial index (TBI). The prevalence of PAD was 38.1%. Among patients with PAD, 87.5% were newly diagnosed with PAD, 42.5% were diagnosed with TBI <0.6 despite ABI ≥ 0.9, and 68.7% had no lower limb symptoms. In patients with PAD, the prevalence rate of cerebrovascular disease was 36.3%, coronary artery disease was 42.5%, spinal stenosis was 33.2%, and vertebral fracture 15.0% and was significantly higher than those of the non-PAD patients. Low high-density lipoprotein cholesterol was the most important biomarker among patients with PAD. PAD has been underdiagnosed and untreated in patients on HD because most patients do not have symptoms that could be due to diabetic neuropathy or have insufficient daily activity to experience exertional leg symptoms. Screening for PAD using the ABI and TBI increased diagnostic efficiency in patients on HD and may lead to effective early treatments, including pharmacotherapy, revascularization therapy, and exercise rehabilitation to avoid the worst possible scenario such as lower limb amputation, cardiovascular event, and death. [ABSTRACT FROM AUTHOR]

We evaluated the effect of reduced activities of protein C (PC) and protein S (PS) on the progression of peripheral arterial disease (PAD). We measured PC and PS activities in 106 patients with PAD and 44 patients with abdominal aortic aneurysm (AAA) in the same period. The incidences of PC deficiency in PAD and AAA were 4.7% and 4.5%, respectively, and those of PS were 14.1% and 11.4%, respectively; these incidences were much higher than those in the normal population. The PC and PS activities were significantly lower in patients having critical limb ischemia (CLI) than in patients with intermittent claudication. In particular, lower PC activity and female gender were determinant factors of CLI in multivariate logistic regression analysis. We suggest that PC deficiency is an independent predictor for the progression of CLI. [ABSTRACT FROM PUBLISHER]

Purpose: The effect of peripheral arterial disease (PAD) among young and middle-aged adults can be significant, but no previous study has examined the prognosis and the associated health care cost of the disease in this population. We evaluated the clinical and economic burden of PAD in patients from a large claims database to clarify the effect of the disease on a relatively young working Japanese population. Methods: Patients aged ≥ 4 5 and ≤ 6 4 years with first PAD diagnosis between 2005 and 2011 comprised the PAD cohort (n = 362); an age- and sex-matched non-PAD comparison cohort (n = 362) was also identified. Rates of cardiovascular events/interventions, health care utilization, and costs were compared. Findings: The mean (SD) age of the cohort was 52.8 (5.6) years and 40.8% were women. Baseline Charlson comorbidity index was significantly higher in the PAD cohort than in the non-PAD cohort (1.90 [2.19] vs 1.16 [1.99]; P < 0.001). The PAD cohort had significantly higher first-year event rates than did the non-PAD cohort for myocardial infarction (2.2% vs 0.2%; P = 0.019) and ischemic stroke (4.1% vs 0.5%; P = 0.001). Health care utilization was significantly greater for the PAD cohort for all parameters assessed (number of hospitalization, inpatient days, and outpatient visits) in the first year (all, P < 0.001). Total annual costs for health care were significantly higher in the PAD cohort than in the non-PAD cohort in the first year (P < 0.001). Among patients with diabetes, patients with PAD (n = 98) had significantly greater first-year event rates (myocardial infarction, ischemic stroke, coronary artery bypass surgery, peripheral arterial revascularization, percutaneous coronary intervention, and limb amputation; all, P < 0.001), significantly greater number of clinic visits (P = 0.023), and total cost burden than did patients without PAD (n = 63). Implications: Even in a relatively young working Japanese population, PAD is associated with substantial clinical and economic burden. [ABSTRACT FROM AUTHOR]

Peripheral artery disease (PAD) and heart failure (HF) share many risk factors; however, the prevalence and characteristics of HF in patients with PAD have not been fully examined. We investigated 120 consecutive patients with PAD, defined by an ankle-brachial index ≤0.9. In all, 36 (30%) patients had brain natriuretic peptide (BNP) levels ≥100 pg/mL (high BNP group), and 84 (70%) patients had BNP levels <100 pg/mL (low BNP group). Univariate analysis showed that high BNP was associated with age, estimated glomerular filtration rate, hypertension, and transmitral E-wave/early diastolic mitral annular velocity (E/e′) ratio. Multivariate logistic regression analysis established that a high BNP was strongly and independently associated with the highest quartile of E/e′, highlighting these patients’ diastolic dysfunction. The prevalence of high BNP levels in patients with PAD suggests that routine BNP measurements might be useful to detect HF. [ABSTRACT FROM PUBLISHER]

It remains unclear whether severity of coronary artery disease (CAD) affects the prognosis of patients with peripheral artery disease (PAD). In this retrospective, multicenter study, we analyzed 537 consecutive patients with symptomatic PAD who underwent both peripheral artery revascularization and coronary angiography (CAG) prior to revascularization. We classified patients into 3 groups based on CAG: no-CAD group, intermediate CAD group (1-2 diseased vessels), and triple-vessel disease (TVD) group. We evaluated clinical outcome including all-cause death, major adverse cardiac events (MACEs), and amputation. The no-CAD, intermediate CAD, and TVD groups comprised 204, 268, and 65 patients, respectively. Mean follow-up duration was 952 ± 497 days. Freedom from any adverse outcome was highest in the no-CAD group and lowest in the TVD group (all-cause death: 86% vs 77% vs 65%, P = .043; MACE: 95% vs 87% vs 78%, P = .044; amputation: 96% vs 92% vs 83%, P = .0015). Severity of CAD affected prognosis of patients with PAD. [ABSTRACT FROM AUTHOR]

Described is a 27-year-old pregnant woman with May-Thurner syndrome who experienced extensive pelvic and lower extremity thromboses during the antepartum period. The patient was referred for a symptomatic deep venous thrombosis at 23 weeks of gestation. Ultrasonography demonstrated a massive thrombus in the left iliofemoral vein. Heparin was given intravenously. Due to the possibility of pulmonary embolism during or immediately after delivery, a temporary inferior vena cava filter was inserted at 36 weeks of gestation. Labor was induced at 37 + 5 weeks of gestation; labor proceeded uneventfully and a male infant was born. Postpartum computed tomography (CT) demonstrated compression of the left common iliac vein by the right common iliac artery and lumbar vertebra. CT venogram demonstrated poor flow through the common iliac vein and well-developed collateral vessels. Critical stenosis at the origin of the left common iliac vein was consistent with a diagnosis of May-Thurner syndrome. [ABSTRACT FROM AUTHOR]

Background and Purpose: This study aimed to identify the recurrence rate and risk factors or clinical variables predictive of vascular events after mild ischemic stroke (IS). Methods: From December 2006 to September 2007, patients with acute IS with a modified Rankin Scale of 0∼1 were consecutively enrolled in this study. Variables including sex, family history of vascular disease, age, height, weight, stroke subtype, blood pressure, lipid profile, fasting glucose, HbA1c, smoking, alcohol consumption, exercise habits, waist circumference, ankle-brachial pressure index, salt intake and physical activity were assessed. The primary outcome was stroke recurrence or other vascular events such as myocardial infarction, angina pectoris, and peripheral artery disease. Survival curves were calculated by Kaplan-Meier survival analysis, and hazard ratios for recurrence were determined by univariate and multivariate Cox proportional hazards regression models. Results: A total of 102 mild IS patients (78 men and 24 women, mean age 64 years) were successfully followed for 3 years. Of those 102 patients, 25 (24.5%) had stroke recurrence, and 4 (3.9%) had a coronary event. Among the variables studied, abnormal ankle-brachial pressure index, metabolic syndrome, stroke subtypes, salt intake and poor lifestyle management were significant independent predictors of stroke recurrence or cardiovascular events. Conclusions: In mild IS patients within 3 years after onset, not only pathophysiological factors but also lifestyle factors can aid in the identification of patients at high risk for recurrence. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Our objectives were to test the hypothesis that the habitual physical activity of elderly individuals is associated with less arterial stiffening, to explore characteristics of any dose/response relationship, and to determine those segments of the arterial tree where associations are most apparent. Participants (89 men and 109 women, aged 65-84) wore a pedometer/accelerometer continuously for 1 year. The daily step count and the duration of moderate-intensity activity (>3 metabolic equivalents, METs) were recorded. At year's end, an automatic waveform analyzer determined the pulse wave velocity between five recording sites: the aortic root, and the carotid, brachial, femoral and tibial arteries. After appropriate adjustments for sex, age, and mean arterial pressure, overall (delta brachio-tibial "velocity") and central arterial stiffness (cardio-femoral velocity) showed small but statistically significant negative correlations with daily step count and the duration of activity >3 METs. Cardio-carotid velocity was also associated with step count. In contrast, cardio-brachial and femoro-tibial velocities were not significantly related to either estimate of habitual activity. Cardio-femoral and delta brachio-tibial velocities were significantly lower in physically active individuals, apparently reaching a minimum in subjects who exceeded counts of about 6,600 steps/day and/or exercised for more than 16 min/day at an intensity >3 METs. The data support our hypothesis, showing weak but statistically significant associations between habitual physical activity and pulse wave assessments of arterial stiffness in elderly adults. Further studies are recommended to test the causality of these associations and to explore why relationships seem more marked for central than for peripheral arterial segments. [ABSTRACT FROM AUTHOR]

Background: Risk models of coronary artery bypass grafting (CABG) using a large database are useful for improving surgical quality. To obtain accurate, high-quality assessments of the surgical outcomes, each country should maintain its own database. This study was conducted to collect Japanese data and prepare a risk stratification of isolated CABG procedures using the Japan Adult Cardiovascular Surgery Database (JACVSD). Methods: We analyzed 7133 CABG-only records from 97 participating sites throughout Japan using a data entry form with 255 variables that was sent to the JACVSD office by our Web-based data collection system. The statistical model was constructed by multiple logistic regression. Model discrimination was tested using the area under the receiver operating characteristic curve (C index). Model calibration was tested by the Hosmer-Lemeshow test. Results: Of 7133 operations, 47.2% had diabetes mellitus, 14.0% were urgent, and 15.6% involved peripheral vascular disease. The observed 30-day and operative mortality rates were 2.02% and 2.72%, respectively. Significant variables with high odds ratios included emergency or salvage status (3.71), preoperative creatinine value exceeding 3.0 mg/dL (3.59), aortic valve stenosis (3.01), and moderate to severe chronic lung disease (2.86). Hosmer-Lemeshow test and C-index values for 30-day mortality were satisfactory at 0.96 and 0.85, respectively. Conclusions: The results obtained in Japan were at least as good as those reported elsewhere. The performance of our risk model also matched those of the Society of Thoracic Surgeons National Adult Cardiac Database and the European Society Database. [Copyright &y& Elsevier]

Introduction: The threshold of blood pressure (BP) reduction in hospitalized cardiovascular patients is debatable due to the J-curve phenomenon, an epiphenomenon of the increased arterial stiffness. Renal resistive index (RRI) significantly correlates with the arterial stiffness parameters as well as the subclinical cardiovascular target organ damage. We hypothesized that the contribution of BP at discharge to the risk of future cardiovascular events will be shown differently in the hospitalized cardiovascular patients with lower vs. higher RRI. Methods: A prospective observational study conducted in Jichi Medical University Hospital, Japan. Hospitalized acute coronary syndromes, acute heart failure, acute aortic diseases and peripheral vascular disease patients were recruited. RRI was measured using Doppler ultrasonography. The association between BP at discharge categorized as quartiles and cardiovascular events was studied in the subgroups of lower (<0.8) and higher RRI (>=0.8). Results: We enrolled 2230 patients (mean age 67.5 years, 75% men). Patients in the higher RRI group were older, had a higher rate of hypertension and diabetes mellitus compared to those with lower RRI, (P <0.001). During a follow-up of 1.9±0.9 years (5563 person-years), 270 cardiovascular events occurred, 23.4% vs.12.4% in the higher and lower RRI group, respectively, (P <0.001). In the higher RRI group, the lowest SBP quartile (<105 mmHg) was the independent risk factor for cardiovascular events after adjusting for conventional risk factors (Hazard ratio, 2.42; 95% confidence interval, 1.17-5.03; P =0.02), while in the lower RRI group, this association was not observed. Conclusion: The lowest quartile of SBP at discharge was a risk factor for future cardiovascular events in the patients with high RRI. The finding suggested that RRI measurement may be useful for guiding the SBP control in the hospitalized cardiovascular patients. [ABSTRACT FROM AUTHOR]

Background: Sex differences in clinical characteristics of ischemic heart disease patients have been widely examined, differences in the type of coronary artery disease (CAD) and their impacts on prognosis have not been well elucidated in Japanese. Methods: The Kumamoto Intervention Conference Study (KICS) is a multicenter registry enrolling consecutive patients undergoing percutaneous coronary intervention (PCI) in 16 centers in Japan. Between August 2008 and March 2014, 11,095 consecutive patients were enrolled in this registry. To clarify the sex differences, depending on the type of coronary artery disease, 10,822 successful PCI subjects with 1-year follow-up were enrolled in this study. Results: In this patient population, 2,983 patients (28.3%) were female and the remaining 7,839 patients (71.7%) were male. Age and comorbidity of chronic kidney disease(CKD) were significantly higher in female, and other atherosclerotic factors were significantly higher in male. The 1-year MACE was significantly higher in female patients (2.6% vs. 2.0%, p=0.084). Sub-analysis in patients with stable coronary artery disease (sCAD) or unstable angina (UA), sex difference was not observed in any 1-year MACE, procedural factors, or medication treatments. Multivariate analysis revealed CKD and peripheral artery disease (PAD) in female, and PAD in males as independent predictors for 1-year MACE. As regards patients with acute myocardial infarction (AMI), 1-year MACE was significantly higher in female (2.5% vs. 1.5%, p=0.023). Proportion of Killip3/4 (11.5% vs. 9.2%, p=0.034) and slow flow/no reflow rate during PCI procedures (11.5% vs. 8.9%, p=0.015) were significantly higher in female than in male. Post dilatation after stent deployments was significantly fewer in female than in male (44.0% vs. 50.7%, p=0.001). Regarding with medication treatments, usage of beta-blocker was significantly lower in female than in male (48.6% vs. 53.4%, p=0.009). Predictive factors for 1-year MACE in AMI patients were high age and left main trunk (LMT) lesions in female, CKD and LMT lesion in male, respectively. Conclusion: Sex differences in the clinical events after PCI were observed only in AMI patients, furthermore, the predictors for the events, depending on the sex, were different among the different type of coronary artery disease. [ABSTRACT FROM AUTHOR]