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Aim: Although recent advances in endovascular devices have markedly improved clinical outcomes of femoropopliteal endovascular therapy, lesions located in the popliteal artery are still a major challenge. This study aimed to determine the association of cardiovascular risk factors, including smoking, diabetes mellitus, and dialysis-dependent renal failure, with the location of atherosclerotic lesions in femoropopliteal artery disease., Methods: We used a multicenter prospective study database registering patients with symptomatic femoropopliteal artery disease undergoing drug-coated balloon treatment. The analysis included 1912 patients with de novo femoropopliteal lesions. The association of clinical characteristics with popliteal lesions was investigated using the logistic regression model. In addition, the femoropopliteal artery was divided into six segments (the proximal, middle, and distal portions of the superficial femoral artery and P1, P2, and P3 segments of the popliteal artery), and the association of clinical characteristics with the presence of atherosclerotic lesions in the respective arterial segments was investigated., Results: Smoking and dialysis-dependent renal failure showed a statistically significant inverse and positive association with the presence of popliteal lesions, respectively (adjusted odds ratio, 0.66 [95% confidence interval, 0.51-0.85] and 2.01 [1.62-2.49]; P=0.001 and P＜0.001), whereas diabetes mellitus did not (P=0.17). The subsequent per-segment analysis presented similar results., Conclusions: Smoking was inversely associated with popliteal lesions, whereas renal failure on dialysis was positively associated in patients with symptomatic femoropopliteal artery disease who underwent drug-coated balloon treatment. Diabetes mellitus was not significantly associated.

Aim: The present study investigated the effects of additional cilostazol administration on the 12-month risk of restenosis after femoropopliteal heparin-bonded stent graft implantation., Methods: This study was a sub-analysis of the Viabahn stent graft placement for femoropopliteal disease reQUIring endovaScular tHerapy (VANQUISH) study, which was a prospective multicenter study investigating patients who received Viabahn stent graft (W.L. Gore & Associates, Flagstaff, AZ, USA) and dual-antiplatelet therapy with aspirin and a thienopyridine. The comparison of clinical outcomes between subgroups with and without cilostazol treatment were performed using the propensity score-matching method to minimize the intergroup differences in baseline characteristics., Results: Cilostazol-treated patients had a lower 12-month proportion of restenosis than cilostazol-free patients (8.2% vs 27.3%). The odds ratio of cilostazol for the 12-month restenosis was 0.27 [95% CI, 0.08 to 0.97] (p=0.045). Furthermore, the cumulative incidence rates of surgical reconstruction, target lesion revascularization and acute thrombotic occlusion (p values by the log-rank test) were 2.6% versus 1.8% (P=0.43), 5.3% versus 20.5% (P=0.067), and 0.0% versus 11.8% (P=0.0499), respectively. The rates of surgical reconstruction and target lesion revascularization (TLR) were not significantly different between both groups., Conclusions: Our study revealed the clinical impact of additional cilostazol treatment on the risk of restenosis and acute thrombotic occlusion following heparin-bonded stent graft implantation, while TLR and surgical reconstruction were not significantly different.

Aim: This study aimed to report injury precipitating tissue loss and to provide updated information on the time from tissue loss occurrence to referral to a vascular center for patients who developed chronic limb-threatening ischemia (CLTI) in Japan., Methods: We examined 450 patients who developed CLTI with tissue loss and were registered in a multicenter prospective study between October 2017 and June 2020. They were referred to the participating vascular centers for revascularization. Information on the injury precipitating tissue loss and time to referral was collected at registration. The severity of tissue loss was evaluated using the Wound, Ischemia, and foot Infection classification., Results: Injury precipitating tissue loss was absent in 52.0% (95% confidence interval, 47.3%-56.6%) of the patients. The absence was associated with lower albumin levels and preserved pressure sensation. Although the time to referral was significantly shorter in cases without a history of prereferral revascularization, 16.8% (12.8%-20.7%) of the patients were referred to the vascular centers more than 3 months after tissue loss occurrence. Time to referral, but not the lack of a clear precipitant for tissue loss, was significantly associated with the severity of tissue loss., Conclusion: A clear precipitant for tissue loss was often lacking, particularly in patients with low albumin levels and preserved pressure sensation. Delayed referral to a vascular center is still common.

Aim: More than 5-year clinical outcomes after femoropopliteal (FP) stenting with bare-nitinol stent (BNS) have not yet been unclear. We investigate the long-term patency and mortality following FP stenting with BNS., Methods: This study was a multicenter retrospective study of a prospectively maintained database. From April 2004 to December 2011, 1824 consecutive patients (2211 limbs) who underwent FP stenting with BNS for de novo lesions were selected and analyzed. Primary endpoint was primary patency which was defined as treated vessel without restenosis and reintervention and its associated factors., Results: The prevalence of diabetes mellitus and dialysis was 60.5% and 23.8%, respectively. Chronic limb-threatening ischemia (CLTI) accounted for 30.8%. Chronic total occlusion (CTO) was found in 52.7%, and lesion length was more than 20 cm in 22.6%. During the median follow-up of 3.8 years (interquartile range, 1.4 to 7.4 years), 1049 cases lost patency, whereas 355 cases were dead without experiencing loss of patency. The primary patency (95% CI) was estimated to be 74.8%, 47.3% and 29.1% at 1-, 5- and 10-year. On multivariate analysis, female sex, age ≥ 80 years, diabetes, dialysis, CLTI, CTO, arterial calcification, long lesion (＞20 cm), and small vessel (≤ 4 mm) were the independent predictors of primary patency after FP stenting. In addition, the prognostic impact of age ≥ 80 years, CLTI, and arterial calcification was significantly attenuated afterwards (P＜0.05)., Conclusions: Ten-year patency after BNS implantation for FP disease has been continuously reducing up to 10 years and the prognostic impact of risk factors was changed over time.

Aim: Maintaining functional status through revascularization is a major goal in patients with chronic limb-threatening ischemia (CLTI). Nevertheless, there is a lack of clarity on the impact of revascularization on mobility over time. This study examined ambulatory status over time after revascularization and predictors of ambulation loss in CLTI patients., Methods: We used a clinical database established by the Surgical reconstruction versus Peripheral INtervention in pAtients with critical limb isCHemia study, a prospective, multicentre, observational study including patients with CLTI. The primary endpoint was mobility over time., Results: Of the 381 patients, the ambulatory proportion at baseline was 71%. The proportion gradually decreased, finally reaching 40% at 36 months. In non-ambulatory patients at revasacularisation, approximately 20-40% of patients achieved ambulation. Multivariate analysis confirmed that age, impaired mobility before CLTI onset and at revascularization, renal failure on dialysis, and WIfI clinical stage 4 were positively associated with ambulation loss at either specific or all time points, whereas male sex and surgical reconstruction were inversely associated with the outcomes at specific time points., Conclusion: Mobility in the overall population gradually decreased, whereas the number of deceased patients increased. Advanced age, impaired mobility before CLTI onset and at revascularization, renal failure on dialysis, and WIfI stage 4 were associated with ambulation loss at almost all points after revascularization.

Aim: This study aimed to reveal the mortality risk by age in patients undergoing femoropopliteal endovascular therapy for intermittent claudication, in comparison to the national age-specific standard value., Methods: We analyzed 2056 patients undergoing endovascular therapy for moderate to severe intermittent claudication between 2010 and 2018, performed at five cardiovascular centers in Japan. The 3-year mortality risk by age was compared with the data from year- and sex-matched Japanese citizens, which were obtained from Japan's national life table data. Clinical characteristics associated with age in the study patients were also explored., Results: The mean age was 73±9 years. The 3-year mortality risk was increased with age in the patient population, from 6.4% for patients aged ＜65 years to 21.2% for those aged ≥ 85 years. On the contrary, its risk ratio relative to the matched citizens of the same age was decreased with age; the relative risk ratio was 3.08 for patients aged ＜65 years (P=0.001) and 0.60 for those aged ≥ 85 years (P=0.016). Current smoking, body mass index ≥ 25 kg/m 2 , hyperlipidemia, diabetes mellitus, and dialysis dependence were inversely associated with age (all P＜0.05)., Conclusion: Mortality risk increased with age, but the risk ratio relative to the matched citizens decreased with age. Younger patients had a higher mortality risk relative to the matched citizens, whereas patients aged ≥ 85 years had a lower mortality risk relative to the matched citizens. Younger patients were more likely to accumulate cardiovascular risk factors.

Aim: This study aimed to demonstrate the clinical impact of various frailty-related aspects in poor-risk patients undergoing revascularization for chronic limb-threatening ischemia (CLTI)., Methods: We analyzed a clinical database of a prospective multicenter observational study. A total of 562 CLTI patients who required assistance for their daily lives and were candidates for revascularization were included. We examined various measures of frailty severity, including activities of daily living (ADL)/mobility, physical performance, nutritional status, cognitive function, and cardiac function at baseline (before revascularization). Data on inflammatory markers at baseline and ADL/mobility before CLTI onset were also collected., Results: The patients were aged 77±10 years, 65% were non-ambulatory, and 38% were categorized as mild dementia or severer. The correlation coefficients between the frailty measures ranged from 0.00 to 0.91. The random forest analysis for one-year mortality risk showed that these frailty-related measures, as well as age and inflammatory markers, had a relatively high variable importance compared with comorbidities and limb severity., Conclusion: The correlations between measures of frailty severity were not always strong but rather widely varied in CLTI patients who required assistance for their daily lives and were candidates for revascularization. Measures of frailty severity, as well as age and inflammatory markers, had a relatively large predictive impact on one-year mortality risk compared with comorbidities and limb severity in the population.

Aim: Originally developed for predicting the risk of stroke in patients with atrial fibrillation (AF), the CHA 2 DS 2 -VASc score also has the potential to predict the risk of other cardiovascular disease. This study aimed to investigate the prognostic value of the CHA 2 DS 2 -VASc score in patients with peripheral artery disease (PAD) requiring Femoral popliteal (FP) endovascular therapy (EVT)., Methods: This multicenter, retrospective study analyzed the clinical database of 2190 patients who underwent FP EVT for symptomatic PAD (Rutherford categories 2-4) between January 2010 and December 2018. We calculated the CHA 2 DS 2 -VASc score and then investigated the association between the score, as well as AF, and their prognosis. Outcome measures were major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs)., Results: During a median follow-up of 3.0 years (interquartile range, 1.5-5.0 years), 532 MACEs and 562 MALEs occurred. The CHA 2 DS 2 -VASc score and AF were independently associated with an increased risk of MACEs; their adjusted hazard ratios [95% confidence intervals] were 1.28 [1.20-1.36] (P＜0.001) per 1-point increase and 1.49 [1.06-2.09] (P=0.022), respectively. The CHA 2 DS 2 -VASc score was almost linearly associated with MACEs, without any clear threshold point. On the other hand, these variables were not associated with MALEs risk (P=0.32 and 0.48)., Conclusion: The CHA 2 DS 2 -VASc score and AF were independently associated with the increased risk of MACEs but not of MALEs in patients with symptomatic PAD who underwent FP EVT. The score might be useful in stratifying the MACEs risk in this type of patients.

Aim: The aim of the current study was to describe the clinical profile, frequency of in-hospital complications, and predictors of adverse events in patients undergoing endovascular therapy (EVT) for acute limb ischemia (ALI), and to compare them with those of patients undergoing EVT for chronic symptomatic peripheral artery disease (PAD)., Methods: The current study compared 2,398 cases of EVT for ALI with 74,171 cases of EVT for chronic symptomatic PAD performed between January 2015 and December 2018 in Japan. We first compared the clinical profiles of ALI patients with those of PAD patients. We then evaluated the proportion of in-hospital complications and investigated their risk factors in the ALI patients. The association of clinical characteristics with the risk of in-hospital complications was analyzed via logistic regression modeling., Results: Patients with ALI were older and had a higher prevalence of female sex, impaired mobility, and history of cerebrovascular disease, but a lower prevalence of cardiovascular risk factors and history of coronary artery disease. The proportion of in-hospital EVT-related complications in ALI was 6.1% and was significantly higher compared with those in chronic symptomatic PAD patients (2.0%, P＜0.001). Bedridden status (adjusted odds ratio [aOR], 1.74 [1.14 to 2.66]; P=0.010), history of coronary artery disease (aOR, 1.80 [1.21 to 2.68]; P=0.004), and a suprapopliteal lesion (aOR, 1.70 [1.05 to 2.74]; P=0.030) were identified as independent risk factors for in-hospital complications., Conclusion: The current study demonstrated that ALI patients with significant comorbidities show a higher proportion of in-hospital complications after EVT.

Aim: Recent studies suggested that past history of obesity or maximum body mass index (BMI) in the past was a strong prognostic predictor in a general population. The current study aimed to survey the distribution of current and maximum BMIs and to investigate their prognostic impact in patients with critical limb ischemia (CLI), whose prognosis was poor even after revascularization., Methods: We analyzed a database of a prospective, multicenter registry in Japan, including 499 CLI patients undergoing revascularization. Their current and maximum BMIs were surveyed at registration. The distribution and the impact on the prognosis were explored., Results: The estimated means (95% confidence intervals) of current and maximum BMIs were respectively 22.0 (21.7 to 22.3) and 25.3 (24.8 to 25.8) kg/m 2 ; the difference was 3.3 (2.9 to 3.7) kg/m 2 . The prevalence of current obesity (BMI ≥ 25 kg/m 2 ) was 18% (15% to 22%), whereas 48% (43% to 53%) had ever been obese (maximum BMI ≥ 25 kg/m 2 ). Past obesity was not rare even in currently lean subjects (BMI ＜18.5 kg/m 2 ), with the prevalence of 18% (7% to 29%). Current BMI, but not maximum BMI, was associated with the mortality risk; the adjusted hazard ratios per 5 kg/m 2 increase were 0.61 [0.46, 0.81] (P=0.001) and 1.07 [0.87, 1.31] (P=0.55), respectively., Conclusion: The prevalence of current obesity was as low as 18% (15% to 22%) in Japanese CLI patients undergoing revascularization, whereas about a half were formerly obese. Maximum BMI was not independently associated with the mortality risk in the population.

Aim: To investigate the associations between preoperative characteristics and the risk of reintervention in patients undergoing revascularization for chronic limb-threatening ischemia (CLTI) in a contemporary real-world setting., Methods: We retrospectively analyzed data from a clinical database formed by the Surgical Reconstruction Versus Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) study, which was a multicenter, prospective, observational study. The study population was composed of 520 CLTI patients with the wound, ischemia, and foot infection (WIfI) classes I-3 with resting pain or classes I-2/3 with ulcers/gangrene. Of the 520 patients, 192 had surgical reconstruction planned, whereas 328 had endovascular therapy (EVT) alone planned at the time of registration. The current analysis was conducted to explore the associations between preoperative characteristics and the risk of reintervention., Results: A total of 452 participants (87%) completed the 3-year follow-up regarding reintervention. The competing risk analysis estimated that the three-year cumulative incidence rates for reintervention and reintervention-free deaths were 44.0% and 28.7%, respectively. No preoperative characteristics had a significant interaction effect with EVT versus surgical reconstruction. The risk analysis identified the following independent risk factors for reintervention: 1) EVT instead of bypass reconstruction, 2) renal dysfunction, 3) history of revascularization after CLTI onset (i.e., requirement of redo revascularization for CLTI), and 4) bilateral CLTI. Patients with more than one of these risk factors had an increased risk of reintervention., Conclusions: The current study identified preoperative characteristics associated with an increased risk of reintervention. No preoperative characteristics had any significant interactions with EVT or surgical reconstruction.

Aim: The aim of the current study is to describe the presentation pattern of symptomatic peripheral artery disease undergoing endovascular therapy (EVT) in comparison to symptomatic coronary artery disease undergoing percutaneous coronary intervention (PCI) based on data from nationwide databases., Methods: Data were extracted from the nationwide procedural databases of EVT and PCI in Japan (J-EVT and J-PCI) between 2012 and 2017. The presentation pattern was investigated using a Poisson regression model, including the month, seasonality, and weekend (versus weekday) as the explanatory variables. Seasonality was expressed as a cosine function of a 12-month period, and its significance was evaluated using the Fisher-Yates shuffle method., Results: A total of 41,906 and 62,585 cases underwent EVT for critical limb ischemia (CLI) and intermittent claudication (IC), respectively, whereas 518,858 and 504,139 cases underwent PCI for acute coronary syndrome (ACS) and stable angina (SA). The procedural volume increased by 21.6%, 12.3%, 4.5%, and 3.6% per year in CLI, IC, ACS, and SA. CLI and ACS, but not IC or SA, showed a significant volume seasonality. Compared with ACS, CLI demonstrated a larger peak-to-trough ratio of seasonality (1.75 versus 1.21; P＜0.001), and a later peak appearance (February-March versus January-February by 1.37 months; P＜0.001). The procedural volume on weekends relative to weekdays was smaller for SA, IC, and CLI than for ACS. These distinct features were observed in a diabetic population and a non-diabetic population., Conclusions: The current study analyzed nationwide procedural databases and demonstrated the presentation pattern of symptomatic PAD and CAD warranting revascularization.

Aim: Paclitaxel-eluting stents' (Eluvia and Zilver PTX) effectiveness has been recently reported for femoropopliteeal (FP) lesions. However, there is no evaluation of one-year late lumen loss (LLL). Therefore, we evaluated one-year LLL after implantation with Eluvia or Zilver PTX., Methods: This was a multicenter, prospective study. Patients who had symptomatic de novo lesions in the native FP artery were enrolled. The primary endpoint was one-year angiographic LLL, and the secondary endpoints were binary restenosis and target lesion revascularization (TLR) at one year., Results: From December 2015 to December 2016, 48 patients (Eluvia, 36 patients; Zilver PTX, 12 patients) were enrolled. No significant difference was found in baseline and lesion characteristics between both groups. One-year, LLL was significantly lower in the Eluvia group (0.60 {plus minus}0.80 mm) than in the Zilver PTX group (1.74 {plus minus}0.89 mm) (P=0.0003). Negative LLL was observed only in the Eluvia group (0% vs. 23%, p=0.096). The binary restenosis rate was significantly lower than in the Zilver PTX group (0% vs. 16.7%, P=0.012). The one-year TLR in the Eluvia group tended to be lower (0% vs. 8.3%, P=0.08). Stent thrombosis was not observed in either group., Conclusion: One-year LLL in the Eluvia group was significantly lower than that in the Zilver PTX group for FP lesions.

Aim: Although current guidelines recommend surgical revascularization as the first-line therapy for chronic total occlusion of the abdominal aorta (Leriche syndrome), endovascular therapy (EVT) has been increasingly utilized because of the development of new technologies and techniques. EVT has demonstrated durable midterm outcomes for aortoiliac occlusive disease (AIOD). Nonetheless, little is known regarding their long-term outcomes and predictors of restenosis., Methods: We retrospectively analyzed a multicenter database of 64 consecutive patients (age, 73±10 years; 64% male; 22% critical limb ischemia) undergoing EVT for aortoiliac occlusive disease between September 2005 and March 2016. The outcome measures were primary and secondary patency, following EVT, calculated using the Kaplan-Meier method. Independent predictors associated with restenosis were assessed using Cox proportional hazard regression model., Results: Technical success was achieved in 61 patients (95%). In total, 214 stents (192 self-expandable stents, 22 balloon-expandable stents) were implanted. During the follow-up of 33±28 months, 11 patients experienced loss of patency. The primary patency rates were 88%, 70%, and 70% at 1, 3, and 5 years, respectively. The secondary patency rates were 98%, 87%, and 77% at 1, 3, and 5 years, respectively. In Cox regression analysis, E-Luminexx stent use (in 29 patients, 48%) was associated with restenosis [hazard ratio, 4.41, P=0.038]., Conclusion: In this retrospective study, EVT for AIOD demonstrated favorable 5-year patency. E-Luminexx stent implantation was associated with restenosis in this population.

Aim: Although the Innova TM self-expanding nitinol stent (Boston Scientific, Marlborough, MA) exhibits acceptable performance in long-term safety and efficacy when used for the treatment of femoropopliteal (FP) lesions, clinical outcomes following its implantation have not been systematically studied in real-world settings. We investigated the one-year clinical outcomes after implantation of Innova TM self-expanding nitinol stents for the treatment of FP lesions in real-world settings., Methods: In this multicenter study, 481 lesions in 453 consecutive patients with peripheral artery disease (PAD) (74±9 years; male, 70%; diabetes mellitus, 61%; dialysis, 27%; critical limb ischemia, 37%) who underwent endovascular therapy with the implantation of Innova TM self-expanding nitinol stents for FP lesions were analyzed from February 2016 to April 2017. The primary endpoint was one-year restenosis, whereas the secondary endpoints included one-year major adverse limb events and predictors for one-year restenosis., Results: The mean lesion length was 18±10 cm. One-year restenosis and major adverse limb event rates were 36% and 18%, respectively. Multivariate analysis revealed that the presence of diabetes mellitus (odds ratio [OR]: 1.83; 95% confidence interval [CI]: 1.07-3.13), distal reference vessel diameter (OR: 1.86; 95% CI: 1.09-3.16), spot stenting (OR: 2.27; 95% CI: 1.27-4.06), and lack of one-year cilostazol treatment (OR: 0.58; 95% CI: 0.33-1.00) were independent risk factors for one-year restenosis., Conclusion: The current study demonstrated one-year clinical outcomes after Innova TM self-expanding nitinol stent placement for the treatment of FP lesions, including challenging cases in real-world settings.

Aim: The treatment strategy for hemodialysis (HD) patients with critical limb ischemia (CLI) has been clinically debatable. Here we compared clinical outcomes after bypass surgery (BSX) and after endovascular therapy (EVT) using propensity score matching., Methods: A retrospective multicenter database of 246 (68 BSX and 178 EVT) consecutive HD patients with CLI (79% with tissue loss) who underwent infrainguinal revascularization from 2007 to 2009 was used to compare clinical outcomes, including overall survival (OS), major amputation (MA), major adverse limb event (MALE: repeat EVT, surgical reconstruction, or MA), and MALE-free survival after BSX vs. EVT using propensity score matching., Results: The median (interquartile range) follow-up duration after revascularization was 21 (8-33) months. The analysis of the 63 propensity score-matched pairs revealed no significant difference in OS (53% vs. 52%, P=0.96), MA (25% vs. 14%, P=0.71), MALE (42% vs. 58%, P=0.63), and MALE-free survival (33% vs. 11%, P=0.37) at 3 year after BSX vs. EVT., Conclusions: In HD patients with CLI who underwent infrainguinal revascularization, OS, MA, MALE, and MALE-free survival rates were not significantly different after EVT vs. BSX. The less invasive EVT should be considered as the first-choice therapeutic strategy for HD patients with CLI.

Aim: The current study investigated how prevalent the absence of a prior history of intermittent claudication would be in patients with critical limb ischemia (CLI) and examined the associated clinical features., Methods: We used a database of 559 Japanese CLI patients participating in a multicenter prospective study. A history of intermittent claudication prior to CLI onset was surveyed at registration. The 95% confidence interval (CI) of its prevalence was calculated using the Clopper-Pearson method. Logistic regression analysis was performed to assess the association between the clinical features and the absence of preceding intermittent claudication., Results: The study subjects were 73±10 years old and 67% were male. Tissue loss occurred in 82% of this population. The prevalence of the absence of prior intermittent claudication was 50% [95% CI: 46-55%]. In multivariate logistic regression analysis, a non-ambulatory status, diabetes mellitus, and regular dialysis were significantly and independently associated with the lack of a prior history of intermittent claudication (all p＜0.05). Indeed, the presence of these features was associated with a higher prevalence of the lack of the history. Regular dialysis, but not non-ambulatory status or diabetes mellitus, lost its statistical significance after further adjustment for the presence of isolated infrapopliteal lesions, whereas the presence of isolated infrapopliteal lesions itself was significantly associated with a lack of prior intermittent claudication., Conclusions: The absence of a prior history of intermittent claudication was prevalent in CLI patients. Patients with a non-ambulatory status, diabetes mellitus, and regular dialysis were more likely to lack a prior history of intermittent claudication.

Aim: It has been reported that beta-blockers (BB) reduce cardiovascular events in patients with atherosclerotic disease. However, little is known about the efficacy of these drugs in patients with critical limb ischemia (CLI). We investigated whether beta-blocker therapy affects the clinical outcomes of CLI patients., Methods: Between March 2004 and December 2011, 1,873 consecutive CLI patients who received endovascular therapy (EVT) (394 BB-treated patients and 1,479 non-BB-treated patients) for de novo infrainguinal lesions were identified retrospectively. A propensity score analysis was used for risk adjustment in a multivariable analysis and one-to-one matching (BB: 305, non-BB 305). The primary endpoint was amputation-free survival (AFS), and the secondary endpoints were overall survival and the rates of limb salvage and freedom from major adverse limb events (MALE; including repeat reintervention, surgical conversion and major amputation). The mean follow-up period was 22 ± 15 months., Results: In the propensity score-matched pair analysis, there were no significant differences in AFS between the patients treated with and without beta-blockers (58.8% vs. 58.5% at three years, log-rank p = 0.76). There were also no significant differences in the limb salvage rate (88.3% vs. 88.8 at three years, log-rank P = 0.41), overall survival (63.0% vs. 62.4% at three years, log-rank P = 0.70) and freedom from MALE (43.6% vs. 44.9% at three years, log-rank P = 0.58) between the patients treated with and without beta-blockers., Conclusions: The present results suggest that beta-blocker therapy does not worsen the clinical outcomes after EVT in CLI patients.

Aim: To investigate the prognosis and to clarify the predictors of both patient and limb survival among hemodialysis (HD) patients with critical limb ischemia (CLI) due to isolated below-the-knee (BK) disease., Methods: An observational cohort study, analyzing a total of 546 HD patients with 681 limbs who underwent endovascular treatment (EVT) for CLI with isolated BK disease at 11 hospitals in Japan between March 2004 and June 2011, was performed., Results: The mean patient age was 69.0±9.5 years, and 420 (76.9%) of the subjects were men. The number of patients classified with Rutherford stage 4, 5 and 6 disease was 103 (18.9%), 332 (60.8%) and 111 (20.3%), respectively. The mean HbA1c level was 6.48±1.20%, and 195 (35.7%) of the subjects were active smokers. During the follow-up period (mean: 557.5 days), 191 (35.0%) patients died and 82 (12.0%) limbs underwent major amputation. The freedom from all-cause death was 75.5%, 53.4% and 36.9% and freedom from major amputation was 86.7%, 83.9% and 83.9% at one, three and five years after EVT, respectively. Cox proportional hazard regression analyses revealed that a non-ambulatory status, low serum albumin level and ＜2 runoff vessels after EVT were significant predictors for both all-cause death and major amputation., Conclusions: Although patient survival remains poor, the limb salvage rate after EVT is favorable among those on HD with CLI due to isolated BK disease. The present results allow for the risk stratification of HD patients with CLI undergoing EVT for isolated BK disease.

Aim: Beta-blockers are not considered to be contraindicated in patients with peripheral artery disease, and carvedilol and bisoprolol are commonly used in patients with PAD in Japan. Because there have been only a few reported comparative studies of the effects of different beta-blockers, we compared the clinical outcomes in patients treated with these beta-blockers after undergoing femoropopliteal stenting., Methods: Between January 2004 and December 2011, 2911 consecutive patients who had undergone their first femoropopliteal stenting were enrolled in this study. Of these patients, 438 patients(532 limbs) on carvedilol(187 patients, 229 limbs) or bisoprolol(251 patients, 303 limbs) were identified and analyzed retrospectively. The primary outcome was the primary patency and the secondary outcomes were the secondary patency and overall survival and freedom from major adverse limb events(MALE; including any repeated revascularization and major amputation), and these were compared between the groups. The mean follow-up interval of the survivors was 27±17 months., Results: The primary patency was significantly higher in the bisoprolol-treated group than in the carvedilol-treated group(82.4% vs. 73.6% at 2 years, p=0.0006) as were the secondary patency (93.5% vs. 88.1% at two years, p=0.0004) and freedom from MALE (unadjusted: 79.6% vs. 67.9% at two years, p＜0.0001). However, the two-year overall survival was similar between the groups(91.2% vs. 89.9% at two years, p=0.44). Even after adjusting for baseline differences, bisoprolol was still found to be significantly more effective for the primary patency (HR 0.56, 95% CI 0.37 to 0.83, adjusted p=0.005)., Conclusion: Our retrospective study suggests that bisoprolol is associated with more favorable outcomes for vessel patency and avoidance of MALE than is carvedilol.

Aim: We investigated whether any seasonal variation is observed in the incidence, severity and prognosis of critical limb ischemia (CLI) requiring endovascular therapy., Methods: We analyzed a multicenter database of 1,568 consecutive CLI cases undergoing primary endovascular therapy for infrainguinal lesions between July 2004 and June 2011. The monthly incidence was assessed according to the cumulative number of cases in each month, using a simple moving average. The data were fitted to a nonlinear regression model with a cosine function. The monthly proportion of cases in each Rutherford classification among the overall CLI population was assessed using a multinomial logistic regression model. The monthly risk of major amputation was evaluated using a Cox proportional hazard regression model., Results: Significant seasonal variation was observed in the incidence of CLI (p＜0.01). It was higher in the period from winter to spring, with a peak in March, and lower in the period from summer to autumn, with a trough in September; the fold difference between the peak and trough was 2.2. The seasonal variation was more markedly observed in the cases with a more severe Rutherford class. The proportion of cases in each Rutherford class among the overall CLI population also exhibited significant seasonal variation (p＜0.01). In addition, the risk of major amputation demonstrated significant seasonal variation (p=0.03); however, the statistical significance was lost following adjustment for the Rutherford classification (p=0.10)., Conclusions: Seasonal variation is observed in the incidence and severity of CLI. The seasonality of the limb prognosis is likely explained by that of the CLI severity.