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Purpose: To examine the efficacy of pedal artery angioplasty (PAA) for chronic limb-threatening ischemia (CLTI) according to the severity of inframalleolar disease. Methods: In total, 257 consecutive CLTI patients (mean age 73.2 years; 175 men) with de novo infrapopliteal and inframalleolar artery disease were enrolled from the retrospective RENDEZVOUS registry. Inframalleolar artery disease was classified as moderate (Kawarada type 2, 144 patients) or severe (Kawarada type 3, 113 patients). PAA was performed in 140 patients: 66 (45.8%) with moderate disease and 74 (65.5%) with severe disease. The remaining 117 patients (78 with moderate disease and 39 with severe disease) underwent interventions that did not include PAA. The primary outcomes were the wound healing and limb salvage rates at 12 months after the initial treatment. The outcomes of the PAA and no-PAA groups were examined to determine any correlation between treatment efficacy and baseline disease severity. Results: The success rates of PAA among the patients with moderate and severe inframalleolar disease were 89.4% and 87.8%, respectively (p=0.683). The wound healing rate at 12 months was significantly higher in the PAA group than in the no-PAA group regardless of the severity of inframalleolar disease [moderate: 58.8% vs 40.0% (p=0.049); severe: 59.6% vs 33.2% (p=0.021), respectively]. The worst limb salvage rate (76.9%) was seen among patients in the no-PAA group with severe inframalleolar disease (no-PAA/moderate: 94.8%; PAA/moderate: 90.9%; and PAA/severe: 87.8%, p=0.028). Conclusion: PAA improves the wound healing rate of patients with CLTI regardless of the severity of inframalleolar disease. This treatment modality also might improve limb salvage rates in patients with severe inframalleolar disease affecting both the anterior and posterior pedal circulations.

Background It remains controversial whether coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) should be optimized to treat coronary artery disease in patients on chronic hemodialysis (HD). Recently, further refinement of drug-eluting stents, such as the everolimus-eluting stent (EES), has led to marked development in this field. We compared long-term clinical outcomes after CABG versus PCI with EES implantation in patients on chronic HD. Patients and methods We compared 138 patients undergoing CABG and 187 patients treated with EES implantation. The endpoint was major adverse cardiac events (MACE) as a composite outcome, including any revascularization, nonfatal myocardial infarction, or mortality. To reduce the selection bias for the two procedures, propensity score-matching was performed. Results During the follow-up period (43 months), 95 (29.2%) MACEs, including 43 (13.2%) revascularizations, 14 (4.3%) nonfatal myocardial infarctions, and 63 (19.4%) deaths, occurred. The freedom rate from MACE and mortality at 5 years were comparable between groups (69.7 vs. 66.7%, P=0.82 and 75.0 vs. 80.6%, P=0.10, respectively); however, those from revascularization at 5 years was higher in the CABG group than the EES group (89.4 vs. 81.0%, P=0.030). In propensity score-matched patients (n=92), the freedom rate from revascularization at 5 years was still higher in the CABG group than in the EES group (93.4 vs. 79.1%, P=0.013). Similarly, the freedom rates from MACE and mortality were comparable (70.0 vs. 66.3%, P=0.69 and 73.8 vs. 79.7%, P=0.30, respectively). Conclusion Even in the second-generation drug-eluting stent era, CABG is still superior for preventing revascularization in patients on chronic HD. However, PCI with EES implantation might not have disadvantages compared with CABG in terms of MACE.

Aim: To investigate the long-term clinical outcome of endovascular therapy (EVT) or bypass surgery in patients on hemodialysis (HD) with critical limb ischemia due to isolated infrapopliteal disease. Methods: We enrolled 254 consecutive HD patients successfully undergoing infrapopliteal revascularization by EVT (126 patients) and bypass surgery (128 patients). They were followed up for five years. Amputation-free survival (AFS) and incidence of any re-intervention were evaluated. A propensity score from all baseline variables was incorporated into Cox analysis. Results: In the EVT group, age was higher (p = 0.039), diabetes and coronary artery disease were more frequent (p = 0.004 and p = 0.0052, respectively), and tissue loss was more rarely observed (p < 0.0001) than in the bypass group. During the follow-up period, 21 major amputations and 64 deaths occurred. The propensity score-adjusted AFS rate at 5 years was comparable between groups (61.0% in EVT group vs. 55.1% in the bypass group, adjusted hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.52–1.42, p = 0.58). The adjusted survival rates were also similar between groups for amputation and all-cause mortality. However, freedom from any reintervention was markedly lower in the EVT than in the bypass group (48.6% vs. 84.6%, adjusted-HR, 3.56, 95% CI 1.95–6.75, p < 0.0001). Conclusions: The rate of AFS was broadly comparable between the two strategies, although compared with bypass surgery, EVT had much higher rates for re-intervention.

Objectives The aim of this study was to investigate the clinical outcomes of pedal artery angioplasty (PAA) for patients with critical limb ischemia. Background Pedal artery disease is considered a predictor of delayed wound healing (DH) after endovascular therapy. Adjunctive PAA might improve the speed and extent of wound healing. Methods Consecutive patients with critical limb ischemia (n = 257) presenting with de novo infrapopliteal and pedal artery disease were retrospectively reviewed from a multicenter registry. Patients were divided into 2 groups according to whether PAA was performed (n = 140) or not (n = 117). The rate of wound healing and time to wound healing were compared between these groups. DH score was calculated using the number of independent predictors of DH. Patients were stratified into 3 groups according to DH score: low risk (DH score = 0), moderate risk (DH score = 1 or 2), and high risk (DH score = 3). Estimated efficacy was analyzed for each risk-stratified population. Results The rate of wound healing was significantly higher (57.5% vs. 37.3%, p = 0.003) and time to wound healing significantly shorter (211 days vs. 365 days; p = 0.008) in the PAA group. In a multivariate analysis, nonambulatory status, target wound depth (UT grade ≥2), and daily hemodialysis were revealed as predictors of DH. In the moderate-risk population, adjunctive PAA significantly improved the rate of wound healing (59.3% vs. 33.9%; p = 0.001). In the high-risk population, however, PAA did not affect wound healing. Conclusions Patients who underwent PAA showed a higher rate of wound healing and shorter time to wound healing, especially in the moderate-risk population. With regard to wound healing, this aggressive strategy might become a salvage procedure for patients with critical limb ischemia presenting with pedal artery disease.

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.

Background: Although there is increasing evidence of the effectiveness of endovascular therapy for complex aortoiliac (AI) occlusive disease, it is not universally applied to TASC D lesions. Methods: A total of 2096 patients, 2601 limbs with AI occlusive disease, were enrolled. The lesions were categorized as TASC D (395) or TASC A-C (2206), and we compared baseline data, procedure, and follow-up result between the 2 groups. Results: The success rate of the procedure was significantly lower in the TASC D group (91.6% vs 99.3%, P < .01), and more procedure complications occurred in the TASC D group (11.1% vs 5.2%, P < .01). The results of a 5-year follow-up revealed no significant difference in primary patency (77.9% vs 77.1%, P = .17) and major adverse cardiovascular and limb events (MACLE; 30.5% vs 33.4%, P = .42) between the 2 groups. A multivariate analysis revealed complications and critical limb ischemia are independent predictors of MACLE in the TASC D group. Conclusion: The success rate of the procedure was lower in the TASC D group. Complications were more frequent in the TASC D group, and they were related to MACLE.

Background and aims Omega-3 (n-3) polyunsaturated fatty acids (PUFAs) are widely recognized to have beneficial effects against cardiovascular disease. We investigated the association of n-3 PUFAs levels with carotid atherosclerosis in patients on hemodialysis (HD), who are at high risk for cardiovascular events. Methods Carotid ultra-sound was performed in a total of 461 patients on HD (male 67%, age 67 ± 12years, diabetes rate 46%). Intima-media thickness (IMT) and the plaque score (PS) in carotid arteries were measured. Carotid atherosclerosis was defined as IMT >1.2 mm and/or PS > 5.0. The levels of n-6 PUFAs [dihomo-gamma-linolenic acid (DHLA) and arachidonic acid (AA)] and n-3 PUFAs [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] were also measured prior to carotid ultra-sound. Results Carotid atherosclerosis was observed in 94 patients (20.4%). Individual PUFAs levels were comparable between patients with and without carotid atherosclerosis. However, the ratio of EPA/AA and that of n-3/n-6 PUFAs were significantly lower in patients with carotid atherosclerosis compared to those without (median 0.36 vs. 0.41, p = 0.031 and 0.85 vs. 0.93, p = 0.041, respectively]. After adjustment for other confounders, the ratio of EPA/AA (OR 0.30, 95% CI 0.12–0.70, p = 0.0055) and the ratio of n-3/n-6 PUFAs (OR 0.45, 95% CI 0.25–0.80, p = 0.0066) showed an independent reverse association with carotid atherosclerosis. In addition, the area under receiver-operating characteristic curves for carotid atherosclerosis was significantly greater in an established risk model with EPA/AA and n-3/n-6 ratios than in the established risk model alone. Conclusions These data suggest that low ratios of both EPA/AA ratio and n-3/n-6 PUFAs were closely associated with carotid atherosclerosis in patients on HD.

Purpose: To examine the 2-year mortality in hemodialysis (HD) patients with critical limb ischemia (CLI) and determine predictors that may aid in the selection of a revascularization strategy [bypass surgery or endovascular therapy (EVT)] according to current guidelines. Methods: From 2007 to 2009, 246 consecutive CLI patients (mean age 69±10 years; 170 men) on HD underwent revascularization for de novo infrainguinal lesions (178 EVT and 68 bypass grafting). The majority of the patients had diabetes (170, 69%) and tissue loss (194, 79%); nearly half (111, 45%) were nonambulatory. Overall survival after revascularization was estimated by Kaplan-Meier analysis. Predictors for 2-year mortality after revascularization were determined using a Cox proportional hazards model; results are given as the hazard ratio (HR) and 95% confidence interval (CI). Results: Overall survival rate was 77% at 1 year and 66% at 2 years. Predictors of 2-year mortality after revascularization were age >75 years (HR 1.82, 95% CI 1.14 to 2.91, p=0.012), albumin

Purpose The impact of hemodialysis (HD) on aortoiliac (AI) occlusive lesions remains unknown. Here, we report the 3-year clinical outcomes of endovascular treatment (EVT) for AI occlusive lesions in propensity-matched populations of patients who did and did not undergo HD. Methods The cohort of this large-scale, multicenter, retrospective registry study included 574 consecutive patients with AI occlusive disease. Propensity score-matched analysis was performed to compare AI occlusive lesions between patients who did and did not undergo HD. The endpoints were primary patency, assisted primary patency, and secondary patency as well as overall survival and major adverse limb events (MALEs). Results A total of 57 matched pairs of patients who did and did not undergo HD were analyzed after propensity score-matched analysis. No significant difference was observed in primary patency, assisted primary patency, secondary patency, and MALEs at 3 years. The survival rate was significantly lower in the HD group than in the without-HD group (68% vs. 93%, P = 0.03). Conclusions Although the survival rate of HD patients was poor, the results of EVT for AI occlusive lesions were reasonable in these patients.

BACKGROUND We prospectively investigated the prognostic value of the combined use of cardiac troponin T (TnT), B-type natriuretic peptide (BNP), and high-sensitivity C-reactive protein (CRP) for long-term mortality in hemodialysis (HD) patients. METHODS AND RESULTS: Baseline measurements of TnT, BNP, and CRP were performed in 516 patients on chronic HD. Patients were followed up for 10 years. Using the Cox multivariate model with these 3 biomarkers as variables categorized into tertiles for mortality, a simplified score was obtained by underscoring individual biomarkers based on the adjusted hazard ratio (HR). The multimarker score was defined as the sum of these points. TnT, BNP, and CRP levels were individually independent predictors for mortality (P

Protein-energy wasting (PEW) is highly prevalent in hemodialysis (HD) patients. We investigated the association of abnormal ankle brachial index (ABI), PEW, and chronic inflammation status with clinical prognosis in HD patients. A total of 973 HD patients were enrolled and were followed-up for 8 years. As a marker of the PEW, geriatric nutritional risk index (GNRI) was used. Cut-off levels were 91.2 for GNRI defined from previous studies and 1.9 mg/L for C-reactive protein (CRP) as median value, respectively. Abnormal ABI was seen in 332 (34.1%) patients. Declined GNRI and elevated CRP levels were independently associated with abnormal ABI (odds ratio (OR) 0.97, 95% confidence interval (CI) 0.96–0.99, p = 0.0009 and OR 1.40, 95% CI 1.07–1.83, p = 0.013, respectively). GNRI levels were also independently correlated with CRP levels (β = −0.126, p < 0.0001). During follow-up period, 283 (29.1%) patients died, including 123 (12.6%) due to cardiovascular disease (CVD). Abnormal ABI (adjusted hazard ratio (HR) 1.62, 95% CI 1.13–2.32, p = 0.0096), GNRI < 91.2 (adjusted HR 1.57, 95% CI 1.06–2.33, p = 0.023) and CRP > 1.9 mg/L (adjusted HR 1.89, 95% CI 1.31–2.77, p = 0.0007) independently predicted mortality due to CVD, respectively. In conclusion, abnormal ABI, GNRI, and CRP levels were closely associated with each other, and the combination of these variables increase their predictive values for the risk of mortality due to CVD and all-cause mortality in HD patients.

Objectives To investigate factors associated with 30-day perioperative complications (POC) after aorto-iliac (AI) stenting, and to compare follow-up cardiovascular prognosis between patients with and without POC. Materials and methods This was a retrospective multicenter study. We used a multicenter database of 2012 consecutive patients who successfully underwent AI stenting for peripheral arterial disease in 18 centers in Japan from January 2005 to December 2009 to analyze independent predictors of POC and impact of POC on prognosis by logistic regression and a Cox proportional hazard regression model, respectively. Results Mean age was 71 ± 9 years (median: 72 years; range: 37–98 years), and 1,636 patients (81%) were men. POC occurred in 126 patients (6.3%). In multivariate logistic regression analysis, old age (≥80 years), critical limb ischemia (CLI), and Trans Atlantic Inter-Societal Consensus (TASC) II class C/D were independently associated with POC with adjusted odds ratios and 95% confidence intervals (CI) of 1.9 (1.3–2.9), 2.3 (1.5–3.4), and 2.4 (1.6–3.4), respectively. Out of 2012 patients, 1995 were followed up for more than 30 days (mean: 2.6 ± 1.5 years; range: 2–2,393 days). In a Cox hazard regression model adjusted for baseline clinical characteristics, POC was positively and independently associated with follow-up major adverse cardiac events (adjusted hazard ratio [HR]: 1.9; 95% CI: 1.3–2.8; p = .002), but not with major adverse limb events and target lesion revascularization (adjusted HR: 1.4; 95% CI: 0.7–2.7; p = .25; and adjusted HR: 1.2; 95% CI 0.6–2.6; p = .568), respectively. Conclusions Age >80 years, CLI, and TASC C/D lesion were positively associated with POC after AI stenting. Occurrence of POC appears to adversely affect follow-up cardiovascular, but not limb and vessel prognosis.

Background: Although endovascular therapy (EVT) has advanced, few reports have compared EVT and bypass surgery in claudication patients with femoropopliteal disease. The present study used data from a multicenter registry in Japan to analyze outcomes of EVT and bypass surgery for claudication patients with Trans-Atlantic Inter-Society Consensus (TASC)-II C and D femoropopliteal lesions. Methods and Results: Of 1,156 patients who underwent revascularization, 696 patients were treated for intermittent claudication. A total of 263 patients with femoropopliteal lesion were classified into TASC-II C and D. The primary and secondary patency rates of the EVT and bypass surgery groups were analyzed. The overall complication rate was 14.4% in the bypass surgery group and 3.5% in the EVT group (P

To compare the safety and efficacy of the S.M.A.R.T. Control stent vs. other stents in patients with symptomatic aortoiliac occlusive disease (AIOD) followed for up to 4 years.A subgroup analysis of data from a retrospective multicenter registry examined 2036 symptomatic patients (1659 men; mean age 71±8 years) who received stent-supported endovascular therapy for 2541 AIOD lesions between April 2005 and December 2009. The cohort was divided into the S.M.A.R.T. stent group (955 patients/1196 lesions) and the "other" stent group (1081 patients/1345 lesions). The main study outcomes of primary patency and event-free survival at 4 years were compared before and after propensity matching analysis. The rates for freedom from major amputation, surgical conversion, target lesion revascularization (TLR), and major adverse limb events were also assessed.The S.M.A.R.T. Control stent group had greater frequency of critical limb ischemia (CLI), TASC C/D lesions, and chronic total occlusions. The mean follow-up was 25±17 months in the S.M.A.R.T. group vs. 29±19 months in the other stent group. After propensity matching, 4-year primary patency (86% vs. 76%, p0.001) and freedom from adverse limb events (93% vs. 90%, p=0.04) were greater in the S.M.A.R.T. Control stent group, while event-free survival rates (75% vs. 77%, p=0.50) were similar between groups. Univariate subgroup analysis showed that use of the S.M.A.R.T. stent was associated with greater primary patency in patients with renal insufficiency (serum creatinine1.5 mg/dL) and CLI.After propensity matching analysis, the durability of the S.M.A.R.T. stent was superior to that of other stents, which might reflect differing design characteristics.

Background Patients on maintenance hemodialysis (HD) are at high risk for restenosis after percutaneous coronary intervention (PCI) even if treated with a sirolimus-eluting stent (SES). The aim of this study was to compare the effects of SES and paclitaxel-eluting stent (PES) in preventing restenosis in HD patients with coronary artery disease. Methods A total of 100 consecutive patients on HD who underwent PCI were enrolled into the study. They were randomly assigned to receive either SES or PES. We compared follow-up angiographic outcomes between the SES and PES groups at 8-month follow-up. Results The angiographical restenosis rate, defined as % diameter stenosis>50% at 8-month follow-up, was 19.7% in the SES group and 20.0% in the PES group (p=0.97). Late loss was also similar between the two groups (0.49±0.70mm vs. 0.48±0.91mm, P =0.94). There were no significant differences in the rates of all-cause death, non-fatal myocardial infarction, or TLR due to stent restenosis-induced ischemia between the two groups (2.0% vs. 4.0%, p=0.56, 2.0% vs. 4.0%, p=0.56, and 16.0% vs. 12.0%, p=0.57, respectively). Conclusions There was no significant difference in angiographical outcome at 8-month follow-up between HD patients treated with SES and PES. Even if treated with DES including SES and PES, patients on HD are at high risk of restenosis after PCI.

Objective Peripheral artery disease (PAD) is frequently seen in hemodialysis patients, endovascular therapy (EVT) often being performed in such cases. We examined combined prognostic utility of pre-procedural serum albumin and C-reactive protein (CRP) in combination for predicting clinical outcome after EVT in HD patients with PAD. Methods A total of 450 hemodialysis patients successfully undergoing EVT for PAD were followed-up for up to 8 years. They were divided according to median serum albumin and CRP levels measured prior to EVT into four groups [those with high albumin and low and high CRP levels, respectively, and low albumin and low and high CRP levels, respectively]. We analyzed the incidence of major adverse events (MAE) as a composite endpoint including target lesion revascularization (TLR), amputation and all-cause death, and major adverse limb events (MALE) as a composite endpoint including TLR and amputation. Results During the follow-up period (36 ± 31months), 206 MAE (46%) including 67 TLR, 45 amputations and 94 deaths occurred. Event-free survival rates from MAE for 8 years were 41.9%, 21.2%, 29.8%, and 13.2% in groups with high albumin and low CRP levels, with high albumin and high CRP levels, with low albumin and low CRP levels, and with low albumin and high CRP levels, respectively (P = 0.0001). Similar tendency was also seen in incidence of MALE (P Conclusion Lower albumin and elevated CRP levels could strongly predict MAE and MALE after EVT in hemodialysis patients.

The aim of this study was to investigate the clinical outcomes of pedal artery angioplasty (PAA) for patients with critical limb ischemia.Pedal artery disease is considered a predictor of delayed wound healing (DH) after endovascular therapy. Adjunctive PAA might improve the speed and extent of wound healing.Consecutive patients with critical limb ischemia (n = 257) presenting with de novo infrapopliteal and pedal artery disease were retrospectively reviewed from a multicenter registry. Patients were divided into 2 groups according to whether PAA was performed (n = 140) or not (n = 117). The rate of wound healing and time to wound healing were compared between these groups. DH score was calculated using the number of independent predictors of DH. Patients were stratified into 3 groups according to DH score: low risk (DH score = 0), moderate risk (DH score = 1 or 2), and high risk (DH score = 3). Estimated efficacy was analyzed for each risk-stratified population.The rate of wound healing was significantly higher (57.5% vs. 37.3%, p = 0.003) and time to wound healing significantly shorter (211 days vs. 365 days; p = 0.008) in the PAA group. In a multivariate analysis, nonambulatory status, target wound depth (UT grade ≥2), and daily hemodialysis were revealed as predictors of DH. In the moderate-risk population, adjunctive PAA significantly improved the rate of wound healing (59.3% vs. 33.9%; p = 0.001). In the high-risk population, however, PAA did not affect wound healing.Patients who underwent PAA showed a higher rate of wound healing and shorter time to wound healing, especially in the moderate-risk population. With regard to wound healing, this aggressive strategy might become a salvage procedure for patients with critical limb ischemia presenting with pedal artery disease.

Although lower limb revascularization has been commonly performed to treat critical limb ischemia (CLI) in patients with chronic kidney disease, the clinical outcomes such as limb salvage or survival rate have been reportedly poorer compared with those without chronic kidney disease after both

It has been reported hemodialysis patients frequently require repeated revascularization after stent placement, however, little is known on the mechanism of recurrence. The aim of this study is to investigate the difference of tissue morphology of in-stent restenosis (ISR) between hemodialysis (HD)

Background Cilostazol has been reported to prevent atherosclerotic events in the general population. However, data have been limited whether there are beneficial effects of cilostazol use on long-term clinical outcomes after endovascular therapy in hemodialysis (HD) patients with peripheral artery disease (PAD). Methods and results This study consisted of 595 HD patients undergoing endovascular therapy for a clinical diagnosis of PAD. They were divided into two groups: patients receiving 100 mg cilostazol twice daily in conjunction with standard therapy ( n = 249 patients, cilostazol group) and those not administered cilostazol ( n = 346 patients, control group). A propensity score analysis was performed to adjust for baseline differences between the two groups. The propensity score-adjusted 10-year event-free survival rate from major adverse cardiovascular events (MACE) was significantly higher in the cilostazol group than in the control group [58.6% vs. 43.7%, hazard ratio (HR) 0.57; 95% confidence interval (CI) 0.41–0.79; p = 0.0010]. Notably, the adjusted stroke-free rate was significantly higher in the cilostazol group than in the control group (81.6% vs. 74.7%; HR = 0.48; 95% CI, 0.25–0.92, p = 0.028). Even after adjusting for other confounders, treatment with cilostazol was an independent predictor for prevention of MACE and stroke ( p = 0.0028 and p = 0.039, respectively). Conclusions Cilostazol administration improves long-term clinical outcomes including prevention of MACE and stroke after endovascular therapy in HD patients with PAD.

To compare endovascular therapy (EVT) outcomes to those of bypass surgery (BSG) for infrainguinal artery disease in patients with critical limb ischemia (CLI).A retrospective review was conducted of 1053 CLI patients (1053 first treated limbs) who underwent BSG (n=230) or EVT (n=823) for de novo infrainguinal lesions between January 2004 and December 2009 at 14 Japanese centers. Propensity score analysis was used for risk adjustment in multivariate analysis and for one-to-one matching (n=200 in each group). Amputation-free survival, overall survival, limb salvage, and freedom from major adverse limb events (any repeat revascularization or major amputation) were calculated.Mean follow-up was 30±16 months. In the overall series, there was no significant difference at 3 years between the EVT and BSG groups in amputation-free survival (60.5% vs. 62.1%, p=0.84), limb salvage (88.7% vs. 85.4%, p=0.24), or overall survival (65.8% vs. 69.2%, p=0.40). However, freedom from adverse limb events was significantly lower in the EVT group (56.6% vs. 69.2%, p=0.02) at 3 years. In the matched pairs analysis, there was no significant difference in any outcome between BSG and EVT at 3 years: amputation-free survival 66.3% vs. 62.0 (p=0.44), limb salvage 88.8% vs. 84.8% (p=0.44), survival 73.8% vs. 68.8% (p=0.61), and freedom from adverse limb events 61.3% vs. 69.1% (p=0.27).Our cohort suggested that the frequency of serious adverse events after EVT was comparable to that after BSG in CLI patients who underwent their first infrainguinal revascularization.

Background: Although revascularization by coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) has been widely performed in hemodialysis (HD) patients who are at the highest risk of cardiovascular disease, there have been limited data which procedure should be optimized. We investigated long-term clinical outcome after CABG or PCI including drug-eluting stent (DES) implantation in HD patients. Methods: A total 997 maintenance HD patients electively undergoing coronary revascularization with either CABG or PCI were enrolled. Of these patients, 210 patients underwent CABG and 787 patients underwent PCI (345 with DES implantation). They were followed up to 10-year, and the incidence of major adverse cardiovascular events (MACE) as a composite endpoint including all-cause death, non-fatal myocardial infarction (MI), stroke, and target lesion revascularization (TLR) were analyzed. To reduce the selection bias between the procedures, adjusting for propensity score with all baseline covariates was also performed. Results: Prevalence of diabetes, multi-vessel disease, left main trunk lesion and left ventricular ejection fraction < 0.4 were higher in patients undergoing CABG than PCI. The rate of 30-day mortality was significantly higher in CABG group compared to PCI group (4.8% vs. 1.9%, p=0.018). During follow-up period (mean 52±39 months), 484 MACEs (death:325, MI:45, stroke:67, and TLR:274) occurred. 10-year freedom rate was higher in CABG group compared to PCI group for MACE (49.6% vs. 32.4%, p=0.0013) and for TLR (83.4% vs. 56.0%, p

BackgroundCardiovascular disease (CVD) is a leading cause of death in end-stage renal disease (ESRD) patients. Protein-energy wasting (PEW) or malnutrition is common in this population, and is associated with increasing risk of mortality. The geriatric nutritional risk index (GNRI) has been developed as a tool to assess the nutritional risk, and is associated with mortality not only in elderly patients but also in ESRD patients. However, whether the GNRI could predict the mortality due to CVD remains unclear in this population. We investigated the prognostic value of GNRI at initiation of hemodialysis (HD) therapy for CVD mortality in a large cohort of ESRD patients.MethodsSerum albumin, body weight, and height for calculating GNRI were measured in 1568 ESRD patients. Thereafter, the patients were divided into quartiles according to GNRI levels [quartile 1 (Q1): 97.3], and were followed up for up to 10 years.ResultsGNRI levels independently correlated with serum C-reactive-protein levels (β=−0.126, p

Background The efficacy of stent-assisted endovascular therapy (EVT) in patients with critical limb ischemia (CLI) compared to bypass surgery (BSX) remains unclear. Methods and results This study was performed as a multicenter retrospective registry. Between January 2004 and December 2009, 460 CLI patients (460 first treated limbs) who underwent BSX (237 patients) or EVT (223 patients) for de novo infrainguinal lesions were identified retrospectively and analyzed. The main endpoints of this study were amputation-free survival (AFS), overall survival, limb salvage rate and freedom from major adverse limb events (MALE; includes any repeat revascularization and major amputation). Three-year AFS, limb salvage rate and overall survival were not different between the BSX and EVT groups (60.3% vs. 58.0%, P=0.43; 85.1% vs. 84.2%, P=0.91; 67.2% vs. 69.8%, P=0.96, respectively), but freedom from MALE was significantly lower in the EVT group during follow-up (69.1% vs. 51.1%, P=0.002). After adjusting endpoints with covariates, there was also no significant difference in AFS, limb salvage, and overall survival between EVT and BSX. Freedom from MALE, however, was still significantly lower in the EVT group (hazard ratio, 0.66; 95% confidence interval: 0.47-0.92, adjusted P=0.01). Conclusions Serious adverse events with the exception of MALE after EVT seem to be acceptable compared to that after BSX in patients with CLI due to infrainguinal disease.

Background: The patency and complications in aorto-iliac (AI) stenting remain poorly understood. The aim of this paper was to investigate the safety and efficacy after AI stenting. Methods and Results: This study was performed as a large-scale multicenter, retrospective registry. A total of 2,147 consecutive patients with AI disease were enrolled. The safety endpoints were procedure success, complications and 30-day mortality. The efficacy endpoints were primary, assisted primary and secondary patency, overall survival, freedom from major adverse cardiovascular events (MACE; all-cause death, myocardial infarction and stroke), and major adverse cardiovascular and limb events (MACLE; any repeat revascularization for limb and leg amputation in addition to MACE). Procedure success, complication rate and 30-day mortality were 97.6%, 6.4% and 0.7%. Primary patency was 92.5%, 82.6% and 77.5% at 1, 3 and 5 years, assisted primary patency was 97.0%, 92.7% and 91.9% at 1, 3 and 5 years and secondary patency was 99.0%, 98.7% and 98.5% at 1, 3 and 5 years. The overall survival rate was 95.0%, 87.6%, and 79.3% at 1, 3 and 5 years. The cause of death was cardiovascular in 44.1%. Freedom from MACE (MACLE) was 93.3% (89.9%), 84.4% (76.7%), and 74.9% (66.8%) at 1, 3 and 5 years. Female gender, diabetes, renal failure, absence of aspirin, reference vessel diameter

Cardiac valve calcification is seen frequently in patients undergoing dialysis. Serum C-reactive protein (CRP) level also is reported to predict future cardiovascular events. We investigated the association among valve calcification, CRP level, and mortality in patients with end-stage renal disease who were just beginning hemodialysis (HD) therapy.Observational cohort.1,290 consecutive patients who just started HD therapy were enrolled and were followed up to 10 years.Patients were divided into 3 groups according to number of calcified valves: those without valve calcification, those with calcification in a single (aortic or mitral) valve, and those with calcification in both valves. They also were divided into tertiles according to CRP level.Cardiovascular and all-cause mortality.Echocardiography and CRP measurement were performed within 1 month after beginning HD therapy.During follow-up (median, 51 months), 335 (25.9%) patients died, including 156 (12.1%) of cardiovascular disease. The adjusted HR for cardiovascular mortality was 2.80 (95% CI, 1.63-4.81) for 2 calcifications versus 0 (P0.001). Furthermore, the risk of cardiovascular mortality was 3.66-fold higher in patients with calcifications in both valves (highest tertile of CRP) compared with patients without valve calcification (lowest tertile of CRP; P0.001).Precise medical treatments or therapeutic interventions were not evaluated.Valve calcification and elevated CRP levels were not only related to additively increased risk of mortality, but also improved the prediction of mortality in patients with end-stage renal disease who had just begun HD therapy.

Background: Even in the drug-eluting stent era, adverse cardiac events, including restenosis after percutaneous coronary intervention (PCI), have been more frequently seen in patients on hemodialysis (HD) than in non-HD patients. The objective of this study was to compare the sirolimus-eluting stent (SES) and everolimus-eluting stent (EES) for prevention of adverse cardiac events, including restenosis, in HD patients. Methods and Results: A total of 100 consecutive patients on HD who underwent PCI were enrolled and randomly assigned to receive SES or EES. Although there was no difference between the 2 groups in baseline patient and lesion characteristics, the angiographic restenosis rate at 8-month follow-up was 21.2% in the SES group and 8.7% in the EES group (P=0.041). Significant differences were also seen in % diameter stenosis (%DS), minimal lumen diameter, and late lumen loss at 8-month follow-up (P=0.0024, P=0.0040, and P=0.033, respectively). During the 1-year follow-up, major adverse cardiac events occurred in 11 (22.0%) patients in the SES group and in 5 (10.0%) patients in the EES group (P=0.10). Conclusions: The use of EES was as safe as that of SES. Moreover, EES significantly prevented restenosis in patients on maintenance HD compared with SES. (Circ J 2012; 76: 351-355)

Percutaneous transluminal angioplasty (PTA) for femoropopliteal lesions in peripheral artery disease has been performed in patients undergoing hemodialysis as well as in the general population. Cilostazol, a selective inhibitor of phosphodiesterase 3, has been reported to reduce target lesion revascularization after PTA for femoropopliteal lesions in the general population.This study investigated the effects of cilostazol use on long-term patency after PTA in patients with femoropopliteal disease undergoing hemodialysis.In this retrospective study, data from patients undergoing hemodialysis who underwent successful PTA for femoropopliteal disease, defined as a final luminal diameter stenosis30% without angiographically visual arterial dissection and no in-hospital complications, were included. One study group received long-term treatment with oral cilostazol 100 mg BID after PTA; the control group did not. The duration of follow-up wasor=6 years. The primary outcome of interest was cumulative patency, as measured by the event-free rate 6 years after PTA, with event defined as restenosis of50% of the vessel diameter in femoropopliteal lesions. Data on baseline characteristics, patency, and covariates (diabetes, hypertension, hyperlipidemia, smoking, coronary artery disease, critical limb ischemia, TransAtlantic Inter-Society Consensus classification, and stenting) were obtained from electronic medical records and telephone interviews with patients. To minimize the effects of selection bias for cilostazol administration, a propensity-matched analysis using Cox univariate and multivariate models including the previously mentioned covariates was conducted. The propensity scores of the 2 groups were matched 1:1 (AUC = 0.69 [receiving operating characteristics analysis]). Data were obtained from electronic medical records and telephone interviews with patients by trained personnel who were blinded to treatment assignment.A total of 358 consecutive lesions of 174 patients undergoing hemodialysis were included (103 men, 71 women; mean [SD] age, 66 [11] years; cilostazol group, 61 patients, 121 lesions; control group, 113 patients, 237 lesions). The mean duration of follow-up was 37 (27) months. The 6-year event-free rate of restenosis of50% of the vessel diameter was significantly higher in the cilostazol group than in the control group (72/121 [59.5%] vs 120/237 [50.6%]; P = 0.005 [logrank test]; hazard ratio [HR] = 0.63; 95% CI, 0.45-0.88; P = 0.008 [Cox univariate analysis]). Also, event-free rates of target lesion revascularization and limb amputation were significantly higher in the cilostazol group than in the control group (40/61 [65.6%] vs 57/113 [50.4%]; P = 0.013 [log-rank test] and 54/61 [88.5%] vs 90/113 [79.6%]; P = 0.047 [logrank test], respectively). On propensity score matching (105 lesions), the baseline characteristics were comparable between the 2 groups. The 6-year eventfree rate of restenosis was significantly higher in the cilostazol group than in the control group (66/105 [62.9%] vs 52/105 [49.5%]; HR = 0.58; 95% CI, 0.38-0.88; P = 0.012 [Cox univariate analysis]). On propensity-matched (Cox multivariate) analysis, cilostazol (HR = 0.51; 95% CI, 0.27-0.84; P = 0.008), age (HR = 1.01; 95% CI, 1.01-1.04; P = 0.031), and critical limb ischemia (HR = 2.21; 95% CI, 1.39-3.53; P = 0.001) were independent predictors of restenosis. None of the patients in the cilostazol group discontinued cilostazol treatment during the follow-up period. Four patients (6.6%) experienced mild headache.This study found that in these patients with femoropopliteal lesions in peripheral artery disease who were undergoing hemodialysis, those treated with cilostazol 100 mg BID after PTA had a higher mean rate of cumulative patency after PTA than those in the control group.

Background: Endovascular therapy (EVT) has become widely performed for peripheral artery disease (PAD) even in haemodialysis (HD) patients. In general population, favorable outcomes have been obtained after EVT for lesions of iliac artery. However, clinical outcomes after EVT for iliac artery lesions have not been fully evaluated in HD patients. We investigated the impact of HD on long-term outcome after iliac artery stenting. Methods: A total of 2096 patients undergoing successfully iliac artery stenting were enrolled from multi-center registry in Japan. Six-year clinical outcomes were compared between HD group (n=377) and non-HD (NHD) group (n=1719). Endpoint was defined as major adverse cardiovascular events (MACE) including death, myocardial infarction (MI) and stroke. Primary patency and major amputation were also analyzed. To reduce the differences of clinical and procedural characteristics between two groups, propensity score matching with all baseline variables was performed. Results: Prevalence of diabetes, coronary artery disease and critical limb ischemia (≥Rutherford grade IV) were higher in HD group than in NHD group. By Kaplan-Meier analysis, 6-year event-free survival rate from MACE was significantly lower in HD group than in NHD group (46.9% vs. 76.1%, p

Methods: The REAL-AI (REtrospective multicenter AnaLysis of primary stenting for AortoIliac artery disease) registry was performed as a multicenter registry in Japan enrolling consecutive patients undergoing primary stenting for de novo aortoiliac artery stenosis. The primary endpoint was a composite of death/myocardial infarction (MI) /stroke, and the secondary endpoints were primary patency (deined as treated vessel without restenosis).

ObjectiveLower extremity bypass surgery has been widely performed to treat critical limb ischemia (CLI) in patients on hemodialysis (HD). However, the clinical outcome still remains unclear. We investigated the limb salvage rate after infrapopliteal bypass surgery in HD patients with CLI.MethodsFrom April 2006 to January 2013, 226 patients with 236 limbs who electively underwent bypass surgery for treatment of CLI due to infrapopliteal disease were enrolled. Patients were grouped by those who were on HD (n = 177) and those who were not (n = 49). They were monitored for 5 years or until December 2013 if the follow-up period was