Mortality risk after use of a paclitaxel-coated stent in femoropopliteal peripheral artery disease.

Although paclitaxel-based devices which demonstrated improved outcomes in the treatment of lower-extremity peripheral artery disease (PAD) have been used worldwide, Katsanos et al. reported a systematic review and summary-level meta-analysis of RCTs in which application of paclitaxel-based devices in the femoropopliteal artery was associated with an increased mortality risk. The purpose of this study was to describe the safety of endovascular therapy (EVT) using paclitaxel-coated stents for femoropopliteal disease by evaluating the mortality risk compared with patients treated with paclitaxel-free devices. A retrospective, multicenter, non-randomized study examined 481 de-novo symptomatic PAD patients treated in 13 Japanese medical centers from January 2011 to December 2015. The risk of all-cause mortality was analyzed between the 65 patients treated with a paclitaxel-coated stent (PTX-coated group) and 416 patients treated with an uncoated balloon or bare nitinol stent (PTX-free group). Overall survival of the PTX-coated group and the PTX-free group were compared after propensity score matching. The 2-year overall survival estimates were 87.7% in the PTX-coated group vs 88.7% in the PTX-free group. There were no significant differences in the mortality risk between the groups through a full follow-up of 2 years (p = 0.80). The multivariate cox proportional hazards model identified three significant predictors of mortality; age (HR, 1.08; 95% CI, 1.03-1.13; p = 0.002), hemodialysis (HR, 3.16; 95% CI, 1.34-7.42; p = 0.008), and albumin (g/dl) (HR, 0.46; 95% CI, 0.25-0.85; p = 0.01).

Outcomes of Pedal Artery Angioplasty Are Independent of the Severity of Inframalleolar Disease: A Subanalysis of the Multicenter RENDEZVOUS Registry.

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.

Comparison of 3-year clinical outcomes after endovascular therapy for aortoiliac artery occlusive disease between patients with and without hemodialysis: Subanalysis of the REAL-AI registry.

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.

Long-term clinical outcomes after coronary artery bypass graft versus everolimus-eluting stent implantation in chronic hemodialysis patients.

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.

Clinical Outcomes after Isolated Infrapopliteal Revascularization in Hemodialysis Patients with Critical Limb Ischemia: Endovascular Therapy versus Bypass Surgery.

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 re-intervention 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.

The Association of Ankle Brachial Index, Protein-Energy Wasting, and Inflammation Status with Cardiovascular Mortality in Patients on Chronic Hemodialysis.

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 (ß = -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.

Clinical Outcomes of Pedal Artery Angioplasty for Patients With Ischemic Wounds: Results From the Multicenter RENDEZVOUS Registry.

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.

Comparison of Clinical Outcomes after Surgical and Endovascular Revascularization in Hemodialysis Patients with Critical Limb Ischemia.

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.

Efficacy and Safety of Endovascular Therapy for Aortoiliac TASC D Lesions.

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.

Reverse association of omega-3/omega-6 polyunsaturated fatty acids ratios with carotid atherosclerosis in patients on hemodialysis.

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.

Treatment with cilostazol improves clinical outcome after endovascular therapy in hemodialysis patients with peripheral artery disease.

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 100mg 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.

Predictors of 2-Year Mortality and Risk Stratification After Surgical or Endovascular Revascularization of Infrainguinal Artery Disease in Hemodialysis Patients With Critical Limb Ischemia.

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 <3 g/dL (HR 2.31, 95% CI 1.39 to 3.84, p=0.001), and ejection fraction <50% (HR 1.73, 95% CI 1.06 to 2.83, p=0.027). Patients with more predictors had a higher incidence of death within 2 years after revascularization. CONCLUSION: Advanced age, low albumin level, and low ejection fraction were independently associated with 2-year mortality after revascularization in HD patients with CLI. Risk stratification by these factors would be useful for deciding on a revascularization strategy.

Multimarker approach to risk stratification for long-term mortality in patients on chronic hemodialysis.

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<0.05). Among low-risk (multimarker score <4), intermediate-risk (multimarker score 4-7), and high-risk (multimarker score ≥7) groups, 10-year survival rates were 83.3%, 54.3%, and 27.2% (P<0.0001), respectively. After adjusting for other confounders, the multimarker score had strong predictive power for mortality (HR: 4.26; P<0.0001 for high-risk vs. low-risk group). Furthermore, adding the multimarker score to a baseline model with established risk factors improved the C-index (P<0.01), net reclassification improvement (P<0.0001), and integrated discrimination improvement (P<0.0001) greater than that of any single biomarker or baseline model alone. CONCLUSIONS: The multimarker approach (ie, simultaneous assessment of TnT, BNP, and CRP, which individually independently predict prognosis) may improve the prediction of long-term mortality in HD patients.

Clinical outcome after infrapopliteal bypass surgery in chronic hemodialysis patients with critical limb ischemia.

OBJECTIVE: Lower 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. METHODS: From 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 <5 years. Amputation-free survival, defined as freedom from major amputation or all-cause death, was primarily evaluated. Incidence of reintervention was also analyzed. RESULTS: Ulcer/gangrene was present in 206 patients (91.2%), and 233 limbs (98.7%) were treated using autogenous vein. Age was younger (67 ± 9 vs 72 ± 9 years; P = .0011) and ulcer/gangrene was more prevalent (93.8% vs 81.6%, P = .0080) in HD patients than in non-HD patients. During the follow-up period (median, 28 months), 33 (14.6%) major amputations and 28 reinterventions (12.4%) occurred, and 65 patients (28.8%) died. The 5-year amputation-free survival rate was significantly lower in HD patients than in non-HD patients (43.6% vs 78.8%, P = .0033), and the adjusted hazard ratio (HR) for amputation or death for HD patients was 2.36 (95% confidence interval [CI], 1.13-4.92; P = .022). Compared with non-HD patients, the status of HD was similarly an independent risk of major amputation (72.4% vs 92.5%; adjusted HR, 4.36; 95% CI, 1.04-18.3; P = .045) and mortality (56.9% vs 83.2%; adjusted HR, 2.81; 95% CI, 1.30-6.09; P = .0085). However, freedom from reintervention was comparable between the two groups (84.3% vs 86.8%; P = .89). In HD patients, body mass index (HR, 0.86; 95% CI, 0.76-0.96; per 1 kg/m(2) increase; P = .014) and C-reactive protein (HR, 1.06; 95% CI, 1.01-1.11; P = .014) independently predicted major amputation. Elevated C-reactive protein levels were also associated with death (HR, 1.04; 95% CI, 1.01-1.09; P = .047). CONCLUSIONS: The clinical outcome after infrapopliteal bypass surgery was poorer in HD patients with CLI compared with non-HD patients. Malnutrition or chronic inflammation was associated with poor outcome in HD patients with CLI due to infrapopliteal occlusive disease.

Propensity score analysis of clinical outcome after bypass surgery vs. endovascular therapy for infrainguinal artery disease in patients with critical limb ischemia.

PURPOSE: To compare endovascular therapy (EVT) outcomes to those of bypass surgery (BSG) for infrainguinal artery disease in patients with critical limb ischemia (CLI). METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Long-term clinical outcome after surgical or percutaneous coronary revascularization in hemodialysis patients.

BACKGROUND: Although revascularization via coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) has been widely performed, there are limited data on which procedure is best in hemodialysis (HD) patients. METHODS AND RESULTS: This 10-year follow-up study consisted of 997 HD patients electively undergoing coronary revascularization (CABG, n=210; PCI, n=787). With an adjustment for propensity scores with all baseline covariates, the incidence of major adverse cardiac events (MACE) was evaluated as a composite endpoint including all-cause death, non-fatal myocardial infarction (MI) and any revascularization. During the follow-up period, 465 MACE (death, n=325; non-fatal MI, n=45; revascularization, n=274) occurred. The 10-year freedom from MACE was higher in the CABG group compared to the PCI group (51.0% vs. 34.8%, adjusted hazard ratio [HR], 0.64; 95% confidence interval [CI]: 0.49-0.82, P=0.0003). On landmark analysis, adjusted HR of death was higher during the first 6 months after CABG compared to PCI (1.72; 95% CI: 1.04-2.79, P=0.036), but lower from 6 months onward (0.69; 95% CI: 0.48-0.97, P=0.033). When compared to patients treated with drug-eluting stent alone (n=345) in the PCI group, the CABG group still had an advantage for any revascularization (adjusted HR, 0.38; 95% CI: 0.22-0.62, P<0.0001), but not for MACE (adjusted HR, 0.86; 95% CI: 0.64-1.15, P=0.33). CONCLUSIONS: CABG was totally clinically advantageous compared to PCI in HD patients.

Comparison of long-term outcome after endovascular therapy versus bypass surgery in claudication patients with Trans-Atlantic Inter-Society Consensus-II C and D femoropopliteal disease.

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<0.01). The 1- and 5-year primary patency rates were 82.1% and 69.4% in the bypass surgery group and 67.8% and 45.2% in the EVT group, respectively. Although the bypass surgery group had a higher primary patency rate than the EVT group (P<0.01, log-rank test), secondary patency rates did not differ significantly between the two groups. CONCLUSIONS: Although bypass surgery is clearly feasible for claudication patients with TASC-II C and D femoropopliteal disease, EVT is also a good option because of its lower complication rate and good secondary patency rate in patients in poor condition for bypass.

Geriatric nutritional risk index accurately predicts cardiovascular mortality in incident hemodialysis patients.

BACKGROUND: Cardiovascular 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. METHODS: Serum 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): < 84.9; Q2: 85.0-91.1; Q3: 91.2-97.2; and Q4: >97.3], and were followed up for up to 10 years. RESULTS: GNRI levels independently correlated with serum C-reactive-protein levels (ß = -0.126, p < 0.0001). Rates of freedom from CVD mortality for 10 years were 57.9%, 73.3%, 80.8%, and 89.2% in Q1, Q2, Q3, and Q4, respectively (p < 0.0001). The GNRI was an independent predictor of CVD mortality (hazard ratio 3.42, 95% confidence interval 2.05-5.70, p < 0.0001 for Q1 vs. Q4). C-index was also greater in an established CVD risk model with GNRI (0.749) compared to that with albumin (0.730), body mass index (0.732), and alone (0.710). Similar results were observed for all-cause mortality. CONCLUSION: GNRI at initiation of HD therapy could predict CVD mortality with incremental value of the predictability compared to serum albumin and body mass index in ESRD patients.

Efficacy of the S.M.A.R.T. Control vs. other stents for aortoiliac occlusive disease in contemporary clinical practice.

PURPOSE: 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. METHODS: 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. RESULTS: 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%, p<0.001) 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 creatinine >1.5 mg/dL) and CLI. CONCLUSION: 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.