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Purpose: To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries. Materials and Methods: The SM-01 study (ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method. Results: The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups. Conclusion: The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the use of the TruePath crossing device as the primary recanalization tool for infrainguinal chronic total occlusions (CTO). Methods: A retrospective analysis was conducted of 50 patients (mean age 75 years; 26 men) with 55 infrainguinal CTOs treated with the TruePath between March 2017 and September 2017 at a single center. The mean occlusion length was 138±55 mm, and femoropopliteal lesions accounted for 65% of the 55 lesions. The primary outcome measure was CTO crossing using the TruePath alone; secondary outcomes were assisted success (>50% lumen gain using the TruePath), device-related complications, and intraluminal crossing evaluated by intravascular ultrasound (IVUS). Results: Complete success was achieved in 33 (60%) of 55 lesions having a mean occlusion length of 145±72 mm. Among these, the true lumen crossing rate was 97% according to IVUS evaluation. Assisted success was achieved in 15 (68%) of the 22 failures. Complete/assisted success, in which the TruePath was thought to have contributed to CTO crossing, was attained in 48 (87%) of the 55 lesions. Three (5.5%) complications were observed: a perforation, an accesssite hematoma, and acute occlusion; only the perforation was device related (1.8%). Multivariate analysis showed PACCS grade 4 (odds ratio 4.5, 95% confidence interval 1.33 to 15.5, p=0.02) was an independent predictor of TruePath failure. Conclusion: Primary use of the TruePath crossing device for infrainguinal CTOs demonstrated a satisfactory complete success rate and a high rate of IVUS-documented intraluminal crossing with few device-related complications. Severe calcification is an independent predictor of TruePath failure. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the midterm safety and effectiveness of cilostazol treatment in claudicant patients undergoing endovascular therapy. Methods: The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study (ClinicalTrials.gov identifier NCT00912756; University Hospital Medical Information Network identifier UMIN000002091) enrolled 200 patients (mean age 73 years; 131 men) treated for femoropopliteal disease from March 2009 to April 2011 at 13 cardiovascular centers in Japan. The participants were randomized 1:1 to receive oral aspirin with or without cilostazol. Of the 100 patients assigned to the 2 treatment groups, 7 patients in the cilostazol group and 2 patients in the no-cilostazol group were withdrawn from the study without undergoing endovascular treatment, leaving 93 patients in the cilostazol group and 98 patients in the no-cilostazol group for follow-up analysis. The primary outcome measure was primary patency; secondary outcome measures were freedom from clinically-driven target lesion revascularization (CD-TLR) and overall survival. Outcomes were analyzed on an intention-to-treat basis using the Kaplan-Meier method; estimates were compared with the log-rank test. Results: The median follow-up was 38.1 months (interquartile range 25.1, 47.7). Among the 93 subjects in the cilostazol group, 7 died and 26 withdrew from administration 1 year after the endovascular procedure. Discontinuation of cilostazol was not a significant factor for restenosis. Primary patency was significantly higher in the cilostazol group than in the no-cilostazol group (69% vs 54%, p=0.026) at 3 years. The cilostazol group also had better 3-year freedom from CD-TLR (78% vs 63%, p=0.014), although overall survival estimates did not differ significantly (p=0.95). Conclusion: These results suggest that the safety and effectiveness of cilostazol treatment were sustained in patients with femoropopliteal disease undergoing endovascular treatment. [ABSTRACT FROM AUTHOR]

AIMS: The Ultimaster bioresorbable polymer sirolimus-eluting stent (BP-SES) is a newly developed drug-eluting stent (DES) that consists of a thin-strut, cobalt chromium with bioresorbable polymer coated only albuminally. We sought to compare tissue coverage in coronary lesions treated with BP-SES with the XIENCE permanent polymer everolimus-eluting stent (PP-EES) using optical coherence tomography (OCT). METHODS AND RESULTS: A total of 36 patients participated in the CENTURY II trial in our institution and were randomly assigned to BP-SES (n = 15) and PP-EES (n = 21). Of these, 27 patients (13 BP-SES and 14 PP-EES) underwent OCT at 9-month follow-up. Tissue coverage and apposition were assessed on each strut, and the results in both groups were compared using multilevel logistic or linear regression models with random effects at three levels: patient, lesion, and struts. A total of 6450 struts (BP-SES, n = 2951; PP-EES, n = 3499) were analysed. Thirty and 79 uncovered struts (1.02 and 2.26%, P = 0.35), and 3 and 4 malapposed struts (0.10 and 0.11%, P = 0.94) were found in BP-SES and PP-EES groups, respectively. Mean neointimal thickness did not significantly differ between both groups (110 ± 10 vs. 93 ± 10 µm, P = 0.22). No significant differences in per cent neointimal volume obstruction (13.2 ± 4.6 vs. 10.5 ± 4.9%, P = 0.14) or other areas-volumetric parameters were detected between both groups. CONCLUSION: BP-SES shows an excellent vascular healing response at 9-month follow-up, which is similar to PP-EES. [ABSTRACT FROM AUTHOR]

Objective: To examine the pressure gradient and peripheral fractional flow reserve (pFFR) measured by a pressure wire as indicators of hemodynamic significance in iliofemoral angiographic intermediate stenosis. Background: The utility of pressure measurements using a pressure wire with vasodilators is unclear in cases with intermediate iliofemoral stenosis. Methods: The mean pressure gradient (MPG) and mean pressure ratio (MPR) were measured at baseline and after injection of isosorbide dinitrate in 23 lesions with angiographically intermediate iliofemoral stenosis. Patients with complex lesions, infrapopliteal artery lesions, chronic total occlusion, and surgical bypass grafts were excluded. Hyperemic MPR was considered equivalent to pFFR. Changes in parameters in response to vasodilators were assessed and correlations of peak systolic velocity ratio (PSVR) with hyperemic MPG and pFFR were examined using duplex ultrasound. Results: After injection of isosorbide dinitrate, hyperemic MPG increased significantly (from 9.0±5.7 to 16.3±6.2 mmHg; P<0.05) and hyperemic MPR (pFFR) decreased significantly (from 0.92±0.06 to 0.81±0.07; P<0.05). PSVR was significantly correlated with hyperemic MPG (R=0.52; P<0.05) and pFFR (R=-0.50; P<0.05). The optimal cut-off value of pFFR as an indicator of significant hemodynamic stenosis (PSVR >2.5) was 0.85 (area under the curve 0.72; sensitivity 94%; specificity 50%, P<0.05). Conclusion: pFFR measured using a pressure wire is reliable for prediction of hemodynamic significance in iliofemoral intermediate stenosis. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: To investigate whether use of intravascular ultrasound (IVUS) improves primary patency following nitinol stenting for TASC II (TransAtlantic Inter-Society Consensus) A-C femoropopliteal lesions. Methods: Using a retrospective multicenter database of 1198 limbs from 965 patients (695 men; mean age 72±9 years) with TASC II A-C lesions (28% critical limb ischemia) treated by provisional stenting from April 2004 to December 2011, primary patency rate was compared between 234 propensity score-matched pairs with vs. without IVUS use. Results: IVUS was used in 22% (n=268) of the overall population. It was more likely to be used in cases with generally more complicated femoropopliteal lesions (e.g., more severe TASC II class, longer lesion length, and narrower reference diameter). Analysis of the 234 propensity score-matched pairs (mean follow-up 1.9± 1.5 years; 142 events) revealed higher 5-year primary patency with than without IVUS use (65%±6% vs. 35%±6%, p<0.001), IVUS resulted in significantly better assisted primary patency (p<0.001), secondary patency (p=0.004), freedom from any reintervention (p<0.001), freedom from any adverse limb event (p<0.001), and event-free survival (p<0.001). Conclusion: IVUS use in femoropopliteal stenting for TASC II A-C lesions appears to be associated with higher primary patency rate. [ABSTRACT FROM AUTHOR]

Purpose: To examine the prognosis of patients with intermittent claudication who received treatment with endovascular techniques. Methods: A retrospective multicenter study was performed involving 2930 consecutive patients (2307 men; mean age 71.5±8.9 years) with intermittent claudication who underwent an endovascular procedure for a de novo iliofemoral artery lesion. The primary outcome measure was overall survival. The secondary outcomes were freedom from major adverse cardiovascular events (MACE: all-cause death, myocardial infarction, and stroke) and from major adverse cardiovascular and limb events (MACE with repeat revascularization or above-knee amputation of the target limb). Cox multivariate regression analysis of selected baseline characteristics, procedure-related complications, and medication use was performed to determine predictors for all-cause mortality. Positive predictors from this analysis were used to stratify patients into low- (1410, 48.1%), moderate- (1406, 48.0%), and high-risk (114, 3.9%) categories. Results: The overall survival rates were 97.2%, 90.8%, and 83.4% at 1, 3, and 5 years, respectively. The cause of death was cardiovascular in 42.8% of cases. Freedom from MACE was 96.7%, 88.6%, and 77.3% at 1, 3, and 5 years, respectively. Cox multivariate regression analysis identified age, dialysis, left ventricular dysfunction, insulin-dependent diabetes, hematoma prolonging hospitalization, coronary artery disease, and superficial femoral plus iliac lesions as positive predictors of all-cause mortality. In the risk stratification analysis, the overall 5-year survival rate was significantly lower in high-risk patients compared to the other groups (90.1% vs. 78.6% vs. 53.5%, p<0.0001). Conclusion: The prognosis in patients with intermittent claudication after endovascular therapy was relatively good but extremely poor for the high-risk patient subgroup. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: To report long-term outcomes of endovascular therapy (EVT) for aortoiliac bifurcation lesions. Methods: Patients enrolled in the multicenter REtrospective AnaLysis of Aorto-Iliac stenting (REAL-AI) registry in Japan were pooled. Of 2096 patients who underwent EVT for de novo aortoiliac disease between January 2005 and December 2009, 190 patients (148 men; mean age 70±9 years) had aortoiliac bifurcation lesions that were treated with stents, whose configuration (single, V, or kissing) and type (balloon-expandable or self-expanding) were subjected to regression analysis to determine any impact on primary patency along with other demographic, clinical, and lesion characteristics, including Trans-Atlantic Inter-Society Consensus II C/D classification. The primary endpoints were restenosis and target lesion revascularization (TLR). Secondary endpoints were all-cause death, major cardiovascular events, and major cardiovascular + limb events. Results: The overall complication rate was 6.3%, and 1- and 5-year primary patency rates were 87% and 73%, respectively. Over a mean follow-up of 31±15 months, there were 36 (19.0%) restenoses, 22 (11.6%)TLRs, and 4 (2.1%) reocclusions; stent fracture (2, 1.1%) and major amputation (2, 1.1%) were rare. Only female gender [adjusted hazard ratio (AHR) 4.26, 95% CI 1.89 to 9.71, p<0.001] and residual diameter stenosis (AHR 1.04, 96% CI 1.01 to 1.06, p=0.01) were independent predictors of primary patency. Conclusion: Stenting for aortoiliac bifurcation lesions was found to be safe and effective. Neither stent configuration nor type appeared to affect vessel patency in true bifurcation lesions. [ABSTRACT FROM AUTHOR]

Background: Post-challenge hyperglycemia (PH) is well-established as one of risk factors for coronary artery disease. However, it remains unclear whether PH affects clinical outcomes in patients with stable angina undergoing percutaneous coronary intervention (PCI). Methods: A total of 828 patients with stable angina undergoing PCI were retrospectively analyzed. Of these, 452 patients with previously diagnosed diabetes mellitus (DM) or fasting plasma glucose (PG) ⩾126 mg/dl and HbA1c ⩾6.5% were defined as known DM. The remaining 376 patients were divided into the two groups according to 2-h PG: PH (2-h PG ⩾140 mg/dl, n=236) and normal glucose tolerance (NGT, 2-h PG <140 mg/dl, n=140). We assessed the rate of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, myocardial infarction, stroke, and clinically-driven revascularization. Results: During the median follow-up of 4.3 years, the MACE rate was significantly higher in the DM and PH groups than the NGT group (39.3% vs. 20.7%, P <0.001; 31.4% vs. 20.7%, P=0.044, respectively). Compared with the NGT group, the cumulative incidence of revascularization was significantly higher in the DM group (35.1% vs. 18.5%, P <0.001) and tended to be higher in the PH group (27.1% vs. 18.5%, P=0.067). In the multivariate analysis, known DM (Hazard ratio [HR]: 2.16, 95% confidence interval (CI): 1.49-3.27, P < 0.001), PH (HR: 1.62, 95% CI: 1.07-2.53, P = 0.023), LDL-C >100 mg/ dl (HR: 1.62, 95% CI: 1.26 to 2.10, P < 0.001), and previous stroke (HR: 1.47, 95% CI: 1.03-2.04, P = 0.034) were predictors of MACE. Conclusion: PH is associated with future cardiovascular events in patients with stable angina undergoing PCI. [ABSTRACT FROM AUTHOR]