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Chronic total occlusion (CTO) of the superficial femoral artery (SFA) with flush occlusion is sometimes difficult to be treated by endovascular treatment (EVT). The guidewire could not pass the proximal cap because the entry of the CTO could not be detected by angiography. Thus, a retrograde approach is considered; however, there was a risk of jeopardizing the adjacent deep femoral artery by subintimal angioplasty. Moreover, the retrograde approach is not feasible when the distal artery could not be punctured because of stenosis, occlusion, or uncomfortable positioning for patients during EVT. Therefore, we considered a novel technique to overcome this problem, called the Proximal superficial femoral Artery Puncture to RecanalIze the Chronic totAl occlusion (PAPRICA) technique. In this technique, to establish wire externalization, a retrograde puncture was performed from the proximal site of the SFA-CTO under ultrasound guidance, and the guidewire was advanced retrogradely from the puncture needle via the CTO site. After wire externalization, the guide catheter could be advanced into the SFA ostium. By pulling up the externalization wire, a strong backup and improved coaxial alignment of the guide catheter were achieved. This report presents two successful cases of flush SFA-CTO using this novel technique., (© 2020 Wiley Periodicals LLC.)

Objectives: The efficacy and clinical outcomes of a novel technique "HIRANODOME" (Interim hemostatic technique with HIgh pressure for Regional blood flow in the superficial femoral Artery, NOninvasive Distal protection Occlusion MEthod) in preventing distal embolization during endovascular treatment (EVT) of femoropopliteal lesions were evaluated., Background: Distal embolization of femoropopliteal lesions may worsen limb ischemia or cause limb loss. Conventional filter wires are cumbersome and expensive and may cause vessel injury. HIRANODOME can, therefore, be a feasible and noninvasive alternative., Methods: Between April 2007 and August 2018, 94 consecutive patients who underwent EVT for femoropopliteal lesions along with anticipated distal embolization were identified. About 9 out of these 94 patients were excluded due to filter device use and 8 were excluded due to acute limb ischemia. Consequently, 77 patients using HIRANODOME for distal protection were included. HIRANODOME involved wrapping the Tometakun around the knee to enable external compression of the popliteal artery, thereby blocking the blood flow. The evaluation items were 30-day mortality, 30-day major amputation, prevention from distal embolization, and thrombus capture rate., Results: The mean age was 74.4 ± 10.3 years, 53.2% were men, 55.8% were diabetic, and 9.1% were on hemodialysis. The mean lesion length was 199.5 ± 94.4 mm; 79.2% were class C/D lesions (TASC II classification). The 30-day mortality and major amputation rates were 1.9 and 1.0%, respectively. The rate of prevention of distal embolization or no-flow/slow-flow phenomenon was 93.4%. Capture of thrombus was observed in 66 lesions (62.3%)., Conclusions: The HIRANODOME technique was effective in preventing distal embolization during EVT of femoropopliteal lesions., (© 2021 Wiley Periodicals LLC.)

To investigate the usefulness of ultrasound-guided (USG) intraluminal approach for femoropopliteal (FP) lesion. 64 patients (73 limbs) with de novo long occlusive (> 15 cm) FP lesions underwent USG intralumial approach from April 2012 to October 2016. Periprocedural intravascular ultrasound findings were collected. Clinical outcome and predictors of restenosis after USG intraluminal approach for de novo long occlusive FP lesion were investigated. Among the study participants, 34% were female, 50% had diabetes mellitus, and 10% received hemodialysis. Lesion and chronic total occlusion (CTO) lengths were 222 ± 55 mm and 201 ± 55 mm, respectively. Procedural success was achieved in 72 lesions (99%). Distal puncture was performed in 7 limbs (10%). The proportion of within-CTO intraplaque, subintimal, and medial routes were 87 ± 21%, 9 ± 15%, and 4 ± 11%, respectively. Primary patency was 71% and 69% at 1 and 2 years. Multivariate analysis revealed that within-CTO intraplaque route proportion [hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.67-0.98, p = 0.0339] and lesion length (HR 1.11; CI 1.00-1.22; p = 0.0447) were independent predictors of restenosis.USG intraluminal approach facilitated acquisition of within-CTO intraplaque route in long occlusive FP lesions and could improve clinical outcome.

Introduction: The proportion of patients with comorbid atrial fibrillation (AF) and peripheral artery disease (PAD) has increased in this era. This study aimed to assess the relationship between AF and totally occlusive in-stent restenosis (ISR) in femoropopliteal (FP) lesions., Methods: In this study, 363 patients (461 stents) who underwent endovascular therapy with de novo stent implantation in our hospital between April 2007 and December 2016 were retrospectively evaluated. The patients were divided into two groups according to the AF status (AF group, 61 patients; sinus group, 302 patients). The primary endpoint was the incidence of totally occlusive ISR within 3 years. The secondary endpoint was the incidence of acute limb ischemia (ALI) due to FP stent occlusion., Results: Baseline characteristics were similar, except for higher age and a lower prevalence of dyslipidemia in the AF group. The incidence of a totally occlusive ISR was higher in the AF group than in the sinus group (29.5% vs. 14.6%, p =0.004). A multiple Cox regression model suggested that presence of AF (hazard ratio, 2.10) and CTO lesion (hazard ratio, 1.97) which were the independent predictors of a totally occlusive ISR within 3 years. The incidence of ALI was significantly higher in the AF group than in the sinus group (3.9% vs. 0%, p =0.0001). In the AF group, the introduction of an anticoagulant did not prevent the occurrence of totally occlusive ISR ( p =0.71) for ALI ( p =0.79)., Conclusions: AF is independently associated with totally occlusive ISR of FP stents; however, anticoagulant use does not prevent stent occlusion., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2021 Yohsuke Honda et al.)

Objective: This retrospective study assessed the safety and efficacy of the ARAHKEY (ARterial sealing with Additional Hemostatic device Kissing with Extravascular and suture-based device deeplY) technique during transcatheter aortic valve replacement (TAVR)., Background: Access site complications are still a major issue to be solved during TAVR using a large caliber sheath., Methods: From February 2014 to June 2019, a total of 302 patients underwent TAVR in our hospital. Twenty-five patients (10.2% of patients who underwent percutaneous transfemoral TAVR [n = 246]) were treated using the ARAHKEY technique, which is the additional use of Exoseal for the common femoral artery puncture site when hemostasis was not achieved with ProGlide alone., Results: Complete hemostasis was achieved in all patients (100%). The mean procedural time for hemostasis was 9.8 ± 4.5 min. No complications, including recurrent bleeding, infection, and late acquired hematoma, were observed in this study cohort., Conclusion: The ARAHKEY technique is a safe method and should be considered as a secondary option when hemostasis is not achieved with ProGlide during TAVR., (© 2019 Wiley Periodicals, Inc.)

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

Following an era of the use of several drug-coated balloons in angioplasty, "leave nothing behind" and stentless strategies have been gaining attention. In stentless strategies, it is necessary to avoid major dissections and limit flow. Balloon dilation is an important step in vessel preparation. In this study, we report a novel predilation technique. We performed prolonged balloon inflation for >10 min after normal ballooning in a procedure to treat an occluded lesion in the superficial femoral artery (SFA). We used a guide extension catheter to avoid foot ischemia and obtained better angiographic results than those using short duration balloon inflation. We named this technique "Ultra-Long Inflation in SFA Stenosis and Occluded Lesions Using Guide Liner" or "Ultra SOUL." The Ultra SOUL technique may be considered a useful option in balloon dilation., (Copyright © 2018 Elsevier Inc. All rights reserved.)

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.

Objectives: The aim of this study was to assess clinical benefit of the Echo-guided ProGlide technique in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI)., Background: The efficacy of the Echo-guided ProGlide technique during percutaneous TF-TAVI was not previously clarified., Methods: A total of 121 consecutive patients who underwent percutaneous TF-TAVI at our institution between February 2014 and July 2017 were enrolled in this study. According to the introduction of this novel technique in March 2016, patients were divided into two groups (echo-guided group who underwent TAVI from March 2016 to July 2017, n = 63; not echo-guided group who underwent TAVI from February 2014 to February 2016, n = 58). The incidence of major vascular complications, defined per the Valve Academic Research Consortium-2 criteria, and ProGlide complications including acute femoral artery stenosis or occlusion and bleeding requiring any intervention., Results: The incidence of major vascular complication and ProGlide complication were significantly lower in the echo-guided group than in not echo-guided group (1.6% vs 17.2%, P < 0.002; 1.6% vs 15.5%, P = 0.003; respectively). Use of the Echo-guided ProGlide technique was independently associated with prevention of ProGlide complications (odds ratio, 0.11; 95% confidential interval, 0.01-0.76; P = 0.03)., Conclusions: This novel Echo-guided ProGlide technique was associated with a lower rate of major vascular complications, particularly ProGlide complications during percutaneous TF-TAVI., (© 2017, Wiley Periodicals, Inc.)

Objective: Angiographic dissection is considered to be associated with restenosis. However, little is known about the impact of the severity of angiographic dissection on future restenosis., Methods: A total of 319 consecutive de novo femoropopliteal lesions were treated by balloon angioplasty alone. All of these lesions were divided into three groups: group A, no angiographic dissection; group B, mild dissection, the width of the dissection was less than one-third of the lumen; and group C, severe dissection, the width of the dissection was more than one-third of the lumen. Kaplan-Meier analysis estimated the primary patency rate at 3 years between the groups., Results: The primary patency rates at 3 years were 66.0% in group A, 63.8% in group B, and 32.5% in group C (log-rank, P < .001). Cox proportional hazards analysis revealed that a lesion length >100 mm (hazard ratio, 1.734; 95% confidence interval, 1.099-2.735; P = .018) and severe angiographic dissection (hazard ratio, 1.956; 95% confidence interval, 1.276-2.997; P = .002) were predictors of primary patency loss at 3 years. When the lesions were divided into two groups according to the lesion length >100 mm or not, angiographic dissection had a larger impact on restenosis in a long lesion >100 mm (≤100 mm: 65.5% in group A, 75.6% in group B, and 48.0% in group C [log-rank, P = .015]; >100 mm: 68.8% in group A, 42.5% in group B, and 24.2% in group C [log-rank, P = .017])., Conclusions: Severe angiographic dissection was associated with future restenosis after balloon angioplasty for femoropopliteal lesions, but mild angiographic dissection was not. Angiographic dissection had more impact on future restenosis particularly in treated long lesions. Stents might not be necessary in short lesions with mild dissection., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: We sought to assess whether balloon angioplasty (BA) alone for small femoropopliteal disease improved the outcome following endovascular therapy as compared with stent implantation., Background: The optimal strategy of endovascular therapy for small vessel arteries in femoropopliteal disease remains unclear., Methods: We performed a multicenter retrospective analysis of 337 consecutive patients (371 limbs) with femoropopliteal arteries 4.0 mm or less in diameter and 150 mm or less in length., Results: Cumulative 3-year incidence of primary patency was significantly higher in the BA group than in the stent group (53.8% vs. 34.2%, P = 0.002). While assisted-primary patency and freedom from any major adverse limb events were also significantly higher in the BA group than in the stent group (70.9% vs. 44.2%, P < 0.001 and 60.6% vs. 36.4%, P = 0.001, respectively), secondary patency did not significantly differ between the two groups (86.9% vs. 86.9%, P = 0.67). Predictors of restenosis were diabetes mellitus (hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.14-2.31; P = 0.01), no administration of cilostazol (HR, 1.50; 95% CI, 1.07-2.13; P = 0.02), stent implantation (HR, 1.68; 95% CI, 1.15-2.41; P = 0.01), and lesion length >75.0 mm(HR, 2.09; 95% CI, 1.50-2.92; P < 0.001)., Conclusions: Lesions in small (<4.0 mm diameter) FP vessels demonstrated better primary patency at 3 years when successfully treated with balloon angioplasty alone as opposed to routine or bailout stenting. This difference was especially pronounced for lesions 75 to 150 mm in length., (© 2017 Wiley Periodicals, Inc.)

Stent placement for treating superficial femoral artery (SFA) lesions has been approved. The Zilver PTX stent, a drug-eluting stent (DES) for treating SFA lesions, has been available in Japan since 2012. However, the penetration rate of this DES has not yet been reported. This prospective multicenter registry study enrolled 314 patients (354 limbs) to be treated by stent placement in 2014 (UMIN000011551). The primary endpoint was the measurement of the penetration rate of the DES. The secondary endpoints were measuring the freedom from restenosis, freedom from target lesion revascularization (TLR), freedom from major adverse limb event (MALE), and the survival rate at 12 months postoperatively. Female patients comprised 28% participants. The mean age was 73.1 ± 9.2 years. A total of 56% patients had diabetes mellitus (DM), 36% patients were receiving hemodialysis, and 30% used cilostazol at baseline. The mean lesion length was 156 ± 101 mm, and the percentage of TASC II C/D lesions was 58%. Critical limb ischemia (CLI) was observed in 32% limbs. The penetration rates of the Zilver PTX stent were only 8%. The primary patency rate was similar between DES and bare-metal stents (BMS) at 12 months postoperatively (77 vs. 84%, p = 0.52). In this study, the rates of freedom from restenosis, freedom from TLR, freedom from MALE, and the survival rate at 12 months postoperatively were 83, 86, 85, and 89%, respectively. The penetration rate of a first-generation DES placement for treating SFA lesions is low in Japan. On the other hand, BMS is well utilized and its primary patency is acceptable.

Objective: We investigated the relationship between the outcomes of endovascular therapy (EVT) for femoropopliteal (FP) lesions and vessel diameter. Several studies have reported a relationship between the outcome of EVT for FP lesions and lesion characteristics. However, the relationship with vessel diameter has not been explored., Methods: We retrospectively analyzed 2656 patients with 3340 de novo FP lesions (mean age, 73.9 ± 9 years; 70% male) who underwent EVT from January 2004 to December 2011. We classified the lesions into four groups according to the vessel diameter: group 1, ≤4 mm; group 2, 4 to 5 mm; group 3, 5 to 6 mm; and group 4, >6 mm. We investigated the relationship between the outcomes of EVT and vessel diameter. The primary outcome measure was restenosis, and the secondary outcome measures were target lesion revascularization and major adverse limb events., Results: The restenosis rate at 3 years in group 1 was significantly higher compared with the other groups (62.2%, 35.7%, 37.1%, and 41.0% for groups 1, 2, 3, and 4, respectively; log-rank, P < .0001). The outcome among small vessels was significantly worse in the stent group, and the outcomes for target lesion revascularization and major adverse limb events were similar. After adjustment, a small vessel ≤4 mm remained an independent predictor of restenosis (hazard ratio, 1.69; 95% confidence interval, 1.44-1.98; P < .0001)., Conclusions: This study suggested that vessel diameter, especially a small vessel ≤4 mm, was associated with poor EVT outcomes. The tendency was particularly evident in the stent group, which suggested that primary stenting should not necessarily be recommended for small vessels., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Aim: To investigate the relationship between intravascular ultrasound (IVUS) findings and restenosis after stent implantation for long occlusive femoropopliteal (FP) lesions using the intraluminal approach., Methods: This was a single-center retrospective study of 45 patients (49 lesions) with de novo long occlusive FP lesions treated with bare metal stents implanted using the intraluminal approach under IVUS guidance from April 2007 to December 2014. All patients were followed up at least 12 months. The preprocedural and postprocedural IVUS findings were compared for patients with and without restenosis, which was defined as a peak systolic velocity ratio of ＞2.4 on duplex ultrasonography or ＞50% diameter stenosis on angiography., Results: Within 12 months, 13 patients (14 lesions) developed restenosis, whereas 32 patients (35 lesions) did not (restenosis rate=29%). The male: female ratio and the prevalence of diabetes mellitus, hemodialysis, and critical limb ischemia were similar between the two groups. No significant differences were observed in lesion length, chronic total occlusion (CTO) length, and the percentage of involving popliteal lesion between the two groups. A whole intraplaque route was gained in 15 lesions (31%). Multivariate analysis revealed that the within-CTO intramedial route proportion and the distal lumen cross-sectional area (CSA) were independent predictors of restenosis. Receiver operating characteristic analysis showed that the best cutoff values of these parameters were 14.4% and 17.7 mm 2 , respectively., Conclusions: In patients with long occlusive FP lesions undergoing stent placement using the intraluminal approach, a whole intraplaque route was gained in 31%. Restenosis is more likely if IVUS shows a within-CTO intramedial route proportion of ＞14.4% or distal lumen CSA of ＜17.7 mm 2 .

Objective: Although clinical trials demonstrated the superiority of the Zilver (Cook Medical, Bloomington, Ind) paclitaxel-eluting stent (PTX), a recently developed drug-eluting stent (DES), to conventional therapy for femoropopliteal (FP) lesions, the incidence and risk factors of the repetition of reintervention after DES implantation in clinical practice remained unrevealed., Methods: This was a subanalysis of the ZEPHYR (ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy) study, enrolling FP lesions undergoing endovascular therapy (EVT) with DES implantation. The current study analyzed the 2-year database including 583 FP lesions in 495 patients undergoing preoperative intravascular ultrasound imaging before DES implantation. The primary outcome measure was re-re-EVT, defined as undergoing additional EVT more than once during the 2-year follow-up after DES implantation. The secondary outcome measure was re-EVT, defined as undergoing at least one additional EVT during the follow-up., Results: Critical limb ischemia (CLI) was present in 28% of the study population, 23% had a history of EVT, and 43% had chronic total occlusion. Mean lesion length was 16 ± 10 cm, and intravascular ultrasound imaging-evaluated external elastic membrane area was 28 ± 10 mm 2 . The cumulative incidence rate of re-re-EVT at 2 years was estimated to be 14%, whereas that of re-EVT was 31%. After multivariate analysis, CLI and smaller external elastic membrane area were independently associated with the outcome., Conclusions: The incidence and risk factors of the repetition of reintervention after DES implantation for FP lesions were revealed. The current findings suggest that DES implantation might be a careful indication in CLI cases especially with a small vessel., (Copyright © 2016. Published by Elsevier Inc.)

Purpose: To report midterm outcomes after subintimal vs intraluminal drug-eluting stent (DES) implantation for femoropopliteal (FP) chronic total occlusion (CTO)., Methods: This subanalysis of the prospective, multicenter ZEPHYR study (ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy) included 176 patients (mean age 74±8 years; 130 men) with 192 de novo FP CTOs that were evaluated by intravascular ultrasound after successful guidewire crossing. The primary outcome was the 2-year restenosis rate after subintimal (n=73) or intraluminal (n=119) DES implantation. Propensity score matching extracted 61 matched pairs (mean age 75 years; 49 men) for patency analysis to minimize baseline intergroup differences. Restenosis rates are reported with the 95% confidence interval (CI)., Results: The 1-year restenosis rates in the groups with subintimal and intraluminal DES implantation were 45% (95% CI 32% to 59%) and 35% (95% CI 22% to 49%), respectively (p=0.352), whereas the corresponding rates at 2 years were not significantly different (p=0.648) at 56% (95% CI 41% to 71%) and 51% (95% CI 34% to 68%). Baseline characteristics had no significant interaction effect on the association of subintimal angioplasty with restenosis risk., Conclusion: In FP CTO, 2-year restenosis rates were comparable after subintimal or intraluminal DES implantation., (© The Author(s) 2016.)

Purpose: To evaluate the clinical efficacy of poststenting fractional flow reserve (FFR) in terms of predicting restenosis in superficial femoral artery (SFA) disease., Methods: This prospective, single-center, nonrandomized study enrolled 48 patients (mean age 76±9 years; 38 men) with 51 SFA lesions from July 2013 to June 2014. Mean FFR (distal mean pressure/proximal mean pressure) and systolic FFR (distal systolic pressure/proximal systolic pressure) were calculated, and the relationship between these FFR values and restenosis at 12 months was investigated using receiver operating characteristic (ROC) curve analysis., Results: Poststenting FFR was significantly lower in the restenosis group (poststenting mean FFR 0.85±0.07 vs 0.93±0.05, p=0.001; poststenting systolic FFR 0.76±0.14 vs 0.87±0.08, p=0.015). The area under the ROC curve for restenosis in poststenting mean FFR was higher, but not statistically significant, than that in poststenting systolic FFR (0.84 vs 0.74, p=0.08). The best poststenting mean FFR cutoff value for predicting restenosis was 0.92 (sensitivity 0.64, specificity 0.91). The 4.5% restenosis rate at 12 months in the high (>0.92) poststenting mean FFR group was significantly lower (35.7%, p=0.008) than in the low (≤0.92) poststenting mean FFR group., Conclusion: Poststenting mean FFR is useful for predicting restenosis in SFA disease., (© The Author(s) 2016.)

Objectives: This study sought to investigate the characteristics of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation for femoropopliteal (FP) lesions, and to examine 1-year prognosis after repeat endovascular therapy (re-EVT) for these DES-ISR., Background: The morphology of DES-ISR and its association with clinical outcomes after re-EVT have not been well examined., Methods: This was a subanalysis of the ZEPHYR (Zilver PTX for the femoral artery and proximal popliteal artery) study. The current study included 210 cases with loss of patency confirmed 1 year after DES implantation. Morphology of DES-ISR was classified into the following subgroups: class I, focal lesions (≤50 mm in length), class II, diffuse lesions (>50 mm in length), and class III, totally occluded ISR. One-year prognosis after re-EVT for DES-ISR was assessed by restenosis and major adverse limb events (MALE)., Results: Classes I, II, and III accounted for 50%, 25%, and 25% of DES-ISR, respectively. Factors associated with the morphology of DES-ISR were the presence of chronic total occlusion and the size of the external elastic membrane area before DES implantation (p = 0.009 and 0.017). Compared with the class I restenotic lesion, the class II and III lesions had a significantly higher risk of restenosis (74% and 78% vs. 53%: p = 0.048 and 0.019, respectively) and MALE (56% and 56% versus 32%: p = 0.025 and 0.022, respectively) 1 year after re-EVT., Conclusions: We evaluated the characteristics of ISR after DES implantation for FP lesions and 1-year prognosis of re-EVT for DES-ISR. The morphology of DES-ISR had a significant association with 1-year prognosis after re-EVT., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aim: The optimal fractional flow reserve (FFR) measurement method for superficial femoral artery (SFA) lesions remains to be established. We clarified the optimal measuring procedure for FFR for SFA lesions and investigated the necessary dose of papaverine for inducing maximal hyperemia in SFA lesions., Methods: Forty-eight patients with SFA lesions who underwent measurement of peripheral FFR (pFFR: distal mean pressure divided by proximal mean pressure) after endovascular treatment by the contralateral femoral crossover approach were prospectively enrolled. In the pFFR measurement, a guide sheath was placed on top of the common iliac bifurcation and pressure equalization was performed. After advancing the pressure wire distal to the SFA lesion, sequential papaverine administration selectively to the affected common iliac artery was performed., Results: There were no symptoms, electrocardiogram changes, and significant pressure drops at the guide sheath tip with increasing papaverine dose. pFFR changes following 20, 30, and 40 mg of papaverine were 0.87±0.10, 0.84±0.10, and 0.84±0.10, respectively (P＜0.001). Although not significantly different, pFFR decreased more in several patients at 30 mg of papaverine than at 20 mg. The pFFR at 40 mg of papaverine was almost similar to that at 30 mg of papaverine. The necessary papaverine dose was not changed according to sex and number of run-off vessels., Conclusions: The contralateral femoral crossover approach is useful in FFR measurement for SFA lesions, and maximal hyperemia is induced by 30 mg of papaverine.

Purpose: To evaluate the relationship between 1-year primary patency and lesion length in patients with femoropopliteal disease treated with bare nitinol stents., Methods: The study was a retrospective analysis of a prospectively maintained multicenter database. Between January 2004 and December 2011, 1047 consecutive patients (mean age 72 years; 765 men) underwent femoropopliteal stenting with nitinol stents in 1373 limbs. The mean vessel diameter was 5.3±0.7 mm and the mean lesion length was 142±75 mm. One-year follow-up data were collected and analyzed to ascertain which lesion length would be expected to demonstrate a 1-year primary patency above the established 66% objective performance goal (OPG)., Results: The lower limit of the 95% confidence interval (CI) for the unadjusted 1-year primary patency was >66% when the lesion length was ≤243 mm. After adjustment of the covariates to match those of the OPG-derived population, the 1-year primary patency decreased linearly with longer lesion length. The 1-year primary patency was 83.2% (95% CI 79.8% to 86.1%) for a 100-mm lesion length, 76.4% (95% CI 71.7% to 80.5%) for a 200-mm lesion length, and 70.7% (95% CI 62.4% to 77.7%) for a 300-mm lesion length. The maximum lesion length providing a 1-year primary patency significantly greater than 66% was calculated to be 263 mm., Conclusion: The 1-year primary patency of femoropopliteal lesions treated with bare nitinol stents decreased linearly with longer lesion length. The maximum lesion length providing a higher patency rate than the OPG of 66% was ~25 cm., (© The Author(s) 2015.)

Purpose: To investigate the relationship between postprocedure intravascular ultrasound (IVUS) findings and restenosis after placement of drug-eluting stents (DES) for femoropopliteal lesions., Methods: Between July 2012 and May 2013, DES were placed in 64 patients with 88 de novo femoropopliteal lesions. In 40 patients (mean age 74.2±9.4 years; 27 men), DES were placed in 50 lesions under IVUS guidance, and restenosis was monitored for 1 year. All patients were symptomatic (Rutherford 2-6), and 17 patients (43%) suffered from critical limb ischemia. IVUS findings after stenting were compared for patients with vs without restenosis, which was defined as a peak systolic velocity ratio >2.4 on duplex ultrasonography or >50% diameter stenosis on angiography., Results: Ten patients (14 lesions) developed restenosis, while 30 patients (36 lesions) did not. There were no significant differences in the frequency of diabetes or dialysis between the 2 groups. Female patients were predominant in the restenosis group (p<0.003). There were no significant differences of the percentage of TransAtlantic Inter-Society Consensus C/D lesions or stent edge dissection. Multivariate analysis indicated that cilostazol use [odds ratio (OR) 0.13; p=0.046], distal lumen cross-sectional area (CSA) (OR 0.86; p=0.035), and axial symmetry index (OR 0.60; p=0.045) were independent predictors of restenosis. Using receiver operator characteristic analysis, the best cutoff values of the distal lumen CSA and axial symmetry index for predicting restenosis were 17.1 cm(2) and 0.6, respectively., Conclusion: IVUS guidance of DES placement in femoropopliteal lesions can offer useful predictors of restenosis at 1 year. The utility of distal lumen CSA and the axial symmetry index in the prediction of restenosis after femoropopliteal DES placement should be confirmed in a larger cohort., (© The Author(s) 2015.)

Purpose: To examine the effectiveness of vascular elastography (VE) for the assessment of totally occluded lower limb arteries prior to endovascular treatment (EVT)., Methods: Of 812 consecutive patients who underwent EVT between April 2010 and April 2012, VE was used to evaluate the hardness of chronic total occlusions of the femoropopliteal segment prior to EVT in 65 consecutive patients (48 men; mean 73.9 years, range 63-86). Elastograms of the CTOs proximally and distally were scored using a 5-point scale, and outcomes in limbs with hard lesions (VE score 0-2) were compared to those with soft lesions (VE score 3-4) according to lesion length. The interventionists who performed the endovascular procedures were not informed of the VE score results., Results: CTO characteristics could be evaluated in all cases. A VE score ≤2 was found in 14 of the 23 lesions <150 mm in length. A flexible guidewire was sufficient for recanalization in more of the soft lesions than in the hard lesions [6/9 vs. 2/14, respectively]. In 39 lesions >150 mm, a VE score of 3 was recorded in most lesions proximally, while lesions distally were hard in many cases (VE score 1 or 2). A flexible guidewire alone was sufficient in many soft CTOs (8/13, p<0.01). In 16 cases, hard calcified plaque was indicated by difficulty in penetrating the lesion even with a stiff guidewire; all these cases had a VE score of 1 or 2. A retrograde approach was required only in hard CTOs (p<0.01). The procedure time was significantly longer for the hard lesion group (152.9±63.2 vs. 87.0±29.8 minutes, p=0.001). In 11 in-stent occlusions, only VE scores of 3 (n=4) or 4 (n=7) were recorded, indicating soft thrombus, which was aspirated under distal protection in 7 cases., Conclusion: VE may be a useful method for determining the hardness of CTO lesions noninvasively before endovascular therapy, providing information that can help plan the procedure.

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.

Objectives: This study sought to investigate factors associated with restenosis after endovascular therapy comparing TASC (Trans-Atlantic Inter-Society Consensus) II classes A to C with class D femoropopliteal (FP) lesions., Background: It is unclear whether the determinants of restenosis for TASC II class D lesions are the same as those for TASC II classes A to C FP lesions., Methods: We studied 2,400 limbs from 1,889 consecutive patients (73 ± 17 years of age; 31% women; 30% critical limb ischemia) who underwent successful endovascular therapy for de novo FP lesions. Predictors for restenosis in TASC II classes A to C and class D lesions were assessed using a Cox proportional hazards model., Results: The 5-year primary patency rate was 50% in TASC II classes A to C and 34% in TASC II class D lesions, respectively (p < 0.001). Overall, restenosis had a significant interaction with sex and renal failure (both p < 0.01). Female sex was a significant risk factor for restenosis in TASC II class D lesions (adjusted hazard ratio [HR]: 1.80, p < 0.001) but not TASC II classes A to C lesions (adjusted HR: 1.10, p = 0.352). Conversely, renal insufficiency was a significant risk factor for restenosis in TASC II classes A to C lesions (adjusted HR: 1.43, p < 0.001) but not TASC II class D lesions (adjusted HR: 0.79, p = 0.129). Diabetes mellitus, no stent use, chronic total occlusion, and poor below-the-knee runoff were shared risk factors for restenosis between TASC II classes A to C and class D lesions (all p < 0.05)., Conclusions: For de novo FP lesions, diabetes, no stent use, chronic total occlusion, and poor below-the-knee runoff were shared restenosis predictors for TASC II classes A to C and class D lesions, whereas renal failure was a predictor for TASC II classes A to C lesions and female sex for TASC II class D lesions., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

Purpose: To compare the safety and success of a retrograde approach using a microcatheter vs. a sheath in the treatment of superficial femoral artery (SFA) chronic total occlusions (CTOs)., Methods: From April 2007 to December 2012, 188 consecutive patients underwent EVT for 229 de novo SFA CTOs using the retrograde approach in 68 patients (35 men; mean age 72 years). This cohort was divided into cases performed with a 4-F or 6-F sheath (n=28, 36 limbs) and those with a 2.1-F microcatheter (n=35, 49 limbs). The primary outcomes were mean time to hemostasis and number of intra- and postoperative puncture site complications, as well as the success of popliteal artery puncture, lesion crossing, and reperfusion., Results: There were no significant differences between two groups in baseline characteristics. PA puncture was successful in all limbs, and the success in crossing the lesion with the wire was not significantly different (91.9% in the sheath group vs. 89.8% in the microcatheter group). Mean time to hemostasis was 8.9±8.8 minutes in the microcatheter group vs. 47.7±13 minutes in the sheath group (p<0.0001). There was a significant difference in intraoperative and postoperative complications (22.2% in the sheath group vs. 2.0% in the microcatheter group, p=0.002)., Conclusion: Based on this retrospective analysis, the use of a microcatheter for SFA CTO retrograde access appears to be superior to 4-F or 6-F sheaths in terms of shorter time to hemostasis and fewer complications.

Objective: Widespread use of self-expanding nitinol stent-based endovascular treatment (EVT) for femoropopliteal (FP) lesions has been fueled by its less-invasive nature and modest durability; however, prevalence, predictors and prognosis of in-stent occlusion are undefined and were investigated here., Methods: This study entailed a multicenter, retrospective analysis of a prospectively maintained database. Between January 2004 and December 2011, 2447 de novo FP lesions (mean length, 143 ± 87 mm; 52% chronic total occlusions) from 2008 patients (mean age, 73.0 ± 9.2 years; 71% male; 61% diabetics; 32% critical limb ischemia; and 24% on hemodialysis) were treated with nitinol stent-based EVT. Study outcome was in-stent occlusion: rates (1, 3, and 5 years), predictors and association with limb prognosis., Results: In-stent occlusion rate was 5.2%, 11.2%, and 16.4% at 1, 3, and 5 years, respectively (mean follow-up, 2.3 ± 1.7 years). Female sex, critical limb ischemia, and Transatlantic Inter-Society Consensus II class C/D (multivariate Cox proportional hazard ratio [HR], 1.75, 1.49, and 3.34, respectively) were independent predictors of in-stent occlusion after FP stenting, which was associated with poor limb prognosis (major amputation, HR 6.35; major adverse limb event, major adverse limb event, HR, 21.1)., Conclusions: Moderate in-stent occlusion rates were observed after nitinol stent-based EVT. Closer attention is warranted with high-risk cases because of poorer limb prognosis., (Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

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

Background: Intraluminal femoropopliteal stenting enables favorable dilation and good immediate results; however, whether this contributes to long-term patency is unclear. We compared patency after femoropopliteal stenting for a long occlusion using either an intraluminal or subintimal approach., Methods: Between January 2004 and December 2011, 902 endovascular procedures using either an intraluminal approach (651 procedures) or a subintimal approach (251 procedures) for long femoropopliteal occlusion were analyzed retrospectively. The outcomes of this study were periprocedural complication; primary, assisted-primary, and secondary patency; and overall survival., Results: The mean follow-up period of survivors was 29 ± 16 months. Between the intraluminal and subintimal approach, technical success (91% vs 90%; P = .71) and periprocedural complications (11% vs 13%; P = .34) were similar. However, procedure time was significantly longer for the intraluminal approach (126 ± 63 minutes vs 98 ± 49 minutes; P = .003). The improvement of ankle-brachial index was also similar. A quarter of cases started with the intraluminal approach were switched to a subintimal approach. There was no significant difference in primary, assisted-primary and secondary patency at 3 years between the two groups (55% vs 53%; P = .30; 65% vs 74%; P = .11; and 80% vs 85%; P = .37). The 3-year overall survival also did not differ significantly between groups (84% vs 86%; P = .55). After adjusting for baseline differences, the subintimal approach was found to be similar to the intraluminal approach for primary patency (hazard ratio, 1.21; 95% confidence interval, 0.94-1.56; adjusted P = .14)., Conclusions: Initial result and 3-year patency was similar in both approaches. Given the longer procedure time and high crossover rate, we suggest that a subintimal approach may be preferred in the treatment of long femoropopliteal occlusions with stenting., (Copyright © 2013 Society for Vascular Surgery. All rights reserved.)

Objective: To investigate the 5-year patency rates and predictors of restenosis after self-expanding nitinol stent implantation for chronic total occlusion (CTO) in superficial femoral and proximal popliteal artery (SFPA) lesions., Background: Outcomes and long-term patency rates after self-expanding nitinol stent for CTO in the SFPA lesions have not been clarified., Methods: From January 2004 to December 2009, 861 serial arteriosclerosis obliterans patients, 1,017 limbs, underwent endovascular therapy with implantation of a self-expanding nitinol stent for SFPA lesions at four institutions in Japan. Of the cohort, 352 patients, 383 limbs, had self-expanding nitinol stents implanted for CTOs in the SFPA and were followed for 5 years. We retrospectively investigated patency rate and multivariate predictors associated with restenosis., Results: Mean age was 72 ± 9 years and 31% were female patients. In total, 58% of the patients had diabetes mellitus and 25% were patients with critical limb ischemia. Occluded length was 194 ± 89 mm, mean total stent length was 198 ± 7 mm, and mean stent diameter was 7.1 ± 0.9 mm. Five-year primary and secondary patency rates were 51.8 and 79.5%, respectively, and the rates of freedom from bypass surgery, major or minor amputation, and all-cause death were 96.1, 96.2, and 78.4%, respectively. Female gender (odds ratio, 1.95; P = 0.0051) and mean stent diameter (odds ratio, 0.77; P = 0.0324) were factors strongly associated with restenosis., Conclusions: Women and patients requiring small stents failed to maintain primary patency when treated with self-expanding nitinol stents for CTO lesions in the SFPA. Although primary patency was low, the secondary patency rate was acceptable., (Copyright © 2013 Wiley Periodicals, Inc.)

Objective: To (1) compare the outcome of self-expandable stents with versus without jailed deep femoral artery (DFA) for proximal superficial femoral artery (SFA) lesions, and to (2) ascertain the fate of jailed DFA., Background: Complex SFA lesions involving the femoral bifurcation (FB) was mostly treated surgically, and the role played by endovascular procedures is uncertain., Methods: We retrospectively identified 104 consecutive, de novo lesions involving the SFA ostium, stented between April 2005 and September 2010. Depending on the proximal stent edge location, the sample was divided between 60 distal common femoral artery (CFA) stenting with jailed DFA and 44 ostial SFA stenting without jailed DFA. The FB was the segment beginning in the distal CFA, 10 mm proximal to the DFA ostium and ending in the SFA and 10 mm distal to the carina. Stented CFA lesions proximal to the FB were excluded. The bifurcation was classified as patent when free of restenosis and repeat revascularization., Results: The overall 12-month bifurcation and primary patency rates were 72.5% and 52.0%, respectively. Predictors of loss of bifurcation patency were ostial SFA stenting and a small stent in the FB. Bifurcation patency (83.3% vs. 56.3%; P < 0.01) and primary patency of the SFA (56.2% vs. 37.5%; P = 0.088) were higher after distal CFA than after ostial SFA stenting. In 95.7% of distal CFA and 100% of ostial SFA stenting, DFA remained patent at 12-month follow-up (P = 0.237)., Conclusions: The 12-month fate of jailed DFA after distal CFA stenting was acceptable, and the bifurcation patency rate was higher than after ostial SFA stenting., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: Restenosis after endovascular treatment for superficial femoral artery (SFA) disease remains a significant clinical issue. We assessed whether cilostazol reduce restenosis after SFA stenting with self-expandable nitinol stent., Methods: The study was a multicenter, prospective maintained database, retrospective analysis. From April 2004 to December 2009, 861 consecutive patients (mean age 71 years, 71% male) who underwent successful stenting for de novo lesions were retrospectively identified. Of them, 492 received cilostazol (cilostazol(+)) and 369 did not receive cilostazol (cilostazol(-)) after procedure. Propensity-score analyses matched 281 cilostazol(+) with 281 cilostazol (-) group. Primary endpoint was binary restenosis rate. Secondary endpoints were reocclusion, all-cause mortality and limb salvage in patients with critical limb ischemia (CLI). Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex., Results: Mean follow-up period was 25 months. According to analysis of matched pairs, binary restenosis rates were significantly lower (31.2% vs. 42.9% at 5-year, P = 0.02). In-stent re-occlusion rate tended to be lower in patients who received cilostazol (10.8% vs. 18.2% at 5-year, P = 0.09) compared with control. No significant difference of all-cause mortality (21.4% vs. 18.3% at 5-year, P = 0.84) and limb salvage rate in patients with CLI (86.2% vs. 78.5% at 5-year, P = 0.29) was found between both groups. After adjustment for prespecified risk factors, cilostazol was an independent negative predictor of restenosis. In subgroup analysis, male, age <75 years, claudicant patients, TASCII C/D, small vessels and poor runoff vessel was significantly lower in binary restenosis., Conclusions: Cilostazol reduced restenosis after SFA stenting with self-expandable nitinol stent and it seems to be more effective in high-risk patients for restenosis., (Copyright © 2011 Wiley Periodicals, Inc.)

Objectives: The purpose of this study was to investigate the relationship between angiographic patterns of in-stent restenosis (ISR) after femoropopliteal (FP) stenting and the frequency of refractory ISR., Background: In-stent restenosis after FP stenting is an unsolved problem. The incidence and predictors of refractory restenosis remain unclear., Methods: This study was a multicenter, retrospective observational study. From September 2000 to December 2009, 133 restenotic lesions after FP artery stenting were classified by angiographic pattern: class I included focal lesions (≤50 mm in length), class II included diffuse lesions (>50 mm in length), and class III included totally occluded ISR. All patients were treated by balloon angioplasty for at least 60 s. Recurrent ISR or occlusion was defined as ISR or occlusion after target lesion revascularization. Restenosis was defined as >2.4 of the peak systolic velocity ratio by duplex scan or >50% stenosis by angiography., Results: Sixty-four percent of patients were male, 67% had diabetes mellitus, and 24% underwent hemodialysis. Class I pattern was found in 29% of the limbs, class II in 38%, and class III in 33%. Mean follow-up period was 24 ± 17 months. All-cause death occurred in 14 patients; bypass surgery was performed in 11 limbs, and major amputation was performed in 1 limb during the follow-up. Kaplan-Meier survival curves showed that the rate of recurrent ISR at 2 years was 84.8% in class III patients compared with 49.9% in class I patients (p < 0.0001) and 53.3% in class II patients (p = 0.0003), and the rate of recurrent occlusion at 2 years was 64.6% in class III patients compared with 15.9% in class I patients (p < 0.0001) and 18.9% in class II patients (p < 0.0001)., Conclusions: Restenotic patterns after FP stenting are important predictors of recurrent ISR and occlusion., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: To investigate the long-term outcomes of nitinol stenting in femoropopliteal lesions and to determine the factors associated with restenosis., Methods: Between December 2003 and December 2009, 861 patients (603 men; mean age 72 years) underwent nitinol stenting of the femoropopliteal segment in 1017 limbs. A quarter (26%) of the patients had critical limb ischemia. Mean lesion length was 152±93 mm. Stent patency was assessed by either duplex ultrasound or angiography and analyzed by Kaplan-Meier estimation. The determinants of restenosis were explored with Cox proportional hazard regression analyses; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). Risk stratification of primary patency was subsequently analyzed using a score based on the significant prognostic factors identified in the multivariate model., Results: Stent fracture occurred in 10% (104 limbs) of the lesions. At 1, 3, and 6 years, the primary patency rates were 77%, 67%, and 63%; secondary patency rates were 91%, 87%, and 87%; freedom from femoropopliteal bypass grafting was 99%, 97%, and 96%, respectively. Multivariate Cox regression analysis identified female gender (HR 1.899; 95% CI 1.318 to 2.737, p<0.001), ankle-brachial index <0.6 (HR 1.921; 95% CI 1.348 to 2.736, p<0.001), TASC II C/D lesion (HR 2.068; 95% CI 1.346 to 3.177, p = 0.0009), stent fracture (HR 1.937; 95% CI 1.203 to 3.118, p = 0.006), and the absence of cilostazol administration (HR 2.102; 95% CI 1.394 to 3.172, p<0.001) as strong independent factors associated with restenosis. After assigning a risk score based on the outcomes of the multivariate regression analysis (1 each for female gender, ABI <0.6, TASC II C/D, stent fracture, and absence of cilostazol therapy), primary patency was found to be lower in limb groups with a higher cumulative score (12-month primary patency: score 0: 93%, score 1: 80%, score 2: 73%, score 3; 47%, score 4: 0%, respectively; p<0.001)., Conclusion: Endovascular therapy using nitinol stents for FP lesions yielded acceptable outcomes up to 6 years. Risk stratification for patency can play an important role in estimating future occurrence of restenosis after nitinol stent implantation in FP lesions.

Background: The aim of this study was to investigate the predictive value of clinical classification schemes that assess primary patency after self-expandable nitinol stent in the superficial femoral artery (SFA)., Methods: This study was a multicenter retrospective study of prospective databases. From April 2004 to December 2009, 1001 limbs (807 patients) that underwent successful nitinol stent implantation for de novo SFA lesions were identified and analyzed. Primary patency was defined as treated vessel without restenosis (defined as >2.4 of peak systolic velocity ratio by duplex) and repeat revascularization. Six items were included in the classification: female, diabetes, dialysis, critical limb ischemia (CLI), lesion length > 150 mm, and poor runoff; the FeDCLIP score. A lesion length >150 mm was scored as 2 points. The others were assigned 1 point each. The scores of 0 to 2, 3 to 4, and ≥5 points were classified as low-, moderate-, and high-risk patients, respectively. Outcome measures were primary and secondary patency and all-cause mortality up to 6 years in each risk group., Results: The mean follow-up interval was 26.8 ± 14.6 months. Primary patencies were 85.7%, 77.3%, and 74.2% in the low-risk group; 71.5%, 54.7%, and 51.9% in the moderate-risk group; and 53.0%, 24.3%, and 20.8% in the high-risk group at 1, 3, and 5 years, respectively. The secondary patencies were 94.6%, 92.3%, and 90.8% in the low-risk group; 89.5%, 83.1%, and 83.1% in the moderate-risk group; and 82.7%, 73.1%, and 73.1% in the high-risk group at 1, 3, and 5 years, respectively. There were significant differences in primary and secondary patency among the three risk groups (P < .0001 and P < .0001, respectively). Overall survival rates were 96.8%, 89.5%, and 81.8% in the low-risk group; 91.5%, 74.4%, and 68.7% in the moderate-risk group; and 78.2%, 63.2%, and 48.7% in the high-risk group at 1, 3, and 5 years, respectively. There were also significant differences in mortality (P < .0001)., Conclusions: New classification schemes based on FeDCLIP score were useful for risk stratification in vessel patency and mortality after self-expandable nitinol stenting for SFA disease., (Copyright © 2011 Society for Vascular Surgery. All rights reserved.)

Objectives: We sought to investigate the timing of restenosis and the restenosis factors following nitinol stenting in the superficial femoral artery (SFA)., Background: Restenosis following nitinol stenting in the SFA remains unsolved., Methods: We analyzed 742 limbs in consecutive 585 patients who underwent successful endovascular therapy for de novo SFA lesions. Patency was assessed by duplex ultrasonography. Primary patency was defined as treated vessels without restenosis and secondary patency was defined as target vessels reopened by repeat revascularization. Receiver-operating characteristic (ROC) analysis was performed to delineate the timing of restenosis. Patients were subsequently classified into three groups: no restenosis, early restenosis, and late restenosis. Cox proportional hazard regression analyses were performed to explore the determinants of restenosis in each restenosis group., Results: Primary and secondary patency was 67 and 86% at 6 years, respectively. ROC curves indicated the 369th day was the best cutoff point distinguishing the early (144 limbs) and the late (42 limbs) restenoses. Sustained patency was observed in 556 limbs. After multivariate analysis, cilostazol (P = 0.0007) was negatively associated; female gender (P = 0.0071), diabetes mellitus (P = 0.0428), critical limb ischemia (P = 0.0435), and stent fracture (P = 0.0004) were positively associated with the early restenosis. Trans Atlantic Inter-Society Consensus II C/D was positively associated with both the early (P = 0.0017) and the late (P = 0.0359) restenoses., Conclusions: Restenosis predominantly occurred within a year following nitinol stenting in the SFA, and the factors associated with the early restenosis were different from those with the late restenosis., (Copyright © 2011 Wiley-Liss, Inc.)

Background: The nitinol stent has proven superior primary patency than balloon angioplasty in superficial femoral artery (SFA) lesions, but a systematic comparison of the patency of 2 different nitinol stents (S.M.A.R.T. and Luminexx) in patients with SFA lesions has not been done., Methods and Results: A multicenter, prospective database that included 511 consecutive patients who had undergone endovascular therapy with nitinol stenting for 638 limbs (S.M.A.R.T.: n=503; Luminexx: n=135) was retrospectively analyzed. Patency was assessed by duplex ultrasound. Outcomes were compared between the groups by the Kaplan-Meier and log-rank methods. To minimize the differences between each group, propensity-matched analysis was also performed. Stent fracture occurred in 11% (57/503) of the S.M.A.R.T. and 23% (31/135) of the Luminexx stents (P=0.0005). Despite a higher prevalence of chronic total occlusion (55% vs. 40%, P=0.002) and longer lesions (154±93mm vs. 135±71mm, P=0.03) in the S.M.A.R.T. group, there was no significant difference in patency for up to 5 years (P=0.50). When 119 lesions per group were assessed after propensity-matched analysis, the 5-year patency rate was 74% for the S.M.A.R.T. and 65% for the Luninexx stent (P=0.10)., Conclusions: Despite a different stent fracture rate, there was no significant difference in terms of patency between the S.M.A.R.T. and Luninexx stents for up to 5 years.

Background: The use of a stent in the treatment of lesions of the superficial femoral artery (SFA) remains controversial. Although some reports have suggested that use of a nitinol stent in conjunction with aggressive medical management is effective for long SFA lesions, few long-term, large-scale studies have been done., Methods and Results: A retrospective analysis was conducted of data from a multicenter study in which the S.M.A.R.T. Control(TM) stent was used for treatment of de novo SFA lesions. A total of 528 lesions in 432 patients were included. Mean patient age was 72.5±9.1 years; mean stent length was 15.7±8.1cm; 259 lesions (49%) were classified as C/D according to the TransAtlantic Inter-Society Consensus (TASC) II classification. Primary and secondary patency at 4 years was 66% and 87%, respectively. No cilostazol administration (41% re-stenosis group vs. 29% no-restenosis group, P<0.01), female gender (42% vs. 26%, P<0.01), younger age (70.7±9.3 years vs. 72.9±9.0 years, P<0.05), and chronic total occlusion (CTO; 72% vs. 52%, P<0.01) were independent predictors of re-stenosis., Conclusions: The S.M.A.R.T. Control(TM) stent provided good long-term durability in the treatment of SFA lesions, and no cilostazol administration, female gender, younger age and CTO were associated with re-stenosis., (All rights are reserved to the Japanese Circulation Society.)

Background: Long-term clinical outcomes after femoropopliteal (FP) stenting with nitinol stents have not yet been clear. We investigated the mid-term efficacy of FP stenting with nitinol stents., Methods: This study was a multicenter retrospective study. From April 2004 to December 2008, 511 consecutive patients (639 limbs; mean age 71 +/- 7 years; 71% male) who underwent successful FP stenting with nitinol stents for de novo lesions were retrospectively selected and analyzed in this multicenter study. All patients had a minimum follow-up of 6 months. Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex or >50% stenosis by angiogram. Primary patency was defined as treated vessels without restenosis and repeat revascularization. Secondary patency was defined as target vessels that become totally occluded and are reopened by repeat revascularization., Results: Sixty-one percent of the patients had diabetes, 76% were claudicant, and 20% were on hemodialysis. Mean lesion length was 151 +/- 75 mm. Mean follow-up period was 22 +/- 11 months. Primary patency was 79.8%, 66.7%, and 63.1%, and secondary patency was 90.4%, 87.3%, and 86.2% at 1, 3, and 5 years, respectively. During the follow-up period, 53 patients (10%) died. Of them, cardiovascular death was 38% and stent fracture had occurred in 14%. On multivariate analysis by Cox proportional hazard ratio, cilostazol administration (hazard ratio [HR], 0.52;P < .0001), stent fracture (HR, 1.6; P = .03), hemodialysis (HR, 1.7; P = .01), and Trans Atlantic Inter-Society Consensus (TASC) II class C/D (HR, 2.4; P < .0001) were the independent predictors of primary patency after successful FP stenting., Conclusion: Clinical efficacy of nitinol stent implantation for FP disease was favorable for up to 5 years.

1. To investigate the underlying mechanism for the angiotensin II-induced desensitization of the contractile response during the prolonged stimulation of the vascular smooth muscle, we determined the effects of angiotensin-II on (1) cytosolic Ca2+ concentration ([Ca2+]i) and tension using fura-2-loaded medial strips of the rabbit femoral artery, (2) 45Ca2+ influx in ring preparations, and (3) Ca(2+)-sensitivity of the contractile apparatus in alpha-toxin permeabilized preparations. 2. In the presence of extracellular Ca2+, high concentrations of angiotensin-II elicited biphasic increases in [Ca2+]i and tension, which consisted of initial transient and subsequent lower and sustained phases. 3. The 45Ca2+ influx initially increased after the application of 10(-6) M angiotensin-II, and thereafter gradually decreased. At 20 min after the application, there was a discrepancy between the level of [Ca2+]i and the extent of 45Ca2+ influx. 4. The relationships between [Ca2+]i and tension suggested that the angiotensin-II-induced increase in the Ca(2+)-sensitivity of the contractile apparatus was maintained during the desensitization of smooth muscle contraction. 5. When 10(-6) M angiotensin-II was applied during the sustained phase of contraction induced by 118 mm K(+)-depolarization, at 10 min after the application, the [Ca2+]i levels were significantly lower and the tension levels were significantly higher than those prior to the application of angiotensin-II. 6. In conclusion, the decrease in [Ca2+]i, which is partially due to the inhibition of the Ca2+ influx, is mainly responsible for the desensitization evoked by high concentrations of angiotensin-II, and angiotensin-II seems to activate additional mechanisms which inhibit Ca2+ signaling during prolonged stimulation.

1. Using front-surface fluorometry of fura-2-loaded strips, and measuring the transmembrane 45Ca2+ fluxes of ring preparations of the rabbit femoral artery, the mechanism underlying a sustained decrease in the cytosolic Ca2+ concentration ([Ca2+]i) induced by angiotensin II (AT-II) was investigated. 2. The application of AT-II during steady-state 118 mM K(+)-induced contractions caused a sustained decrease in [Ca2+]i following a rapid and transient increase in [Ca2+]i, while the tension was transiently enhanced. 3. When the intracellular Ca2+ stores were depleted by thapsigargin, the initial rapid and transient increase in [Ca2+]i was abolished, however, neither the sustained decrease in [Ca2+]i nor the enhancement of tension were affected. 4. Depolarization with 118 mM K+ physiological salt solution containing 1.25 mM Ba2+ induced a sustained increase in both the cytosolic Ba2+ concentration ([Ba2+]i) level and tension. However, the application of 10(-6) M AT-II during sustained Ba(2+)-contractions was found to have no effect on [Ba2+]i, but it did enhance tension. 5. After thapsigargin treatment, AT-II neither decreased nor increased the enhanced Ca2+ efflux rate induced by 118 mM K(+)-depolarization, whereas AT-II did increase the enhanced 45Ca2+ influx and the 45Ca2+ net uptake induced by 118 mM K(+)-depolarization. 6. Pretreatment with calphostin-C, partially, but significantly inhibited the decrease in [Ca2+]i induced by AT-II. 7. These findings therefore suggest that AT-II stimulates Ca2+ sequestration into the thapsigargin-insensitive Ca2+ stores, and thus induces a decrease in [Ca2+]i in the high external K(+)-stimulated rabbit femoral artery.