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Objective: This study aimed to determine the impact of infrapopliteal (IP) revascularisation establishing in line flow to the wound (IFW) on wound healing in chronic limb threatening ischaemia (CLTI), using a core laboratory assessment for wounds and in line flow., Methods: The Wound directed Angiosome RevasculaRIsation apprOach to patients with cRitical limb iSchaemia (WARRIORS) multicentre observational study enrolled patients with CLTI with tissue loss undergoing IP revascularisation in Japan, with scheduled two year follow up. The primary outcome measure was complete wound healing, defined as achievement of complete epithelialisation of all wounds without major amputation. IP revascularisation establishing IFW was defined as revascularisation after which a tibiopedal artery that actually fed an injured pedal unit was patent. The incidence of wound healing was compared between the IFW and non-IFW groups using inverse probability of treatment weighting based on the propensity score., Results: A total of 440 patients with CLTI (median age, 75 years; male, 64.1%; diabetes mellitus, 72.0%; dialysis, 57.7%) with tissue loss (Wound, Ischaemia, and foot Infection stage 4, 66.4%) who underwent IP revascularisation (endovascular procedure, n = 304; bypass grafting, n = 136) between October 2017 and June 2020 were registered. During a median follow up of 23.6 months, 51.1% achieved wound healing. Successful IP revascularisation with IFW was achieved in 68.2%. After analysis, the IFW group had a higher rate of wound healing than the non-IFW group (34.5 vs. 16.1 per 100 person years; p = .030). The association between IFW and wound healing was not statistically different between patients undergoing bypass grafting and those undergoing an endovascular procedure (p for interaction = .38). There was no statistically significant interaction effect between IFW and direct revascularisation for wound healing (p for interaction = .51)., Conclusion: IP revascularisation establishing IFW was statistically significantly associated with a higher wound healing rate in patients with CLTI., (Copyright © 2024 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Introduction: The safety and effectiveness of the GORE VIABAHN Endoprosthesis for treatment of symptomatic patients with peripheral artery disease (PAD) and complex femoropopliteal (FP) lesions was assessed in a real-world Japanese practice setting. Methods : A prospective, multicenter, postmarket surveillance study was conducted from 2016 to 2017 at 64 sites in Japan. Symptomatic patients with PAD and FP lesions ⩾ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment. Outcome measures evaluated at 5 years were primary patency (PP), primary-assisted patency (PAP), secondary patency (SP), freedom from target lesion revascularization (fTLR), occurrence of device- or procedure-related serious adverse events (SAEs), and stent fractures. Results : A total of 321 patients were enrolled and were a mean age of 73.9 ± 8.7 years; 77.3% were men and 26.5% had chronic limb-threatening ischemia (CLTI). The mean lesion length was 23.6 ± 6.6 cm and the frequency with TASC II C/D lesions and chronic total occlusions was 86.6% and 70.4%, respectively. The Kaplan-Meier estimated PP, PAP, SP, and fTLR at 5 years was 62.4%, 74.1%, 82.3%, and 75.9%, respectively. The mean ankle-brachial index was 0.92 ± 0.15 and the mean improvement in Rutherford class was 2.3 ± 1.4, which was maintained through 5 years. The rate of cumulative device- or procedure-related SAEs through 5 years was 19.9% with only 9.3% of those occurring after the first year. No stent fractures were observed through 5 years by x-ray evaluation. Conclusion : The 5-year safety and efficacy outcomes of the endoprosthesis were clinically acceptable for treating complex FP lesions in a real-world cohort of Japanese patients with PAD. ( ClinicalTrials.gov Identifier: NCT04706273) ., Competing Interests: Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Osamu Iida – advisory boards: Boston Scientific, Cordis; consultant: Boston Scientific, Otsuka Medical; honorarium: Boston Scientific Japan, Becton Dickinson, Cordis, W. L. Gore, Medtronic Japan, Terumo Co., Ltd. Takao Ohki – consultant: W. L. Gore. Yoshimitsu Soga – honorarium: Boston Scientific, Cordis, Kaneka Medics, Medtronic Japan, Terumo Co., Ltd. Tatsuya Nakama – advisory boards: Asahi Intecc; consultant: Becton Dickinson, Boston Scientific, COOK Medical, Century Medical Inc., Cordis, NIPRO, OrbusNeichi; honorarium: Abbott Vascular, KANEKA, Medtronic, Terumo Co., Ltd. Terutoshi Yamoaka – consultant: JAPAN LIFELINE; honorarium: W. L. Gore, Boston Scientific Japan, Kaneka Medix. Kazuki Tobita – honorarium: W. L. Gore, Boston Scientific, Medtronic, Terumo, Kaneka Medics, Becton Dickinson. The other authors have no conflicts of interest to declare.

Background: Sirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising., Objectives: The authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population., Methods: This multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data., Results: The mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13)., Conclusions: The SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients., Competing Interests: Funding Support and Author Disclosures This study was sponsored by MedAlliance Japan K.K. Dr Iida has served on advisory boards for Boston Scientific and Cordis; is a consultant for Boston Scientific, Otsuka Medical Devices, and Nipro; and has received honoraria from Boston Scientific, Becton Dickinson, Cordis, W.L. Gore, Medtronic, Terumo, and Kaneka Medix. Dr Soga has received honoraria from Boston Scientific, Cordis, Kaneka Medix, Medtronic, and Terumo. Dr Mano has received research support from Abbott Vascular. Dr Hayakawa has received honoraria from Terumo, Kaneka Medix, Medicos Hirata, Boston Scientific, Medtronic, and Becton Dickinson. Dr Ichihashi has received honoraria from Boston Scientific, Becton Dickinson, Cordis, W.L. Gore, Medtronic, and Terumo. Dr Kawasaki is a consultant for Cordis and Nipro. Dr Yamaoaka is a consultant for Japan Lifeline; and has received honoraria from W.L. Gore, Boston Scientific, and Kaneka Medix. Dr Nakama is on Asahi Intecc’s advisory board; is a consultant for Becton Dickinson, Boston Scientific, Cook Medical, Century Medical. Cordis, Nipro, and Orbus Neich; and has received honoraria from Abbott Vascular, Kaneka Medix, Medtronic, and Terumo. Dr Fujihara is a consultant for Century Medical, Nipro, Terumo, and Cordis; and has received honoraria from Boston Scientific, Medtronic, W.L. Gore, and Terumo. Dr Nakamura has received endowed department from Boston Scientific Japan, Kaneka, Terumo, Nipro, Otsuka Medical, Japan Lifeline, Asahi Intecc, and Biotronik Japan. Dr Lansky is on the advisory boards and has received honoraria from Cordis, Abiomed, Sinomed, Microport, and Boston Scientific; and has received institutional research support from Bard, Silkroad Medical, Abbott Vascular, Emboline, and Filterlex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

The objective of the study is to investigate the difference in 1-year late lumen loss (LLL) between the high- (IN.PACT Admiral) and low-dose (Lutonix) paclitaxel-coated balloon (PCB). Although a recent randomized clinical trial demonstrated no difference in efficacy endpoint between high- and low-dose PCB, it remains unclear whether high-dose PCB was superior to low-dose PCB in actual clinical practice. We enrolled 64 patients with 67 de novo femoropopliteal lesions who underwent PCB angioplasty at Kokura Memorial Hospital from May 2014 to March 2020 and subsequent follow-up angiography after 1 year. The primary endpoint was 1-year LLL, whereas the secondary endpoints were binary restenosis and clinically driven target lesion revascularization (CD-TLR) after 1 year. The high- and low-dose PCB groups had 45 and 22 lesions, respectively. Although the low-dose PCB group had higher rates of coronary artery disease, hemodialysis, and chronic limb-threatening ischemia than the high-dose PCB group, the latter had a longer lesion length and more lesions with a TASC classification C or D than the former. The high-dose PCB group had a significantly lower LLL than the low-dose PCB group (0.40 ± 1.05 vs. 1.19 ± 1.03 mm; P = 0.003, respectively). Moreover, the high-dose PCB group had significantly lower rates of binary restenosis at 1 year than the low-dose PCB group (22.2% vs. 50.0%; P = 0.02, respectively). Moreover, negative LLL was only observed in the high-dose PCB group (33.3% vs. 0%, P = 0.005). The high-dose PCB group had a significantly lower LLL than the low-dose PCB group., (© 2024. The Author(s).)

Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer-based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer-coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n = 465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5 years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5 years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; p = 0.0058) for patients treated with Eluvia (n = 56) than for those treated with Zilver PTX (n = 30). Through the 5-year study follow-up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p = 0.3540) and mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.

Purpose: In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients., Methods: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate., Results: Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD., Conclusion: This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months., Level of Evidence: Level 3, Cohort study., Clinical Trial Registration: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018., (© 2024. The Author(s).)

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

The aim of this study was to evaluate midterm clinical outcomes after implantation of LifeStent self-expanding nitinol stents for the treatment of femoropopliteal lesions. This retrospective, multicenter, non-randomized study examined 260 femoropopliteal lesions in 250 consecutive patients with peripheral artery disease implanted with LifeStents from April 2016 to April 2017. The prevalence of chronic total occlusion (CTO), lesion length ≥25 cm, and distal reference vessel diameter (RVD) <5 mm was 58%, 35%, and 50%, respectively. The 3-year restenosis rate in the overall population was estimated to be 72.9% and a major adverse limb event was observed in 36.9%. Multivariate analysis revealed that chronic limb-threatening ischemia (CLTI) (odds ratio [OR]: 8.04; 95% confidence interval [CI]: 1.86-34.7), CTO (OR: 4.87; 95% CI: 1.43-16.6), lesion length ≥25 cm (OR: 5.95; 95% CI: 1.11-32.0), and distal RVD <5 mm (OR: 4.43; 95% CI: 1.34-14.6) were independent risk factors for 3-year restenosis. The present study demonstrated the midterm clinical outcomes and risk factors for restenosis after implantation of the LifeStent in femoropopliteal artery lesions. CLTI, CTO, lesion length ≥25 cm, and distal RVD <5 mm predicted decreased patency after a 3-year follow-up.

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

Purpose: To report the 3-year results of Innova™ stent implantation for the treatment of femoropopliteal (FP) lesions in a real-world setting., Methods: This single-arm, retrospective, multicenter clinical study analyzed 481 lesions from 453 consecutive patients with symptomatic peripheral artery diseases (Rutherford category 1-6) who underwent endovascular therapy with implantation of Innova™ self-expanding nitinol stent for FP lesions. The primary outcome measure was the 3-year restenosis rate based on doppler-ultrasound or angiographic criteria. The secondary outcome measures included the rates of 3-year major amputation and major adverse limb events., Results: Restenosis following Innova™ implantation was found in 61% of the cases at 3 years. At the end of 3 years, the rates of major amputations and major adverse limb events were 3 and 31%, respectively. In cases free from restenosis at 1 year, no predictive factors for restenosis at 3 years could be determined., Conclusion: The present study demonstrated mid-term clinical outcomes after Innova™ stent implantation for the treatment of FP lesions in a real-world population. The Innova™ stent demonstrated acceptable clinical outcomes in a real-world setting., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).)

Background The subintimal approach (SA) is widely used in endovascular therapy for femoropopliteal chronic total occlusion lesions. However, when compared with the intraluminal approach (IA), the safety and efficacy of SA in real-world practice are not well characterized. Furthermore, there is a paucity of data on the clinical impact of subintimal and intraluminal wire passage (SWP and IWP, respectively) assessed by intravascular ultrasound. Methods and Results From the IVORY (Intravascular Ultrasound-Supported Endovascular Therapy in Superficial Femoral Artery) registry, this study included 500 patients undergoing endovascular therapy for femoropopliteal chronic total occlusion lesions (SA, n=67; IA, n=433; and SWP, n=186; IWP, n=314). The primary end point was the cumulative 1-year incidence of restenosis. The rate of perioperative complications was also assessed. Propensity score matching analysis was performed to adjust for the intergroup differences. After propensity score matching, the final study population consisted of 59 pairs (SA, n=59; IA, n=348) and 170 pairs (SWP, n=170; IWP, n=293), respectively. Cumulative 1-year incidence of restenosis was comparable between the SA and IA groups (41.0% versus 43.4%, P =0.40). No significant difference in 1-year restenosis rate between the SWP and IWP groups was observed (48.2% versus 40.8%, P =0.40), although the SWP group tended to be a higher rate of perioperative complications than the IWP group (8.2% versus 4.1%, P =0.07). Conclusions At 1 year, both SA and IA showed acceptable results for femoropopliteal chronic total occlusion lesions. Cumulative 1-year incidence of restenosis was not significantly different between SWP and IWP, whereas perioperative complications occurred more frequently in SWP than in IWP. Registration URL: https://www.umin.ac.jp; Unique identifier: UMIN000020472.

Objective: Zilver PTX polymer-free, paclitaxel-coated stents and Viabahn stent grafts are effective for the treatment of femoropopliteal lesions. The aim of this study was to compare clinical outcomes between the two devices in patients with symptomatic peripheral arterial disease in real-world settings., Methods: This multicenter, retrospective study concerned a clinical database of 445 patients with symptomatic peripheral arterial disease (Rutherford categories 1-6) who underwent either Zilver PTX or Viabahn implantation for a femoropopliteal lesion of 10 cm or longer with reference vessel diameters of 4.0 to 7.5 mm between 2012 and 2018 at five hospitals in Japan. Outcome measures were primary patency, freedom from stent thrombosis, freedom from any target lesion reintervention, limb salvage, and overall survival. After propensity score matching, these clinical outcomes were compared between patients treated with the Zilver PTX and those treated with the Viabahn. Also assessed were the interaction effects of baseline characteristics on the association of the Zilver PTX and Viabahn with restenosis and stent thrombosis., Results: In total, 271 patients were treated with the Zilver PTX, and 174 patients were treated with the Viabahn. Propensity score matching extracted 133 patient pairs with no major intergroup differences in baseline characteristics. The Zilver PTX group had a lower rate of 3-year primary patency (59.5%; [95% confidence interval (CI), 53.0%-66.2%] vs 69.6% [95% CI, 59.3%-79.4%]; P = .005), but a higher rate of 3-year freedom from stent thrombosis (93.6% [95% CI, 90.0%-96.3%] vs 82.4% [95% CI, 74.5%-89.0%], P = .038). There was no significant difference in overall survival, limb salvage, or freedom from reintervention (all P > .05). An interaction analysis showed that the restenosis risk of the Zilver PTX was significantly higher vs the Viabahn in patients with no or one below-the-knee runoff vessel and in those with intravascular ultrasound use than in patients with two or three below-the-knee runoff vessels and in those without intravascular ultrasound use, respectively (P for interaction = .046 and .010, respectively), whereas the stent thrombosis risk of the Zilver PTX was significantly smaller vs the Viabahn in patients not on dialysis than in those on dialysis (P for interaction = .034)., Conclusions: Compared with Viabahn stent grafts, Zilver PTX stents have a lower rate of primary patency but a higher rate of freedom from stent thrombosis., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To report additional endpoints, including 2-year primary patency, patient outcomes, and safety results, as well as the initial assessment of hypoechogenic halo from the IMPERIAL Randomized Controlled Trial (RCT)., Materials and Methods: IMPERIAL RCT is a prospective, randomized (2:1), multicenter study of patients with symptomatic femoropopliteal artery lesions (length 30-140 mm, Rutherford category 2-4) treated with the Eluvia paclitaxel-eluting nitinol stent or the Zilver PTX paclitaxel-coated stent. Two-year follow-up included patency, safety, and mortality assessments and core laboratory-reviewed B-mode ultrasound imaging to screen for hypoechogenic halo in the stented segment, and assess blood flow., Results: At 24 months, all-cause mortality was 7.1% (21/295) for Eluvia and 8.3% (12/145) for Zilver PTX (P = 0.6649). The clinically driven target lesion revascularization rate was significantly less for patients treated with Eluvia vs Zilver PTX (12.7% vs 20.1%; P = 0.0495). The Kaplan-Meier estimate of primary patency at 24 months was 83.0% for Eluvia and 77.1% for Zilver PTX (log rank P = 0.1008). Transverse ultrasound imaging was implemented during the 24-month follow-up window and was evaluable for 27.5% (128/465) of patients. Hypoechogenic halo prevalence rates did not differ significantly between Eluvia and Zilver PTX study arms (33.7% [29/86] vs 21.4% [9/42]; P = 0.153). In no case was flow documented within the halo; no adverse events were associated with these ultrasound findings., Conclusion: Two-year follow-up suggests a sustained advantage for Eluvia for avoiding target lesion revascularization. Initial hypoechogenic halo assessment showed no difference in prevalence between the study arms, no flow within the halo, and no associated adverse events., Clinical Trial Registration: clinicaltrials.gov identifier NCT02574481. Date of registration: October 14, 2015., Level of Evidence: Level 1; randomized controlled trial.

Background: This study aimed to reveal the association of diabetes mellitus and dialysis-dependent renal failure with the lesion severity and chronic total occlusion (CTO) in patients undergoing femoropopliteal endovascular therapy for intermittent claudication., Methods: This multicenter retrospective study analyzed the data of 2056 consecutive patients with moderate to severe intermittent claudication, who underwent endovascular therapy for de novo lesions in the superficial femoral artery to the proximal popliteal artery between 2010 and 2018 at five cardiovascular centers in Japan. The association of the clinical characteristics with severity of the lesions, as assessed by the Trans-Atlantic Inter-Society Consensus (TASC) II classification, was investigated using the ordinal logistic regression model. Their association with CTO, lesion length, and severity of calcifications was additionally analyzed using the binomial logistic regression model., Results: The prevalence of diabetes mellitus and dialysis-dependent renal failure was 54.7% and 21.4%, respectively; 12.5% of the patients had lesions corresponding to TASC II class D, and 39.3% of the patients had CTO. Current smoking and severe claudication were associated with more severe lesions assessed according to the TASC II classification; diabetes mellitus and dialysis dependence were inversely associated with disease severity. The adjusted odds ratios of diabetes mellitus and dialysis dependence were 0.82 (95% confidence interval 0.70-0.97; p = 0.018) and 0.76 (0.62-0.94; p = 0.009), respectively. Diabetes mellitus and dialysis dependence were also inversely associated with CTO (both p < 0.05). Furthermore, diabetes mellitus was inversely associated with a long lesion (p < 0.05). Diabetes mellitus and dialysis dependence were positively associated with severe calcification (both p < 0.05)., Conclusions: Diabetes mellitus and dialysis-dependent renal failure were inversely associated with the lesion severity, as assessed by the TASC II classification, and CTO in patients undergoing femoropopliteal endovascular therapy for intermittent claudication.

Purpose: To present a novel angiographic scoring system that stratifies the risk of restenosis after endovascular therapy (EVT) to inform the decision to use paclitaxel-eluting devices in the femoropopliteal segment., Materials and Methods: A prospective, multicenter registry including 1799 limbs of 1578 patients (mean age 74±9 years; 1090 men) with symptomatic peripheral artery disease undergoing intravascular ultrasound-supported femoropopliteal EVT was used as the basis for developing the angiographic score. Multivariable analysis identified baseline patient and limb characteristics associated with restenosis at 12 months. These risk factors for 12-month restenosis were explored using a generalized linear mixed model with a logit-link function in which the inter-institutional and inter-subject variability were treated as random effects. The multiple imputation method was adopted to address missing data. Results of the regression analysis are presented as the odds ratio (OR) with 95% confidence interval (CI)., Results: Twelve-month primary patency was estimated to be 65.1% (95% CI 62.7% to 67.5%). After multivariable analysis, distal reference vessel diameter per 1 mm (OR 0.71, 95% CI 0.62 to 0.81, p<0.001), lesion length per 10 cm (OR 1.39, 95% CI 1.19 to 1.62, p<0.001), and chronic total occlusion (OR 1.56, 95% CI 1.15 to 2.10, p=0.004) were independently associated with the 12-month restenosis risk, whereas baseline patient risk factors were not. Compared to bare nitinol stent implantation, plain angioplasty (OR 2.31, 95% CI 1.67 to 3.18, p<0.001) was independently associated with a higher risk of 12-month restenosis, while drug-eluting stents (OR 0.65, 95% CI 0.43 to 0.99, p=0.045) and stent-grafts (OR 0.24, 95% CI 0.12 to 0.50, p<0.001) were independently associated with a lower risk of 12-month restenosis. The angiographic score, which was developed by using the 3 angiographic factors but not the TransAtlantic Society Consensus II (TASC) class, was significantly and independently associated with 12-month restenosis., Conclusion: The current study demonstrated a novel angiographic score for 12-month restenosis after femoropopliteal EVT in a real-world clinical practice. The developed score was significantly and independently associated with the 12-month restenosis risk, but the TASC class was not.

To examine clinical outcomes for combination therapy of heparin-bonded covered stent [VIABAHN™ stent (VIA)] and bare-nitinol stent (BNS), and to determine independent predictors of restenosis after VIA implantation assessed by intravascular ultrasound (IVUS). A retrospective analysis was conducted on VIA use in the femoropopliteal artery of 71 patients (81 lesions) treated between June 2012 and November 2018. We divided the treated lesions into two groups; that is, whether BNS was added at the proximal site of the VIA or not (combination of VIA and BNS group [COM; n = 21] vs. VIA group [n = 60]). The median follow-up duration was 21.6 months (interquartile range, 13.2-28.8 months). Restenosis at 2 years was observed in 5 lesions (33%) in COM group and 17 lesions (38%) in VIA group (log-rank, P = 0.74). In VIA group, 14 lesions developed restenosis within 12 months. Multivariate logistic regression analysis of VIA group revealed that the proximal plaque burden was an independent predictor of restenosis within 12 months after VIA implantation (odds ratio 1.15, 95% confidence interval 1.01-1.30, P = 0.01), with the optimal cutoff value of 43% (area under the receiver operator characteristic curve 0.79, sensitivity 91%, specificity 69%). A remaining plaque of > 43% at the proximal reference segment was an independent predictor of restenosis after VIA implantation. When residual stenosis is observed at the proximal site of SFA after VIA implantation, combination therapy of VIA and BNS would be an optimal management.

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

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.

Purpose: To describe a multi-center preliminary experience of treating prosthetic above knee femoropopliteal (AKFP) bypass occlusion by placing a Viabahn stent graft inside the occluded prosthetic bypass graft., Materials and Methods: Retrospective analysis of consecutive 14 patients (mean age 73.2 ± 10.2, 78.6% male) receiving Viabahn stent graft inside the occluded prosthetic bypass graft for the treatment of prosthetic AKFP bypass occlusion in the collaborating hospitals from November 2016 to June 2019 was performed., Results: Technical success was achieved in all patients. Mean lesion length was 34.0 ± 3.5 cm, concomitant thrombectomy or thrombus aspiration was performed in 11 patients (78.6%), and average of 1.57 ± 0.65 Viabahn stent grafts were used. Mean ankle-brachial index improved from 0.24 ± 0.23 to 0.98 ± 0.14 after the treatment. All patients had preoperative ischemic symptoms with 9 patients (64.3%) having Rutherford class > 4 symptoms; however, all preoperative symptoms resolved after the treatment. During the mean follow-up of 450.9 ± 234.7 days, there were two target lesion revascularizations, leading to a primary patency rate of 92.9% and a secondary patency of 100.0% at 1 year., Conclusion: Placing a Viabahn stent graft inside the occluded prosthetic bypass graft for the treatment of prosthetic AKFP bypass occlusion appears to be effective from our preliminary experience. Even though sample size is limited in our study, it may be considered as a potential treatment option before surgical reintervention.

Objective: Although spot stenting (SS) for femoropopliteal (FP) lesions has been preferred compared with full coverage stenting (FCS), which stenting strategy results in better outcomes has remained unclear in the real-world clinical setting. Therefore, we compared the clinical outcomes of SS and FCS for FP lesions using a propensity-matched analysis., Methods: The present multicenter, retrospective study examined data from a clinical database of 1554 consecutive patients who had undergone FP endovascular therapy for symptomatic peripheral artery disease from January 2010 to December 2016. Of these patients, 1151 had undergone FP stenting. The outcome measures were primary patency and primary assisted patency obtained using propensity score matching. Interaction analysis was also performed to explore the effects of the baseline characteristics on the association between SS and primary patency., Results: After propensity score matching, SS for FP lesions demonstrated a significantly lower primary patency rate compared with FCS at 3 years (29% vs 53%; P = .011). Additionally, primary assisted patency at 3 years was significantly lower in the group with SS than in the FCS group (53% vs 72%; P = .014). Interaction analysis showed that chronic total occlusion lesions, lesion location A (proximal superficial femoral artery portion), and lesion length ≥138 mm were associated with the noninferiority of SS compared with FCS for primary patency., Conclusions: The propensity-matched analysis demonstrated that primary patency and primary assisted patency at 3 years were significantly lower with SS compared with FCS for FP lesions in real-world clinical settings. The interaction analysis suggested that SS might be suited to more complex FP lesions (ie, chronic total occlusion lesions, proximal superficial femoral artery lesion, lesion length ≥138 mm)., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To examine if endovascular therapy (EVT) with paclitaxel-coated stents increases the mortality risk in patients with symptomatic lower limb peripheral artery disease (PAD)., Materials and Methods: A retrospective analysis was conducted of paclitaxel-coated stent use in the femoropopliteal segment of 1535 symptomatic (Rutherford category 2 to 4) patients treated between January 2010 and December 2016 at 4 hospitals in Japan. The risk of all-cause mortality was examined between the 285 patients (mean age 73±8 years; 213 men) treated with a paclitaxel-coated stent (PTX-coated group) and 1250 patients (mean age 73±9 years; 872 men) not exposed to a paclitaxel-coated device (PTX-free group) during EVT. Propensity score matching was employed to balance baseline characteristics. Cox proportional hazards models stratified on the quintiles of the propensity score were used to investigate paclitaxel-coated stent use and mortality risk as well as interactions among baseline variables and the main outcome. Interactions between a PXT-coated stent and subgroups of the PTX-free group (bare stent and angioplasty) were also investigated, as was the impact of paclitaxel dose on mortality risk. The results of regression analysis are reported as the hazard ratio (HR) and 95% confidence interval (CI)., Results: The 3-year overall survival estimates were 86.4% in the PTX-coated group vs 87.7% in the PTX-free group; the corresponding 5-year estimates were 77.5% vs 73.7%, respectively. There was no significant difference in all-cause mortality between the 2 groups (HR 0.89, 95% CI 0.66 to 1.19, p=0.41). The cause of death also showed no remarkable difference between the groups. Chronic renal failure (p=0.044) and arterial calcification (p=0.022) demonstrated a significant interaction effect on the association of the use of a PTX-coated stent with all-cause mortality. No subgroup demonstrated that the use of a paclitaxel-coated stent was associated with an increased risk of all-cause mortality. A dose dependency was not evident., Conclusion: Mortality risk following application of a PTX-coated stent did not increase over 5 years, irrespective of the dose. A PTX-coated stent for femoropopliteal lesions in PAD patients is a safe treatment option.

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

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: To assess the longer-term safety and efficacy of the IN.PACT Admiral (MDT-2113) drug-coated balloon (DCB) for the treatment of de novo and non-stented restenotic lesions in the superficial femoral and/or proximal popliteal arteries versus uncoated percutaneous transluminal angioplasty (PTA) in a Japanese cohort., Background: Although DCBs are the newest endovascular strategy for patients with peripheral artery disease presenting with femoropopliteal lesions, there remains a paucity of results in non-Caucasian populations., Methods: IN.PACT SFA Japan is an independently-adjudicated, prospective, multicenter, randomized, single-blinded trial. Endpoints through 2 years included primary patency and a composite safety endpoint of freedom from device- and procedure-related death through 30 days, freedom from target limb major amputation and freedom from clinically-driven target vessel revascularization at 24 months., Results: One hundred patients were assigned by 2:1 randomization to treatment with the IN.PACT Admiral DCB (n = 68) or PTA (n = 32). The groups were well-matched at baseline. Mean lesion length for the DCB and PTA groups were 9.15 ± 5.85 and 8.89 ± 6.01 cm (P = 0.838), respectively. Patients treated with DCB exhibited superior 24-month primary patency compared to PTA (79.8% vs. 46.9%; log rank P < 0.001). The 24-month clinically driven target lesion revascularization rate was 9.1% for DCB versus 20.7% for PTA (P = 0.177). There were no device- or procedure-related deaths, major amputations, or thromboses in either group., Conclusions: Two-year results from IN.PACT SFA Japan demonstrated persistently superior patency and low CD-TLR rates through 2 years when compared to uncoated PTA in Japanese patients. These data are consistent with other IN.PACT DCB trials., (© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

Background: The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions., Methods: In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of -10% at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov, number NCT02574481., Findings: Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8% (231/266) in the Eluvia group and 81·5% (106/130) in the Zilver PTX group (difference 5·3% [one-sided lower bound of 95% CI -0·66]; p<0·0001). 259 (94·9%) of 273 patients in the Eluvia group and 121 (91·0%) of 133 patients in the Zilver PTX group had not had a major adverse event at 12 months (difference 3·9% [one-sided lower bound of 95% CI -0·46]; p<0.0001). No deaths were reported in either group. One patient in the Eluvia group had a major amputation and 13 patients in each group required target lesion revascularisation., Interpretation: The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease., Funding: Boston Scientific., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

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 access-site 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.

Unlike coronary arteries, little is known about peri-stent contrast staining (PSS) formation after drug-eluting stent (DES) implantation for infrapopliteal arteries. Herein, we report exacerbated PSS assessed by serial angiography and optical coherence tomography (OCT) after platinum-chromium everolimus-eluting stent (PtCr-EES) implantation for infrapopliteal artery lesions. A 68-year-old women with recurrent left critical limb ischemia was admitted to our hospital. Standard endovascular techniques were performed for the popliteal artery (POP) and tibioperoneal trunk (TPT), but residual stenosis occurred. Therefore, a 4.0 × 38-mm PtCr-EES was placed from the distal POP to TPT using OCT guidance. Ten months later, the patient was referred to our hospital due to recurrent left leg rest pain. Angiography showed severe stenosis from the distal POP to the proximal site of the stent, and diffuse in-stent restenosis (ISR). At the ISR site, stent fracture and compression were observed and vessel evaginations were newly detected on OCT. At that time, good angiographic results were obtained by conventional balloon angioplasty alone. At 6 months follow-up, recurrence of ISR was suspected on duplex ultrasonography. Angiography showed no significant ISR, but PSS had markedly exacerbated from focal type to segmental type. OCT showed exacerbated vessel evagination and in-stent thrombus. The incidence and clinical impact of PSS after DES implantation in infrapopliteal artery lesions remain unclear; therefore, careful follow-up may be needed in such cases.

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.

Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort., Methods: MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months., Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups., Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.

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.)

Purpose: To investigate whether administering cilostazol after treatment for femoropopliteal in-stent restenosis (ISR) can have a positive impact on recurrent ISR (Re-ISR)., Methods: The database of a multicenter, retrospective, observational registry was interrogated to identify 338 consecutive patients (mean age 72.3±8.8 years; 148 men) who underwent endovascular therapy for femoropopliteal ISR in 379 limbs from January 2010 to December 2014. Ninety-seven patients (103 limbs) who received cilostazol after the initial stent implantation procedure were excluded. This left 24 ISR patients (30 limbs) who received cilostazol initially after ISR treatment for comparison with 217 ISR patients (246 limbs) who did not receive the drug. The primary endpoint was 2-year Re-ISR after treatment. The secondary endpoints were recurrent target lesion revascularization (Re-TLR) and reocclusion at 2 years. Restenosis was determined by a peak systolic velocity ratio >2.4 on a duplex scan or >50% stenosis on angiography., Results: The mean follow-up was 23.3±15.5 months. At 2 years, freedom from Re-ISR was significantly higher in the cilostazol group than in the no cilostazol group (48.6% vs 32.4%, p=0.047). However, freedom from Re-TLR and reocclusion between the 2 groups did not differ significantly [64.7% vs 53.8% (p=0.15) and 88.3% vs 73.9% (p=0.11), respectively]. After adjusting for prespecified risk factors, cilostazol administration was a negative predictor of Re-ISR., Conclusion: This small comparative study suggests that administering cilostazol for ISR lesions after femoropopliteal stenting reduces recurrent ISR.

Optimal medical therapy following endovascular therapy (EVT) for femoropopliteal (FP) lesions remains unclear. Therefore, we investigated whether sarpogrelate improves primary patency after EVT for FP lesions. This study was performed as a multicenter, randomized, open-label clinical trial. 186 patients (mean age 75 ± 9 years, 78 % men) with Rutherford class 2-5 due to an FP lesion were randomly assigned to receive or not receive sarpogrelate in addition to aspirin. Primary endpoint was 1-year primary patency and the secondary endpoints were target lesion revascularization (TLR) and secondary patency. Primary patency was defined as a treated vessel without restenosis or repeat revascularization. Restenosis was defined as >2.5 of peak systolic velocity ratio. Patient, lesion, and procedural characteristics did not differ significantly between two groups (mean lesion length 156 ± 94 mm, total occlusion 35 %). Stenting was performed in 133 patients (76 %). Eighty-four (94 %) could ingest sarpogrelate during follow-up period. Primary patency was 66 % in sarpogrelate group and 56 % in non-sarpogrelate group, showing no significant difference between the groups (p = 0.33). The incidence of TLR did not differ in both groups (sarpogrelate 24 % vs non-sarpogrelate 32 %, p = 0.12). Secondary patency also did not differ (sarpogrelate 90 % vs non-sarpogrelate 92 %, p = 0.43). When the interaction of sarpogrelate with the primary patency was analyzed in previously established subgroups, no interactions were noted for any subset. Sarpogrelate did not improve primary patency after EVT for FP disease in this study.

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.)

Background: Cilostazol improves clinical endovascular therapy outcomes for femoropopliteal (FP) lesions in patients with symptomatic peripheral arterial disease, but whether it also has clinical benefits for patients after drug-eluting stent implantation remains unclear., Methods: This study is a subanalysis of the ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy (ZEPHYR) study, a prospective multicenter study investigating FP lesions treated with the Zilver (Cook Medical, Bloomington, Ind) paclitaxel-eluting stent. The present study analyzed 475 lesions in 459 limbs of 399 patients who maintained therapy with aspirin and thienopyridine, with or without cilostazol, during the 1-year follow-up period., Results: Restenosis rates at 1 year were assessed with duplex ultrasound imaging (peak systolic velocity ratio >2.4) or angiography (≥50% diameter stenosis) and compared in the groups with and without cilostazol. Propensity score matching was performed to minimize intergroup differences in baseline characteristics. The present study included 93 cilostazol-treated and 382 cilostazol-free cases. Among the patients, 71% had diabetes mellitus and 31% were on dialysis. Critical limb ischemia accounted for 29% of cases. The prevalence of de novo lesions was 76%, and in-stent restenosis was present in 15%. Propensity score matching was performed in 91 pairs. The 1-year restenosis rate was 33% (95% confidence interval [CI], 23%-43%) in the cilostazol-treated group and 51% (95% CI, 41%-62%) in the cilostazol-free group (P = .008). The odds ratio was 0.5 (95% CI, 0.3-0.8)., Conclusions: The propensity score-matching analysis demonstrated that additional cilostazol administration was associated with a significantly lower restenosis incidence 1 year after drug-eluting stent implantation for FP lesions., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

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 compare primary patency between MISAGO (Terumo Corporation, Tokyo, Japan) and S.M.A.R.T. CONTROL (Cordis Corporation, Miami Lakes, Florida), second-generation and first-generation nitinol stents, in femoropopliteal lesions., Materials and Methods: This multicenter, retrospective study included 240 cases with MISAGO stent implantation and 1,265 cases with S.M.A.R.T. stent implantation. The S.M.A.R.T. group had more Trans-Atlantic Inter-Society of Consensus (TASC) II class C/D lesions (53% vs 41%, P = .001) and smaller reference vessel diameter (RVD) (5.3 mm ± 0.9 vs 5.5 mm ± 0.9, P < .001)., Results: Kaplan-Meier estimates of 2-year primary patency after S.M.A.R.T. and MISAGO stent implantation were 67% and 55% (P = .007). Interaction analysis revealed that TASC II classification and RVD had a significant influence on the association of MISAGO versus S.M.A.R.T. stents with the outcome. The study population was stratified according to TASC II classification and RVD, and MISAGO and S.M.A.R.T. stents were compared after propensity score matching. There was no significant difference in 2-year patency between the 2 stents in the subgroup with TASC II class A/B and RVD ≥ 5 mm (S.M.A.R.T. 82% ± 4 vs MISAGO 74% ± 5, P = .480). MISAGO stents had lower primary patency than S.M.A.R.T. stents in cases with TASC II class C/D or RVD < 5 mm (S.M.A.R.T. 62% ± 6 vs MISAGO 25% ± 6, P = .015)., Conclusions: S.M.A.R.T. and MISAGO stents had similar patency in simple lesions, but MISAGO stents had lower patency than S.M.A.R.T. stents in more complex lesions., (Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.)

Purpose: To assess the influence of repeat intervention on the risk of major amputation after infrapopliteal angioplasty for patients with critical limb ischemia (CLI)., Methods: A multicenter database of Japanese CLI patients was interrogated to identify patients who underwent balloon angioplasty for isolated infrapopliteal lesions from April 2004 to December 2012. In that time frame, 1298 limbs of 1065 patients (mean age 72±10 years; 739 men) were eligible for this analysis. The prevalence of tissue loss was 76%, with 33% accompanied by infection. The association between repeat intervention and future risk for major amputation was evaluated using a mixed effects logistic regression model. A stratification analysis was also performed with baseline variables. A supplementary analysis compared baseline characteristics between the cases with and without repeat intervention. Hazard ratios (HR) and their 95% confidence intervals (CI) are reported., Results: Median follow-up was 1.2 years (interquartile range 0.4-2.5), during which time 143 (11.0%) limbs had major amputations and 499 (38.4%) underwent repeat intervention. The mixed effects modeling revealed that repeat intervention was significantly associated with future risk for major amputation (unadjusted HR 3.01, 95% CI 2.05 to 4.41, p=0.001). From the stratification analysis, repeat intervention significantly increased future risk of major amputation in cases with regular dialysis (HR 3.35, 95% CI 2.14 to 5.26, p<0.001), whereas it did not in those without dialysis. The supplemental analysis showed that patients with repeat intervention within 1 year had a higher prevalence of nonambulatory status, regular dialysis, tissue loss, and infection at baseline compared to those without repeat intervention for 1 year., Conclusion: In the patients with CLI due to infrapopliteal lesions, the need for repeat intervention increased the risk of future major amputation. However, this correlation was not applicable to nondialysis patients., (© The Author(s) 2016.)

Purpose: To compare drug-eluting stent (DES) implantation with percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal in-stent restenosis (ISR)., Methods: A comparison was performed of data from 112 ZEPHYR registry patients (mean age 74±9 years; 60 men) with 119 femoropopliteal ISR lesions treated with a drug-eluting stent (Zilver PTX) with historical data from 116 patients (mean age 72±8 years; 83 men) with 133 lesions treated with PTA. The patients were stratified for analysis by lesions with (101/252, 40%) and without (n=151) in-stent occlusion. The primary outcome measure was the 1-year incidence of recurrent restenosis; the secondary outcome was major adverse limb events (MALE). Multivariate logistic regression analysis was performed to look for any independent association of DES implantation with 1-year recurrent restenosis in the respective subgroups; results are presented as the odds ratio (OR) and 95% confidence interval (CI)., Results: In the subgroup without in-stent occlusion, there was no significant difference between DES and PTA in the 1-year incidence of recurrent restenosis (40.5% vs 45.7%, p=0.583, respectively) or MALE (27.8% vs 20.7%, p=0.322, respectively). However, in the subgroup with in-stent occlusion, DES implantation was associated with significantly lower incidences of recurrent restenosis (44.1% vs 90.3% for PTA, p<0.001) and MALE (25.5% vs 53.6% for PTA, p<0.001). Multivariate analysis confirmed that DES implantation had a significant independent negative association with the risk of recurrent restenosis in the subgroup with occlusion (OR 0.2, 95% CI 0.1 to 0.6, p=0.006)., Conclusion: DES implantation may be more effective than PTA in the management of femoropopliteal ISR with occlusion, but equally effective to PTA in nonocclusive ISR lesions. These results require confirmation in prospective randomized studies., (© The Author(s) 2016.)

Purpose: To compare optimal balloon angioplasty with nitinol stenting and drug-eluting stent (DES) implantation for femoropopliteal in-stent occlusion (ISO)., Methods: A dual center, retrospective study was performed from January 2004 to December 2014 encompassing 110 ISOs after bare nitinol stenting for a femoropopliteal lesion in 100 patients (mean age 72.7±10.1 years; 58 men). These patients underwent optimal balloon angioplasty with implantation of a bare stent (conventional group, n=79) or a DES (n=21). The primary endpoint was recurrent in-stent restenosis (Re-ISR); secondary endpoints were recurrent target lesion revascularization (Re-TLR), reocclusion, and major adverse limb events (MALE). Re-ISR or reocclusion was defined as ISR or occlusion after TLR. Restenosis was defined as a peak systolic velocity ratio >2.4 on a duplex scan or >50% stenosis on angiography. Univariate Cox regression analysis was used to identify any relationships between patient and procedure variables and the occurrence of Re-ISR; the results are presented as the hazard ratio (HR) and the 95% confidence interval (CI)., Results: The mean follow-up period was 34.9±27.4 months. At 2 years, Kaplan-Meier estimated freedom from Re-ISR rates were 79.3% in the DES group and 20.2% in the conventional group, respectively (p<0.001). The rates of freedom from Re-TLR, reocclusion, and MALE at 2 years were 85.7%, 85.9%, and 85.7% in the DES group and 27.1%, 42.5%, and 25.3% in the conventional group, respectively (p<0.001, p=0.006, and p<0.001, respectively). Univariate analysis showed only postprocedure stenosis (HR 1.04, 95% CI 1.02 to 1.07, p<0.001) as a predictor of Re-ISR. Postprocedure ABI (HR 0.06, 95% CI 0.01 to 0.30, p<0.001) and DES use (HR 0.20, 95% CI 0.07 to 0.44, p<0.001) were associated with a lower likelihood of developing Re-ISR., Conclusion: In this small comparative study, DES stent implantation gives more favorable outcomes than conventional treatment for ISO after femoropopliteal stenting., (© The Author(s) 2016.)

Purpose: To investigate the thus far poorly defined impact of perioperative complications (POCs) on clinical outcomes after endovascular therapy (EVT) of diabetic patients with critical limb ischemia (CLI) due to isolated infrapopliteal lesions., Methods: A multicenter registry of CLI patients was interrogated to identify 780 consecutive diabetic patients (mean age 71 ± 10 years; 553 men) who successfully underwent balloon angioplasty for isolated infrapopliteal lesions. More than half of the population (487 patients) was on dialysis. Independent predictors (logistic regression) and prognostic impact on outcomes (Cox proportional hazards model) of POC (ie, death, myocardial infarction, stroke, pseudoaneurysm, puncture site hemorrhage/hematoma, distal emboli, vascular rupture, transfusion, dialysis, and gastrointestinal hemorrhage) were investigated. Outcomes are presented as the odds ratio (OR) and hazard ratio (HR), respectively, with 95% confidence intervals (CI)., Results: POCs occurred in 12.3% (96/780) of the population. Multivariate modeling identified body mass index (BMI) <18.5 kg/m(2) (adjusted OR 1.71, 95% CI 1.01 to 2.89, p=0.047) and tissue loss (adjusted OR 2.43, 95% CI 1.14 to 5.15, p=0.021) as independent predictors of POCs. In a Cox regression model adjusted for baseline clinical characteristics, the occurrence of POCs was independently associated with major adverse limb events (HR 1.87, 95% CI 1.12 to 3.13, p=0.016) but not with mortality or wound healing. In follow-up, freedom from major adverse limb events was higher in the group without POC (85.2%) than with POC (69.7%, p=0.006) at up to 3 years., Conclusion: POCs within 30 days after balloon angioplasty for infrapopliteal disease in diabetics with CLI were more likely to occur in patients with low BMI and tissue loss. POC occurrence was associated with major adverse limb events in follow-up but not with mortality or wound healing., (© The Author(s) 2016.)

Purpose: To present a propensity score matching analysis comparing the 1-year outcomes of de novo femoropopliteal lesions treated with drug-eluting stents (DES) or bare nitinol stents (BNS)., Methods: A retrospective review was conducted of 452 limbs in 389 patients (mean age 74±8 years; 284 men) treated with DES implantation and 1808 limbs in 1441 patients (mean age 72±9 years; 1023 men) implanted with BNS for de novo femoropopliteal lesions. One-year follow-up data were available on all patients. The primary endpoint was 12-month restenosis assessed by duplex ultrasonography or follow-up angiography within ±2 months. Secondary endpoint was major adverse limb events (MALE) including major amputation, any reintervention, and restenosis., Results: The BNS group was more likely to have current smoking, chronic total occlusion, and poor below-the-knee runoff. The stratification analysis demonstrated that diabetes mellitus (DM) and reference vessel diameter (RVD) had a significant interaction on the association of DES vs BNS implantation with restenosis (interaction p<0.05). Thus, the population was stratified into 4 subgroups (1: -DM, RVD ≥5 mm, 2: +DM, RVD ≥5 mm, 3: -DM, RVD <5 mm, and 4: +DM, RVD <5 mm); the RVD threshold was empirically determined. There were no significant intergroup differences in baseline variables after matching. There was no significant difference in restenosis risk between DES and BNS in the RVD ≥5 mm subgroup regardless of the presence of DM. The DES group had a significantly higher restenosis risk in the RVD <5 mm subgroup regardless of the presence of DM. No significant difference was observed in the risk of major amputation, reintervention, or MALE in any subgroup., Conclusion: These results suggest that a first-generation DES was not superior to a conventional BNS for femoropopliteal lesions., (© The Author(s) 2015.)

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.)

Objectives and Background: Among hemodialysis (HD)-dependent patients with critical limb ischemia (CLI), Endovascular therapy (EVT) of isolated infrapopliteal lesions improves limb salvage. Accordingly, we sought to determine the outcomes of this group of patients based on the extent of tissue loss at baseline., Methods: From 2004 to 2011, 449 consecutive HD patients with CLI had ischemic wounds and underwent EVT for isolated infrapopliteal lesions. The "minor tissue loss" (MI) group was confirmed by 340 HD patients with wounds located distal to the metatarsophalangeal joints, and the "major tissue loss" (MA) group included 109 HD patients with wounds that extended beyond this point. The two groups were compared for limb salvage and amputation free survival (AFS) rates by Kaplan-Meier analysis., Results: There was no significant difference in the percentage of diabetic patients (MI: 76.5 vs. MA: 75.2%). The percentage with direct flow to the wound site was lower in the MA group than in the MI group (MI: 63.5 vs. MA: 45.9%, P < 0.01). After EVT the MI group had a significantly better limb salvage rate (MI: 83.7 vs. MA: 71.2% at 3 years, P < 0.01), and AFS rate (MI: 44.1 vs. MA: 29.1% at 3 years, P < 0.01) compared to the MA group., Conclusions: EVT is an efficient treatment for HD patients with minor tissue loss, achieving >80% limb salvage rates at 3 years. However, AFS rates in all HD patients with tissue loss are <50% at 3 years, making their prognosis poor., (© 2015 Wiley Periodicals, Inc.)

Purpose: To investigate 5-year clinical outcomes after infrapopliteal endovascular therapy (EVT) for critical limb ischemia (CLI) patients on or not on hemodialysis (HD), and compare the clinical efficacy of EVT between the 2 groups., Methods: The subjects were 1091 CLI patients (1310 limbs) who underwent EVT for isolated infrapopliteal lesions from 2004 to 2012, and were classified into 2 groups for comparative study: the patients on HD group (670 patients, 830 limbs) and not on HD group (421 patients, 480 limbs)., Results: The HD group had a significantly lower rate of freedom from major adverse limb events or perioperative death (HD 78.4% vs. non-HD 86.0% at 1 year, HD 70.3% vs. non-HD 82.4% at 5 years, P = 0.01), or amputation-free survival (AFS) rate (HD 65.7% vs. non-HD 78.7% at 1 year, HD 34.4% vs. non-HD 59.8% at 5 years, P < 0.01) after EVT compared with the non-HD group. Independent predictors of AFS in HD patients were nonambulatory, diabetes mellitus, albumin <3.0 g/dL, ejection fraction ≤0.48, and no patent pedal arch arteries before EVT. AFS at 1 year was 81% in patients with 0 or 1 predictor, surpassing the suggested AFS objective performance goal (OPG) end points of 68%, but AFS in patients with 2 or more predictors failed to reach the OPG., Conclusions: In comparison with non-HD patients, the clinical efficacy of infrapopliteal EVT for HD patients was poor. Preoperative risk stratification based on AFS predictors can be used as an index for predicting the prognosis., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objectives: This study sought to assess the rate and predictors of 1-year restenosis after drug-eluting stent implantation for femoropopliteal (FP) lesions in patients with peripheral arterial disease., Background: Zilver PTX, a paclitaxel-eluting stent for FP lesions, provides superior outcomes to angioplasty and bare-metal stents in clinical trials. However, its real-world outcomes and the associated features remain unclear., Methods: This was a prospective multicenter study enrolling 831 FP lesions (797 limbs, 690 patients) treated by Zilver PTX implantation. The primary endpoint was 1-year restenosis. Secondary endpoints included major adverse limb event and stent thrombosis., Results: Mean lesion length was 17 ± 10 cm. One-year restenosis, major adverse limb event, and stent thrombosis rates were 37%, 22%, and 2%, respectively. The generalized linear mixed model showed that lesion length ≥16 cm assessed by angiography and distal external elastic membrane area ≤27 mm(2) and minimum stent area ≤12 mm(2) assessed by intravascular ultrasound were independent risk factors for restenosis. One-year restenosis rates were 15% in cases with none of these risk factors and 50% in those with ≥2 risk factors., Conclusions: The current study demonstrated 1-year real-world outcomes after drug-eluting stent treatment for FP lesions, including challenging ones in clinical practice. Lesion length, external elastic membrane area, and minimum stent area were independent predictors for restenosis. (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery-Prospective Multicenter Registry [ZEPHYR]; UMIN000008433)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: Despite wide use, high initial success, and acceptable durability of endovascular therapy (EVT) for femoropopliteal (FP) lesions, the frequency of 30-day perioperative complications (POCs) and their effect on clinical outcomes have not been systematically evaluated, which is the subject of this study., Methods: We used a multicenter database of 2145 consecutive patients (70% male; overall mean age, 73 ± 9 years) who successfully underwent EVT for FP lesions to investigate independent predictors of POCs (logistic regression analysis) and effect of POCs on prognostic outcomes (Cox proportional regression)., Results: POCs were observed in 209 patients (10%). In multivariate logistic regression analysis, body mass index <18.5 kg/m(2), critical limb ischemia, and TransAtlanic Inter-Society Consensus for the Management of Peripheral Arterial Disease class D lesions were independently associated with POCs (adjusted odds ratios [95% confidence intervals], 2.0 [1.3-2.9], 2.5 [1.9-3.3], and 1.6 [1.2-2.1], respectively). After risk stratification of POCs according to the number of these risk factors, the incidence of POCs was higher in the groups with higher scores. Follow-up for >30 days (mean, 2.3 ± 1.8 years) was available for 2079 of 2145 patients. A Cox hazard regression model adjusted for baseline clinical characteristics showed POCs were negatively and independently associated with future occurrence of major adverse limb events (defined as major amputation and major reintervention) or death (hazard ratio [95% confidence interval], 1.6 [1.2-2.1]; P < .05)., Conclusions: Body mass index <18.5 kg/m(2), critical limb ischemia, and TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease class D lesion were positively associated with POCs after EVT for FP lesions. The occurrence of POCs may adversely affect clinical outcomes in the chronic phase., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To investigate the relationship between body mass index (BMI) and long-term outcomes of patients with CLI after endovascular treatment (EVT)., Design: Retrospective multicenter study., Subjects: 1088 consecutive patients (1306 limbs, mean age 72 ± 10 years) with CLI who underwent EVT for isolated infrapopliteal artery lesions were evaluated. These subjects were identified in the J-BEAT III registry., Methods: The patients were divided into groups based on BMI <18.5 kg/m2 (underweight, n = 188; 219 limbs), 18.5 to 24.9 kg/m2 (normal weight, n = 718; 868 limbs), and >25.0 kg/m2 (overweight/obese, n = 182; 219 limbs). The endpoints were overall survival and freedom from major adverse limb events (MALE)., Results: The median follow up period was 1.5 years (range: 1 month-8.7 years). The 3 year overall survival rates were 33.3%, 61.2%, and 69.8% in underweight, normal, and overweight/obese patients, respectively. The survival rate was significantly lower in underweight patients and significantly higher in overweight/obese patients compared with patients of normal weight (both p < .0001). The 3 year rates of freedom from MALE did not differ significantly among the three groups (36.4%, 45.4%, and 52.3%, respectively, p = .32). Age, BMI <18.5 kg/m2, heart failure, aortic valve stenosis, renal failure, triglyceride levels, serum albumin <3.0 g/dL, anticoagulant treatment, non-ambulatory status, and Rutherford 6 classification all were significantly associated with overall survival., Conclusions: BMI has a complex correlation with mortality in patients with CLI after EVT for isolated infrapopliteal artery lesions. Underweight patients with CLI have an extremely poor prognosis. Such patients have many other factors associated with mortality, but low BMI was identified as an independent predictor of a poor prognosis in patients with CLI. Similarly, normal weight patients had a small but significant increase in mortality compared with overweight/obese patients., (Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Purpose: To investigate the impact of angiosome-oriented revascularization on clinical outcomes in critical limb ischemia (CLI) patients excluding those with both diabetes and wound infection., Methods: Using a retrospective multicenter database, a propensity score matching analysis was performed of 539 consecutive CLI patients (375 men; mean age 71±11 years) without concurrent wound infection and diabetes who underwent balloon angioplasty of isolated infrapopliteal lesions. Propensity score matching produced 2 groups of 182 patients each who underwent angiosome-oriented direct revascularization (123 men; mean age 72±11 years) or indirect revascularization (125 men; mean age 72±11 years). The groups were compared for wound healing rate, freedom from major adverse limb events (MALE), and amputation-free survival (AFS)., Results: In the overall population, indirect revascularization was performed in 36.6% (n=197). In the propensity matching analysis, the complete wound healing rate at 12 months was higher in the direct group than the indirect revascularization patients (75% vs. 64%, p=0.01), while freedom from MALE (p=0.99) and AFS (p=0.17) were not significantly different at up to 24 months. In multivariate analysis, indirect revascularization had an independent negative impact on wound healing (adjusted hazard ratio 0.7, p=0.008)., Conclusion: After propensity matching analysis for CLI patients other than those with both diabetes and wound infection, the wound healing rate was higher after direct revascularization than after indirect revascularization, whereas MALE and AFS were not significantly different.