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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.

Purpose: To examine with intravascular ultrasound (IVUS) the crossing pathways of the TruePath reentry device during primary antegrade recanalization of infrainguinal chronic total occlusions (CTOs). Methods: Between July 2017 and September 2018, a prospective multicenter study enrolled 143 consecutive patients (mean age 75±9 years; 101 men) with 146 CTOs treated in an antegrade approach using the TruePath reentry device with IVUS assessment of the crossing pathway in successful cases. Outcome measures were complete success (reentry device reached the distal true lumen), assisted success (reentry device use followed by a conventional guidewire to reach the distal true lumen), reentry device crossing route by IVUS assessment, and procedure- and device-related complications. Regression analyses were employed to identify any relevant associations between baseline patient variables and the outcome measures; results are presented as the odds ratio (ORs) and 95% confidence interval (CI). Results: Complete success was achieved in 82 (56.2%) lesions; any success (complete plus assisted) was documented in 117 (80.1%) lesions. Four (3%) perioperative device-related complications were observed. The crossing route was intraplaque for most of the total crossing distance in both complete success cases (95.3%±13.2%) and any success cases (94.8%±14.4%), with relatively short subintimal (3.6%±10.2% and 4.2%±11.2%, respectively) or intramedial (1.2%±5.8% and 1.0%±5.4%, respectively) crossing. CTO length was a significant risk factor for not achieving complete success (OR 1.74, 95% CI 1.13 to 2.68, p=0.012), and a history of failed revascularization was associated with not achieving any success (OR 6.40, 95% CI 1.28 to 28.9, p=0.038). Conclusion: The intraplaque route was the primary pathway taken by the TruePath reentry device as it crossed infrainguinal CTOs. Crossing rates were acceptable, with few device-related complications. However, a longer CTO length and a failed revascularization history negatively affected the success rate.

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 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.

A 60-year-old man, who had claudication in his right limb due to total occlusion of the right superficial femoral artery, received bare metal stents. Although the bare metal stents in the superficial femoral artery did not show restenosis 5 years after stent implantation, angiography revealed significant in-stent restenosis when he developed right critical limb ischemia at 8 years post implantation. Ballooning for in-stent lesions did not result in full expansion. His right limb was amputated above the knee due to progressive limb ischemia. In the pathological findings in the superficial femoral artery, marked calcification was observed in the entire circumference of the luminal surface of the neointima. However, lipid core formation was not identified in the neointima. Although several cracks following balloon angioplasty were observed at the superficial calcified layers, injury to neointimal tissue such as compression was not observed. The neointima exhibited heavy calcification in the very late phase of in-stent restenosis after bare metal stent implantation in superficial femoral artery. Therefore, balloon angioplasty in the very late phase of in-stent restenosis potentially results in underexpansion.

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.)

The safety and patency of endovascular treatment (EVT) in isolated common femoral artery (CFA) and popliteal artery (PA) remain poorly understood. We investigated the efficacy after EVT for isolated CFA and PA disease. This study was performed as a multicenter retrospective registry of a prospectively maintained database. Between January 2001 and December 2010, consecutive 183 patients (214 lesions; CFA 111, PA 103) who received endovascular procedure for de novo isolated CFA and PA disease were enrolled. The main endpoints of this study were primary and secondary patency after EVT. Procedure success was 95.8 %. The 1- and 5-year primary patencies for CFA (PA) lesions after EVT were 73.5 % (75.5 %) and 46.9 % (56.2 %), respectively. There was no significant difference of primary patency rate between CFA and PA (46.9 vs. 56.2 % at 5-year, p = 0.83). However, secondary patency significantly differed between CFA and PA (97.6 vs. 86.2 % at 5-year, p = 0.009). Stent placement was not effective for the reduction of restenosis in both CFA and PA lesion. On multivariate analysis to define the predictors of primary patency for the CFA, renal failure, coronary artery disease, calcified lesion and residual stenosis after EVT were independent predictors. Also, the predictors of primary patency for the PA were BMI, reference vessel diameter, anemia and residual stenosis after EVT. Short-term patency after EVT for isolated CFA and PA lesion seems to be feasible. However, long-term patency was not promising. Furthermore, stent placement does not improve the primary patency.