Covered stent versus bare-metal stents for chronic total occluded long complicated femoropopliteal lesions

Lin, Ting-Chao; Chen, Po‐Lin; Lee, Chiu-Yang; Shih, Chang-tai; Chen, I‐Ming

doi:10.1097/jcma.0000000000000005

Cited by 4 publications

(4 citation statements)

References 22 publications

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“…8 A more recent analysis of the Viabahn stent-graft and BMS in long FP CTOs found significantly improved ABI at 12- and 24-month follow-up in the Viabahn stent-graft group, as well as lower rates of stent thrombosis and TLR, despite significantly longer lesions and more advanced disease. 9 Primary patency trended higher with the Viabahn stent-graft arm though did not attain statistical significance, likely due in part to small sample size.…”

Section: Discussionmentioning

confidence: 93%

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries

et al. 2021

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Purpose: To assess the midterm safety and effectiveness of the Gore® Viabahn® Endoprosthesis as treatment for symptomatic peripheral arterial disease (PAD) in the superficial femoral arteries (SFA). Materials and Methods: A prospective, multicenter, post-market surveillance study was conducted in Japan. Patients with symptomatic SFA lesions ≥ 10 cm and reference vessel diameters ranging from 4.0 to 7.5 mm were eligible for enrollment; patients with traumatic or iatrogenic vessel injury in the thoracic, abdominal, or pelvic arteries were excluded. Outcomes evaluated at 12 months 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: From August 2016 to May 2017, 321 patients were enrolled at 64 Japanese sites (mean age, 73.9±8.7 years; 77.3% male). Hypertension, diabetes, and end stage renal disease were present in 84.4%, 54.8%, and 23.1% of patients, respectively. Mean lesion length was 23.6 cm±6.6 cm, with lesions ≥ 15 cm in 271 patients (84.4%). TASC C/D lesions accounted for 86.6% (39.1% TASC C, 47.5% TASC D); 26.5% had critical limb ischemia. Baseline ABI was 0.60±0.16. A total of 562 devices were implanted in 324 limbs, with a majority of patients (68.8%) receiving 2 stents. Through 12 months, 92.1% of patients were evaluable. Kaplan-Meier-estimated PP, PAP, and SP at 12 months was 85.6%, 91.7%, and 94.8%, respectively. Twelve-month fTLR was 92.3%. Mean change in ABI at 12 months was 0.343±0.21; mean improvement in Rutherford class was 2.5. Device- or procedure-related SAEs occurred in 3.1% through 30 days, with a majority of early SAEs consisting of access complications. Through 12 months, a cumulative 10.6% had device- or procedure-related SAEs, with the most common being device occlusions in 4.0%. Lower limb amputation occurred in 0.9% and was related to pre-existing ulceration or gangrene in all 3 cases. No stent fractures were observed at 12-month x-ray evaluation. Conclusion: In a real-world Japanese patient population characterized by long SFA lesions and complex PAD, the Viabahn endoprosthesis was associated with excellent patency rates through 12 months and an acceptable safety profile.

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Section: Discussionmentioning

confidence: 93%

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries

et al. 2021

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“…A study from Taiwan compared the self-expanding polytetrafluoroethylene-covered Viabahn stent to BMS in chronic total occluded long femoropopliteal lesions. Compared with the BMS group, the Viabahn group had significantly less in-stent restenosis (18.2% vs. 42.9%) and TLR (21.8% vs. 50.0%) ( 13 ). The results with the DES from the current study were considerably better, although the lesions were not as challenging as the lesions in the study from Taiwan.…”

Section: Discussionmentioning

confidence: 99%

First peripheral drug-eluting stent clinical results from China: 1-year outcomes of the Zilver PTX China study

Böhme

et al. 2022

Front. Cardiovasc. Med.

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PurposeThe benefit of using the Zilver PTX drug-eluting stent (DES) in superficial femoral artery (SFA) lesions has been demonstrated in multiple clinical studies. This prospective, multicenter study evaluated the 1-year safety and effectiveness of the DES for the treatment of femoropopliteal lesions in a Chinese patient population.MethodsPatients with a single de novo or restenotic SFA lesion ≤140 mm and a Rutherford classification of 2 to 4 were treated with the DES. The primary endpoint was primary patency assessed by duplex ultrasound at 1-year. Secondary endpoints included adverse events, event-free survival (EFS), and freedom from target lesion revascularization (TLR). Clinical outcomes included Rutherford classification, ankle-brachial index (ABI), and the walking impairment questionnaire (WIQ).ResultsIn this study, 178 patients with symptomatic peripheral artery disease were enrolled at nine institutions in China. The average lesion length was 79.0 ± 48.6 mm (range 14.8–245.4 mm) and 50.0% of lesions were total occlusions. The 1-year primary patency rate was 81.9%. Covariate analysis revealed that lesion length (p < 0.01) was the only significant factor for patency. No paclitaxel-related adverse events or amputations were reported. The 1-year rate for EFS was 94.9% and freedom from TLR was 95.5%. Through 1-year, treatment with the DES resulted in statistically significant improvement in ABI and WIQ scores compared with pre-procedure (p < 0.001). Clinical improvement of at least 1 Rutherford class was achieved in 142 of 174 patients (81.6%).ConclusionThis study showed promising short-term results for the treatment of SFA lesions with Zilver PTX DES in Chinese patients.Unique identifierClinicalTrials.gov, identifier: NCT02171962.

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“…Gore & Associates Inc, Flagstaff, AZ, USA) vs bare metal stents (BMS) for the treatment of long femoropopliteal occlusions. 9 In comparison with the Viabahn group, the BMS group had significantly more in-stent restenosis and target lesion revascularization (TLR) after 2 years. 9 A prospective multicenter study also showed better primary patency after treatment with the Viabahn endoprosthesis compared with BMS.…”

Section: Introductionmentioning

confidence: 99%

“…9 In comparison with the Viabahn group, the BMS group had significantly more in-stent restenosis and target lesion revascularization (TLR) after 2 years. 9 A prospective multicenter study also showed better primary patency after treatment with the Viabahn endoprosthesis compared with BMS. However, there was no significant impact on clinical outcomes or TLR rate at 2 years.…”

Section: Introductionmentioning

confidence: 99%

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial

et al. 2020

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Purpose: To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries. Materials and Methods: This prospective, multicenter, single-arm trial ( ClinicalTrials.gov; identifier NCT01263665) enrolled 71 patients (mean age 66.7±8.3 years; 50 men) with lifestyle-limiting claudication or rest pain (Rutherford category 2–4) and long (>20-cm) lesions of the superficial femoral and proximal popliteal arteries. Primary endpoint was primary patency at 36 months. Secondary endpoints included primary assisted patency; secondary patency; freedom from target lesion revascularization (TLR); freedom from a composite of death, target vessel revascularization (TVR), and amputation; clinical success; and freedom from device fracture. Results: Primary patency estimated by Kaplan-Meier analysis was 40.6% at 36 months. Primary assisted patency and secondary patency estimates were 53.0% and 96.9%, respectively. Within 36 months, 27 patients had to undergo a TLR. Twenty-five patients (35.2%) had a TVR. Freedom from the composite of death, TVR, and amputation endpoint was 44.5%. The estimate of the sustained clinical success with stable or improved Rutherford category was 58.5%. No stent fracture was detected during follow-up. Conclusion: The primary patency rate without reintervention after treatment of long femoropopliteal lesions is low. However, secondary patency after implantation of a Viabahn endoprosthesis is high and seems to be superior to the use of other revascularization techniques, resulting in persistent clinical improvement.

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Covered stent versus bare-metal stents for chronic total occluded long complicated femoropopliteal lesions

Cited by 4 publications

References 22 publications

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries

Twelve-Month Outcomes From the Japanese Post-Market Surveillance Study of the Viabahn Endoprosthesis as Treatment for Symptomatic Peripheral Arterial Disease in the Superficial Femoral Arteries

First peripheral drug-eluting stent clinical results from China: 1-year outcomes of the Zilver PTX China study

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial

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