TY - JOUR
T1 - Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon for revascularization of complex femoro-popliteal lesions
AU - Stahlberg, Erik
AU - Allmendinger, Ann Christin
AU - Anton, Susanne
AU - Planert, Mathis
AU - Jacob, Fabian
AU - Barkhausen, Jörg
AU - Goltz, Jan Peter
N1 - Funding Information:
This study was not supported by any funding. The authors declare that they have no conflict of interest. Written, informed consent was not applicable, as this was a retrospective study involving no human subjects. Local ethic review committee approval was granted (no.: 16-265A).
Publisher Copyright:
© 2020, Japanese Association of Cardiovascular Intervention and Therapeutics.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/8/16
Y1 - 2020/8/16
N2 - To evaluate technical success, safety and efficacy of post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon (PCB) for revascularization of complex femoro-popliteal lesions. Thirty patients (26 male, mean age 70 ± 7 years) suffering from peripheral artery disease (PAD) (Rutherford category II–III) underwent revascularization of chronic total occlusions (n = 22, 73%) or severe stenosis (n = 8, 27%) of the femoro-popliteal segment. Mean lesion length was 251 ± 85 mm. Lesions were treated by pre-dilatation (POBA), implantation of a helical interwoven stent and post-dilatation with a PCB. Technical success was defined as residual stenosis < 30%. Follow-up included clinical visits, duplex ultrasound and ABI at 6 and 12 months. Endpoints were patency (re-stenosis < 50%), complications, improvement of Rutherford category and ABI. Regarding patency two sub-groups were compared: long-(“LL”; < 25 cm, n = 12, mean 175 ± 38 mm) and ultra-long lesions (“ULL”; ≥ 25 cm, n = 13, mean 322 ± 43 mm). Technical success was 100%. In 1/30 patients (3.3%), a minor complication occurred (embolism). The overall primary and secondary patency rates at 12 months were 80.0% (95% CI 72.5–96.9%) and 92.0% (95% CI 84.7–100%). In the LL-sub-group, primary patency was 100%, and in the ULL-sub-group, primary patency was 61.5% (95% CI 51.8–92.3%) (p = 0.056), and secondary patency 84.6% (95% CI 71.3–100%), respectively. Rutherford category increased by at least one category in 92% of patients, ABI increased from 0.52 ± 0.13 (baseline) to 0.9 ± 0.14 (12 months) (p = 0.001). Five patients underwent target lesion revascularization during follow-up (bypass: n = 1, endovascular: n = 4). No death was observed during follow-up. Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated-balloon proved to be safe and effective with promising outcomes in long- and ultra-long lesions up to 12 months of follow-up.
AB - To evaluate technical success, safety and efficacy of post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon (PCB) for revascularization of complex femoro-popliteal lesions. Thirty patients (26 male, mean age 70 ± 7 years) suffering from peripheral artery disease (PAD) (Rutherford category II–III) underwent revascularization of chronic total occlusions (n = 22, 73%) or severe stenosis (n = 8, 27%) of the femoro-popliteal segment. Mean lesion length was 251 ± 85 mm. Lesions were treated by pre-dilatation (POBA), implantation of a helical interwoven stent and post-dilatation with a PCB. Technical success was defined as residual stenosis < 30%. Follow-up included clinical visits, duplex ultrasound and ABI at 6 and 12 months. Endpoints were patency (re-stenosis < 50%), complications, improvement of Rutherford category and ABI. Regarding patency two sub-groups were compared: long-(“LL”; < 25 cm, n = 12, mean 175 ± 38 mm) and ultra-long lesions (“ULL”; ≥ 25 cm, n = 13, mean 322 ± 43 mm). Technical success was 100%. In 1/30 patients (3.3%), a minor complication occurred (embolism). The overall primary and secondary patency rates at 12 months were 80.0% (95% CI 72.5–96.9%) and 92.0% (95% CI 84.7–100%). In the LL-sub-group, primary patency was 100%, and in the ULL-sub-group, primary patency was 61.5% (95% CI 51.8–92.3%) (p = 0.056), and secondary patency 84.6% (95% CI 71.3–100%), respectively. Rutherford category increased by at least one category in 92% of patients, ABI increased from 0.52 ± 0.13 (baseline) to 0.9 ± 0.14 (12 months) (p = 0.001). Five patients underwent target lesion revascularization during follow-up (bypass: n = 1, endovascular: n = 4). No death was observed during follow-up. Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated-balloon proved to be safe and effective with promising outcomes in long- and ultra-long lesions up to 12 months of follow-up.
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UR - https://www.mendeley.com/catalogue/24eb71f0-95dd-382a-9e1e-d882ab4486cd/
U2 - 10.1007/s12928-020-00697-9
DO - 10.1007/s12928-020-00697-9
M3 - Journal articles
AN - SCOPUS:85089457126
JO - Cardiovascular Intervention and Therapeutics
JF - Cardiovascular Intervention and Therapeutics
SN - 1868-4300
ER -
