Drug-Eluting Stent Shows Similar Patency Results as Prosthetic Bypass in Patients with Femoropopliteal Occlusion in a Randomized Trial

Björkman, Patrick; Auvinen, Tommi; Hakovirta, Harri; Romsi, Pekka; Turtiainen, Johanna; Manninen, Hannu; Venermo, Maarit

doi:10.1016/j.avsg.2018.04.014

Cited by 13 publications

(11 citation statements)

References 22 publications

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“…The mean lesion length of 264 mm was higher than in any comparable trial with values ranging from 132 to 241 mm. 7–9 Other studies only report 2-year results (primary patency: 56%-70%, freedom from TLR: 70%–86%), including the use of drug-coated balloons, novel NS and heparin-bonded stent grafts, which were comparable to our results (primary patency:48%; freedom from TLR:73%; at 2 years). The higher lesion length in our stent group may have impaired secondary patency at 2 years with only 64% compared to those studies with 80% to 98%.…”

Section: Discussionsupporting

confidence: 84%

Vein Bypass Versus Nitinol Stent in Long Femoropopliteal Lesions

et al. 2022

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Objectives: The aim of this study was to compare technical success, patency rates and clinical outcomes of vein bypass (VBP) with angioplasty and nitinol stents (NS) in femoropopliteal Trans-Atlantic Intersociety Consensus (TASC) II C and D lesions. Summary Background Data: Guidelines widely recommend an endovascular-first strategy for long femoropopliteal lesions without sufficient data comparing it with vein bypass surgery. Methods: A single-center prospective, randomized controlled trial (RCT) was performed, after approval of the local ethics committee, with technical success, primary and secondary patency as primary endpoints. Secondary endpoints were limb salvage, survival, complications, and clinical improvement. Results: Between 2016 and 2020, 218 limbs (109 per group) in 209 patients were included. Baseline and lesion characteristics were similar in both groups with a mean lesion length of 268 mm. The indication for treatment was chronic limb threatening ischemia in 53% of limbs in both groups. Technical success was feasible in 88% in the stent group. During a 4-year follow-up, primary patency, freedom from target lesion revascularizations, limb salvage, survival and complications showed no significant differences between the groups. At 48 months secondary patency for the bypass group was 73% versus 50% in the stent group (P = 0.021). Clinical improvement was significantly superior in the bypass group with 52% versus 19% reaching a Rutherford 0 category (P < 0.001). Conclusions: This is the largest RCT comparing angioplasty with NS and vein bypass in femoropopliteal TASC II C and D lesions and the first to report 4-year results. The data underline the feasibility of endovascular treatment in long lesions but also emphasize the advantages of VBP.

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Section: Discussionsupporting

confidence: 84%

Vein Bypass Versus Nitinol Stent in Long Femoropopliteal Lesions

et al. 2022

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“…Our search identified 57 eligible RCTs from 69 articles enrolling a total of 9,362 patients comparing seven revascularization strategies (balloon angioplasty vs. bare metal stent vs. covered stent vs. paclitaxel eluting stent vs. other drug eluting stent vs. paclitaxel‐coated balloon vs. bypass surgery; Figure 1). 1,2,16‐82 Other drug eluting stents category included sirolimus/zotarolimus/everolimus eluting stent. Cochrane risk of bias is summarized in Figure S2a, b. Baseline characteristics are shown in Table 1.…”

Section: Resultsmentioning

confidence: 99%

Mortality in patients undergoing revascularization with paclitaxel eluting devices for infrainguinal peripheral artery disease: Insights from a network meta‐analysis of randomized trials

Kuno

Ueyama

Mikami

et al. 2020

Cathet Cardio Intervent

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Objectives: We aimed to evaluate whether paclitaxel eluting devices increased the risk of death in patients undergoing revascularization for infrainguinal peripheral artery disease using network meta-analyses. Methods: PUBMED and EMBASE were searched through April 2020 for randomized trials in patients with infrainguinal peripheral artery disease who underwent revascularization with or without a paclitaxel eluting device (balloon/stent). Short-term mortality defined as death at 6-12 months, and long-term mortality defined as death at >12 months after revascularization. Results: Our search identified 57 eligible randomized controlled studies enrolling a total of 9,362 patients comparing seven revascularization strategies (balloon angioplasty vs. bare metal stent vs. covered stent vs. paclitaxel eluting stent vs. other drug eluting stent vs. paclitaxel-coated balloon vs. bypass surgery). Overall, paclitaxel eluting stent and paclitaxel-coated balloons did not increase short-term mortality (eg, vs.

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“…Patency rates between the groups did not differ significantly after 12 and 24 months. 20 In these studies, the primary patency rate after 12 months for endovascular therapy was 63% to 65% and 64% to 67% after bypass surgery. Furthermore, secondary patency for both endovascular therapy and bypass surgery after 1 and 2 years was lower (72% to 86%) 18,20 than the 97% secondary patency in the current study after 3 years.…”

Section: Discussionmentioning

confidence: 90%

“…Thus, several studies with different endovascular approaches showed equivalent outcomes after endovascular therapy vs bypass surgery. 18–20 A study comparing BMS to vein bypass in long femoropopliteal lesions (mean lesion length 276 mm) showed no significant differences between groups regarding patency, limb salvage, survival, or complications after 24 months. 18 After 1 year, the SuperB study, 19 which compared heparin-bonded endoluminal bypass with femoropopliteal bypass (two-thirds being venous bypass grafts), revealed promising results after endovascular therapy with lower morbidity, faster recovery, and improvement in quality of life.…”

Section: Discussionmentioning

confidence: 99%

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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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Drug-Eluting Stent Shows Similar Patency Results as Prosthetic Bypass in Patients with Femoropopliteal Occlusion in a Randomized Trial

Abstract: The trial was preregistered at ClinicalTrials.org (NCT01450722).

Cited by 13 publications

References 22 publications

Vein Bypass Versus Nitinol Stent in Long Femoropopliteal Lesions

Vein Bypass Versus Nitinol Stent in Long Femoropopliteal Lesions

Mortality in patients undergoing revascularization with paclitaxel eluting devices for infrainguinal peripheral artery disease: Insights from a network meta‐analysis of randomized trials

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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