EVOLUTION Study: 12-month results

Bosiers, Marc; Deloose, Koen; Callaert, Joren; Peeters, Patrick; Verbist, Jürgen; Eynde, Wouter Van den; Maene, Lieven; Beelen, Roel; Keirse, Koen; Wauters, Jeroen

doi:10.23736/s0021-9509.19.10706-9

Cited by 3 publications

(4 citation statements)

References 7 publications

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“…The sample size was calculated according to the hypothesis that DES would perform at least 50% better than BMS regarding restenosis as shown in earlier studies, 34,44,45 In an optimal setting with low-risk patients the rate of restenosis in DES treatment of FP lesions can be as low as 14-17% at 1 year. [45][46][47] The rate of restenosis at 12 months in a cohort with only CLTI and long lesions are higher, reaching at least 35% in earlier studies of BMS treatment 34 and 23% in earlier DES studies on long FP lesions. 46 The sample size in this study to perform 50% better than a restenosis rate of 30-40%, thus reached 100 subjects in each group, with a power of 85% and an alfa-level of .05.…”

Section: Discussionmentioning

confidence: 93%

“…[45][46][47] The rate of restenosis at 12 months in a cohort with only CLTI and long lesions are higher, reaching at least 35% in earlier studies of BMS treatment 34 and 23% in earlier DES studies on long FP lesions. 46 The sample size in this study to perform 50% better than a restenosis rate of 30-40%, thus reached 100 subjects in each group, with a power of 85% and an alfa-level of .05.…”

Section: Discussionmentioning

confidence: 93%

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Randomized clinical Trial Comparing drug Eluting Stent Zilver PTX® Versus Bare Metal Stent Zilver Flex® for Treatment of Lesions in Femoral and Popliteal Arteries in Chronic Limb Threatening Ischemia

Fransson

Gottsäter

Abdulrasak

et al. 2023

Vasc Endovascular Surg

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Objective Drug eluting stents (DES) might improve the results of stenting in the femoropopliteal (FP) segment, but randomized data between DES and BMS in the treatment of patients with chronic limb threatening ischemia (CLTI) is lacking. The aim of this study was to perform a randomized comparison, between DES and bare metal stent (BMS) implantation in a subgroup of CLTI patients with lesions in the superficial femoral artery (SFA) and the P1-P2 portion of the popliteal artery. Methods Patients presenting with CLTI scheduled for endovascular treatment of FP lesions were randomly assigned by blinded envelopes 1:1 in a single blinded, parallel group design to DES or BMS after lesion crossing. Primary endpoints were target lesion revascularization (TLR) at 12 and 24 months and primary patency at 12 and 24 months. Secondary endpoints were technical success (TS), clinical success, secondary patency at 12 and 24 months, limb salvage, serious adverse events (SAE) at 24 month and survival at five years. Results A total of 48 CLTI patients and 49 limbs, were enrolled, 22 in the BMS group and 27 in the DES group. Demographics, comorbidities, and Rutherford class were similar in both treatment arms. The overall rate of total occlusions was 96% and the corresponding overall median lesion length was 240 mm. No patients were lost to follow up. No significant differences were detected between groups regarding TLR and primary patency. The overall primary patency at 12 and 24 months was 42.9% and 36.7% respectively and the overall freedom from TLR was 67.3% and 61.2% respectively. The results in the two groups were also similar regarding secondary outcomes. Conclusions This single centre, randomized study could not demonstrate superiority of DES compared to BMS when treating long FP lesions in patients with CLTI but was limited by insufficient patient inclusion.

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Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 93%

Randomized clinical Trial Comparing drug Eluting Stent Zilver PTX® Versus Bare Metal Stent Zilver Flex® for Treatment of Lesions in Femoral and Popliteal Arteries in Chronic Limb Threatening Ischemia

Fransson

Gottsäter

Abdulrasak

et al. 2023

Vasc Endovascular Surg

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“…Unfavorable impact of lesion length on patency was already noted in earlier studies on laser-cut nitinol stents and polymer-free DES. 13,[27][28][29] It is argued whether stent fractures should be considered as possible cause. 30 No direct comparison between laser-cut and interwoven stents for long lesions is provided until now; however, subgroup analysis from the SUPERA 500 registry suggests that with interwoven nitinol stents, lesion length has less unfavorable impact on patency.…”

Section: Discussionmentioning

confidence: 99%

Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry

Thieme

Arjumand

Spanagel³

et al. 2022

J Endovasc Ther

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Purpose: This postmarketing surveillance study aimed to assess effectiveness and safety of a peripheral self-expanding stent with high torsional strength (POLARIS stent) for the treatment of de novo superficial femoral artery (SFA) lesions in the routine clinical practice. Materials and Methods: Consecutive patients with symptomatic de novo SFA occlusive disease who underwent POLARIS stent implantation were enrolled into the prospective, multicenter, observational postmarket surveillance study. Primary outcome measure was freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Main secondary outcomes were procedural success, primary clinical improvement, and freedom from major adverse cardiovascular and limb events (MACLE) throughout 24 months. Results: A total of 199 participants (70±11 years, 70.4% men) were included in the study at 9 German sites from December 2014 to August 2018. Half of them (52.6%) were current smokers, 37.6% had diabetes, and 25.0% were obese. Most participants suffered from intermittent claudication (88.4%). Mean lesion length was 98±83 mm, 43.5% of lesions were occluded, and 27.3% were severely calcified. Freedom from 12 months cdTLR was 94.4% (95% confidence interval [CI], 90.6–98.2). At 24 months, freedom from cdTLR was 88.7% (95% CI, 83.0–94.4). Procedural success was achieved in 96.2% of participants. Primary clinical improvement occurred in 87.5% and 85.4% of participants at 12 and 24 months, respectively. Freedom from MACLE was 94.8% (95% CI, 91.4–98.1) and 93.8% (95% CI, 89.9–97.6) at 12 and 24 months, respectively. Conclusions: Treatment of SFA occlusive disease in a real-world setting using the POLARIS stent with high bidirectional torsional strength is efficacious and does not raise any safety concern in the medium term. The study is registered with ClinicalTrials.gov (Identifier: NCT02307292).

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“…In the Efficacy of the Self-Expanding iVolution® n itinol s tent f or treatment of femoropopliteal lesions (EVOLUTION) study reported that iVolution® self-expanding nitinol stent (iVascular, S.L.U., Barcelona, Spain) had showed 86.3% primary patency rate and 88.0% freedom from revascularization at 12 months and 76.7% and 77.2% at 24 months, respectively. [ 25 , 26 ] However, Deloose[ 27 , 28 ] reported that, in the Clinical Trial Investigating the Combination Therapy With Luminor® D CB a nd iVolution Stent in TASC C and D Femoropopliteal Lesions (TINTIN), a primary patency of 96.5% and freedom from revascularization rate of 98.9% at six months and these figures were 90.5% and 94.4% at 12 months, respectively.…”

Section: Discussionmentioning

confidence: 99%

Endovascular balloon angioplasty for infrainguinal arterial occlusive disease: Efficacy analysis

Sarıcaoğlu¹

2021

Turk Gogus Kalp Dama

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Background We present early and mid-term clinical outcomes of endovascular revascularization for femoropopliteal involvement of peripheral arterial disease. Methods A total of 128 patients (113 males, 15 females; mean age: 63.4±9.9 years; range, 32 to 87 years) who underwent percutaneous transluminal angioplasty for femoropopliteal lesions between August 2016 and April 2018 were analyzed retrospectively. Treatment with Luminor® paclitaxel-coated drug-eluting balloon catheter or bailout therapy with iVolution® self-expanding nitinol stent were performed. Overall patency rates and freedom from reintervention rates were analyzed using the Kaplan-Meier analysis. The primary patency and freedom from reintervention to target lesion rates at 12 and 24 months were evaluated. Results Technical success was achieved in 133 (93%) of the interventions with a median follow-up of 11 (range, 1 to 35) months. At 12 and 24 months, the mean overall patency rates were 85.6±3.7% and 66.8±6.7%, respectively and the mean freedom from reintervention to target lesion rates were 91.6±2.9% and 78.1±6.3%, respectively. The primary patency and freedom from reintervention to target lesion rates were significantly higher in the bailout stenting group than the drug-eluting balloon group at 12 months (97.3±2.7% vs. 94.8±6.1%, respectively, p=0.025 and 97.1±2.9% vs. 84.2±5.5%, respectively, p=0.005) and at 24 months (76.9±7.9% vs. 55.8±13.4%, respectively, p=0.025 and 85.2±7.0% vs. 70.2±13.6%, respectively, p=0.005). Conclusion Endovascular procedures including drug-eluting balloon and bailout stenting seem to be effective alternative treatment modalities for treatment of infrainguinal peripheral arterial disease and can be also used in patients with long lesions and/or total occlusion of femoropopliteal arteries.

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EVOLUTION Study: 12-month results

Cited by 3 publications

References 7 publications

Randomized clinical Trial Comparing drug Eluting Stent Zilver PTX® Versus Bare Metal Stent Zilver Flex® for Treatment of Lesions in Femoral and Popliteal Arteries in Chronic Limb Threatening Ischemia

Randomized clinical Trial Comparing drug Eluting Stent Zilver PTX® Versus Bare Metal Stent Zilver Flex® for Treatment of Lesions in Femoral and Popliteal Arteries in Chronic Limb Threatening Ischemia

Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry

Endovascular balloon angioplasty for infrainguinal arterial occlusive disease: Efficacy analysis

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