Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study

Laird, John R.; Zeller, Thomas; Holden, Andrew; Scheinert, Dierk; Moore, E. Whitney G.; Mendes, Robert; Schmiedel, Rainer; Settlage, Richard A; Lansky, Alexandra J.; Jaff, Michael R.; Elmasri, Fakhir; Robinson, William P.; Beasley, Robert E.; Mego, David M.; Marica, Silviu; Bersin, Robert M.; Kujath, Scott W.; Razavi, Mahmood K.; Teßarek, J.; Schulte, Karl-Ludwig

doi:10.1016/j.jvir.2018.12.031

Cited by 16 publications

(14 citation statements)

References 36 publications

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“…Of the prospective studies, three were pilot/feasibility studies performed in Europe and Oceania 26,28,32 and five were safety/efficacy trials performed in Europe, Oceania, and the United States. 14,25,27,[34][35][36] Of the retrospective studies, all were about the Advanta V12/iCast, three were performed in the United States, 29,33,37 two were in Europe, 30,31 and one was in Oceania. 38 The search identified nine published studies of the Advanta V12/iCast, two of the Viabahn VBX, one of the BeGraft, one of the LifeStream, and one of the JOSTENT.…”

Section: Resultsmentioning

confidence: 99%

“…[22][23][24] A total of 15 publications (14 studies) were ultimately included in this review and underwent data extraction (Table I). 14,[25][26][27][28][29][30][31][32][33][34][35][36][37][38] The complete dataset comprised patients treated in both the prospective trial and retrospective, real-world settings. Clinical trial setting conformed to strict inclusion and exclusion criteria of the protocol.…”

Section: Methodsmentioning

confidence: 99%

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A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

Mwipatayi

Ouriel²,

Anwari

et al. 2020

Journal of Vascular Surgery

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Objective: To evaluate and compare studies reporting the outcomes of the use of covered balloon-expandable (CBE) stents for the treatment of aortoiliac occlusive disease. Methods: A systematic literature search was conducted to identify studies that investigated the use of CBE stents for the treatment of aortoiliac occlusive disease and were published between 2000 and 2019. Baseline demographic data, procedural variables, and long-term outcomes were extracted from publications for analysis. Results: A total of 15 published articles about 14 studies were included in the review. Of these, eight studies were prospective clinical trials and six studies were retrospective real-world studies. The articles included data regarding five different CBE stents, namely, the iCast/Advanta V12, Viabahn VBX, BeGraft, LifeStream, and JOSTENT. Lesion severity was higher in real-world studies, with more TransAtlantic Inter-Society Consensus Classification class D lesions and a higher percentage of occlusions. All studies showed high rates of technical success and patency over the course of 12 months. Long-term data were only available for the iCast/Advanta V12 device, which had a primary patency rate of 74.7% at 5 years. Conclusions: CBE stents are a viable treatment option for patients with complex aortoiliac lesions because of their high rates of technical success and favorable patency across all devices at 12 months. However, long-term data are only available for a single device, the iCast/Advanta V12. The results of using this device were favorable over the course of 5 years.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

Mwipatayi

Ouriel²,

Anwari

et al. 2020

Journal of Vascular Surgery

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“…14 Although they were single-arm studies, more recent analyses confirmed previous reports supporting the utilization of newer covered stents for the treatment of anatomically complex iliac artery disease. 23,24 The "Atrium iCAST Iliac Stent Pivotal Study" (iCARUS), was a multicenter study enrolling 152 subjects with AIOD treated with covered stents at several sites in USA and Germany. 23 The authors reported that covered stents are safe and effective for AIOD, demonstrating 96.4% 9-month primary patency (no revascularization/ bypass/ target limb amputation).…”

Section: Discussionmentioning

confidence: 99%

“…23 Similarly, an analysis from the BOLSTER multicenter study provided satisfactory 9-month clinical outcomes, in terms of target lesion revascularization with newer balloon-expandable covered stents. 24 Additionally, a prospective single arm multicenter study (VBX FLEX study) by Bismuth et al studied 134 patients with 213 iliac lesions undergoing endovascular therapy with balloon expandable covered stents. 5 The study demonstrated exceptional technical success (100%), with only 3 patients experiencing a major adverse event during 9-month follow up.…”

Section: Discussionmentioning

confidence: 99%

Covered Stents for Endovascular Treatment of Aortoiliac Occlusive Disease: A Systematic Review and Meta-Analysis

Mallory

Giannopoulos

Lee

et al. 2021

Vasc Endovascular Surg

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Purpose: The treatment of aortoiliac occlusive disease (AIOD) has largely shifted to endovascular techniques, with primary stenting constituting the preferred treatment approach. The goal of the current study was to summarize available literature and to determine whether covered stents are superior to bare metal stents for the treatment of AIOD, in terms of both periprocedural and long-term outcomes. Methods: A meta-analysis of 47 studies was conducted with the use of random effects modeling. The incidence of adverse events during follow up among the individual included studies was synthesized. Results: Most of the lesions were located at the common iliac arteries and were chronic total occlusions. The procedure was technically successful in almost all cases in both groups, with a low rate of periprocedural complications observed in both groups. The reported primary patency rates for the non-covered and covered stent group during an average follow up of 24.3 months among the individual studies, were 84% and 92% respectively, while surgical or endovascular re-intervention was required in 10% of non-covered stent cases and in 6% of covered stent cases. Eight studies comparing covered vs non-covered stents in terms of patency demonstrated superiority of covered stents (OR: 2.47; 95% CI: 1.01-6.01; p = 0.047 Combining TASC C/D lesions together 12 studies reported 92% (95%CI:89%-95%) primary patency in the covered stent group, while 7 studies reported 75% (95%CI: 60%-88%) primary patency for cases treated with non-covered stents. Conclusion: This study demonstrated that covered stents are safe and effective when utilized for the treatment of AIOD. Covered stents were associated with a statistically significant higher odds of primary patency in both the overall cohort and in more complex TASC C/D lesions. However, additional high-quality comparative analyses between covered vs bare metal stents and between several types of covered stents are needed to determine the most optimal treatment modality for AIOD.

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“…The Lifestream balloon expandable covered stent is the most recently US approved iliac stent. The results of a multicenter single arm trial of 155 patients, balloon expandable vascular covered stent in the treatment of iliac artery occlusive disease (BOLSTER), evaluated the performance of this stainless steel stent encapsulated between two stretched PTFE layers 43 . At 9 months, primary patency was 89.1% and freedom from TLR was 96.1% by Kaplan–Meier estimate.…”

Section: Devicesmentioning

confidence: 99%

SCAI guidelines on device selection in Aorto‐Iliac arterial interventions

Feldman

Armstrong

Aronow

et al. 2020

Cathet Cardio Intervent

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Aorto-iliac (Ao-I) disease is quite prevalent and leads to significant limitation in functional status and quality of life. Advances in endovascular therapy (EVT) techniques in the last 25 years, low risk of periprocedural complications and excellent long-term patency have made it possible to treat most symptomatic patients with Ao-I disease using an endovascular-first rather than a surgical approach in addition to guidelines-directed medical therapy. The approach to intra-procedural assessment of Ao-I lesions has evolved over time to include pressure gradient measurement and intravascular imaging. In 2017, the Society for Cardiovascular Angiography and Interventions (SCAI) published an update to the Appropriate Use Criteria (AUC) for EVT in the Ao-I, femoral-popliteal (FP), infra-popliteal and renal arterial circulations. 1 In 2018, a multi-societal AUC document for EVT was released by the

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Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study

Cited by 16 publications

References 36 publications

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

Covered Stents for Endovascular Treatment of Aortoiliac Occlusive Disease: A Systematic Review and Meta-Analysis

SCAI guidelines on device selection in Aorto‐Iliac arterial interventions

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