Paclitaxel-Eluting Balloon vs. Standard Angioplasty to Reduce Recurrent Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: The DEBATE-ISR Study

Liïstro, Francesco; Angioli, Paolo; Porto, Italo; Ricci, Lucia; Ducci, Kenneth; Grotti, Simone; Falsini, Giovanni; Ventoruzzo, Giorgio; Turini, Filippo; Bellandi, Guido; Bolognese, Leonardo

doi:10.1583/13-4420r.1

Cited by 118 publications

(90 citation statements)

References 22 publications

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“…The majority of previously assessed data on SFA ISR treatment have not been convincing. Results have been derived from single-arm observations (DCBA 12,13 ), historical comparisons (DCBA versus POBA 14 ), subgroup analyses (drug-eluting stent 18 ), studies on specific lesions (chronic total occluded ISR 19 ), and initial experiments (cutting balloon versus POBA 17 ). In some cases, high rates of bailout stenting (10% 13 and 15.9% 14 ) or additional laser mediated debulking (10% 13 ) weaken the significance of the findings.…”

Section: Discussionmentioning

confidence: 99%

“…In a small, prospective registry of DCBA for SFA ISR, 12,13 recurrent restenosis rates were 7.9% (4 of 39) and 29.7% (11 of 37) at 12 and 24 months, respectively. For diabetic patients, Liistro et al 14 reported significantly lower recurrent ISR rates at 12 months after DCBA compared with a historical POBA group (19.5% [8 of 41] …”

Section: Editorial See P 2198 Clinical Perspective On P 2236mentioning

confidence: 99%

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Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis

et al. 2015

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Background-Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain. Methods and Results-One hundred nineteen patients with superficial femoral artery in-stent restenosis and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n=62) or POBA (n=57

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Section: Discussionmentioning

confidence: 99%

Section: Editorial See P 2198 Clinical Perspective On P 2236mentioning

confidence: 99%

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis

et al. 2015

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“…94 Long-term stent implantation triggers smooth muscle cell migration and 95 Hence, there is still an unmet demand for development of novel materials to antagonize in-stent restenosis and thrombosis. [95][96][97][98] Thus, the nanocomposites which hold a great potential to improve stent hemocompatibility can be considered as a putative candidate for developing cardiovascular stents.…”

Section: Nanocomposites To Improve Hemocompatibility Of Stentmentioning

confidence: 99%

Multifaceted prospects of nanocomposites for cardiovascular grafts and stents

Vellayappan¹,

Balaji²,

Subramanian³

et al. 2015

IJN

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Cardiovascular disease is the leading cause of death across the globe. The use of synthetic materials is indispensable in the treatment of cardiovascular disease. Major drawbacks related to the use of biomaterials are their mechanical properties and biocompatibility, and these have to be circumvented before promoting the material to the market or clinical setting. Revolutionary advancements in nanotechnology have introduced a novel class of materials called nanocomposites which have superior properties for biomedical applications. Recently, there has been a widespread recognition of the nanocomposites utilizing polyhedral oligomeric silsesquioxane, bacterial cellulose, silk fibroin, iron oxide magnetic nanoparticles, and carbon nanotubes in cardiovascular grafts and stents. The unique characteristics of these nanocomposites have led to the development of a wide range of nanostructured copolymers with appreciably enhanced properties, such as improved mechanical, chemical, and physical characteristics suitable for cardiovascular implants. The incorporation of advanced nanocomposite materials in cardiovascular grafts and stents improves hemocompatibility, enhances antithrombogenicity, improves mechanical and surface properties, and decreases the microbial response to the cardiovascular implants. A thorough attempt is made to summarize the various applications of nanocomposites for cardiovascular graft and stent applications. This review will highlight the recent advances in nanocomposites and also address the need of future research in promoting nanocomposites as plausible candidates in a campaign against cardiovascular disease.

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“…The DEBATE-ISR (Drug Eluting Balloon in Peripheral Intervention for In-Stent Restenosis) RCT utilized DCB in 44 and PTA in 42 patients, with similar lesion lengths (175±90 mm vs. 160±82 mm; p= 0.4), percentage of CLI patients (75 % vs. 67 %; p=0.8), and provisional stent use (16 % vs. 26 %; p=0.2), respectively [30]. Of note, the disease severity was markedly higher in this study compared with aforementioned de novo RCT examining DCB.…”

Section: Drug-coated Balloonsmentioning

confidence: 99%

Drug-Coated Balloon and Stent Therapies for Endovascular Treatment of Atherosclerotic Superficial Femoral Artery Disease

et al. 2015

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Endovascular management of superficial femoral artery disease has historically been limited to percutaneous balloon angioplasty, atherectomy, and bare-metal stents. However, these therapies have been plagued by high restenosis and target lesion revascularization rates. More recent technologies such as drug-coated stents and balloons are designed to combat restenosis by locally delivering antiproliferative drugs. Several randomized controlled trials have directly compared these antiproliferative drug-delivering devices to their non-drug-coated counterparts. Additionally, trials are currently ongoing to compare use of drug-coated technologies in combination with traditional therapies in hope of synergistic effects. This review gathers data from currently published clinical trials, provides an overview of upcoming clinical studies utilizing drug-coated technology, and explores the possible impact these devices may have on clinical practice.

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Paclitaxel-Eluting Balloon vs. Standard Angioplasty to Reduce Recurrent Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: The DEBATE-ISR Study

Abstract: Using DEB for treating femoropopliteal ISR led to a significant reduction in recurrent restenosis and repeat angioplasty at 1-year follow-up as compared to historical controls.

Cited by 118 publications

References 22 publications

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis

Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis

Multifaceted prospects of nanocomposites for cardiovascular grafts and stents

Drug-Coated Balloon and Stent Therapies for Endovascular Treatment of Atherosclerotic Superficial Femoral Artery Disease

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