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

Krankenberg, Hans; Tübler, Thilo; Ingwersen, Maja; Schlüter, Michael; Scheinert, Dierk; Blessing, Erwin; Sixt, Sebastian; Kieback, Arne; Beschorner, Ulrich; Zeller, Thomas

doi:10.1161/circulationaha.115.017364

Cited by 125 publications

(36 citation statements)

References 22 publications

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“…Table 4 summarizes studies and registries containing data about DCB use in ISR lesions (lesion length: 81–137 mm) in the SFA 31–35. The number of diabetic and CLI patients was higher than in the herein-cited studies (up to 100% diabetics in DEBATE ISR35 and 67%–75% CLI in the FAIR34 and the COPA CABANA trials 33. At 12 months, all studies showed promising TLR rates after DCB treatment compared to the respective uncoated control (Figure 5).…”

Section: Dcb Use In Isr Lesions Of the Sfamentioning

confidence: 91%

“…In ISR, recent studies showed superior results for DCBs, with TLR rates for DCB of 9.2% and 30% which were significantly lower than those for appropriate standard PTA, with 47% and 63%, respectively 33,34. Potential alternative endovascular treatment options for ISR, apart from balloon angioplasty (PTA), are brachytherapy, cutting or scoring balloon technique, cryoplasty, and repeated stenting with a nitinol stent, stentgraft, or DES 63.…”

Section: Are Dcbs the Best Treatment Method? For Sfa? For Btk? For Isr?mentioning

confidence: 99%

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Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Herten¹,

Torsello²,

Schönefeld³

et al. 2016

VHRM

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Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans. In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem. The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation. Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis. This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons. A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie, www.clinicaltrials.gov), and 3) abstracts of scientific sessions. Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel –DCB technology. However, calcified lesions seem to affect the efficacy of DCB. Combinations of preconditioning methods with DCBs showed promising results. Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated. Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind. Reinterventions are easier to perform because DCBs leave no metal behind. Various combinations of DCBs with other treatment modalities may prove to be viable options in future. The follow-up results of clinical studies will evaluate the long-term impact of DCBs.

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Section: Dcb Use In Isr Lesions Of the Sfamentioning

confidence: 91%

Section: Are Dcbs the Best Treatment Method? For Sfa? For Btk? For Isr?mentioning

confidence: 99%

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Herten¹,

Torsello²,

Schönefeld³

et al. 2016

VHRM

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“…Drug-coated balloons also prevent restenosis when used prior to bare-metal stent deployment 28 , and offer more durable treatment of instent restenosis of the femoral artery 29 . The evidence supporting drug-eluting stents and drug-coated balloons is much stronger than for covered-self expanding stents, which have uncertain effects on restenosis and stent thrombosis 30 .…”

Section: Endovascular Revascularizationmentioning

confidence: 99%

Management of Critical Limb Ischemia

Kinlay

2016

Circ: Cardiovascular Interventions

122

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Critical limb ischemia (CLI) is a clinical syndrome of ischemic pain at rest or tissue loss, such as non-healing ulcers or gangrene, related to peripheral artery disease. CLI has a high short-term risk of limb loss and cardiovascular events. Non-invasive or invasive angiography help determine the feasibility and approach to arterial revascularization. An “endovascular-first” approach is often advocated based on a lower procedural risk, however, specific patterns of disease may be best treated by open surgical revascularization. Balloon angioplasty and stenting form the backbone of endovascular techniques, with drug-eluting stents and drug-coated balloons offering low rates of repeat revascularization. Combined antegrade and retrograde approaches can increase success in long total occlusions. Below the knee, angiosome-directed angioplasty may lead to greater wound healing, but failing this, any straight line flow into the foot is pursued. Hybrid surgical techniques such as iliac stenting and common femoral endarterectomy are commonly used to reduce operative risk. Lower extremity bypass grafting is most successful with a good quality, long, single-segment autogenous vein of at least 3.5mm diameter. Minor amputations are often required for tissue loss as part of the treatment strategy. Major amputations (at or above the ankle) limit functional independence and their prevention is a key goal of CLI therapy. Medical therapy after revascularization targets risk factors for atherosclerosis and assesses wound healing and new or recurrent flow limiting disease. The ongoing NIH sponsored BEST-CLI study is a randomized trial of the contemporary endovascular versus open surgical techniques in patients with CLI.

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“…In this issue of Circulation, Krankenberg and colleagues 19 report the results of the Femoral Artery In-Stent Restenosis (FAIR) trial. This was an investigator-initiated, prospective, multicenter, randomized study conducted at 5 experienced vascular centers in Germany.…”

Section: Dcba Versus Pta For Sfa Isr 2199mentioning

confidence: 99%

Drug-Coated Balloons as the New Standard of Care for Femoropopliteal In-Stent Restenosis

Laird

Singh

2015

Circulation

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Editorial 2198T he femoropopliteal segment is increasingly treated via an endovascular-first approach for both lifestyle-limiting claudication and critical limb ischemia. Nitinol stents have been shown to be superior to percutaneous transluminal angioplasty (PTA) and have become one of the primary modalities for the treatment of femoropopliteal obstructive atherosclerotic disease because of the improved structural integrity and conformability of newer devices.1-3 Current nitinol stents have low rates of stent fracture and excellent clinical patency out to 3 years.2,4 Despite these advances, femoropopliteal in-stent restenosis (FP-ISR) remains an important clinical problem, occurring in up to 19% to 37% of cases after stenting of moderate-length (up to 150 mm) lesions and more frequently after treatment of longer lesions. 1,2,5 Article see p 2230Tosaka and colleagues 6 have described the angiographic patterns of FP-ISR. Class I FP-ISR consists of focal (<50 mm) ISR within the stent body, stent edge, or a combination of the two. Class II FP-ISR consists of diffuse lesions (>50 mm) within the stent body or stent edge. Class III FP-ISR lesions consist of total occlusion within the stent. They described the outcomes of PTA for the treatment of FP-ISR and found that in-stent occlusion (class III FP-ISR) was a significant predictor of recurrent restenosis (84.8%) and reocclusion (64.6%) at 2 years. Two-year outcomes for patients with focal (class I) and diffuse (class II) ISR were similar, with recurrent restenosis in 49.9% and 53.3% and stent occlusion in 15.9% and 18.9%, respectively. These results highlighted the lack of efficacy of PTA for FP-ISR, particularly for in-stent occlusion. In a follow-up to that study, we evaluated a multimodality approach to the treatment of FP-ISR.7 Seventy-five patients underwent endovascular treatment of FP-ISR using a variety of adjunctive devices, including laser atherectomy, excisional atherectomy, and repeat stenting. Despite the use of these adjunctive therapies in the majority of cases, rates of repeat restenosis at 2 years were 39% for class I ISR, 67% for class II ISR, and 72% for class III ISR. Class III ISR was also associated with a significantly increased rate of recurrent occlusion (hazard ratio, 5.8; 95% CI, 1.8-19.0) compared with other angiographic categories of FP-ISR.Debulking of in-stent intimal hyperplastic tissue is a theoretically attractive approach, and laser atherectomy has been evaluated for the treatment of FP-ISR. 8,9 In the Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis (EXCITE) trial, excimer laser atherectomy (Spectranetics, Colorado Springs, CO) was found to be superior to PTA for the treatment of FP-ISR, but 1-year primary patency rates for both treatment groups were disappointing. 9 Other modalities evaluated for the treatment of FP-ISR include the Viabahn covered stent graft (W.L. Gore, Inc, Flagstaff, AZ), 10,11 and the Zilver PTX drug eluting stent (Cook Medical, Bloomington, IN).12 Each of these the...

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

Cited by 125 publications

References 22 publications

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Management of Critical Limb Ischemia

Drug-Coated Balloons as the New Standard of Care for Femoropopliteal In-Stent Restenosis

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

Cited by 125 publications

References 22 publications

Critical appraisal of paclitaxel balloon angioplasty for femoral&ndash;popliteal arterial disease

Critical appraisal of paclitaxel balloon angioplasty for femoral&ndash;popliteal arterial disease

Management of Critical Limb Ischemia

Drug-Coated Balloons as the New Standard of Care for Femoropopliteal In-Stent Restenosis

Contact Info

Product

Resources

About

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease