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 135 publications

(57 citation statements)

References 22 publications

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“…3,4 Many factors contribute to limitations on outcomes in the FP segment, including the complex mechanical forces placed on these vessels (e.g., compression, flexion, torsion), combined with the need for longer stents to cover lesions, leading to high rates of FP in-stent restenosis (FP-ISR). [5][6][7] The incidence of FP-ISR varies by stent type, but is between 19% and 37% at 12 months, 50% at 24 months, and 60% at 36 months. 4,5,8 Among current treatment options for FP-ISR, balloon angioplasty (BA) alone has yielded poor results, with under 50% primary patency 6 months following revascularization.…”

Section: Introductionmentioning

confidence: 99%

Laser atherectomy and drug‐coated balloons for the treatment of femoropopliteal in‐stent restenosis: 2‐Year outcomes

Kokkinidis

Behan

Jawaid

et al. 2019

Cathet Cardio Intervent

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Background Femoropopliteal (FP) artery is one of the most anatomically challenging areas for sustained stent patency. The incidence of FP in‐stent restenosis (ISR) is estimated at 50% at 24 months. Prior studies have shown that lesion debulking with laser atherectomy (LA) combined with drug coated balloon (DCB) have superior outcomes compared to LA + balloon angioplasty (BA) ISR, but there have not been studies evaluating 2‐year outcomes. Methods This was a dual‐center retrospective cohort study that compared patients with FP‐ISR treated with LA + DCB versus LA + BA. Cox regression analysis was used to examine 2‐year outcomes of target lesion revascularization (TLR) and the composite outcome of TLR or restenosis. Multivariable analysis was performed for clinical and statistically significant (in the univariate analysis) variables. Results One hundred and seventeen consecutive patients with Tosaka II (n = 32) and III (n = 85) ISR were analyzed. Sixty‐six patients were treated with LA + DCB and 51 with LA + BA. The LA + DCB group had more lesions with moderate to severe calcification (58% vs. 13%; p < .0001). The LA + DCB group was more likely to be treated with the use of embolic protection devices (64% vs. 23%, p < .001) and cutting balloons (61% vs. 6%, p < .001). Bail‐out stenting rates were lower in the LA + DCB group (32% vs. 57%, p = .008). LA + DCB was superior (HR: 0.57; 95% CI: 0.34–0.9, p = .027) for the composite outcome of 2‐year TLR or restenosis. The 12‐month KM estimates for freedom from TLR or restenosis were 66% in the LA + DCB group versus 46% in the LA + BA group. The 24‐month KM estimates were 45% in the LA + DCB group versus 24% in the LA + BA group. Conclusions The combination of DCB + LA was associated with decreased rates of bail‐out stenting and improved 2‐year TLR or restenosis rates. Randomized clinical trials examining the DCB + LA combination for FP‐ISR are needed.

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Section: Introductionmentioning

confidence: 99%

Laser atherectomy and drug‐coated balloons for the treatment of femoropopliteal in‐stent restenosis: 2‐Year outcomes

Kokkinidis

Behan

Jawaid

et al. 2019

Cathet Cardio Intervent

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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%

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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“…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

136

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

Cited by 135 publications

References 22 publications

Laser atherectomy and drug‐coated balloons for the treatment of femoropopliteal in‐stent restenosis: 2‐Year outcomes

Laser atherectomy and drug‐coated balloons for the treatment of femoropopliteal in‐stent restenosis: 2‐Year outcomes

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

Management of Critical Limb Ischemia

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

Cited by 135 publications

References 22 publications

Laser atherectomy and drug‐coated balloons for the treatment of femoropopliteal in‐stent restenosis: 2‐Year outcomes

Laser atherectomy and drug‐coated balloons for the treatment of femoropopliteal in‐stent restenosis: 2‐Year outcomes

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

Management of Critical Limb Ischemia

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