Drug-Coated Balloons vs. Drug-Eluting Stents for Treatment of Long Femoropopliteal Lesions

Zeller, Thomas; Rastan, Aljoscha; Macharzina, Roland; Tepe, Gunnar; Kaspar, Matthias; Chavarría, Jorge; Beschorner, Ulrich; Schwarzwälder, Uwe; Schwarz, Thomas; Noory, Elias

doi:10.1583/13-4630mr.1

Cited by 123 publications

(79 citation statements)

References 35 publications

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“…At 1 year, the primary patency rate was 76.1% and freedom from TLR was 84.4% for the drugcoated balloon. 22 International consensus and guideline documents recommend that femoropopliteal lesions of the kind investigated in the present study be treated primarily with bypass surgery. [4][5][6] However, the endovascular treatment of PAD has the advantage of low morbidity and mortality, early recovery, and the potential for outpatient delivery.…”

Section: Discussionmentioning

confidence: 97%

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: The Viabahn-25 cm Trial

Zeller

Peeters

Bosiers

et al. 2014

Journal of Endovascular Therapy

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Purpose: To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery. Methods: The 25-cm Gore Viabahn Endoprosthesis study (ClinicalTrials.gov identifier NCT01263665) is a prospective, multicenter, single-arm study that enrolled 71 patients (50 men; mean age 66.7 ± 8.34 years) with lifestyle-limiting claudication (Rutherford class 2 to 4) and lesions longer than 20 cm (mean length 26.5 ± 5.31 cm, range 20-40). The majority of lesions (92.9%) were total occlusions. The primary performance outcome was post-deployment stent length within ± 10% of the pre-deployment stent length determined angiographically by quantitative vascular analysis. The primary safety outcome was device- and procedure-related serious adverse events occurring within 30 days of the procedure. The patients underwent follow-up examinations at 1 month and 1 year. Results : The median follow-up was 12.3 months (mean 12.3 ± 0.6). Nine (12.7%) patients discontinued the study due to different reasons including 2 bypass surgeries. Angiography was available in 60 patients to determine the primary performance outcome, which was met in all cases. Two (2.8%) patients experienced a procedure-/device-related adverse event (dissection) during the 30-day follow-up. Kaplan-Meier estimates for 1-year primary and secondary patency were 67.0% [95% confidence interval (CI) 53.5% to 77.3%] and 96.9% (95% CI 88.0% to 99.2%), respectively. Changes in ankle-brachial index and Rutherford category at 1 and 12 months each showed sustained improvement. Conclusion : This study confirms that the 25-cm Viabahn endoprosthesis acutely performs as intended and is safe when used as indicated in complex femoropopliteal lesions. One-year primary and secondary patency rates are satisfying and comparable to historical prosthetic bypass graft outcomes.

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Section: Discussionmentioning

confidence: 97%

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: The Viabahn-25 cm Trial

Zeller

Peeters

Bosiers

et al. 2014

Journal of Endovascular Therapy

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“…Unlike other studies, that study did not count bailout stenting as balloon failure. 38 Similar binary restenosis rates and clinically driven target lesion revascularization between DEB (IN.PACT Adrimal and IN.PACT Pacific, Metronic Vascular, Roncadelle, Italy) and DES (Zilver PTX, Cook Medical) was also demonstrated by Zeller et al, 39 in that both performed similarly in long femorotion into vessel wall. 31 In a prospective multicenter global registry, a total of 479 patients were randomized either to PTA (n=238) or paclitaxel-eluting stent groups (n=236).…”

Section: Drug Elutionmentioning

confidence: 52%

Primary Stenting in Femoropopliteal Occlusive Disease　– What Is the Appropriate Role? –

Yiu¹,

Conte²

2015

Circ J

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“…The analysis of the subgroup DCB + BMS (bailout stenting) vs DES showed a trend toward better clinical outcome in terms of TLR 57. The meta-analysis of DES vs PTA + BMS (611 vs 307 patients) in infrapopliteal arteries resulted in reduced risk for intervention, restenosis, and amputations for the DES therapy, while there were no differences in terms of survival and RU 58.…”

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

confidence: 94%

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 vs. Drug-Eluting Stents for Treatment of Long Femoropopliteal Lesions

Abstract: DCB and DES perform equally well in the endovascular treatment of femoropopliteal lesions ≥10 cm and better than traditional endovascular treatment. In a real world setting of TASC C and D lesions, the provisional stent rate in the DCB cohort is low.

Cited by 123 publications

References 35 publications

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: The Viabahn-25 cm Trial

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: The Viabahn-25 cm Trial

Primary Stenting in Femoropopliteal Occlusive Disease　– What Is the Appropriate Role? –

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

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Drug-Coated Balloons vs. Drug-Eluting Stents for Treatment of Long Femoropopliteal Lesions

Abstract: DCB and DES perform equally well in the endovascular treatment of femoropopliteal lesions ≥10 cm and better than traditional endovascular treatment. In a real world setting of TASC C and D lesions, the provisional stent rate in the DCB cohort is low.

Cited by 123 publications

References 35 publications

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: The Viabahn-25 cm Trial

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: The Viabahn-25 cm Trial

Primary Stenting in Femoropopliteal Occlusive Disease – What Is the Appropriate Role? –

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

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Primary Stenting in Femoropopliteal Occlusive Disease　– What Is the Appropriate Role? –

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