Drug-coated balloons versus 1ry stenting for TASC C and D femoropopliteal lesions

Authors

  • Baker Ghoneim Department of Vascular Surgery, Cairo University, Cairo, Egypt
  • Ahmed Shaker Department of Vascular Surgery, Cairo University, Cairo, Egypt
  • Ahmed Karmoota Department of Vascular Surgery, Cairo University, Cairo, Egypt
  • Hany Abdelmola Department of Vascular Surgery, Cairo University, Cairo, Egypt

DOI:

https://doi.org/10.18203/2349-2902.isj20190390

Keywords:

DCB, Femoropopliteal lesions, Nitinol stent, Paclitaxel

Abstract

Background: To compare the effectiveness and outcome of Drug-Coated Balloon (DCB) versus primary nitinol stenting for the treatment of long femoropopliteal lesions (TASC II C and D).

Methods: This was retrospective study along 3 years included all the cases of femeropopliteal disease TASC C and D that was treated with DEB or primary stenting. The safety endpoint was 30-day free from major limb amputation and mortality. The primary end point was primary patency and freedom from clinically driven target lesion revascularization at 6 and 12 months, patient genders, demographics, co-morbidities, smoking history, indications for intervention were recorded.

Results: PTA and post-dilation with paclitaxel-eluting balloons was done in 32 patients (group I) and 1ry stenting was done in 30 patients (group II) with either stenosis or occlusion. The mean lesion length was 18.43±2cm in group 1 and 18.8±2.32cm in group. The technical success rate was 100% in group II and 93.7% in group I. 6 months and 12-month patency rate for group I and II were 93.3% vs. 93.3% and 83.3% vs. 86.6%, respectively. There were no 30 days related major amputations or mortalities in either group.

Conclusions: DCB for long femoropopliteal lesions showed a comparable result to primary stenting and provide durable results and lower incidence of target revascularization in patients with TASC C and D lesions.

References

Surowiec SM, Davies MG, Eberly SW, Rhodes JM, Illig KA, Shortell CK, et al. Percutaneous angioplasty and stenting of the superficial femoral artery. J Vascular Surg. 2005;41(2):269-78.

Smouse HB, Nikanorov A, Laflash D. Biomechanical forces in the femoropopliteal arterial segment. Endovascular Today. 2005;4(6):60-6.

Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, et al. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheterization Cardiovascular Interventions. 2009;74(7):1090-5.

Matsumura JS, Yamanouchi D, Goldstein JA, Pollock CW, Bosiers M, Schultz GA, et al. The United States study for evaluating endovascular treatments of lesions in the superficial femoral artery and proximal popliteal by using the Protégé Everflex nitinol stent system II (Durability II). J Vascular Surg. 2013;58(1):73-83.

Banerjee S, Sarode K, Mohammad A, Gigliotti O, Baig MS, Tsai S, et al. Femoropopliteal artery stent thrombosis: report from the excellence in peripheral artery disease registry. Circulation: Cardiovascular Interventions. 2016;9(2):e002730.

Speck U, Cremers B, Kelsch B, Biedermann M, Clever YP, Schaffner S, et al. Do pharmacokinetics explain persistent restenosis inhibition by a single dose of paclitaxel?. Circulation: Cardiovascular Interventions. 2012:392-400.

Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN. PACT SFA. J Am Coll Cardiol. 2015;66:2329-38.

Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, et al. IN. PACT SFA Trial Investigators: drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN. PACT SFA randomized trial. Circulation. 2015;131(5):495-502.

Schroeder H, Werner M, Meyer DR, Reimer P, Krüger K, Jaff MR, et al. Low-dose paclitaxel-coated versus uncoated percutaneous transluminal balloon angioplasty for femoropopliteal peripheral artery disease: 1-year results of the illumenate European randomized clinical trial. Circulation. 2017:2227.

Jaff MR, White CJ, Hiatt WR, Fowkes GR, Dormandy J, Razavi M, et al. An update on methods for revascularization and expansion of the TASC lesion classification to include below-the-knee arteries: a supplement to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Ann Vascular Dis. 2015;8(4):343-57.

Indolfi CI, Stabile EU, Perrino CI, Chiariello MA. Mechanisms of restenosis after angioplasty and approach to therapy. Inter J Molecular Med. 1998;2(2):143-291.

Axel DI, Kunert W, Göggelmann C, Oberhoff M, Herdeg C, Küttner A, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997;96(2):636-45.

Werner M, Paetzold A, Banning-Eichenseer U, Scheinert S, Piorkowski M, Ulrich M, et al. Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results from the Leipzig SUPERA 500 registry. Euro Intervention: J EuroPCR Collab Working Group Interventional Cardiol Euro Soc Cardiol. 2014;10(7):861-8.

Bosiers M, Peeters P, Tessarek J, Deloose K, Strickler S. The Zilver® PTX® Single Arm Study: 12-month results from the TASC C/D lesion subgroup. J Cardiovascul Surg. 2013;54(1):115-22.

Schmidt A, Piorkowski M, Görner H, Steiner S, Bausback Y, Scheinert S, et al. Drug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registry. JACC: Cardiovascul Interventions. 2016;9(7):715-24.

Schillinger M, Exner M, Mlekusch W, Haumer M, Sabeti S, Ahmadi R, et al. Effect of smoking on restenosis during the 1st year after lower-limb endovascular interventions. Radiol. 2004;231:831-8.

Fanelli F, Cannavale A, Gazzetti M, Lucatelli P, Wlderk A, Cirelli C, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovascul Interventional Radiol. 2014;37(4):898-907.

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Published

2019-01-28

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Original Research Articles