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

Abstract

Purpose

To compare the performance of drug-coated balloons (DCB) and drug-eluting stents (DES) in long femoropopliteal lesions.

Methods

A retrospective dual center study included 228 patients (139 men; median age 69 years) with femoropopliteal lesions ≥10 cm suffering from peripheral artery disease (Rutherford categories 1–5) treated either with DCB or DES. Propensity score stratification was used to minimize bias. The 131 DCB patients (77 men; mean age 68.9±10.5 years) had a mean lesion length of 194.4±86.3 mm (range 100–450), while the 97 DES patients (62 men; mean age 68.2±8.0 years) had lesions averaging 195.0±64.5 mm (range 100–350) in length. Restenotic lesions were treated in 68 (51.9%) DCB patients and 43 (44.3%) DES patients; over half the lesions in both groups were total occlusions [DCB: 69 (52.7%), DES: 61 (62.9%)]. Outcome measures were patency (peak systolic velocity ratio <2.4), clinically driven target lesion revascularization (TLR), event-free survival, and freedom from worsening of Rutherford classification by ≥2 categories.

Results

In the DCB cohort, provisional stent placement was performed in 24 (18.3%) lesions for refractory stenosis (5, 3.8%), flow-limiting dissection (13, 9.9%), and other reasons (6, 4.6%). There was no procedure-related mortality in either cohort. The binary restenosis rates were 23.9% (26/109) and 30.4% (24/79, p=0.319) in the DCB and DES cohorts, respectively, and clinically driven TLR rates were 15.6% (17/109) vs. 19.0% (15/79, p=0.543), respectively. Estimates for freedom from clinically driven TLR and event-free survival were not different between the study cohorts nor were outcomes regarding the ankle-brachial index and Rutherford category.

Conclusion

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.

Keywords

peripheral artery disease restenosis drug-eluting balloon drug-eluting stent drug-coated balloon paclitaxel superficial femoral artery popliteal artery femoropopliteal segment stenosis occlusion provisional stenting

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References

Klinkert

Schepers

Burger

. Vein versus polytetrafluoroethylene in above-knee femoropopliteal bypass grafting: five-year results of a randomized controlled trial. J Vasc Surg. 2003;37:149–155.

Pereira

Albers

Romiti

. Meta-analysis of femoropopliteal bypass grafts for lower extremity arterial insufficiency. J Vasc Surg. 2006;44:510–517.

Norgren

Hiatt

Dormandy

. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5–67.

Abbott

Green

Matsumoto

. Prosthetic above-knee femoropopliteal bypass grafting: results of a multicenter randomized prospective trial. Above-knee Femoropopliteal Study Group. J Vasc Surg. 1997;25:19–28.

Green

Abbott

Matsumoto

. Prosthetic above-knee femoropopliteal bypass grafting: five-year results of a randomized trial. J Vasc Surg. 2000;31:417–425.

Devine

McCollum

. Heparin-bonded Dacron or polytetrafluoroethylene for femoropopliteal bypass: five-year results of a prospective randomized multicenter clinical trial. J Vasc Surg. 2004;40:924–931.

Jensen

Lepäntalo

Fossdal

. Dacron of PTFE for above-knee femoropopliteal bypass. A multicenter randomized study. Eur J Vasc Endovasc Surg. 2007;34:44–49.

Nydahl

Hartshorne

Bell

. Subintimal angioplasty of infrapopliteal occlusions in critically ischaemic limbs. Eur J Vasc Endovasc Surg. 1997;14:212–216.

Laxdal

Jenssen

Pedersen

. Subintimal angioplasty as a treatment of femoro-popliteal artery occlusions. Eur J Vasc Endovasc Surg. 2003;25:578–582.

10.

Schillinger

Sabeti

Loewe

. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–1888.

11.

Laird

Katzen

Scheinert

.; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010;3:267–276.

12.

Bosiers

Torsello

Gissler

. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009;16:261–269.

13.

Bosiers

Deloose

Callaert

. Results of the Protégé EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal lesions. J Vasc Surg. 2011;54:1042–1050.

14.

Rastan

Krankenberg

Baumgartner

. Stent placement versus balloon angioplasty for the treatment of obstructive lesions of the popliteal artery: a prospective, multi-centre, randomized trial. Circulation. 2013;127:2535–2541.

15.

Lammer

Zeller

Hausegger

. Heparin-bonded covered stents versus bare metal stents for symptomatic peripheral arterial disease: the VIASTAR trial. J Am Coll Cardiol. 2013;62:1320–1327.

16.

Dake

Scheinert

Tepe

.; Zilver PTX Single-Arm Study Investigators. Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther. 2011;18:613–623.

17.

Dake

Ansel

Jaff

. On behalf of the Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: 12-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4:495–504.

18.

Dake

Ansel

Jaff

. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: two-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol. 2013;61:2417–2427.

19.

Tepe

Zeller

Albrecht

. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358:689–699.

20.

Werk

Langner

Reinkensmeier

. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008;118:1358–1365.

21.

Werk

Albrecht

Meyer

. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv. 2012;5:831–840.

22.

Scheinert

Duda

Zeller

. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014;7:10–19.

23.

Micari

Cioppa

Vadala

. Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. JACC Cardiovasc Interv. 2012;5:331–338.

24.

Micari

Cioppa

Vadala

. 2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease: evidence from a multicenter registry. JACC Cardiovasc Interv. 2013;6:282–289.

25.

Bosiers

Peeters

Tessarek

. The Zilver PTX Single Arm Study: 12-month results from the TASC C/D lesion subgroup. J Cardiovasc Surg (Torino). 2013;54:115–22.

26.

Joffe

Rosenbaum

. Invited commentary: propensity scores. Am J Epidemiol. 1999;150:327–333.

27.

Cochran

. The effectiveness of adjustment by subclassification in removing bias in observational studies. Biometrics. 1968;24:295–313.

28.

Schmieder

. Endovascular superficial femoral artery treatment: can it be as good as bypass? Sem Vasc Surg. 2008;21:186–194.

29.

Davaine

Azéma

Guyomarch

. One-year clinical outcome after primary stenting for Trans-Atlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions (The STELLA “STEnting Long de L'Artère fémorale superficielle” Cohort). Eur J Vasc Endovasc Surg. 2012;44:432–441.

30.

Krankenberg

Schlüter

Steinkamp

. Nitinol stent implantation vs. percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the Femoral Artery Stenting Trial (FAST). Circulation. 2007;116:285–292.

31.

Duda

Bosiers

, Lammer J, et al., for the SIROCCO study group. Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. J Vasc Interv Radiol. 2005;16:331–338.

32.

Duda

Bosiers

Lammer

. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006;13:701–710.