Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis 2 | Clinical Trial - LEVANT 2


The goal of this trial was to assess safety and efficacy of a paclitaxel-coated balloon compared with routine percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal peripheral artery disease (PAD).

Contribution to the Literature: The LEVANT 2 trial shows that PTA with a paclitaxel-based DEB is superior to PTA with a regular balloon for primary patency in patients with short to moderately long femoropopliteal arterial lesions.

Study Design

Patients with short to moderately long superficial femoral artery (SFA) and/or popliteal arterial stenoses were randomized in a 2:1 fashion to balloon angioplasty with a drug-coated balloon (DEB) (n = 316) or standard balloon (n= 160).

  • Total number of enrollees: 476
  • Duration of follow-up: 12 months
  • Mean patient age: 68.2 years
  • Percentage female: 37%
  • Percentage diabetics: 43%
  • Current smokers: 35%,
  • Previous coronary artery revascularization: 41%, previous stroke: 11%, prior target limb revascularization: 21%
  • Rutherford class 2 (moderate claudication): 31%
  • Target limb ankle-brachial index: 0.74
  • Mean lesion length: 62.8 mm, mean treated length: 107.9 mm
  • Total occlusions: 21%

Inclusion criteria:

  • Rutherford class 2-4 symptoms
  • Lesion in SFA and/or popliteal arteries
  • Stenosis ≥70%
  • Total treated lesion length <150 mm
  • Target vessel diameter 4-6 mm
  • Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the tibioperoneal trunk
  • Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion
  • Patent inflow and outflow (to the ankle, ≥1) vessel
  • No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment

Exclusion criteria:

  • Hemorrhagic stroke within 3 months
  • Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure
  • History of myocardial infarction, thrombolysis, or angina within 2 weeks of enrollment
  • Prior vascular surgery of the index limb
  • Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure
  • Ipsilateral retrograde access
  • Severe calcification that renders the lesion un-dilatable;
  • Use of adjunctive treatment modalities (i.e., laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.)
  • Flow-limiting dissection after initial ballooning with standard balloon (1 mm smaller than reference vessel diameter)
  • Need for stent placement

Principal Findings:

  • Primary efficacy endpoint: Primary patency at 12 months for DEB vs. standard balloon: 65.2% vs. 52.6%, p = 0.02

  • Primary safety endpoint: Composite of freedom from perioperative death within 30 days, freedom from index-limb amputation, reintervention, or limb-related death at 12 months

  • Other endpoints: Total target lesion revascularization: 12.3% vs. 16.8%, p = 0.21; target vessel revascularization: 13.3% vs. 18.2%, p = 0.19; major amputation: 0.3% vs. 0%, p = 0.37; reintervention for thrombosis: 0.4% vs. 0.7%, p = 0.62


The results of this trial indicate that PTA with a paclitaxel-coated balloon is superior to PTA with standard angioplasty alone in short to moderately long lesions in the SFA and/or popliteal arteries. Although the primary patency rates improved significantly with DEB PTA, the rate of failure at 12 months remains woefully high (more than one third).

Direct comparison with drug-eluting stents is awaited; in the ZILVER-PTX trial with paclitaxel-eluting stents (PES), the rate of primary patency with PES was 83.1% at 1 year (mean lesion length 65 mm). Cost-effectiveness analyses are also awaited. The efficacy of DEB in in-stent restenosis lesions will also be important to assess.


Rosenfield K, Jaff MR, White CJ, et al., on behalf of the LEVANT 2 Investigators. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med 2015;Jun 24:[Epub ahead of print].

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Interventions and Vascular Medicine

Keywords: Angioplasty, Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Ankle Brachial Index, Constriction, Pathologic, Coronary Vessels, Drug-Eluting Stents, Femoral Artery, Paclitaxel, Peripheral Arterial Disease, Popliteal Artery, Stents, Stroke, Thrombosis

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