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

Contribution To Literature:

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


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

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 (DCB) (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 DCB 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

Five-year outcomes: The 5-year survival for DCB vs. PTA was 80.8% vs. 87.7% (p = 0.084, hazard ratio [HR] 1.60, 95% confidence interval [CI] 0.94-2.72). On combining data from LEVANT 1, LEVANT 2, LEVANT 2 continued access, and LEVANT Japan, the 5-year survival was similar between DCB and PTA (HR 1.01, 95% CI 0.68-1.52, p = 0.95).


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 DCB 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 DCB in in-stent restenosis lesions will also be important to assess.

The long-term data are helpful given the recent controversy and concerns about a higher risk of long-term mortality with DCBs. The LEVANT 2 data indicate a numerically higher rate with DCBs at 5 years, but the combined LEVANT program did not suggest a higher risk for DCBs compared with PTA alone. Long-term outcomes from other trials are eagerly awaited as well.


Ouriel K, Adelman MA, Rosenfield K, et al. Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC Cardiovasc Interv 2019;Sep 28:[Epub ahead of print].

Presented by Dr. Kenneth Ouriel at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2019), San Francisco, CA, September 28, 2019.

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;373:145-53.

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, Transcatheter Cardiovascular Therapeutics, TCT19

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