Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease

Jatin Patel, Mercer University College of Pharmacy

According to The Pharmacological Basis of Therapeutics, taxanes such as Taxol® (paclitaxel) have become central components of regimens for treating metastatic ovarian, breast, lung, gastrointestinal, genitourinary, and head and neck cancers.1 Food and Drug Administration has approved paclitaxel-coated balloon catheter for percutaneous transluminal angioplasty (PTA), after pre-dilatation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.2

A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines suggested that for patients with limb-threatening lower extremity ischemia and an estimated life expectancy of two years or less or in patients in whom an autogenous vein conduit is not available, balloon angioplasty is reasonable to perform when possible as the initial procedure to improve distal blood flow.3 Specifically, according to review article, percutaneous balloon catheters coated with antiproliferative drugs have been developed with the purpose of reducing restenosis after percutaneous intervention in peripheral vessels.4

Title: Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease5
Design Single-blind, prospective, multicenter, randomized study; N=476
Objective To expand on angiographic findings, from a different clinical trial, about late lumen loss was 58% lower among those who underwent angioplasty with the drug-coated balloon than among those who underwent standard percutaneous transluminal angioplasty and the safety results were similar in the two groups
Study Groups Paclitaxel-coated balloon group and a standard angioplasty balloon group
Methods Patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions (diameter of stenosis, ≥70%) were randomly assigned in a 2:1 ratio to undergo percutaneous transluminal angioplasty with the use of either a paclitaxel-coated balloon or a standard angioplasty balloon. Patients received 75 to 325 mg of Ecotrin® (aspirin) and a loading dose of Plavix® (clopidogrel) or Effient® (prasugrel) per day before the procedure. In addition, patients received 75 mg to 100 mg of aspirin per day indefinitely and 75 mg of clopidogrel or 5 to 10 mg of prasugrel per day for at least one month after the procedure. Follow-up clinical evaluations and assessments of quality of life were performed after the procedure and at 30 days, 6 months, and 12 months.
Duration July 2011 to July 2012
Primary Outcome Measure Primary patency of the target lesion at 12 months and a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death, amputation, and reintervention
Baseline Characteristics Drug-coated balloon (n=316) Standard angioplasty (n=160)
Age (years) 67.8±10.0 69.0±9.0
Sex, male (%) 193 (61.1) 107 (66.9)
Race, white (%) 287 (90.8) 136 (85.0)
Diabetes mellitus (%) 137 (43.4) 67 (41.9)
Hypertension (%) 282 (89.2) 140 (87.5)
Hypercholesterolemia (%) 283 (89.6) 138 (86.2)
History of coronary-artery revascularization 132 (41.8) 62 (38.8)
Results Drug-coated balloon, n (%) Standard angioplasty balloon, n (%) Difference, percentage points (95% confidence interval) p-value
Primary patency at 12 months 172 (65.2) 71 (52.6) 12.6 (2.4 to 22.8) 0.02
Safety composite 240 (83.9) 113 (79.0) 4.9 (-2.6 to 12.3) 0.005
Perioperative death 0 0 0
Index-limb amputation 1 (0.3) 0 0.3 (-0.3 to 1)
Index-limb reintervention 44 (15.4) 30 (21) -5.5 (-13.4 to 2.3)
Index-limb-related death 0 0 0
Adverse Events Common Adverse Events: N/A
Serious Adverse Events:
Drug-coated balloon Standard angioplasty balloon
Death (%) 2.4 2.8
Major amputation (%) 0.3 0
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety.

At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty. There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, reintervention, or target-lesion revascularization due to study design, lacking the power to detect a difference in the groups. Therefore, the study does not provide definitive guidance concerning the potential role of this paclitaxel-coated balloon in clinical practice. Although the findings are encouraging, long-term follow-up will be useful in determining whether the benefit of this intervention is sustained, increased, or attenuated over time.


  1. Chabner BA, Bertino J, Cleary J, Ortiz T, Lane A, Supko JG, Ryan D. Chapter 61. Cytotoxic Agents. In: Brunton LL, Chabner BA, Knollmann BC. Goodman & Gilman’s The Pharmacological Basis of Therapeutics, 12e. New York, NY: McGraw-Hill; 2011. Accessed July 18, 2015.
  2. Medtronic IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter. Device Approvals, Denials, and Clearances. Food and Drug Administration Web site. Available at: Accessed July 18, 2015.
  3. 2011 ACCF/AHA Focused Update of the Guideline for the Management of patients with peripheral artery disease (Updating the 2005 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2011;124(18):2020-45.
  4. Cassese S, Byrne RA, Ott I, et al. Paclitaxel-coated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a meta-analysis of randomized trials. Circ Cardiovasc Interv. 2012;5(4):582-9.
  5. Rosenfield K, Jaff MR, White CJ, et al. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. 2015;373(2):145-53.

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