Drug-Eluting Balloon Continues Strong Showing in SFA Lesions

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A paclitaxel-eluting balloon achieved improvements in clinical endpoints and quality of life measures in patients with short- to intermediate-length lesions of the superficial femoral artery (SFA), according to results from a prospective registry published in the March 2012 issue of JACC: Cardiovascular Interventions.

The results were first reported in November 2011 at the annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, CA.

For the study, researchers led by Antonio Micari, MD, PhD, of Maria Eleonora Hospital (Palermo, Italy), looked at 105 patients with SFA (89.5%) or popliteal (10.5%) lesions (mean length 76.3 ± 38.3 mm) treated at 6 Italian hospitals with the In.Pact Admiral paclitaxel-eluting balloon (Medtronic, Fraunfeld, Switzerland). The In.Pact balloon is coated with a proprietary formulation of paclitaxel and urea, which serves as a hydrophilic spacer to facilitate separation and release of paclitaxel into the vessel wall.

In.Pact Yields Clinical Improvements, Low Stent Rate

The majority of the patients were Rutherford class 2 (26.7%) or 3 (64.8%). The drug-eluting balloon was successfully deployed in 100% of cases, with a technical success rate of 89.6%. Immediate residual stenosis greater than 30% occurred in 10.4% of 114 treated lesions. Ultimately, bailout stenting was required in 12.3% of cases, mostly for persistent flow-limiting dissections.

Primary patency at 6 and 12 months was 87.8% and 83.7%, respectively, with a 1-year secondary patency rate of 90.2%. Clinical safety outcomes were consistently low at 3, 6, and 12 months (table 1).

Table 1. Clinical Safety Outcomes


3 Months
(n = 89)

6 Months
(n = 90)

12 Months
(n = 92)













There was a corresponding shift in Rutherford class, as the proportion of patients in classes 2, 3, and 4 was significantly reduced by 3 months, with 85.6% of patients remaining in Rutherford class 0 or 1 at 12 months (P < 0.001 vs. baseline). Similar improvements were achieved in ankle brachial index (ABI), peak systolic velocity ratio (PSVR), and absolute claudication distance (table 2).

Table 2. Change in Clinical Outcomes from Baseline



12 Months

P Value




< 0.0001




< 0.0001

Claudication Distance, m



< 0.0001

Walking capacity, based on walking impairment questionnaire scores combining several measures (distance, speed, ability to climb stairs, symptoms), improved from a median score of 40.3 at baseline to 86.1 at 12 months.

Health-related quality of life, as reflected on the EuroQoL-5D questionnaire, also improved by 3 months in the areas of mobility, usual activities, pain (P < 0.001 for each), and anxiety/depression (P = 0.002), and were maintained through 12 months.

“[Angioplasty] of femoropopliteal arterial disease using [paclitaxel-eluting balloons] resulted in a high primary patency rate that was sustained through 12 months with a low rate of stenting. Consistent improvement in clinical endpoints, functional status, and associated QOL were observed,” the researchers conclude. “The low rate of TLR over 12 months suggests that the use of [paclitaxel-eluting balloons] offers durable safety and effectiveness in this population.”

‘A Powerful Treatment Alternative’

In an accompanying editorial, Dierk Scheinert, MD, of Park Hospital Leipzig (Leipzig, Germany), praised the study authors “for these outstanding results, which strongly support the concept that [drug-coated balloons] might be a powerful treatment alternative for femoropopliteal disease.”

He added that the bailout stenting rate was “remarkably low” given the mean lesion length and the fact that almost two-thirds had moderate or severe calcification.

Nevertheless, the total experience with drug-eluting balloons in the SFA is less than 200 patients, necessitating randomized trials between the technology and stents to provide clinically meaningful data, Dr. Scheinert says.

Several Randomized Trials, but None vs. Stenting

In an e-mail communication with TCTMD, Bruno Scheller, MD, of the University of Saarland (Homburg, Germany), noted that the findings are supportive of several previous randomized trials evaluating various drug-eluting balloons: THUNDER, FEMPac, LEVANT 1, and PACIFIER.

“The four randomized trials showed consistently a significant angiographic and clinical benefit of [drug-coated balloons] compared to conventional angioplasty in the SFA,” Dr. Scheller said. “The results of this nonrandomized study support these findings.” However, he reiterated Dr. Scheinert’s comments that there have as yet been no randomized comparisons of drug-coated balloons with stents in SFA disease.

In terms of the particular technology used, Dr. Scheller noted that the In.Pact balloon compares well with the “gold standard” Paccocath paclitaxel-eluting balloon (Bayer Schering Pharma, Berlin, Germany) in that “similar amounts of paclitaxel were transferred to the vessel wall in the porcine coronary model. Furthermore, a similar reduction of neointimal formation was seen.” In particular, “the critical factor enabling successful drug transfer is the formulation used to coat the In.Pact balloon,” he said.

Balloon Procedures on the Rise in Europe

Dr. Scheller noted that in Europe, where drug-coated balloons are approved for clinical use, procedures using the technology are steadily increasing. “Coronary [in-stent restenosis lesions] were first treated mainly. Now [there are] almost as many de novo lesions,” he said. “In the peripheral area, SFA and below-the-knee stenosis are the main indications, with lower numbers for renal arteries, dialysis shunts, and intracranial stenosis.”

For the future, both Drs. Scheller and Scheinert agreed that because of the increased likelihood of stent fracture and subsequent in-stent restenosis in femoropopliteal disease, non-stent technologies such as drug-eluting balloons represent an important therapeutic option.

In addition, “the combination of [drug-coated balloons] with spot stenting might be an important concept to explore as a treatment modality for long segment disease,” Dr. Scheinert writes. “Alternatively, other combination therapies like atherectomy followed by [a drug-coated balloon] might be viable options and need further evaluation.”


1. Micari A, Cioppa A, Vadalà G, et al. Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. J Am Coll Cardiol Intv. 2012;5:331-338.

2. Scheinert D. Treatment paradigms for the superficial femoral artery: Are they a-changin? J Am Coll Cardiol Intv. 2012;5:339-340.



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Jason R. Kahn, the former News Editor of TCTMD, worked at CRF for 11 years until his death in 2014…

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  • Dr. Micari reports serving as a consultant for Medtronic.
  • Dr. Scheinert reports serving as a consultant for Abbott Vascular, Boston Scientific, Cook Medical, Cordis, Covidien, Lutonix, Medtronic, Terumo, and W.L. Gore and as a minor shareholder of IDEV Technologies.
  • Dr. Scheller reports being a shareholder of InnoRa GmbH, which performed preclinical and clinical studies with the coating for the In.Pact balloon.