Drug-Eluting Balloon Provides Strong Primary Patency in SFA at 1 Year

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Patients with superficial femoral artery (SFA) disease are far more likely to retain primary patency at 1 year when treated with a drug-eluting balloon (DEB) rather than conventional balloon angioplasty, according to data from the IN.PACT SFA trial presented at the Charing Cross International Symposium in London, United Kingdom, on April 5, 2014.

For the study, Gunnar Tepe, MD, of RoMed Klinikum Rosenheim (Rosenheim, Germany), and colleagues enrolled 331 patients with claudication or rest pain due to superficial femoral lesions (6.8% with proximal popliteal artery involvement). Patients were randomized in a 2:1 ratio to treatment with the IN.PACT Admiral paclitaxel-eluting balloon (Medtronic; Minneapolis, MN; n = 220) or angioplasty (n = 111). Patients were enrolled in 2 phases:

  • 150 subjects at 13 European centers from September 2010 to April 2011
  • 181 subjects at 44 US sites from April 2012 to January 2013

Primary Patency Markedly Better with DEB

Device success and procedural success (residual diameter stenosis ≤ 50% in non-stented patients and ≤ 30% in stented patients) were very high at more than 98% and similar between the therapies.

In intention-to-treat analysis, at 12 months the DEB group bested the angioplasty group in terms of primary patency (primary outcome), clinically driven TLR, primary sustained clinical improvement (upgrade in Rutherford classification ≥ 1 class in amputation- and TVR-free surviving patients), primary safety endpoint (freedom from 30-day device- and procedure-related death and  from target limb major amputation and clinically driven TVR through 12 months), and MACE (death, clinically driven TVR, target limb major amputation, and thrombosis; table 1).

Table 1. One-Year Outcomesa


(n = 220)

(n = 111)

Primary Patency



Clinically Driven TLR



Primary Sustained Clinical Improvement



Primary Safety Endpoint






aP < 0.001 for all.

Per protocol analysis excluding patients who underwent stenting showed similar outcomes.

“The results of this rigorously conducted randomized controlled trial warrant a review of current treatment guidelines for peripheral artery disease in the lower extremities,” Dr. Tepe said in a Medtronic press release. “In fact, they should lead to a reconsideration of how we treat patients with claudication, as the highest level of clinical evidence now distinguishes the IN.PACT Admiral drug-coated balloon as a primary therapy for atherosclerosis in the SFA.”

Setting a Standard

“These numbers, coming out of the box, are extremely encouraging and in fact better than anticipated,” Michael D. Dake, MD, of Stanford University School of Medicine (Stanford, CA), an IN.PACT SFA trial investigator, told TCTMD in a telephone interview. “Certainly right now they set a standard.

“But they’re still at 1 year,” he continued. “Now the burden is… to see if in follow-up going out to 2 and 3 years they follow the curve that we would like them to follow.”

In an email to TCTMD, Bruno Scheller, MD, of the University of Saarland (Homburg, Germany), indicated he too was impressed with the data. “To my knowledge, this represents indeed the highest 1-year patency and lowest TLR rates ever reported in the SFA, especially for lesions of almost 9 cm on average,” he wrote. “It will be interesting to see the 1-year data of LEVANT 2, especially if [that] balloon will have a similar effect on clinical outcomes. If not, this will be [additional]proof that there is no class effect for [DEBs].”

LEVANT 2 is comparing the Moxy DEB (CR Bard; Murray Hill, NJ) with standard balloon angioplasty in more than 450 patients.

Dr. Scheller noted that 5-year follow-up is planned in the current trial. Encouragingly, he noted, 5-year data from the THUNDER trial showing superior efficacy of the Cotavance balloon with Paccocath technology (Medrad/Bayer HealthCare; Warrendale, PA) over conventional balloon angioplasty showed no late catch-up for the DEB.

Lesion Preparation Key to Low Stenting Rate

Dr. Dake said that “if you had to pick” at the current study, it could be argued that the authors should have considered bailout stenting as balloon failure. “I don’t think that’s necessarily valid,” he added, “because this is kind of real-world standard of practice.”

Dr. Scheller observed that “the low stent rate is explained by the careful lesion preparation in both groups, [with] long dilatation with the study balloon, and a high rate of postdilatation.” Nonetheless, he added, other trials have shown “excellent outcomes when combining stents and [DEBs] in the SFA.”

Another possible quibble with regard to the comparative efficacy of the DEB, Dr. Dake noted, is that in contrast with the current study, the randomized trial of the Zilver PTX DES (Cook Medical; Bloomington, IN) vs standard angioplasty used a more conservative criterion for patency (a peak systolic velocity ratio < 2, whereas IN.PACT SFA set the bar at 2.4). Even so, he added, if the Zilver results were recalculated using the current stricter standard, the DES primary patency rate would increase by only about 4%.

 Most experts believe that there are differences within the DEB class, Dr. Dake observed, and “now it’s up to everyone else to show that they can measure up to what is now de facto the best in class.”

“This is a great opening chapter,” Dr. Dake continued. “Now we have to try and understand where [the IN.PACT balloon] is not necessarily appropriate. In heavily calcified lesions, what do we do there? If we get a true flow-limiting dissection, what is the best treatment for that?” In addition, he said, researchers will be exploring whether the same careful lesion preparation used in this trial, applied to other technologies, might also yield better results.

As to limitations with lesion length, Dr. Scheller noted that the IN.PACT balloon not only performed well in the relatively long lesions (9 cm on average) in the current trial but also showed efficacy in long (20 cm), high-risk lesions in the Leipzig registry data, presented at the Charing Cross symposium as well.

“The IN.PACT SFA study is a landmark trial with the highest level of clinical evidence aiming for [US Food and Drug Administration] approval,” Dr. Scheller concluded.

Study Details

Treatment groups were well matched for baseline clinical characteristics. All patients were in Rutherford class 2-4. More DEB patients than PTA patients underwent predilatation (96.4% vs 85.6%; P < 0.001), and there was a trend toward more postdilatation in the DEB group (26.8% vs 18.9%; P = 0.135).

Primary patency was defined as freedom from clinically driven TLR and restenosis as determined by duplex ultrasound peak systolic velocity ratio ≤ 2.4. Clinically driven TLR was defined as any reintervention at the target lesion due to symptoms or drop of ankle-brachial index/toe-brachial index ratio of > 20% or > 0.15 compared to postprocedure.


Tepe G. IN.PACT SFA: randomized trial of IN.PACT Admiral DCB vs. PTA for the treatment of atherosclerotic lesions in the SFA and/or PPA. Presented at: Charing Cross International Symposium. April 5, 2014. London, United Kingdom.



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Drug-Eluting Balloon Provides Strong Primary Patency in SFA at 1 Year

Patients with superficial femoral artery (SFA) disease are far more likely to retain primary patency at 1 year when treated with a drug-eluting balloon (DEB) rather than conventional balloon angioplasty
  • Dr. Tepe reports serving as a consultant to Medtronic.
  • Dr. Dake reports serving as an investigator for the IN.PACT SFA trial and a consultant to Medtronic.
  • Dr. Scheller reports having research contracts with AngioScore, B. Braun, and MDT; holding stock in InnoRa GmbH; and being named as co-inventor on several patent applications.