Paclitaxel-Eluting Balloon Shows Positive Results in Peripheral Disease

PARIS, France—A drug-eluting balloon showed consistent clinical improvements over 12 months and reduced the need for provisional stenting in patients with femoropopliteal artery disease and moderate to severe claudication, according to late-breaking results presented Tuesday, May 17 at EuroPCR 2011.

Researchers led by Antonio Micari, MD, of Villa Maria Eleonora Hospital (Palermo, Italy), investigated the IN.PACT Admiral drug-eluting balloon (Medtronic/Invatec, Roncadelle,

Italy) in 105 patients with de novo femoropopliteal atherosclerotic lesions. The balloon features a hydrophilic coating that separates paclitaxel molecules and facilitates absorption into the vessel wall.

Patients in the 6-site, Italian registry study had Rutherford class 2 (26.7%), 3 (64.8%), and 4 (7.6%) disease, corresponding to moderate claudication, severe claudication, and rest pain. Over half of the 114 lesions had moderate (50%) or severe (16.7%) calcification, and there were 34 (29.8%) total occlusions. The vast majority of lesions were located in the proximal (12.3%), mid (48.2%), or distal (28.9%) superficial femoral artery (SFA).

Predilatation was performed with a conventional, undersized balloon. Inflow and outflow were reestablished in 100% of cases, with 100% device success and 89.6% technical success. Stenting was necessary in only 12.3% of cases for flow limiting dissections or persistent residual stenosis greater than 50%. Postprocedure residual percent diameter stenosis was 12.2 ± 9.5%.

Improved Patency, Quality of Life

At 12 months (n = 92), no patients required amputation. The mortality and TLR rates were 2.2% and 8.7%, respectively, with a primary patency rate of 83.7% (defined as 12-month survival from TLR, occlusion, and restenosis greater than 50%).

By 6 months, 95% of patients had registered improvement in Rutherford class. By 12 months, the cohort had experienced a significant decrease in Rutherford class (P < 0.001 vs. baseline), with the majority showing class 0 (68%), class 1 (18%), class 2 (14%), and class 3 (1%) disease.

Other measures that improved included ankle brachial index (ABI), peak systolic velocity ratio (PSVR), and absolute claudication-free walking distance (ACD; table 1).

Table 1. Twelve-Month Outcomes

On a questionnaire assessing quality of life measures, patients reported substantial drops in problems with mobility (62% to 11%), self care (10% to 2%), usual activities (44% to 6%), pain/discomfort (87% to 10%), and anxiety/depression (40% to 19%) by 12 months.

“Clinical benefit is consistently shown across multiple endpoints including walking capacity and quality of life,” Dr. Micari concluded.

In response to a panelist question, Dr. Micari explained that for dual antiplatelet therapy, he uses a 3-month regimen for drug-eluting balloon cases, and 6 months for those that require stenting.

But this is not based on any guidance from the literature. “This is a very critical issue,” he said. “We don’t have any data saying which is the correct time for dual antiplatelet therapy for superficial femoral artery stenting in general, so this is something we do based on our experience or based on what we believe is the right time.”

Fear of Stenting

Panelist Dierk Scheinert, MD, of the University of Leipzig (Leipzig, Germany), commented to Dr. Micari on the high level of calcification present in the lesions, “which is theoretically not the best target for balloon based treatment, [and] at the same time you had a very low stent rate. Would you say it’s a practical way to stay away from stenting with regard to these complicated lesions?”

In response, Dr. Micari noted that, based on his experience, “when I see a very calcified SFA, I’m really afraid to stent it because the number of reocclusions and fractures is so high. So if we use a drug-eluting balloon and post-dilatation, if we get an angiographic result that maybe is not optimal for your vessel, maybe it is optimal for your patient.”

 

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Source:
Micari A. Drug eluting balloon for the treatment of femoro-popliteal arterial disease. Mid-term results from a multicenter Italian registry. Presented at: EuroPCR; May 17, 2011; Paris, France.

 

Disclosures:

• Dr. Micari reports no relevant conflicts of interest.

 

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