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HOLLYWOOD, Florida – Five-year results of the IN.PACT trials in the U.S. and Europe show that drug-coated balloon angioplasty is superior to plain balloon angioplasty in treating patients with femoropopliteal disease, researchers reported here.

Freedom from clinically driven target vessel revascularization was achieved by 74.5% of the patients who were assigned to receive the IN.PACT Admiral paclitaxel coated balloon after 5 years of follow-up compared with 65.3% of patients who were treated with percutaneous transluminal angioplasty – or plain old balloon angioplasty (POBA), (P=0.0196), said Gary Ansel, MD, of OhioHealth in Columbus.

In his oral "Hot Topics" presentation at the 2019 International Symposium on Endovascular Therapy, Ansel said the results "support drug-coated balloon angioplasty as a first-line strategy for the treatment of femoropopliteal disease."

He described the results as "the first independently adjudicated, blinded randomized trial to demonstrate superior effectiveness of a drug-coated balloon through 5 years."

The 5-year assessment criteria was used to determine the percentage of patients who were diagnosed with clinically driven target vessel revascularization as adjudicated by an independent clinical events committee who were blinded to the assigned treated patients, based on a re-intervention at the target lesion due to symptoms of a drop of ankle brachial index of at least 20% greater than 0.15 when compared with baseline ankle brachial index.

Ansel and colleagues also demonstrated that the use of the balloon device was safe -- i.e., there were no device-related deaths in either arm of the trial. The IN.PACT SFA 1 (conducted in Europe) and the IN.PACT SFA II (conducted in the U.S.) enrolled 331 patients, assigning 220 to treatment with the drug-coated balloon and 111 to percutaneous transluminal angioplasty.

One patient in the drug-coated balloon group had a major target limb amputation due to femoropopliteal disease.

Ansel reported that 70.7% of the patients in the drug-coated balloon groups experienced the primary composite for safety compared with 59.8% of the patients receiving plain balloon angioplasty, but that difference was not statistically significant (P=0.156).

He also discussed outcomes based on the dose of paclitaxel used in the trial, and noted that there was no difference in cumulative dose among patients who died during the trial while on the drug-coated device and those who survived and among those who were lost to follow-up: "We saw no relationship between paclitaxel dose and mortality rate," he said.

The trial was not powered for mortality, he added. To do that, Ansel said, would require thousands of participants and would not be feasible. "We would never get a trial done," he said.

He and his co-authors observed a 2.2% rate of thrombosis in the patients assigned to receive the drug-coated balloons compared with a rate of 4.8% for patients treated with POBA.

"This is a very robust dataset," Ansel said. "And it is a very well-randomized trial with no differences between groups." He noted that most trials of drug-coated balloons in the setting of peripheral artery disease have a maximum follow-up of 3 years. Only the IN.PACT series have been longer, out to 4 or 5 years, he said.

Ansel also pointed out that the trial utilized an independent and blinded core laboratory, an independent clinical events committee, and an independent safety monitoring board.

The patients included in the trial were approximately 68 years; about 66% were men; about 37% were current smokers; and their Rutherford Class was similar – with more than 55% of the patients diagnosed in Rutherford Class 3, and another 38% diagnosed as Rutherford Class 2. The lesion length was about nine centimeters, and calcifications were observed in 59% of the patients, Ansel said.

Fedor Lurie, MD, of the Jobst Vascular Institute in Toledo, Ohio, called the results "convincing."

"They pretty much confirm what we are doing in our practice," he said. "IN.PACT will not change our practice, because we already favor the use of drug-coated balloons in treating these patients. This trial does not compare different types of drug-coated balloons; it just shows that a drug-coated balloon may be better in the long-term than a POBA.

"The science in this study is good," Lurie continued. "But in real practice one still has to determine which treatment is best for an individual patient. Saying that a drug-coated balloon is better than POBA in every patient would be the wrong conclusion."

Lurie, a vascular surgeon, said that in some cases a surgical treatment might also be advised, but it all depends on the condition and desires of the patient.