COMPARE Pilot: No difference between two DCBs in 2-year patency

Thomas Zeller

HOLLYWOOD, Fla. — Two-year results from the first 150 patients in the COMPARE Pilot study show similar patency with two drug-coated balloons for the treatment of patients with symptomatic peripheral artery disease.

“The study objective was, for the first time, to compare two different drug-coated balloons with different coatings and different paclitaxel dose densities,” Thomas Zeller, MD, PhD, head of the department of angiology at the University Heart Center Freiburg-Bad Krozingen in Germany, said during a presentation at the International Symposium on Endovascular Therapy.

Kaplan-Meier estimates of primary patency at 710 days were 75% in the Ranger group and 77% in the IN.PACT group, and at 770 days were 66% in a group assigned to treatment with a low-dose paclitaxel-coated balloon (Ranger, Boston Scientific) compared with 60% in a group assigned a standard-dose paclitaxel-coated balloon (IN.PACT Admiral or IN.PACT Pacific, Medtronic; censored log-rank P = .5708), Zeller said here.

“At the end of the window, there was a slight trend toward better primary patency for the Ranger, but this difference was not statistically significant,” he said.

At 2 years, two patients died in the Ranger group and one in the IN.PACT group among the first 150 patients. Four deaths occurred in patients subsequently enrolled, Zeller said, noting that no deaths were attributed to the devices or the procedure.

The full cohort will consist of 414 patients.

The first 150 patients in COMPARE Pilot all had symptomatic PAD and Rutherford class 2 to 4, with > 70% stenosis or total occlusion of the superficial femoral or proximal popliteal artery. For the first 150 patients, the mean age was 69 years in both groups. The Ranger cohort was 60% men and the IN.PACT cohort was 70% men. Only 7% of the Ranger group and 6% of the IN.PACT group had critical limb ischemia (Rutherford class 4).

In the Ranger group, mean target lesion length was 117.4 mm, mean percent diameter stenosis was 82.7% and 39.2% had total occlusion. In the IN.PACT group, mean target lesion length was 122.3 mm, mean percent diameter stenosis was 84.2% and 44.7% had total occlusion. The majority of patients in both groups had moderately severe or severe calcification.

Bailout stents were required in 25.7% of the Ranger group vs. 22.4% of the IN.PACT group (P = .6), Zeller said. Postprocedure percent diameter stenosis was 25.8% in the Ranger group vs. 26% in the IN.PACT group (P = .9).

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“There was excellent efficacy at 2 years for both tested drug-coated balloons,” Zeller said. “We can conclude from this study that the Ranger DCB, with a lower drug dose on top of the balloon surface, did perform comparably to the established IN.PACT DCB.”

Cardiology Today’s Intervention previously reported similar patency with the Ranger and IN.PACT DCBs at 1 year.

The Ranger DCB is not yet approved for use in the United States. – by Erik Swain

Reference:

Zeller T, et al. Hot topics and late-breaking trials. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 27-30, 2019; Hollywood, Fla.

Disclosures: The study was investigator-initiated and funded through a research grant from Boston Scientific. Zeller reports he has financial ties with Abbott Vascular, Biotronik, Boston Scientific, Cook Medical, Medtronic, Philips/Spectranetics, QT Medical, Shockwave Medical, Terumo, TriReme, Veryan and W.L. Gore and Associates.