ILLUMENATE: Paclitaxel Balloon in SFA Bests Standard Balloon for Restenosis

Larry Hand

November 09, 2016

WASHINGTON, DC — The Stellarex (Spectranetics) drug-coated balloon (DCB) achieved better angiographic and clinical outcomes than standard balloon angioplasty in a complex clinical trial population with superficial femoral artery (SFA) disease, according to 1-year results presented at TCT 2016[1].

"The ILLUMENATE 12-month pivotal trial met its primary safety and efficacy end points because of the high level of calcium," Dr Sean Lyden (Cleveland Clinic, OH) told heartwire from Medscape. "[Stellarex] continues to show superiority over angioplasty with excellent results, and I think it really reaffirms that this therapy continues to expand how it can treat our patients going forward.

"Drug-coated balloons have shown improved patency over angioplasty in randomized trials for severe calcium, diabetes, and chronic kidney disease, but use in women with small doses [of paclitaxel] remains a problem for current technology," he said during the TCT presentation.

Lyden and colleagues conducted the ILLUMENATE Pivotal Stellarex DCB IDE Study, an investigational-device-exemption trial, involving 300 patients with SFA at 43 US and European sites. They randomized the patients 2:1 to either Stellarex DCB with 2-µg/mm2 paclitaxel or to balloon angioplasty. They plan for 5 years of follow-up.

The primary safety end points were freedom from device- and procedure-related death in 30 days and freedom from target limb major amputation and clinically driven target lesion revascularization (TLR) for 12 months.

The primary efficacy end point was primary patency at 12 months, which they defined as freedom from target lesion restenosis (determined by duplex ultrasound peak system velocity ratio of <2.5) and freedom from clinically driven TLR at 12 months.

Study inclusion criteria included Rutherford class 2 to 4, lesion located in the SFA/popliteal, at least one patent runoff vessel below the knee, and lesion length 3 to 18 cm.

In the Stellarex group, patient mean age was 68.3 years, 93% had hypertension, 88% had hyperlipidemia, and 45% had prior coronary revascularization. In the standard-balloon group, patient mean age was 69.8, 94% had hypertension, 90% had hyperlipidemia, and 48% had prior coronary revascularization.

Males accounted for 56% of patients in the Stellarex group and 64% in the standard-balloon group. About half the patients in each group had diabetes and were current or previous smokers. The mean body-mass index was 39.5 in the Stellarex group and 30 in the balloon-angioplasty group.

At baseline, 43.9% of the Stellarex group and 43% of the standard-balloon group had severe calcification, and 32.5% of the Stellarex group and 30.5% in the balloon-angioplasty group had 0 to one patent runoff vessels.

Device inflation time varied from 3.9 minutes per lesion for Stellarex to 3.7 for standard balloon angioplasty.

For the primary safety end point, 92.1% of Stellarex patients met it compared with 83.2% of PTA patients for a difference of 8.3% (95% CI 0.03, 0.03%–16.57%, P=0.001).

At 12 months, 9.4% of Stellarex patients had major adverse events, compared with 17.7% of control patients, while CV death was 1.2% and 2.1%, respectively. No patients experienced target limb amputation, while 7.9% and 16.8% respectively had clinically driven TLR.

All-cause mortality at 12 months was 2.6% and 2.1% respectively.

Absence of restenosis and freedom from clinically driven TLR occurred in 76.3% of Stellarex patients and 56.6% of standard-therapy patients for a difference of 16.9% (95% CI 5.1%–28.7%, P=0.003).

Primary patency at 12 months came to 82.3% for the Stellarex group and 70.9% for the standard-balloon group. That compares with primary patency rates in previous trials ranging from 73.5% to 89.0%.

"The Stellarex program builds on the prior reports from first-in-human pharmacokinetics in a European clinical trial and the ongoing European global trial," Lyden said. "One thing that was different in this trial was that we had a much higher incidence of severe calcium, at 43%."

"If you look at the global perspective for the clinical trials, this is a more complex subset. Despite having a lower dose, it has similar patency," Dr Sahil Farikh (University Hospitals Cleveland Medical Center, OH) commented during a panel discussion.

"The conclusion criteria were fairly typical for this kind of trial. The follow-up was rigorous. It was a well-done trial," Dr William Gray (New York-Presbyterian Hospital/Columbia University) told heartwire after the presentation. "There was a significant biological effect of the ILLUMENATE drug-coated balloon over balloon angioplasty, both from a restenosis standpoint as well as target lesion revascularization.

"Those differences were significant and that is in a population that has more diabetics, more women, and more calcium. It's a little more complex population than we normally deal with. As you look at these trial data as compared with other trial data, it fits very nicely into one of the most highly performing data sets we have," he said.

Lyden reported that he or his spouse received research support from Cook, Cordis, Gore, Endologix, Bolton, Silkroad, Trivascular, Medtronic, Spectranetics, and Bard and consulting income from Spectranetics, Bionet, Endologix, and TVA Medical.

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