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WASHINGTON -- A novel paclitaxel-coated balloon kept diseased peripheral arteries open better than conventional balloon angioplasty alone for a complex patient population in the ILLUMENATE pivotal trial.

Safety, in terms of freedom from 30-day device- and procedure-related death and from target-limb major amputation and clinically-driven target lesion revascularization through 12 months, met both noninferiority and superiority for the Stellarex balloon compared with angioplasty with a noncoated balloon (92.1% versus 83.2%, P=0.0013 for non-inferiority and 0.0246 for superiority).

The balloon, which delivers low-dose paclitaxel (2 mcg/mm²), also was at least as good as its comparator for the primary efficacy endpoint of freedom from duplex-detected restenosis and from clinically-driven target lesion revascularization through 12 months (76.3% versus 57.6%, P=0.003 for noninferiority).

While , of the Cleveland Clinic, reported here at the Transcatheter Cardiovascular Therapeutics meeting that the trial also showed superiority for the efficacy endpoint against standard angioplasty, he did not present any P-values in that regard.

A representative for device maker Spectranetics provided this statement: "Superiority of the drug-coated balloon group over the percutaneous transluminal angioplasty group for primary effectiveness was met with the lower bound of the confidence interval >0% and the 1-sided P-value from the multiple imputation analysis <0.025."

Although the trial endpoints were defined for analysis at 12 months, the statistics reported were actually calculated on follow-up through day 410.

The open-label trial included 300 patients in the U.S. and Europe with Rutherford class 2, 3, or 4 arterial disease in the superficial femoral arteries, popliteal arteries , or both, who were randomized to the Stellarex drug-coated balloon or EverCross percutaneous transluminal angioplasty.

Lyden pointed to the patient population as "one of the most complex patient groups studied in drug-coated balloon investigational device exemption trials," with severe calcification in 43.9%, diabetes in 49.5%, and one or no patent runoff vessels in 32.5%.

The trial "really shows a biologic effect. It looks like it's going to be roughly keeping in terms of the efficacy outcomes with the other drug-coated balloons on the market today, at least in the U.S.," , of Lankenau Heart Institute in Wynnewood, Pa., commented as a discussant at a press conference.

Although Stellarex would be "a third in three-horse race" if approved, Gray suggested the additional option would be useful even if just because "competition leads to greater price sensitivity at the hospital level. That's not insignificant, actually. And as time goes on and we see more data from global registries and so on, maybe we will parse whether some of the balloons are more effective."

He and fellow panel member , of Wellmont CVA Heart Institute in Kingsport, Tenn., said they were struck by even how well the control arm did.

"This was the best we've ever seen angioplasty do and probably twice as good as what we expected them to do 5 or 10 years ago," Metzger said.

One factor might be longer ballooning times, Lyden said. "We're much more patient to accept a non-ballooning dissection than we were 5 years, 10 years ago when our reaction was to just stent everybody. And I think that's reflected in our own learning curves."

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