Paclitaxel Stent Next Step in SFA

LAS VEGAS -- Is paclitaxel the answer for stenting of the superficial femoral artery?

SFA stenting has not been an "unbridled success," but investigators are continuing to try, Dr. John R. Laird said at a meeting on vascular interventions sponsored by Medical Media Communications.

Trials of endovascular stenting in the superficial femoral artery have been largely disappointing, , said Dr. Laird, director of peripheral vascular interventions at the Cardiovascular Research Institute in Washington.

The first trial to investigate wall stenting with stenotic or occluded vessels reported that 80% of 109 patients treated had an angiographically patent artery at 6 months, but at 1 year, the trial investigators reported that only 61% of the patients' arteries were still clinically patent, and at 2 years, only 49%. Further investigations showed that the fracture rates of the early stents may be as high as 40%, and generally leads to restenosis.

But results have been improving, and while trials of sirolimus-eluting nitinol stents have not definitively shown an advantage over bare stents yet, they have suggested that better results may still be possible, Dr. Laird said.

The RESILIENT trial has shown that, with advanced-design nitinol stents, a patency rate of 93% could be found at 6 months. Follow-up will continue for 3 years.

The Sirocco II trial suggested that sirolimus-eluting stents appear to at least delay restenosis, compared with bare stents, though the differences were not statistically significant.

Currently, a trial of a paclitaxel-eluting stent known as the Zilver PTX (Cook Inc.), is being conducted at up to 50 centers. The investigators intend to enroll 480 patients.

"Endovascular treatment patterns for SFA occlusive disease tend to vary widely among subspecialists," said Dr. Ron Fairman, chief of the division of vascular surgery, Hospital of the University of Pennsylvania, Philadelphia, when asked to comment on this article.

"In our institution, SFA lesions are managed by primary angioplasty (including subintimal angioplasty) when approached by interventional radiologists and vascular surgeons; whilst primary stenting in conjunction with atherectomy and/or laser-assisted angioplasty is more frequently utilized by the interventional cardiologists" said Dr. Fairman.

"Certainly early results with all these modalities are acceptable, however durability is less predictable. Controlled clinical results from the RESILIENT trial as well as the Zilver PTX stent trial should provide some meaningful guidelines," he concluded.