Study results evaluating stenting of the superficial femoral artery (SFA) have been conflicting, with stent fractures playing a major role in patency loss. However, newer nitinol stents show more promise than previous-generation stents because of their flexibility and durability.
“Over the last 10 years, treatment approaches for peripheral arterial disease have evolved tremendously, starting with a push to use percutaneous balloon angioplasty. However, that seems to have been supplanted by an interest in stenting,” says Srinivas Iyengar, MD, an interventional cardiologist at the Bradenton Cardiology Center in Bradenton, Fla., and principal investigator of the OSPREY trial, which is investigating the Misago self-expanding nitinol stent (Terumo Medical) for the SFA.
In 2006, Shillinger et al published a study evaluating 104 patients who received either a self-expanding nitinol stent (Dynalink or Absolute, Abbott Vascular) or percutaneous transluminal angioplasty (PTA) (N Engl J Med 2006; 354:1879-1888). They concluded that their low fracture rate of 2 percent is “consistent with the hypothesis that differences in stent design may substantially influence the likelihood of fractures.”
The recent RESILIENT trial showed that stenting may trump PTA in the SFA, at least for medium-length lesions (Circ Cardiovasc Interv 2010;3:267-276). The trend toward stenting the SFA may be shifting the focus from other repair approaches, such as laser atherectomy, remote endarterectomy or PTA. While RESILIENT and other studies, like the Zilver PTX trial, have shown good patency rates with SFA stenting, Iyengar urges restraint in wholesale adoption of stenting over other techniques, due to the fact that stents often fracture or restenose.
Based on the RESILIENT trial, however, the FDA approved the LifeStent (Bard), a self-expanding nitinol stent, for medium-sized SFA lesions. (The median lesion length in the stenting arm was 71 mm.) Two other self-expanding stents are FDA-approved for the SFA: Viabahn (W. L. Gore) and IntraCoil (ev3). Yet, other stents are used off-label in the U.S. for the SFA, and the European Union has several more stents approved for this purpose.
The FDA has been hesitant to approve SFA stents because of their tendency to fracture and their high restenosis rates. In RESILIENT, John Laird, MD, medical director of the University of California Davis Vascular Center in Sacramento, Calif., and colleagues randomized 206 patients with obstructive lesions (up to 15 cm) in the SFA and/or proximal popliteal artery and intermittent claudication at a 2:1 ratio to receive either the stent or PTA.
At six and 12 months, patients in the stent arm had better target lesion revascularization—the trial’s primary endpoint, as well as better primary patency rates at 12 months. The stent fracture rate was 3.1 percent at 12 months, which the investigators wrote was comparatively low. “The RESILIENT trial results have made people less hesitant to use stents in the SFA,” says Laird.
Is stenting the answer?
The SFA is a “strange animal” because of its many complexities, says John D. Martin, MD, vascular surgeon and director of the Anne Arundel Medical Center Vascular Institute in Annapolis, Md. “SFA repair approaches are completely dependent on the extent of the disease, its location and its length,” he says.
While Martin prefers PTA for SFA repair, he says stenting becomes a viable option when PTA fails, especially for longer lesions that don’t respond well to PTA. In addition, stents become a “quick option” in cases of a recurrent lesion or a dissection.
Laird concurs that PTA works best for short-segment lesions that are less than 4 to 5 cm in length, but says nitinol stents show benefit in the treatment of medium length lesions (10 to 12 cm in length). He says that the second-generation self-expanding nitinol stents for femoral access offer more longitudinal flexibility “to reduce the likelihood of fracture,” while Martin says the helical pattern design of the LifeStent allows for the adjustment of the forces within the SFA.
Problems and alternatives
|SFA Stent Trials Approved by the FDA|