SFA Intervention in the Treatment of Total Occlusions: Can Endovascular Therapy Compete with Surgical Bypass?

I read with interest the report by Cho et al. on the results of SFA intervention for treatment of occlusive (not stenotic) lesions. They compared the 6-month outcome of PTA alone with stenting using the Smart nitinol device. We are not told how many patients underwent an attempt at recanalization overall as only “successful cases” are being reported. This and other significant shortcomings limit the value of their experience,¹ but it is refreshing to see that the authors acknowledged such shortcomings in the manuscript. The subject of nonsurgical recanalization of SFA occlusions has considerable appeal. Such lesions are frequent, and surgical revascularization continues to be the accepted standard of care. While efforts at catheter-based therapy have been pursued for more than 20 years and interventional approaches are known to have a high initial success rate, results at the mid-term and beyond have been disappointing. As discussed by the authors, use of Palmaz stents and the Wallstent have added little if anything to angioplasty (PTA) alone. The advent of new-generation nitinol devices represents a likely improvement, as demonstrated by our own uncontrolled experience and several others. The recently reported 6-month results of the Sirocco trial1 adds credence to such statement. While the study was aimed at confirming the superiority of sirolimus-coated Smart stents over non-drug-eluting devices, the rate of restenosis with uncoated Smart nitinol stents was a low 30.9%. This figure is considerably better than historical results with use of Palmaz or Wallstents. It is true that these are only early (6-month) results, and that conclusions cannot be extrapolated to similarly favorable long-term outcomes. On the other hand, its significance is undeniable given the fact that the majority of restenoses occur within the first several months after stent implantation. The use of drug-eluting stents is widely expected to revolutionize interventional therapies yet one more time. SFA procedures are likely to increase in scope and frequency, and it may be that improved outcomes justify the treatment of most symptomatic occlusions with a catheter-based approach, reserving surgical revascularization for recanalization-resistant lesions and failures of endovascular therapy. However, such enthusiasm must be tempered with caution as confirmatory hard data do not currently exist. Within this context, I must take issue with the authors’ conclusions since they failed to obtain imaging studies to ascertain patency, and did not directly assess patients’ quality of life at the 6-month endpoint. It would be of great interest to have the authors report again on their SFA interventional experience in the future, perhaps with a larger group of patients and longer follow-up. However, they will need to keep in mind that both objective confirmation of patency and quality of life (i.e. claudication symptoms) are the two yardsticks by which “success” after infrainguinal revascularization is judged. In closing, I would like to clarify my own views (and current practice) on the relative merits of endovascular recanalization and surgical revascularization on patients who present with severe claudication or critical ischemia caused by SFA occlusion. An attempt at percutaneous intervention is probably well justified in most cases where the occlusion is not flush with the common femoral artery, and when there is reconstitution of the above-knee popliteal or superficial femoral artery, with at least one good-vessel distal runoff. Femoro-popliteal bypass is reserved for cases where such approach fails, or when multiple failures occur after initial successful recanalization. PTA and nitinol stents are the main tools to achieve and maintain arterial patency. Drug-eluting devices will likely play a significant future role in this arterial territory.

1. Duda SH, Pusich B, Richter G, et al. Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: Six-month results. Circulation 2002;106:1505–1509.