Peripheral arterial disease (PAD) is a common manifestation of atherosclerosis and is associated with a high risk of cardiovascular morbidity and mortality. Despite the magnitude of the problem, PAD is often poorly recognized in clinical practice. What is also clear is that the field of peripheral vascular disease treatment continues to be based on anecdotes, case series and small case-control and randomized trials that lack the power to truly guide clinical practice. The fact that the majority of stents used in the periphery are used off label and have been approved for different indications (e.g., biliary) attests to the need for well-designed, randomized, adequately powered clinical trials that may guide treatment of these patients.1–3 While treatment of aorto-iliac4,5 occlusive disease has certainly demonstrated improved long-term benefits, interventional therapies directed at superficial femoral occlusive disease (SFA) and infratibial disease have had mixed results.6,7 As with coronary artery disease treatment, medical therapy and a regular exercise program have been shown to compare favorably to percutaneous intervention in these patients.3,7–9 This is particularly true with total occlusion and extensive SFA disease, with a prohibitive restenosis rate and a poor understanding of the mechanism of these failures, being stent fracture, thrombosis, intimal proliferation, plaque protrusion and so forth.
The authors in this issue of the Journal attempted to address this complex problem in a complex high-risk population: TASC D lesions and report the outcome of 32 patients with chronic total occlusion of the SFA that was treated primarily with ePTFE Viabahn Stent Grafts (WL Gore & Associates, Inc., Flagstaff, Arizona). They reported reasonable 1-year outcomes with occlusions in 4 patients and restenosis in an additional 2 patients with a 1-year assisted patency of 86%.10 These results compare favorably to other treatment modalities, but fall short of suggesting a switch to primary stent graft use for such lesions. We do use stent grafts for secondary failures of stenting and balloon angioplasty, however, we are reluctant to recommend their routine use before more robust results from currently ongoing randomized clinical trials (with early encouraging results) emerge.11,12 Our reluctance stems from several factors:
1. Covered stents may compromise collateral supply to the distal vasculature, particularly in long total occlusions (TASC D). This may thus transform a claudicant into an acute limb ischemia patient with a resultant increase in mortality and morbidity.
2. Stent grafts necessitate larger delivery sheaths and may increase access-site complications.
3. Stent grafts, at least currently, increase procedural cost.
This, coupled with a decreasing incidence of critical-limb ischemia with early diagnosis and improved medical therapy, risk factor modification and exercise programs, should keep all options open for these patients including the well-proven medical therapy and surgical revascularization.
The availability of coated stent grafts and stents and a better understanding of failure mechanisms may, after adequate long-term studies, shift our practice to an endovascular approach, particularly in high-risk surgical patients. The recurring theme, however, appears to be that more data are needed and better adequately powered randomized, controlled studies should be conducted before final recommendations can be made. Until then, the treatment of peripheral vascular disease will remain more of an art than a science in an era where evidence-based medicine rules. We suggest that all patients with TASC C and D lesions undergoing revascularization (whether surgical or percutaneous) be enrolled in clinical studies with long-term follow up and careful, unbiased assessment of symptoms and patency. As Socrates had once said:
“Scio me nihil scire”
– I know that I know nothing.
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From the Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston Massachusetts.
The author reports no conflicts of interest regarding the content herein.
Address for correspondence: Roger Laham, MD, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA 02215. E-mail: rlaham@bidmc.harvard.edu
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