Image: CC/Frank C. Müller
Key study points:
- Stent patency rates at one year are significantly better in the drug-eluting versus bare stents.
- Mortality, amputation, and revascularization rates were not significantly improved at one year.
Primer: Patients with limb-threatening peripheral artery disease frequently have extensive comorbidities and carry a less than two-year life expectancy. For these more severe patients, open bypass surgery is not an option. Aside from amputation, few treatment options satisfactorily address the symptoms of claudication and pain at rest that cripple this patient population of 8-10 million Americans.
Drug-eluting stents initially developed for heart disease are under investigation for complex lesions in peripheral vessels, with the hopes that their similarities to coronary arteries in diameter and mode of endothelial injury will translate into similar boosts in outcomes.
This [randomized controlled] study: 200 patients with critical limb ischemia due to peripheral artery disease were randomized to either sirolimus-eluting stents or percutaneous transluminal angioplasty for their infrapopliteal blockages. The primary endpoint was 12-month binary restenosis (diagnosed by angiography) and the secondary endpoints were death, repeat revascularization, and limb amputation. Restenosis was significantly lower in the drug eluting stent group (p=0.019 overall and p<0.001 for diabetics), and though outcomes were numerically lower in the drug-eluting stent arm for all three outcomes, statistical significance was not reached in mortality, repeat revascularization, or amputation.
In sum: Sirolimus-eluting stents demonstrate significantly improved patency rates in treated vessels versus bare stents, but it is unclear whether this difference translates into improved function or time to amputation for patients with critical limb ischemia.
Limitations to this study include enrollment of patients only with focal infrapopliteal disease, and a substantial loss to follow up (8%). Finally, eight patients crossed over from percutaneous angioplasty to sirolimus-eluting stents, and the investigators only published intent-to-treat results, not as-treated populations.
More from this author: CABG demonstrates better rates of survival versus PCI in diabetic patients: FREEDOM trial, Modifying mitral valve structure concurrently with coronary bypass helps post-MI patients optimize cardiac function and improve functional status
By [GS] and [AH]
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