Horizon scan of invasive interventions for lower extremity peripheral artery disease and systematic review of studies comparing stent placement to other interventions

About 12 million people in the United States have peripheral arterial disease (PAD) and it is increasing in frequency. In the lower extremities, PAD affects three major arterial segments: aorto-iliac arteries, femoral popliteal arteries, and infrapopliteal (primarily tibial) arteries. The disease is commonly classified clinically based on claudication, rest pain, or degree of tissue loss due to chronic ischemia. Treatment is based on lifestyle changes, including exercise, and medications to improve blood flow. Patients with more severe clinical disease often require invasive interventions aimed at reestablishing bloodflow to the affected limbs.Invasive treatment options include open surgery of the lower extremity with either autogenous or synthetic grafts to bypass the arterial occlusion(s), endarterectomy, and catheter-based endovascular procedures. These latter procedures include percutaneous transluminal angioplasty (where the vessel lumen is expanded at the site of the occlusion with a balloon), balloon-expandable stents (which are left in place to support the opened lumen), and more recently self-expanding stents, in addition to other less commonly used interventions or cointerventions such as brachytherapy, cryotherapy, drug-eluting stents, and atherectomy.In 2007, the Transatlantic Intersociety Consensus (TASC) Committee updated a consensus document on managing lower extremity PAD. TASC II updated a classification scheme for the disease based on anatomy of the disease and the extent of lesions. Treatment recommendations were established for the four classifications (A to D). The American College of Cardiology (ACC) and the American Heart Association (AHA) also published recommendations in 2006 based on clinical symptoms and anatomic level of disease.The Centers for Medicare and Medicaid Services (CMS) has requested a technology assessment report from The Technology Assessment Program (TAP) at the Agency for Healthcare Research and Quality (AHRQ) on invasive interventions to treat occlusive lesions related to PAD, focusing primarily on peripheral artery angioplasty with stent placement. For this topic, CMS is primarily interested in clinical outcomes, in contradistinction to the most commonly researched outcome in the field of PAD, artery patency. AHRQ assigned this report to the following Evidence-based Practice Center: Tufts Evidence-based Practice Center (Contract No. HHSA-290-2007-10055-1-EPC3).