Endovascular treatment for claudication still awaits long-term results

Abstract

Ever since the advent of the endovascular revolution, there has been a drive to prove endovascular revascularization to be as good as or better than its surgical counterpart. Countless manuscripts have been published on this topic, and yet we are still far from an evidence-based consensus of what type of revascularization works best for whom. Ohki and colleagues1Ohki T. Kichikawa K. Yokoi H. Uematsu M. Yamaoka T. Maeda K. et al.Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions.J Vasc Surg. 2017; 66: 130-142Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar “threw down another gauntlet” by evaluating short-term outcomes in a cohort of mostly claudicants with long superficial femoral artery (SFA) lesions treated with self-expanding stent grafts. The “invasiveness” of stent grafting was compared with data derived from historical controls treated with prosthetic femoral above-knee popliteal bypass. Their prospective, multicenter, Japanese registry included 100 patients with intermittent claudication who were judged to be candidates for surgical bypass. To be included in the registry, patients had to have had adequate aortoiliac inflow, no previous SFA stenting, distal SFA diameter of 4 to 7.5 mm, and at least one patent tibial artery. Patients were treated with GORE Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts, observed for 12 months, and compared with 68 consecutive, contemporaneous patients treated with prosthetic bypass. In the stent graft cohort, the median SFA lesion length was 22 cm, and the majority of lesions were classified as TransAtlantic Inter-Society Consensus II type C. The median stent graft coverage length was 25 mm, and technical success was excellent. Primary assisted patency rate and freedom from target lesion revascularization at 12 months were 95.9% and 94.9%. During follow-up, there were five graft occlusions free of acute limb ischemia. In comparison with the historical surgical controls, the endovascular cohort had less use of general anesthesia, shorter procedural times, less blood loss, less need for transfusion, and shorter length of stay. The authors concluded that their results support the use of stent grafts as an alternative to femoral above-knee popliteal bypass. Although these results add to the growing literature that supports short-term outcomes of the Viabahn stent graft in the SFA, they do not clarify how to best treat claudicants who require revascularization. Recently published Society for Vascular Surgery practice guidelines dedicated to the management of intermittent claudication rightfully state that “a minimum threshold of a >50% likelihood of sustained efficacy for at least 2 years is suggested as a benchmark.”2Conte M.S. Pomposelli F.B. Clair D.G. Geraghty P.J. McKinsey J.F. Mills J.L. et al.Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication.J Vasc Surg. 2015; 61: 2S-41SAbstract Full Text Full Text PDF PubMed Scopus (239) Google Scholar This is a nod to the importance of durability of revascularization to patients with intermittent claudication who are intervened on so as to improve walking ability and quality of life. Therefore, outstanding 12-month patency data of stent grafts in the SFA reported by Ohki et al1Ohki T. Kichikawa K. Yokoi H. Uematsu M. Yamaoka T. Maeda K. et al.Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions.J Vasc Surg. 2017; 66: 130-142Abstract Full Text Full Text PDF PubMed Scopus (49) Google Scholar are not compelling. Similarly, data suggesting that stent grafting is less invasive than surgical bypass is not earth-shattering. Such data do not dissuade me as a vascular surgeon from using a femoral popliteal bypass with vein in a claudicant. The questions that do need to be answered relate to the circumstances under which drug-coated balloons, stents (bare metal and drug eluting), stent grafts, prosthetic bypass, or vein bypass should be used in this population of patients. The recent guidelines try to answer these questions, but published data to support such answers are woefully inadequate. Badly needed are well-designed comparative effectiveness studies that help guide therapy for the multiple clinical scenarios that our patients present with, keeping in mind that while studying claudicants, we need to focus on long-term clinical, quality of life, and cost outcomes. Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesionsJournal of Vascular SurgeryVol. 66Issue 1PreviewThe objective of this study was to assess 1-year safety, efficacy, and invasiveness outcomes of endovascular stent grafting of symptomatic long lesions (≥10 cm) in the superficial femoral artery (SFA) as a substitute for above-knee open bypass surgery. Full-Text PDF Open Access