By Mamood Razavi
An estimated two million people suffer from critical limb ischaemia, the most severe manifestation of peripheral arterial disease, in Western countries alone. The treatment is multifaceted and involves control of pain, infection and skin ulcers as well as revascularisation. Amputation becomes necessary when revascularisation and local measures are unsuccessful.
Surgical bypass has been the traditional method of revascularisation in this patient population. Recent progress in endovascular techniques and technologies, however, is fuelling a major shift away from surgical bypass, in favour of endovascular approaches.
The expanding toolbox and improving skill set among interventionists is now challenging the long-standing surgical standard of therapy and creating controversy as to which is the best approach.
While there is a large body of literature on surgical techniques and conduits, there is a paucity of high-level data comparing bypass to endovascular therapies. This is largely due to the evolving nature of endovascular technologies. The BASIL (Bypass vs. angioplasty in severe ischaemia of the leg) trial has been the only randomised trial comparing bypass to one endovascular technique, angioplasty. This study showed a similar amputation-free survival as well as quality of life between the two groups. The one-year cost of treatment was significantly lower in the angioplasty group.
The results of BASIL, however, are no longer relevant. The devices and techniques for endovascular approaches have improved substantially over the past decade resulting in significantly improved acute outcome as compared to what was reported in BASIL. Results of both multicentre prospective registries and single-centre observational studies reveal one-year limb salvage rates of 85–90% employing modern endovascular techniques. These are comparable to surgical bypass results seen in large trials such as PREVENT and other surgical series using optimal vein bypass grafts. It should be noted that the use of disadvantaged conduits for infrapopliteal bypass is likely to yield efficacy results inferior to that of endovascular techniques.
The improvement in devices has been accompanied by a substantial rise in the cost of endovascular therapies since the completion of the BASIL trial. Hence, an endovascular-first approach may no longer be the most cost-effective approach in patients with critical limb ischaemia. Studies using the Medicare Nationwide Inpatient Sample Database suggest that per patient cost of endovascular techniques is now similar to bypass surgery in critical limb ischaemia patients, and higher in intermittent claudication.
In summary, based on similar efficacy and lower complication rates, endovascular first approach is the preferred choice by both patients and most physicians treating critical limb ischaemia patients. This trend, however, may reverse if the costs of endovascular techniques rise at the current unsustainable pace.
Mahmood Razavi is director, Center for Clinical Trials and Research, Heart and Vascular Center, St Joseph Hospital, Orange, California, USA.