Point/Counterpoint: Endo first for the treatment of infrainguinal PAD?

The BASIL study originally published in the Lancet in 2005 (366:1925-34) and subsequently reiterated in multiple publications proposes that an endovascular approach should be utilized as the first invasive treatment modality in patients with infrainguinal peripheral arterial disease whose life expectancy is less than 2 years. By contrast, those patients expected to live beyond 2 years usually should be offered bypass surgery first, especially where a vein is available as a conduit. However, as can be seen from this month’s Point/Counterpoint by Dr. George Meier III and Dr. Michael S. Conte, the debate still rages as to the benefit of open vs. endovascular procedures for these patients. We encourage readers to voice their opinions in our “Letters to the Editor” section, as well as by participating in our web-based Quick Poll to the right of this story.
  - Dr. Russell Samson, Medical Editor, Vascular Specialist

POINT/COUNTERPOINT

Yes, endo is generally the way to go.

By Dr. George  Meier III

Endovascular treatment of lower-extremity arterial disease has rapidly expanded, now approaching the standard for treatment of patients with lower-extremity disease. While open bypass remains a gold standard for the clinical treatment of limb-threatening ischemia, there are many limitations to the use of open surgery.

First and foremost, open surgical intervention represents pain and suffering for the patient as well as a delayed recovery, compared with endovascular treatment. All other factors being equal, most patients would prefer a less-invasive approach to minimize these factors and to maximize the speed of recovery. Open surgical interventions typically require 6 weeks or longer to get back to a functional status even remotely close to the patient’s initial level of function. With more severe tissue loss or with greater pain preoperatively, the difficulty of getting the patient back to full functional status remains problematic. In John Porter’s classic paper published in the Journal of Vascular Surgery in 1998,¹ wound complications occurred in 24% of the patients with a 5-year survival rate of only 49% in this relatively young population, average age 66 years. Repeat operations to maintain graft patency, treat wound complications, or treat recurrent or contralateral ischemia were required in 54% of the patients and 23% ultimately required major limb amputation.

Of the 112 patients in this study, only 14.3% achieved the ideal surgical result of an uncomplicated operation: long-term symptom relief, maintenance of functional status, and no recurrence or repeat operations. These are sobering statistics for anyone facing open revascularization for critical limb ischemia.

The BASIL trial is often put forward as an example of the best data available currently to define patient treatments in patients with critical limb ischemia.² Despite this, BASIL was a flawed trial from the beginning because of the difficulties of truly randomizing patients with vascular disease to open surgical treatment vs. percutaneous treatment. First, all patients had to be appropriate candidates for both open and endovascular treatment. In the real world, we readily recognize that the luxury of this choice is not available to many of our patients. A lack of conduit or increased surgical risk results in endovascular treatment being the only management option for many. Additionally, patient preference increasingly plays a role in treatment selection, obviously increasing the likelihood of less invasive percutaneous treatment. Yes, the mortality of open bypass in BASIL is reported to be in the 1%-3% range, but this population has been carefully selected based on screening and treatment of underlying cardiac disease. The true incidence of cardiovascular disease is impossible to determine since significant cardiac disease negated randomization.

Unfortunately, even with all of the advances in endovascular treatments the results of percutaneous treatment have never reached the results of open bypass. Nonetheless, while the success may not be as great the risks are not as high either. The main challenge to endovascular treatment is the durability of the intervention. While we can usually treat pre-existing disease in the lower-extremity arterial tree, maintaining patency and durability is the challenge. As my esteemed colleague has noted, failure of endovascular treatment in the BASIL trial resulted in significantly worse outcomes for open bypass in those patients. While much was made about this fact when the BASIL trial was published, endovascular treatment after open failure has even a worse outcome than did open treatment after endovascular failure. The truth of the matter is that, for obvious reasons, failure begets failure.

Generally, there are two imaging approaches to defining the extent of vascular disease: first, contrast angiography via percutaneous access; and second, CT angiography using intravenous contrast. If contrast angiography is undertaken to diagnose the extent of disease, then it is a relatively limited extrapolation to treat the patient’s disease percutaneously at the time of the diagnostic angiogram. For this reason, I discuss with all patients coming for diagnostic angiography the issue of endovascular treatment. It is rare that we make patients worse with an attempt at endovascular treatment by an experienced interventionalist. Similarly, it is rare that we alter a bypass level based on an attempt at endovascular treatment. If, in my opinion, the risk of an attempted endovascular treatment is acceptable, then this is done at the time of the diagnostic angiogram. Patients appreciate this discussion prior to proceeding with diagnostic angiography.