Regarding “AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial”

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To the Editors: 

The original article by Zarins et al (J Vasc Surg 1999;29:292-308) was instructive and adds to the growing observation worldwide that the immediate results and the results at less than 12 months of endoluminal repair of abdominal aortic aneurysm are probably roughly comparable with those results after open surgery in these selected patients.

I would like to raise the issue of terminology. It is accepted that this was a “prospective” study as the authors describe, but it is not accurate to label it as a “clinical trial.” It is better described as a “case control study.”

A clinical trial implies that it is not just prospective but also that it is randomized. A case control study does not carry the same scientific and intellectual clout as a properly conducted randomized trial, and thus to call the study a clinical trial may be misleading.

Investigators in the United Kingdom are about to initiate a prospective randomized trial of open versus endoluminal surgery in fit patients with large aneurysms (>55 mm) with appropriate geometry and a separate randomized control trial of endoluminal repair versus best medical treatment in patients with large aneurysms who were rejected for open surgery on the grounds of high risk. It is expected that these studies would provide answers to questions that are currently posed in this area and that can only be partly answered with case control studies.

The jargon of our specialty is littered with misnomers, not the least of which is the term “graft,” which we invariably use when we mean prosthesis. This letter is a plea to ask not to muddy the waters again and to reserve the term “clinical trial” for prospective randomized studies that work with statistically appropriate numbers.