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February 10, 2010

Comparing Endovascular and Open Repair of Abdominal Aortic Aneurysm—Reply

JAMA. 2010;303(6):513-514. doi:10.1001/jama.2010.89

In Reply: We agree with Dr Dalainas that the different endovascular systems are made to treat somewhat different patients. This is why at randomization we recorded the system that would be used if patients were assigned to endovascular repair to ensure comparison with patients assigned to the appropriate open repair in the subgroup analysis. The inclusion criteria were as stated in the article, with the pertinent issues being the AAA diameter and the requirement that patients had to be considered a candidate for both procedures by the participating vascular surgeon and meet the manufacturer's indications for the endovascular system that would be used if so assigned. Although the manufacturer's indications are quite specific, the study inclusion criteria could not be because they had to accommodate endovascular systems that were not yet approved at the time the study was planned. We also intended that inclusion be as unrestricted and reflective of usual practice as possible. In response to Dalainas' request for more detail on endoleaks, our article focused on the comparison of clinical outcomes after open and endovascular repair, such as secondary procedures, some of which resulted from endoleaks. However, endoleaks per se are not a clinical outcome that can be meaningfully compared with open repair outcomes. Detailed descriptions of endoleaks and anatomic characteristics of enrolled patients may be included in future analyses.

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