Randomized prospective trial comparing femoral versus humeral approach for lower limbs arteriography

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Abstract

Background 
The femoral artery is the most commonly selected site of puncture for lower limbs arteriography (LEA). The humeral access appears as an alternative route. lt is more comfort­able for the patient (P) and can be used even when the femo­ral approach is contraindicated. 

Objectives 
To compare efficacy and safety of both femoral and humeral access in a prospective, randomized fashion, in ambulatory P subjected to LEA.

Methods 
Between March 1999 and September 2000, 575 patients were referred to us for LEA. Two hundred and ninety three sub­jects (50%) matched the inclusion criteria and were random­ized to either procedure. A series of 10 variables were com­pared both in a global manner and divided between the first and second half of the group, with the intention to evaluate the "learning curve" effect. We used the "t" test to compare quantitative variables and the "chi square" or the "Fisher 's exact test" for the qualitative ones. We considered signifi­cant all differences bigger than 0.05. We used the SPSS pro­gram (8.0 version) to process the data. 

Results 
The demographic characteristics of the population were simi­lar in both groups (p=NS). The rate of cross-over was higher for the humeral access. However, if we consider only the second half of the group, the difference was not statistically significant. There were no major complications in any pa­tient. The humeral approach involves longer procedure and radiation time and also requires a larger number of 2-wall punctures of the artery. There were no differences in the number of punctures per patient, time to obtain access or contrast volume between the groups.

Conclusions 
The humeral access is as safe as the femoral one for LEA. No major complications were registered. The femoral ac­cess allows shorter procedure radiation time, as well as less 2-wall punctures. The "learning curve" effect neutralized the more frequent cross-over rate and higher number of minor complications observed in the first half of the study. We conclude that our "ambulatory vascular radiology pro­gram" provides a reasonable safety approach.