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Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,632
Online ISSN 1827-191X
Bosiers M. 1, Deloose K. 1, Callaert J. 1, Verbist J. 2, Keirse K. 2, Peeters P. 2
1 Department Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium;
2 Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium
AIM:The BRAVISSIMO study is a prospective, non-randomized, multicenter, multinational, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports on the BRAVISSIMO TASC A&B iliac lesion cohort, based on data collected up to the 13-month time point. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without Target Lesion Revascularization (TLR) within 12 months.
METHODS: Between July 2009 and February 2010, a total of 190 patients who presented with TASC A or TASC B aorto-iliac lesions were included, of which 140 patients were enrolled in Belgium and 50 in Italy.
RESULTS: The demographic data were comparable for the TASC A and TASC B patients groups. The number of occlusions, the average degree of stenosis, the average lesion length was significantly higher in the group of TASC B lesions, which is congruent with the TASC lesions definitions. Similarly, there were significantly more unilateral lesions in the TASC A group, compared to the TASC B group. The 12-month primary patency rate was 94.0% for TASC A lesions and 96.5% for TASC B lesions, which is not statistically significant. The 12-month primary patency rate was 92.9% in lesions treated with the Omnilink Elite stent, 97.1% in lesions treated with the Absolute Pro stent groups, and 100% in lesions treated with both stents.
CONCLUSION: Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A/B aortoiliac lesions. Currently, we are collecting the 12-month data for the TASC C/D subgroup in the BRAVISSIMO study. Upon release of the results from this subgroup, we will be able to compare the results from both arms of this large-scale international study.