Title
BRAVISSIMO : 12-month results from a large scale prospective trial BRAVISSIMO : 12-month results from a large scale prospective trial
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Publication type
article
Publication
Torino ,
Subject
Human medicine
Source (journal)
The journal of cardiovascular surgery. - Torino
Source (book)
CIRSE Congress, 2012, Lisbon, PORTUGAL
Volume/pages
54(2013) :2 , p. 235-253
ISSN
0021-9509
0021-9509
ISI
000318208200009
Carrier
E
Target language
English (eng)
Affiliation
University of Antwerp
Abstract
The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. 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. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.
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