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The Journal of Cardiovascular Surgery 2013 April;54(2):235-53


language: English

BRAVISSIMO: 12-Month Results from a Large Scale Prospective Trial

Bosiers M. 1, Deloose K. 1, Callaert J. 1, Maene L. 2, Beelen R. 2, Keirse K. 3, Verbist J. 3, Peeters P. 3, Schroë H. 4, Lauwers G. 4, Lansink W. 4, Vanslembroeck K. 4, D’archambeau O. 5, Hendriks J. 5, Lauwers P. 5, Vermassen F. 6, Randon C. 6, Van Herzeele I. 6, De Ryck F. 6, De Letter J. 7, Lanckneus M. 7, Van Betsbrugge M. 8, Thomas B. 8, Deleersnijder R. 8, Vandekerkhof J. 9, Baeyens I. 9, Berghmans T. 10, Buttiens J. 11, Van Den Brande P. 12, Debing E. 12, Rabbia C. 13, Ruffino A. 13, Tealdi D. 14, Nano G. 14, Stegher S. 14, Gasparini D. 15, Piccoli G. 15, Coppi G. 16, Silingardi R. 16, Cataldi V. 16, Paroni G. 17, Palazzo V. 17, Stella A. 18, Gargiulo M. 18, Muccini N. 18, Nessi F. 19, Ferrero E. 19, Pratesi C. 20, Fargion A. 20, Chiesa R. 21, Marone E. 21, Bertoglio L. 21, Cremonesi A. 22, Dozza L. 22, Galzerano G. 23, De Donato G. 23, Setacci C. 23

1 A.Z. Sint-Blasius, Dendermonde, Belgium; 2 OLV, Aalst, Belgium; 3 Imelda Hospital, Bonheiden, Belgium; 4 ZOL, Genk, Belgium; 5 Antwerp University Hospital, Edegem, Belgium; 6 Ghent University Hospital, Ghent, Belgium; 7 AZ Sint-Jan, Brugge, Belgium; 8 Sint-Augustinus, Wilrijk, Belgium; 9 Virga Jesse, Hasselt, Belgium; 10 Heilig Hart Hospital, Mol, Belgium; 11 A.Z. Sint-Maarten, Mechelen, Belgium; 12 University Hospital Brussels, Brussels, Belgium; 13 San Giovanni Battista Hospital, Turin, Italy; 14 Istituto San Donato, Milan, Italy; 15 Santa Maria Misericordia Hospital, Udine, Italy; 16 Policlinico of Modena, Modena, Italy; 17 Casa di Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy; 18 University of Bologna, Bologna, Italy; 19 Mauriziano Hospital, Turin, Italy; 20 University of Florence, Florence, Italy; 21 University Vita-Salute, Milan, Italy; 22 Villa Maria Cecilia, Cotignola, Ravenna, Italy; 23 University of Siena, Siena, Italy


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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