ORIGINAL ARTICLES  VASCULAR SECTION 

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

Copyright © 2013 EDIZIONI MINERVA MEDICA

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.