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.
BRAVISSIMO: 12-month results from a large scale prospective trial / Bosiers M.; Deloose K.; Callaert J.; Maene L.; Beelen R.; Keirse K.; Verbist J.; Peeters P.; Schroe H.; Lauwers G.; Lansink W.; Vanslembroeck K.; D'Archambeau O.; Hendriks J.; Lauwers P.; Vermassen F.; Randon C.; Van Herzeele I.; De Ryck F.; De Letter J.; Lanckneus M.; Van Betsbrugge M.; Thomas B.; Deleersnijder R.; Vandekerkhof J.; Baeyens I.; Berghmans T.; Buttiens J.; Van Den Brande P.; Debing E.; Rabbia C.; Ruffino A.; Tealdi D.; Nano G.; Stegher S.; Gasparini D.; Piccoli G.; Coppi G.; Silingardi R.; Cataldi; Paroni G.; Palazzo V.; Stella A.; Gargiulo M.; Muccini N.; Nessi F.; Ferrero E.; Pratesi C.; Fargion A.; Chiesa R.; Marone E.; Bertoglio L.; Cremonesi A.; Dozza L.; Galzerano G.; De Donato G.; Setacci C.. - In: JOURNAL OF CARDIOVASCULAR SURGERY. - ISSN 0021-9509. - ELETTRONICO. - 54:(2013), pp. 235-253.
BRAVISSIMO: 12-month results from a large scale prospective trial
Pratesi C.;Fargion A.;
2013
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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