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.

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; Schroë, 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, Gioachino; Silingardi, R; Cataldi, V; 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. - STAMPA. - 54:2(2013), pp. 235-253.

BRAVISSIMO: 12-month results from a large scale prospective trial

Coppi, Gioachino;Silingardi, R;Cataldi, V;
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.
54
2
235
253
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; Schroë, 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, Gioachino; Silingardi, R; Cataldi, V; 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. - STAMPA. - 54:2(2013), pp. 235-253.
Bosiers, M; Deloose, K; Callaert, J; Maene, L; Beelen, R; Keirse, K; Verbist, J; Peeters, P; Schroë, 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, Gioachino; Silingardi, R; Cataldi, V; 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.
File in questo prodotto:
Non ci sono file associati a questo prodotto.
Pubblicazioni consigliate

Caricamento pubblicazioni consigliate

Licenza Creative Commons
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11380/1064089
Citazioni
  • ???jsp.display-item.citation.pmc??? 5
  • Scopus 33
  • ???jsp.display-item.citation.isi??? 31
social impact