title: BRAVISSIMO: 12-month results from a large scale prospective trial.
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.
authors.affiliation: AZ Sint-Blasius, Dendermonde, Belgium. marc.bosiers@telenet.be
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mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D005260:Female; D006801:Humans; D007083:Iliac Artery; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000473:pathology / Q000628:therapy*; D012008:Recurrence; D015607:Stents
chemical_list: D000497:Alloys; C013616:nitinol