Two-year data from a prospective, multicentre study suggest that endovascular therapy with stenting may be considered the preferred first-line treatment option for aortoiliac lesions, irrespectively of TASC lesion category.
The results from BRAVISSIMO (Physician initiated multicentre Belgian-Italian trial investigating Abbott Vascular iliac stents in the treatment of TASC A, B, C & D iliac lesions), a non-randomised trial including 325 patients with aortoiliac lesions, were presented at the Society for Vascular Surgery Annual Meeting (5–7 June, Boston, USA).
According to the TASC II recommendations, TASC A and B lesions should be treated endovascularly and TASC C and D lesions should be treated with surgery. The objective of the BRAVISSIMO study was to evaluate the long-term (up to 24 months) outcome of using stenting as a primary approach also for TASC C and D iliac lesions in a controlled setting, Gianmarco de Donato, Vascular and Endovascular Surgery Unit, University of Siena, Siena, Italy, told delegates.The Absolute Pro self-expanding stent and the Omnilink Elite balloon-expandable stent were used in the study, which was carried out in 12 centres in Belgium and 11 centres in Italy.
The endpoint was primary patency at 24 months, defined as a target lesion without a haemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio >2.0). A separate analysis for TASC A and B vs. TASC C and D population was performed.
Marc Bosiers, Department of Vascular Surgery, Algemeen Ziekenhuis Sint-Blasius, Dendermonde, Belgium, was the primary investigator of the study.
Between July 2009 and September 2010, 190 patients with TASC A or B (140 in Belgium and 50 in Italy), and 135 patients with TASC C or D (85 in Belgium and 50 in Italy) aortoiliac lesions were included. According to the investigators, the demographic data were comparable for TASC A and B cohort and TASC C and D cohort.
Technical success was 100%. Significantly more balloon-expandable stents were deployed in TASC A and B lesions, and considerably more self-expanding stents were placed in TASC C and D (p=0.001).
The results showed that primary patency rate after 24 months for the total population was 87.9% (88% for TASC A, 88.5% for TASC B, 91.9% for TASC C and 83.1% for TASC D). There was no statistically significant difference between the groups.
The study also demonstrated that the 24-month primary patency rates were 92.1% for patients treated with the Absolute Pro self-expanding stent, 85.2% for patients treated with the Omnilink Elite balloon-expandable stent and 75.3% for patients treated with a combination of both stents (p=0.06).
Univariate and multivariable regression analyses using Cox proportional hazards model identified kissing stent configuration (p=0.0012) and obesity (p=0.0109) as independent predictors of restenosis (primary patency failure).
This trial, de Donato stated, confirms the findings of earlier retrospective data concerning excellent results of endovascular repair in all iliac lesions. He added, “Mixed use of balloon-expandable and self-expanding stents increases with complexity of the lesion configuration and does not influence primary patency results”.
“The 24-month data confirms that endovascular therapy may be considered the preferred first-line treatment option of iliac lesions, irrespectively of TASC lesion category. Neither TASC classification nor lesion length was (independently) predictive of restenosis,” he said.