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

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Endovascular Therapy

Background:

• Aortoiliac lesions pose significant challenges in vascular disease management.
• Treatment options range from open surgery to endovascular interventions.
• Assessing the efficacy of endovascular therapy across different Transatlantic Inter-Society Consensus (TASC) lesion classifications is crucial.

Purpose of the Study:

• To evaluate the 12-month primary patency rates of endovascular therapy for TASC A-D aortoiliac lesions.
• To compare outcomes between TASC A/B and TASC C/D lesion cohorts.
• To establish primary stenting as a preferred treatment modality.

Main Methods:

• Prospective, non-randomized, multi-center trial (BRAVISSIMO study).
• 190 patients with TASC A/B lesions and 135 with TASC C/D lesions.
• Primary endpoint: 12-month primary patency (Duplex ultrasound and no target lesion revascularization).

Main Results:

• Overall 12-month primary patency rate was 93.1%.
• Patency rates for TASC A, B, C, and D lesions were 94.0%, 96.5%, 91.3%, and 90.2%, respectively.
• No significant difference in patency observed across TASC classifications.

Conclusions:

• Endovascular therapy, specifically primary stenting, is a preferred treatment for TASC A-D aortoiliac lesions.
• Endovascular outcomes are comparable to surgical results but with less invasiveness.
• The study supports the efficacy of endovascular approaches for a broad spectrum of aortoiliac disease severity.