Clinical Research24-Month Data from the BRAVISSIMO: A Large-Scale Prospective Registry on Iliac Stenting for TASC A & B and TASC C & D Lesions
Introduction
In the last 20 years endovascular therapy has gained widespread popularity as the treatment of choice for iliac artery occlusive disease, especially for stenoses and short occlusions.1, 2 Stents are often used to improve the outcome of percutaneous transluminal angioplasty (PTA), although the randomized controlled Dutch Iliac Stenting trial failed to demonstrate superiority of primary stenting over PTA with additional stenting in short lesions.3, 4, 5 Although hard data are lacking, more complex lesions have been treated with endovascular procedures because of the technical developments and the introduction of new stent types.
The TASC-II (Trans-Atlantic Inter-Society Consensus) treatment recommendations,6 which are based on several factors such as availability of expertise in the percutaneous or conventional vascular surgical techniques, the patient's preference, and the lesion's morphology, suggest endovascular therapy as the treatment of choice for TASC A & B lesions and surgery as preferred therapy for good-risk patients with TASC C lesions and all TASC D lesions.
Although endovascular treatment of iliac lesions of every TASC category has been reported as feasible and with acceptable results,7, 8, 9 prospective data on mid- and long-term durability are still lacking.
The objective of this clinical investigation is to evaluate, in a controlled setting, the 24-month outcome of iliac stenting in TASC A & B and TASC C & D lesions.
Section snippets
Methods
The BRAVISSIMO (physician-initiated multicenter Belgian–Italian tRial investigating Abbott Vascular Iliac StentS In the treatMent of TASC A, B, C, & D iliac lesiOns) study is a prospective, nonrandomized, multicenter, multinational, monitored registry including patients with aortoiliac lesions. The study was conducted at 12 centers in Belgium and 11 centers in Italy.
Patients were selected based on the investigator's assessment and evaluation of the underlying disease, and consecutively enrolled
Results
Between July 2009 and September 2010, a total of 325 patients were included in the study: 190 with TASC A or B and 135 with TASC C or D iliac lesions.
The demographic data are presented in Table III. As expected, >50% of the study population was current or previous smokers in all patient groups. Hypercholesterolemia was also reported in >50% of the total cohort, in all TASC subgroups. The number of claudicants was significantly higher in the TASC A & B population, meaning that the number of
Discussion
This is the first large, prospective, multicenter study focusing on endovascular iliac treatment of all TASC category lesions. In general, based on the evidence from retrospective case-series studies, endovascular therapy is recommended as the treatment of choice for TASC A & B lesions and surgery is preferred for good-risk patients with TASC C lesions and all TASC D lesions. Nevertheless, it should be stated that it is feasible to treat with good technical success and sustained durability TASC
Conclusion
Although not coming from a randomized controlled trial, the 24-month data from this large, prospective, multicenter study confirms that endovascular therapy may be considered the preferred first-line treatment option of iliac lesions, irrespectively of TASC lesion category (excluding the case of aortic disease involvement).
Durability at 2 years is satisfying and comparable with those reported after open surgery. Finally, reintervention can be regularly managed percutaneously, offering an
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2022, Annals of Vascular SurgeryCitation Excerpt :However, following a decade of advancement, some centers now advocate an ‘endovascular-first’ approach, even in the face of complex iliac lesions.5 There is some evidence to support primary endovascular intervention for TASC-II C and D lesions, particularly in high-volume centers.6,7 However, endovascular reconstruction continues to be associated with poor long-term patency, especially in the presence of concomitant femoral disease.8–12
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2021, Annals of Vascular SurgeryCitation Excerpt :A series of significant considerations can be made by analyzing our results in the light of the literature. Aortoiliac TASC C and D lesions1,2 have been considered historically difficult to be treated endovascularly due to the extension of the disease and the presence of a complete occlusion. As a matter of fact, in the last decades, the EVT of aortoiliac obstructive disease has evolved significantly, and different techniques and materials are now available, allowing excellent results in terms of patency and low complications’ rates.3–6