24-Month Data from the BRAVISSIMO: A Large-Scale Prospective Registry on Iliac Stenting for TASC A & B and TASC C & D Lesions.
BACKGROUND
To evaluate the 24-month outcome of stenting in Trans-Atlantic Inter-Society Consensus (TASC) A & B and TASC C & D iliac lesions in a controlled setting.


METHODS
The BRAVISSIMO study is a prospective, nonrandomized, multicenter, multinational, monitored registry including 325 patients with aortoiliac lesions. The end point is the primary patency at 24 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio >2.0). A separate analysis for TASC A & B versus TASC C & D population is performed.


RESULTS
Between July 2009 and September 2010, 190 patients with TASC A or B and 135 patients with TASC C or D aortoiliac lesions were included. The demographic data were comparable for TASC A & B cohort and TASC C & D cohort. Technical success was 100%. Significantly more balloon-expandable stents were deployed in TASC A & B lesions, and considerably more self-expanding stents were placed in TASC C & D (P = 0.01). The 24-month primary patency rate after 24 months for the total population was 87.9% (88.0% for TASC A, 88.5% for TASC B, 91.9% for TASC C, and 84.8% for TASC D). No statistically significant difference was shown when comparing these groups. The 24-month primary patency rates were 92.1% for patients treated with the self-expanding stent, 85.2% for patients treated with the 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 only kissing stent configuration (P = 0.0012) and obesity (P = 0.0109) as independent predictors of restenosis (primary patency failure). Interestingly, as all TASC groups enjoyed high levels of patency, neither TASC category nor lesion length was predictive of restenosis.


CONCLUSIONS
The 24-month data from this large, prospective, multicenter study confirm that endovascular therapy may be considered the preferred first-line treatment option of iliac lesions, irrespectively of TASC lesion category.
Department of Medicine, Surgery and Neuroscience, Vascular and Endovascular Surgery Unit, University of Siena, Siena, Italy. Electronic address: dedonato@unisi.it.
Gianmarco
G
de Donato
Department of Vascular Surgery, Algemeen Ziekenhuis Sint-Blasius, Dendermonde, Belgium.
Marc
M
Bosiers
Department of Surgery "P. Valdoni", Sapienza University, Rome, Italy.
Francesco
F
Setacci
Department of Vascular Surgery, Algemeen Ziekenhuis Sint-Blasius, Dendermonde, Belgium.
Koen
K
Deloose
Department of Medicine, Surgery and Neuroscience, Vascular and Endovascular Surgery Unit, University of Siena, Siena, Italy.
Giuseppe
G
Galzerano
Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
Jürgen
J
Verbist
Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
Patrick
P
Peeters
Department of Medicine, Surgery and Neuroscience, Vascular and Endovascular Surgery Unit, University of Siena, Siena, Italy.
Carlo
C
Setacci
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001530:Belgium; D003251:Constriction, Pathologic; D005260:Female; D006801:Humans; D007083:Iliac Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency