VASCULAR SECTION ORIGINAL ARTICLES J CARDIOVASC SURG 2013;54:235-53
BRAVISSIMO: 12-Month Results from a Large Scale Prospective Trial
IN C ER O V P A Y R M IG E H DI T C ® A
M. BOSIERS 1, K. DELOOSE 1, J. CALLAERT 1, L. MAENE 2, R. BEELEN 2, K. KEIRSE 3, J. VERBIST 3, P. PEETERS 3, H. SCHROË 4, G. LAUWERS 4, W. LANSINK 4, K. VANSLEMBROECK 4, O. D’ARCHAMBEAU 5, J. HENDRIKS 5, P. LAUWERS 5, F. VERMASSEN 6, C. RANDON 6, I. VAN HERZEELE 6, F. DE RYCK 6, J. DE LETTER 7, M. LANCKNEUS 7 , M. VAN BETSBRUGGE 8, B. THOMAS 8, R. DELEERSNIJDER 8, J. VANDEKERKHOF 9, I. BAEYENS 9, T. BERGHMANS 10, J. BUTTIENS 11, P. VAN DEN BRANDE 12, E. DEBING 12, C. RABBIA 13, A. RUFFINO 13, D. TEALDI 14, G. NANO 14, S. STEGHER 14, D. GASPARINI 15, G. PICCOLI 15, G. COPPI 16, R. SILINGARDI 16, V. CATALDI 16, G. PARONI 17, V. PALAZZO 17, A. STELLA 18, M. GARGIULO 18, N. MUCCINI 18, F. NESSI 19, E. FERRERO 19, C. PRATESI 20, A. FARGION 20, R. CHIESA 21, E. MARONE 21, L. BERTOGLIO 21, A. CREMONESI 22, L. DOZZA 22, G. GALZERANO 23, G. de DONATO 23, C. SETACCI 23
M
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 Corresponding author: M. Bosiers, MD, Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium. E-mail:
[email protected]
Vol. 54 - No. 2
1A.Z. Sint-Blasius, Dendermonde, Belgium
2OLV, Aalst, Belgium Hospital, Bonheiden, Belgium 4ZOL, Genk, Belgium 5Antwerp University Hospital, Edegem, Belgium 6Ghent University Hospital, Ghent, Belgium 7AZ Sint-Jan, Brugge, Belgium 8Sint-Augustinus, Wilrijk, Belgium 9Virga Jesse, Hasselt, Belgium 10Heilig Hart Hospital, Mol, Belgium 11A.Z. Sint-Maarten, Mechelen, Belgium 12University Hospital Brussels, Brussels, Belgium 13San Giovanni Battista Hospital, Turin, Italy 14Istituto San Donato, Milan, Italy 15Santa Maria Misericordia Hospital, Udine, Italy 16Policlinico of Modena, Modena, Italy 17Casa di Sollievo della Sofferenza San Giovanni Rotondo, Foggia, Italy 18University of Bologna, Bologna, Italy 19Mauriziano Hospital, Turin, Italy 20University of Florence, Florence, Italy 21University Vita-Salute, Milan, Italy 22Villa Maria Cecilia, Cotignola, Ravenna, Italy 23University of Siena, Siena, Italy 3Imelda
lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery. Key words: Iliac artery - Endovascular procedures - Stents.
THE JOURNAL OF CARDIOVASCULAR SURGERY
235
BOSIERS
BRAVISSIMO: 12-Month Results from a Large Scale Prospective Trial
E
Those lesions for which more evidence is needed, but are more likly to respond better to surgery, are category TASC C.5 In practice, the most complex iliac lesions are listed under TASC C and D categories. The endovascular evolution in terms of materials and techniques in the years following the TASC 2000 recommendations resulted in 2007 in the publication of the TASC II document, containing a revision and update of their earlier recommendations.6 An overview of the TASC aortoiliac lesion classification and its evolution over the past few years, is shown in Table I. With the current stent systems the technique and modalities are available to treat TASC C & D lesions endovascularly, in addition to the commonly accepted TASC A & B lesions. The ob-
IN C ER O V P A Y R M IG E H DI T C ® A
ndovascular techniques are well accepted in the treatment of iliac occlusive disease and have gained widespread popularity. With the introduction of stents, the endovascular iliac results of percutaneous transluminal angioplasty (PTA) were optimized.1-4 When the first TransAtlantic Inter-Society Consensus (TASC) aortoiliac recommendations were published in 2000, they aimed at defining the best form of treatment for each specific arterial lesion configuration at that time. For lesions belonging to the TASC A category endovascular therapy is the treatment of choice. For TASC D category lesions, classic surgery is indicated. The lesions without strong supportive evidence, which are more likely to respond better to endovascular therapy, are categorized as TASC B.
M
Table I.—TASC classification for aortoiliac lesions.
236
THE JOURNAL OF CARDIOVASCULAR SURGERY
April 2013
BOSIERS
IN C ER O V P A Y R M IG E H DI T C ® A
BRAVISSIMO: 12-Month Results from a Large Scale Prospective Trial
Figure 1.—Enrollment overview for all Belgian sites, TASC A/B population (black) and TASC C/D population (grey).
University of Siena
San Giovanni Battista Hospital, Turin Istituto San Donato, Milan
Santa Maria Misericordia, Udine Policlinico of Modena
Casa di Sollievo della Sofferenza, San Giovanni Rotondo
University of Bologna
Mauriziano Hospital, Torino University of Florence
M
University Vita-Salute, Milan
Villa Maria Cecilia, Cotignola
Figure 2.—Enrollment overview for all Italian sites, TASC A/B population (black) and TASC C/D population (grey).
jective of the BRAVISSIMO study is to evaluate, in a controlled setting, the long-term (up to 24 months) outcome of the self-expanding nitinol Absolute Pro (Abbott Vascular) and the balloon-
Vol. 54 - No. 2
expandable Omnilink Elite (Abbott Vascular) stent in TASC A&B and TASC C&D iliac lesions. A separate analysis of both patient populations is performed.
THE JOURNAL OF CARDIOVASCULAR SURGERY
237
BOSIERS
BRAVISSIMO: 12-Month Results from a Large Scale Prospective Trial
Table II.—Patient demographics, TASC A/B versus TASC C/D. TASC A/B N.=190
TASC C/D N.=135
P-value
140 (73.68%) 50 (26.32%) 65 (32-86; 10.99)
91 (67.41%) 44 (32.59%) 64 (37-87; 10.24)
0.27 0.27 0.41
40 (21.05%) 99 (52.11%) 51 (26.84%)
22 (16.30%) 80 (59.26%) 33 (24.44%)
0.35 0.25 0.72
Characteristics
*protocol deviation
IN C ER O V P A Y R M IG E H DI T C ® A
Gender (%) — Male — Female Age (min-max; ±SD) Medical history Nicotine abuse — Never — Current — Previous Hypertension — No — Yes, medically treated — Yes, not medically treated Diabetes mellitus — No — Yes, insulin dependent — Yes, non-insulin dependent Renal insufficiency — No — Yes Hypercholesterolemia — No — Yes Obesity — No — Yes Rutherford categorization Claudication — Rutherford 2 — Rutherford 3 Critical limb ischemia — Rutherford 4 — Rutherford 5 — Rutherford 6*
70 (36.84%) 108 (56.84%) 12 (6.32%)
47 (34.81%) 79 (58.52%) 9 (6.67%)
0.80 0.85 0.92
145 (76.32%) 18 (9.47%) 27 (17.89%)
110 (81.48%) 8 (5.93%) 17 (12.59%)
0.33 0.34 0.25
170 (89.47%) 20 (10.53%)
121 (89.63%) 14 (10.37%)
0.89 0.89
69 (36.32%) 121 (63.68%)
53 (39.26%) 82 (60.74%)
0.67 0.67
151 (79.47%) 39 (20.53%)
102 (75.56%) 33 (24.44%)
0.48 0.48
166 (87.37%) 93 (48.95%) 73 (38.42%) 24 (12.63%) 9 (4.74%) 14 (7.37%) 1 (
