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The Journal of Cardiovascular Surgery 2007 December;48(6):719-26


lingua: Inglese

Non-randomized, prospective, multi-centre evaluation of the ABSOLUTE .035 peripheral self-expanding stent system for occluded or stenotic superficial femoral or proximal popliteal arteries (ASSESS Trial): acute and 30-day results

Zeller T. 1, Saratzis N. 2, Scheinert D. 3, Minar E. 4, Beregi J. P. 5, Schillinger M. 4, Hausegger H. A. 6, Amor M. 7, Quaretti P. 8, Moratto R. 9, Dorange C. 11, Boone E. 11, Krankenberg H. 10

1 Department of Angiology Herz-Zentrum Bad Krozingen Bad Krozingen, Germany 2 Papageorgiou Hospital, Thessaloniki, Greece 3 Herzzentrum Leipzig, Leipzig, Germany 4 Allgemeines Krankenhaus der Stadt, Wien, Austria 5 Duplex and Angiographic Core Lab, Loos, France 6 Landeskrankenhaus, Klagenfurt, Austria 7 Policlinique Louis Pasteur, Essey-les-Nancy, France 8 Policlinico San Matteo, Pavia, Italy 9 Nuovo Ospedale Civile Sant’Agostino, Modena, Italy 10 Abbott Vascular International BVBA, Diegem, Belgium 11 Universitäres Herz- und Gefäßzentrum Hamburg, Germany


Aim. The aim of the paper was to investigate the performance of the ABSOLUTE .035 Peripheral Self-Expanding Stent System in preventing restenosis of superficial femoral or proximal popliteal arteries. Due to a lack of large controlled trials proving its long-term durability femoropopliteal artery stenting is still a matter of debate. In this paper we report the study design, the acute and short-term results of a prospective European registry on the treatment of TASC B and C femoropopliteal lesions with the use of the ABSOLUTE stent.
Methods. This prospective, non-randomized, multi-centre study enrolled 122 patients with symptomatic peripheral occlusive disease at 14 sites in Europe. Patients were included with obstructed femoropopliteal arteries. Key inclusion criteria were de novo lesions ≥4.0 mm and ≤7.0 mm in diameter, and ≥40 mm and ≤200 mm in length. Single target vessel treatment had to be performed with a maximum of three stents.
Results. Mean target lesion length was 108±44 mm (range 22.2 to 200 mm) and mean reference vessel diameter 4.6±0.8 mm by quantitative angiography; 71% of the lesions analyzable by quantitative angiography (QA) had total occlusions. A total of 227 stents were implanted, 224 of which were deployed successfully (98.7%). Mean percentage of diameter stenosis was reduced from 90.9±15.5 % (range 41.3 to 100) to 19.0±8.4% (range 2.3 to 41.5). Device and procedural success were 83.6% each whereas technical success reached 100%. Sixteen lesions had a ≥30% residual stenosis post-procedure, 6 of them (37.5%) rated as being calcified. Eleven patients experienced major complications (9.1%) and 6 patients experienced minor complications (5%) within 30 days. Duplex ultrasound based 1-month restenosis rate was 9.3%. Target lesion revascularization (TLR) and target vessel revascularization (TVR) rates were 0.8% and 1.7%, respectively and amputation rate was 0.8%. Mean ankle-brachial index (ABI) at rest and after exercise increased significantly from baseline to 30 days follow-up by 0.63± 0.20 to 0.94±0.17 and from 0.44±0.23 to 0.85±0.21, respectively (P<0.001 each).
Conclusion. The treatment of TASC B and C femoro-popliteal lesions with use of the ABSOLUTE stent is safe and feasible. Short-term follow-up documents persistent improvement of hemodynamics. The 6- and 12-month data have to be awaited for further conclusions.

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