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DOI: 10.1055/s-2004-813377
© Georg Thieme Verlag KG Stuttgart · New York
PTA versus Stent bei Stenosen der A. femoralis und A. poplitea: Ergebnisse einer prospektiv randomisierten Multizenterstudie (REFSA)
PTA Versus Palmaz Stent Placement in Femoropopliteal Artery Stenoses: Results of a Multicenter Prospective Randomized Study (REFSA)Publikationsverlauf
Publikationsdatum:
26. August 2004 (online)
Zusammenfassung
Zielsetzung: Vergleich der Stentimplantation mit der perkutanen transluminalen Angioplastie (PTA) bei der Behandlung chronischer Symptome bei kurzen femoropoplitealen Stenosen. Material und Methodik: In den 3 Studienzentren Heidelberg, Kiel und Wien wurden insgesamt 124 Becken-Bein-Angiographien bei 116 Patienten durchgeführt. Dabei erfolgte randomisiert bei n = 53 eine PTA und n = 71 eine Stentimplantation (Palmaz, Cordis, USA). Einschlusskriterien waren Claudicatio intermittens oder chronische kritische Extremitätenischämie mit kurzer Stenose oder Verschluss (≤ 5 cm) und mindestens ein 1-Gefäßunterschenkelabstrom. Nachuntersuchungen beinhalteten neben der klinischen Untersuchung die FKDS und/oder Angiographie nach 6, 12 und 24 Monaten. Ergebnisse: Initialer technischer Erfolg wurde in der PTA-Gruppe in 50/53 Fällen erzielt (94,4 %) versus 70/71 in der Stent-Gruppe (98,6 %). Schwere Komplikationen traten in 9,5 % (n = 11) auf; n = 4 in der PTA-Gruppe und n = 7 in der Stent-Gruppe. Die 1- bzw. 2-Jahres-Offenheitsrate (> 30 % Restlumen) betrug bei Stent 66,1 und 49,1 versus 76,1 und 66,1 % bei PTA. Die sekundäre 1- bzw. 2-Jahres-Offenheitsrate betrug 88,5 und 53,3 % bei Stent versus 82,7 und 76,2 % bei PTA. Schlussfolgerungen: Initialer technischer Erfolg war bei Stentapplikation häufiger als bei der PTA. Bei der angiographischen 1- und 2-Jahres-Offenheitsrate und beim klinischen und hämodynamischen Erfolg schnitt die PTA tendenziell besser ab.
Abstract
Purpose: To evaluate whether stent placement is superior to percutaneous transluminal angioplasty (PTA) in the treatment of chronic symptoms in short femoropopliteal arterial stenoses. Materials and Methods: One hundred twenty-four limbs in 116 patients, who ranged in age from 39 to 87 years (mean age, 67 years), were randomized to PTA (n = 53) versus PTA followed by implantation of long-medium Palmaz-Stents (n = 71). Inclusion criteria were intermittent claudication or chronic critical limb ischemia, short stenosis or occlusion (lesion length ≤ 5 cm), and at least one patent run-off vessel at angiography. The follow-up included clinical assessment, measurement of ankle/brachial index (ABI), color duplex ultrasound, and/or angiography at 6, 12 and 24 months. Angiographic follow-up between 12 and 36 months was available in 54 limbs (45 %). Results: Initial technical success was achieved in 50 of 53 limbs (94.4 %) in the PTA group versus 70 of 71 limbs (98.6 %) in the stent group. Overall, major complications occurred in 9.5 % (n = 11), with n = 4 in the PTA group compared to n = 7 in the stent group. No difference was found between the groups of treatment: clinical success at 1 and 2 years was 80.5 and 77.1 % in the PTA group versus 78.1 and 71.0 % in the stent group. The cumulative 1-year and 2-year angiographic primary patency rates were 66.1 and 49.1 % in the stent group versus 76.1 and 66.1 % in the PTA group. The secondary 1-year and 2-year angiographic patency rates were 88.5 and 53.3 % in the stent group versus 82.7 % and 76.2 % in the PTA group. Conclusion: The primary success rate was slightly higher after stent placement than after PTA. However, the angiographic, clinical and hemodynamic success after 1 and 2 years tends to be slightly better for PTA.
Key words
Arteries, extremities - transluminal angioplasty - stents - claudication
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Dr. med. L. Grenacher
Abt. Radiodiagnostik der Universität Heidelberg
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