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Die ABC- („Angioplasty or Bypass Surgery in Intermittent Claudication“-)Studie

Hintergrund und Studienaufbau

The ABC (Angioplasty or Bypass Surgery in Intermittent Claudication) Trial

Background and Study Design

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Zusammenfassung

Sowohl in der Anzahl der publizierten Artikel, als auch in den absoluten Behandlungszahlen zeigte sich in den letzten Jahren eine deutliche Zunahme der endovaskulären Interventionen für arteriosklerotische Gefäßprozesse. Trotz schwacher Evidenzlage wurde dies sowohl in der nationalen S3-Leitlinie zur „Diagnostik und Therapie der peripheren arteriellen Verschlusskrankheit (PAVK)“ als auch in internationalen Veröffentlichungen (Transatlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease; TASC II) berücksichtigt.

Aufgrund fehlender valider Level-I-Daten in Hinblick auf die gängigsten invasiven Behandlungsmethoden für die Claudicatio intermittens, wurde die ABC-Studie („Angioplasty or Bypass Surgery in Intermittent Claudication“) konzipiert. Dabei handelt es sich um eine prospektiv randomisierte Multicenterstudie für Patienten mit fortgeschrittenen Stenosen/Verschlüssen (10–20 cm) der A. femoralis superficialis zum Vergleich der endovaskulären (Stentangioplastie) und konventionell-chirurgischen Verfahren (femoro-poplitealer PI-Bypass). Der primäre Endpunkt ist die klinische Verbesserung ≥1 Stadium nach Rutherford (Laufband: 3,2 km/h, 12% Steigung) ohne erneute Revaskularisierung der Zielläsion bei überlebenden Patienten innerhalb von 24 Monaten. Um einen Unterschied von 15% im primären Endpunkt zwischen den beiden Behandlungen mit einer Power von 80% nachweisen zu können, müssen in beide Studienarme insgesamt 470 Patienten randomisiert werden.

Abstract

As shown by the number of published articles as well as by the absolute treatment numbers, endovascular therapy for arteriosclerotic vascular disease has increased in recent years. Although this development does not have an evidence-based background, it was included in the German S3 guideline for the treatment of peripheral occlusive disease („Diagnostik und Therapie der peripheren arteriellen Verschlusskrankheit (PAVK)“) and even in international publications [Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II)].

Because of the lack of valid level-I data on the treatment of intermittent claudication with established invasive therapies, the ABC (Angioplasty or Bypass Surgery in Intermittent Claudication) trial was designed. This is a randomized controlled trial involving patients with complex lesions of the superficial femoral artery (10–20 cm) for the purpose of comparing endovascular treatment (stent-protected angioplasty) and the best surgical treatment (femoropopliteal bypass above the knee). The primary efficacy end point is clinical improvement by one class without the need for repeated target lesion revascularization within 24 months in surviving patients, as assessed by treadmill testing (3.2 km/h, 12% incline). To detect a difference of 15% for the primary end point between the two study arms with a power of 80, 470 patients must be recruited.

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Authors and Affiliations

  1. Klinik für Gefäßchirurgie, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str. 22, 81675, München, Deutschland

    A. Zimmermann &  H.-H. Eckstein

  2. Abteilung für Interventionelle Radiologie, Klinikum rechts der Isar, Technische Universität München, München, Deutschland

    H. Berger

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  1. A. Zimmermann
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  3. H.-H. Eckstein
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Correspondence to H.-H. Eckstein.

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Zimmermann, A., Berger, H. & Eckstein, HH. Die ABC- („Angioplasty or Bypass Surgery in Intermittent Claudication“-)Studie. Gefässchirurgie 15, 5–10 (2010). https://doi.org/10.1007/s00772-009-0719-8

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