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Phlebologie 2014; 43(01): 5-11
DOI: 10.12687/phleb2184-01-2014
Original article
Schattauer GmbH

Efficacy and safety of a new pneumatic compression device for peripheral arterial disease with intermittent claudication

A prospective, randomized, multi-center clinical trialWirksamkeit und Sicherheit einer neuen pneumatischen Kompressionstherapie bei peripherer arterieller Verschlusskrankheit mit Claudicatio intermittensProspektive, randomisierte, multizentrische klinische Studie
F. X. Breu
1   Practice for Vascular Medicine, Rottach-Egern, Germany
,
A. Zelikovski
2   NARA medical center affiliated to Rabin Medical Center, Ramat-Gan, Israel
,
Z. Loberman
3   Assuta Medical Center, Haifa, Israel
,
G. Rauh
4   Practice for Angiology, Munich, Germany
› Author Affiliations
Further Information

Publication History

Received: 02 January 2014

Accepted: 10 January 2014

Publication Date:
04 January 2018 (online)

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Summary

Background: The primary objective of the study was to demonstrate that Intermittent Pneumatic Compression (IPC) with the new ANGIO PRESS™ IPC device can significantly improve the walking distance, i.e. pain free initial intermittent claudication distance (ICD) and the absolute claudication distance (ACD) in patients with stage II peripheral arterial occlusive disease (PAD) compared to control treatment.

Patients and methods: A total of 67 patients were screened and randomized into the study in four clinical centers based in Israel and Germany. Patients were randomized to one of the two study groups: 1. Medication treatment with ASS / Clopidogrel and standardized walking exercise with additional IPC treatment, two times per day for 1.5 hours for three months. 2. Medication treatment and standardized walking exercise alone. The safety and efficacy of the ANGIO PRESS™ device was determined for the treatment of symptoms of PAD Fontaine stage IIb by measuring the pain free walking distance, the absolute walking distance, the ankle-brachial-index (ABI) and the walking pain. Additionally the quality of life (QOL) of each subject was assessed according to the SF-36 questionnaire. Subjects were followed up at six weeks and 3 months.

Results: No statistical differences were observed in any of the demographic characteristics and baseline scores. A significant difference was found between the treatment and control group in the ACD and the walking pain scale. Subjects in the treatment group improved their total walking distance in 54 meters, an improvement of 40% compared to their baseline distance. The walking pain improved by 1.89 points in the treatment group. Despite the fact that the difference in the ICD between the study groups were not found significantly different, the mean change from baseline in ICD score at the three month visit in the treatment group of 37 m was found statistically significant (p=0.0002), whereas the mean change of 20.7 m in the control group was not found significantly different. No changes were found between the study groups in the ABI and the QOL. The treatment was easy to tolerate and most patients suffered no side-effects, nor complained of any significant discomfort. Two subjects suffered from SAEs which were determined as not related to the study treatment.

Conclusion: The ANGIO PRESS™ is a non-invasive, easy to use, home treatment which is safe and moderately effective for the treatment of intermittent claudication. The ability of subjects to improve their absolute walking distance and reduce the walking pain on the same time may offer a significant value for patients at early stages of PAD who are not indicated for an invasive treatment.

Zusammenfassung

Hintergrund: Als primäres Ziel sollte die Studie zeigen, dass die intermittierende pneumatische Kompressionstherapie mit dem neuen ANGIO PRESS®-Gerät sowohl die schmerzfreie (ICD) wie auch die absolute Gehstrecke (ACD) bei Patienten mit Claudicatio intermittens (im Stadium IIb der pAVK) im Vergleich zum alleinigen Gehtraining signifi-kant bessert.

Patienten und Methoden: 67 Patienten wurden in 4 angiologischen Zentren in Israel und Deutschland in eine der zwei Studiengruppen randomisiert: 1. Gruppe: Übliche medikamentöse Therapie, standardisiertes Gehtraining und zusätzliche intermittierende super-systolische pneumatische Kompressionstherapie zweimal täglich, je 1,5 Stunden lang über 3 Monate. 2. Gruppe: Übliche medikamentöse Therapie und Gehtraining alleine. Sicherheit und Wirksamkeit des ANGIO PRESS®-Gerätes wurde durch die Ermittlung der schmerzfreien und absoluten Gehstrecke auf dem Laufband, des dopplersonografisch gemessenen Knöchel-Arm-Index (ABI) in Ruhe und nach Belastung und des Schmerzgrades anhand einer visuellen Analogskala untersucht. Zusätzlich wurde die Lebensqualität mit dem SF36-Fragebogen bestimmt. Die Patienten wurden 6 Wochen und 3 Monate nachverfolgt.

Ergebnisse: Die beiden Gruppen unterschieden sich signifikant in der maximalen Gehstrecke (ACD) und im Gehschmerz-Score. Die Patientengruppe mit zusätzlicher intermittierender pneumatischer Kompression verlängerte ihre maximale Gehstrecke im Mittel um 54 Meter, was einer Verbesserung um 40 % der Ausgangsstrecke entsprach. Der Gehschmerz-Score besserte sich in der Behandlungsgruppe um 1,89 Punkte. Ungeachtet der Tatsache, dass die schmerzfreie Gehstrecke (ICD) in beiden Behandlungsgruppen keinen signifikanten Unterschied zeigte, verlängerte sich die Gehstrecke in der Gruppe mit zusätzlicher apparativer Kompression um im Mittel 37 Meter signifikant zum Ausgangswert (p=0,002), wobei die Kontrollgruppe mit alleinigem Gehtraining eine nicht signifikante Verlängerung um nur 20,7 Meter zeigte. Kein signifikanter Unterschied beider Studienarme ergab sich beim ABI und QOL-Score. Die Kompressionstherapie mit dem ANGIO PRESS®-System wurde von den Patienten gut toleriert. Es waren keine therapiespezifischen Komplikationen und Nebenwirkungen zu verzeichnen.

Schlussfolgerung: Das ANGIO PRESS®-System zur intermittierenden supersystolischen apparativen Kompressionstherapie, zusätzlich zum Gehtraining, ist eine nicht-invasive, einfach zu handhabende, sichere und wirksame häusliche Behandlungsmethode bei Patienten mit peripherer arterieller Verschlusskrankheit mit Claudicatio intermittens. Ihr Wert liegt in der Verlängerung der schmerzfreien und maximalen Gehstrecke, sowie in der Verminderung des belastungsabhängigen Schmerzes selbst.

Keywords

Intermittent Pneumatic Compression - IPC - Peripheral Arterial Disease - intermittent claudication - walking exercise

Schlüsselwörter

Intermittierende pneumatische Kompression - IPK - Claudicatio intermittens - PAVK - Gehtraining
 

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