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CardioVascular and Interventional Radiology

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01.02.2015 | Clinical Investigation

Sustained Benefit at 2 Years for Covered Stents Versus Bare-Metal Stents in Long SFA Lesions: The VIASTAR Trial

verfasst von: Johannes Lammer, Thomas Zeller, Klaus A. Hausegger, Philipp J. Schaefer, Manfred Gschwendtner, Stefan Mueller-Huelsbeck, Thomas Rand, Martin Funovics, Florian Wolf, Aljoscha Rastan, Michael Gschwandtner, Stefan Puchner, Ulrich Beschorner, Robin Ristl, Maria Schoder

Erschienen in: CardioVascular and Interventional Radiology | Ausgabe 1/2015

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Abstract

Purpose

The hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only.

Methods

A prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN^® Endoprosthesis) or BMS. Clinical outcomes and patency rates were assessed at 1, 6, 12, and 24 months. Mean lesion length was 19.0 ± 6.3 cm in the VIABAHN^® versus 17.3 ± 6.6 cm in the BMS group.

Results

The 24-month primary patency rates in the VIABAHN^® and BMS group were: intention-to-treat 63.1 (95 % CI 0.52–0.76) versus 41.2 % (95 % CI 0.29–0.57; log rank p = 0.04) and TPP 69.4 (95 % CI 0.58–0.83) versus 40.0 % (95 % CI 0.28–0.56; log rank p = 0.004). Freedom from target-lesion-revascularization (TLR) was 79.4 (95 % CI 0.70–0.90) versus 73.0 % (95 % CI 0.63–0.85) for VIABAHN^® versus BMS (log rank p = 0.37). For the TPP group in lesions ≥20 cm, the 24-month patency rates were 65.2 (95 % CI 0.50–0.85) versus 26.7 % (95 % CI 0.12–0.59; log rank p = 0.004) for VIABAHN^® versus BMS, and freedom from TLR was 80.0 (95 % CI 0.68–0.94) versus 61.9 % (95 % CI 0.44–0.87; log rank p = 0.13). The ankle brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN^® versus the BMS group, respectively.

Conclusion

At 24-month, this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS, however, without a significant impact on clinical outcomes and TLR rate (Reg. Nr. ISRCTN48164244).

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Titel: Sustained Benefit at 2 Years for Covered Stents Versus Bare-Metal Stents in Long SFA Lesions: The VIASTAR Trial
verfasst von: Johannes Lammer
Thomas Zeller
Klaus A. Hausegger
Philipp J. Schaefer
Manfred Gschwendtner
Stefan Mueller-Huelsbeck
Thomas Rand
Martin Funovics
Florian Wolf
Aljoscha Rastan
Michael Gschwandtner
Stefan Puchner
Ulrich Beschorner
Robin Ristl
Maria Schoder
Publikationsdatum: 01.02.2015
Verlag: Springer US
Erschienen in: CardioVascular and Interventional Radiology / Ausgabe 1/2015
Print ISSN: 0174-1551
Elektronische ISSN: 1432-086X
DOI: https://doi.org/10.1007/s00270-014-1024-9

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Sustained Benefit at 2 Years for Covered Stents Versus Bare-Metal Stents in Long SFA Lesions: The VIASTAR Trial

Abstract

Purpose

Methods

Results

Conclusion

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Abstract

Purpose

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Results

Conclusion

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