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

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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Acknowledgments

We thank Mrs. Johanna Moyses, research coordinator at Cardiovascular and Interventional Radiology, Medical University Vienna, for the data management; WL Gore for the grant for CorLab review of the CDUS studies; the Medical University Vienna for monitoring by the Clinical Coordination Center KKS.

Conflict of interest

Dr. Lammer reports grant to the institution for CDUS CorLab analysis from WL Gore, during the conduct of the study; personal fees from Abbott, Boston Scientific, and Gore, outside the submitted work; Dr. Zeller reports grants and personal fees from Gore, during the conduct of the study; Dr. Schaefer reports personal fees from Gore, Jotec, and Covidien outside the submitted work; Dr. Funovics reports personal fees from Gore Medical outside the submitted work; Dr. Hausegger, Dr. Gschwendtner, Dr. Mueller-Huelsbeck, Dr. Rand, Dr. Wolf, Dr. Rastan, Dr. Gschwandtner, Dr. Puchner, Dr. Beschorner, Dr. Ristl, and Dr. Schoder have nothing to disclose.

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Correspondence to Johannes Lammer.

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Lammer, J., Zeller, T., Hausegger, K.A. et al. Sustained Benefit at 2 Years for Covered Stents Versus Bare-Metal Stents in Long SFA Lesions: The VIASTAR Trial. Cardiovasc Intervent Radiol 38, 25–32 (2015). https://doi.org/10.1007/s00270-014-1024-9

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Keywords

  • Peripheral arterial disease
  • Femoropopliteal
  • Stent
  • Stentgraft