Sustained Benefit at 2 Years for Covered Stents Versus Bare-Metal Stents in Long SFA Lesions: The VIASTAR Trial
- 1.1k Downloads
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.
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.
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.
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).
KeywordsPeripheral arterial disease Femoropopliteal Stent Stentgraft
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.
- 2.Doomernik DE, Golchehr B, Lensvelt MM, Reijnen MM (2012) The role of superficial femoral artery endoluminal bypass in long de novo lesions and in-stent restenosis. J Cardiovasc Surg (Torino) 53:447–457Google Scholar
- 8.Siablis D, Diamantopoulos A, Katsanos K, Spiliopoulos S, Kagadis GC, Papadoulas S et al (2012) Subintimal angioplasty of long chronic total femoropopliteal occlusions: long-term outcomes, predictors of angiographic restenosis, and role of stenting. Cardiovasc Intervent Radiol 35:483–490CrossRefPubMedGoogle Scholar
- 9.Davaine JM, Azéma L, Guyomarch B, Chaillou P, Costargent A, Patra P et al (2012) One-year clinical outcome after primary stenting for Trans-Atlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions (the STELLA “STEnting Long de L’Artère fémorale superficielle” cohort). Eur J Vasc Endovasc Surg 44:432–441CrossRefPubMedGoogle Scholar
- 15.Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M et al (2010) RESILIENT investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv 3:267–276CrossRefPubMedGoogle Scholar
- 19.McQuade K, Gable D, Pearl G, Theune B, Black S (2010) Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg 52:584–590CrossRefPubMedGoogle Scholar
- 20.Kuhan G, Abisi S, Braithwaite BD, MacSweeney ST, Whitaker SC, Habib SB et al (2012) Early results with the use of heparin-bonded stent graft to rescue failed angioplasty of chronic femoropopliteal occlusive lesions: TASC D lesions have a poor outcome. Cardiovasc Intervent Radiol 35:1023–1028CrossRefPubMedGoogle Scholar
- 22.Dake MD, Scheinert D, Tepe G, Tessarek J, Fanelli F, Bosiers M et al (2011) Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther 18:613–623CrossRefPubMedGoogle Scholar
- 23.Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB et al (2013) Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol 61:2417–2427CrossRefPubMedGoogle Scholar
- 24.Fanelli F, Di Primo M, Boatta E, Johnston K, Sapoval M et al (2013) Drug-eluting nitinol stent treatment of the superficial femoral artery and above-the-knee popliteal artery (the Zilver PTX single-arm clinical study): a comparison between diabetic and nondiabetic patients. Cardiovasc Intervent Radiol 36:1232–1240CrossRefPubMedGoogle Scholar