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J Am Coll Cardiol. 2013 Jun 18;61(24):2417-2427. doi: 10.1016/j.jacc.2013.03.034. Epub 2013 Apr 10.

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.

Author information

Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, California. Electronic address:
Center for Critical Limb Care, Riverside Methodist Hospital, Columbus, Ohio.
The Vascular Center, Massachusetts General Hospital, Boston, Massachusetts.
Department of Surgery, Jikei University Hospital, Tokyo, Japan.
Department of Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, Oceanside, California.
Department of Radiology, OSF St. Francis Medical Center, Peoria, Illinois.
MED Institute, Inc., West Lafayette, Indiana.
Department of Radiology, Klinikum Rosenheim, Rosenheim, Germany.
Department of Cardiology, Center for Vascular Medicine, Park Hospital, Leipzig, Germany.
Department of Angiology, Herz Zentrum, Bad Krozingen, Germany.

Erratum in

  • J Am Coll Cardiol. 2013 Aug 13;62(7):666.



A prospective, multinational randomized controlled trial (RCT) and a complementary single-arm study evaluated the 2-year safety and effectiveness of a paclitaxel-coated drug-eluting stent (DES) in patients with superficial femoral artery lesions. The RCT compared the DES with percutaneous transluminal angioplasty (PTA) and provisional bare-metal stent (BMS) placement.


Local drug delivery for superficial femoral artery lesions has been investigated with the intent of limiting restenosis similarly to DES for the coronary arteries. One-year outcomes of DES in the superficial femoral artery are promising, but longer-term benefits have not been established.


In the RCT, patients were randomly assigned to primary DES implantation (n = 236) or PTA (n = 238). Acute PTA failure occurred in 120 patients, who underwent secondary randomization to DES (n = 61) or BMS (n = 59) placement. The single-arm study enrolled 787 patients with DES treatment.


Compared with the control group, the primary DES group demonstrated significantly superior 2-year event-free survival (86.6% vs. 77.9%, p = 0.02) and primary patency (74.8% vs. 26.5%, p < 0.01). In addition, the provisional DES group exhibited superior 2-year primary patency compared with the provisional BMS group (83.4% vs. 64.1%, p < 0.01) and achieved higher sustained clinical benefit (83.9% vs. 68.4%, p = 0.05). Two-year freedom from target lesion revascularization with primary DES placement was 80.5% in the single-arm study and 86.6% in the RCT.


Two-year outcomes with the paclitaxel-eluting stent support its sustained safety and effectiveness in patients with femoropopliteal artery disease, including the long-term superiority of the DES to PTA and to provisional BMS placement. (Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery; NCT00120406; Zilver(®) PTX™ Global Registry; NCT01094678).

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