TY - JOUR
T1 - Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions
T2 - 2-year follow-up from the zilver PTX randomized and single-arm clinical studies
AU - Dake, Michael D.
AU - Ansel, Gary M.
AU - Jaff, Michael R.
AU - Ohki, Takao
AU - Saxon, Richard R.
AU - Smouse, H. Bob
AU - Snyder, Scott A.
AU - O'Leary, Erin E.
AU - Tepe, Gunnar
AU - Scheinert, Dierk
AU - Zeller, Thomas
N1 - Funding Information:
These studies were sponsored by Cook Medical. Dr. Dake is a member of the advisory boards of Abbott Vascular, W. L. Gore, TriVascular, and Vortex Medical and is a member of the board of directors of VIVA Physicians, a not-for-profit 501(c)(3) education and research organization, and has received speaking honoraria from Cook Medical. Dr. Ansel is a consultant for Cook Medical, Cordis Endovascular, C. R. Bard, W. L. Gore, and Flexible Stenting Solutions; has financial ownership in Flexible Stenting Solutions; has received payments for speakers’ bureau appointments from Cook Medical, Cordis Endovascular, and W. L. Gore; and has received research grants from Cook Medical . Dr. Jaff is a member of the board of directors of VIVA Physicians. Dr. Ohki has received speaking honoraria from Cook Medical. Dr. Saxon is a member of the advisory board of Abbott Vascular and serves as a consultant for W. L. Gore; has received speaking honoraria from W. L. Gore; has received research grants from Cook Medical, W. L. Gore, Covidien, and Lutonix/C. R. Bard; and was an expert witness for a device unrelated to this study. Dr. Smouse is a consultant for Cook Medical. Drs. Snyder and O’Leary are paid employees of MED Institute, Inc., a contract research organization and Cook Group company. Dr. Tepe is a consultant for Cook Medical. Dr. Zeller is a member of the advisory boards of Medtronic-Invatec, W. L. Gore, Angioslide, Medtronic-Ardian, and Covidien; has received consulting fees or speaking honoraria from Sanofi-Aventis, C. R. Bard, Johnson & Johnson Cordis, Covidien, Boston Scientific Corporation, Straub Medical, Cook Medical, Invatec, Biotronik, Optimed, Pathway Medical, and W. L. Gore; and has received research grants from Cook Medical, Krauth Medical , Pathway Medical , Abbott Vascular , Johnson & Johnson Cordis , Angioslide , Ardian , Biotronik , Invatec , InnoRa , and W. L. Gore. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
PY - 2013/6/18
Y1 - 2013/6/18
N2 - Objectives 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. Background 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. Methods 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. Results 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. Conclusions 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).
AB - Objectives 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. Background 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. Methods 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. Results 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. Conclusions 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).
KW - angioplasty
KW - drug-eluting stent(s)
KW - paclitaxel-eluting stent(s)
KW - peripheral arterial disease
UR - https://www.scopus.com/pages/publications/84878920130
UR - https://www.scopus.com/pages/publications/84878920130#tab=citedBy
U2 - 10.1016/j.jacc.2013.03.034
DO - 10.1016/j.jacc.2013.03.034
M3 - Article
C2 - 23583245
AN - SCOPUS:84878920130
SN - 0735-1097
VL - 61
SP - 2417
EP - 2427
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 24
ER -