Nitinol Stent Implantation in the Superficial Femoral Artery and Proximal Popliteal Artery: Twelve-Month Results From the Complete SE Multicenter Trial - (Page 202)
202
J ENDOVASC THER
2014;21:202-212
^ CLINICAL
INVESTIGATION --------------------------
^
Nitinol Stent Implantation in the Superficial Femoral Artery
and Proximal Popliteal Artery: Twelve-Month Results From
the Complete SE Multicenter Trial
John R. Laird, MD1; Ash Jain, MD2; Thomas Zeller, MD3; Robert Feldman, MD4;
Dierk Scheinert, MD5; Jeffrey J. Popma, MD6; Ehrin J. Armstrong, MD1; and Michael R. Jaff, DO7
for the Complete SE Investigators
1
University of California Davis Health System, Sacramento, California, USA. 2Washington
Hospital, Fremont, California, USA. 3Heart Center Bad Krozingen, Germany. 4Munroe Regional
Medical Center, Ocala, Florida, USA. 5Park Hospital and Leipzig Heart Center, Leipzig, Germany.
6
Beth Israel Deaconess Medical Center, and 7Massachusetts General Hospital,
Boston, Massachusetts, USA.
^
^
Purpose: To determine the safety and efficacy of a new-generation nitinol stent with
enhanced flexibility in arterial lesions in the superficial femoral artery (SFA) and proximal
popliteal artery (PPA).
Methods: The Complete Self-Expanding (SE) Multicenter Trial (ClinicalTrials.gov identifier
NCT00814970) enrolled 196 patients (124 men; mean age 68.7610.5 years) from 28 centers
in the United States and Europe. The patients presented with intermittent claudication (193/
196) or ischemic rest pain (3/196) and were treated with nitinol stents for obstructive lesions
of the SFA or PPA. Over a quarter of lesions (29.9%) were chronic total occlusions. The
mean lesion length was 60.7 mm. Moderate to severe calcification was present in 91.0% of
lesions.
Results: A total of 225 stents were successfully implanted in 213 (99.5%) of 214 lesions.
Acute lesion success (,30% residual stenosis) was achieved in 90.0%. There were no inhospital major adverse events. Primary patency (defined as a peak systolic velocity ratio
,2.0) at 12 months was 72.6%. Clinically-driven target lesion revascularization (TLR) was
required in 8.4% of patients at 12 months. The mean ankle-brachial index increased from 0.7
at baseline to 0.9, and there was sustained improvement in the Rutherford category, with
83% of patients classified as Rutherford category 0 or 1 at 12-month follow-up. No stent
fractures were detected through 12 months.
Conclusion: In this multicenter trial, primary implantation of a new-generation selfexpanding nitinol stent in the SFA and PPA was associated with a low rate of TLR and
sustained clinical benefit at 12 months without stent fracture.
J Endovasc Ther. 2014;21:202-212
This study was funded by Medtronic Vascular.
John Laird is a paid consultant to Medtronic Vascular and a board member for VIVA Physicians, a 501c3 not-for-profit
education and research organization. He is also on the scientific advisory boards of Medtronic, Bard, Boston Scientific
Corporation, Covidien, and Abbott. Thomas Zeller is a member of the advisory board for Medtronic. Robert Feldman
received research funding from Medtronic. Jeffrey J. Popma receives research grants from Medtronic. Michael Jaff is a
non-compensated advisor for Medtronic Vascular and a board member for VIVA Physicians. The other authors declare no
association with any individual, company, or organization having a vested interest in the subject matter/products
mentioned in this article.
Corresponding author: John R. Laird, MD, UC Davis Vascular Center, Lawrence J. Ellison Ambulatory Care Center, 4860
Y Street, Suite 3400, Sacramento, CA 95817 USA. E-mail: john.laird@ucdmc.ucdavis.edu
Q 2014 by the INTERNATIONAL SOCIETY
OF
ENDOVASCULAR SPECIALISTS
Available at www.jevt.org
http://www.ClinicalTrials.gov
http://www.jevt.org
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