Direct Stenting With the TAXUS Liberté Drug-Eluting StentResults From the TAXUS ATLAS DIRECT STENT Study
John A. Ormiston, MB, ChB*,*,
Ehtisham Mahmud, MD ,
Mark A. Turco, MD, FACC, FSCAI ,
Jeffrey J. Popma, MD ,
Neil Weissman, MD||,
Louis A. Cannon, MD¶,
Tift Mann, MD#,
Michael J. Lucca, MD, FACC, FSCAI**,
Soo-Teik Lim, MBBS,
Jack J. Hall, MD,
Dougal McClean, MD,
David Dobies, MD, FACC, FSCAI||||,
Lazar Mandinov, MD¶¶,
Donald S. Baim, MD, FACC¶¶
* Mercy Angiography Unit, Mercy Hospital, Auckland, New Zealand
University of California, San Diego, San Diego, California
Center for Cardiac & Vascular Research, Washington Adventist Hospital, Takoma Park, Maryland
Angiographic Core Laboratory, Brigham and Women’s Hospital, Boston, Massachusetts
|| Cardiovascular Research Institute, Washington Hospital Center, Washington, DC
¶ Cardiac & Vascular Research Center, Northern Michigan Hospital, Petoskey, Michigan
# Wake Heart Associates, Wake Medical Center, Raleigh, North Carolina
** St. Mary’s Duluth Clinic Regional Heart Center, Duluth, Minnesota
National Heart Centre, Singapore
The Heart Center, St. Vincent’s Hospital, Indianapolis, Indiana
Christchurch Hospital, Christchurch, New Zealand
|||| Genesys Regional Medical Center, Grand Blanc, Michigan
¶¶ Boston Scientific Corporation, Natick, Massachusetts.
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Figure 1 TAXUS ATLAS DIRECT STENT Study Flow
*Only 60% of pre-dilation control patients versus 100% of direct stent patients were included in the intravascular ultrasound (IVUS) subset; starting at 12 months, only per-protocol population (PP) patients will continue to be followed. Angio = angiography; F/U = follow-up; ITT = intent-to-treat.
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Figure 3 Primary End Point: 9-Month Analysis Segment %DS
(A) Unadjusted (Unadj) and propensity score-adjusted (Adj) rates are shown for both the intention-to-treat (ITT) and per-protocol (PP) populations. The primary end point is based on the adjusted PP analysis. (B) Schematic representation of noninferiority testing results of analysis segment % diameter stenosis (%DS). The pre-specified noninferiority margin, difference (Diff) between the control and direct stent values, and upper 1-sided 95% confidence interval (CI) are presented.
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Figure 4 Binary Restenosis Edge Analysis
Nine-month results from the intention-to-treat population are shown. (A) Unadjusted binary restenosis rates for the proximal edge, in-stent segment, and distal edge. In-stent restenosis patterns are also indicated for the in-stent segment. (B) Unadjusted and propensity score-adjusted binary restenosis rates of the analysis segment. D = diffuse; F = focal; P = proliferative; TO = total occlusion.
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