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Direct Stenting With the TAXUS Liberté Drug-Eluting Stent

Results 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.

^_* Reprint requests and correspondence: Dr. John A. Ormiston, Mercy Angiography Unit, Ltd., 1st Floor, 98 Mountain Road, Epsom, Auckland 1003, New Zealand. (Email: johno{at}mercyangiography.co.nz).

Objectives: This study was conducted to determine whether direct stenting with TAXUS Liberté is noninferior to stenting after pre-dilation.

Background: Direct stenting is performed in approximately 30% of patients, but data on clinical and angiographic outcomes with drug-eluting stents are limited.

Methods: The TAXUS ATLAS DIRECT STENT is a single-arm, multicenter study that enrolled patients with de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is the quantitative coronary angiography (QCA) subset of the TAXUS ATLAS trial, which used identical inclusion and exclusion criteria but mandated pre-dilation. The primary end point is 9-month analysis-segment percent diameter stenosis (%DS).

Results: Baseline patient characteristics were similar between the groups. On QCA analysis, significantly shorter lesions with larger lumen diameter and less calcification were observed in the direct stent group. Direct stenting was successful in 97.6% of patients and was associated with a shorter procedure time and fewer complications. Follow-up %DS was noninferior for direct stent (26.41%) versus pre-dilation (29.14%) with a 1-sided 95% confidence interval of the difference between the groups (–0.34%) well below the pre-specified noninferiority margin (6.75%). Additionally, significantly lower restenosis (5.9% vs. 11.4%, p = 0.0229) and target lesion revascularization (TLR) 2.9% vs. 7.8%, p = 0.0087) rates were seen for direct stent versus pre-dilation.

Conclusions: Direct stenting of TAXUS Liberté is feasible and highly successful in carefully selected lesions. Direct stenting is noninferior to stenting after pre-dilation on the basis of %DS and can significantly reduce procedural time, procedural complications, and possibly angiographic restenosis and TLR. (TAXUS Liberté-SR Paclitaxel-Eluting Coronary Stent System; NCT00371423).

Abbreviations and Acronyms   %DS = percent diameter stenosis   ARC = Academic Research Consortium   CI = confidence interval   HR = hazard ratio   ITT = intention-to-treat   IVUS = intravascular ultrasound   MACE = major adverse coronary events   MLD = minimum lumen diameter   PP = per-protocol   QCA = quantitative coronary angiography   RVD = reference vessel diameter   TLR = target lesion revascularization   TVR = target vessel revascularization

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