Direct stenting with the TAXUS Liberté drug-eluting stent: results from the Taxus Atlas Direct Stent Study.
OBJECTIVE
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.
Ormiston
John A
JA
Mercy Angiography Unit, Mercy Hospital, Auckland, New Zealand. johno@mercyangiography.co.nz
Mahmud
Ehtisham
E
Turco
Mark A
MA
Popma
Jeffrey J
JJ
Weissman
Neil
N
Cannon
Louis A
LA
Mann
Tift
T
Lucca
Michael J
MJ
Lim
Soo-Teik
ST
Hall
Jack J
JJ
McClean
Dougal
D
Dobies
David
D
Mandinov
Lazar
L
Baim
Donald S
DS
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D054855:Drug-Eluting Stents; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D012846:Singapore; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D002317:Cardiovascular Agents; D017239:Paclitaxel