Direct Stenting With the TAXUS Liberté Drug-Eluting Stent
| Autor: | Louis Cannon, John A. Ormiston, Ehtisham Mahmud, Lazar Mandinov, Dougal McClean, Tift Mann, Neil J. Weissman, Soo-Teik Lim, Jack J. Hall, Michael J. Lucca, David Dobies, Mark Turco, Donald S. Baim, Jeffrey J. Popma |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
medicine.medical_specialty
biology business.industry medicine.medical_treatment Stent equipment and supplies biology.organism_classification medicine.disease Confidence interval Surgery Taxus Restenosis Drug-eluting stent Inclusion and exclusion criteria Coronary stent medicine Radiology business Cardiology and Cardiovascular Medicine Mace |
| Zdroj: | JACC: Cardiovascular Interventions. 1(2):150-160 |
| ISSN: | 1936-8798 |
| DOI: | 10.1016/j.jcin.2008.01.003 |
| Popis: | Objectives This study was conducted to determine whether direct stenting with TAXUS Liberte 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 Liberte 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 Liberte-SR Paclitaxel-Eluting Coronary Stent System; NCT00371423). |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|