Document Detail

Final 5-year results of the TAXUS II trial: a randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for de novo coronary artery lesions.
MedLine Citation:
PMID:  19786634     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The TAXUS II trial was designed to evaluate the safety and efficacy of the commercialized slow-release (SR) and an investigation-only moderate-release (MR) polymer-based TAXUS paclitaxel-eluting stent compared with a bare-metal stent for the treatment of de novo coronary lesions. METHODS AND RESULTS: This prospective, randomized, double-blind, controlled trial enrolled 536 patients in 2 consecutive cohorts to compare TAXUS SR (n=131) and TAXUS MR (n=135) with an identical but uncoated bare-metal stent control (n=270). The present analysis reports final 5-year clinical outcomes of TAXUS II. At 5 years, both TAXUS SR and MR showed superior outcomes compared with control. The 5-year rates of major adverse cardiac events were 27.6%, 20.4%, and 15.1% (P=0.01); rates of target-vessel revascularization were 22.5%, 16.6%, and 9.0% (P=0.004); and rates of target-lesion revascularization were 18.4%, 10.3%, and 4.5% (P<0.001) for the control, TAXUS SR, and TAXUS MR groups, respectively. The rates of all-cause death and myocardial infarction were low and similar between groups, with 2 stent thromboses with bare-metal stents compared with no event beyond 2 years with either of the TAXUS stents. CONCLUSIONS: TAXUS II is the first large TAXUS trial to have reached 5-year follow-up. Both the SR and MR stents lowered the rates of target-vessel and target-lesion revascularization, which indicates their sustained efficacy. Furthermore, the low overall rates of all death, myocardial infarction, and stent thrombosis support the long-term safety of the TAXUS stent system.
Sigmund Silber; Antonio Colombo; Adrian P Banning; Karl Hauptmann; Janusz Drzewiecki; Eberhard Grube; Dariusz Dudek; Donald S Baim
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Publication Detail:
Type:  Comparative Study; Controlled Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-09-28
Journal Detail:
Title:  Circulation     Volume:  120     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-10-13     Completed Date:  2009-11-17     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1498-504     Citation Subset:  AIM; IM    
Cardiology Practice and Hospital, Am Isarkanal 36, D-81379 Munich, Germany.
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MeSH Terms
Cohort Studies
Coronary Artery Disease / drug therapy*,  mortality
Coronary Restenosis / mortality,  prevention & control
Delayed-Action Preparations / administration & dosage
Double-Blind Method
Drug Delivery Systems / methods*
Drug-Eluting Stents*
Follow-Up Studies
Middle Aged
Paclitaxel / administration & dosage*,  chemistry
Polymers / administration & dosage*,  chemistry
Prospective Studies
Survival Rate / trends
Treatment Outcome
Reg. No./Substance:
0/Delayed-Action Preparations; 0/Polymers; 33069-62-4/Paclitaxel

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