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.
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.


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.
Silber
Sigmund
S
Cardiology Practice and Hospital, Am Isarkanal 36, D-81379 Munich, Germany. sigmund@silber.com
Colombo
Antonio
A
Banning
Adrian P
AP
Hauptmann
Karl
K
Drzewiecki
Janusz
J
Grube
Eberhard
E
Dudek
Dariusz
D
Baim
Donald S
DS
D000328:Adult; D000368:Aged; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000401:mortality; D023903:Coronary Restenosis / Q000401:mortality / Q000517:prevention & control; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D016503:Drug Delivery Systems / Q000379:methods*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000737:chemistry; D011108:Polymers / Q000008:administration & dosage* / Q000737:chemistry; D011446:Prospective Studies; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D011108:Polymers; D017239:Paclitaxel