Long-term safety and efficacy of paclitaxel-eluting stents final 5-year analysis
from the TAXUS Clinical Trial Program.
Author(s): Stone GW, Ellis SG, Colombo A, Grube E, Popma JJ, Uchida T, Bleuit JS, Dawkins
KD, Russell ME.
Affiliation(s): Department of Cardiology, Columbia University, Medical Center/New
York-Presbyterian Hospital, New York, New York 10022, USA. firstname.lastname@example.org
Publication date & source: 2011, JACC Cardiovasc Interv. , 4(5):530-42
OBJECTIVES: These studies sought to evaluate the clinical outcomes of the
slow-release Taxus paclitaxel-eluting stent (PES) versus an otherwise identical
bare-metal stent (BMS).
BACKGROUND: Prior studies were not individually powered to generate reliable
estimates of low-frequency safety endpoints or to characterize the long-term
safety and efficacy profile of PES.
METHODS: The completed 5-year databases from the prospective, randomized,
double-blind TAXUS I, II, IV, and V trials were pooled for a patient-level
RESULTS: The study population comprised 2,797 randomized patients (1,400 PES and
1,397 BMS). At the end of the 5-year study period, PES compared with BMS
significantly reduced the rate of ischemia-driven target lesion revascularization
(12.3% vs. 21.0%, p < 0.0001), with consistent reductions across high-risk
subgroups and in patients with and without routine angiographic follow-up. There
were no significant differences between the stent types in the 1-year or
cumulative 5-year rates of death or myocardial infarction (MI). However, cardiac
death or MI between 1 and 5 years was increased with PES (6.7% vs. 4.5%, p =
0.01), as was stent thrombosis (protocol definition: 0.9% vs. 0.2%, p = 0.007;
ARC definition: 1.4% vs. 0.9%, p = 0.18).
CONCLUSIONS: In this pooled patient-level analysis from the prospective,
randomized, double-blind TAXUS trials, PES compared with BMS resulted in a
durable 47% reduction in the 5-year rate of ischemia-driven target lesion
revascularization in simple and complex lesions, with nonsignificant differences
in the cumulative 5-year rates of death or MI. Between 1 and 5 years, however,
the rates of cardiac death or MI and protocol-defined stent thrombosis were
increased with PES.