TY - JOUR
T1 - Long-term safety and efficacy of paclitaxel-eluting stents
T2 - Final 5-year analysis from the TAXUS clinical trial program
AU - Stone, Gregg W.
AU - Ellis, Stephen G.
AU - Colombo, Antonio
AU - Grube, Eberhard
AU - Popma, Jeffrey J.
AU - Uchida, Takahiro
AU - Bleuit, Jill S.
AU - Dawkins, Keith D.
AU - Russell, Mary E.
PY - 2011/5
Y1 - 2011/5
N2 - 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 analysis. 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.
AB - 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 analysis. 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.
KW - bare-metal stent(s)
KW - drug-eluting stent(s)
KW - myocardial infarction
KW - target lesion revascularization
KW - target vessel revascularization
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U2 - 10.1016/j.jcin.2011.03.005
DO - 10.1016/j.jcin.2011.03.005
M3 - Article
C2 - 21596326
AN - SCOPUS:79956277262
VL - 4
SP - 530
EP - 542
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
SN - 1936-8798
IS - 5
ER -