Long-Term Safety and Efficacy of Paclitaxel-Eluting Stents: Final 5-Year Analysis From the TAXUS Clinical Trial Program

Study Questions:

What is the long-term outcome of patients treated with paclitaxel-eluting stents (PES) compared with those treated with bare-metal stents (BMS)?

Methods:

The authors reported on a pooled 5-year patient-level analysis from the prospective, randomized, double-blind TAXUS I, II, IV, and V trials.

Results:

The pooled study cohort was comprised of 2,797 patients, of whom 1,400 were treated with PES and 1,397 were treated with a BMS. Use of PES was associated with a significant reduction in 5-year incidence of ischemia-driven target lesion revascularization (12.3% vs. 21.0%, p < 0.0001). There was no difference in the 5-year rate of death (9.8% vs. 9.1%, p = 0.53) or myocardial infarction (MI) (7.7 vs. 6.6%, p = 0.33). Between 1-5 years, randomization to PES was associated with an increase in cardiac death or MI (6.7% vs. 4.5%, p = 0.01) and stent thrombosis (protocol definition: 0.9% vs. 0.2%, p = 0.007; Academic Research Consortium definition: 1.4% vs. 0.9%, p = 0.18).

Conclusions:

Use of PES was associated with a durable reduction in target vessel revascularization, although there was a slight increase in risk of MI or cardiac death beyond 1 year.

Perspective:

This study demonstrates the dramatic clinical benefit of PES with an absolute reduction in need for coronary artery bypass grafting of 3.2% (numbers needed to treat, 31). However, the small increase in long-term risk of stent thrombosis is a major concern, especially since over 6 million of these stents have been implanted. The incidence of late stent thrombosis appears to be lower with the newer generation drug-eluting stents, and ongoing studies will define if this risk can be reduced further with prolonged dual antiplatelet therapy.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention

Keywords: Paclitaxel, Myocardial Infarction, Drug-Eluting Stents, Coronary Artery Bypass, Stents


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