J Korean Med Sci.  2013 Nov;28(11):1609-1614. 10.3346/jkms.2013.28.11.1609.

A Prospective, Randomized Comparison of Promus Everolimus-Eluting and TAXUS Liberte Paclitaxel-Eluting Stent Systems in Patients with Coronary Artery Disease Eligible for Percutaneous Coronary Intervention: The PROMISE Study

• Kim U
• Lee CH
• Jo JH
• Lee HW
• Choi YJ
• Son JW
• Lee SH
• Park JS
• Shin DG
• Kim YJ
• Jeong MH
• Cho MC
• Bae JH
• Lee JH
• Kang TS
• Jung KT
• Jung KH
• Lee SW
• Cho JH
• Kim W
• Hur SH
• Kim KS
• Park HS
• Kim MH
• Hwang JY
• Kim DI
• Kim TI

• KMID: 1777657
• DOI: http://doi.org/10.3346/jkms.2013.28.11.1609

Abstract

We aimed comparing two-year clinical outcomes of the Everolimus-Eluting Promus and Paclitaxel-Eluting TAXUS Liberte stents used in routine clinical practice. Patients with objective evidence of ischemia and coronary artery disease eligible for PCI were prospectively randomized to everolimus-eluting stent (EES) or paclitaxel-eluting stent (PES) groups. The primary end-point was ischemia-driven target vessel revascularization (TVR) at 2 yr after intervention, and the secondary end-point was a major adverse cardiac event (MACE), such as death, myocardial infarction (MI), target lesion revascularization (TLR), TVR or stent thrombosis. A total of 850 patients with 1,039 lesions was randomized to the EES (n=425) and PES (n=425) groups. Ischemic-driven TVR at 2 yr was 3.8% in the PES and 1.2% in the EES group (P for non-inferiority=0.021). MACE rates were significantly different; 5.6% in PES and 2.5% in EES (P = 0.027). Rates of MI (0.8% in PES vs 0.2% in EES, P = 0.308), all deaths (1.5% in PES vs 1.2% in EES, P = 0.739) and stent thrombosis (0.3% in PES vs 0.7% in EES, P = 0.325) were similar. The clinical outcomes of EES are superior to PES, mainly due to a reduction in the rate of ischemia-driven TVR.

Keyword

Everolimus-Eluting Stent; Paclitaxel-Eluting Stent

MeSH Terms

Antineoplastic Agents, Phytogenic/administration & dosage/therapeutic use
Coronary Artery Disease/*drug therapy/mortality
Coronary Restenosis/prevention & control
*Drug-Eluting Stents
Female
Humans
Immunosuppressive Agents/administration & dosage/therapeutic use
Male
Middle Aged
Paclitaxel/administration & dosage/*therapeutic use
Percutaneous Coronary Intervention/*methods
Prospective Studies
Sirolimus/administration & dosage/*analogs & derivatives/therapeutic use
Thrombosis
Treatment Outcome
Antineoplastic Agents, Phytogenic
Immunosuppressive Agents
Paclitaxel
Sirolimus

Figure

• 

  Fig. 1 Initial study design and study flow chart. EES, everolimus-eluting stent; PES, paclitaxel-eluting stent; Id-TVR, ischemia-driven target vessel revascularization; MACE, major adverse cardiac events; TLR, target lesion revascularization; MI, myocardial death.

• 

  Fig. 2 The primary study end-point was ischemia-driven target vessel revascularization (TVR)-free survival rate at 2 yr post-PCI, and a significant difference was found between the two study groups (99% for the Promus™ Everolimus-eluting stent and 96% for the Taxus Liberbe™ Paclitaxel-eluting stent, P = 0.023).

• 

  Fig. 3 Major adverse cardiac event (MACE)-free survival at 2 yr post-PCI. A significant difference was found between the two study groups (97% for the Promus™ Everolimus-eluting stent vs 94% for the Taxus Liberbe™ Paclitaxel-eluting stent, P = 0.030).

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