5-year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT III trial (clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions).
OBJECTIVE
This study sought to evaluate the long-term safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in patients with obstructive coronary artery disease.


BACKGROUND
The use of EES compared to PES has been shown to result in improved clinical outcomes in patients undergoing PCI. However, there have been concerns regarding the durability of these benefits over longer-term follow-up.


METHODS
SPIRIT III was a prospective, multicenter trial in which 1,002 patients were randomized 2:1 to EES versus PES. Endpoints included ischemia-driven target vessel failure (TVF) (death, myocardial infarction (MI), or ischemia-driven target vessel revascularization [TVR]), the pre-specified primary endpoint), target lesion failure (TLF) (cardiac death, target-vessel MI, or ischemia-driven target lesion revascularization [TLR]), major adverse cardiac events (MACE) (cardiac death, MI, or ischemia-driven TLR), their individual components and stent thrombosis.


RESULTS
Five-year follow-up was available in 91.9% of patients. Treatment with EES versus PES resulted in lower 5-year Kaplan-Meier rates of TVF (19.3% vs. 24.5%, p = 0.05), TLF (12.7% vs. 19.0%, p = 0.008), and MACE (13.2% vs. 20.7%, p = 0.007). EES also resulted in reduced rates of all-cause death (5.9% vs. 10.1%, p = 0.02), with nonsignificantly different rates of MI, stent thrombosis, and TLR, and no evidence of late catch-up of TLR over time.


CONCLUSIONS
At 5 years after treatment, EES compared to PES resulted in durable benefits in composite safety and efficacy measures as well as all-cause mortality. Additionally, the absolute difference in TLR between devices remained stable over time without deterioration of effect during late follow-up.
Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
Hemal
H
Gada
Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
Ajay J
AJ
Kirtane
Wake Medical Center, Raleigh, North Carolina.
William
W
Newman
St. Patrick Hospital, Missoula, Montana.
Mark
M
Sanz
The Heart Center of Indiana, Indianapolis, Indiana.
James B
JB
Hermiller
Duke Clinical Research Institute, Durham, North Carolina.
Kenneth W
KW
Mahaffey
Harvard Clinical Research Institute, Boston, Massachusetts.
Donald E
DE
Cutlip
Abbott Vascular, Santa Clara, California.
Krishnankutty
K
Sudhir
Abbott Vascular, Santa Clara, California.
Liming
L
Hou
Abbott Vascular, Santa Clara, California.
Kai
K
Koo
Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York. Electronic address: gs2184@columbia.edu.
Gregg W
GW
Stone
D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology / Q000401:mortality; D003328:Coronary Thrombosis / Q000209:etiology / Q000401:mortality; D054855:Drug-Eluting Stents; D000068338:Everolimus; D006801:Humans; D053208:Kaplan-Meier Estimate; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality; D017239:Paclitaxel / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D002317:Cardiovascular Agents; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus
DES; EES; MACE; PES; TLF; TLR; TVF; coronary artery disease; drug-eluting stent(s); everolimus-eluting stent(s); in-stent restenosis; major adverse cardiac event(s); paclitaxel-eluting stent(s); stent thrombosis; target lesion failure; target lesion revascularization; target vessel failure