Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial.
BACKGROUND
A thin, cobalt-chromium stent eluting the antiproliferative agent everolimus from a nonadhesive, durable fluoropolymer has shown promise in preliminary studies in improving clinical and angiographic outcomes in patients with coronary artery disease.


OBJECTIVE
To evaluate the safety and efficacy of an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent.


METHODS
The SPIRIT III trial, a prospective, randomized, single-blind, controlled trial enrolling patients at 65 academic and community-based US institutions between June 22, 2005, and March 15, 2006. Patients were 1002 men and women undergoing percutaneous coronary intervention in lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 mm. Angiographic follow-up was prespecified at 8 months in 564 patients and completed in 436 patients. Clinical follow-up was performed at 1, 6, 9, and 12 months.


METHODS
Patients were randomized 2:1 to receive the everolimus-eluting stent (n = 669) or the paclitaxel-eluting stent (n = 333).


METHODS
The primary end point was noninferiority or superiority of angiographic in-segment late loss. The major secondary end point was noninferiority assessment of target vessel failure events (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months. An additional secondary end point was evaluation of major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization) at 9 and 12 months.


RESULTS
Angiographic in-segment late loss was significantly less in the everolimus-eluting stent group compared with the paclitaxel group (mean, 0.14 [SD, 0.41] mm vs 0.28 [SD, 0.48] mm; difference, -0.14 [95% CI, -0.23 to -0.05]; P < or = .004). The everolimus stent was noninferior to the paclitaxel stent for target vessel failure at 9 months (7.2% vs 9.0%, respectively; difference, -1.9% [95% CI, -5.6% to 1.8%]; relative risk, 0.79 [95% CI, 0.51 to 1.23]; P < .001). The everolimus stent compared with the paclitaxel stent resulted in significant reductions in composite major adverse cardiac events both at 9 months (4.6% vs 8.1%; relative risk, 0.56 [95% CI, 0.34 to 0.94]; P = .03) and at 1 year (6.0% vs 10.3%; relative risk, 0.58 [95% CI, 0.37 to 0.90]; P = .02), due to fewer myocardial infarctions and target lesion revascularization procedures.


CONCLUSIONS
In this large-scale, prospective randomized trial, an everolimus-eluting stent compared with a paclitaxel-eluting stent resulted in reduced angiographic late loss, noninferior rates of target vessel failure, and fewer major adverse cardiac events during 1 year of follow-up.


BACKGROUND
clinicaltrials.gov Identifier: NCT00180479.
Stone
Gregg W
GW
Columbia University Medical Center, The Cardiovascular Research Foundation, 111 E 59th St, 11th Floor, New York, NY 10022, USA. gs2184@columbia.edu
Midei
Mark
M
Newman
William
W
Sanz
Mark
M
Hermiller
James B
JB
Williams
Jerome
J
Farhat
Naim
N
Mahaffey
Kenneth W
KW
Cutlip
Donald E
DE
Fitzgerald
Peter J
PJ
Sood
Poornima
P
Su
Xiaolu
X
Lansky
Alexandra J
AJ
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000453:epidemiology / Q000517:prevention & control; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018084:Ultrasonography, Interventional
D007166:Immunosuppressive Agents; D000068338:Everolimus; D017239:Paclitaxel; D020123:Sirolimus