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Everolimus-Eluting versus Paclitaxel-Eluting Stents in Coronary Artery Disease

http://content.nejm.org/cgi/content/short/362/18/1663?query=TOC
Volume 362:1663-1674 May 6, 2010 Number 18

Gregg W. Stone, M.D., Ali Rizvi, M.D., William Newman, M.D., Kourosh Mastali, M.D., John C. Wang, M.D., Ronald Caputo, M.D., Julie Doostzadeh, Ph.D., Sherry Cao, M.S., Charles A. Simonton, M.D., Krishnankutty Sudhir, M.D., Ph.D., Alexandra J. Lansky, M.D., Donald E. Cutlip, M.D., Dean J. Kereiakes, M.D., for the SPIRIT IV Investigators

ABSTRACT

Background
Previous studies have established the superiority of coronary everolimus-eluting stents over paclitaxel-eluting stents with respect to angiographic findings. However, these trials were not powered for superiority in clinical end points.

Methods
We randomly assigned 3687 patients at 66 U.S. sites to receive everolimus-eluting stents or paclitaxel-eluting stents without routine follow-up angiography. The primary end point was the 1-year composite rate of target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization).

Results
Everolimus-eluting stents were superior to paclitaxel-eluting stents with respect to the primary end point of target-lesion failure (4.2% vs. 6.8%; relative risk, 0.62; 95% confidence interval, 0.46 to 0.82; P=0.001). Everolimus-eluting stents were also superior with respect to the major secondary end point of the 1-year rate of ischemia-driven target-lesion revascularization (P=0.001) and were noninferior with respect to the major secondary end point of the 1-year composite rate of cardiac death or target-vessel myocardial infarction (P<0.001 for noninferiority; P=0.09 for superiority). The 1-year rates of myocardial infarction and stent thrombosis were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9% vs. 3.1%, P=0.02 for myocardial infarction; 0.17% vs. 0.85%, P=0.004 for stent thrombosis). Target-lesion failure was consistently reduced with everolimus-eluting stents as compared with paclitaxel-eluting stents in 12 prespecified subgroups, except in the subgroup of patients with diabetes (6.4% vs. 6.9%, P=0.80).

Conclusions
Everolimus-eluting stents, as compared with paclitaxel-eluting stents, resulted in reduced rates of target-lesion failure at 1 year, results that were consistent in all patients except those with diabetes, in whom the results were nonsignificantly different. (ClinicalTrials.gov number, NCT00307047 [ClinicalTrials.gov] .)

Source Information

From Columbia University Medical Center/New York–Presbyterian Hospital and the Cardiovascular Research Foundation, New York (G.W.S., A.J.L.); Heart Center of Indiana, Indianapolis (A.R.); Wake Medical Center, Raleigh, NC (W.N.); St. Joseph Medical Center, Towson (K.M.), and Union Memorial Hospital, Baltimore (J.C.W.) — both in Maryland; St. Joseph's Hospital Syracuse, Syracuse, NY (R.C.); Abbott Vascular, Santa Clara, CA (J.D., S.C., C.A.S., K.S.); Harvard Clinical Research Institute, Boston (D.E.C.); and Christ Hospital Heart and Vascular Center–Lindner Research Center, Cincinnati (D.J.K.).

Address reprint requests to Dr. Stone at Columbia University Medical Center, Cardiovascular Research Foundation, 111 E. 59th St., 11th Fl., New York, NY 10022, or at [e-mail].