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Comparison of zotarolimus-eluting and everolimus-eluting coronary stents

BACKGROUND: New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration. METHODS: In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months. RESULTS: At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (+/-SD) of in-stent stenosis (21.65+/-14.42% for zotarolimus vs. 19.76+/-14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27+/-0.43 mm in the zotarolimus-stent group versus 0.19+/-0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events. CONCLUSIONS: At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084.)

Trial
Journal Ref. Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, et al: Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med 2010, 363:136-146.
Intervention Drug - Second generation Zotarolimus-eluting resolute stents
Number of sites 22
Countries involved the Netherlands, Germany, Poland, Belgium, Spain, France, United Kingdowm, Israel, Italy, Switzerland
Sample size 2292
Type of statistical analyses Intention-to-treat
Risk of bias Overall: Unclear details
Participant characteristics Age: 64.2 ± 10.8
Condition: chronic stable coronary disease or acute coronary syndromes
Baseline severity: Requiring stents
Duration of trial 6 months: April 30 2008 to October 2008
Primary outcome Target-lesion failure - composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel) or clinically indicated target-lesion revascularisation at 12 months
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
101 1119 108 1126 -0.57 %
P = 0.66 Effect size Primary endpoint - Target-vessel failure defined as death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-vessel revascularization.
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
4 5 4 5 5 -1 3 3 5