ZEST AMI (vs SES), 2009 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of zotarolimus eluting stent versus sirolimus eluting stent in Acute Myocardial Infarction Patients (STEMI)requiring primary angioplasty with symptom onset <= 12 hours

        Z

NCT00422565    Am J Cardiol 2009;104:1370-6  



Studied treatment zotarolimus-eluting stent (Endeavor)
Endeavor (ABT 578-eluting balloon expandable stent, Medtronic)
Control treatment sirolimus-eluting stents (Cypher)
Concomittant treatmentPretreatement with aspirin 300mg and clopidogrel 600 mg. During the procedure: bolus of heparin 100 U/kg, with a repeat bolus of 2,000 U to maintain an activated clotting time 300 seconds. Aspirin 100 to 200 mg daily given indefinitely and clopidogrel 75mg daily for 12 months
age 60 y
Female (%) 18%



Patients Acute Myocardial Infarction Patients (STEMI)requiring primary angioplasty with symptom onset <= 12 hours
Group sizes108 / 110
Inclusion criteriachest pain 30 minutes, presentation within 12 hours after onset of symptoms, and ST-segment elevation (1mm in 2 standard leads or 2mm in 2 contiguous precordial leads)
Exclusion criteriaPrevious administration of fibrinolytic agents; Previously documented left ventricular ejection fraction <30%; Previous MI Concomitant left main disease; cardiogenic shock Estimated life expectancy of <12 months
history of MI (%)
diabetes (%) 26%
Smoker (%)
unstable angina (%) 0%
%QCA follow-up
QCA follow-up duration



Blindness open Inclusion period sep 2006 - sept 2007
Follow-up duration 1 year (mean) Centers 12
Lost to FU geographical localisation Korea
Primary endpoint death, MI, or ischemia-driven TVR Design Parallel groups
PeriodeInclusionsep 2006 - sept 2007
HypotheseSuperiority
LAD (%) 46.8%
RCA (%) 44.5%
LCx (%) 8.7%
lesion length (mm) 27.15 mm
reference-vessel diameter 2.99 mm
lesion length inclusion criteria
Lesion diameter inclusion criteria
lesions in a bypass graft
left main coronary artery disease
restenotic lesion
totally occluded lesions
bifurcated lesions 10.3%
ostial lesion 8.71%
PCI for multivessel disease
STEMI 100%
Stable angina 0%



EndpointX1N1X0N0TE95% CI target lesion failure - 108 - 110 no data MACE 12 108 10 110 1,22[0,50; 2,96] all cause mortality 3 108 4 110 0,76[0,17; 3,50] cardiac death - 108 - 110 no data MI 0 108 2 110 0,20[0,01; 4,29] Recurrent myocardial infarction - 108 - 110 no data CABG - 108 - 110 no data angioplastie - 108 - 110 no data target-vessel revascularization 9 108 6 110 1,49[0,53; 4,19] clinically driven TVR - 108 - 110 no data target lesion revascularisation (TLR ) - 108 - 110 no data target vessel failure - 108 - 110 no data in-lesion binary restenosis - 108 - 110 no data angiographic restenosis - 108 - 110 no data 2 yr Death (all cause) - 108 - 110 no data 2 yr MACE - 108 - 110 no data 2 yr MI (all) - 108 - 110 no data 2 yr TLR - 108 - 110 no data 2y target lesion failure - 108 - 110 no data 4 yr mortality from all causes - 108 - 110 no data 4 yr MI - 108 - 110 no data 4 yr TLR - 108 - 110 no data 4 yr death or MI - 108 - 110 no data MACE at 5yr - 108 - 110 no data Acute stent thrombosis (<=24h) - 108 - 110 no data sub acute stent thrombosis (1-30 days) - 108 - 110 no data late stent thrombosis (31d - 1year) - 108 - 110 no data stent thrombosis (ARC) - 108 - 110 no data Stent thrombosis (any, end of follow-up) 0 108 4 110 Out of scale0,11[0,01; 2,13] 2yr stent thrombosis - 108 - 110 no data 4 yr stent thrombosis - 108 - 110 no data0,22,01,0

Lee CW, Park DW, Lee SH, Kim YH, Hong MK, Kim JJ, Park SW, Yun SC, Seong IW, Lee JH, Lee NH, Cho YH, Cheong SS, Lim DS, Yang JY, Lee SG, Kim KS, Yoon J, Jeong MH, Seung KB, Hong TJ, Park SJ Comparison of the efficacy and safety of zotarolimus-, sirolimus-, and paclitaxel-eluting stents in patients with ST-elevation myocardial infarction. Am J Cardiol 2009;104:1370-6     [PMID: 19892052]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT00422565



Registering number NCT00422565 (see trial on clinicaltrials.gov)
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