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
Studied treatment |
zotarolimus-eluting stent (Endeavor) Endeavor (ABT 578-eluting balloon expandable stent, Medtronic) |
Control treatment |
sirolimus-eluting stents (Cypher)
|
Concomittant treatment | Pretreatement 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 sizes | 108 / 110 |
Inclusion criteria | chest 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 criteria | Previous 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 |
PeriodeInclusion | sep 2006 - sept 2007 | ||
Hypothese | Superiority | ||
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% |
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
Comment:
All trials of zotarolimus eluting stent
Appears in following systematic reviews: