Related trials
SORT-OUT-3, 2010 - zotarolimus eluting stent vs sirolimus eluting stent
SPIRIT IV, 2010 - everolimus eluting stent vs paclitaxel eluting stent
RESOLUTE All comers, 2010 - zotarolimus eluting stent vs everolimus eluting stent
ISAR-DESIRE-2, 2010 - sirolimus eluting stent vs paclitaxel eluting stent
BASKET-PROVE (EES), 2010 - everolimus eluting stent vs bare-metal stent
GISSOC II, 2010 - sirolimus eluting stent vs bare-metal stent
BASKET-PROVE (SES), 2010 - sirolimus eluting stent vs bare-metal stent
STICH (ventricular reconstruction), 2009 - CABG+surgical ventricular reconstruction vs CABG
ISAR TEST 2 (vs ZES), 2009 - dual sirolimus, probucol eluting stent vs zotarolimus eluting stent
SYNTAX, 2009 - paclitaxel eluting stent vs CABG
ISAR-LEFT-MAIN, 2009 - sirolimus eluting stent vs paclitaxel eluting stent
COMPARE, 2009 - everolimus eluting stent vs paclitaxel eluting stent
ISAR TEST 3 (PF), 2009 - polymer free sirolimus stent vs sirolimus eluting stent
PASEO, 2009 - drug-eluting stents vs bare-metal stent
ZEST AMI (vs PES), 2009 - zotarolimus eluting stent vs paclitaxel eluting stent
ISAR TEST 2 (vs SES), 2009 - dual sirolimus, probucol eluting stent vs sirolimus eluting stent
BARI 2D, 2009 - CABG or PCI vs medical treatment
ISAR-TEST-4 (biodegradable polymer), 2009 - sirolimus biodegradable polymer vs sirolimus eluting stent
ISAR TEST 3 (BP), 2009 - sirolimus biodegradable polymer vs sirolimus eluting stent
ENDEAVOR IV, 2009 - zotarolimus eluting stent vs paclitaxel eluting stent
GENIUS-STEMI, 2009 - Genous stent vs bare-metal stent
ZEST (vs SES), 2009 - zotarolimus eluting stent vs sirolimus eluting stent
ZEST AMI (vs SES), 2009 - zotarolimus eluting stent vs sirolimus eluting stent
Thiele, 2009 - sirolimus ES vs MIDCAB
ZEST (vs PES), 2009 - zotarolimus eluting stent vs paclitaxel eluting stent
See also:
All coronary artery disease clinical trials
All stable angina clinical trials
All clinical trials of myocardial revascularization
All clinical trials of zotarolimus eluting stent
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Treatments
Studied treatment |
zotarolimus-eluting stents
Endeavor
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Control treatment |
sirolimus-eluting stents
Cypher
|
Concomittant treatment |
Pre-Procedure: aspirin (>= 100mg), clopidogrel (loading dose) 300 or 600 mg;
During Procedure: heparin: IV bolus + boluses to maintain ACT>250s, GP IIb/IIIa inhibitors at physician�s discretion ;
After Discharge: aspirin 100-325 mg/day indefinitely, clopidogrel: 75 mg once daily for at least 12 months
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Remarks |
3 arms: ZES compared vs SES (Cypher) and PES (Taxus) |
Patients
Patients |
Patients with coronary artery disease |
Inclusion criteria |
significant CAD (>=50% stenosis), amenable to stent-assisted PCI; silent ischemia, stable angina, and ACS (unstable angina, NSTEMI)
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Exclusion criteria |
severe left ventricular dysfunction (left ventricular ejection fraction <25%); cardiogenic shock; renal insufficiency; liver dysfunction; left main stenosis; in-stent restenosis of a drug-eluting stent; poor life expectancy
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Baseline characteristics |
age |
62y |
diabetes (%) |
30% |
unstable angina (%) |
55% |
LAD (%) |
52% |
RCA (%) |
27% |
LCx (%) |
21% |
lesion length (mm) |
27.9 mm |
Female (%) |
34% |
restenotic lesion |
1% |
totally occluded lesions |
6% |
bifurcated lesions |
15% |
ostial lesion |
7% |
multi vessels patients |
47% |
No of stent per lesions |
1.2 |
No of lesions per patients |
1.4 |
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Method and design
Randomized effectives |
883 / 878 (studied vs. control) |
Design |
Parallel groups |
Blinding |
Open |
Follow-up duration |
1 year |
Number of centre |
19 |
Geographic area |
Korea |
Primary endpoint |
death, myocardial infarction, TLR |
Remarks |
clinical follow-up at 12 months; angiographic follow-up at 9 months |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
MACE
89 / 883
73 / 878
1,21 [0,90;1,63]
All cause death
6 / 883
7 / 878
classic
0,85 [0,29;2,53]
MI (fatal and non fatal)
47 / 883
55 / 878
0,85 [0,58;1,24]
target-vessel revascularization
89 / 883
73 / 878
1,21 [0,90;1,63]
Stent thrombosis (any, end of follow up)
4 / 883
0 / 878
classic
16,90 [0,30;953,46]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
MACE
|
89 / 883 (10,1%) |
73 / 878 (8,3%) |
1,21 |
[0,90;1,63] |
|
|
All cause death
|
6 / 883 (0,7%) |
7 / 878 (0,8%) |
0,85 |
[0,29;2,53] |
|
|
MI (fatal and non fatal)
|
47 / 883 (5,3%) |
55 / 878 (6,3%) |
0,85 |
[0,58;1,24] |
|
|
target-vessel revascularization
|
89 / 883 (10,1%) |
73 / 878 (8,3%) |
1,21 |
[0,90;1,63] |
|
|
Stent thrombosis (any, end of follow up)
|
4 / 883 (0,5%) |
0 / 878 (0,1%) |
7,95 |
[0,42;150,25] |
|
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The primary endpoint (if exists) appears in blod characters
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Reference(s) used for data extraction:
0:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
MACE |
10,08% |
8,31% |
1,8%
|
All cause death |
6,80‰ |
7,97‰ |
-1,2‰
|
MI (fatal and non fatal) |
5,32% |
6,26% |
-9,4‰
|
target-vessel revascularization |
10,08% |
8,31% |
1,8%
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Meta-analysis of all similar trials:
Drug eluting stent in coronary artery disease for all type of patients
Drug eluting stent in coronary artery disease for unparticular patients
myocardial revascularization in coronary artery disease for all type of patient
myocardial revascularization in stable angina for all type of patient
Reference(s)
-
Park DW, Kim YH, Yun SC, Kang SJ, Lee SW, Lee CW, Park SW, Seong IW, Lee JH, Tahk SJ, Jeong MH, Jang Y, Cheong SS, Yang JY, Lim DS, Seung KB, Chae JK, Hur SH, Lee SG, Yoon J, Lee NH, Choi YJ, Kim HS, Kim KS, Kim HS, Hong TJ, Park HS, Park SJ.
Comparison of Zotarolimus-Eluting Stents With Sirolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization The ZEST (Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent with Sirolimus-Eluting and PacliTaxel-Eluting Stent for Coronary Lesions) Randomized Trial..
J Am Coll Cardiol 2010 Oct 5;56:1187-95
- 10.1016/j.jacc.2010.03.086
Pubmed
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Hubmed
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