Related trials
SORT-OUT-3, 2010 - zotarolimus eluting stent vs sirolimus eluting stent
TRIANA, 2009 - primary ballon angioplasty vs tenecteplase
NORDISTEMI, 2009 - thrombolysis + angioplasty vs immediate thrombolysis
DEBATER (SES vs BMS), 2009 - sirolimus eluting stent vs bare-metal stent
Juwana, 2009 - sirolimus eluting stent vs paclitaxel eluting stent
ZEST AMI (vs PES), 2009 - zotarolimus eluting stent vs paclitaxel eluting stent
GENIUS-STEMI, 2009 - Genous stent vs bare-metal stent
PASEO, 2009 - drug-eluting stents vs bare-metal stent
ZEST AMI (vs SES), 2009 - zotarolimus eluting stent vs sirolimus eluting stent
CARESS, 2008 - thrombolysis + angioplasty vs immediate thrombolysis
SORT OUT II, 2008 - sirolimus eluting stent vs paclitaxel eluting stent
HORIZONS-AMI Stent, 2008 - paclitaxel eluting stent vs bare-metal stent
MISSION, 2008 - sirolimus eluting stent vs bare-metal stent
DEDICATION, 2008 - drug-eluting stents vs bare-metal stent
Díaz de la Llera, 2007 - sirolimus eluting stent vs bare-metal stent
SESAMI, 2007 - sirolimus eluting stent vs bare-metal stent
PROSIT, 2006 - sirolimus eluting stent vs paclitaxel eluting stent
HAAMU-STENT, 2006 - paclitaxel eluting stent vs bare-metal stent
PASSION, 2006 - paclitaxel eluting stent vs bare-metal stent
WEST, 2006 - systematic PCI (+stent) vs no systematic PCI
TYPHOON, 2006 - sirolimus eluting stent vs bare-metal stent
ZWOLLE 6, 2005 - primary stenting vs balloon angioplasty
CAPITAL AMI, 2005 - systematic PCI (+stent) vs no systematic PCI
senior PAMI, 2005 - primary PCI vs Thrombolysis
CAPITAL AMI, 2005 - thrombolysis + angioplasty vs immediate thrombolysis
See also:
All coronary artery disease clinical trials
All acute myocardial infarction clinical trials
All clinical trials of PCI
All clinical trials of sirolimus eluting stent
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Treatments
Studied treatment |
sirolimus-eluting stents
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Control treatment |
uncoated stents
|
Concomittant treatment |
abciximab bolus 0.25µg/kg, infuson 0.125µg/kg/min for 12 hours;
heparin bolus 17U/kg [max 7000U] aditional dose for ACT 200-250s;
aspirin loasing dose 300-500mg then 100mg/d indefinitely; clopidogrel loading dose 300 or 600 mg then 75mg/d for at leat 1 (BMS) or 9 months (SES) |
Patients
Patients |
primary percutaneous coronary intervention for acute myocardial infarction with ST-segment elevation |
Exclusion criteria |
reference diameter <2.25 mm and >4.0 mm
by visual estimation in the infarction-related artery (IRA) |
Baseline characteristics |
age |
64.47 |
history of MI (%) |
7.37 |
diabetes (%) |
27.46 |
Smoker (%) |
68.3 |
unstable angina (%) |
0% |
LAD (%) |
42.36 |
RCA (%) |
43.67 |
LCx (%) |
13.26 |
lesion length (mm) |
29.54 (stent) |
male (%) |
79.19 |
Lesion diameter inclusion criteria |
2.25-4.0 mm |
left main coronary artery disease |
0.81 |
STEMI |
100% |
Stable angina |
0% |
single vessel patients |
53.44 |
multi vessels patients |
46.56 |
|
Method and design
Randomized effectives |
60 / 54 (studied vs. control) |
Design |
Parallel groups |
Blinding |
open |
Follow-up duration |
1y |
Geographic area |
Spain |
Hypothesis |
Superiority |
Primary endpoint |
cardiac death, MI, TLR |
Results
Endpoints and data reported in the trial's publication(s)
Endpoint |
Events (%) |
Relative Risk |
95% CI |
|
Studied treat. |
Control treat. |
Death at 30D |
2 / 60 (3,3%) |
2 / 54 (3,7%) |
0,90 |
[0,13;6,17] |
|
Death or nonfatal reinfarction at 30D |
3 / 60 (5,0%) |
3 / 54 (5,6%) |
0,90 |
[0,19;4,27] |
|
Urgent TVR at 30D |
1 / 60 (1,7%) |
1 / 54 (1,9%) |
0,90 |
[0,06;14,04] |
|
Acute or subacute stent thrombosis at 30D |
1 / 60 (1,7%) |
1 / 54 (1,9%) |
0,90 |
[0,06;14,04] |
|
Death/reinfarction/urgent TVR at 30D |
3 / 60 (5,0%) |
3 / 54 (5,6%) |
0,90 |
[0,19;4,27] |
|
Death at 1y |
3 / 60 (5,0%) |
2 / 54 (3,7%) |
1,35 |
[0,23;7,78] |
|
Death or nonfatal reinfarction at 1y |
4 / 60 (6,7%) |
3 / 54 (5,6%) |
1,20 |
[0,28;5,12] |
|
TVR at 1y |
0 / 60 (0,8%) |
3 / 54 (5,6%) |
0,15 |
[0,01;2,93] |
|
Late stent thrombosis at 1y |
1 / 60 (1,7%) |
0 / 54 (0,9%) |
1,80 |
[0,06;52,60] |
|
Total death/reinfarction/TVR at 1y |
4 / 60 (6,7%) |
6 / 54 (11,1%) |
0,60 |
[0,18;2,01] |
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Meta-analysis of all similar trials:
Drug eluting stent in coronary artery disease for acute myocardial infarction
myocardial revascularization in acute myocardial infarction for all type of patients
PCI in acute myocardial infarction for all type of patients
Reference(s)
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Daz de la Llera LS, Ballesteros S, Nevado J, Fernndez M, Villa M, Snchez A, Retegui G, Garca D, Martnez A.
Sirolimus-eluting stents compared with standard stents in the treatment of patients with primary angioplasty..
Am Heart J 2007;154:164.e1-6
Pubmed
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Hubmed
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