Related trials
TRIANA, 2009 - primary ballon angioplasty vs tenecteplase
DEBATER (SES vs BMS), 2009 - sirolimus eluting stent vs bare-metal stent
NORDISTEMI, 2009 - thrombolysis + angioplasty vs immediate thrombolysis
Juwana, 2009 - sirolimus eluting stent vs paclitaxel eluting stent
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PASEO, 2009 - drug-eluting stents vs bare-metal stent
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D�az de la Llera, 2007 - sirolimus eluting stent vs bare-metal stent
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HAAMU-STENT, 2006 - paclitaxel eluting stent vs bare-metal stent
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senior PAMI, 2005 - primary PCI vs Thrombolysis
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See also:
All acute myocardial infarction clinical trials
All clinical trials of PCI
All clinical trials of sirolimus eluting stent
|
|
Treatments
Studied treatment |
sirolimus coated Cypher stent
|
Control treatment |
paclitaxel coated
Taxus stent
|
Patients
Patients |
patients with STEMI undergoing primary PCI |
Inclusion criteria |
patients with STEMI within 6 hours after
symptom onset or between 6 to 24 hours with
persistent chest pain associated with clinical evidence of
ongoing ischemia; culprit lesion
in a native coronary artery, suitable for stenting, with a
lesion length 30 mm and a vessel diameter 2.5 mm |
Exclusion criteria |
women of child-bearing potential,
patients with severe hepatic or renal disease, previous participation
in the study, life expectancy 1 year, factors
making follow-up difficult, pretreatment with thrombolysis,
unprotected left main coronary artery disease or single remaining
vessel, target lesion in a bifurcation with a large side branch, known sensitivity to aspirin, clopidogrel, or
coumarin |
Baseline characteristics |
age |
61 y |
diabetes (%) |
8.6% |
Smoker (%) |
50% (current) |
LAD (%) |
42% |
RCA (%) |
41% |
LCx (%) |
15.9% |
lesion length (mm) |
23.24 mm |
male (%) |
72% |
reference-vessel diameter |
3.2 mm |
STEMI |
100� |
multi vessels patients |
34.5% |
|
Method and design
Randomized effectives |
196 / 201 (studied vs. control) |
Design |
Parallel groups |
Blinding |
open |
Follow-up duration |
9 months (12 months) |
Number of centre |
single center |
Geographic area |
The Netherlands |
Primary endpoint |
late lumen loss |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
MACE
19 / 196
19 / 201
1,03 [0,56;1,88]
All cause death
7 / 196
5 / 201
classic
1,44 [0,46;4,45]
MI (fatal and non fatal)
6 / 196
6 / 201
classic
1,03 [0,34;3,13]
target-vessel revascularization
11 / 196
13 / 201
0,87 [0,40;1,89]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
MACE
|
19 / 196 (9,7%) |
19 / 201 (9,5%) |
1,03 |
[0,56;1,88] |
|
|
All cause death
|
7 / 196 (3,6%) |
5 / 201 (2,5%) |
1,44 |
[0,46;4,45] |
|
|
MI (fatal and non fatal)
|
6 / 196 (3,1%) |
6 / 201 (3,0%) |
1,03 |
[0,34;3,13] |
|
|
target-vessel revascularization
|
11 / 196 (5,6%) |
13 / 201 (6,5%) |
0,87 |
[0,40;1,89] |
|
|
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
MACE |
9,69% |
9,45% |
2,4‰
|
All cause death |
3,57% |
2,49% |
1,1%
|
MI (fatal and non fatal) |
3,06% |
2,99% |
0,8‰
|
target-vessel revascularization |
5,61% |
6,47% |
-8,6‰
|
Meta-analysis of all similar trials:
myocardial revascularization in acute myocardial infarction for all type of patients
PCI in acute myocardial infarction for all type of patients
Reference(s)
-
Juwana YB, Suryapranata H, Ottervanger JP, De Luca G, van't Hof AW, Dambrink JH, de Boer MJ, Gosselink AT, Hoorntje JC.
Comparison of rapamycin- and paclitaxel-eluting stents in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction..
Am J Cardiol 2009;104:205-9
Pubmed
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Hubmed
| Fulltext
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