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
ZEST AMI (vs PES), 2009 - zotarolimus eluting stent vs paclitaxel eluting 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
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
D�az 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
Di Lorenzo et al., 2005 - sirolimus eluting stent vs paclitaxel eluting stent
GRACIA-1, 2004 - systematic PCI (+stent) vs no systematic PCI
MERLIN (Sutton), 2004 - immediate systematic ballon angioplastyte vs no immediate angioplasty
See also:
All acute myocardial infarction clinical trials
All clinical trials of PCI
All clinical trials of thrombolysis + angioplasty
|
|
Treatments
Studied treatment |
full-dose tenecteplase (TNK) plus PCI
thrombolysis with full-dose TNK followed by immediate transfer for angiography and possible PCI
|
Control treatment |
thrombolysis alone
|
Patients
Patients |
high-risk MI patients within six hours of symptom onset |
Method and design
Randomized effectives |
86 / 84 (studied vs. control) |
Design |
Parallel groups |
Blinding |
open |
Follow-up duration |
6 months |
Number of centre |
4 |
Geographic area |
US |
Results
Endpoints and data reported in the trial's publication(s)
Endpoint |
Events (%) |
Relative Risk |
95% CI |
|
Studied treat. |
Control treat. |
In-hospital Death |
2 / 86 (2,3%) |
3 / 84 (3,6%) |
0,65 |
[0,11;3,80] |
|
In-hospital Reinfarction |
3 / 86 (3,5%) |
11 / 84 (13,1%) |
0,27 |
[0,08;0,92] |
|
In-hospital Recurrent unstable ischemia� |
5 / 86 (5,8%) |
15 / 84 (17,9%) |
0,33 |
[0,12;0,86] |
|
In-hospital Stroke |
1 / 86 (1,2%) |
1 / 84 (1,2%) |
0,98 |
[0,06;15,36] |
|
In-hospital Death, reinfarction, or stroke |
5 / 86 (5,8%) |
14 / 84 (16,7%) |
0,35 |
[0,13;0,93] |
|
In-hospital Primary end point |
7 / 86 (8,1%) |
18 / 84 (21,4%) |
0,38 |
[0,17;0,86] |
|
Death At 30 days |
2 / 86 (2,3%) |
3 / 84 (3,6%) |
0,65 |
[0,11;3,80] |
|
Reinfarction At 30 days |
4 / 86 (4,7%) |
11 / 84 (13,1%) |
0,36 |
[0,12;1,07] |
|
Recurrent unstable ischemia At 30 days |
6 / 86 (7,0%) |
15 / 84 (17,9%) |
0,39 |
[0,16;0,96] |
|
Stroke At 30 days |
1 / 86 (1,2%) |
1 / 84 (1,2%) |
0,98 |
[0,06;15,36] |
|
Death, reinfarction, or stroke At 30 days |
6 / 86 (7,0%) |
14 / 84 (16,7%) |
0,42 |
[0,17;1,04] |
|
Primary end point At 30 days |
8 / 86 (9,3%) |
18 / 84 (21,4%) |
0,43 |
[0,20;0,94] |
|
Death At 6 months |
3 / 86 (3,5%) |
3 / 84 (3,6%) |
0,98 |
[0,20;4,70] |
|
Reinfarction At 6 months |
5 / 86 (5,8%) |
12 / 84 (14,3%) |
0,41 |
[0,15;1,11] |
|
Recurrent unstable ischemia At 6 months |
7 / 86 (8,1%) |
17 / 84 (20,2%) |
0,40 |
[0,18;0,92] |
|
Stroke At 6 months |
1 / 86 (1,2%) |
1 / 84 (1,2%) |
0,98 |
[0,06;15,36] |
|
Death, reinfarction, or stroke At 6 months |
8 / 86 (9,3%) |
15 / 84 (17,9%) |
0,52 |
[0,23;1,16] |
|
Primary end point At 6 months |
10 / 86 (11,6%) |
20 / 84 (23,8%) |
0,49 |
[0,24;0,98] |
|
Endpoints used by the meta-analysis and data retained for this trial
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
stroke (fatal and non fatal)
1 / 86
1 / 84
classic
0,98 [0,06;15,36]
reinfarction
5 / 86
12 / 84
0,41 [0,15;1,11]
death, reinfarctus, stroke
8 / 86
15 / 84
0,52 [0,23;1,16]
All cause death
3 / 86
3 / 84
classic
0,98 [0,20;4,70]
recurrent angina
7 / 86
17 / 84
0,40 [0,18;0,92]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
stroke (fatal and non fatal)
|
1 / 86 (1,2%) |
1 / 84 (1,2%) |
0,98 |
[0,06;15,36] |
Stroke At 6 months |
0 |
reinfarction
|
5 / 86 (5,8%) |
12 / 84 (14,3%) |
0,41 |
[0,15;1,11] |
Reinfarction At 6 months |
0 |
death, reinfarctus, stroke
|
8 / 86 (9,3%) |
15 / 84 (17,9%) |
0,52 |
[0,23;1,16] |
Death, reinfarction, or stroke At 6 months |
0 |
All cause death
|
3 / 86 (3,5%) |
3 / 84 (3,6%) |
0,98 |
[0,20;4,70] |
Death At 6 months |
0 |
recurrent angina
|
7 / 86 (8,1%) |
17 / 84 (20,2%) |
0,40 |
[0,18;0,92] |
Recurrent unstable ischemia At 6 months |
0 |
The primary endpoint (if exists) appears in blod characters
|
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. |
stroke (fatal and non fatal) |
1,16% |
1,19% |
-0,3‰
|
reinfarction |
5,81% |
14,29% |
-84,7‰
|
death, reinfarctus, stroke |
9,30% |
17,86% |
-85,5‰
|
All cause death |
3,49% |
3,57% |
-0,8‰
|
recurrent angina |
8,14% |
20,24% |
-121,0‰
|
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)
-
Le May MR, Wells GA, Labinaz M, Davies RF, Turek M, Leddy D, Maloney J, McKibbin T, Quinn B, Beanlands RS, Glover C, Marquis JF, O'Brien ER, Williams WL, Higginson LA.
Combined angioplasty and pharmacological intervention versus thrombolysis alone in acute myocardial infarction (CAPITAL AMI study)..
J Am Coll Cardiol 2005 Aug 2;46:417-24
Pubmed
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Hubmed
| Fulltext
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