Related trials
OPTIMA, 2009 - immediate invasive management vs delayed invasive strategy
TIMACS, 2009 - early invasive management vs delayed invasive strategy
ABOARD, 2009 - immediate invasive management vs delayed invasive strategy
ICTUS, 2007 - routine invasive strategy vs concervative strategy
NQWMI (Eisenberg), 2005 - routine invasive strategy vs concervative strategy
ISAR-COOL, 2003 - early intervention vs early strategy
RITA 3, 2002 - routine invasive strategy vs concervative strategy
VINO, 2002 - routine invasive strategy vs concervative strategy
TACTICS-TIMI 18, 2001 - routine invasive strategy vs concervative strategy
TRUCS, 2000 - routine invasive strategy vs concervative strategy
FRISC 2, 1999 - routine invasive strategy vs concervative strategy
MATE, 1998 - routine invasive strategy - noncomptemporary vs concervative strategy
VANQWISH, 1998 - routine invasive strategy - noncomptemporary vs concervative strategy
TIMI 3B, 1995 - t-PA vs placebo
TIMI 3B (PTCA), 1994 - routine invasive strategy - noncomptemporary vs concervative strategy
TAUSA, 1994 - intracoronary urokinase vs placebo
TIMI 3A, 1993 - t-PA vs placebo
Freeman, 1992 - t-PA vs placebo
UNASEM, 1992 - anistreplase vs placebo
charbonnier, 1992 - t-PA vs placebo
van der Brand, 1991 - t-PA vs placebo
Ardissino, 1990 - t-PA vs placebo
Williams, 1990 - t-PA vs placebo
Nicklas, 1989 - t-PA vs placebo
Topol, 1988 - t-PA vs placebo
See also:
All acute coronary syndrome clinical trials
All clinical trials of myocardial revascularization
All clinical trials of routine invasive strategy
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TACTICS-TIMI 18 study, 2001
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Treatments
| Studied treatment |
early invasive management strategy
coronary angiography at 4 to 48 hours
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| Control treatment |
conservative management strategy
medical therapy and predischarge exercise testing
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| Treatments description |
| history of MI |
866 (39%) |
| Female (%) |
34% |
| Age |
62 |
| Time to cardiac catheterization routine invasive group, h |
22 h (median) |
| ST-segment elevation |
266 (12%) |
| ST-segment depression |
688 (31%) |
| T-wave inversion |
777 (35%) |
| diabetes |
28% |
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Patients
| Patients |
patients with non–ST-segment elevation acute coronary syndrome |
| Inclusion criteria |
older than
18 years of age; episode of angina in the preceding
24 hours; |
| Exclusion criteria |
persistent ST-segment elevation; secondary angina; percutaneous coronary revascularization or coronary bypass surgery within the previous 6 months; a history of gastrointestinal bleeding, platelet disorder, or thrombocytopenia; any history of hemorrhagic cerebrovascular disease or a history of nonhemorrhagic cerebrovascular disease or transient ischemic attack within 1 year; left bundle-branch block or paced rhythm; severe congestive heart failure or cardiogenic shock; clinically important systemic disease; serum creatinine concentration greater than 220 µmol/L; treatment with a glycoprotein IIb/IIIa antagonist within the past 96 hours; or ongoing long-term treatment with ticlopidine, clopidogrel, or warfarin |
| Baseline characteristics |
| GpIIb/IIIa inhibitors, % |
94%/99% |
| Background antithrombotic treatment |
Aspirin, UFH, tirofiban |
| Time to cardiac catheterization, median (h) |
22/79 |
| Thrombolytic therapy |
0 |
| Suspected MI at randomization |
826 (37%) |
| Revascularization during initial hopsitalization (routine/selective) % |
60%/36% |
| revascularization at end of follow up (routine/selective) % |
61/44 |
| PCI with stent (%) |
83/86 |
| Inductible ischemia in conservative strategy |
No recommendation |
| Thienopyridine with PCI, % |
NA |
| Statin at follow-up, % |
NA |
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Method and design
| Randomized effectives |
1114 / 1106 (studied vs. control) |
| Design |
Parallel groups |
| Blinding |
open |
| Follow-up duration |
6 mo |
| Number of centre |
169 |
| Geographic area |
9 countries |
| Hypothesis |
Superiority |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
In hospital non fatal MI
27 / 1114
44 / 1106
0,61 [0,38;0,98]
In-hospital death
16 / 1114
8 / 1106
classic
1,99 [0,85;4,62]
In hospital death or MI
38 / 1114
49 / 1106
0,77 [0,51;1,17]
All cause death
37 / 1114
39 / 1106
0,94 [0,61;1,47]
Deaths or MI
81 / 1114
105 / 1106
0,77 [0,58;1,01]
rehospitalization
123 / 1114
152 / 1106
0,80 [0,64;1,00]
Non fatal MI
53 / 1114
76 / 1106
0,69 [0,49;0,97]
CCS class III-IV angina
80 / 1114
73 / 1106
1,09 [0,80;1,48]
0
2
1.0
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Relative risks
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| Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
| Studied treat. |
Control treat. |
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In hospital non fatal MI
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27 / 1114 (2,4%) |
44 / 1106 (4,0%) |
0,61 |
[0,38;0,98] |
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In-hospital death
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16 / 1114 (1,4%) |
8 / 1106 (0,7%) |
1,99 |
[0,85;4,62] |
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In hospital death or MI
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38 / 1114 (3,4%) |
49 / 1106 (4,4%) |
0,77 |
[0,51;1,17] |
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All cause death
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37 / 1114 (3,3%) |
39 / 1106 (3,5%) |
0,94 |
[0,61;1,47] |
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Deaths or MI
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81 / 1114 (7,3%) |
105 / 1106 (9,5%) |
0,77 |
[0,58;1,01] |
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rehospitalization
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123 / 1114 (11,0%) |
152 / 1106 (13,7%) |
0,80 |
[0,64;1,00] |
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Non fatal MI
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53 / 1114 (4,8%) |
76 / 1106 (6,9%) |
0,69 |
[0,49;0,97] |
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CCS class III-IV angina
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80 / 1114 (7,2%) |
73 / 1106 (6,6%) |
1,09 |
[0,80;1,48] |
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The primary endpoint (if exists) appears in blod characters
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Reference(s) used for data extraction:
0:
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| Endpoint |
studied treat. |
control treat. |
mean diff |
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Absolute risk reduction
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| Endpoint |
Events rate |
Absolute risk reduction (ARR) |
| Studied treat. |
Control treat. |
| In hospital non fatal MI |
2,42% |
3,98% |
-15,5‰
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| In-hospital death |
1,44% |
7,23‰ |
7,1‰
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| In hospital death or MI |
3,41% |
4,43% |
-10,2‰
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| All cause death |
3,32% |
3,53% |
-2,0‰
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| Deaths or MI |
7,27% |
9,49% |
-22,2‰
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| rehospitalization |
11,04% |
13,74% |
-27,0‰
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| Non fatal MI |
4,76% |
6,87% |
-21,1‰
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| CCS class III-IV angina |
7,18% |
6,60% |
5,8‰
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Reference(s)
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Cannon CP, Weintraub WS, Demopoulos LA, Vicari R, Frey MJ, Lakkis N, Neumann FJ, Robertson DH, DeLucca PT, DiBattiste PM, Gibson CM, Braunwald E.
Comparison of early invasive and conservative strategies in patients with unstable coronary syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban..
N Engl J Med 2001 Jun 21;344:1879-87
Pubmed
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Hubmed
| Fulltext
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