One-year results of the Thrombolysis in Myocardial Infarction investigation (TIMI) Phase II Trial.
Why the study?
Does a routine invasive strategy reduce death and nonfatal reinfarction compared to a conservative strategy in patients with acute myocardial infarction treated with rt-PA?
Population
3,339 patients with acute myocardial infarction treated with intravenous recombinant tissue-type plasminogen…
Comparison
Invasive strategy (routine cardiac… vs Conservative strategy
Design
RCT, randomized
Follow-up
1 year
Authors
Discussion
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Implication
Routine invasive strategy after thrombolysis offers no advantage; confirms conservative ischemia-guided approach as standard in AMI.
Key Points
- To evaluate one-year clinical outcomes of a routine invasive strategy compared with a conservative ischemia-guided strategy following thrombolytic therapy for acute myocardial infarction.
- Randomized trial allocating 3,339 acute myocardial infarction patients receiving intravenous rt-PA to either routine early cardiac catheterization and PTCA (invasive, n=1,681) or catheterization only for spontaneous/provoked ischemia (conservative, n=1,658).
- Completed one-year follow-up in 3,316 patients (99.3% follow-up rate) to track mortality, nonfatal reinfarction, and revascularization procedures.
- The primary endpoint of death and nonfatal reinfarction at 1 year occurred in 14.7% of the invasive group and 15.2% of the conservative group (p = NS).
- Individual 1-year outcomes showed no significant differences for overall mortality (6.9% invasive vs 7.4% conservative; p = NS) or recurrent infarction (9.4% invasive vs 9.8% conservative; p = NS).
- In a subgroup analysis of patients with a history of myocardial infarction, 1-year mortality was lower with the invasive strategy (10.3%) compared to the conservative strategy (17.0%; p = 0.03).
Structured PICO
Does a routine invasive strategy reduce death and nonfatal reinfarction compared to a conservative strategy in patients with acute myocardial infarction treated with rt-PA?
P
Population
3,339 patients with acute myocardial infarction treated with intravenous recombinant tissue-type plasminogen activator (rt-PA)
I
Intervention
Invasive strategy (routine cardiac catheterization, and when anatomically appropriate, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass grafting 18-48 hours after infarction)
C
Comparator
Conservative strategy (cardiac catheterization and revascularization only in response to the occurrence of spontaneous or provoked ischemia)
O
Outcome
Composite of death and nonfatal reinfarction at 1 yearcomposite
A routine invasive strategy 18-48 hours after thrombolysis for acute myocardial infarction does not improve 1-year mortality or reinfarction rates compared to a conservative, ischemia-guided strategy.
Cite This Study
Williams et al. (1992) studied this question.