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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.

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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

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Indications for fibrinolytic therapy in suspected acute myocardial infarction: collaborative overview of early mortality and major morbidity results from all randomised trials of more than 1000 patients


Review published: .

Authors' objectives

To measure the effects on morbidity and mortality of treatment with fibrinolytic therapy (FT), on patients with suspected acute myocardial infarction (AMI) in randomised trials of more than 1,000 patients.


The authors do not state which sources were searched, or how they were searched.

Study selection

Study designs of evaluations included in the review

Randomised controlled trials (RCTs).

Specific interventions included in the review

FT: streptokinase, anistreplase, tissue plasminogen activator (alteplase or duteplase) and urokinase.

Participants included in the review

Patients with suspected MI; 58,600 patients randomised equally to treatment and control groups.

Outcomes assessed in the review

Proportional and absolute mortality at 35 days. Proportional and absolute number of strokes and non-cerebral bleeding events.

How were decisions on the relevance of primary studies made?

The authors do not state how the papers were selected for the review, or how many of the authors performed the selection.

Assessment of study quality

Individual patient data obtained from studies were checked and reanalysed.

Trials were included if randomisation was carried out in a manner that precluded prior knowledge of the next treatment; only those that did not include other confounding treatments and had sample sizes of at least 1,000 patients were included. The authors do not state how the papers were assessed for validity, or how many of the authors performed the validity assessment.

Data extraction

The required tabular data were calculated from original patient data in 7 studies, and obtained from the authors for the remaining 2 studies.

Methods of synthesis

How were the studies combined?

The overall effect of FT and the effects in subgroups were estimated using Peto's method of meta-analysis (see Other Publications of Related Interest).

How were differences between studies investigated?

Effects were analysed in 8 subgroups, as defined by entry ECG, hours from onset of symptoms, age, sex, systolic blood-pressure, heart rate, history of AMI and presence of diabetes. Tests for heterogeneity were carried out.

Results of the review

Nine RCTs involving 58,600 patients were included.

Mortality Outcomes.

Overall: fibrinolytic 9.6%, control 11.5%.

This is an 18% (standard deviation-squared, SD2) proportional reduction in 35-day mortality (95% confidence interval: 13, 23), which represents the avoidance of about 18 deaths per 1,000 patients allotted treatment.

Mortality rates were higher on the day of randomisation with an excess of 5 deaths per 1,000 patients allotted treatment.

There were significant trends towards greater proportional and absolute mortality reductions among patients treated earlier after symptom onset: 26% in patients presenting in less than 3 hours, 18% in patients presenting in 4 to 6 hours and 14% in patients presenting at 7 to 12 hours.

Older patients are at higher absolute risk of death from AMI, but absolute mortality reductions appear similar among older and younger patients.

The benefit of FT is highest amongst patients with bundle-branch block or ST elevation. Patients with ST depression or other ECG abnormalities showed no conclusive evidence of benefit.

Strokes and non-cerebral bleeding.

FT was associated with a small but significant number of extra strokes occurring within the first day, i.e. 3.9 (SD 0.8) per 1,000 patients, and also an extra 7.3(SD 0.7) nonfatal major bleeds per 1,000 patients.

Authors' conclusions

This overview of the 9 largest fibrinolytic trials demonstrates that treatment is beneficial for a wide range of patients with suspected AMI, many of whom are still not routinely given FT. Moreover, it has helped to characterise the early excess of deaths and strokes associated with FT, and to show that this is outweighed by a much larger benefit in the proceeding weeks.

CRD commentary

A detailed review of the largest trials in this area, which when combined allow the drawing of conclusions previously in doubt; in particular, the area of patient benefits and how soon treatment must be delivered to be effective. The absence of information on treatment regime differences does not allow generalisations regarding the 'best' form of treatment, only that FT is generally advantageous. The absence of information also requires the reader to gather further information prior to making a definitive decision regarding the delivery of care to patients with suspected AMI.


British Heart Foundation.

Bibliographic details

Fibrinolytic Therapy Trialists' (FTT) Collaborative Group. Indications for fibrinolytic therapy in suspected acute myocardial infarction: collaborative overview of early mortality and major morbidity results from all randomised trials of more than 1000 patients. Lancet 1994; 343(8893); 343(8899): 311-322; 742. [PubMed: 7905143]

Other publications of related interest

Yusuf S, Peto R, Lewis J, Collins R, Sleight P. Beta blockade during and after myocardial infarction: an overview of the randomized trials. Prog Cardiovasc Dis 1985;27:335-71.

Indexing Status

Subject indexing assigned by NLM


Adult; Aged; Anistreplase /therapeutic use; Female; Humans; Male; Middle Aged; Morbidity; Multicenter Studies as Topic; Myocardial Infarction /drug therapy /mortality; Odds Ratio; Randomized Controlled Trials as Topic /statistics & numerical data; Streptokinase /therapeutic use; Thrombolytic Therapy; Tissue Plasminogen Activator /therapeutic use; Urokinase-Type Plasminogen Activator /therapeutic use



Database entry date


Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

Copyright © 2014 University of York.
Bookshelf ID: NBK66304


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