What does this research mean for the field?

High doses of intravenous hirudin and weight-adjusted heparin used as adjunctive therapy to thrombolysis in acute myocardial infarction result in unacceptably high rates of major hemorrhage, which are strongly associated with prolonged aPTT levels. Novelty: ClaimNovelty.CONTRADICTORY. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

What question did this study set out to answer?

This trial aimed to compare the efficacy and safety of hirudin with heparin as treatment for acute myocardial infarction.

October 1, 1994Circulation

Hirudin in acute myocardial infarction. Safety report from the Thrombolysis and Thrombin Inhibition in Myocardial Infarction (TIMI) 9A Trial.

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Why the study?

Does intravenous hirudin compared to heparin improve safety (reduce major hemorrhage or anaphylaxis) in patients with acute myocardial infarction receiving thrombolysis and aspirin?

Key Points

This trial aimed to compare the efficacy and safety of hirudin with heparin as treatment for acute myocardial infarction.
Enrolled 757 patients in a randomized trial comparing intravenous hirudin and modified heparin therapy.
Hirudin administered as a 0.6 mg/kg bolus followed by a 96-hour infusion of 0.2 mg/kg per hour.
Heparin administered with initial bolus and infusion based on patient weight with aPTT aimed at 60 to 90 seconds.
Major spontaneous hemorrhage occurred in 7.0% of hirudin patients versus 3.0% in heparin patients (P = .02).
Incident of intracranial hemorrhage was 1.7% with hirudin and 1.9% with heparin (P = NS).
Higher aPTT levels correlated with increased risk of major hemorrhage in both groups.

Structured PICO

Does intravenous hirudin compared to heparin improve safety (reduce major hemorrhage or anaphylaxis) in patients with acute myocardial infarction receiving thrombolysis and aspirin?

Population

757 patients with acute myocardial infarction

Intervention

Intravenous hirudin (bolus 0.6 mg/kg followed by a fixed-dose 96-hour infusion of 0.2 mg/kg per hour) as adjunctive therapy to thrombolysis and aspirin

Comparator

Heparin (modified weight-adjusted regimen: 5000-U bolus and infusion of 1000 U/h for patients < 80 kg or 1300 U/h for patients >= 80 kg, titrated to a target aPTT of 60 to 90 seconds) as adjunctive therapy to thrombolysis and aspirin

Outcome

Occurrence of major hemorrhage or anaphylaxissafety

The TIMI 9A trial demonstrated that the selected doses of hirudin and heparin as adjuncts to thrombolysis in AMI caused unacceptably high rates of major hemorrhage, necessitating dose reductions and strict aPTT monitoring in subsequent trials.

Discussion

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Implication

Hirudin increases major nonintracranial bleeding versus heparin in thrombolyzed AMI; challenges phase II safety estimates and prompted subsequent dose reductions.

Cite This Study

Elliott M. Antman (1994) studied this question.

synapsesocial.com/papers/6a12831a8edbaba0bf676a9d https://doi.org/10.1161/01.cir.90.4.1624

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Implication

Hirudin increases major nonintracranial bleeding versus heparin in thrombolyzed AMI; challenges phase II safety estimates and prompted subsequent dose reductions.

Hirudin in acute myocardial infarction. Safety report from the Thrombolysis and Thrombin Inhibition in Myocardial Infarction (TIMI) 9A Trial.

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Hirudin in acute myocardial infarction. Safety report from the Thrombolysis and Thrombin Inhibition in Myocardial Infarction (TIMI) 9A Trial.

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Also Consider

Also Consider