Triflusal in Myocardial Infarction - TIM

Aug 10, 2005
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Date Published:
01/01/2000
Date Updated:
08/10/2005
Original Posted Date:
08/10/2005
References

Description:

TIM was a double-blind, multicenter, randomized, active-control study designed to compare triflusal with aspirin for the prevention of cardiovascular events after acute myocardial infarction.

Hypothesis:

Treatment with triflusal would decrease cardiovascular events and have a favorable safety profile in patients after acute myocardial infarction compared with aspirin.

Study Design

Study Design:

Patients Screened: 6615
Patients Enrolled: 2124
Mean Follow Up: 35 days
Mean Patient Age: 18-80 years, mean age 61 years
Female: 18

Patient Populations:

Acute myocardial infarction within 24 hours and either 1) ST-elevation >1mm in 2 limb leads or >2mm in 2 consecutive precordial leads, Q wave or new Q wave or 2) CK > twice the upper limit of normal within 24 hours of symptoms.

Exclusions:

Antiplatelet drugs within 15 days, history of peptic ulcer disease or blood dyscrasia, hepatic or renal disease, history of cerebrovascular hemorrhage, diastolic BP > 115 mmHg, requirement for NSAIDs, HIV, pregnant or breast-feeding women, or life expectancy less than one year.

Primary Endpoints:

Combined death, non-fatal myocardial reinfarction, or non-fatal cerebrovascular event

Secondary Endpoints:

Individual outcomes of death, non-fatal myocardial reinfarction, non-fatal cerebrovascular event, and urgent revascularization.

Drug/Procedures Used:

Patients presenting with acute myocardial infarction and no recent antiplatelet agent use were enrolled within 24 hours of symptom onset. Patients were randomized to treatment with triflusal 600 mg or aspirin 300 mg orally once daily for 35 days in a double-blind fashion. Patients were evaluated at enrollment, hospital discharge, and at the conclusion of treatment on day 35.

Concomitant Medications:

Beta blockers (42%), ACE inhibitors (29%), Heparin (88%), fibrinolytic agents (71%)

Principal Findings:

2124 patients were followed for 35 days after acute MI. Baseline characteristics did not differ significantly between the two groups. 94% of patients had no history of myocardial infarction, 22% were diabetics, and 71% of patients enrolled received fibrinolytic therapy.

The primary combined endpoint occurred in 9.1% of patients receiving triflusal vs. 10.15% in patients receiving aspirin (OR 0.89, p=NS). Triflusal was associated with lower rate of non-fatal cerebrovascular events compared with aspirin (0.5% vs 1.3%, p=0.03). There was no significant difference in the other secondary endpoints of death, non-fatal MI, or urgent revascularization. The incidence of adverse events was similar in the 2 groups (34% for both groups), though there was lower rate of central nervous system bleeding associated with triflusal (0.3% vs 1.0%, p=0.03).

Interpretation:

Among patients with acute myocardial infarction, treatment with triflusal was associated with a similar rate of cardiovascular events at 30 days compared with aspirin. Triflusal was associated with a significantly lower incidence of cerebrovascular events and central nervous system hemorrhage. The majority of patients in this study were treated with fibrinolytic therapy, and follow-up was limited to 35 days after acute myocardial infarction.

References:

Cruz-Fernandez JM, Lopez-Bescos L, Gardcia-Dorado D, et al. Randomized comparative trial of triflusal and aspirin following acute myocardial infarction. Eur Heart J 2000;21:457-465.

Keywords: Salicylates, Thrombolytic Therapy, Myocardial Infarction, Follow-Up Studies, Platelet Aggregation Inhibitors, Nervous System, Coronary Disease, Diabetes Mellitus


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