CLINICAL RESEARCH: CLINICAL TRIAL
The safety and efficacy of subcutaneous enoxaparin versus intravenous unfractionated heparin and tirofiban versus placebo in the treatment of acute ST-segment elevation myocardial infarction patients ineligible for reperfusion (TETAMI)
A randomized trial
Marc Cohen, MD, FACC*,*,
Gian Franco Gensini, MD ,
Frans Maritz, MD ,
Enrique P. Gurfinkel, MD, PhD, FACC ,
Kurt Huber, MD, FACC||,
Ari Timerman, MD, PhD¶,
Maria Krzeminska-Pakula, MD#,
Nicolas Danchin, MD, FACC**,
Harvey D. White, DSc,
Jose Santopinto, MD, FACC,
Frederique Bigonzi, MD,
Carole Hecquet, MS,
Luc Vittori, MS TETAMI Investigators
* Newark Beth Israel Medical Center, Newark, New Jersey, USA
University of Florence, Florence, Italy
Karl Bremer Hospital, Bellville, South Africa
Favaloro Foundation, Buenos Aires, Argentina
|| University Clinic for Internal Medicine, Vienna, Austria
¶ Dante Pazzanese Institute of Cardiology, São Paulo, Brazil
# Medical University Lodz, Lodz, Poland
** Georges Pompidou Hospital, Paris, France
Green Lane Hospital, Auckland, New Zealand
Leonidas Lucero Municipal Hospital, Bahia Blanca, Argentina
Aventis Pharmaceuticals, Paris, France
Manuscript received March 12, 2003;
revised manuscript received April 28, 2003,
accepted May 9, 2003.
* Reprint requests and correspondence: Dr. Marc Cohen, Cardiac Catheterization Laboratory, Newark Beth Israel Medical Center, Newark, New Jersey 07112, USA.
marcohen{at}sbhcs.com
OBJECTIVES: The aims of the Safety and Efficacy of Subcutaneous Enoxaparin Versus Intravenous Unfractionated Heparin and Tirofiban Versus Placebo in the Treatment of Acute ST-Segment Elevation Myocardial Infarction Patients Ineligible for Reperfusion (TETAMI) study were to demonstrate that enoxaparin was superior to unfractionated heparin (UFH) and that tirofiban was better than placebo in patients with acute ST-segment elevation myocardial infarction (STEMI) who do not receive timely reperfusion.
BACKGROUND: An optimal treatment strategy has not been identified for the many STEMI patients ineligible for acute reperfusion.
METHODS: A total of 1,224 patients were enrolled in 91 centers in 14 countries between July 1999 and July 2002. Patients with STEMI ineligible for reperfusion were randomized to enoxaparin, enoxaparin plus tirofiban, UFH, or UFH plus tirofiban. All patients received oral aspirin. The primary efficacy end point was the 30-day combined incidence of death, reinfarction, or recurrent angina; the primary analysis was the comparison of the pooled enoxaparin and UFH groups.
RESULTS: The incidence of the primary efficacy end point was 15.7% enoxaparin versus 17.3% for UFH (odds ratio 0.89 [95% confidence interval {CI} = 0.66 to 1.21]) and 16.6% for tirofiban versus 16.4% for placebo (odds ratio 1.02 [95% CI 0.75 to 1.38]). The Thrombolysis In Myocardial Infarction (TIMI) major hemorrhage rate was 1.5% for enoxaparin versus 1.3% for UFH (odds ratio 1.16 [95% CI 0.44 to 3.02]) and 1.8% versus 1% for tirofiban versus placebo (odds ratio 1.82 [95% CI 0.67 to 4.95]).
CONCLUSIONS: This study did not show that enoxaparin significantly reduced the 30-day incidence of death, reinfarction, and recurrent angina compared with UFH in non-reperfused STEMI patients. However, enoxaparin appears to have a similar safety and efficacy profile to UFH and may be an alternative treatment. Additional therapy with tirofiban did not appear beneficial.
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Abbreviations and Acronyms
| | aPTT | = activated partial thromboplastin time | | CABG | = coronary artery bypass grafting | | CI | = confidence interval | | LMWH | = low-molecular-weight heparin | | MI | = myocardial infarction | | PCI | = percutaneous coronary interventions | | PTCA | = percutaneous transluminal coronary angioplasty | | STEMI | = ST-segment elevation myocardial infarction | | TETAMI | = Safety and Efficacy of Subcutaneous Enoxaparin Versus Intravenous UFH With and Without Tirofiban in the Treatment of Acute Myocardial Infarction in patients ineligible for reperfusion | | UFH | = unfractionated heparin |
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