PMID- 14563573 OWN - NLM STAT- MEDLINE DCOM- 20031107 LR - 20190708 IS - 0735-1097 (Print) IS - 0735-1097 (Linking) VI - 42 IP - 8 DP - 2003 Oct 15 TI - 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. PG - 1348-56 AB - 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 1224 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. FAU - Cohen, Marc AU - Cohen M AD - Newark Beth Israel Medical Center, Newark, New Jersey 07112, USA. marcohen@sbhcs.com FAU - Gensini, Gian Franco AU - Gensini GF FAU - Maritz, Frans AU - Maritz F FAU - Gurfinkel, Enrique P AU - Gurfinkel EP FAU - Huber, Kurt AU - Huber K FAU - Timerman, Ari AU - Timerman A FAU - Krzeminska-Pakula, Maria AU - Krzeminska-Pakula M FAU - Danchin, Nicolas AU - Danchin N FAU - White, Harvey D AU - White HD FAU - Santopinto, Jose AU - Santopinto J FAU - Bigonzi, Frederique AU - Bigonzi F FAU - Hecquet, Carole AU - Hecquet C FAU - Vittori, Luc AU - Vittori L CN - TETAMI Investigators LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 RN - 0 (Enoxaparin) RN - 0 (Fibrinolytic Agents) RN - 0 (Platelet Glycoprotein GPIIb-IIIa Complex) RN - 42HK56048U (Tyrosine) RN - 9005-49-6 (Heparin) RN - GGX234SI5H (Tirofiban) RN - R16CO5Y76E (Aspirin) SB - IM CIN - J Am Coll Cardiol. 2003 Oct 15;42(8):1357-9. PMID: 14563574 MH - Administration, Oral MH - Aspirin/administration & dosage/therapeutic use MH - Double-Blind Method MH - Drug Therapy, Combination MH - Electrocardiography MH - Enoxaparin/administration & dosage/*therapeutic use MH - Female MH - Fibrinolytic Agents/administration & dosage/*therapeutic use MH - Heparin/administration & dosage/*therapeutic use MH - Humans MH - Incidence MH - Injections, Intravenous MH - Injections, Subcutaneous MH - Male MH - Middle Aged MH - Myocardial Infarction/*drug therapy/mortality MH - Platelet Glycoprotein GPIIb-IIIa Complex/*antagonists & inhibitors MH - Recurrence MH - Time Factors MH - Tirofiban MH - Tyrosine/administration & dosage/analogs & derivatives/*therapeutic use EDAT- 2003/10/18 05:00 MHDA- 2003/11/08 05:00 CRDT- 2003/10/18 05:00 PHST- 2003/10/18 05:00 [pubmed] PHST- 2003/11/08 05:00 [medline] PHST- 2003/10/18 05:00 [entrez] AID - S0735109703010404 [pii] AID - 10.1016/s0735-1097(03)01040-4 [doi] PST - ppublish SO - J Am Coll Cardiol. 2003 Oct 15;42(8):1348-56. doi: 10.1016/s0735-1097(03)01040-4.