PMID- 17161049 OWN - NLM STAT- MEDLINE DCOM- 20070108 LR - 20220318 IS - 1097-6744 (Electronic) IS - 0002-8703 (Linking) VI - 152 IP - 6 DP - 2006 Dec TI - Efficacy and safety of enoxaparin compared with unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention in the Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial. PG - 1042-50 AB - BACKGROUND: Enoxaparin reduces ischemic events more effectively than unfractionated heparin (UFH) in patients treated conservatively for non-ST-segment elevation acute coronary syndrome. The SYNERGY trial compared these agents in high-risk patients undergoing early invasive treatment. Enoxaparin was noninferior to UFH for the 30-day primary end point of death/myocardial infarction (MI), but modestly increased bleeding. METHODS AND RESULTS: This article compares the outcomes of the 4687 SYNERGY patients (47%) undergoing percutaneous coronary intervention, who were randomized to receive enoxaparin or UFH. Antithrombotic therapy was administered prerandomization in 78%. Crossover (usually in the catheterization laboratory) to the alternative antithrombotic occurred in 14.6% of enoxaparin patients and 2.9% of UFH-treated patients (P < .0001). Stenting was performed in 86.3%. Abrupt vessel closure occurred in 1.3% of enoxaparin patients and 1.7% of UFH-treated patients (P = .318). The rates of death/MI were similar at 30 days (13.1% with enoxaparin vs 14.2% with UFH, P = .289). GUSTO severe bleeding occurred with similar frequency in both groups (1.5% vs 1.6%, P = .688). TIMI major bleeding was more common with enoxaparin (3.7% vs 2.5% with UFH, P = .028). Transfusions were more frequent with enoxaparin than with UFH (6.8% vs 5.4%, P = .047). TIMI major bleeding increased with crossover from enoxaparin to UFH (from 3.7% to 7.8%) and from UFH to enoxaparin (from 2.5% to 8.6%). Statistical adjustment to model reasons for crossover did not affect the overall safety and efficacy outcomes. CONCLUSIONS: In high-risk patients undergoing early percutaneous coronary intervention for acute coronary syndrome, enoxaparin avoids the need for monitoring and achieves similar effectiveness to UFH but is associated with more bleeding. FAU - White, Harvey D AU - White HD AD - Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. harveyw@adhb.govt.nz FAU - Kleiman, Neal S AU - Kleiman NS FAU - Mahaffey, Kenneth W AU - Mahaffey KW FAU - Lokhnygina, Yuliya AU - Lokhnygina Y FAU - Pieper, Karen S AU - Pieper KS FAU - Chiswell, Karen AU - Chiswell K FAU - Cohen, Marc AU - Cohen M FAU - Harrington, Robert A AU - Harrington RA FAU - Chew, Derek P AU - Chew DP FAU - Petersen, John L AU - Petersen JL FAU - Berdan, Lisa G AU - Berdan LG FAU - Aylward, Philip E G AU - Aylward PE FAU - Nessel, Christopher C AU - Nessel CC FAU - Ferguson, James J 3rd AU - Ferguson JJ 3rd FAU - Califf, Robert M AU - Califf RM LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Am Heart J JT - American heart journal JID - 0370465 RN - 0 (Anticoagulants) RN - 0 (Enoxaparin) RN - 0 (Platelet Glycoprotein GPIIb-IIIa Complex) RN - 9005-49-6 (Heparin) SB - IM EIN - Am Heart J. 2007 Feb;153(2):327 MH - Acute Disease MH - Aged MH - *Angioplasty, Balloon, Coronary MH - Anticoagulants/adverse effects/*therapeutic use MH - Blood Transfusion MH - Coronary Disease/*therapy MH - Cross-Over Studies MH - Enoxaparin/adverse effects/*therapeutic use MH - Female MH - Hemorrhage/chemically induced/therapy MH - Heparin/adverse effects/*therapeutic use MH - Humans MH - Male MH - Middle Aged MH - Platelet Glycoprotein GPIIb-IIIa Complex/*antagonists & inhibitors MH - Risk Factors MH - Syndrome MH - Treatment Outcome EDAT- 2006/12/13 09:00 MHDA- 2007/01/09 09:00 CRDT- 2006/12/13 09:00 PHST- 2006/04/11 00:00 [received] PHST- 2006/08/02 00:00 [accepted] PHST- 2006/12/13 09:00 [pubmed] PHST- 2007/01/09 09:00 [medline] PHST- 2006/12/13 09:00 [entrez] AID - S0002-8703(06)00718-6 [pii] AID - 10.1016/j.ahj.2006.08.002 [doi] PST - ppublish SO - Am Heart J. 2006 Dec;152(6):1042-50. doi: 10.1016/j.ahj.2006.08.002.