PMID- 24012033 OWN - NLM STAT- MEDLINE DCOM- 20131210 LR - 20220316 IS - 1879-1913 (Electronic) IS - 0002-9149 (Linking) VI - 112 IP - 9 DP - 2013 Nov 1 TI - A direct comparison of intravenous enoxaparin with unfractionated heparin in primary percutaneous coronary intervention (from the ATOLL trial). PG - 1367-72 LID - S0002-9149(13)01510-5 [pii] LID - 10.1016/j.amjcard.2013.07.003 [doi] AB - Intravenous enoxaparin did not reduce significantly the primary end point (p = 0.06) compared with unfractionated heparin (UFH) in the randomized Acute Myocardial Infarction Treated with primary angioplasty and intravenous enoxaparin Or unfractionated heparin to Lower ischemic and bleeding events at short- and Long-term follow-up (ATOLL) trial. We present the results of the prespecified per-protocol analysis excluding patients who did not receive the treatment allocated by randomization or received both enoxaparin and UFH. We evaluated all-cause mortality, complication of myocardial infarction, procedural failure, or major bleeding (primary end point) and all-cause mortality, recurrent acute coronary syndrome, or urgent revascularization (main secondary end point). Baseline and procedural characteristics were well balanced between the 2 treatment groups. Of 910 randomized patients, 795 patients (87.4%) were treated according to the protocol with consistent anticoagulation using intravenous enoxaparin (n = 400) or UFH (n = 395). Enoxaparin reduced significantly the rates of the primary end point (relative risk [RR] 0.76, 95% confidence interval [CI] 0.62 to 0.94, p = 0.012) and the main secondary end point (RR 0.37, 95% CI 0.22 to 0.63, p <0.0001). There was less major bleeding with enoxaparin (RR 0.46, 95% CI 0.21 to 1.01, p = 0.050) contributing to the significant improvement of the net clinical benefit (RR 0.46, 95% CI 0.3 to 0.74, p = 0.0002). All-cause mortality was also reduced with enoxaparin (RR 0.36, 95% CI 0.18 to 0.74, p = 0.003). In conclusion, in the per-protocol analysis of the ATOLL trial, pertinent to >87% of the study population, enoxaparin was superior to UFH in reducing ischemic end points and mortality. CI - Copyright (c) 2013 Elsevier Inc. All rights reserved. FAU - Collet, Jean-Philippe AU - Collet JP AD - Institut de Cardiologie, INSERM UMRS937, Hopital Pitie-Salpetriere (AP-HP), Universite Paris 6, Paris, France; ACTION study group, Paris, France. FAU - Huber, Kurt AU - Huber K FAU - Cohen, Marc AU - Cohen M FAU - Zeymer, Uwe AU - Zeymer U FAU - Goldstein, Patrick AU - Goldstein P FAU - Pollack, Charles Jr AU - Pollack C Jr FAU - Silvain, Johanne AU - Silvain J FAU - Henry, Patrick AU - Henry P FAU - Varenne, Olivier AU - Varenne O FAU - Carrie, Didier AU - Carrie D FAU - Coste, Pierre AU - Coste P FAU - Angioi, Michael AU - Angioi M FAU - Le Breton, Herve AU - Le Breton H FAU - Cayla, Guillaume AU - Cayla G FAU - Elhadad, Simon AU - Elhadad S FAU - Teiger, Emmanuel AU - Teiger E FAU - Filippi, Emmanuelle AU - Filippi E FAU - Aout, Mounir AU - Aout M FAU - Vicaut, Eric AU - Vicaut E FAU - Montalescot, Gilles AU - Montalescot G CN - ATOLL Investigators LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130905 PL - United States TA - Am J Cardiol JT - The American journal of cardiology JID - 0207277 RN - 0 (Anticoagulants) RN - 0 (Enoxaparin) RN - 9005-49-6 (Heparin) SB - IM MH - Aged MH - Anticoagulants/administration & dosage MH - Austria/epidemiology MH - Cause of Death/trends MH - Dose-Response Relationship, Drug MH - Drug Therapy, Combination MH - *Electrocardiography MH - Enoxaparin/*administration & dosage MH - Female MH - Follow-Up Studies MH - France/epidemiology MH - Germany/epidemiology MH - Heparin/*administration & dosage MH - Humans MH - Incidence MH - Injections, Intravenous MH - Injections, Subcutaneous MH - Intraoperative Period MH - Male MH - Middle Aged MH - Myocardial Infarction/*drug therapy/mortality MH - *Percutaneous Coronary Intervention MH - Postoperative Complications/epidemiology MH - Prospective Studies MH - Survival Rate/trends MH - Treatment Outcome MH - United States/epidemiology EDAT- 2013/09/10 06:00 MHDA- 2013/12/16 06:00 CRDT- 2013/09/10 06:00 PHST- 2013/05/22 00:00 [received] PHST- 2013/07/12 00:00 [revised] PHST- 2013/07/12 00:00 [accepted] PHST- 2013/09/10 06:00 [entrez] PHST- 2013/09/10 06:00 [pubmed] PHST- 2013/12/16 06:00 [medline] AID - S0002-9149(13)01510-5 [pii] AID - 10.1016/j.amjcard.2013.07.003 [doi] PST - ppublish SO - Am J Cardiol. 2013 Nov 1;112(9):1367-72. doi: 10.1016/j.amjcard.2013.07.003. Epub 2013 Sep 5.