A direct comparison of intravenous enoxaparin with unfractionated heparin in primary percutaneous coronary intervention (from the ATOLL trial).

Abstract

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.

• Authors: Jean-Philippe Collet, Kurt Huber, Marc Cohen, Uwe Zeymer, Patrick Goldstein, Charles Pollack Jr, Johanne Silvain, Patrick Henry, Olivier Varenne, Didier Carrié, Pierre Coste, Michael Angioi, Hervé Le Breton, Guillaume Cayla, Simon Elhadad, Emmanuel Teiger, Emmanuelle Filippi, Mounir Aout, Eric Vicaut, Gilles Montalescot, ATOLL Investigators
• Journal: The American journal of cardiology (Am J Cardiol) Vol. 112 Issue 9 Pg. 1367-72 (Nov 01 2013) ISSN: 1879-1913 [Electronic] United States
• PMID: 24012033 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Elsevier Inc. All rights reserved.

Chemical References

• Anticoagulants
• Enoxaparin
• Heparin

Topics

• Aged
• Anticoagulants (administration & dosage)
• Austria (epidemiology)
• Cause of Death (trends)
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Electrocardiography
• Enoxaparin (administration & dosage)
• Female
• Follow-Up Studies
• France (epidemiology)
• Germany (epidemiology)
• Heparin (administration & dosage)
• Humans
• Incidence
• Injections, Intravenous
• Injections, Subcutaneous
• Intraoperative Period
• Male
• Middle Aged
• Myocardial Infarction (drug therapy, mortality)
• Percutaneous Coronary Intervention
• Postoperative Complications (epidemiology)
• Prospective Studies
• Survival Rate (trends)
• Treatment Outcome
• United States (epidemiology)