title: 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.affiliation: Institut de Cardiologie, INSERM UMRS937, Hôpital Pitié-Salpêtrière (AP-HP), Université Paris 6, Paris, France; ACTION study group, Paris, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Collet
authors.forename: Kurt
authors.initials: K
authors.lastname: Huber
authors.forename: Marc
authors.initials: M
authors.lastname: Cohen
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.forename: Patrick
authors.initials: P
authors.lastname: Goldstein
authors.forename: Charles
authors.initials: C
authors.lastname: Pollack
authors.forename: Johanne
authors.initials: J
authors.lastname: Silvain
authors.forename: Patrick
authors.initials: P
authors.lastname: Henry
authors.forename: Olivier
authors.initials: O
authors.lastname: Varenne
authors.forename: Didier
authors.initials: D
authors.lastname: Carrié
authors.forename: Pierre
authors.initials: P
authors.lastname: Coste
authors.forename: Michael
authors.initials: M
authors.lastname: Angioi
authors.forename: Hervé
authors.initials: H
authors.lastname: Le Breton
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cayla
authors.forename: Simon
authors.initials: S
authors.lastname: Elhadad
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Teiger
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Filippi
authors.forename: Mounir
authors.initials: M
authors.lastname: Aout
authors.forename: Eric
authors.initials: E
authors.lastname: Vicaut
authors.forename: Gilles
authors.initials: G
authors.lastname: Montalescot
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage; D001317:Austria / Q000453:epidemiology; D002423:Cause of Death / Q000639:trends; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D017984:Enoxaparin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D005602:France / Q000453:epidemiology; D005858:Germany / Q000453:epidemiology; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D015994:Incidence; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D007432:Intraoperative Period; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality; D062645:Percutaneous Coronary Intervention; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D006493:Heparin