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A direct comparison of intravenous enoxaparin with unfractionated heparin in primary percutaneous coronary intervention (from the ATOLL trial)
- Source :
- The American journal of cardiology. 112(9)
- Publication Year :
- 2013
-
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, p0.0001). 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 to87% of the study population, enoxaparin was superior to UFH in reducing ischemic end points and mortality.
- Subjects :
- Male
medicine.medical_specialty
Randomization
medicine.medical_treatment
Injections, Subcutaneous
Myocardial Infarction
Revascularization
law.invention
Electrocardiography
Intraoperative Period
Percutaneous Coronary Intervention
Postoperative Complications
Randomized controlled trial
law
Internal medicine
Cause of Death
Germany
medicine
Clinical endpoint
Humans
Myocardial infarction
Prospective Studies
Enoxaparin
Prospective cohort study
Aged
Dose-Response Relationship, Drug
business.industry
Heparin
Incidence
Percutaneous coronary intervention
Anticoagulants
Middle Aged
medicine.disease
United States
Survival Rate
Treatment Outcome
Austria
Injections, Intravenous
Cardiology
Drug Therapy, Combination
Female
France
Cardiology and Cardiovascular Medicine
business
medicine.drug
Follow-Up Studies
Subjects
Details
- ISSN :
- 18791913
- Volume :
- 112
- Issue :
- 9
- Database :
- OpenAIRE
- Journal :
- The American journal of cardiology
- Accession number :
- edsair.doi.dedup.....5546fc1919d73c6fcbd6f7036e5bfdee