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CLINICAL STUDY

A randomized, placebo-controlled trial of enoxaparin after high-risk coronary stenting: the ATLAST trial

Wayne B. Batchelor, MD, MHS^*, Kenneth W. Mahaffey, MD, FACC^*, Peter B. Berger, MD, FACC, Ezra Deutsch, MD, Susan Meier, BS, Vic Hasselblad, PhD^*, Edward T. Fry, MD^||, Paul S. Teirstein, MD, FACC^¶, Allan M. Ross, MD, FACC^#, Cynthia A. Binanay, RN^*, James P. Zidar, MD, FACC^*,* the ATLAST Trial Investigators

^* the Duke Clinical Research Institute, Durham, North Carolina, USA
Mayo Clinic, Rochester, Minnesota, USA
New York Presbyterian Hospital, New York, New York, USA
Aventis Pharma, Bridgewater, New Jersey, USA
^|| St. Vincent’s Hospital, Indianapolis, Indiana, USA
^¶ Scripps Clinic, La Jolla, California, USA
^# George Washington University, Washington, D.C., USA

Manuscript received February 28, 2001; revised manuscript received July 10, 2001, accepted August 8, 2001.

^* Reprint requests and correspondence: Dr. James P. Zidar, Duke University Medical Center, 7405 Hospital North, Box 3290, Erwin Road, Durham, North Carolina 27710 USA
zidar001{at}mc.duke.edu

OBJECTIVES

We performed a multicenter, double-blind placebo-controlled trial to examine the efficacy and safety of enoxaparin in patients at high risk for stent thrombosis (ST).

BACKGROUND

The optimal antithrombotic regimen for such patients is unknown.

METHODS

We randomized 1,102 patients with clinical, angiographic or ultrasonographic features associated with an increased risk of ST to receive either twice-daily injections of weight-adjusted enoxaparin or placebo for 14 days after stenting. All patients received aspirin and ticlopidine. The primary end point was a 30-day composite end point of death, myocardial infarction (MI) or urgent revascularization.

RESULTS

The target enrollment for the study was 2,000 patients. However, the trial was terminated prematurely at 1,102 patients after interim analysis revealed an unexpectedly low event rate. The primary outcome occurred in 1.8% enoxaparin-treated patients versus 2.7% treated with placebo (odds ratio [OR] 0.66; 95% confidence interval [CI] 0.29 to 1.5, p = 0.30); for death or MI the rates were 0.9% vs. 2.2%, respectively (OR 0.41, 95% CI 0.14 to 1.2, p =0.13); and for MI, 0.4% vs. 1.6%, respectively (OR 0.22, 95% CI 0.05 to 0.99, p = 0.04). The groups had comparable rates of major bleeding (3.3% for enoxaparin, 1.6% for placebo, p =0.08), but minor nuisance bleeding was increased with enoxaparin (25% vs. 5.1%, p < 0.001).

CONCLUSIONS

The clinical outcomes of patients at increased risk of ST are more favorable than previously reported, rendering routine oral antiplatelet therapy adequate for most. However, given its relative safety and potential to reduce the risk of subsequent infarction, a 14-day course of enoxaparin may be considered for carefully selected patients.

Abbreviations and Acronyms   ACS = acute coronary syndromes   ATLAST = Antiplatelet Therapy versus Lovenox plus Antiplatelet Therapy for Patients with an Increased Risk of Stent Thrombosis   CABG = coronary artery bypass surgery   CEC = Clinical Events Committee   CK = creatine kinase   DSMB = Data and Safety Monitoring Board   FDA = Food and Drug Administration   LMWH = low-molecular-weight heparin   MI = myocardial infarction   PCI = percutaneous coronary intervention   SC = Steering Committee   ST = stent thrombosis   TIMI = Thrombolysis In Myocardial Infarction   UFH = unfractionated heparin

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