Original Article
Enoxaparin versus Unfractionated Heparin in Elective Percutaneous Coronary Intervention
N Engl J Med 2006; 355:1006-1017September 7, 2006
- Abstract
Background
Despite its limitations, unfractionated heparin has been the standard anticoagulant used during percutaneous coronary intervention (PCI). Several small studies have suggested that intravenous enoxaparin may be a safe and effective alternative. Our primary aim was to assess the safety of enoxaparin as compared with that of unfractionated heparin in elective PCI.
Methods
In this prospective, open-label, multicenter, randomized trial, we randomly assigned 3528 patients with PCI to receive enoxaparin (0.5 or 0.75 mg per kilogram of body weight) or unfractionated heparin adjusted for activated clotting time, stratified according to the use or nonuse of glycoprotein IIb/IIIa inhibitors. The primary end point was the incidence of major or minor bleeding that was not related to coronary-artery bypass grafting. The main secondary end point was the percentage of patients in whom the target anticoagulation levels were reached.
Results
Enoxaparin at a dose of 0.5 mg per kilogram was associated with a significant reduction in the rate of non–CABG-related bleeding in the first 48 hours, as compared with unfractionated heparin (5.9% vs. 8.5%; absolute difference, –2.6; 95% confidence interval [CI], –4.7 to –0.6; P=0.01), but the higher enoxaparin dose was not (6.5% vs. 8.5%; absolute difference, –2.0; 95% CI, –4.0 to 0.0; P=0.051). The incidence of major bleeding was significantly reduced in both enoxaparin groups, as compared with the unfractionated heparin group. Target anticoagulation levels were reached in significantly more patients who received enoxaparin (0.5-mg-per-kilogram dose, 79%; 0.75-mg-per-kilogram dose, 92%) than who received unfractionated heparin (20%, P<0.001).
Conclusions
In elective PCI, a single intravenous bolus of 0.5 mg of enoxaparin per kilogram is associated with reduced rates of bleeding, and a dose of 0.75 mg per kilogram yields rates similar to those for unfractionated heparin, with more predictable anticoagulation levels. The trial was not large enough to provide a definitive comparison of efficacy in the prevention of ischemic events. (ClinicalTrials.gov number, NCT00077844.)
Media in This Article
Figure 1
Incidence of Non–CABG-Related Major or Minor Bleeding during the First 48 Hours.Figure 2
Odds Ratios from a Multivariate Analysis of Risk Factors for Non–CABG-Related Major or Minor Bleeding during the First 48 Hours.Article Activity
- Article
The American College of Cardiology, the American Heart Association, and the European Society of Cardiology recommend the use of intravenous unfractionated heparin, with the dose adjusted for the activated clotting time, during percutaneous coronary intervention (PCI).1,2 However, better anticoagulation regimens are needed for PCI, given the limitations of unfractionated heparin, which include its sometimes difficult-to-manage effects on coagulation, the need for repeated monitoring of coagulation, the narrow therapeutic window, the potential induction of platelet activation, and the risk of thrombocytopenia.3
The use of low-molecular-weight heparins as anticoagulants is increasing in patients with acute coronary syndrome who undergo PCI4-6 and in those undergoing elective procedures.7,8 As compared with unfractionated heparin, low-molecular-weight heparins are considered to induce a more stable and predictable anticoagulant dose response (obviating the necessity for coagulation monitoring), and to have a longer half-life and a greater ratio of anti–factor Xa activity to anti–factor IIa activity, which reduces the generation and activation of thrombin.3,9 Low-molecular-weight heparins are also less apt to induce platelet activation, release of the von Willebrand factor, and inflammation.10-13
Small or noncomparative trials have evaluated a single intravenous bolus of enoxaparin — 1 mg,14-18 0.75 mg,14,19-21 or 0.5 mg7,22 per kilogram of body weight — in patients undergoing PCI with or without the administration of glycoprotein IIb/IIIa inhibitors. However, these uncontrolled studies have not allowed definite conclusions to be drawn about the efficacy of enoxaparin as compared with that of standard anticoagulation regimens involving unfractionated heparin. In a meta-analysis of data from randomized studies comparing intravenous low-molecular-weight heparins and intravenous unfractionated heparin in patients undergoing PCI, there was a nonsignificant trend toward a reduction in major bleeding with low-molecular-weight heparins and no difference between groups in the occurrence of ischemic events.8 In an additional analysis, a dose of less than 1 mg of enoxaparin per kilogram resulted in fewer ischemic and bleeding events than a dose of 1 mg per kilogram.
We conducted a large-scale, randomized, controlled trial to evaluate whether the safety of intravenous low-molecular-weight heparins was superior to that of unfractionated heparin in patients undergoing elective PCI.
Methods
The Safety and Efficacy of Enoxaparin in PCI Patients, an International Randomized Evaluation (STEEPLE) trial was a prospective, open-label, parallel-group trial evaluating intravenous enoxaparin at a dose of 0.5 mg or 0.75 mg per kilogram, as compared with intravenous unfractionated heparin, in patients undergoing elective PCI.
The protocol was written by Dr. Montalescot and modified on the basis of discussions with the sponsor (Sanofi-Aventis) and the members of the steering committee (see the Appendix). The data were gathered by the sponsor and were maintained and analyzed by Altizem, a contract research organization. The steering committee vouches for the integrity and completeness of the data, and the statistician vouches for the accuracy of the data analysis. The publication committee prepared the manuscript with suggestions from the steering committee and the sponsor. The publication committee had final authority over the content of the manuscript.
Patients
Patients were enrolled at 124 sites in nine countries. Patients were eligible for the study if they were older than 17 years of age, were scheduled to undergo elective PCI with a femoral approach, and did not meet any of the exclusion criteria: recent thrombolysis, a planned staged procedure, an increased risk of bleeding, treatment with a parenteral antithrombotic agent before PCI, or a known hypersensitivity to the drugs used in the study. The study was conducted according to the Declaration of Helsinki and local regulations. Approval for the trial was obtained from the institutional review board at each site. All patients gave written informed consent.
Study Protocol
Eligible patients were randomly assigned to receive an intravenous bolus of unfractionated heparin, adjusted for activated clotting time according to current guidelines,1 or intravenous enoxaparin at a dose of 0.5 or 0.75 mg per kilogram. We assigned patients using an interactive voice-response system at the central randomization center. Random permuted blocks were used to make assignments in a 1:1:1 ratio that were stratified according to center and planned use of glycoprotein IIb/IIIa inhibitors (no or yes). All patients received aspirin (75 to 500 mg per day) and thienopyridines, according to local practice.
Patients who were assigned to either enoxaparin group received a single intravenous bolus of enoxaparin, without anticoagulation monitoring, after sheath insertion and immediately before PCI. The assigned dose was used regardless of whether a patient was also receiving the glycoprotein IIb/IIIa inhibitor. When procedures were prolonged by more than 2 hours, an additional bolus of enoxaparin (half the original dose) was recommended.23
Patients who were randomly assigned to receive unfractionated heparin and who were not receiving concurrent glycoprotein IIb/IIIa inhibitors were given an initial intravenous bolus of 70 to 100 IU per kilogram to achieve a target activated clotting time of 300 to 350 seconds. Patients who received concurrent glycoprotein IIb/IIIa inhibitors were given an initial bolus of 50 to 70 IU of unfractionated heparin per kilogram to achieve a target activated clotting time of 200 to 300 seconds. Additional boluses of unfractionated heparin were given before the PCI if the lower limit of the target activated clotting time was not reached. Unfractionated heparin was readministered during the procedure, at the discretion of the investigator, when measurements of activated clotting time dropped below the recommended range. In all centers, activated clotting time was measured with a standardized Hemochron device (ITC).
Arterial closure devices were permitted according to the practice at each institution. Sheath removal was authorized at an activated clotting time between 150 and 180 seconds in the unfractionated heparin group,24 4 to 6 hours after the end of the PCI in the group given 0.75 mg of enoxaparin per kilogram, and immediately after the end of the PCI in the group given 0.5 mg of enoxaparin per kilogram. No monitoring of anticoagulation was required before sheath removal in patients receiving enoxaparin.
End Points
The primary end point of the trial was the occurrence of major or minor bleeding not related to coronary-artery bypass grafting (CABG) during the first 48 hours after the index PCI, according to prespecified definitions (Table 1Table 1
Definitions of Major and Minor Bleeding.). The main secondary efficacy end point was the achievement of therapeutic anticoagulation at the beginning and end of PCI. Specifically, we compared the proportion of patients receiving enoxaparin in whom the target anti–factor Xa levels of 0.5 to 1.8 IU per milliliter (analyzed centrally) were achieved25,26 with the proportion of patients receiving unfractionated heparin in whom the target activated clotting time (200 to 300 seconds with glycoprotein IIb/IIIa inhibitors or 300 to 350 seconds without)1 was achieved, at the start and the end of PCI.We also studied other secondary end points. The first was a composite of non–CABG-related major bleeding up to 48 hours after the index PCI, death from any cause, nonfatal myocardial infarction (defined by a new Q wave in two or more leads or a total creatine kinase level or creatine kinase MB fraction that was ≥3 times the upper limit of the normal range during hospitalization for the index PCI or that was ≥2 times the upper limit of the normal range after discharge), or urgent target-vessel revascularization during the first 30 days after the index PCI. The second was a composite of death from any cause or nonfatal myocardial infarction during the first 30 days after the index PCI, whichever occurred first. The third was a composite of death from any cause, nonfatal myocardial infarction, or urgent target-vessel revascularization during the first 30 days after the index PCI, whichever occurred first. The fourth consisted of each of the individual end points during the first 30 days after the index PCI. All events were adjudicated by an independent clinical-events committee whose members were unaware of the treatment assignments.
Statistical Analysis
We initially estimated that we would need to enroll 2700 patients, given a 7% incidence of any type of bleeding up to 48 hours after PCI in the unfractionated heparin group, a statistical power of 80% to detect a relative risk reduction of 47% with enoxaparin, and a type I, two-sided error rate of 2.5% for each comparison of the enoxaparin groups with the unfractionated heparin group. At a planned interim evaluation, the sample size was reevaluated, and because the overall bleeding rate was lower than the anticipated rate (3.5% vs. 4.8%), a final enrollment goal of 3690 patients was set.
All analyses were performed according to the intention-to-treat principle and included all randomized patients analyzed according to the treatment assigned. The primary end point was also analyzed in the safety population, which included all patients who received at least one dose of study drug, analyzed according to the treatment actually received. For all end-point analyses, each enoxaparin dose was compared with unfractionated heparin. The Simes adjustment for multiplicity was applied to ensure a global type I error of 0.05: if both P values were 0.05 or less, both were considered to indicate statistical significance; if the highest P value was greater than 0.05, the other P value had to be 0.025 or less to be considered to indicate statistical significance.27 Analyses were performed with SAS statistical software, version 8.2 (SAS Institute).
Logistic-regression analysis was used to compare the incidence of the primary end point between the enoxaparin and unfractionated heparin groups, with adjustment for the use or nonuse of glycoprotein IIb/IIIa inhibitors. If enoxaparin was not found to be superior to unfractionated heparin, we evaluated whether enoxaparin was noninferior to unfractionated heparin with the use of a two-sided, adjusted confidence interval (CI) for the differences in event rates as planned; the noninferiority margin was set at 30% of the observed bleeding rates in the unfractionated heparin group.
For secondary end points, target anti–factor Xa levels or activated clotting times were analyzed with a logistic-regression model, with adjustment for the use or nonuse of glycoprotein IIb/IIIa inhibitors. The objective for the composite quadruple end point was to test for the noninferiority of the enoxaparin doses with the use of a two-sided CI of the difference in event rates; the noninferiority margin was set at 39% of the observed rates in the unfractionated heparin group. Time-to-event analyses for the other secondary end points up to day 30 were performed with Cox proportional-hazards models.
An independent data-monitoring committee followed the progress of the trial to ensure that patient safety was not compromised. The committee met four times during the trial; the fourth interim analysis, which included 3089 patients, indicated that there were more deaths from any cause in the group given 0.5 mg of enoxaparin per kilogram (9 patients) than in either the unfractionated heparin group (3 patients, P=0.1477) or the group given 0.75 mg of enoxaparin per kilogram (1 patient, P=0.0265). On the basis of the Pocock boundary of 0.0266, the committee recommended that randomization to the group given 0.5 mg of enoxaparin per kilogram be discontinued. Enrollment was suspended in that group on November 22, 2004, just before the end of the enrollment period in December 2004. Because the decision to stop enrollment in this group could have altered decisions about the inclusion of a patient or the conduct of the study, the final analyses were adjusted for whether a patient underwent randomization before or after November 22, 2004.
Results
Characteristics of the Patients
Between January 2004 and December 2004, 3528 patients were enrolled: 1070 were randomly assigned to receive 0.5 mg of enoxaparin per kilogram intravenously, 1228 to receive 0.75 mg of enoxaparin per kilogram intravenously, and 1230 to receive unfractionated heparin intravenously. Baseline characteristics were well balanced among the treatment groups (Table 2Table 2
Baseline Characteristics of Patients and Procedures.).Characteristics of the Procedure
The procedural characteristics were similar for all three groups (Table 2). Of patients receiving unfractionated heparin, 16.5% received at least one additional bolus because of a low activated clotting time. At least one additional bolus of enoxaparin was administered during a prolonged procedure (>2 hours) in 0.6% of patients receiving 0.5 mg of enoxaparin per kilogram and 0.2% of patients receiving 0.75 mg of enoxaparin per kilogram. The median activated clotting time at the start and end of PCI was 336 and 292 seconds, respectively, for patients receiving unfractionated heparin alone and 300 and 255 seconds, respectively, for patients receiving unfractionated heparin with glycoprotein IIb/IIIa inhibitors.
Primary End Point
Non–CABG-related major or minor bleeding during the first 48 hours occurred in 5.9% of patients assigned to receive 0.5 mg of enoxaparin per kilogram, 6.5% of patients assigned to receive 0.75 mg of enoxaparin per kilogram, and 8.5% of patients assigned to receive unfractionated heparin (Table 3Table 3
End Points. and Figure 1Figure 1Incidence of Non–CABG-Related Major or Minor Bleeding during the First 48 Hours.). These values represent a relative reduction of 31% in the primary end point with 0.5 mg of enoxaparin per kilogram as compared with unfractionated heparin, meeting the criteria for the superiority of enoxaparin over unfractionated heparin (P=0.01), and a 24% relative reduction with 0.75 mg of enoxaparin per kilogram (P=0.051), meeting the prespecified criteria for noninferiority (95% CI, –4.0 to 0.0; excluding the noninferiority margin of 30% [absolute margin, +2.6%]). This effect was primarily driven by the 57% reduction in non–CABG-related major bleeding (absolute risk reduction, 1.6%) in both enoxaparin groups (0.5 mg per kilogram, 1.2%, vs. 2.8% in the unfractionated heparin group, P=0.004; 0.75 mg per kilogram, 1.2% vs. 2.8%, P=0.007) (Table 3 and Figure 1). Among patients who did not receive glycoprotein IIb/IIIa inhibitors, non–CABG-related major or minor bleeding at 48 hours occurred in 4.1% of those in the group given 0.5 mg of enoxaparin per kilogram, 3.6% of those given 0.75 mg of enoxaparin per kilogram, and 6.8% of those given unfractionated heparin; among patients who received glycoprotein IIb/IIIa inhibitors, the rates were 8.6%, 10.8%, and 11.2%, respectively. Transfusion rates during the first 48 hours after PCI were extremely low (Table 3).Similar results were obtained in the analysis of safety: the incidence of the primary end point was significantly reduced among patients receiving 0.5 mg of enoxaparin per kilogram, as compared with patients receiving unfractionated heparin (6.1% vs. 8.6%, P=0.02) but not among patients receiving 0.75 mg of enoxaparin per kilogram (6.7% vs. 8.6%, P=0.07). The incidence of major bleeding was significantly reduced in the group given 0.5 mg of enoxaparin per kilogram (1.3%, vs. 2.8% in the unfractionated heparin group; P=0.005) and the group given 0.75 mg of enoxaparin per kilogram (1.3% vs. 2.8%, P=0.008).
Consistent results were found across all major subgroups with respect to the primary end point. Multivariate analysis showed that significant independent correlates of the primary end point included treatment with 0.5 mg of enoxaparin per kilogram but not treatment with 0.75 mg of enoxaparin per kilogram (Figure 2Figure 2
Odds Ratios from a Multivariate Analysis of Risk Factors for Non–CABG-Related Major or Minor Bleeding during the First 48 Hours.).Although not prespecified in the protocol, bleeding that was classified according to the Thrombolysis in Myocardial Infarction (TIMI) trial28 criteria and the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) study criteria29 was also assessed (Table 3). The rates of TIMI bleeding (major or minor) were not significantly different among the groups. The rate of GUSTO bleeding was significantly reduced only in the group given 0.5 mg of enoxaparin per kilogram.
Secondary End Points
Prespecified target anti–factor Xa levels of 0.5 to 1.8 IU per milliliter (the main secondary efficacy end point) were achieved in significantly more patients receiving enoxaparin (78.8% in the group given 0.5 mg per kilogram and 91.8% in the group given 0.75 mg per kilogram) than in patients receiving unfractionated heparin adjusted for the activated clotting time (19.7%, P<0.001 for both comparisons) (Table 3).
When a narrower anti–factor Xa range was selected (0.5 to 1.2 IU per milliliter), corresponding to adequate anticoagulation levels in the treatment of acute coronary syndrome,25,26,30 75.5% of patients given 0.5 mg of enoxaparin per kilogram reached the target range, as did 59.4% of patients given 0.75 mg of enoxaparin per kilogram. Both these proportions were significantly higher than that in the group given unfractionated heparin (P<0.001 for both comparisons).
The composite quadruple end point occurred in 6.9% of patients receiving 0.5 mg of enoxaparin per kilogram and 7.7% of those receiving 0.75 mg of enoxaparin per kilogram, as compared with 8.2% of patients receiving unfractionated heparin, meeting the prespecified criteria for noninferiority for both enoxaparin doses (Table 3). The incidence of death from any cause or nonfatal myocardial infarction during the first 30 days after PCI did not differ significantly among the three groups (Figure 3Figure 3
Kaplan–Meier Estimates of Death or Nonfatal Myocardial Infarction during the First 30 Days after PCI. and Table 3). No significant difference was observed among the three groups in the incidence of the composite end point of death from any cause, nonfatal myocardial infarction, or urgent target-vessel revascularization during the first 30 days or its individual components (Table 3).The mortality rate during an interim analysis in the group given 0.5 mg of enoxaparin per kilogram (10 patients [1.0%]), which led to early termination of enrollment in that group, was not significantly higher in the final analysis than the rate in the group given unfractionated heparin (5 patients [0.4%]) or in the group given 0.75 mg of enoxaparin per kilogram (3 patients [0.2%]) (Table 3). Four deaths in the group given 0.5 mg of enoxaparin per kilogram were considered by the investigators to be possibly related to treatment. These included one cardiac arrest after successful PCI and hospital discharge (on day 4), one intracranial hemorrhage (on day 2), one episode of cardiac tamponade related to peri-procedure coronary rupture (on day 1), and one peri-procedure coronary occlusion after rotablator dissection of the main coronary trunk (on day 1). None of the deaths in the other two groups were considered to be possibly related to treatment.
Discussion
We compared the safety of intravenous enoxaparin with that of unfractionated heparin in elective PCI as currently practiced (including the frequent use of drug-eluting stents and glycoprotein IIb/IIIa inhibitors as well as almost universal use of clopidogrel). A dose of 0.5 mg of enoxaparin per kilogram significantly reduced the primary end point of any bleeding (as prospectively defined by our protocol), as compared with a regimen of unfractionated heparin adjusted for activated clotting time, whereas a dose of 0.75 mg of enoxaparin per kilogram was noninferior to unfractionated heparin with respect to this end point. Both doses of enoxaparin significantly reduced the incidence of major bleeding, as compared with unfractionated heparin. The benefit of the 0.5-mg dose of enoxaparin per kilogram with respect to bleeding was also evident with the use of the GUSTO criteria but was not significant with the use of the TIMI criteria. These definitions, developed for use in trials of fibrinolysis, may not be optimal for assessing the risk of bleeding after PCI.
The effect of enoxaparin on the risk of bleeding was achieved with the use of a treatment protocol that was simpler than that typically used for unfractionated heparin. Enoxaparin was administered as a single intravenous bolus before the start of PCI, without anticoagulation monitoring; a similar dose was used whether or not glycoprotein IIb/IIIa inhibitors were given; and immediate removal of the sheath after PCI was recommended with the 0.5-mg dose of enoxaparin per kilogram.
As compared with unfractionated heparin, enoxaparin resulted in a significant increase (by a factor of four) in the rate of achievement of target anticoagulation levels. This finding highlights the superior bioavailability of enoxaparin; in contrast, unfractionated heparin requires careful coagulation monitoring. Whether there is an optimal anti–factor Xa level with enoxaparin therapy among patients undergoing PCI is still unknown, although it was shown recently that such levels were independently associated with the risk of death at 30 days in a large population of patients with non–ST-elevation acute coronary syndrome.25 In our study, even when we aimed for a tighter anti–factor Xa range (0.5 to 1.2 IU per milliliter),25,26,30 the results obtained with enoxaparin remained significantly more predictable and stable than those obtained with unfractionated heparin anticoagulation: more patients reached the target range with the 0.5-mg dose of enoxaparin per kilogram.
There was no significant difference in the double or triple ischemic end point or any individual component of the composite end point, including mortality, between patients treated with enoxaparin and those treated with unfractionated heparin. However, there were wide CIs for the ischemic end points (Table 3), and our trial was not powered to detect differences or draw conclusions with regard to these measures of drug efficacy. The mortality rate in the trial was low (0.5%) and similar to that in other recent PCI trials.31-33 The early closure of the low-dose enoxaparin group was based on an apparent increase in the number of deaths from any cause as compared with the number in the group given unfractionated heparin. In the final analysis, the apparent increase was found to be nonsignificant, but the CIs were wide. For the combined end point incorporating both bleeding and ischemic events, both doses of enoxaparin were noninferior to unfractionated heparin.
In summary, the STEEPLE trial demonstrated that, depending on the dose, intravenous enoxaparin is associated with bleeding rates that are similar to or lower than those with unfractionated heparin in patients undergoing elective PCI. The resulting levels of anticoagulation were more predictable with enoxaparin than with unfractionated heparin. The slightly but not significantly higher death rate with low-dose enoxaparin remains unexplained. Whether the rates of ischemic events are similar for enoxaparin and unfractionated heparin was not definitively established.
Supported by Sanofi-Aventis.
Dr. Montalescot reports having received grant support, consulting fees, and lecture fees from Sanofi-Aventis, Eli Lilly, and Bristol-Myers Squibb; consulting fees and lecture fees from Merck Sharp & Dohme; consulting fees from Procter & Gamble, AstraZeneca, and Schering-Plough; and lecture fees from GlaxoSmithKline and Nycomed. Dr. White reports having received grant support, consulting fees, and lecture fees from Sanofi-Aventis, the Medicines Company, and AstraZeneca and grant support from Procter & Gamble, Alexion, Schering-Plough, and Eli Lilly. Dr. Gallo reports having received grant support, consulting fees, and lecture fees from Sanofi-Aventis; lecture fees from Abbott, Oryx Pharmaceuticals, and Biovail Pharmaceuticals; and consulting fees from Biovail Pharmaceuticals. Dr. Cohen reports having received grant support from Aventis Pharmaceuticals, consulting fees from Sanofi-Aventis and AstraZeneca, and lecture fees from Sanofi-Aventis, Merck, and Schering. Dr. Steg reports having received grant support from Sanofi-Aventis and Bristol-Myers Squibb; consulting fees from Sanofi-Aventis, Takeda, AstraZeneca, Merck Sharp & Dohme, GlaxoSmithKline, Bristol-Myers Squibb, and Servier; and lecture fees from Sanofi-Aventis, Bristol-Myers Squibb, Merck Sharp & Dohme, Nycomed, GlaxoSmithKline, Boehringer Ingelheim, and Servier. Dr. Aylward reports having received grant support from Sanofi-Aventis, Procter & Gamble, Alexion, the Medicines Company, Schering-Plough, and Eli Lilly and consulting and lecture fees from Sanofi-Aventis and Bristol-Myers Squibb. Dr. Bode reports having received consulting fees and lecture fees from Sanofi-Aventis, Eli Lilly, and GlaxoSmithKline; consulting fees from Nycomed; and lecture fees from AstraZeneca. Dr. Chiariello reports having received consulting fees from Schering-Plough and Nycomed and lecture fees from Merck Sharp & Dohme, GlaxoSmithKline, and IFB Stroder. Dr. King reports having received grant support from Medtronic and lecture fees from Sanofi-Aventis and Bristol-Myers Squibb. Dr. Harrington reports having received grant support, consulting fees, and lecture fees from Sanofi-Aventis. Dr. Steinhubl reports having received consulting fees from Sanofi-Aventis, the Medicines Company, Eli Lilly, and AstraZeneca. No other potential conflict of interest relevant to this article was reported.
We are indebted to the patients who agreed to participate in this trial; to the study contributors; to Dr. Marcel Meijer, who assisted in the preparation of this manuscript; and to the investigators who recruited patients.
Source Information
From Institut de Cardiologie, Centre Hospitalier Universitaire Pitié–Salpêtrière, Paris (G.M.); the Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (H.D.W.); the Montreal Heart Institute, Université de Montréal, Montreal (R.G.); the Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ (M.C.); the Service de Cardiologie, Hôpital Bichat, Paris (P.G.S.); Department of Cardiology, Flinders Medical Center, Adelaide, SA, Australia (P.E.G.A.); Abteilung Innere Medizin III, Universitätsklinikum Freiburg, Freiburg, Germany (C.B.); the Division of Cardiology, Federico 2nd University, Naples, Italy (M.C.); Fuqua Heart Center of Atlanta at Piedmont Hospital, Atlanta (S.B.K.); the Division of Cardiology, Duke University Medical Center, Durham, NC (R.A.H.); University Hospital Gasthuisberg, Leuven, Belgium (W.J.D.); Servicio de Cardiología, Hospital Universitario, Madrid (C.M.); and the Division of Cardiology, University of Kentucky, Lexington (S.R.S.).
Address reprint requests to Dr. Montalescot at Institut de Cardiologie, Bureau 2-236, Centre Hospitalier Universitaire Pitié–Salpêtrière, 47 Boulevard de l'Hôpital, 75013 Paris, France, or at gilles.montalescot@psl.aphp.fr.
Participants in the Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients, an International Randomized Evaluation (STEEPLE) trial are listed in the Appendix.
Appendix
The following investigators participated in the STEEPLE trial: Steering Committee — France — G. Montalescot (Cochair), P.G. Steg; Australia — P.E.G. Aylward; New Zealand — H.D. White; Belgium — W. Desmet; Canada — R. Gallo; Germany — C. Bode; Italy — M. Chiariello; Spain — C. Macaya; United States — S.R. Steinhubl (Cochair), R.A. Harrington, S.B. King III, M. Cohen; Data-Monitoring Committee — United States — M. Klapholz (Chair), D. Mukherjee; United Kingdom — n. Stallard; Belgium — W. Wijns; Clinical Events Committee — United States — B.R. Chaitman (Chair), P. Bjerrgaard, R. Bach; Publication Committee — France — G. Montalescot (Chair); United States — S.R. Steinhubl; New Zealand — H.D. White; Canada — R. Gallo; Key Sanofi-Aventis Personnel — V. Bertuit, W.B. Drusedum (study managers), D. Sbaï (study coordinator), G. Salette (statistician), A. Wajman, W. Byra, M.-F. Bregeault (clinical directors); Investigators — Australia — D. Chew, L. Arnolda, I. Meredith, C. Jurgens, A. Farshid; Belgium — W. Desmet, P. Coussement, P. Vermeersch, K. Dujardin, M. Vrolix; Canada — J. Ducas, A. Fung, R. Gallo, W. Hui, W. Kostuk, R. Kuritzky, C. Lazzam, A.-U.-R. Quraishi, B. Rose, J. Ross, E. Schampaert, F. Spence, J. Velianou, J. Webb, R. Welsh; France — G. Montalescot, O. Wittenberg, H. Le Breton, J.-M. LaBlanche, H. Eltchaninoff, P. Coste, P.G. Steg, F. Paganelli, B. Charbonnier, D. Carrie, N. Meneveau, T. Lefevre, G. Bayet; Germany — C. Bode, M. Beyer, K.H. Kuck, T. Heitzer, F.M. Bahr, L. Pizzukki, G. Richardt, R. Tolg, H. Darius, S. Behrens, W. Jung, T. Munzel; Italy — M. Chiariello, P. Golino, A. Bartorelli, G. Ambrosio, A.S. Petronio, C. Tamburino, P. Danna, G. Richichi; New Zealand — H.D. White, S. Pasupati; Spain — C. Macaya, R. Melgares, J.M. Ruiz Nodar, J. Moreu, J. Hernandez Garcia, F. Fernandez-Vazquez, C. Moris, A. Cequier, T. Colman, M. Sanmartin, I. Lekuona, A. Rincon de Arellano; United States — A. Arnold, M. D'Urso, N. Perlmutter, M. Turco, J. Smith, S. Jain, P. Kraft, N. Lakkis, G. Levine, S. Yakubov, H. Ladley, E. Rivera, M. Cohen, E. Goudreau, J. Moss, M. Fenster, E. Fry, M. Lawrence, G. Schaer, T. Stuckey, M. Moran, V.K. Raman, A. Moreyra, M. Warner, B. Bartolet, A.R.Z. Masud, R. Carlson, F. Tilli, D. Henderson, D. Churchill, R. Piana, N. Shadoff, P. Counihan, S. Brener, A. Sonel, M. Zughaib, R.A. Harrington, N. Srivastava, B. Murad, D. Lee, M. DeGregorio, B. Jaski, R. Agah, J. Breall, L. Iliadis, P. Fenner, W. French, M. Lim, N. Mayer, J. Martin, T. Shapiro, D. Moliterno, T. Jayasundera, C. Nelson, G.L. Chang, F. Ling, G. Levine, D. Marks, M. Ayres.
- References
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Marc Cohen, Walter P. Jeske, Jose C. Nicolau, Gilles Montalescot, Jawed Fareed. (2012) US Food and Drug Administration approval of generic versions of complex biologics: implications for the practicing physician using low molecular weight heparins. Journal of Thrombosis and Thrombolysis
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J. W. Yau, A. R. Stafford, P. Liao, J. C. Fredenburgh, R. Roberts, J. I. Weitz. (2011) Mechanism of catheter thrombosis: comparison of the antithrombotic activities of fondaparinux, enoxaparin, and heparin in vitro and in vivo. Blood
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, C. W. Hamm, J.-P. Bassand, S. Agewall, J. Bax, E. Boersma, H. Bueno, P. Caso, D. Dudek, S. Gielen, K. Huber, M. Ohman, M. C. Petrie, F. Sonntag, M. S. Uva, R. F. Storey, W. Wijns, D. Zahger, , J. J. Bax, A. Auricchio, H. Baumgartner, C. Ceconi, V. Dean, C. Deaton, R. Fagard, C. Funck-Brentano, D. Hasdai, A. Hoes, J. Knuuti, P. Kolh, T. McDonagh, C. Moulin, D. Poldermans, B. A. Popescu, Z. Reiner, U. Sechtem, P. A. Sirnes, A. Torbicki, A. Vahanian, S. Windecker, , S. Windecker, S. Achenbach, L. Badimon, M. Bertrand, H. E. Botker, J.-P. Collet, F. Crea, N. Danchin, E. Falk, J. Goudevenos, D. Gulba, R. Hambrecht, J. Herrmann, A. Kastrati, K. Kjeldsen, S. D. Kristensen, P. Lancellotti, J. Mehilli, B. Merkely, G. Montalescot, F.-J. Neumann, L. Neyses, J. Perk, M. Roffi, F. Romeo, M. Ruda, E. Swahn, M. Valgimigli, C. J. Vrints, P. Widimsky. (2011) ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). European Heart Journal
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P. G. Steg, K. Huber, F. Andreotti, H. Arnesen, D. Atar, L. Badimon, J.-P. Bassand, R. De Caterina, J. A. Eikelboom, D. Gulba, M. Hamon, G. Helft, K. A. A. Fox, S. D. Kristensen, S. V. Rao, F. W. A. Verheugt, P. Widimsky, U. Zeymer, J.-P. Collet. (2011) Bleeding in acute coronary syndromes and percutaneous coronary interventions: position paper by the Working Group on Thrombosis of the European Society of Cardiology. European Heart Journal 32:15, 1854-1864
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Gilles Montalescot, Uwe Zeymer, Johanne Silvain, Bertrand Boulanger, Marc Cohen, Patrick Goldstein, Patrick Ecollan, Xavier Combes, Kurt Huber, Charles Pollack, Jean-François Bénezet, Olivier Stibbe, Emmanuelle Filippi, Emmanuel Teiger, Guillaume Cayla, Simon Elhadad, Frédéric Adnet, Tahar Chouihed, Sébastien Gallula, Agnès Greffet, Mounir Aout, Jean-Philippe Collet, Eric Vicaut. (2011) Intravenous enoxaparin or unfractionated heparin in primary percutaneous coronary intervention for ST-elevation myocardial infarction: the international randomised open-label ATOLL trial. The Lancet 378:9792, 693-703
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Gregg W Stone, E Magnus Ohman. (2011) Antithrombin alternatives in STEMI. The Lancet 378:9792, 643-645
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Gilles Montalescot, Genevieve Salette, Gabriel Steg, Marc Cohen, Harvey D. White, Richard Gallo, Steven R. Steinhubl. (2011) Development and validation of a bleeding risk model for patients undergoing elective percutaneous coronary intervention. International Journal of Cardiology 150:1, 79-83
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Harold L. Dauerman, Sunil V. Rao, Frederic S. Resnic, Robert J. Applegate. (2011) Bleeding Avoidance Strategies. Journal of the American College of Cardiology 58:1, 1-10
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J. Kvasnička, J. Horák, Z. Zenáhlíková, Tomáš Kvasnička, S. Šimek, T. Kovárník, I. Malíková, A. Linhart, M. Aschermann. (2011) Reduced Thrombin Generation and Soluble P-selectin After Intravenous Enoxaparin During PCI. Cardiovascular Drugs and Therapy 25:3, 243-250
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Zafar Iqbal, Marc Cohen. (2011) Enoxaparin: a pharmacologic and clinical review. Expert Opinion on Pharmacotherapy 12:7, 1157-1170
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Vamsi Kodumuri, Sashi Adigopula, Param Singh, Paari Swaminathan, Rohit Arora MD, Sandeep Khosla. (2011) Comparison of Low Molecular Weight Heparin With Unfractionated Heparin During Percutaneous Coronary Interventions: A Meta-Analysis. American Journal of Therapeutics 18:3, 180-189
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Eric Heller, George D. Dangas. 2011. Heparin, LMWH, GIIb/IIIa, and Direct Thrombin Inhibitors. , 110-143.
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Young-Hak Kim, Jong-Young Lee, Jung-Min Ahn, Haegeun Song, Won-Jang Kim, Sung-Cheol Yun, Duk-Woo Park, Soo-Jin Kang, Seung-Whan Lee, Cheol Whan Lee, Seong-Wook Park, Seung-Jung Park. (2011) Impact of Bleeding on Subsequent Early and Late Mortality After Drug-Eluting Stent Implantation. JACC: Cardiovascular Interventions 4:4, 423-431
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Gilles Montalescot, Leonardo Bolognese, Dariusz Dudek, Patrick Goldstein, Christian Hamm, Jean-Francois Tanguay, Jur ten Berg, Petr Widimsky, Junxiang Luo, Debra L. Miller, Jochen Goedicke. (2011) A Comparison of prasugrel at the time of percutaneous Coronary intervention or as pretreatment at the time of diagnosis in patients with non–ST-segment elevation myocardial infarction: Design and rationale for the ACCOAST study. American Heart Journal 161:4, 650-656.e1
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Charles Brown, Brijen Joshi, Nauder Faraday, Ashish Shah, David Yuh, Jeffrey J. Rade, Charles W. Hogue. (2011) Emergency Cardiac Surgery in Patients with Acute Coronary Syndromes. Anesthesia & Analgesia 112:4, 777-799
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Philip Urban, Alexandre Abizaid, Adrian Banning, Antonio L. Bartorelli, Ana Cebrian Baux, Vladimír Džavík, Stephen Ellis, Runlin Gao, David Holmes, Myung Ho Jeong, Victor Legrand, Franz-Josef Neumann, Maria Nyakern, Christian Spaulding, Stephen Worthley. (2011) Stent Thrombosis and Bleeding Complications After Implantation of Sirolimus-Eluting Coronary Stents in an Unselected Worldwide Population. Journal of the American College of Cardiology 57:13, 1445-1454
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David Brieger, Jean-Philippe Collet, Johanne Silvain, Antoine Landivier, Olivier Barthélémy, Farzin Beygui, Anne Bellemain-Appaix, Anne Mercadier, Remi Choussat, Nicolas Vignolles, Dominique Costagliola, Gilles Montalescot. (2011) Heparin or enoxaparin anticoagulation for primary percutaneous coronary intervention. Catheterization and Cardiovascular Interventions 77:2, 182-190
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Eltigani Abdelaal, Jonathan Byrne. (2011) Bleeding avoidance strategies among patients undergoing percutaneous coronary intervention. Interventional Cardiology 3:1, 13-16
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Freek W.A. Verheugt, Steven R. Steinhubl, Martial Hamon, Harald Darius, Philippe Gabriel Steg, Marco Valgimigli, Steven P. Marso, Sunil V. Rao, Anthony H. Gershlick, A. Michael Lincoff, Roxana Mehran, Gregg W. Stone. (2011) Incidence, Prognostic Impact, and Influence of Antithrombotic Therapy on Access and Nonaccess Site Bleeding in Percutaneous Coronary Intervention. JACC: Cardiovascular Interventions 4:2, 191-197
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, Richard C. Becker, Kenneth W. Mahaffey, Hongqiu Yang, A. J. Marian, Mark I. Furman, A. Michael Lincoff, Stanley L. Hazen, John L. Petersen, Craig J. Reist, Neal S. Kleiman. (2011) Heparin-associated anti-Xa activity and platelet-derived prothrombotic and proinflammatory biomarkers in moderate to high-risk patients with acute coronary syndrome. Journal of Thrombosis and Thrombolysis 31:2, 146-153
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Philippe Gabriel Steg, Shamir Mehta, Sanjit Jolly, Denis Xavier, Hans-Juergen Rupprecht, Jose Luis Lopez-Sendon, Susan Chrolavicius, Sunil V. Rao, Christopher B. Granger, Janice Pogue, Shiona Laing, Salim Yusuf. (2010) Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute coronary syndromes (FUTURA/OASIS 8): A randomized trial of intravenous unfractionated heparin during percutaneous coronary intervention in patients with non–ST-segment elevation acute coronary syndromes initially treated with fondaparinux. American Heart Journal 160:6, 1029-1034.e1
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Mitul B. Kadakia, Nihar R. Desai, Karen P. Alexander, Anita Y. Chen, JoAnne M. Foody, Christopher P. Cannon, Stephen D. Wiviott, Benjamin M. Scirica. (2010) Use of Anticoagulant Agents and Risk of Bleeding Among Patients Admitted With Myocardial Infarction. JACC: Cardiovascular Interventions 3:11, 1166-1177
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Matthias Lenski, Felix Mahfoud, Christian Werner, Axel Bauer, Michael Böhm. (2010) Hotline sessions and clinical trial updates presented at the European Society of Cardiology Congress in Stockholm 2010. Clinical Research in Cardiology 99:11, 679-692
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H. M. Nef, H. Mollmann, C. W. Hamm. (2010) Anticoagulation in percutaneous coronary interventions: no man's land?. European Heart Journal 31:20, 2447-2448
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M. VALGIMIGLI, G. CAMPO, M. TEBALDI, M. MONTI, S. GAMBETTI, A. SCALONE, G. PARRINELLO, R. FERRARI, . (2010) Randomized, double-blind comparison of effects of abiciximab bolus only vs. on-label regimen on ex vivo inhibition of platelet aggregation in responders to clopidogrel undergoing coronary stenting. Journal of Thrombosis and Haemostasis 8:9, 1903-1911
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Olivier F. Bertrand, Éric Larose, Josep Rodés-Cabau, Stéphane Rinfret, Jean-Pierre Déry, Rodrigo Bagur, Onil Gleeton, Can M. Nguyen, Guy Proulx, Robert De Larochellière, Paul Poirier, Olivier Costerousse, Louis Roy. (2010) Incidence, Range, and Clinical Effect of Hemoglobin Changes Within 24 Hours After Transradial Coronary Stenting. The American Journal of Cardiology 106:2, 155-161
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Dabit Arzamendi, Hung Quoc Ly, Jean-François Tanguay, Mark Yan Yee Chan, Pierre Chevallereau, Richard Gallo, Reda Ibrahim, Philippe L'Allier, Sylvie Levesque, Gilbert Gosselin, Pierre DeGuise, Michel Joyal, Jean Gregoire, Raoul Bonan, Jacques Crepeau, Serge Doucet. (2010) Effect on Bleeding, Time to Revascularization, and One-Year Clinical Outcomes of the Radial Approach During Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction. The American Journal of Cardiology 106:2, 148-154
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Sunil V. Rao, Mauricio G. Cohen, David E. Kandzari, Olivier F. Bertrand, Ian C. Gilchrist. (2010) The Transradial Approach to Percutaneous Coronary Intervention. Journal of the American College of Cardiology 55:20, 2187-2195
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Uwe Raaz, Michael Buerke, Marese Busshardt, Lars Maegdefessel, Alexander Plehn, Baerbel Hauroeder, Karl Werdan, Axel Schlitt. (2010) Efficacy of enoxaparin, certoparin and dalteparin in preventing cardiac catheter thrombosis: an in vitro approach. Journal of Thrombosis and Thrombolysis 29:3, 265-270
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José G. Díez, James M. Wilson. (2010) Practical Strategies for the Management of Anticoagulation Therapy: Unsolved Issues in the Cardiac Catheterization Laboratory. Cardiovascular Drugs and Therapy 24:2, 161-174
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Johanne Silvain, Farzin Beygui, Annick Ankri, Anne Bellemain-Appaix, Ana Pena, Olivier Barthelemy, Guillaume Cayla, Vanessa Gallois, Sophie Galier, Dominique Costagliola, Jean-Philippe Collet, Gilles Montalescot. (2010) Enoxaparin Anticoagulation Monitoring in the Catheterization Laboratory Using a New Bedside Test. Journal of the American College of Cardiology 55:7, 617-625
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Gilles Montalescot, Stephen G. Ellis, Mark A. de Belder, Luc Janssens, Olivier Katz, Wladyslaw Pluta, Patrick Ecollan, Michal Tendera, Ad J. van Boven, Petr Widimsky, Henning R. Andersen, Amadeo Betriu, Paul Armstrong, Bruce R. Brodie, Howard C. Herrmann, Franz-Josef Neumann, Mark B. Effron, Jiandong Lu, Elliot S. Barnathan, Eric J. Topol. (2010) Enoxaparin in Primary and Facilitated Percutaneous Coronary Intervention. JACC: Cardiovascular Interventions 3:2, 203-212
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Harvey D. White, Philip E. Aylward, Richard Gallo, Christoph Bode, Gabriel Steg, Steven R. Steinhubl, Gilles Montalescot. (2010) Hematomas of at least 5 cm and outcomes in patients undergoing elective percutaneous coronary intervention: Insights from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial. American Heart Journal 159:1, 110-116
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