Original Article
Platelet Glycoprotein IIb/IIIa Receptor Blockade and Low-Dose Heparin during Percutaneous Coronary Revascularization
N Engl J Med 1997; 336:1689-1697June 12, 1997
- Abstract
Background
Blockade of the platelet glycoprotein IIb/IIIa receptor with abciximab (a monoclonal-antibody Fab fragment directed against the receptor) has been shown to diminish ischemic complications among patients undergoing high-risk coronary angioplasty or atherectomy but increases bleeding complications. The widespread applicability of this treatment is unknown, particularly in view of the observed risk of hemorrhage.
Methods
In a prospective, double-blind trial, we randomly assigned patients undergoing urgent or elective percutaneous coronary revascularization at 69 centers to receive abciximab with standard-dose, weight-adjusted heparin (initial bolus of 100 U per kilogram of body weight); abciximab with low-dose, weight-adjusted heparin (initial bolus of 70 U per kilogram); or placebo with standard-dose, weight-adjusted heparin. The primary efficacy end point was death from any cause, myocardial infarction, or urgent revascularization within 30 days of randomization.
Results
The trial was terminated at the first interim analysis, with 2792 of the planned 4800 patients enrolled. At 30 days, the composite event rate was 11.7 percent in the group assigned to placebo with standard-dose heparin; 5.2 percent in the group assigned to abciximab with low-dose heparin (hazard ratio, 0.43; 95 percent confidence interval, 0.30 to 0.60; P<0.001); and 5.4 percent in the group assigned to abciximab with standard-dose heparin (hazard ratio, 0.45; 95 percent confidence interval, 0.32 to 0.63; P<0.001). There were no significant differences among the groups in the risk of major bleeding, although minor bleeding was more frequent among patients receiving abciximab with standard-dose heparin.
Conclusions
Inhibition of the platelet glycoprotein IIb/IIIa receptor with abciximab, together with low-dose, weight-adjusted heparin, markedly reduces the risk of acute ischemic complications in patients undergoing percutaneous coronary revascularization, without increasing the risk of hemorrhage.
Media in This Article
Figure 2
Hazard Ratios and 95 Percent Confidence Intervals for the 30-Day Primary Efficacy End Point in Prespecified Subgroups Defined According to Risk Stratum, Indication for Revascularization, Weight, Age, and Sex.Figure 1
Kaplan–Meier Estimate of the Probability of the Primary Efficacy End-Point Events (Death, Myocardial Infarction, or Urgent Repeated Revascularization) within 30 Days after Randomization, According to Treatment Assignment.Article Activity
- Article
New strategies for preventing ischemic complications during percutaneous coronary revascularization have focused on the platelet surface-membrane glycoprotein IIb/IIIa receptor.1 In a previous large-scale trial (Evaluation of 7E3 for the Prevention of Ischemic Complications, or EPIC), blockade of this receptor by abciximab (c7E3 Fab, ReoPro, Centocor, Malvern, Pa.), a human–murine chimeric antibody Fab fragment, was shown to reduce the incidence of acute ischemic events by 35 percent among patients undergoing “high-risk” percutaneous coronary revascularization2 but was accompanied by a doubling of the incidence of major bleeding complications. Important questions were thus raised regarding the balance between risk and benefit with glycoprotein IIb/IIIa receptor blockade during coronary intervention, particularly among patients not considered to be at high risk for ischemic complications. The concurrent administration of high doses of heparin, however, may have potentiated the hemorrhagic toxicity of abciximab observed in the EPIC trial.2,3 A pilot study suggested that the blood loss associated with abciximab might be attenuated by using lower doses of heparin, as well as by early removal of the vascular sheath to eliminate the need for the postprocedural infusion of heparin.4
The objectives of the present trial were first, to determine whether the clinical benefits of abciximab therapy could be extended to all patients undergoing coronary intervention, regardless of their risk of ischemic complications, and second, to evaluate whether the incidence of hemorrhagic complications associated with this agent could be reduced without loss of efficacy by adjusting the heparin dose for body weight or reducing it.
Methods
Study Population
The Evaluation in PTCA to Improve Long-Term Outcome with Abciximab GP IIb/IIIa Blockade (EPILOG) study was a randomized, double-blind, placebo-controlled trial conducted at 69 clinical sites in the United States and Canada. Patients undergoing elective or urgent percutaneous coronary revascularization with a device approved by the Food and Drug Administration were eligible for inclusion if they were over 21 years old and had a target lesion in which there was stenosis of at least 60 percent of the diameter of the vessel. Because the previous trial had suggested that abciximab provided substantial clinical benefit among patients with acute ischemic syndromes,2 patients who had either acute myocardial infarction or unstable angina with associated electrocardiographic changes during the previous 24 hours were excluded. Other exclusion criteria were planned stent implantation or rotational atherectomy; percutaneous coronary intervention performed within the previous three months; a left-main-coronary-artery stenosis of more than 50 percent not protected by collateral vessels; concurrent warfarin therapy or a base-line prothrombin time more than 1.2 times the control value; cerebrovascular accident within the previous two years or a residual neurologic deficit; intracranial neoplasm, aneurysm, or arteriovenous malformation; history of vasculitis, known hemorrhagic diathesis, or active internal bleeding; hypertension, with a systolic blood pressure of more than 180 mm Hg or a diastolic blood pressure of more than 100 mm Hg; and major surgery, gastrointestinal bleeding, or genitourinary bleeding within the previous six weeks. The protocol was approved by the institutional review board at each clinical site, and all patients gave informed consent.
Study Protocol
Patients were given 325 mg of aspirin orally two hours before the percutaneous revascularization procedure and daily thereafter. Patients were randomly assigned in a double-blind fashion by means of a central telephone hot line to one of three treatment groups: placebo with standard-dose, weight-adjusted heparin; abciximab with standard-dose, weight-adjusted heparin; or abciximab with low-dose, weight-adjusted heparin. For those receiving abciximab, a bolus of 0.25 mg per kilogram of body weight was administered 10 to 60 minutes before inflation of the balloon or activation of the device, followed by an infusion of 0.125 μg per kilogram per minute (maximum, 10 μg per minute) for 12 hours. The standard-dose, weight-adjusted heparin regimen consisted of an initial bolus of 100 U of heparin per kilogram (maximum, 10,000 U) before the interventional procedure, with additional weight-adjusted boluses calculated according to an algorithm intended to achieve and maintain an activated clotting time of at least 300 seconds. The group assigned to low-dose, weight-adjusted heparin received an initial bolus of 70 U of heparin per kilogram (maximum, 7000 U), with additional boluses as necessary to achieve and maintain an activated clotting time of at least 200 seconds. To preserve the blinding of all investigators and personnel involved in patient care, a heparin coordinator at each clinical site performed all measurements of activated clotting time and directed the administration of heparin. The protocol recommended that heparin be discontinued immediately after the interventional procedure and that vascular sheaths be removed when the activated clotting time was 175 seconds or less (usually 2 to 6 hours later).
Implantation of stents was discouraged and was reserved as a means of maintaining patency after manifest or threatened abrupt closure. Specific guidelines for sites of vascular access stressed the early removal of sheaths, avoidance of routine placement of venous sheaths, selective anterior-arterial-wall puncture, compression of the femoral access site for 30 minutes to achieve hemostasis after removal of the vascular sheath, and strict bed rest and immobilization of limbs for 6 to 8 hours after the cessation of abciximab treatment and removal of sheaths. Algorithms were provided for the management of uncontrolled bleeding, urgent coronary-artery bypass surgery, and thrombocytopenia, and it was recommended that red-cell transfusions be administered according to the clinical guidelines of the American College of Physicians.5
Study End Points
The primary efficacy end point was a composite of death from any cause, myocardial infarction or reinfarction, or severe myocardial ischemia requiring urgent coronary bypass surgery or repeated percutaneous coronary revascularization within 30 days after randomization. A second efficacy end point was a composite of death, myocardial infarction, or coronary bypass surgery or repeated percutaneous revascularization (urgent or nonurgent) within six months after randomization. End-point classifications of a clinical-events committee, blinded to study-group assignment, were used for the final analyses.
An end-point in-hospital myocardial infarction was defined by one of two criteria: new, clinically significant Q waves in two or more contiguous electrocardiographic leads; or elevation in creatine kinase or its MB isoenzyme to at least three times the upper limit of normal, representing an increase of at least 50 percent over the previous trough level, in two samples collected at different times (enzyme analysis was conducted on blood obtained before and 2 hours after the initiation of treatment with the study agent, every 6 hours up to 24 hours, and then every 8 hours up to 48 hours or discharge). After discharge from the hospital, myocardial infarction was defined by the occurrence of Q waves or the elevation of creatine kinase or its MB isoenzyme to more than twice the upper limit of normal. The MB isoenzyme value was used if it was available; if not, the total creatine kinase value was used.
Bleeding events were classified as major or minor according to the criteria used by the Thrombolysis in Myocardial Infarction Study Group.6 Hemoglobin was measured before and 12 and 36 hours after initiation of the study agent (or at discharge). To account for the influence of red-cell transfusions on measured hemoglobin values, the estimated decreases in hemoglobin were adjusted according to the technique suggested by Landefeld et al.7 Platelet counts were obtained before and 1/2, 2, 12, 24, 48, and 72 hours after administration of the study agent (or at discharge). All suspected occurrences of stroke or intracranial hemorrhage were adjudicated by an independent neurologist.
Data Management and Statistical Analysis
Data were collected on case-report forms by study coordinators at the clinical sites and verified with medical records by study monitors. The investigators, study coordinators, and trial sponsor (Centocor) remained blinded to the treatment assignments until after the data were entered and reviewed by the clinical-events committee and the analysis plan was made final.
The differences among patients with regard to efficacy and bleeding variables were examined according to an intention-to-treat analysis. Hazard ratios were based on time-to-event analyses using the Cox proportional-hazards model. The P values for efficacy end points were derived from the log-rank statistic, and the P values for dichotomous safety end points were calculated with the Pearson chi-square statistic or Fisher's exact test.
An interim analysis was performed to review efficacy and safety data for the first 1500 patients, in order to ensure that the low-dose heparin regimen did not result in a higher rate of ischemic complications than placebo. The primary end point of this interim analysis was the occurrence of death or myocardial infarction within 30 days after randomization. An unbalanced stopping rule was applied that favored termination of the trial for reasons of safety rather than efficacy, requiring a one-sided P value of <0.025 if an abciximab group had a higher event rate than the placebo group, but a one-sided P value of <0.0005 if an abciximab group had a lower event rate than the placebo group.
The goal of the prespecified final analyses was to test whether either abciximab group had a lower rate of the 30-day or 6-month composite end point than the placebo group. Simulations were performed for the computation of the type I error. We controlled for type I error for each end point by requiring consistent effects for the combined abciximab groups as compared with the placebo group; a screening test was required to show significance at a level of P = 0.0287 for a given end point before pairwise testing could be performed. Both screening and pairwise tests were one-sided. With this strategy, the total probability of concluding that either abciximab group fared better than the placebo group with respect to any one or more of the 30-day, 6-month, or interim-analysis end points was less than 5 percent if, in fact, no difference existed. A sample of 4800 patients was chosen to provide an 80 percent power to detect a 35 percent reduction in the rate of the 30-day primary end point, assuming a base-line (placebo-group) event rate of 7 percent.
Results
Enrollment began on February 27, 1995. End-point and safety data for the first 1500 patients were reviewed by the Data and Safety Monitoring Committee on December 11, 1995. This interim analysis revealed that the incidence of death or myocardial infarction at 30 days was 8.2 percent for patients in the placebo group, as compared with 2.6 percent for patients treated with abciximab and low-dose heparin, and 3.6 percent for patients treated with abciximab and standard-dose heparin (P<0.001). Since the prespecified stopping rule was met, the trial was terminated on December 14, 1995, with a total of 2792 of the planned 4800 patients enrolled.
There were no significant differences in base-line characteristics among patients in the three treatment groups (Table 1Table 1
Base-Line Demographic, Clinical, and Procedural Characteristics of the Study Patients.). Notably, despite the exclusion of patients with unstable angina accompanied by reversible electrocardiographic changes within the previous 24 hours, 48 percent of the patients enrolled met other clinical criteria for unstable angina.The incidence of the composite end point of death, myocardial infarction, or urgent revascularization for severe myocardial ischemia at 30 days (Figure 1Figure 1
Kaplan–Meier Estimate of the Probability of the Primary Efficacy End-Point Events (Death, Myocardial Infarction, or Urgent Repeated Revascularization) within 30 Days after Randomization, According to Treatment Assignment.) was 11.7 percent in the placebo group, 5.2 percent in the group assigned to abciximab with low-dose heparin (hazard ratio, 0.43; 95 percent confidence interval, 0.30 to 0.60; P<0.001), and 5.4 percent in the group assigned to abciximab with standard-dose heparin (hazard ratio, 0.45; 95 percent confidence interval, 0.32 to 0.63; P<0.001). Each of the components of the composite end point was similarly reduced (Table 2Table 2
Components of the 30-Day Primary Composite Efficacy End Point.). The treatment effect of abciximab with either heparin regimen was homogeneous among all patient groups (Figure 2Figure 2Hazard Ratios and 95 Percent Confidence Intervals for the 30-Day Primary Efficacy End Point in Prespecified Subgroups Defined According to Risk Stratum, Indication for Revascularization, Weight, Age, and Sex.). Proportional-hazards regression using the base-line variables in Table 1 identified no significant interactions between the characteristics of the patients and the effect of abciximab treatment.The rates of hemorrhagic complications during hospitalization are summarized in Table 3Table 3
Bleeding End Points.. There were no significant differences among the treatment groups in the risk of major bleeding. Patients receiving abciximab with standard-dose heparin, but not those receiving abciximab with low-dose heparin, had significantly more minor bleeding events than patients receiving placebo. The rate of red-cell transfusions was significantly lower among patients receiving abciximab with low-dose heparin than among those receiving placebo. One patient in each abciximab group, but none in the placebo group, had a hemorrhagic stroke; two patients receiving abciximab with standard-dose heparin had other intracranial bleeding or a nonhemorrhagic stroke. Severe thrombocytopenia (platelet count, <50,000 per cubic millimeter) occurred in four patients in the placebo group (0.4 percent), four patients assigned to abciximab and low-dose heparin (0.4 percent), and eight patients in the group assigned to abciximab and standard-dose heparin (0.9 percent, P = 0.260).At six months, the cumulative incidence of death, myocardial infarction, or repeated revascularization was 25.8 percent in the placebo group, 22.8 percent in the group assigned to abciximab with low-dose heparin (11.7 percent risk reduction, P = 0.07), and 22.3 percent in the group assigned to abciximab with standard-dose heparin (13.7 percent risk reduction, P = 0.04). The treatment effect observed at 30 days for the reduction in acute ischemic complications (death, myocardial infarction, or urgent revascularization) was maintained throughout the 6-month follow-up period; thus, the attenuation of risk reduction observed for the 6-month composite end point was due to the lack of effect of abciximab on the incidence of nonurgent repeated revascularization procedures (Table 4Table 4
Components of the Six-Month Composite Efficacy End Point.). There were no significant differences in the incidence of target-vessel revascularization among the three treatment groups.Discussion
The EPIC study demonstrated the efficacy of abciximab in reducing complications among patients at high risk during coronary intervention because of unstable ischemic syndromes or unfavorable lesion morphology on angiography.2 However, important questions were raised regarding whether such a strategy should be used for all patients undergoing percutaneous coronary revascularization, particularly in view of the increased risk of hemorrhage associated with the use of abciximab. In the current trial, abciximab administered with a reduced-dose, weight-adjusted heparin regimen decreased the rate of the composite 30-day end point by 56 percent across a broad spectrum of patients without an attendant increase in the risk of major bleeding complications.
A noteworthy consistency of treatment effect was observed for each of the components of the composite end point, as well as for the magnitude of benefit among the various subgroups of patients. The reduction in acute ischemic complications after abciximab treatment was durable over six months of follow-up, although incremental efficacy in reducing the need for nonurgent revascularization procedures was not observed. This study not only establishes the central role of platelet aggregation in the pathogenesis of acute ischemic complications associated with routine percutaneous revascularization, regardless of the patient's risk profile, but also provides proof that the clinical benefit derived from the inhibition of platelet thrombus formation by blockade of glycoprotein IIb/IIIa receptor may be uncoupled from the risk of hemorrhage.
Although it is correlated with the risk of hemorrhage during catheterization or interventional procedures,8-11 adjunctive heparin therapy is universally employed in patients undergoing percutaneous revascularization. On the basis of observational data indicating that the probability of abrupt vessel closure or ischemic complications may be related to lower levels of anticoagulation,12-14 the standard of care in many catheterization laboratories has been the routine administration of a bolus of 10,000 to 15,000 U of heparin to achieve an activated clotting time of at least 300 to 350 seconds before coronary angioplasty is begun.15,16
Previous studies demonstrating benefit from aggressive anticoagulant therapy with heparin during percutaneous coronary revascularization may not, however, be relevant when more potent platelet inhibition is achieved. Moreover, heparin appears to potentiate the bleeding risk of glycoprotein IIb/IIIa receptor blockade. In the EPIC study,2 the rate of major bleeding was increased from 6.6 percent among patients receiving placebo to 14 percent among those receiving abciximab, with the greatest risk of bleeding in the patients of lowest body weight, for whom the fixed heparin doses were highest on a weight-adjusted basis.2,3
Because the heparin doses in the current trial were adjusted for body weight (Table 1), even the patients on the standard-dose heparin regimen received less heparin than the boluses of 10,000 to 15,000 U that are frequently used empirically in clinical practice. Moreover, other interventions included early removal of the sheath (with elimination of postprocedural heparin infusion), meticulous care of the vascular access site, and transfusion guidelines. With this integrated strategy, major hemorrhage and the need for transfusions occurred infrequently in all three treatment groups, although the lowest rates of hemorrhagic complications, particularly minor bleeding, were observed when abciximab was administered with low-dose heparin.
Despite the reduction in the dosage of heparin, the treatment effect of abciximab in limiting ischemic complications of coronary revascularization was marked: for every 1000 patients treated, 65 fewer had acute adverse events. No other therapy has been reported to produce this degree of reduction in important myocardial ischemic events in a broad population of patients undergoing coronary intervention. The rates of myocardial infarction, most frequently non–Q-wave infarction, and of urgent revascularization were reduced by a similar magnitude (relative risk reductions of 58 and 68 percent, respectively). Although the clinical significance of periprocedural non–Q-wave myocardial infarction after percutaneous coronary revascularization remains somewhat controversial, several recent reports have clearly demonstrated that patients who have elevated levels of creatine kinase after coronary intervention are at significantly greater risk for late death from cardiac causes than those who do not.17-21 An increased risk of late events has been observed in these studies even among patients with small elevations of creatine kinase MB (from more than 1 to 1.5 times the control value),19,21 but the risk of death appears to be proportional to the degree of enzyme elevation. The reduction in the rate of periprocedural myocardial infarction by abciximab in this trial occurred mainly for large, non–Q-wave infarctions (creatine kinase MB, >5 times the control value). This observation confirms that the ischemic events that were prevented would have been clinically relevant and not merely laboratory abnormalities.
Notably, the six-month outcome in the EPILOG trial differed from that in the EPIC trial with regard to the incidence of repeated revascularization events. In the EPIC trial, abciximab therapy was associated with a 26 percent reduction in the need for revascularization of the target vessel (defined as further revascularization in a vessel treated during the index procedure),22 leading to the hypothesis that this agent may inhibit the process of restenosis. In the EPILOG trial, in contrast, no differences in long-term revascularization rates were observed. Acute ischemic events (death, myocardial infarction, and urgent revascularization), however, were suppressed by abciximab throughout the six-month follow-up period. The reasons for the disparate effects of abciximab on nonurgent-revascularization rates in these two large-scale trials are unknown, but they may relate in part to changes in coronary interventional practice (including the unplanned use of stents in 12 percent of the patients in the EPILOG trial), or to differences in patient populations or the dosage of heparin.
The clinical applicability of glycoprotein IIb/IIIa receptor blockade during percutaneous coronary revascularization is potentially broad. However, the cost of abciximab ($1,407 per dose, on average)23 is an obstacle to the widespread use of this therapy. A formal economic analysis of the EPILOG trial will explore the key issue of the cost effectiveness of this treatment. Other important considerations include the associated risk of thrombocytopenia and the currently unknown consequences of readministration of this chimeric antibody fragment (IgG antibody response develops in approximately 6 percent of patients on first administration).
In summary, this trial establishes that blockade of platelet glycoprotein IIb/IIIa receptor with abciximab has potentially broad clinical use in reducing ischemic complications associated with percutaneous coronary revascularization. Optimal use of this treatment in clinical practice will require minimizing bleeding complications by using low-dose heparin therapy in conjunction with abciximab.
Supported by Centocor, Malvern, Pa., and Eli Lilly and Company, Indianapolis.
Dr. Lincoff, as principal investigator of the study, assumes overall responsibility for the content and integrity of the article.
Source Information
Address reprint requests to Dr. A. Michael Lincoff at the Department of Cardiology, F-25, Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44195.
The principal investigators and study coordinators of the Evaluation in PTCA to Improve Long-Term Outcome with Abciximab GP IIb/IIIa Blockade (EPILOG) Study Group are listed in the Appendix.
Appendix
The following centers and investigators participated in the EPILOG Trial: Operations Committee: E.J. Topol (Study Chairman), R.M. Califf, A.M. Lincoff, J.E. Tcheng, C.F. Cabot, H.F. Weisman. Site Principal Investigators and Study Coordinators (patient enrollment in parentheses): Christ Hospital and University of Cincinnati Medical Center, Cincinnati, OH (238): D. Kereiakes, D. Lausten, J.P. Runyon, W. Howard. Moses Cone Memorial Hospital, Greensboro, NC (176): T. Kelly, D. Muncy. William Beaumont Hospital, Royal Oak, MI (148): G. Timmis, M. Safian, D. Davey. Baylor College of Medicine, Houston, TX (144): N.S. Kleiman, D. Rose, L. Basinger. Cleveland Clinic Foundation, Cleveland, OH (125): A.M. Lincoff, C. Rouse. Our Lady of Lourdes, Cherry Hill, NJ (124): J. Kramer, R. Wilson. University of Arkansas, Little Rock, AR (118): J.D. Talley, M. Boyles. Mother Frances Hospital, Tyler, TX (88): F.I. Navetta, R. LeBueuf. Henry Ford Heart and Vascular Institute, Detroit, MI (85): P. Kraft, L. Dvorak. Duke University Medical Center, Durham, NC (83): J. Tcheng, R.M. Smigla. Texas Heart Institute, Houston, TX (73): J. Ferguson, M. Harlan. Lakeland Regional Medical Center, Lakeland, FL (71): K. Browne, M. Telatnik. Geisinger Medical Center, Danville, PA (70): J. Blankenship, L. Demko. Florida Hospital, Orlando, FL (67): R.J. Ivanhoe, C. Jackson. Presbyterian Hospital, Albuquerque, NM (62): N. Shadoff, S. Goebel. Deborah Heart and Lung Center, Browns Mills, NJ (56): M. Taylor, E. Cleary. Rochester General Hospital, Rochester, NY (53): G. Gacioch, V. Chiodo. University of Michigan Medical Center, Ann Arbor, MI (53): E. Bates, L. Quain. Cooper Medical Center, Haddon Heights, NJ (49): H. Snyder, R. Wilson. University Medical Center, Jacksonville, FL (43): T.A. Bass, G. Rohman. Western Pennsylvania Hospital, Pittsburgh, PA (41): A. Gradman, L. Boltey. Iowa Heart Center, Des Moines, IA (38): M. Tannenbaum, D. Stengl. Miriam Hospital, Providence, RI (36): P. Gordon, N. Wright. Milwaukee Heart and Vascular Clinic, Milwaukee, WI (36): F. Cummins, J. Nonnweiler. Johns Hopkins Hospital, Baltimore, MD (34): T. Aversano, L. Peltzer. Methodist Hospital–Iowa Heart, Des Moines, IA (34): P. Bear, M.B. Craig. United Medical Center, Cheyenne, WY (30): L. Hattel, G. Tooke. Hermann Hospital, Houston, TX (30): H.V. Anderson, L. Weigelt. Dartmouth–Hitchcock Medical Center, Lebanon, NH (30): B. Hettleman, S. Kennedy. Scripps Clinic and Research Foundation, La Jolla, CA (29): P.S. Teirstein, D. Claire. University of Virginia, Charlottesville, VA (28): I. Sarembock, S. Sayre. Northwestern Memorial Hospital, Chicago, IL (26): C.J. Davidson, A. Schaechter. St. Louis University Hospital, St. Louis, MO (25): F. Aguirre, T. Stonner. University of Connecticut Health Center, Farmington, CT (25): M. Azrin, J. Bodett, M.B. Barry. Lancaster General Hospital, Lancaster, PA (24): S. Worley, L.A. Frey. Ottawa Civic Hospital, Ottawa, ON (24): J.F. Marquis, F. Reid. Morton Plant Hospital, Clearwater, FL (23): D.J. Spriggs, S.A. Wahl. Hartford Hospital, Hartford, CT (23): M. Azrin, D. Hall. Tampa General Hospital, Tampa, FL (22): M.W. Weston, K. Yedinak. Riverside Hospital, Columbus, OH (21): B. George, D. Smith, C. Gilliland, D. Smith. Vancouver General Hospital, Vancouver, BC (21): D.R. Ricci, R. Fox. Sentara Norfolk General Hospital, Norfolk, VA (20): C. Hartman, S. Lunow. Allegheny General Hospital, Pittsburgh, PA (20): T. Farah, S. Petruolo. Louisiana State University Medical Center, New Orleans, LA (20): G. Sander, A. Stevens, K. Delise. Presbyterian Hospital, Charlotte, NC (18): B. Reen, D. Whisnant, L. Henderson. Arizona Heart Institute and Foundation, Phoenix, AZ (18): R. Heuser, K. Swiderski, M. Kaluzniak. Evanston Hospital, Evanston, IL (17): T. Larkin, B.J. Jackson. Washington Hospital Center, Washington, DC (17): J. Popma, N. Prunka. St. Patrick's Hospital, Missoula, MT (17): M. Sanz, D. Mayer, K. Mackey. University of Alberta Hospital, Edmonton, AB (17): J. Burton, N. Hogg. Royal Columbian Hospital, New Westminster, BC (14): R. Brown, K. Stevens. Harbor–UCLA Medical Center, Torrance, CA (13): W. French, S. Wang. Mount Sinai Hospital, Toronto, ON (13): A.G. Adelman, V. Foulger, S. Weber. Graduate Hospital, Philadelphia, PA (9): R. Gottlieb, J. Lavoie. Emory University Hospital, Atlanta, GA (9): S. King, F. Frerichs. St. Joseph's Hospital, Lancaster, PA (7): S. Worley, L. Hollywood. Health Sciences Center, Winnipeg, MB (7): J. Ducas, U. Schick. St. Luke's–Roosevelt Hospital, New York, NY (6): J.S. Hochman, J. Slater, D. Tormey. Victoria General Hospital, Halifax, NS (5): B.J. O'Neill, K. Foshay, N. Fitzgerald. St. Boniface General Hospital, Winnipeg, MB (5): P.K. Cheung, D. Bedard. Calgary Foothills Hospital, Calgary, AB (4): M.L. Knudtson, D. Galbraith, H. Watt. Baptist Memorial Hospital East, Memphis, TN (4): J. Samaha, B. Hamilton. Rush–Presbyterian–St. Luke's Medical Center, Chicago, IL (3): L.W. Klein, L. Hebson. Victoria Hospital Corp., London, ON (2): D. Almond, J. White. Lutheran General Hospital, Park Ridge, IL (1): M.J. Rosenberg, S. Teully. Keesler Medical Center, Keesler AFB, MS (1): M. Unks, K. Rodgers. Data and Safety Monitoring Committee: D. Faxon (Chairman), J. Gore, S. Kelsey, K. Lee, D. Sane, L. Walters. Coordinating Center: J. Booth (Study Coordinator), R. Cannata, V. Castle, H. Cohen, S. DeLuca, M. Kutner, T. Knuth, A. Lincoff, T. McCollough, J. McPherson, J. Melton, D. Miller, M. Pulliam, S. Sapp, K.N. Sigmon. Clinical Events Committee: E. Montague (Committee Coordinator), K. Alexander, R. Augostini, C. Bajzer, B. Bart, G. Belli, J. Carlson, R. Challapalli, B. Crenshaw, I. Dawson, S. DeLuca, A. Dickey, A. Echols, B. Erickson, M.B. Fontana, S. Ghaffari, C. Gordon, C. Granger, G. Grano, R. Grimm, T. Johnson, N. Juran, A. Kingsley, K. Kruse, M. Lauer, K. Mahaffey, K. Malone, D. Mark, T. Marwick, R. Migrino, J. Miller, K. Newby, C. Pace, E. Peterson, R. Rabbani, J. Ragan, C. Rimmerman, S. Rodkey, V. Savor, W.F. Shaw, C. Sila, M. Silver, W. Tan, D. Tobiasz, P. Vandervoort, C.W. Wang, C. Ward, J. Waters, D. Wiehle, M. Winchell. Electrocardiographic Core Laboratory: D. Underwood (Chairman), P. Clemons, S. Heupler, M. Lauer, J. Powers, D. Rubin, E. Sgarbossa, S. Steinhubl. Angiographic Core Laboratory: D. Moliterno (Medical Director), D. Debowey (Director), E. Balazs, T. Crowe, T. Ivanc, L. Ols, R. Poliszczuk, H. Vilsack, B. Witherspoon. Economics and Quality of Life: D. Mark, L. Davidson-Ray. Centocor, Inc.: K.M. Anderson, C.F. Cabot, K.M. Giel, M.H. Musco, G.L. Stoner, H.F. Weisman.
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CHETAN SHENOY, KISHORE J. HARJAI. (2011) Thrombocytopenia following Percutaneous Coronary Intervention. Journal of Interventional Cardiology 24:1, 15-26
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R. S. Hermanides, J. P. Ottervanger, J.-H. E. Dambrink, M.-J. de Boer, J. C. A. Hoorntje, A. T. M. Gosselink, H. Suryapranata, F. Zijlstra, A. W. J. van ‘t Hof, . (2011) Suboptimal anticoagulation with pre-hospital heparin in ST-elevation myocardial infarction. Thrombosis and Haemostasis 106:4, 636-640
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Glenn N. Levine, Eric R. Bates, James C. Blankenship, Steven R. Bailey, John A. Bittl, Bojan Cercek, Charles E. Chambers, Stephen G. Ellis, Robert A. Guyton, Steven M. Hollenberg, Umesh N. Khot, Richard A. Lange, Laura Mauri, Roxana Mehran, Issam D. Moussa, Debabrata Mukherjee, Brahmajee K. Nallamothu, Henry H. Ting, Alice K. Jacobs, Jeffrey L. Anderson, Nancy Albert, Mark A. Creager, Steven M. Ettinger, Robert A. Guyton, Jonathan L. Halperin, Judith S. Hochman, Frederick G. Kushner, E. Magnus Ohman, William Stevenson, Clyde W. Yancy. (2011) 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. Catheterization and Cardiovascular Interventionsn/a-n/a
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G. Ganesha Babu, J. Malcolm Walker, D. M. Yellon, D. J. Hausenloy. (2011) Peri-procedural myocardial injury during percutaneous coronary intervention: an important target for cardioprotection. European Heart Journal 32:1, 23-31
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Elias B. Hanna, Sunil V. Rao, Steven V. Manoukian, Jorge F. Saucedo. (2010) The Evolving Role of Glycoprotein IIb/IIIa Inhibitors in the Setting of Percutaneous Coronary Intervention. JACC: Cardiovascular Interventions 3:12, 1209-1219
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David J. Schneider. (2010) Anti-platelet therapy: Glycoprotein IIb-IIIa Antagonists. British Journal of Clinical Pharmacologyno-no
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Samuel Chackalamannil. 2010. Antiplatelet Agents. .
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Xavier Bosch, Jaume Marrugat, Juan Sanchis, Xavier Bosch. 2010. Platelet glycoprotein IIb/IIIa blockers during percutaneous coronary intervention and as the initial medical treatment of non-ST segment elevation acute coronary syndromes. .
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M. Valgimigli. (2010) Balancing safety and efficacy: recent clinical evidence optimizing outcomes in patients with intermediate to high-risk non-ST-segment elevated acute coronary syndrome. European Heart Journal Supplements 12:Suppl D, D14-D23
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Manivannan Srinivasan, Charanjit S. Rihal, Mandeep Singh, Ryan J. Lennon, David R. Holmes, Abhiram Prasad. (2010) Percutaneous Coronary Intervention in Native Vessels With Angiographically Visible Thrombus. JACC: Cardiovascular Interventions 3:9, 937-946
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Ananth Kidambi, Gnanamoorthy Mayurathan, Girish Viswanathan, Clyde Schechter, Azfar G. Zaman. (2010) Unfractionated Heparin during Elective PCI: Fixed Dose or Weight Adjusted?. Cardiovascular Therapeuticsno-no
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Nethnapha Paredes, Tapas Mondal, Leonardo R Brandão, Anthony KC Chan. (2010) Management of myocardial infarction in children with Kawasaki disease. Blood Coagulation & Fibrinolysis1
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Jorge F. Saucedo. (2010) Balancing the benefits and risks of antiplatelet agents in patients with non-ST-segment elevated acute coronary syndromes and undergoing percutaneous coronary intervention. Journal of Thrombosis and Thrombolysis 30:2, 200-209
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Khalil Kanjwal, Christopher J. Cooper, Renu Virmani, Steven Haller, Joseph I. Shapiro, Mark W. Burket, Michael Steffes, Pamela Brewster, Haifeng Zhang, William R. Colyer. (2010) Predictors of embolization during protected renal artery angioplasty and stenting: Role of antiplatelet therapy. Catheterization and Cardiovascular Interventions 76:1, 16-23
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Michael Koutouzis, Lars Grip. (2010) Glycoprotein IIb/IIIa inhibitors during percutaneous coronary interventions. Interventional Cardiology 2:3, 301-318
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A. De Labriolle, L. Bonello, G. Lemesle, P. Roy, D. H. Steinberg, Z. Xue, W. O. Suddath, L. F. Satler, K. M. Kent, A. D. Pichard, J. Lindsay, R. Waksman. (2010) Decline in platelet count in patients treated by percutaneous coronary intervention: definition, incidence, prognostic importance, and predictive factors. European Heart Journal 31:9, 1079-1087
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Michel R Hoenig, Constantine N Aroney, Ian A Scott, Michel R Hoenig. 2010. Early invasive versus conservative strategies for unstable angina and non-ST elevation myocardial infarction in the stent era. .
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Jean-Etienne Fabre, Mark E. Gurney. (2010) Limitations of current therapies to prevent thrombosis: a need for novel strategies. Molecular BioSystems 6:2, 305
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Behnam Banihashemi, Shaun G. Goodman, Raymond T. Yan, Robert C. Welsh, Shamir R. Mehta, Gilles Montalescot, Jan M. Kornder, Graham C. Wong, Gabor Gyenes, Ph. Gabriel Steg, Andrew T. Yan. (2009) Underutilization of clopidogrel and glycoprotein IIb/IIIa inhibitors in non–ST-elevation acute coronary syndrome patients: The Canadian Global Registry of Acute Coronary Events (GRACE) experience. American Heart Journal 158:6, 917-924
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JACOB A. DOLL, EUGENIA NIKOLSKY, GREGG W. STONE, ROXANA MEHRAN, A. MICHAEL LINCOFF, ADRIANO CAIXETA, BRENT MCLAURIN, ECATERINA CRISTEA, MARTIN FAHY, VIJAYA KESANAKURTHY, ALEXANDRA J. LANSKY. (2009) Outcomes of Patients with Coronary Artery Perforation Complicating Percutaneous Coronary Intervention and Correlations with the Type of Adjunctive Antithrombotic Therapy: Pooled Analysis from REPLACE-2, ACUITY, and HORIZONS-AMI Trials. Journal of Interventional Cardiology 22:5, 453-459
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John P Vavalle, Sunil V Rao. (2009) Impact of bleeding complications on outcomes after percutaneous coronary interventions. Interventional Cardiology 1:1, 51-62
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Dong-Hyun Choi, Jung-Won Suh, Kyung-Woo Park, Hyun-Jae Kang, Hyo-Soo Kim. (2009) Assessment of the bioequivalence of brand and biogeneric formulations of abciximab for the treatment of acute coronary syndrome: A prospective, open-label, randomized, controlled study in Korean patients. Clinical Therapeutics 31:8, 1804-1811
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Sohita Dhillon. (2009) Argatroban. American Journal Cardiovascular Drugs 9:4, 261-282
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Renato Valenti, Guido Parodi, Angela Migliorini. 2009. Platelet Glycoprotein IIb-IIIa Inhibitors. , 67-76.
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Randall T. Higashida, Philip M. Meyers, Constantine C. Phatouros, John J. Connors III, John D. Barr, David Sacks. (2009) Reporting Standards for Carotid Artery Angioplasty and Stent Placement. Journal of Vascular and Interventional Radiology 20:7, S349-S373
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Jason N. Katz and, Robert A. Harrington. 2009. Intravenous Glycoprotein IIb/IIIa Antagonists. , 429-456.
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Allison G. Dupont, Don A. Gabriel, Mauricio G. Cohen. (2009) Antiplatelet therapies and the role of antiplatelet resistance in acute coronary syndrome. Thrombosis Research 124:1, 6-13
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R.A. Willinsky, J. Peltz, L. da Costa, R. Agid, R.I. Farb, K.G. terBrugge. (2009) Clinical and Angiographic Follow-up of Ruptured Intracranial Aneurysms Treated with Endovascular Embolization. American Journal of Neuroradiology 30:5, 1035-1040
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Magnus Wahlin, Per Albertsson, Thomas Karlsson, Göran Matejka, Annika Odell, Farshad Tahmasebiepour, Christina Wolmeryd, Lars Grip. (2009) Switch from abciximab to eptifibatide during percutaneous coronary intervention. International Journal of Cardiology 134:3, 393-400
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CHETAN SHENOY, PAMELA ORSHAW, SRINIVAS DEVARAKONDA, KISHORE J. HARJAI. (2009) Occurrence, Predictors, and Outcomes of Post-Percutaneous Coronary Intervention Thrombocytopenia in an Unselected Population. Journal of Interventional Cardiology 22:2, 156-162
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Harvey D White. (2009) HORIZONS trial: a step forward for primary percutaneous coronary intervention. Expert Review of Cardiovascular Therapy 7:2, 125-129
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Cedric W. Lefebvre, James W. Hoekstra, Marc Bonaca, Robert Giugliano. (2009) Glycoprotein IIb-IIIa Inhibitors in the Emergency Department for Patients with Non-ST-Elevation Acute Coronary Syndromes: Principles and Practices. The Journal of Emergency Medicine 36:2, 162-170
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Tadayuki Uetani, Tetsuya Amano, Soichiro Kumagai, Hirohiko Ando, Kiminobu Yokoi, Tomohiro Yoshida, Bunichi Kato, Masataka Kato, Nobuyuki Marui, Michio Nanki, Tatsuaki Matsubara, Hideki Ishii, Hideo Izawa, Toyoaki Murohara. (2009) Intracoronary Electrocardiogram Recording With a Bare-Wire System. JACC: Cardiovascular Interventions 2:2, 127-135
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Sun-Jung Song, Kyoung Seok Kim, Yu Jeong Park, Myung Ho Jeong, Yeong-Mu Ko, Dong Lyun Cho. (2009) Preparation of a dual-drug-eluting stent by grafting of ALA with abciximab on a bare metal stent. Journal of Materials Chemistry 19:43, 8135
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You-Jeong Oh, Tae-Ho Park, Yun-Jung Choi, Su-Hyun Cho, Jae-Hyuk Choi, Dong-Hyun Lee, Sun-Yi Park, Kwang-Soo Cha, Moo-Hyun Kim, Young-Dae Kim. (2009) Abciximab (ReoPro)-Induced Thrombocytopenia Diagnosed Through Measurement of Heparin-Dependent Antibody. Korean Circulation Journal 39:2, 75
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Enrico Vizzardi, Antonio D’Aloia, Gregoriana Zanini, Elena Antonioli, Claudio Pedrinazzi, Riccardo Raddino, Livio Dei Cas. (2008) A case report of alveolar haemorrhage associated with severe thrombocytopenia induced by abciximab infusion in a patient with an acute coronary syndrome. Internal and Emergency Medicine 3:4, 345-347
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Refat Jabara, Radhika Gadesam, Lakshmana Pendyala, Nicolas Chronos, Larry V. Crisco, Spencer B. King, Jack P. Chen. (2008) Ambulatory discharge after transradial coronary intervention: Preliminary US single-center experience (Same-day TransRadial Intervention and Discharge Evaluation, the STRIDE Study). American Heart Journal 156:6, 1141-1146
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Gennaro Galasso, Federico Piscione, Fulvio Furbatto, Dario Leosco, Adele Pierri, Roberta De Rosa, Plinio Cirillo, Antonio Rapacciuolo, Giovanni Esposito, Massimo Chiariello. (2008) Abciximab in elderly with Acute Coronary Syndrome invasively treated: Effect on outcome. International Journal of Cardiology 130:3, 380-385
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Umesh U Tamhane, Hitinder S Gurm. (2008) The chimeric monoclonal antibody abciximab: a systematic review of its safety in contemporary practice. Expert Opinion on Drug Safety 7:6, 809-819
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B. S. Coller, S. J. Shattil. (2008) The GPIIb/IIIa (integrin IIb 3) odyssey: a technology-driven saga of a receptor with twists, turns, and even a bend. Blood 112:8, 3011-3025
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Barry F. Uretsky, Yochai Birnbaum, Abdulfatah Osman, Rajiv Gupta, Oscar Paniagua, Antonio Chamoun, Amir Pohwani, Charles Lui, Eli Lev, Todd McGehee, Darren Kumar, Asif Akhtar, Angelo Anzuini, Ernst R. Schwarz, Fen Wei Wang. (2008) Distal myocardial protection with intracoronary beta blocker when added to a Gp IIb/IIIa platelet receptor blocker during percutaneous coronary intervention improves clinical outcome. Catheterization and Cardiovascular Interventions 72:4, 488-497
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R.G. Jones, I. Davagnanam, S. Colley, R.J. West, D.A. Yates. (2008) Abciximab for Treatment of Thromboembolic Complications during Endovascular Coiling of Intracranial Aneurysms. American Journal of Neuroradiology 29:10, 1925-1929
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R. J. Gumina, E. H. Yang, G. S. Sandhu, A. Prasad, J. F. Bresnahan, R. J. Lennon, C. S. Rihal, D. R. Holmes, M. Singh. (2008) Survival Benefit With Concomitant Clopidogrel and Glycoprotein IIb/IIIa Inhibitor Therapy at Ad Hoc Percutaneous Coronary Intervention. Mayo Clinic Proceedings 83:9, 995-1001
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Caroline Johnson Girardeau, Deborah Montague. (2008) Implementing Consultant Recommendations in Percutaneous Coronary Interventions: Look Before You Leap. Hospital Pharmacy 43:8, 635-642
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MARC COHEN, JAMES HOEKSTRA, ROBERT GIUGLIANO, CHRISTOPHER B. GRANGER, PAUL A. GURBEL, JUDD E. HOLLANDER, STEVEN V. MANOUKIAN, CHARLES V. POLLACK, JR, JORGE F. SAUCEDO. (2008) Treatment Strategies in Non-ST-Elevation Acute Coronary Syndromes in Patients Undergoing Percutaneous Coronary Intervention: An Evidence-Based Review of Clinical Trial Results and Treatment Guidelines: Report on a Roundtable Discussion. Journal of Interventional Cardiology 21:4, 283-299
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Daniel H. Steinberg, Palak Shah, Tim Kinnaird, Tina L. Pinto Slottow, Probal K. Roy, Teruo Okabe, Laurent Bonello, Axel de Labriolle, Kimberly A. Smith, Rebecca Torguson, Zhenyi Xue, William O. Suddath, Kenneth M. Kent, Lowell F. Satler, Augusto D. Pichard, Joseph Lindsay, Ron Waksman. (2008) Bleeding Risk and Outcomes of Bivalirudin Versus Glycoprotein IIb/IIIa Inhibitors With Targeted Low-Dose Unfractionated Heparin in Patients Having Percutaneous Coronary Intervention for Either Stable or Unstable Angina Pectoris. The American Journal of Cardiology 102:2, 160-164
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