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Ann Thorac Surg 2000;70:866-871
© 2000 The Society of Thoracic Surgeons

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Original articles: cardiovascular

Immediate coronary artery bypass surgery after platelet inhibition with eptifibatide: results from PURSUIT

^a The Sanger Clinic, Charlotte, North Carolina, USA
^b Cor Therapeutics, South San Francisco, California, USA
^c Duke Clinical Research Institute, Durham, North Carolina, USA
^d Mid-America Heart Institute, Kansas City, Missouri, USA

Address reprint requests to Dr Dyke, The Sanger Clinic, 2555 Court Dr, Suite 200, Gastonia, NC 28054
e-mail: cdyke{at}mindspring.com

Presented at the Thirty-sixth Annual Meeting of The Society of Thoracic Surgeons, Ft. Lauderdale, FL, Jan 31–Feb 2, 2000.

	Abstract

Top Abstract Introduction Material and methods Results Comment References

 
Background. The platelet GP IIb/IIIa inhibitor eptifibatide improves outcomes in patients with acute coronary syndromes. Patients requiring emergent coronary artery bypass grafting, however, may be at increased risk for bleeding if exposed to eptifibatide. Data from the PURSUIT trial were reviewed to assess this risk in patients undergoing coronary surgery immediately after exposure to eptifibatide.

Methods. In PURSUIT, 10,948 patients who presented with non-ST segment elevation acute coronary syndromes were prospectively randomized to receive eptifibatide (180 µg/kg bolus plus 2 µg/kg/min infusion) or placebo. A total of 78 patients underwent immediate coronary artery bypass surgery within 2 hours of cessation of study drug (placebo, n = 46; eptifibatide, n = 32). Clinical outcome, bleeding, and transfusion requirements within this subset were examined.

Results. Major bleeding was not different between groups, occurring in 64% of patients receiving placebo and 63% of patients receiving eptifibatide. The incidence of blood transfusion was similar as well (57% vs 59%). Postoperative thrombocytopenia occurred less often after eptifibatide exposure. Perioperative myocardial infarction was significantly reduced in patients who received eptifibatide (46% vs 22%, p < 0.05). There was no difference in perioperative stroke (2.2% vs 6.3%) or mortality (6.3% vs 6.5%).

Conclusions. Patients may safely undergo coronary artery bypass surgery within 2 hours of discontinuation of eptifibatide. Eptifibatide infusion in the immediate preoperative period had no adverse clinical effects, but did significantly decrease the incidence of perioperative myocardial infarction. Additionally, platelet counts after surgery were higher in the group of patients who received eptifibatide, perhaps indicative of a platelet-sparing effect during cardiopulmonary bypass.

	Introduction

Top Abstract Introduction Material and methods Results Comment References

 
Eptifibatide (Integrelin; Cor Therapeutics/Key Pharmaceuticals, South San Francisco, CA) is a cyclic heptapeptide that binds with high specificity to the platelet GP IIb/IIIa receptor, inhibiting platelet aggregation. It has been demonstrated to be effective in reducing the incidence of death and myocardial infarction in patients with unstable angina and non-Q wave myocardial infarction [1]. Additionally, eptifibatide reduces complications during percutaneous coronary interventions [1, 2]. The dramatic impact of eptifibatide and the other GP IIb/IIIa inhibitors (tirofiban and abciximab) for the treatment of patients with acute coronary syndromes has prompted Topol to describe the current era as a "new frontier" in myocardial reperfusion therapy, one of "platelet preeminence" [3]. While the vast majority of patients tolerate these potent platelet inhibitors without difficulty, a small but not insignificant number may be at risk for bleeding complications, especially when emergent or urgent cardiac surgery is necessary [4–8].

The impact of eptifibatide on patients undergoing emergent cardiac surgery is unclear. It has been suggested that GP IIb/IIIa inhibitors with a shorter half-life have an improved safety profile, as platelet aggregation more rapidly returns to baseline. Little clinical data exist, however, on patients who require immediate coronary surgery after receiving eptifibatide. Accordingly, data from the Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrelin Therapy (PURSUIT) trial were retrospectively reviewed. PURSUIT was a large, randomized, double-blinded, placebo-controlled trial of eptifibatide in patients suffering from acute coronary syndromes. We identified patients enrolled in PURSUIT who underwent immediate coronary surgery to assess clinical outcomes and potential bleeding complications of eptifibatide in a cardiac surgical population.

	Material and methods

Top Abstract Introduction Material and methods Results Comment References

 
Randomization and treatment
The details of the PURSUIT trial have been previously published [1]. Briefly, PURSUIT was a prospective, randomized, placebo-controlled, double-blinded trial designed to test the hypothesis that eptifibatide reduced death or myocardial infarction in patients with acute coronary syndromes. Ten thousand nine hundred forty-eight patients at 726 participating hospitals in 27 countries were enrolled. The trial was designed so treatment was instituted early (upon presentation with chest pain), and was not limited to those patients in whom coronary revascularization (either percutaneous or surgical) had already been deemed necessary. Accordingly, treatment algorithms varied between centers. Of all the patients enrolled in PURSUIT, 78 patients underwent coronary artery bypass grafting within 2 hours of drug infusion (placebo or eptifibatide) and form the cohort upon which this study was based. Data were gathered retrospectively from the PURSUIT database.

Randomization was performed in a double-blind manner by coordinating centers in the United States and The Netherlands. After randomization, the study drug was infused until discharge from the hospital or for 72 hours, whichever came first. Cardiac catheterization and percutaneous or surgical revascularization were performed at the discretion of the treating physicians. Of the 78 patients who went to surgery within 2 hours of study drug, 32 received eptifibatide (a bolus dose of 180 µg/kg followed by an infusion of 2.0 µg/kg/min). Forty-six patients received a placebo bolus and infusion. Ninety-eight percent and 96% of patients who received placebo and eptifibatide, respectively, were placed on concomitant heparin therapy. The eptifibatide dosing regimen was expected to provide plasma concentrations that exceed the level needed to reach the 80% inhibitory concentration in the majority of patients. All patients received aspirin (80 to 325 mg per day per physician discretion) at presentation.

Clinical endpoints
The primary endpoint of the trial was prespecified as the incidence of the composite of death or myocardial infarction at 30 days. A Clinical Endpoints Committee was used to adjudicate the occurrence of myocardial infarction on the basis of source documentation obtained from each investigative site. The determination of myocardial infarction after coronary artery bypass grafting required an elevation of the CK-MB fraction to five or more times the upper limit of normal or the presence of new Q waves in two electrocardiographic leads. Neurologic evaluation and brain imaging with computed tomography or magnetic resonance imaging were recommended in cases of suspected stroke. Strokes were classified as hemorrhagic or ischemic.

Bleeding was assessed using the thrombolysis in myocardial infarction (TIMI) scale [9]. Complications were categorized as major or minor on the basis of hemoglobin/hematocrit changes after adjustment for transfusions. Major bleeding was defined as either intracranial hemorrhage or bleeding associated with a drop of 15 percentage points or more in the hematocrit or of 5 g/dL or more in the hemoglobin concentration. Minor bleeding was defined as a drop of more than 10 percentage points in the hematocrit or of 3 g/dL or more in the hemoglobin concentration. Mediastinal blood loss in those patients who had surgical revascularization was not a predetermined clinical endpoint in PURSUIT and was not adjudicated.

Statistical analysis
Comparison of treatment groups with respect to event rates and rates of other dichotomous variables used the unadjusted ² statistic. The Wilcoxon rank-sum test was used for between-group comparisons of continuous variables. Predetermined level of significance was p less than 0.05. SAS version 6.12 (Statistical Software, Cary, NC) was used for all analyses.

	Results

Top Abstract Introduction Material and methods Results Comment References

 
In PURSUIT, a total of 1,558 patients underwent coronary artery bypass grafting after randomization (Fig 1). Of these, 32 patients randomized to receive eptifibatide went to surgery less than 2 hours after discontinuation of the drug; 48 patients who received a placebo went to surgery within 2 hours. Overall, relatively fewer patients in the eptifibatide group required immediate surgery (3.7% vs 6.6%), though this difference was not statistically significant. In the placebo group, 18% of patients underwent percutaneous transluminal coronary angioplasty before surgery, compared with 31% in the eptifibatide group. This difference was not statistically significant. The geographic distribution of patients is detailed in Figure 2.

View larger version (18K): [in this window] [in a new window]   Fig 1. Incidence of CABG in PURSUIT. A total of 1,558 patients in the entire PURSUIT study underwent CABG at some time after randomization. A total of 78 patients had surgery within 2 hours of randomization.

View larger version (18K): [in this window] [in a new window]   Fig 2. Geographic distribution of patients. The vast majority of patients were treated in North America and Western Europe. Few patients were treated in Eastern Europe and Latin America.

View larger version (12K): [in this window] [in a new window]   Fig 3. Change in hemoglobin after CABG. Hemoglobin levels dropped equally in both groups after coronary artery bypass grafting, consistent with the hemodilution seen after cardiopulmonary bypass.

View larger version (21K): [in this window] [in a new window]   Fig 4. Change in platelet count after CABG. The mean platelet count after surgery fell in both groups, although not severely. The absolute decrease in platelet number was significantly less in patients who received eptifibatide, implying a potential platelet-sparing effect of eptifibatide.

	Comment

Top Abstract Introduction Material and methods Results Comment References

Despite the significant advances in intracoronary stenting and percutaneous interventions in the 1990s, immediate surgical revascularization is occasionally required, with a reported incidence between 0.5% and 2% [15–17]. Considering that approximately 700,000 percutaneous interventions are performed annually in the United States and that GP IIb/IIIa inhibition during intracoronary stenting is commonplace, cardiac surgeons may be expected to treat thousands of patients annually who present acutely with profound platelet inhibition. It may also be expected that this number will increase as the indications for GP IIb/IIIa inhibition continue to broaden (to include unstable angina, non-Q wave myocardial infarction, and acute myocardial infarction in combination with thrombolytic therapy).

As the first GP IIb/IIIa inhibitor approved for clinical use, more data exist regarding abciximab (ReoPro) and emergent or urgent coronary surgery than the other GP IIb/IIIa inhibitors. While it appears that preoperative exposure to abciximab does not increase surgical mortality, exposure before surgery has been reported to increase postoperative bleeding and transfusion requirements and is associated with a higher incidence of mediastinal reexploration (although this remains somewhat controversial) [4, 5, 18–21]. Effective surgical management for these patients includes platelet transfusion (frequently large amounts), reduction of heparin dosing, delay of operative intervention (when appropriate), and perhaps the use of a hemoconcentrator during cardiopulmonary bypass [22, 23]. Eptifibatide is a short-acting GP IIb/IIIa inhibitor with a half-life of approximately 90 minutes; whether these measures are necessary for patients exposed to eptifibatide immediately before surgery is unclear. The PURSUIT trial is especially suited to answer this question as it is a large, multicenter, randomized, double-blinded, placebo-controlled study in which individual treatment decisions were left to the discretion of the treating physician. As such, patient management algorithms ranged from early aggressive catheterization and revascularization to conservative medical therapy. We chose to study patients who underwent coronary artery bypass grafting within 2 hours of drug cessation, regardless of the indication for surgery. Our assumption was that clinically significant blood levels would still be present in these patients. Gammie and others have previously reported that the interval from drug infusion to operation significantly affects postoperative bleeding and transfusion requirements, with shorter intervals increasing risk [4, 24]. Other reports of patients undergoing surgery after GP IIb/IIIa inhibition have included patients with wide variations in the interval to surgery, complicating interpretation [25]. In PURSUIT, although the overall proportion of patients who went immediately to surgery was comparatively small, this cohort nonetheless represents the largest randomized group of patients who required immediate surgical intervention after GP IIb/IIIa blockade.

Eptifibatide infusion immediately before surgery did not adversely affect clinical outcomes. There was no difference in early or 30-day mortality between patients who received eptifibatide or placebo. Similarly, there was no difference in the incidence of stroke or other serious morbidity. The safety of eptifibide is likely due to its relatively rapid clearance; by the time patients are identified as needing emergent or urgent operation, and after several hours of operating time, platelet function would be expected to have normalized.

In PURSUIT, eptifibatide infusion immediately before surgery significantly reduced the incidence of perioperative myocardial infarction compared with placebo. This is consistent with data from the entire PURSUIT study, in which patients who received eptifibatide had a lower incidence of myocardial infarction, regardless of the treatment strategy [1]. Regardless of the means of revascularization (percutaneous or surgical), eptifibatide minimizes intracoronary thrombus formation and reduces the nidus for clot formation, resulting in fewer postprocedural ischemic events.

Eptifibatide infusion immediately before surgery had no effect on postoperative bleeding. The fall in hemoglobin that occurred postoperatively is consistent with hemodilution during cardiopulmonary bypass. The only patient in either group who required mediastinal reexploration received a placebo. Transfusion requirements in patients who received eptifibatide immediately before surgery were also no different from patients who received placebo. The nearly 60% incidence of packed red blood cell transfusion in both groups is consistent with other reports of patients undergoing emergent coronary surgery before the common utilization of GP IIb/IIIa inhibitors [16–18]. Whether patients who undergo emergent surgery after eptifibatide infusion have fewer bleeding problems than those who are exposed to a long-acting inhibitor such as abciximab is speculative and requires a head-to-head comparitive analysis. Nonetheless, based on the data from PURSUIT, it does not appear that eptifibatide infusion immediately before coronary surgery increases postoperative bleeding.

This study also provides evidence that eptifibatide may have a platelet-sparing effect during cardiopulmonary bypass. Although patients in both groups sustained a decrease in platelet count postoperatively, the change in platelet count was significantly less profound in patients who received eptifibatide immediately before surgery (Fig 4). These data support the hypothesis that the thrombocytopenia and platelet dysfunction that occurs during cardiopulmonary bypass may be ameliorated by eptifibatide. Edmunds and associates have hypothesized that intense and reversible inhibition of platelet aggregation during cardiopulmonary bypass ("platelet anesthesia") may actually improve postoperative platelet function and reduce bleeding [26]. In their baboon model, they report that short-acting GP IIb/IIIa inhibition during cardiopulmonary bypass has a salutory effect upon postoperative blood loss. Whether there is a clinical role for the use of eptifibatide during cardiac surgery to reduce perioperative myocardial infarction and attenuate platelet dysfunction during cardiopulmonary bypass requires further investigation.

A drawback of the present study is that it was not designed as a surgical trial to assess postoperative bleeding. As such, important data (such as mediastinal chest tube output) were not prospectively collected. Additionally, specific in vitro testing of platelet aggregation was not performed. Practice patterns were not controlled, so that individual centers and practitioners were allowed to transfuse and care for patients as they saw fit. Additionally, the large numbers of patients enrolled in PURSUIT resulted in relatively large numbers of patients in the groups reported here. The inherent difficulties of subgroup analysis do exist, however.

Summary
Eptifibatide infusion immediately before coronary artery bypass grafting is safe and does not increase postoperative bleeding. Early and late mortality were not affected by the inhibition of platelet aggregation with eptifibatide just before surgery. Perioperative morbidity was not adversely affected and transfusion requirements were no different compared with placebo. The incidence of perioperative myocardial infarction, however, was significantly lower in patients who received eptifibatide, implying a protective effect likely mediated by a reduction in the nidus for intracoronary thrombus. Additionally, these data suggest that eptifibatide may have a platelet-sparing effect during cardiopulmonary bypass, though this is hypothetical. Whether eptifibatide has a beneficial role during cardiac surgery due to its effect upon perioperative myocardial infarction and its potential effect upon platelet preservation is a matter of ongoing study.

	References

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Cornelius M. Dyke Devinder Bhatia Barbara E. Tardiff Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Dyke, C. M. Articles by Harrington, R. A. Search for Related Content PubMed PubMed Citation Articles by Dyke, C. M. Articles by Harrington, R. A. Related Collections Related Article