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CLINICAL STUDY: INTERVENTIONAL CARDIOLOGY

Relationship between heparin anticoagulation and clinical outcomes in coronary stent intervention

observations from the ESPRIT trial

Thaddeus R. Tolleson, MD^*, J. Conor O’Shea, MD^*, John A. Bittl, MD, FACC, William B. Hillegass, MD, Kathryn A. Williams, MS^*, Glenn Levine, MD, Robert A. Harrington, MD, FACC^* and James E. Tcheng, MD, FACC^*,*

^* Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USA
Ocala Heart Institute, Ocala, Florida, USA
University of Alabama, Birmingham, Alabama, USA
Baylor College of Medicine, Houston, Texas, USA

Manuscript received March 1, 2002; revised manuscript received September 26, 2002, accepted October 10, 2002.

^* Reprint requests and correspondence: Dr. James E. Tcheng, Duke North Pavilion, Office 7021, 2400 Pratt Street, Durham, North Carolina 27705, USA.
tchen001{at}mc.duke.edu

OBJECTIVES: We evaluated the relationship between the degree of heparin anticoagulation and clinical efficacy and bleeding in patients undergoing contemporary percutaneous coronary intervention (PCI) with stent implantation.

BACKGROUND: Despite universal acceptance of heparin anticoagulation as a standard of care in PCI, considerable controversy still exists regarding the appropriate dosing of heparin.

METHODS: The study population (n = 2,064) comprised all patients enrolled in the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial. The index activated clotting time (ACT) was defined as the ACT measured after the last heparin dose and before first device activation and was correlated with outcome and bleeding events.

RESULTS: No association was observed between decreasing ACT levels and the rate of ischemic events in the treatment or placebo arms. The incidence of the primary composite end point (death, myocardial infarction, urgent target vessel revascularization, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy at 48 h) was actually lowest in the lowest ACT tertile for both the placebo (10.0%) and treatment groups (6.1%). When analyzed by tertile, major bleeding rates did not increase in the lowest ACT tertile in patients given placebo (0.6%) versus those receiving eptifibatide (0.7%). Major bleeding rates increased as the ACT increased in the eptifibatide-treated patients.

CONCLUSIONS: Ischemic end points in patients undergoing contemporary PCI with stent placement do not increase by decreasing ACT levels, at least to a level of 200 s. Bleeding events do increase with increasing ACT levels and are enhanced with eptifibatide treatment. An ACT of 200 to 250 s is reasonable in terms of efficacy and safety with the use of contemporary technology and pharmacotherapy.

Abbreviations and Acronyms   ACT   activated clotting time   CK-MB   creatine kinase, MB isoenzyme   ESPRIT   Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy trial   GP   glycoprotein   IMPACT-II   Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis-II trial   MI   myocardial infarction   PCI   percutaneous coronary intervention   TIMI   Thrombolysis In Myocardial Infarction trial   TVR   target vessel revascularization

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