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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Bivalirudin and Clopidogrel With and Without Eptifibatide for Elective Stenting: Effects on Platelet Function, Thrombelastographic Indexes, and Their Relation to Periprocedural Infarction

Results of the CLEAR PLATELETS-2 (Clopidogrel With Eptifibatide to Arrest the Reactivity of Platelets) Study

Paul A. Gurbel, MD^_*,_*, Kevin P. Bliden, BS^_*, Jorge F. Saucedo, MD, Thomas A. Suarez, MD^_*, Joseph DiChiara, BS^_*, Mark J. Antonino, BS^_*, Elisabeth Mahla, MD^_*, Anand Singla, MD^_*, William R. Herzog, MD^_*, Ashwani K. Bassi, MD^_*, Thomas A. Hennebry, MB, BCh, BAO, Tania B. Gesheff, RN^_* and Udaya S. Tantry, PhD^_*

^_* Sinai Center for Thrombosis Research, Baltimore, Maryland
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma

Manuscript received August 11, 2008; revised manuscript received October 17, 2008, accepted October 26, 2008.

^_* Reprint requests and correspondence: Dr. Paul A. Gurbel, Sinai Center for Thrombosis Research, Shapiro Building, Suite 209, 2401 West Belvedere Avenue, Baltimore, Maryland 21215 (Email: pgurbel{at}lifebridgehealth.org).

Objectives: The primary objective of this study was to compare the effect of therapy with bivalirudin alone versus bivalirudin plus eptifibatide on platelet reactivity measured by turbidometric aggregometry and thrombin-induced platelet-fibrin clot strength (TIP-FCS) measured by thrombelastography in percutaneous coronary intervention (PCI) patients. The secondary aim was to study the relation of platelet aggregation and TIP-FCS to the occurrence of periprocedural infarction.

Background: Bivalirudin is commonly administered alone to clopidogrel naïve (CN) patients and to patients on maintenance clopidogrel therapy (MT) undergoing elective stenting. The effect of adding eptifibatide to bivalirudin on platelet reactivity (PR) and TIP-FCS, and their relation to periprocedural infarction in these patients are unknown.

Methods: Patients (n = 200) stratified to clopidogrel treatment status were randomly treated with bivalirudin (n = 102) or bivalirudin plus eptifibatide (n = 98). One hundred twenty-eight CN patients were loaded with 600 mg clopidogrel immediately after stenting, and 72 MT patients were not loaded. The PR, TIP-FCS, and myonecrosis markers were serially determined.

Results: In CN and MT patients, bivalirudin plus eptifibatide was associated with markedly lower PR at all times (5- and 20-µM adenosine diphosphate–induced, and 15- and 25-µM thrombin receptor activator peptide–induced aggregation; p < 0.001 for all) and reduced mean TIP-FCS (p < 0.05). Patients who had a periprocedural infarction had higher mean 18-h PR (p < 0.0001) and TIP-FCS (p = 0.002).

Conclusions: For elective stenting, the addition of eptifibatide to bivalirudin lowered PR to multiple agonists and the tensile strength of the TIP-FCS, 2 measurements strongly associated with periprocedural myonecrosis. Future studies of PR and TIP-FCS for elective stenting may facilitate personalized antiplatelet therapy and enhance the selection of patients for glycoprotein IIb/IIIa blockade. (Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin [CLEAR PLATELETS-2]; NCT00370045

Key Words: eptifibatide • clopidogrel • bivalirudin • platelets • myonecrosis • stents

Abbreviations and Acronyms   ADP = adenosine diphosphate   B = bivalirudin   C = clopidogrel   CK-MB = creatinine kinase-myocardial band   CN = clopidogrel naïve   E = eptifibatide   GP = glycoprotein   MT = clopidogrel maintenance treatment/therapy   PCI = percutaneous coronary intervention   PPACK = D-phenylalanyl-L-prolyl-L-arginine chloromethyl ketone   PR = platelet reactivity   R = time to initial platelet-fibrin clot formation   TEG = thrombelastography   TIP-FCS = thrombin-induced platelet-fibrin clot strength   TRAP = thrombin receptor activator peptide   UFH = unfractionated heparin

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J. Am. Coll. Cardiol. 2009 53: A21-A24. [Full Text] [PDF]