Methods for measuring platelet reactivity of patients that have received drug eluting stents

a technology for elcosanoid stents and platelet aggregation, which is applied in the field of diagnostic assays, can solve the problems of inability to meet the needs of patients, inconvenient clinical environment, and inability to achieve optimal selection, so as to reduce the ability to form platelet thrombosis, enhance and enhance the effect of the signal transduction pathway

Inactive Publication Date: 2007-10-18
ACCUMETRICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Benefits of technology

[0022] These and other objects of the present invention are achieved in a method of measuring platelet reactivity of a PCI patient that has a (DES). A blood sample is obtained from the patient. The blood sample is mixed in combination with 1) an anticoagulant; 2) sufficient buffer to maintain the pH and salt concentration of the anticoagulated blood within a range suitable for platelet aggregation; 3) a platelet GPIIb/IIIa receptor ligand immobilized on a solid surface; 4) one or more agents to enhance a signal transduction pathway and 5) a receptor activator. The combination is incubated under conditions for agglutinating particles. Platelet-mediated agglutination is assessed in the mixture. The absence of agglutination indicates that the patient has reduced ability to form platelet thrombi.
[0023] In another embodiment of the present invention, a method is provided for identifying a patient with DES at risk for stent thrombosis. A blood sample is obtained from the patient. The blood sample is mixed in combination with 1) an anticoagulant; 2) sufficient buffer to maintain the pH and salt concentration of the anticoagulated blood within a range suitable for platelet aggregation; 3) a platelet GPIIb/IIIa receptor ligand immobilized on a solid surface; 4) one or more agents to enhance a signal transduction pathway and 5) a receptor activator. The combination is incubated under conditions for agglutinating particles. The absence of agglutination indicates that the patient has reduced ability to form platelet thrombi. Platelet reactivity of the patient is measure. In response to the measurement a determination is made of a risk level of the patient for stent thrombosis.
[0024] In another embodiment of the present in

Problems solved by technology

Current assays to measure platelet aggregation are expensive, time-consuming, cumbersome, and generally not suitable for a clinical environment.
However, since ADP activates at least two different receptors (P2Y1 and P2Y12 and perhaps P2X1), it has the potential for lower specificity and background noise.
However collagen is highly variable due its quaternary structure, which dramatically affects it ability to activate platelets and due to the fact it is derived from biol

Method used

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  • Methods for measuring platelet reactivity of patients that have received drug eluting stents
  • Methods for measuring platelet reactivity of patients that have received drug eluting stents
  • Methods for measuring platelet reactivity of patients that have received drug eluting stents

Examples

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example 1

[0058] The following examples are offered by way of illustration and without limitation. Parts and percentages are by weight unless otherwise indicated

[0059] The following examples and preparations are intended to illustrate the invention but are not intended to limit its scope.

[0060] Dose response testing was performed withADP (Chronolog) and PGE1 (SIGMA) at 20 μM and 22 nM final concentrations respectively. ADP was diluted in Hepes / Saline, pH 7.4 buffer to a final concentration of 200 μM prior to use on the aggregometer. PGE1 was diluted in Hepes / Saline, pH 7.4 buffer to a final concentration of 220 nM prior to use on the aggregometer. A P2Y12 receptor blocker was diluted in DMF to final concentrations of 1 mM, 2 mM and 5 mM.

[0061] Five microliters of the diluted P2Y12 compound were spiked into 5 mL whole blood. Samples were inverted and incubated for one hour at room temperature. The whole blood baseline sample did not receive any additive. Once incubation was complete, whole ...

example 2

[0068] A study of PCI patients was conducted. The patients selected had at least one of the following, at least one lesion ≧50% diameter stenosis requiring PCI, a reference vessel diameter between 2.25 and 4.0 mm, target lesion located within a native coronary artery or bypass graft that was either de novo or restenotic and no known allergy to aspirin, clopidogrel, or any component of an DES.

Measurement of Platelet Reactivity

[0069] Whole blood was obtained from the sideport of the arterial sheath prior to anticoagulant or anti-thrombin therapy and by phlebotomy 12 hours post-PCI. The inhibitory effect of clopidogrel was measured using the VerifyNow® P2Y12 assay (Accumetrics, San Diego, Calif.). The percentage inhibition induced by clopidogrel in patients with a baseline sample prior to clopidogrel exposure was calculated using the formula:

1−(PRU post-clopidogrel / PRU baseline)×100.

[0070] If the post-treatment ADP-induced aggregation was greater after clopidogrel than at baseline,...

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Abstract

A method is providing for measuring platelet reactivity of a PCI patient that has a (DES). A blood sample is obtained from the patient. The blood sample is mixed in combination with 1) an anticoagulant; 2) sufficient buffer to maintain the pH and salt concentration of the anticoagulated blood within a range suitable for platelet aggregation; 3) a platelet GPIIb/IIIa receptor ligand immobilized on a solid surface; 4) one or more agents to enhance a signal transduction pathway and 5) a receptor activator. The combination is incubated under conditions for agglutinating particles. Platelet-mediated agglutination is assessed in the mixture. The absence of agglutination indicates that the patient has reduced ability to form platelet thrombi.

Description

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application is a continuation-in-part of U.S. Ser. No. 10 / 886,155 filed Jul. 6, 2004, which claims the benefit of U.S. Ser. No. 60 / 485,703, filed Jul. 7, 2003. All of the above applications are fully incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to the field of diagnostic assays, and in particular to methods for measuring platelet reactivity of patients that have received drug-eluting stents (DES). [0004] 2. Description of the Related Art [0005] The role of platelets in mammalian physiology is extraordinarily diverse, but their primary role is in promoting hemostasis. In many situations, an evaluation of the ability of blood to clot is desired, a parameter that is frequently controlled by the ability of platelets to adhere and / or aggregate. Of interest, therefore, is the assessment of the adhesive functions of platelets. For example, questions of interest ...

Claims

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Application Information

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IPC IPC(8): G01N33/50A61K31/557A61K39/395G01N33/567
CPCG01N33/86G01N2800/50G01N2800/226G01N2800/222C12Q1/56
Inventor COLLER, BARRY S.DURBIN, DENNIS
Owner ACCUMETRICS INC
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