Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Patients With Low-Risk ACS Undergoing Ad Hoc PCI.

MedStar author(s):
Citation: Journal of the American College of Cardiology. 67(6):603-13, 2016 Feb 16.PMID: 26868683Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Clinical Trial, Phase IV | Journal Article | Multicenter Study | Randomized Controlled TrialSubject headings: *Acute Coronary Syndrome/th [Therapy] | *Adenosine/aa [Analogs & Derivatives] | *Percutaneous Coronary Intervention/mt [Methods] | *Preoperative Care/mt [Methods] | *Ticlopidine/aa [Analogs & Derivatives] | *Troponin/bl [Blood] | Acute Coronary Syndrome/bl [Blood] | Adenosine/ad [Administration & Dosage] | Adenosine/pk [Pharmacokinetics] | Administration, Oral | Aged | Dose-Response Relationship, Drug | Female | Follow-Up Studies | Humans | Male | Middle Aged | Platelet Aggregation Inhibitors/ad [Administration & Dosage] | Platelet Aggregation Inhibitors/pk [Pharmacokinetics] | Platelet Aggregation/de [Drug Effects] | Platelet Function Tests | Prospective Studies | Purinergic P2Y Receptor Antagonists/ad [Administration & Dosage] | Purinergic P2Y Receptor Antagonists/pk [Pharmacokinetics] | Ticlopidine/ad [Administration & Dosage] | Ticlopidine/pk [Pharmacokinetics] | Treatment OutcomeYear: 2016Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007ISSN:
  • 0735-1097
Name of journal: Journal of the American College of CardiologyAbstract: BACKGROUND: Many low-risk acute coronary syndrome (ACS) patients are not pre-treated with a P2Y12 receptor inhibitor, and percutaneous coronary interventions (PCIs) are often performed on an ad hoc basis in this population. Pharmacodynamic (PD) studies comparing ticagrelor versus clopidogrel in patients undergoing ad hoc PCI are lacking.CONCLUSIONS: In low-risk ACS patients undergoing ad hoc PCI, ticagrelor LD provides more prompt and potent platelet inhibition, and lower HPR rates, compared with clopidogrel LD. (Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients: NCT01603082).Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.METHODS: This was a prospective, open-label, randomized, multicenter, parallel-group, phase IV PD study. One hundred P2Y12 inhibitor-naive patients presenting with biomarker-negative ACS and undergoing ad hoc PCI, on a background of aspirin therapy, were randomized to receive either ticagrelor 180 mg LD or clopidogrel 600 mg LD. Platelet reactivity (P2Y12 reaction units [PRU]; VerifyNow assay) was measured at 5 time points: pre-LD, at 0.5, 2, and 8 h post-LD, and at end of PCI. The primary endpoint was PRU levels 2 h post-LD; secondary endpoints included PRU levels at all other time points and inhibition of platelet aggregation; an exploratory analysis evaluated rates of high on-treatment platelet reactivity (HPR) (PRU >208).OBJECTIVES: This study sought to assess PD effects of ticagrelor versus clopidogrel loading dose (LD) in the peri-procedural period among troponin-negative ACS patients undergoing ad hoc PCI.RESULTS: At 2 h, PRU levels were significantly lower with ticagrelor versus clopidogrel (98.4 +/- 95.4 vs. 257.5 +/- 74.5; p < 0.001; primary endpoint). PRU levels diverged as early as 0.5 h post-LD, with significant differences observed by the end of PCI (mean 0.6 h post-LD) and maintained up to 8 h post-LD. HPR rates were also significantly reduced with ticagrelor compared with clopidogrel at the end of PCI (p = 0.030), and at 2 h (p < 0.001) and 8 h (p < 0.001) after LD.All authors: Angiolillo DJ, Carlson G, Franchi F, Khan N, Mehran R, Raveendran G, Sweeny JM, Teng R, Waksman R, Zhao YFiscal year: FY2016Digital Object Identifier: Date added to catalog: 2016-07-15
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 26868683 Available 26868683

Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007

BACKGROUND: Many low-risk acute coronary syndrome (ACS) patients are not pre-treated with a P2Y12 receptor inhibitor, and percutaneous coronary interventions (PCIs) are often performed on an ad hoc basis in this population. Pharmacodynamic (PD) studies comparing ticagrelor versus clopidogrel in patients undergoing ad hoc PCI are lacking.

CONCLUSIONS: In low-risk ACS patients undergoing ad hoc PCI, ticagrelor LD provides more prompt and potent platelet inhibition, and lower HPR rates, compared with clopidogrel LD. (Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients: NCT01603082).Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

METHODS: This was a prospective, open-label, randomized, multicenter, parallel-group, phase IV PD study. One hundred P2Y12 inhibitor-naive patients presenting with biomarker-negative ACS and undergoing ad hoc PCI, on a background of aspirin therapy, were randomized to receive either ticagrelor 180 mg LD or clopidogrel 600 mg LD. Platelet reactivity (P2Y12 reaction units [PRU]; VerifyNow assay) was measured at 5 time points: pre-LD, at 0.5, 2, and 8 h post-LD, and at end of PCI. The primary endpoint was PRU levels 2 h post-LD; secondary endpoints included PRU levels at all other time points and inhibition of platelet aggregation; an exploratory analysis evaluated rates of high on-treatment platelet reactivity (HPR) (PRU >208).

OBJECTIVES: This study sought to assess PD effects of ticagrelor versus clopidogrel loading dose (LD) in the peri-procedural period among troponin-negative ACS patients undergoing ad hoc PCI.

RESULTS: At 2 h, PRU levels were significantly lower with ticagrelor versus clopidogrel (98.4 +/- 95.4 vs. 257.5 +/- 74.5; p < 0.001; primary endpoint). PRU levels diverged as early as 0.5 h post-LD, with significant differences observed by the end of PCI (mean 0.6 h post-LD) and maintained up to 8 h post-LD. HPR rates were also significantly reduced with ticagrelor compared with clopidogrel at the end of PCI (p = 0.030), and at 2 h (p < 0.001) and 8 h (p < 0.001) after LD.

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