PMID- 22682553 OWN - NLM STAT- MEDLINE DCOM- 20121009 LR - 20181201 IS - 1558-3597 (Electronic) IS - 0735-1097 (Linking) VI - 60 IP - 5 DP - 2012 Jul 31 TI - Prognostic value of a high on-clopidogrel treatment platelet reactivity in bivalirudin versus abciximab treated non-ST-segment elevation myocardial infarction patients. ISAR-REACT 4 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment-4) platelet substudy. PG - 369-77 LID - 10.1016/j.jacc.2012.02.044 [doi] AB - OBJECTIVES: The ISAR-REACT 4 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment-4) platelet substudy aimed to determine the relevance of high on-clopidogrel treatment platelet reactivity (HPR) in non-ST-segment elevation myocardial infarction patients that received abciximab with unfractionated heparin (UFH) or bivalirudin during percutaneous coronary intervention (PCI). BACKGROUND: In patients undergoing PCI, HPR has been linked to a higher risk for ischemic events. The influence of HPR on clinical outcomes may differ with regard to the adjunctive antithrombotic treatment administered. In ISAR-REACT 4, bivalirudin treatment showed similar efficacy profiles as compared to abciximab with UFH. The impact of HPR on clinical outcomes in abciximab with UFH versus bivalirudin treated non-ST-segment elevation myocardial infarction patients has never been investigated specifically. METHODS: A total of 564 patients (274 in abciximab/UFH group vs. 290 in bivalirudin group) were enrolled in this study. Presence or absence of HPR following clopidogrel loading was determined by platelet function testing on a Multiplate analyzer (Verum Diagnostica, Munich, Germany). Per study group and stratified in HPR and no-HPR patients, the 30-day incidence of a combined efficacy endpoint (death, myocardial infarction, urgent target vessel revascularization) was determined. RESULTS: For abciximab with UFH, the incidence of the efficacy endpoint was similar in HPR versus no-HPR patients (9.4% vs. 6.7%; odds ratio: 1.4; 95% confidence interval: 0.6 to 3.5; p = 0.43). For bivalirudin, the incidence of the efficacy endpoint was significantly higher in HPR versus no-HPR patients (22.0% vs. 5.0%; odds ratio: 5.4; 95% confidence interval: 2.4 to 12.1; p < 0.0001). CONCLUSIONS: For patients with a risk profile similar to the subjects enrolled in this platelet substudy, the impact of HPR on clinical outcomes may depend on the type of adjunctive antithrombotic therapy used during PCI. Further investigations are warranted to clarify whether assessment of platelet function may help tailoring antithrombotic therapy during PCI. CI - Copyright (c) 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. FAU - Sibbing, Dirk AU - Sibbing D AD - Deutsches Herzzentrum Munchen and 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universitat Munchen, Lazarettstrasse36, Munich, Germany. dirk@sibbing.net FAU - Bernlochner, Isabell AU - Bernlochner I FAU - Schulz, Stefanie AU - Schulz S FAU - Massberg, Steffen AU - Massberg S FAU - Schomig, Albert AU - Schomig A FAU - Mehilli, Julinda AU - Mehilli J FAU - Kastrati, Adnan AU - Kastrati A LA - eng SI - ClinicalTrials.gov/NCT00373451 PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20120606 PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 RN - 0 (Antibodies, Monoclonal) RN - 0 (Anticoagulants) RN - 0 (Antithrombins) RN - 0 (Hirudins) RN - 0 (Immunoglobulin Fab Fragments) RN - 0 (Peptide Fragments) RN - 0 (Platelet Aggregation Inhibitors) RN - 0 (Recombinant Proteins) RN - 9005-49-6 (Heparin) RN - A74586SNO7 (Clopidogrel) RN - OM90ZUW7M1 (Ticlopidine) RN - TN9BEX005G (bivalirudin) RN - X85G7936GV (Abciximab) SB - IM CIN - J Am Coll Cardiol. 2012 Jul 31;60(5):378-80. PMID: 22682552 MH - Abciximab MH - Aged MH - *Angioplasty, Balloon, Coronary MH - Antibodies, Monoclonal/adverse effects/*therapeutic use MH - Anticoagulants/adverse effects/*therapeutic use MH - Antithrombins/adverse effects/*therapeutic use MH - Clopidogrel MH - Cohort Studies MH - Combined Modality Therapy MH - Dose-Response Relationship, Drug MH - Drug Administration Schedule MH - Drug Therapy, Combination MH - Electrocardiography/drug effects MH - Female MH - Heparin/adverse effects/*therapeutic use MH - Hirudins/adverse effects MH - Humans MH - Immunoglobulin Fab Fragments/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Myocardial Infarction/blood/mortality/*therapy MH - Peptide Fragments/adverse effects/*therapeutic use MH - Platelet Aggregation/*drug effects MH - Platelet Aggregation Inhibitors/*therapeutic use MH - Platelet Function Tests MH - Prognosis MH - Recombinant Proteins/adverse effects/therapeutic use MH - Signal Processing, Computer-Assisted MH - *Stents MH - Survival Analysis MH - Ticlopidine/adverse effects/*analogs & derivatives/therapeutic use EDAT- 2012/06/12 06:00 MHDA- 2012/10/10 06:00 CRDT- 2012/06/12 06:00 PHST- 2011/12/16 00:00 [received] PHST- 2012/02/08 00:00 [revised] PHST- 2012/02/23 00:00 [accepted] PHST- 2012/06/12 06:00 [entrez] PHST- 2012/06/12 06:00 [pubmed] PHST- 2012/10/10 06:00 [medline] AID - S0735-1097(12)01236-3 [pii] AID - 10.1016/j.jacc.2012.02.044 [doi] PST - ppublish SO - J Am Coll Cardiol. 2012 Jul 31;60(5):369-77. doi: 10.1016/j.jacc.2012.02.044. Epub 2012 Jun 6.