Dániel Aradi1, Ajay Kirtane2, Laurent Bonello3, Paul A Gurbel4, Udaya S Tantry4, Kurt Huber5, Matthias K Freynhofer5, Jurrien ten Berg6, Paul Janssen6, Dominick J Angiolillo7, Jolanta M Siller-Matula8, Rossella Marcucci9, Giuseppe Patti10, Fabio Mangiacapra10, Marco Valgimigli11, Olivier Morel12, Tullio Palmerini13, Matthew J Price14, Thomas Cuisset15, Adnan Kastrati16, Gregg W Stone2, Dirk Sibbing17. 1. Department of Cardiology, Heart Center Balatonfüred and Semmelweis University, Heart and Vascular Center, 2 Gyogy Ter Balatonfüred, Budapest 8230, Hungary daniel_aradi@yahoo.com. 2. Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA. 3. Département de Cardiologie, Hôpital Universitaire Nord, Aix-Marseille University, Marseille, France. 4. Sinai Center for Thrombosis Research, Sinai Hospital of Baltimore, Baltimore, MD, USA. 5. 3rd Department of Internal Medicine, Cardiology and Emergency Medicine, Wilhelminen Hospital, Vienna, Austria. 6. Department of Cardiology, St. Antonius Hospital, Nieuwegein, Netherlands. 7. Cardiovascular Research Center, University of Florida College of Medicine, Jacksonville, FL, USA. 8. Department of Cardiology, Medical University of Vienna, Vienna, Austria. 9. Department of Medical and Surgical Critical Care, University of Florence, Florence, Italy. 10. Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Rome, Italy. 11. Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. 12. Pôle d'activité médico-chirurgicale Cardiovasculaire, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, France. 13. Cardiovascular Department, Policlinico S. Orsola, Bologna, Italy. 14. Scripps Clinic and Scripps Translational Science Institute, La Jolla, CA, USA. 15. Département de Cardiologie, CHU Timone, Marseille F-13385, France. 16. Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. 17. DZHK (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Ludwig-Maximilians-Universität München, Munich, Germany.
Abstract
AIMS: Although platelet reactivity during P2Y12-inhibitors is associated with stent thrombosis (ST) and bleeding, standardized and clinically validated thresholds for accurate risk stratification after percutaneous coronary intervention (PCI) are lacking. We sought to determine the prognostic value of low platelet reactivity (LPR), optimal platelet reactivity (OPR), or high platelet reactivity (HPR) by applying uniform cut-off values for standardized devices. METHODS AND RESULTS: Authors of studies published before January 2015, reporting associations between platelet reactivity, ST, and major bleeding were contacted for a collaborative analysis using consensus-defined, uniform cut-offs for standardized platelet function assays. Based on best available evidence for each device (exploratory studies), LPR-OPR-HPR categories were defined as <95, 95-208, and >208 PRU for VerifyNow, <19, 19-46, and >46 U for the Multiplate analyser and <16, 16-50, and >50% for VASP assay. Seventeen studies including 20 839 patients were used for the analysis; 97% were treated with clopidogrel and 3% with prasugrel. Patients with HPR had significantly higher risk for ST [risk ratio (RR) and 95% CI: 2.73 (2.03-3.69), P < 0.00001], yet a slight reduction in bleeding [RR: 0.84 (0.71-0.99), P = 0.04] compared with those with OPR. In contrast, patients with LPR had a higher risk for bleeding [RR: 1.74 (1.47-2.06), P < 0.00001], without any further benefit in ST [RR: 1.06 (0.68-1.65), P = 0.78] in contrast to OPR. Mortality was significantly higher in patients with HPR compared with other categories (P < 0.05). Validation cohorts (n = 14) confirmed all results of exploratory studies (n = 3). CONCLUSIONS: Platelet reactivity assessment during thienopyridine-type P2Y12-inhibitors identifies PCI-treated patients at higher risk for mortality and ST (HPR) or at an elevated risk for bleeding (LPR). Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: Although platelet reactivity during P2Y12-inhibitors is associated with stent thrombosis (ST) and bleeding, standardized and clinically validated thresholds for accurate risk stratification after percutaneous coronary intervention (PCI) are lacking. We sought to determine the prognostic value of low platelet reactivity (LPR), optimal platelet reactivity (OPR), or high platelet reactivity (HPR) by applying uniform cut-off values for standardized devices. METHODS AND RESULTS: Authors of studies published before January 2015, reporting associations between platelet reactivity, ST, and major bleeding were contacted for a collaborative analysis using consensus-defined, uniform cut-offs for standardized platelet function assays. Based on best available evidence for each device (exploratory studies), LPR-OPR-HPR categories were defined as <95, 95-208, and >208 PRU for VerifyNow, <19, 19-46, and >46 U for the Multiplate analyser and <16, 16-50, and >50% for VASP assay. Seventeen studies including 20 839 patients were used for the analysis; 97% were treated with clopidogrel and 3% with prasugrel. Patients with HPR had significantly higher risk for ST [risk ratio (RR) and 95% CI: 2.73 (2.03-3.69), P < 0.00001], yet a slight reduction in bleeding [RR: 0.84 (0.71-0.99), P = 0.04] compared with those with OPR. In contrast, patients with LPR had a higher risk for bleeding [RR: 1.74 (1.47-2.06), P < 0.00001], without any further benefit in ST [RR: 1.06 (0.68-1.65), P = 0.78] in contrast to OPR. Mortality was significantly higher in patients with HPR compared with other categories (P < 0.05). Validation cohorts (n = 14) confirmed all results of exploratory studies (n = 3). CONCLUSIONS: Platelet reactivity assessment during thienopyridine-type P2Y12-inhibitors identifies PCI-treated patients at higher risk for mortality and ST (HPR) or at an elevated risk for bleeding (LPR). Published on behalf of the European Society of Cardiology. All rights reserved.
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