Stefano Barco1, Serena Granziera2, Michiel Coppens3, Jonathan Douxfils4, Mathilde Nijkeuter5, Nicoletta Riva6, Thomas Vanassche7, George Zhang8, Min Lin8, Pieter W Kamphuisen9,10, Alexander T Cohen11, Jan Beyer-Westendorf12,13. 1. Center for Thrombosis and Hemostasis (CTH), University Medical Centre of the Johannes Gutenberg University, Mainz, Germany. 2. Department of Physical and Rehabilitation Medicine, "Villa Salus" Hospital, Mestre, Italy. 3. Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam UMC, Amsterdam, The Netherlands. 4. Department of Pharmacy, Namur Thrombosis and Hemostasis Center, Namur Research Institute for Life Sciences, Namur, Belgium. 5. Department of Internal Medicine, University Medical Centre Utrecht, Utrecht, The Netherlands. 6. Department of Pathology, Faculty of Medicine and Surgery, University of Malta, Msida, Malta. 7. Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium. 8. Daiichi Sankyo Inc., Basking Ridge, New Jersey, United States. 9. Department of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands. 10. Department of Internal Medicine, Tergooi Hospital, Hilversum, The Netherlands. 11. Guy's and St Thomas' NHS Foundation Trust Hospital, King's College London, London, United Kingdom. 12. Thrombosis Research Unit, Division of Hematology, Department of Medicine I, University Hospital "Carl Gustav Carus," Dresden, Germany. 13. Kings Thrombosis Service, Department of Hematology, Kings College London, London, United Kingdom.
Abstract
BACKGROUND:Time in therapeutic range (TTR) measures the quality of vitamin K antagonist (VKA) anticoagulation. In patients with atrial fibrillation, the dichotomized SAMe-TT2-R2 score (≥2 vs. < 2 points) can predict if adequate TTR is unlikely to be achieved. AIMS: We validated the SAMe-TT2-R2 score in patients with venous thromboembolism (VTE) randomized to the warfarin arm of the Hokusai-VTE trial. PATIENTS AND METHODS: A total of 3,874 patients were included in the primary analysis (day 31-180 from randomization). The efficacy and safety outcomes were symptomatic recurrent VTE and major or clinically relevant non-major bleeding. RESULTS: The rates of recurrent VTE and bleeding events were higher in patients with a TTR below the median (< 66% vs. ≥66%) resulting in an absolute risk difference (ARD) of +0.5% (95% confidence interval: 0%, +1.1%) and +2.2% (0.9%, +3.5%), respectively. Patients with high SAMe-TT2-R2 score were 76% of total and had lower median TTR (64.7% vs. 70.7%). The SAMe-TT2-R2 score exhibited low negative (0.59) and positive (0.52) predictive value (TTR threshold 66%), and poor discrimination (c-statistic, 0.58). ARD between patients with high and low score was 0% (-0.6%, +0.7%) for recurrence and +1.3% (-0.1%, +2.7%) for bleeding. Results were confirmed in sensitivity analyses focusing on the whole study period (day 1-365). CONCLUSION: In VTE patients, the SAMe-TT2-R2 score showed unsatisfactory discrimination and predictive value for individual TTR and did not correlate well with clinical outcomes. The choice of starting a patient on VKA cannot be based on this parameter and its routine use after VTE may not translate into clinical usefulness. Georg Thieme Verlag KG Stuttgart · New York.
RCT Entities:
BACKGROUND: Time in therapeutic range (TTR) measures the quality of vitamin K antagonist (VKA) anticoagulation. In patients with atrial fibrillation, the dichotomized SAMe-TT2-R2 score (≥2 vs. < 2 points) can predict if adequate TTR is unlikely to be achieved. AIMS: We validated the SAMe-TT2-R2 score in patients with venous thromboembolism (VTE) randomized to the warfarin arm of the Hokusai-VTE trial. PATIENTS AND METHODS: A total of 3,874 patients were included in the primary analysis (day 31-180 from randomization). The efficacy and safety outcomes were symptomatic recurrent VTE and major or clinically relevant non-major bleeding. RESULTS: The rates of recurrent VTE and bleeding events were higher in patients with a TTR below the median (< 66% vs. ≥66%) resulting in an absolute risk difference (ARD) of +0.5% (95% confidence interval: 0%, +1.1%) and +2.2% (0.9%, +3.5%), respectively. Patients with high SAMe-TT2-R2 score were 76% of total and had lower median TTR (64.7% vs. 70.7%). The SAMe-TT2-R2 score exhibited low negative (0.59) and positive (0.52) predictive value (TTR threshold 66%), and poor discrimination (c-statistic, 0.58). ARD between patients with high and low score was 0% (-0.6%, +0.7%) for recurrence and +1.3% (-0.1%, +2.7%) for bleeding. Results were confirmed in sensitivity analyses focusing on the whole study period (day 1-365). CONCLUSION: In VTEpatients, the SAMe-TT2-R2 score showed unsatisfactory discrimination and predictive value for individual TTR and did not correlate well with clinical outcomes. The choice of starting a patient on VKA cannot be based on this parameter and its routine use after VTE may not translate into clinical usefulness. Georg Thieme Verlag KG Stuttgart · New York.
Authors: Eman Nawash Alhmoud; Hazem Elewa; Mohammed S Abdul Gelil; Osama B Abd El Samad; Abdelnasser Y Elzouki Journal: Clin Appl Thromb Hemost Date: 2020 Jan-Dec Impact factor: 2.389