Relationship of the SAMe-TT2 R2 Score to Poor-Quality Anticoagulation, Stroke, Clinically Relevant Bleeding, and Mortality in Patients With Atrial Fibrillation
Abstract
Background The efficacy and safety of anticoagulation with use of vitamin K antagonists (VKAs) is highly dependent on the quality of anticoagulation control as reflected by the average time in a therapeutic range of 2.0 to 3.0. A clinical dilemma is trying to predict which anticoagulation-naive patients with atrial fibrillation (AF) would do well on a VKA (with a time in therapeutic range > 70%) and which are less likely to do well on a VKA but could be managed with novel oral anticoagulants.Methods The cohort comprised 8,120 patients, among whom 4,637 patients were receiving VKA. We investigated whether the SAMe-TT₂R₂ (sex female, age < 60 years, medical history [more than two comorbidities], treatment [interacting drugs, eg, amiodarone for rhythm control], tobacco use [doubled], race [doubled]) score could discriminate among patients with AF who were likely to have a labile international normalized ratio (INR) during follow-up as well as stroke/thromboembolism (TE), clinically relevant bleeding (defined as severe bleeding and as Bleeding Academic Research Consortium [BARC]-defined major bleeding), and death while being treated with a VKA.Results During a mean follow-up of 1,016 ± 1,108 days, there was a significant increase in risk of severe bleeding events (risk ratio [RR], 1.38; 95% CI, 1.12-2.68; P = .002) and a significant increase in risk of major BARC bleeding (RR, 1.77; 95% CI, 1.29-2.44; P = .0005) in patients with AF with a high SAMe-TT₂R₂ score (> 2). Increasing SAMe-TT₂R₂ score was associated with an increasing risk of labile INR (P = .004), stroke/TE (P = .007), severe bleeding (P < .0001), major BARC bleeding (P < .0001), and death (P = .002) at follow-up. Among the patients taking VKAs, the SAMe-TT₂R₂ score was predictive of labile INR (C statistic approximately 0.58) as well as of stroke/TE, severe bleeding, major BARC bleeding, and death (C statistic, 0.54-0.57 for events), reflecting the suboptimal time in therapeutic range in such patients. This was not the case for patients who were not taking VKAs.Conclusions We demonstrate that the SAMe-TT₂R₂ score was predictive for an increasing risk of stroke/TE, severe bleeding, major BARC bleeding, and death, reflecting poor anticoagulation control (and labile INRs) among patients with AF given VKAs.
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Patients who fare well on the SAMe-TT2R2 score, when treated with a vitamin K antagonist, have on average a higher time in therapeutic range than patients who do not fare well on the score.
“Patients who fare well on this score, when treated with a VKA, have on average a higher TTR than patients who do not fare well on the score.398,399”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [398]
Cites
Lip, G. Y. H., Nieuwlaat, R., Pisters, R., Lane, D. A., & Crijns, H. J. G. M. (2010) · Chest · doi:10.1378/chest.09-1584 · Cited by 6,879 · see citing works
Self-citationGage, B. F., Waterman, A. D., Shannon, W., Boechler, M., Rich, M. W., & Radford, M. J. (2001) · JAMA · doi:10.1001/jama.285.22.2864 · Cited by 4,832 · see citing works
Pisters, R., Lane, D. A., Nieuwlaat, R., de Vos, C. B., Crijns, H. J. G. M., & Lip, G. Y. H. (2010) · CHEST Journal · doi:10.1378/chest.10-0134 · Cited by 4,517 · see citing works
Self-citationA Method to Determine the Optimal Intensity of Oral Anticoagulant Therapy
Rosendaal, F. R., Cannegieter, S. C., van der Meer, F. J. M., & Briët, E. (1993) · Thrombosis and Haemostasis · doi:10.1055/s-0038-1651587 · Cited by 2,070 · see citing works
Apostolakis, S. Z., Sullivan, R. M., Olshansky, B., & Lip, G. Y. H. (2013) · CHEST Journal · doi:10.1378/chest.13-0054 · Cited by 480 · see citing works
Self-citationParenteral anticoagulants in heart disease: Current status and perspectives (Section II)
Husted, S., Wallentin, L. C., Andreotti, F., Arnesen, H., Bachmann, F., Baigent, C., Huber, K., Jespersen, J., Kristensen, S. D., Lip, G. Y. H., et al. (2013) · Thrombosis and Haemostasis · doi:10.1160/th12-06-0403 · Cited by 366 · see citing works
Self-citationGallagher, A. M., Setakis, E., Plumb, J., Clemens, A., & van Staa, T. P. (2011) · Thrombosis and Haemostasis · doi:10.1160/th11-05-0353 · Cited by 358 · see citing works
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Self-citationGeneral mechanisms of coagulation and targets of anticoagulants (Section I)
Husted, S., Wallentin, L. C., Andreotti, F., Arnesen, H., Bachmann, F., Baigent, C., Huber, K., Jespersen, J., Kristensen, S. D., Lip, G. Y. H., et al. (2013) · Thrombosis and Haemostasis · doi:10.1160/th12-10-0772 · Cited by 181 · see citing works
Self-citationStroke and bleeding risk assessment in atrial fibrillation: when, how, and why?
Lip, G. Y. H. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehs435 · Cited by 159 · see citing works
Self-citationAssessing the Risk of Bleeding in Patients With Atrial Fibrillation
Lip, G. Y. H., Banerjee, A., Lagrenade, I., Lane, D. A., Taillandier, S., & Fauchier, L. (2012) · Circulation Arrhythmia and Electrophysiology · doi:10.1161/circep.112.972869 · Cited by 78 · see citing works
Self-citationNovel oral anticoagulants in non-valvular atrial fibrillation
Potpara, T., & Lip, G. Y. H. (2013) · Best Practice & Research Clinical Haematology · doi:10.1016/j.beha.2013.07.008 · Cited by 36 · see citing works
Self-citationPredicting the Quality of Anticoagulation During Warfarin Therapy
Boriani, G. (2013) · CHEST Journal · doi:10.1378/chest.13-1285 · Cited by 13 · see citing works
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2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehw210 · Cited by 6,418 · see citing works
Self-citation2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezw313 · Cited by 1,403 · see citing works
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- Authors
- Lip, G. Y. H., Haguenoer, K., Saint-Etienne, C., & Fauchier, L.
- Affiliations
- Birmingham City Hospital (GB)
- Université de Tours (FR)
- Corresponding author
- Lip, Gregory Y.H.
- Venue
- Chest
- Publisher
- Elsevier BV
- Published
- 2014-09
- Volume
- 146
- Issue
- 3
- Pages
- 719-726
- ISSN
- 0012-3692 (ISSN-L)
- OpenAlex
- W2142878294
- Cited by
- 120
- References
- 13
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 2 · 2023: 5 · 2022: 3 · 2021: 3 · 2020: 6 · 2019: 8 · 2018: 8 · 2017: 13 · 2016: 28 · 2015: 30 · 2014: 12
- FWCI
- 18.97
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- CHEST Journal (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Funders
- Bayer
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
- Keywords
- atrial fibrillation, vitamin K antagonists, SAMe-TT2R2 score, anticoagulation quality, time in therapeutic range, major bleeding, mortality, direct oral anticoagulants, risk prediction, comorbidities, amiodarone, tobacco use, sex differences, racial differences, bleeding risk
- MeSH terms
- Adult, Age Factors, Aged, Aged, 80 and over, Anticoagulants, Atrial Fibrillation, Cerebral Hemorrhage, Drug Interactions, Female, Follow-Up Studies, Humans, Male, Middle Aged, Predictive Value of Tests, Sex Factors, Vitamin K, Cohort Studies, Comorbidity, Survival Rate, Treatment Outcome, Risk Assessment, International Normalized Ratio, Stroke, Racial Groups, Tobacco Use
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