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Randomized Controlled Trial
. 2021 Mar-Apr;62(2):152-157.
doi: 10.1016/j.hjc.2020.11.009. Epub 2020 Dec 15.

Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry

George Ntaios  1 , Menno V Huisman  2 , Hans-Christoph Diener  3 , Jonathan L Halperin  4 , Christine Teutsch  5 , Sabrina Marler  6 , Venkatesh K Gurusamy  5 , Milla Thompson  7 , Gregory Y H Lip  8 , Brian Olshansky  9 ; GLORIA-AF Investigators
Collaborators, Affiliations
Free article
Randomized Controlled Trial

Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry

George Ntaios et al. Hellenic J Cardiol. 2021 Mar-Apr.
Free article

Abstract

Aim: The SAMe-TT2R2 score helps identify patients with atrial fibrillation (AF) likely to have poor anticoagulation control during anticoagulation with vitamin K antagonists (VKA) and those with scores >2 might be better managed with a target-specific oral anticoagulant (NOAC). We hypothesized that in clinical practice, VKAs may be prescribed less frequently to patients with AF and SAMe-TT2R2 scores >2 than to patients with lower scores.

Methods and results: We analyzed the Phase III dataset of the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF), a large, global, prospective global registry of patients with newly diagnosed AF and ≥1 stroke risk factor. We compared baseline clinical characteristics and antithrombotic prescriptions to determine the probability of the VKA prescription among anticoagulated patients with the baseline SAMe-TT2R2 score >2 and ≤ 2. Among 17,465 anticoagulated patients with AF, 4,828 (27.6%) patients were prescribed VKA and 12,637 (72.4%) patients an NOAC: 11,884 (68.0%) patients had SAMe-TT2R2 scores 0-2 and 5,581 (32.0%) patients had scores >2. The proportion of patients prescribed VKA was 28.0% among patients with SAMe-TT2R2 scores >2 and 27.5% in those with scores ≤2.

Conclusions: The lack of a clear association between the SAMe-TT2R2 score and anticoagulant selection may be attributed to the relative efficacy and safety profiles between NOACs and VKAs as well as to the absence of trial evidence that an SAMe-TT2R2-guided strategy for the selection of the type of anticoagulation in NVAF patients has an impact on clinical outcomes of efficacy and safety. The latter hypothesis is currently being tested in a randomized controlled trial.

Clinical trial registration: URL: https://www.clinicaltrials.gov//Unique identifier: NCT01937377, NCT01468701, and NCT01671007.

Keywords: SAMe-TT(2)R(2); atrial fibrillation; non-vitamin-K antagonist oral anticoagulants; vitamin-K-antagonist oral anticoagulants.

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Conflict of interest statement

Disclosures George Ntaios: Speaker fees/Advisory Boards/Research support from Amgen; Bayer; BMS/Pfizer; Boehringer-Ingelheim; Elpen; Galenica; Sanofi; and Winmedica. The authors did not receive any fees directly or personally. Menno V. Huisman: Grants from ZonMW Dutch Healthcare Fund; grants and personal fees from Boehringer-Ingelheim, Pfizer-BMS, Bayer Health Care, Aspen, Daiichi-Sankyo, outside the submitted work. Hans-Christoph Diener: Received honoraria for participation in clinical trials; contribution to advisory boards or oral presentations from: Abbott, Bayer Vital, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Pfizer, Portola, Sanofi-Aventis, and WebMD Global. Financial support for research projects was provided by Boehringer Ingelheim. Chairs the Treatment Guidelines Committee of the German Society of Neurology and contributed to the EHRA and ESC guidelines for the treatment of AF. Jonathan L. Halperin: Consulting activities with Boehringer Ingelheim, for advisory activities involving anticoagulants, and he is a member of the Executive Steering Committee of the GLORIA-AF Registry. Christine Teutsch; Sabrina Marler; Venkatesh K. Gurusamy; and Milla Thompson: are employees of Boehringer Ingelheim. Gregory Y. H. Lip: Consultant for Bayer/Janssen, BMS/Pfizer, Medtronic, Boehringer Ingelheim, Novartis, Verseon, and Daiichi-Sankyo. He has been a speaker for Bayer, BMS/Pfizer, Medtronic, Boehringer Ingelheim, and Daiichi-Sankyo. The authors did not receive any fees directly or personally. Brian Olshansky: Consulting fees from Boehringer Ingelheim and Lundbeck; and has served as DSMB Chair for Amarin (REDUCE IT Trial).

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