title: Evaluation of SAMe-TT2R2 risk score for predicting the quality of anticoagulation control in a real-world cohort of patients with non-valvular atrial fibrillation on vitamin-K antagonists.
abstract: OBJECTIVE
  Clinicians need to get better at identifying patients who would have poor quality of anticoagulation control with vitamin-K antagonists (VKAs). We assessed the predictive ability of SAMe-TT2R2 score, recently conceived for the prior purpose, and examined its relationship with major bleeding, thromboembolic (TE) complications, and death.
  
  
  RESULTS
  Retrospectively, 911 consecutive patients with non-valvular atrial fibrillation (NVAF) started on VKAs within 8 months were studied. The percentage of international normalized ratios in therapeutic range (PINRR) at different levels was used as a metric of anticoagulation quality. We also tested the SAMe-TT2R2 predictability for major bleeding, TE complications, and death throughout 10 ± 3 months. The PINRR decreased from 62% at zero point to 53% at ≥4 points of SAMe-TT2R2. 82.1% of patients who achieved PINRR ≥ 70% had 0 or 1 point of SAMe-TT2R2. SAMe-TT2R2 performed significantly better at PINRR 70% than at 65 and 60% (c-statistic = 0.60 vs. c-statistic = 0.56). The calibration of SAMe-TT2R2 was excellent (Hosmer-Lemeshow test P-values ≥ 0.6). SAMe-TT2R2 showed significant association with the composite outcome of major bleeding, TE complications, and death [n = 98; hazard ratio (HR) = 1.32; 95% confidence interval (CI) 1.08-1.60]; the c-statistic was 0.57 (95% CI: 0.51-0.62) and P = 0.03. As individual outcomes, SAMe-TT2R2 was significantly associated with death (n = 60; HR = 1.3; 95% CI: 1.03-1.69), but not with either major bleeding (n = 30; HR = 1.2; 95% CI: 0.85-1.76) or TE complications (n = 15; HR = 1.01; 95% CI: 0.58-1.77).
  
  
  CONCLUSIONS
  Among NVAF patients, SAMe-TT2R2 could represent a useful clinical tool to identify patients who would have poor quality of anticoagulation control with VKAs. SAMe-TT2R2 successfully predicts the composite outcome of major bleeding, TE complications, and death.
authors: Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, A choupana s/n, Santiago de Compostela 15706, Spain drrami2012@hotmail.com.
authors: Rami Riziq-Yousef
authors: RR
authors: Abumuaileq
authors: Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, A choupana s/n, Santiago de Compostela 15706, Spain.
authors: Emad
authors: E
authors: Abu-Assi
authors: Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, A choupana s/n, Santiago de Compostela 15706, Spain.
authors: Sergio
authors: S
authors: Raposeiras-Roubin
authors: Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, A choupana s/n, Santiago de Compostela 15706, Spain.
authors: Andrea
authors: A
authors: López-López
authors: Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, A choupana s/n, Santiago de Compostela 15706, Spain.
authors: Alfredo
authors: A
authors: Redondo-Diéguez
authors: Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, A choupana s/n, Santiago de Compostela 15706, Spain.
authors: Diego
authors: D
authors: Álvarez-Iglesias
authors: Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, A choupana s/n, Santiago de Compostela 15706, Spain.
authors: Moisés
authors: M
authors: Rodríguez-Mañero
authors: Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, A choupana s/n, Santiago de Compostela 15706, Spain.
authors: Carlos
authors: C
authors: Peña-Gil
authors: Cardiology Department, Hospital Clínico Universitario de Santiago de Compostela, A choupana s/n, Santiago de Compostela 15706, Spain.
authors: Jose Ramón
authors: JR
authors: González-Juanatey
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D001777:Blood Coagulation / Q000187:drug effects*; D003661:Decision Support Techniques; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011237:Predictive Value of Tests; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000097:blood / Q000175:diagnosis / Q000401:mortality / Q000517:prevention & control*; D013923:Thromboembolism / Q000097:blood / Q000175:diagnosis / Q000401:mortality / Q000517:prevention & control*; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors*
chemical_list: D000925:Anticoagulants; D014812:Vitamin K
keywords: Anticoagulation quality control; Atrial fibrillation; SAMe-TT2R2; Vitamin-K antagonists