Clinical usefulness of the SAMe-TT2R2 score: A systematic review and simulation meta-analysis

BACKGROUND: Vitamin K antagonist (VKA) therapy is safer and more effective when patients have a high time within the therapeutic range and low international normalised ratio variability. The SAMe-TT(2)R(2) score aims to identify those at risk for poor VKA control. OBJECTIVES: To evaluate the predictive value and clinical usefulness of the SAMe-TT(2)R(2) score to identify those at risk for poor VKA control. METHODS: We performed a systematic review in MEDLINE and Embase for original research papers assessing the SAMe-TT(2)R(2)’s relation to poor TTR. We performed a meta-analysis where scores ≥ 2 and ≥ 3 predicting TTR < 70%. When studies evaluated other cutoffs for TTR or SAMe-TT(2)R(2), they were harmonised by multiple simulations with patient characteristics from the individual studies, if the data were available. RESULTS: 16 studies were identified and used in the meta-analysis: 4 and 2 times directly, 8 and 8 times harmonised for scores ≥ 2 and ≥ 3, respectively (not all studies provided information about both cutoffs). The sensitivities and specificities were too heterogeneous to pool. The positive likelihood ratios were 1.25 (1.14-1.38) for a score ≥ 2, and 1.24 (1.09-1.40) for a score ≥ 3; the negative ones were 0.87 (0.82-0.93) and 0.96 (0.91-1.02), respectively. This shows that the post-test probabilities hardly differ from the prior probability (prevalence). CONCLUSION: The SAMe-TT(2)R(2) score does predict low TTR, but the effect is small. Its effect on individual patients is too limited to be clinically useful.