Stavros Apostolakis1, Renee M Sullivan2, Brian Olshansky2, Gregory Y H Lip3. 1. University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, England. 2. Division of Cardiovascular Medicine University of Iowa Hospitals and Clinics, Iowa City, IA. 3. University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, England. Electronic address: g.y.h.lip@bham.ac.uk.
Abstract
BACKGROUND: When oral anticoagulation with adjusted-dose vitamin K antagonist (VKA) is used, the quality of anticoagulation control (as reflected by the time in therapeutic range [TTR] of the international normalized ratio [INR]) is an important determinant of thromboembolism and bleeding. Our objective was to derive a validated scheme using patient-related clinical parameters to assess the likelihood of poor INR control among patients with atrial fibrillation (AF) on VKA therapy. METHODS: The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial population was randomly divided into derivation and internal validation cohorts using a 1:1 ratio. We used linear regression analysis to detect the clinical factors associated with TTR and binary logistic regression to evaluate the predictive performance of a model incorporating these factors for different cutoff values of TTR. The derived model was validated externally in a cohort of patients receiving anticoagulant therapy who were recruited prospectively. RESULTS: In the linear regression model, nine variables emerged as independent predictors of TTR: female sex (P < .0001), age < 50 years (P < .0001), age 50 to 60 years (P = .02), ethnic minority status (P < .0001), smoking (P = .03), more than two comorbidities (P < .0001), and being treated with a β-blocker (P = .02), verapamil (P = .02), or, inversely, with amiodarone (P = .05). We incorporated these factors into a simple clinical prediction scheme with the acronym SAMe-TT₂R (sex female, age < 60 years, medical history [more than two comorbidities], treatment [interacting drugs, eg, amiodarone for rhythm control], tobacco use [doubled], race [doubled]). The score demonstrated good discrimination performance in both the internal and external validation cohorts (c-index, 0.72; 95% CI, 0.64-0.795; and c-index, 0.7; 95% CI, 0.57-0.82, respectively). CONCLUSIONS: Common clinical and demographic factors can influence the quality of oral anticoagulation. We incorporated these factors into a simple score (SAMe-TT₂R₂) that can predict poor INR control and aid decision-making by identifying those patients with AF who would do well on VKA (SAMe-TT₂R₂ score = 0-1), or conversely, those who require additional interventions to achieve acceptable anticoagulation control (SAMe-TT₂R₂ score ≥ 2).
RCT Entities:
BACKGROUND: When oral anticoagulation with adjusted-dose vitamin K antagonist (VKA) is used, the quality of anticoagulation control (as reflected by the time in therapeutic range [TTR] of the international normalized ratio [INR]) is an important determinant of thromboembolism and bleeding. Our objective was to derive a validated scheme using patient-related clinical parameters to assess the likelihood of poor INR control among patients with atrial fibrillation (AF) on VKA therapy. METHODS: The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial population was randomly divided into derivation and internal validation cohorts using a 1:1 ratio. We used linear regression analysis to detect the clinical factors associated with TTR and binary logistic regression to evaluate the predictive performance of a model incorporating these factors for different cutoff values of TTR. The derived model was validated externally in a cohort of patients receiving anticoagulant therapy who were recruited prospectively. RESULTS: In the linear regression model, nine variables emerged as independent predictors of TTR: female sex (P < .0001), age < 50 years (P < .0001), age 50 to 60 years (P = .02), ethnic minority status (P < .0001), smoking (P = .03), more than two comorbidities (P < .0001), and being treated with a β-blocker (P = .02), verapamil (P = .02), or, inversely, with amiodarone (P = .05). We incorporated these factors into a simple clinical prediction scheme with the acronym SAMe-TT₂R (sex female, age < 60 years, medical history [more than two comorbidities], treatment [interacting drugs, eg, amiodarone for rhythm control], tobacco use [doubled], race [doubled]). The score demonstrated good discrimination performance in both the internal and external validation cohorts (c-index, 0.72; 95% CI, 0.64-0.795; and c-index, 0.7; 95% CI, 0.57-0.82, respectively). CONCLUSIONS: Common clinical and demographic factors can influence the quality of oral anticoagulation. We incorporated these factors into a simple score (SAMe-TT₂R₂) that can predict poor INR control and aid decision-making by identifying those patients with AF who would do well on VKA (SAMe-TT₂R₂ score = 0-1), or conversely, those who require additional interventions to achieve acceptable anticoagulation control (SAMe-TT₂R₂ score ≥ 2).
Authors: Akash Kataruka; Xiaowen Kong; Brian Haymart; Eva Kline-Rogers; Steve Almany; Jay Kozlowski; Gregory D Krol; Scott Kaatz; Michael W McNamara; James B Froehlich; Geoffrey D Barnes Journal: Vasc Med Date: 2017-02-01 Impact factor: 3.239
Authors: Bulent Gorenek; Antonio Pelliccia; Emelia J Benjamin; Giuseppe Boriani; Harry J Crijns; Richard I Fogel; Isabelle C Van Gelder; Martin Halle; Gulmira Kudaiberdieva; Deirdre A Lane; Torben Bjerregaard Larsen; Gregory Y H Lip; Maja-Lisa Løchen; Francisco Marin; Josef Niebauer; Prashanthan Sanders; Lale Tokgozoglu; Marc A Vos; David R Van Wagoner; Laurent Fauchier; Irina Savelieva; Andreas Goette; Stefan Agewall; Chern-En Chiang; Márcio Figueiredo; Martin Stiles; Timm Dickfeld; Kristen Patton; Massimo Piepoli; Ugo Corra; Pedro Manuel Marques-Vidal; Pompilio Faggiano; Jean-Paul Schmid; Ana Abreu Journal: Eur J Prev Cardiol Date: 2016-11-04 Impact factor: 7.804
Authors: Bulent Gorenek; Antonio Pelliccia; Emelia J Benjamin; Giuseppe Boriani; Harry J Crijns; Richard I Fogel; Isabelle C Van Gelder; Martin Halle; Gulmira Kudaiberdieva; Deirdre A Lane; Torben Bjerregaard Larsen; Gregory Y H Lip; Maja-Lisa Løchen; Francisco Marín; Josef Niebauer; Prashanthan Sanders; Lale Tokgozoglu; Marc A Vos; David R Van Wagoner; Laurent Fauchier; Irina Savelieva; Andreas Goette; Stefan Agewall; Chern-En Chiang; Márcio Figueiredo; Martin Stiles; Timm Dickfeld; Kristen Patton; Massimo Piepoli; Ugo Corra; Pedro Manuel Marques-Vidal; Pompilio Faggiano; Jean-Paul Schmid; Ana Abreu Journal: Europace Date: 2017-02-01 Impact factor: 5.214
Authors: Tetz C Lee; Min Qian; Gregory Y H Lip; Marco R Di Tullio; Susan Graham; Douglas L Mann; Koki Nakanishi; John R Teerlink; Ronald S Freudenberger; Ralph L Sacco; J P Mohr; Arthur J Labovitz; Piotr Ponikowski; Dirk J Lok; Conrado Estol; Stefan D Anker; Patrick M Pullicino; Richard Buchsbaum; Bruce Levin; John L P Thompson; Shunichi Homma; Siqin Ye Journal: Am J Cardiol Date: 2018-06-04 Impact factor: 2.778