Grzymala-Lubanski Bartosz, Svensson Peter J, Renlund Henrik, Jeppsson Anders, Själander Anders
Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
Department of Coagulation Disorders, University of Lund, Malmö, Sweden.
Heart. 2017 Feb;103(3):198-203. doi: 10.1136/heartjnl-2016-309585. Epub 2016 Sep 2.
To study the impact of time in therapeutic range (TTR) and international normalised ratio (INR) variability on the risk of thromboembolic events, major bleeding complications and death after mechanical heart valve (MHV) implantation. Additionally, the importance of different target INR levels was elucidated.
A retrospective, non-randomised multicentre cohort study including all patients with mechanical heart valve (MVH) prosthesis registered in the Swedish National Quality Registry Auricula from 2006 to 2011. Data were merged with the Swedish National Patient Registry, SWEDEHEART and Cause of Death Registry.
In total 4687 ordination periods, corresponding to 18 022 patient-years on warfarin, were included. High INR variability (above mean ≥0.40) or lower TTR (≤70%) was associated with a higher risk of bleeding (rate per 100 years 4.33 (95% CI 3.87 to 4.82) vs 2.08 (1.78 to 2.41); HR 2.15 (1.75 to 2.61) and 5.13 (4.51 to 5.82) vs 2.30 (2.03 to 2.60); HR 2.43 (2.02 to 2.89)), respectively. High variability and low TTR combined was associated with an even higher risk of bleedings (rate per 100 years 4.12 (95% CI 3.68 to 4.51) vs 2.02 (1.71 to 2.30); HR 2.16 (1.71 to 2.58) and 4.99 (4.38 to 5.52) vs 2.36 (2.06 to 2.60); HR 2.38 (2.05 to 2.85)) compared with the best group.Higher treatment intensity (mean INR 2.8-3.2 vs 2.2-2.7) was associated with higher rate of bleedings (2.92 (2.39 to 3.47) vs 2.48 (2.21 to 2.77); HR 1.29 (1.06 to 1.58)), death (3.36 (2.79 to 4.02) vs 1.89 (1.64 to 2.17), HR 1.65 (1.31 to 2.06)) and complications in total (6.61 (5.74 to 7.46) vs 5.65 (5.20 to 6.06); HR 1.24 (1.06 to 1.41)) after adjustment for MHV position, age and comorbidity.
A high warfarin treatment quality improves outcome after MHV implantation, both measured with TTR and INR variability. No benefit was found with higher treatment intensity (mean INR 2.8-3.2 vs 2.2-2.7).
研究治疗范围内时间（TTR）和国际标准化比值（INR）变异性对机械心脏瓣膜（MHV）植入术后血栓栓塞事件、大出血并发症及死亡风险的影响。此外，还阐明了不同目标INR水平的重要性。
一项回顾性、非随机多中心队列研究，纳入2006年至2011年在瑞典国家质量登记处Auricula登记的所有接受机械心脏瓣膜（MVH）假体植入的患者。数据与瑞典国家患者登记处、瑞典心脏疾病登记处（SWEDEHEART）及死亡原因登记处的数据进行合并。
共纳入4687个排序期，相当于华法林治疗的18022患者年。高INR变异性（高于均值≥0.40）或低TTR（≤70%）与出血风险较高相关（每100年发生率4.33（95%CI 3.87至4.82）对比2.08（1.78至2.41）；HR 2.15（1.75至2.61）和5.13（4.51至5.82）对比2.30（2.03至2.60）；HR 2.43（2.02至2.89））。高变异性与低TTR联合存在时，出血风险更高（每100年发生率4.12（95%CI
3.68至4.51）对比2.02（1.71至2.30）；HR 2.16（1.71至2.58）和4.99（4.38至5.52）对比2.36（2.06至2.60）；HR 2.38（2.05至2.85）），与最佳组相比。调整MHV位置、年龄和合并症后，更高的治疗强度（平均INR 2.8 - 3.2对比2.2 - 2.7）与更高的出血率（2.92（2.39至3.47）对比2.48（2.21至2.77）；HR 1.29（1.06至
1.58））、死亡率（3.36（2.79至4.02）对比1.89（1.64至2.17），HR 1.65（1.31至2.06））及总体并发症发生率（6.61（5.74至7.46）对比5.65（5.20至6.06）；HR 1.24（1.06至1.41））相关。
高华法林治疗质量可改善MHV植入后的预后，这可通过TTR和INR变异性来衡量。未发现更高治疗强度（平均INR 2.8 - 3.2对比2.2 - 2.7）有任何益处。
