Dong L, Xu J P, Zhu D
Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.
Adult Cardiac Center, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing 100037, China.
Zhonghua Yi Xue Za Zhi. 2023 Aug 15;103(30):2314-2319. doi: 10.3760/cma.j.cn112137-20230401-00527.
To explore the optimal intensity of anticoagulation therapy for Chinese patients after mechanical heart valve replacement. This is a prospective, multicenter, cohort study. The anticoagulation data from in-hospital patients of 35 medical centers and patients in outpatient clinic of 11 medical centers from Anticoagulation Therapy Database of Chinese Patients after Heart Valve Replacement between January 2011 and December 2015 were analyzed. The anticoagulation-relevant complications among different coagulation intensities were compared, and the optimal value of anticoagulation intensity for Chinese patients after mechanical heart valve replacement were analyzed. A total of 24 433 patients were in the final analysis, including 13 634 females and 10 799 males, with a median age of 49.0 (3-80) years. International normalized ratio (INR) values of in-hospital patients were recorded 94 286 times, with the mean value of 1.8±0.7, and 87.6% (82 595/94 286) of them were within the range of 1.5 to 2.5. During a median follow-up time of 19.2 (1.0-58.8) months, a total of 17 331 outpatient clinic patients were followed up, with the follow-up rate of 89.1% (17 331/19 452) and a total of 27 803 patient-years (Pty), including 4 038 aortic valve replacement (AVR), 8 215 mitral valve replacement (MVR), 4 437 AVR plus MVR (double valve replacement, DVR) replacement and 641 tricuspidvalve replacement (TVR). A total of 101 860 INR measurements were recorded, with the mean value of 1.8±0.5, and 64.8% (66 005/101 860) of them were within the range of 1.5-2.5. The rates of anticoagulation-related complications of the patients with INR of 1.5-2.5 (0.65/100 Pty) were lower than those of other INR value patients (INR<1.5: 1.31/100 Pty, =2.01, 95%: 1.59-2.51, <0.001; INR>2.5: 2.34/100 Pty, =3.60, 95%: 2.84-4.52, <0.001). The rates of anticoagulation-related complications of AVR and MVR patients without risk factors and with INR of 1.5-2.0 were lower than those of other INR value patients (AVR: 0.15/100 Pty vs 0.38/100 Pty, =2.57, 95%: 1.02-7.28, =0.029; MVR: 0.23/100 Pty vs 0.56/100 Pty, =2.42, 95%: 1.39-4.38, <0.001), and the rate of anticoagulation-related complications of DVR patients with INR of 2.0-2.5 was lower than those of other INR value patients (0.32/100 Pty vs 0.62/100 Pty, =1.94, 95%: 1.03-3.79, =0.029). A target INR range of 1.5-2.5 is recommended for Chinese patients after mechanical heart valve replacement. The optimal INR value for isolated AVR or MVR patients without risk factors was 1.5-2.0, while the optimal INR value for isolated AVR or MVR patients with risk factors and all the TVR or DVR patients was 2.0-2.5.
探讨中国机械心脏瓣膜置换术后患者抗凝治疗的最佳强度。这是一项前瞻性、多中心队列研究。分析了2011年1月至2015年12月期间心脏瓣膜置换术后中国患者抗凝治疗数据库中35个医疗中心住院患者和11个医疗中心门诊患者的抗凝数据。比较了不同凝血强度下与抗凝相关的并发症，并分析了中国机械心脏瓣膜置换术后患者抗凝强度的最佳值。最终分析共纳入24433例患者，其中女性13634例，男性10799例，中位年龄49.0（3 - 80）岁。住院患者的国际标准化比值（INR）值共记录94286次，平均值为1.8±0.7，其中87.6%（82595/94286）在1.5至2.5范围内。在中位随访时间19.2（1.0 - 58.8）个月期间，共随访门诊患者17331例，随访率为89.1%（17331/19452），总计27803患者年（Pty），包括4038例主动脉瓣置换（AVR）、8215例二尖瓣置换（MVR）、4437例AVR加MVR（双瓣置换，DVR）和641例三尖瓣置换（TVR）。共记录101860次INR测量值，平均值为1.8±0.5，其中64.8%（66005/101860）在1.5 - 2.5范围内。INR为1.5 - 2.5的患者抗凝相关并发症发生率（0.65/100 Pty）低于其他INR值患者（INR < 1.5：1.31/100 Pty，χ² = 2.01，95%：1.59 - 2.51，P < 0.001；INR > 2.5：2.34/100 Pty，χ² = 3.60，95%：2.84 - 4.52，P < 0.001）。无危险因素且INR为1.5 - 2.0的AVR和MVR患者抗凝相关并发症发生率低于其他INR值患者（AVR：0.15/100 Pty对0.38/100 Pty，χ² = 2.57，95%：1.02 - 7.28 = 0.029；MVR：0.23/100 Pty对0.56/100 Pty，χ² = 2.42，95%：1.39 - 4.38，P < 0.001），且INR为2.0 - 2.5的DVR患者抗凝相关并发症发生率低于其他INR值患者（0.32/100 Pty对0.62/100 Pty，χ² = 1.94，95%：1.03 - 3.79 = 0.029）。建议中国机械心脏瓣膜置换术后患者的目标INR范围为1.5 - 2.5。无危险因素孤立AVR或MVR患者的最佳INR值为1.5 - 2.0，而有危险因素的孤立AVR或MVR患者以及所有TVR或DVR患者的最佳INR值为2.0 - 2.5。
