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Association of Renin-Angiotensin Inhibitor Treatment With Mortality and Heart Failure Readmission in Patients With Transcatheter Aortic Valve Replacement
JAMA ( IF 120.7 ) Pub Date : 2018-12-04 , DOI: 10.1001/jama.2018.18077
Taku Inohara 1, 2 , Pratik Manandhar 1 , Andrzej S. Kosinski 1 , Roland A. Matsouaka 1 , Shun Kohsaka 2 , Robert J. Mentz 1 , Vinod H. Thourani 3 , John D. Carroll 4 , Ajay J. Kirtane 5 , Joseph E. Bavaria 6 , David J. Cohen 7, 8 , Todd L. Kiefer 1 , Jeffrey G. Gaca 1 , Samir R. Kapadia 9 , Eric D. Peterson 1 , Sreekanth Vemulapalli 1
Affiliation  

Importance Data are lacking on the effect of a renin-angiotensin system (RAS) inhibitor prescribed after transcatheter aortic valve replacement (TAVR). Treatment with a RAS inhibitor may reverse left ventricular remodeling and improve function. Objective To investigate the association of prescription of a RAS inhibitor and outcomes after TAVR. Design, Setting, and Participants Retrospective cohort study of TAVR procedures performed in the United States (using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry) between July 2014 and January 2016 that were linked to Medicare claims data (final date of follow-up: March 31, 2017). To account for differences in demographics, echocardiographic findings, and in-hospital complications, 1:1 propensity matching was performed. Exposures Initial hospital discharge prescription of a RAS inhibitor after TAVR. Main Outcomes and Measures Primary outcomes were all-cause death and readmission due to heart failure at 1 year after discharge, which were considered separately. The secondary outcome was health status assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ; score range: 0-100, with a higher score indicating less symptom burden and better quality of life; a small effect size was defined as 5 points) at 1 year. Results Among 21 312 patients who underwent TAVR at 417 US sites, 8468 patients (39.7%) were prescribed a RAS inhibitor at hospital discharge. After propensity matching, 15 896 patients were included (mean [SD] age, 82.4 [6.8] years; 48.1% were women; mean [SD] left ventricular ejection fraction [LVEF], 51.9% [11.5%]). Patients with a prescription for a RAS inhibitor vs those with no prescription had lower mortality rates at 1 year (12.5% vs 14.9%, respectively; absolute risk difference [ARD], −2.4% [95% CI, −3.5% to −1.4%]; hazard ratio [HR], 0.82 [95% CI, 0.76 to 0.90]) and lower heart failure readmission rates at 1 year (12.0% vs 13.8%; ARD, −1.8% [95% CI, −2.8% to −0.7%]; HR, 0.86 [95% CI, 0.79 to 0.95]). When stratified by LVEF, having a prescription for a RAS inhibitor vs no prescription was associated with lower 1-year mortality among patients with preserved LVEF (11.1% vs 13.9%, respectively; ARD, −2.81% [95% CI, −3.95% to −1.67%]; HR, 0.78 [95% CI, 0.71 to 0.86]), but not among those with reduced LVEF (18.8% vs 19.5%; ARD, −0.68% [95% CI, −3.52% to 2.20%]; HR, 0.95 [95% CI, 0.81 to 1.12]) (P = .04 for interaction). Of 15 896 matched patients, 4837 (30.4%) were included in the KCCQ score analysis and improvements at 1 year were greater in patients with a prescription for a RAS inhibitor vs those with no prescription (median, 33.3 [interquartile range, 14.2 to 51.0] vs 31.3 [interquartile range, 13.5 to 51.1], respectively; difference in improvement, 2.10 [95% CI, 0.10 to 4.06]; P < .001), but the effect size was not clinically meaningful. Conclusions and Relevance Among patients who underwent TAVR, receiving a prescription for a RAS inhibitor at hospital discharge compared with no prescription was significantly associated with a lower risk of mortality and heart failure readmission. However, due to potential selection bias, this finding requires further investigation in randomized trials.

中文翻译:

肾素-血管紧张素抑制剂治疗与经导管主动脉瓣置换术患者死亡率和心力衰竭再入院的相关性

缺乏关于经导管主动脉瓣置换术 (TAVR) 后处方肾素-血管紧张素系统 (RAS) 抑制剂效果的重要数据。RAS 抑制剂治疗可逆转左心室重构并改善功能。目的 探讨 RAS 抑制剂处方与 TAVR 术后结局的相关性。设计、设置和参与者 2014 年 7 月至 2016 年 1 月在美国进行的 TAVR 手术的回顾性队列研究(使用胸外科医师协会/美国心脏病学会经导管瓣膜治疗登记处)与医疗保险索赔数据相关联(最终日期)随访时间:2017 年 3 月 31 日)。为了解释人口统计学、超声心动图结果和院内并发症的差异,进行了 1:1 倾向匹配。暴露 TAVR 后 RAS 抑制剂的初始出院处方。主要结局和指标主要结局是出院后1年时因心力衰竭导致的全因死亡和再入院,这两个指标单独考虑。次要结局是由堪萨斯城心肌病问卷(KCCQ;评分范围:0-100,评分越高表示症状负担越轻,生活质量越好;小效应量定义为 5 分)在 1 年时评估的健康状况. 结果 在美国 417 个地点接受 TAVR 的 21312 名患者中,8468 名患者(39.7%)在出院时服用了 RAS 抑制剂。倾向匹配后,纳入 15 896 名患者(平均 [SD] 年龄,82.4 [6.8] 岁;48.1% 为女性;平均 [SD] 左心室射血分数 [LVEF],51.9% [11.5%])。有处方 RAS 抑制剂的患者与没有处方的患者相比,1 年死亡率较低(分别为 12.5% 和 14.9%;绝对风险差 [ARD],-2.4% [95% CI,-3.5% 至 -1.4) %];风险比 [HR],0.82 [95% CI,0.76 至 0.90])和较低的 1 年心力衰竭再入院率(12.0% 对 13.8%;ARD,-1.8% [95% CI,-2.8% 至-0.7%];HR,0.86 [95% CI,0.79 至 0.95])。当按 LVEF 分层时,使用 RAS 抑制剂处方与未处方相比,LVEF 保留患者的 1 年死亡率较低(分别为 11.1% 和 13.9%;ARD,-2.81% [95% CI,-3.95%至 -1.67%];HR,0.78 [95% CI,0.71 至 0.86]),但不在 LVEF 降低的患者中(18.8% 对 19.5%;ARD,-0.68% [95% CI,-3.52% 至 2.20%) ];HR,0.95 [95% CI,0.81 至 1.12])(交互作用 P = .04)。在 15896 名匹配的患者中,4837 名 (30. 4%) 被包括在 KCCQ 评分分析中,并且在 1 年时,处方 RAS 抑制剂的患者与没有处方的患者相比改善更大(中位数,33.3 [四分位距,14.2 至 51.0] vs 31.3 [四分位距,13.5]至 51.1];改善差异为 2.10 [95% CI,0.10 至 4.06];P < .001),但效果大小没有临床意义。结论和相关性 在接受 TAVR 的患者中,出院时接受 RAS 抑制剂处方与未处方相比与较低的死亡率和心力衰竭再入院风险显着相关。然而,由于潜在的选择偏倚,这一发现需要在随机试验中进一步调查。
更新日期:2018-12-04
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