Ronald Witteles MD , John L. Jefferies MD, MPH , Suraj Kapa MD , Francesco Cappelli MD, PhD , Marla B. Sultan MD, MBA , Balarama Gundapaneni MS , Margot K. Davis MD, MS , Pablo Garcia-Pavia MD
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The impact of AF/AFL on tafamidis efficacy was explored by adding an interaction term for AF/AFL status and treatment.</p></div><div><h3>Results</h3><p>ATTR-ACT enrolled 441 patients with ATTR-CM (median age 75 years; 90% male); 314 (71.2%) had baseline or historical AF/AFL at enrollment. AF/AFL was an independent prognostic factor for all-cause mortality after adjusting for covariates prespecified in the ATTR-ACT model (treatment, genotype, New York Heart Association functional class; HR: 0.550; 95% CI: 0.368-0.821) but not in an expanded stepwise model selection analysis including 23 covariates (blood urea nitrogen and N-terminal pro–B-type natriuretic peptide concentration, 6-minute walk test distance, genotype, treatment, and global longitudinal strain were prognostic [<em>P</em> < 0.01]). The interactions between tafamidis treatment and AF/AFL for all-cause mortality (<em>P</em> = 0.33) and changes in Kansas City Cardiomyopathy Questionnaire Overall Summary score (<em>P</em> = 0.83) and 6-minute walk test distance (<em>P</em> = 0.82) were not significant.</p></div><div><h3>Conclusions</h3><p>In ATTR-ACT, baseline or historical AF/AFL was prognostic for all-cause mortality in analyses with limited adjustment but not after accounting for additional indicators of disease severity. Baseline or historical AF/AFL did not impact the efficacy of tafamidis treatment. 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引用次数: 0
摘要
背景心房颤动/心房扑动（AF/AFL）是转甲状腺素淀粉样变性心肌病（ATTR-CM）的常见表现，但尚未发现其可预测死亡率。方法在为期 30 个月的 ATTR-ACT（Tafamidis in Transthyretin Cardiomyopathy Clinical Trial）研究中，使用 Cox 比例危险模型评估了 AF/AFL 作为全因死亡率的独立预后因素。结果ATTR-ACT共招募了441名ATTR-CM患者（中位年龄75岁；90%为男性），其中314人（71.2%）在入组时存在基线或历史性房颤/AFL。在调整 ATTR-ACT 模型中预设的协变量（治疗、基因型、纽约心脏协会功能分级；HR：0.550；95% CI：0.368-0.821）后，心房颤动/心房颤动是全因死亡率的独立预后因素，但在扩展模型中并非如此。HR：0.550；95 CI：0.368-0.821），但在包括 23 个协变量（血尿素氮和 N 末端前 B 型钠尿肽浓度、6 分钟步行测试距离、基因型、治疗和全局纵向应变）的扩展逐步模型选择分析中则不具有预后意义 [P<；0.01]）。结论在ATTR-ACT中，基线或历史房颤/AFL在有限调整的分析中是全因死亡率的预后因素，但在考虑了疾病严重程度的其他指标后则不是。基线或既往房颤/AFL对他法米迪的疗效没有影响。(塔法米地斯治疗转甲状腺素心肌病患者的安全性和疗效[ATTR-ACT]；NCT01994889）。
Atrial Fibrillation as a Prognostic Factor for All-Cause Mortality in Patients With Transthyretin Amyloid Cardiomyopathy
Background
Atrial fibrillation/atrial flutter (AF/AFL) are common manifestations of transthyretin amyloid cardiomyopathy (ATTR-CM) but have not been found to be predictive of mortality.
Objectives
This analysis aimed to examine whether baseline or historical AF/AFL at enrollment was prognostic for all-cause mortality.
Methods
In the ATTR-ACT (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial), a 30-month study of tafamidis vs placebo for ATTR-CM, AF/AFL was evaluated as an independent prognostic factor for all-cause mortality using Cox proportional hazards modelling. The impact of AF/AFL on tafamidis efficacy was explored by adding an interaction term for AF/AFL status and treatment.
Results
ATTR-ACT enrolled 441 patients with ATTR-CM (median age 75 years; 90% male); 314 (71.2%) had baseline or historical AF/AFL at enrollment. AF/AFL was an independent prognostic factor for all-cause mortality after adjusting for covariates prespecified in the ATTR-ACT model (treatment, genotype, New York Heart Association functional class; HR: 0.550; 95% CI: 0.368-0.821) but not in an expanded stepwise model selection analysis including 23 covariates (blood urea nitrogen and N-terminal pro–B-type natriuretic peptide concentration, 6-minute walk test distance, genotype, treatment, and global longitudinal strain were prognostic [P < 0.01]). The interactions between tafamidis treatment and AF/AFL for all-cause mortality (P = 0.33) and changes in Kansas City Cardiomyopathy Questionnaire Overall Summary score (P = 0.83) and 6-minute walk test distance (P = 0.82) were not significant.
Conclusions
In ATTR-ACT, baseline or historical AF/AFL was prognostic for all-cause mortality in analyses with limited adjustment but not after accounting for additional indicators of disease severity. Baseline or historical AF/AFL did not impact the efficacy of tafamidis treatment. (Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy [ATTR-ACT]; NCT01994889)
期刊介绍：
JACC: CardioOncology is a specialized journal that belongs to the esteemed Journal of the American College of Cardiology (JACC) family. Its purpose is to enhance cardiovascular care for cancer patients by publishing high-quality, innovative scientific research and sharing evidence-based knowledge.
The journal aims to revolutionize the field of cardio-oncology and actively involve and educate professionals in both cardiovascular and oncology fields. It covers a wide range of topics including pre-clinical, translational, and clinical research, as well as best practices in cardio-oncology. Key areas of focus include understanding disease mechanisms, utilizing in vitro and in vivo models, exploring novel and traditional therapeutics (across Phase I-IV trials), studying epidemiology, employing precision medicine, and investigating primary and secondary prevention.
Amyloidosis, cardiovascular risk factors, heart failure, and vascular disease are some examples of the disease states that are of particular interest to the journal. However, it welcomes research on other relevant conditions as well.
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