静脉注射羧麦芽糖铁治疗伴有和不伴有糖尿病的急性心力衰竭患者的铁补充：随机 AFFIRM-AHF 试验的亚组分析。
Intravenous ferric carboxymaltose for iron repletion following acute heart failure in patients with and without diabetes: a subgroup analysis of the randomized AFFIRM-AHF trial.
机构信息
Department of Medical Sciences, Centre for Clinical and Basic Research, IRCCS San Raffaele, Rome, Italy.
Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.
出版信息
Cardiovasc Diabetol. 2023 Aug 17;22(1):215. doi: 10.1186/s12933-023-01943-z.
BACKGROUND
In AFFIRM-AHF, treatment of iron deficiency with intravenous ferric carboxymaltose (FCM) reduced the risk of heart failure (HF) hospitalization and improved quality of life (QoL) vs placebo in patients stabilized following an acute HF (AHF) episode, with no effect on cardiovascular (CV) death. Diabetes and iron deficiency frequently accompany AHF. This post hoc analysis explored the effects of diabetes on outcomes in AFFIRM-AHF patients.
METHODS
Patients were stratified by diabetes yes/no at baseline. The effects of FCM vs placebo on primary (total HF hospitalizations and CV death) and secondary (total CV hospitalizations and CV death; CV death; total HF hospitalizations; time to first HF hospitalization or CV death; and days lost due to HF hospitalizations or CV death) endpoints at Week 52 and change vs baseline in disease-specific QoL (12-item Kansas City Cardiomyopathy Questionnaire [KCCQ-12]) at Week 24 were assessed by subgroup. For each endpoint, the interaction between diabetes status and treatment outcome was explored.
RESULTS
Of 1108 AFFIRM-AHF patients, 475 (FCM: 231; placebo: 244) had diabetes and 633 (FCM: 327; placebo: 306) did not have diabetes. Patients with diabetes were more commonly male (61.5% vs 50.9%), with a higher frequency of ischemic HF etiology (57.9% vs 39.0%), prior HF history (77.7% vs 66.5%), and comorbidities (including previous myocardial infarction [49.3% vs 32.9%] and chronic kidney disease [51.4% vs 32.4%]) than those without diabetes. The annualized event rate/100 patient-years with FCM vs placebo for the primary endpoint was 66.9 vs 80.9 in patients with diabetes (rate ratio [RR]: 0.83, 95% CI 0.58-1.81) and 51.3 vs 66.9 in patients without diabetes (RR: 0.77, 95% CI 0.55-1.07), with no significant interaction between diabetes status and treatment effect (p = 0.76). Similar findings were observed for secondary outcomes. Change from baseline in KCCQ-12 overall summary score was numerically greater with FCM vs placebo at almost all time points in both subgroups, with no interaction between diabetes and treatment effect at Week 24.
CONCLUSIONS
The clinical and QoL benefits observed with intravenous FCM in patients with iron deficiency following stabilization from an AHF episode are independent of diabetes status. Trial registration Clinicaltrials.gov, NCT02937454 (registered 10.18.2016).
背景
在 AFFIRM-AHF 研究中，与安慰剂相比，静脉注射铁羧基麦芽糖（FCM）治疗缺铁可降低心力衰竭（HF）住院风险和改善生活质量（QoL），但对心血管（CV）死亡无影响。糖尿病和缺铁常伴随急性心力衰竭（AHF）。本事后分析探讨了糖尿病对 AFFIRM-AHF 患者结局的影响。
方法
根据基线时是否患有糖尿病将患者分为糖尿病阳性/阴性。通过亚组评估 FCm 与安慰剂对主要（总 HF 住院和 CV 死亡）和次要终点（总 CV 住院和 CV 死亡；CV 死亡；总 HF 住院；首次 HF 住院或 CV 死亡的时间；因 HF 住院或 CV 死亡导致的天数损失）的影响，评估时间点为第 52 周；评估第 24 周时疾病特异性 QoL（12 项堪萨斯城心肌病问卷[KCCQ-12]）与基线相比的变化。对每个终点，都探讨了糖尿病状态与治疗结果之间的交互作用。
结果
在 1108 例 AFFIRM-AHF 患者中，475 例（FCM：231 例；安慰剂：244 例）患有糖尿病，633 例（FCM：327 例；安慰剂：306 例）未患有糖尿病。患有糖尿病的患者更常见为男性（61.5% vs 50.9%），缺血性 HF 病因更常见（57.9% vs 39.0%），HF 病史更常见（77.7% vs 66.5%），合并症更常见（包括既往心肌梗死[49.3% vs 32.9%]和慢性肾脏病[51.4% vs 32.4%]）。与无糖尿病患者相比，FCM 组与安慰剂组的主要终点年发生率/100 患者年分别为 66.9 例和 80.9 例（风险比[RR]：0.83，95%CI 0.58-1.81），无糖尿病患者分别为 51.3 例和 66.9 例（RR：0.77，95%CI 0.55-1.07），糖尿病状态与治疗效果之间无显著交互作用（p=0.76）。次要结局也观察到类似的发现。在两个亚组中，几乎所有时间点的 FCM 与安慰剂相比，KCCQ-12 总综合评分的变化都从基线有所增加，且在第 24 周时，糖尿病与治疗效果之间无交互作用。
结论
静脉注射 FCM 可改善缺铁性 AHF 稳定患者的临床和生活质量，与糖尿病状态无关。临床试验注册：Clinicaltrials.gov，NCT02937454（于 2016 年 10 月 18 日注册）。
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