接受经皮冠状动脉介入治疗的急性心肌梗死后使用 SGLT2 抑制剂治疗的糖尿病患者的结局：SGLT2-I AMI PROTECT 登记研究。
Outcomes in diabetic patients treated with SGLT2-Inhibitors with acute myocardial infarction undergoing PCI: The SGLT2-I AMI PROTECT Registry.
机构信息
Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium; Dept. of Advanced Biomedical Sciences, University Federico II, Naples, Italy.
Unit of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine-DIMES, University of Bologna, Sant'Orsola-Malpighi Hospital, IRCCS, Bologna, Italy.
出版信息
Pharmacol Res. 2023 Jan;187:106597. doi: 10.1016/j.phrs.2022.106597. Epub 2022 Dec 5.
AIMS
To investigate in-hospital and long-term prognosis in T2DM patients presenting with acute myocardial infarction (AMI) treated with SGLT2-I versus other oral anti-diabetic agents (non-SGLT2-I users).
METHODS
In this multicenter international registry all consecutive diabetic AMI patients undergoing percutaneous coronary intervention between 2018 and 2021 were enrolled and, based on the admission anti-diabetic therapy, divided into SGLT-I users versus non-SGLT2-I users. The primary endpoint was defined as a composite of cardiovascular death, recurrent AMI, and hospitalization for HF (MACE). Secondary outcomes included i) in-hospital cardiovascular death, recurrent AMI, occurrence of arrhythmias, and contrast-induced acute kidney injury (CI-AKI); ii) long-term cardiovascular mortality, recurrent AMI, heart failure (HF) hospitalization.
RESULTS
The study population consisted of 646 AMI patients (with or without ST-segment elevation): 111 SGLT2-I users and 535 non-SGLT-I users. The use of SGLT2-I was associated with a significantly lower in-hospital cardiovascular death, arrhythmic burden, and occurrence of CI-AKI (all p < 0.05). During a median follow-up of 24 ± 13 months, the primary composite endpoint, as well as cardiovascular mortality and HF hospitalization were lower for SGLT2-I users compared to non-SGLT2-I patients (p < 0.04 for all). After adjusting for confounding factors, the use of SGLT2-I was identified as independent predictor of reduced MACE occurrence (HR=0.57; 95%CI:0.33-0.99; p = 0.039) and HF hospitalization (HR=0.46; 95%CI:0.21-0.98; p = 0.041).
CONCLUSIONS
In T2DM AMI patients, the use of SGLT2-I was associated with a lower risk of adverse cardiovascular outcomes during index hospitalization and long-term follow-up. Our findings provide new insights into the cardioprotective effects of SGLT2-I in the setting of AMI.
REGISTRATION
Data are part of the observational international registry: SGLT2-I AMI PROTECT.
CLINICALTRIALS
gov Identifier: NCT05261867.
目的
研究在接受钠-葡萄糖协同转运蛋白 2 抑制剂（SGLT2-I）与其他口服抗糖尿病药物（非 SGLT2-I 使用者）治疗的急性心肌梗死（AMI）合并 2 型糖尿病（T2DM）患者中，院内和长期预后的差异。
方法
在这项多中心国际注册研究中，连续纳入了 2018 年至 2021 年间接受经皮冠状动脉介入治疗的所有糖尿病合并 AMI 患者，并根据入院时的抗糖尿病治疗情况，分为 SGLT2-I 使用者和非 SGLT2-I 使用者。主要终点定义为心血管死亡、再发 AMI 和心力衰竭（HF）住院的复合终点（MACE）。次要结局包括 i）院内心血管死亡、再发 AMI、心律失常的发生和造影剂诱导的急性肾损伤（CI-AKI）；ii）长期心血管死亡率、再发 AMI、HF 住院。
结果
研究人群包括 646 例 AMI 患者（有或无 ST 段抬高）：111 例 SGLT2-I 使用者和 535 例非 SGLT-I 使用者。SGLT2-I 的使用与院内心血管死亡、心律失常负担和 CI-AKI 的发生率显著降低相关（均 P<0.05）。在中位随访 24±13 个月期间，与非 SGLT2-I 患者相比，SGLT2-I 使用者的主要复合终点、心血管死亡率和 HF 住院率均较低（所有 P<0.04）。在校正混杂因素后，SGLT2-I 的使用被确定为 MACE 发生率降低的独立预测因素（HR=0.57；95%CI：0.33-0.99；P=0.039）和 HF 住院率降低的独立预测因素（HR=0.46；95%CI：0.21-0.98；P=0.041）。
结论
在 T2DM 合并 AMI 患者中，SGLT2-I 的使用与住院期间和长期随访期间不良心血管结局的风险降低相关。我们的研究结果为 SGLT2-I 在 AMI 中的心脏保护作用提供了新的见解。
登记信息
数据为观察性国际注册研究 SGLT2-I AMI PROTECT 的一部分。
临床试验
gov 标识符：NCT05261867。
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