Department of Cardiology, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
German Center for Cardiovascular Research, Partner Site Hamburg/Luebeck/Kiel, Germany.
Europace. 2024 Jun 3;26(6). doi: 10.1093/europace/euae121.
Clinical concerns exist about the potential proarrhythmic effects of the sodium channel blockers (SCBs) flecainide and propafenone in patients with cardiovascular disease. Sodium channel blockers were used to deliver early rhythm control (ERC) therapy in EAST-AFNET 4.
We analysed the primary safety outcome (death, stroke, or serious adverse events related to rhythm control therapy) and primary efficacy outcome (cardiovascular death, stroke, and hospitalization for worsening of heart failure (HF) or acute coronary syndrome) during SCB intake for patients with ERC (n = 1395) in EAST-AFNET 4. The protocol discouraged flecainide and propafenone in patients with reduced left ventricular ejection fraction and suggested stopping therapy upon QRS prolongation >25% on therapy. Flecainide or propafenone was given to 689 patients [age 69 (8) years; CHA2DS2-VASc 3.2 (1); 177 with HF; 41 with prior myocardial infarction, coronary artery bypass graft, or percutaneous coronary intervention; 26 with left ventricular hypertrophy >15 mm; median therapy duration 1153 [237, 1828] days]. The primary efficacy outcome occurred less often in patients treated with SCB [3/100 (99/3316) patient-years] than in patients who never received SCB [SCBnever 4.9/100 (150/3083) patient-years, P < 0.001]. There were numerically fewer primary safety outcomes in patients receiving SCB [2.9/100 (96/3359) patient-years] than in SCBnever patients [4.2/100 (135/3220) patient-years, adjusted P = 0.015]. Sinus rhythm at 2 years was similar between groups [SCB 537/610 (88); SCBnever 472/579 (82)].
Long-term therapy with flecainide or propafenone appeared to be safe in the EAST-AFNET 4 trial to deliver effective ERC therapy, including in selected patients with stable cardiovascular disease such as coronary artery disease and stable HF. Clinical Trial Registration ISRCTN04708680, NCT01288352, EudraCT2010-021258-20, www.easttrial.org.
在患有心血管疾病的患者中，临床关注钠通道阻滞剂（SCB）氟卡尼和普罗帕酮潜在的致心律失常作用。在 EAST-AFNET 4 中，SCB 用于提供早期节律控制（ERC）治疗。
我们分析了 EAST-AFNET 4 中 ERC 患者（n = 1395）在服用 SCB 时的主要安全性结局（死亡、中风或与节律控制治疗相关的严重不良事件）和主要疗效结局（心血管死亡、中风和因心力衰竭恶化或急性冠状动脉综合征而住院）。该方案不鼓励在左心室射血分数降低的患者中使用氟卡尼和普罗帕酮，并建议在治疗期间 QRS 延长>25%时停止治疗。氟卡尼或普罗帕酮给予 689 例患者[年龄 69（8）岁；CHA2DS2-VASc 3.2（1）；177 例心力衰竭；41 例既往心肌梗死、冠状动脉旁路移植术或经皮冠状动脉介入治疗；26 例左心室肥厚>15mm；中位治疗持续时间 1153[237，1828]天]。接受 SCB 治疗的患者主要疗效结局的发生率低于从未接受 SCB 治疗的患者[SCBnever 4.9/100（150/3083）患者年，P<0.001]。接受 SCB 治疗的患者主要安全性结局的发生率低于 SCBnever 患者[2.9/100（96/3359）患者年，调整后的 P=0.015]。两组 2 年窦性心律的发生率相似[SCB 537/610（88）；SCBnever 472/579（82）]。
在 EAST-AFNET 4 试验中，氟卡尼或普罗帕酮的长期治疗似乎是安全的，可以提供有效的 ERC 治疗，包括在稳定型心血管疾病（如冠状动脉疾病和稳定型心力衰竭）的选定患者中。临床试验注册 ISRCTN86222145，NCT01288352，EudraCT2010-021258-20，www.easttrial.org。
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