Shvartz Vladimir, Le Tatyana, Enginoev Soslan, Sokolskaya Maria, Ispiryan Artak, Shvartz Elena, Nudel Daria, Araslanova Naylyana, Petrosyan Andrey, Donakanyan Sergey, Chernov Igor, Bockeria Leo, Golukhova Elena
Bakulev Scientific Center for Cardiovascular Surgery, 121552 Moscow, Russia.
Federal Center for Cardiovascular Surgery of the Russian Federation Ministry of Healthcare (Astrakhan), 414011 Astrakhan, Russia.
J Cardiovasc Dev Dis. 2022 Oct 20;9(10):363. doi: 10.3390/jcdd9100363.
In patients who underwent cardiac surgery, first-time postoperative atrial fibrillation (POAF) is associated with increased incidence of hospital-acquired complications and mortality. Systemic inflammation is one of confirmed triggers of its development. The anti-inflammatory properties of colchicine can be effective for the POAF prevention. However, the results of several studies were questionable and required further investigation. Hence, we aimed to evaluate the effectiveness of low-dose short-term colchicine administration for POAF prevention in patients after the open-heart surgery. This double-blind randomized placebo-controlled trial included 267 patients, but 27 of them dropped out in the course of the study. Study subjects received the test drug on the day before the surgery and on postoperative days 2, 3, 4 and 5. The rhythm control was conducted immediately after the operation and until the discharge from the hospital. The final analysis included 240 study subjects: 113 in the colchicine group and 127 in the placebo group. POAF was observed in 21 (18.6%) patients of the colchicine group vs. 39 (30.7%) control patients (OR 0.515; 95% Cl 0.281-0.943; = 0.029). We observed no statistically significant differences between the patient groups in the secondary endpoints of the study (hospital mortality, respiratory failure, stroke, bleeding, etc.). For other parameters characterizing the severity of inflammation (pericardial effusion, pleural effusion, WBC count, neutrophil count), there were statistically significant differences between the groups in the early postoperative period (days 3 and 5). Also, statistically significant differences between the groups in the frequency of adverse events were revealed: the incidence of diarrhea in the colchicine group was 25.7% vs. 11.8% in the placebo group (OR 2.578; 95% Cl 1.300-5.111; = 0.005); for abdominal pain, incidence values were 7% vs. 1.6%, correspondingly (OR 4.762; 95% Cl 1.010-22.91; = 0.028). Thus, there were statistically significant differences between groups in the primary endpoint, thereby confirming the effectiveness of short-term colchicine use for the POAF prevention after coronary artery bypass grafting and/or aortic valve replacement. Also, we detected statistically significant differences between groups in the frequency of side effects to colchicine: diarrhea and abdominal pain were more common in the colchicine group. This clinical trial is registered with ClinicalTrials database under a unique identifier: NCT04224545.
在接受心脏手术的患者中，首次术后房颤（POAF）与医院获得性并发症和死亡率的增加相关。全身炎症是其发生的已证实触发因素之一。秋水仙碱的抗炎特性可能对预防POAF有效。然而，几项研究的结果存在疑问，需要进一步调查。因此，我们旨在评估低剂量短期使用秋水仙碱对心脏直视手术后患者预防POAF的有效性。这项双盲随机安慰剂对照试验纳入了267例患者，但其中27例在研究过程中退出。研究对象在手术前一天以及术后第2、3、4和5天接受试验药物。术后立即进行节律控制，直至出院。最终分析纳入了240例研究对象：秋水仙碱组113例，安慰剂组127例。秋水仙碱组21例（18.6%）患者发生POAF，而对照组为39例（30.7%）（比值比0.515；95%置信区间0.281 - 0.943；P = 0.029）。在研究的次要终点（医院死亡率、呼吸衰竭、中风、出血等）方面，两组患者之间未观察到统计学上的显著差异。对于表征炎症严重程度的其他参数（心包积液、胸腔积液、白细胞计数、中性粒细胞计数），术后早期（第3天和第5天）两组之间存在统计学上的显著差异。此外，还发现两组在不良事件发生率方面存在统计学上的显著差异：秋水仙碱组腹泻发生率为25.7%，而安慰剂组为11.8%（比值比2.578；95%置信区间1.300 - 5.111；P = 0.005）；腹痛发生率分别为7%和1.6%（比值比4.762；95%置信区间1.010 - 22.91；P = 0.028）。因此，在主要终点方面两组之间存在统计学上的显著差异，从而证实了短期使用秋水仙碱对冠状动脉搭桥术和/或主动脉瓣置换术后预防POAF的有效性。此外，我们检测到两组在秋水仙碱副作用发生率方面存在统计学上的显著差异：腹泻和腹痛在秋水仙碱组更为常见。本临床试验已在ClinicalTrials数据库注册，唯一标识符为：NCT04224545。
