De Vecchis Renato, Ariano Carmelina, Giasi Anna, Cioppa Carmela
Unit of Cardiology, Presidio Sanitario Intermedio "Elena d'Aosta", ASL Napoli 1 Centro, Naples, Italy -
Unit of Cardiology, Presidio Sanitario Intermedio "Elena d'Aosta", ASL Napoli 1 Centro, Naples, Italy.
Minerva Cardioangiol. 2018 Jun;66(3):349-359. doi: 10.23736/S0026-4725.17.04349-3. Epub 2017 May 10.
Recent evidence from relatively small randomized controlled trials would seem to support a useful role of ranolazine for the prevention and treatment of atrial fibrillation (AF). The present study is aimed at providing information about the possible beneficial anti-arrhythmic properties of ranolazine. In particular, the meta-analysis carried out in this study focuses on the application of ranolazine to prophylaxis and treatment of atrial fibrillation.
Both methods randomized controlled trials (RCTs) and non-randomized observational studies concerning the effects of ranolazine on AF were included in the meta-analysis. In each of the considered studies, a comparison was made between a group of patients taking ranolazine and a second group treated instead with another antiarrhythmic therapy, or assigned to placebo. Efficacy outcomes were the risk of new-onset AF, the probability of conversion to sinus rhythm of patients with recent occurrence (≤48 h) of AF and the time to conversion to sinus rhythm. Safety endpoints were death, adverse events, QTc prolongation and hypotension.
Ten studies (8 RCTs and 2 nonrandomized observational studies) were gathered on the whole. Ranolazine was effective in preventing the occurrence of AF when compared to controls (RR=0.60; 95% CI: 0.43-0.83; P=0.002). Subgroup analysis showed a more pronounced preventive effect of ranolazine against AF in the postoperative setting of coronary artery bypass grafting (CABG) surgery (RR=0.39; 95% CI: 0.18-0.83; P=0.02) when compared to non-postoperative AF (RR=0.76; 95% CI: 0.63-0.92; P=0.04). Ranolazine enhanced the chances of successful cardioversion when added to intravenous amiodarone compared to amiodarone alone (RR 1.18; 95% CI: 1.05-1.33; P=0.004) and significantly decreased the time to cardioversion (SMD= -10.35 h; 95% CI: -18.13 hours to -2.57 hours; P<0.001). Overall risks of death, adverse events, and QTc prolongation were shown to be similar in the comparison between patients treated with ranolazine and controls.
Ranolazine given orally at appropriate doses showed the property to significantly quicken the conversion of AF to sinus rhythm when combined with the IV amiodarone, compared to IV amiodarone alone. Furthermore, in patients in sinus rhythm, ranolazine proved to reduce the frequency of new onset AF as well as of its recurrences, especially in patients undergone CABG surgery, known to be at high risk of developing postoperative AF. In addition, ranolazine use seems to be safe and associated with relatively few adverse events.
来自相对较小规模随机对照试验的最新证据似乎支持雷诺嗪在预防和治疗心房颤动（AF）方面的有益作用。本研究旨在提供有关雷诺嗪可能具有的有益抗心律失常特性的信息。特别是，本研究中进行的荟萃分析聚焦于雷诺嗪在心房颤动预防和治疗中的应用。
荟萃分析纳入了关于雷诺嗪对房颤影响的随机对照试验（RCT）和非随机观察性研究这两种方法。在每项纳入研究中，对服用雷诺嗪的一组患者与接受另一种抗心律失常治疗或分配至安慰剂组的第二组患者进行了比较。疗效指标为新发房颤风险、近期发生（≤48小时）房颤患者转为窦性心律的概率以及转为窦性心律的时间。安全性终点为死亡、不良事件、QTc延长和低血压。
总共收集了10项研究（8项RCT和2项非随机观察性研究）。与对照组相比，雷诺嗪在预防房颤发生方面有效（RR = 0.60；95% CI：0.43 - 0.83；P = 0.002）。亚组分析显示，与非术后房颤（RR = 0.76；95% CI：0.63 - 0.92；P = 0.04）相比，雷诺嗪在冠状动脉旁路移植术（CABG）术后预防房颤方面具有更显著的效果（RR = 0.39；95% CI：0.18 - 0.83；P = 0.02）。与单独使用静脉胺碘酮相比，雷诺嗪与静脉胺碘酮联合使用时可提高成功复律的几率（RR 1.18；95% CI：1.05 - 1.33；P = 0.004），并显著缩短复律时间（SMD = -10.35小时；95% CI：-18.13小时至-2.57小时；P < 0.001）。在接受雷诺嗪治疗的患者与对照组的比较中，总体死亡、不良事件和QTc延长风险显示相似。
与单独使用静脉胺碘酮相比，适当剂量口服雷诺嗪与静脉胺碘酮联合使用时，显示出能显著加快房颤转为窦性心律的特性。此外，在窦性心律患者中，雷诺嗪被证明可降低新发房颤及其复发的频率，尤其是在接受CABG手术且已知术后发生房颤风险较高的患者中。此外，使用雷诺嗪似乎是安全的，且不良事件相对较少。
