PolarX 与 Arctic Front 用于阵发性 AF 的冷冻球囊消融：随机比较 CRYO 研究。
PolarX vs Arctic Front for Cryoballoon Ablation of Paroxysmal AF: The Randomized COMPARE CRYO Study.
机构信息
Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
出版信息
JACC Clin Electrophysiol. 2024 Jul;10(7 Pt 1):1367-1376. doi: 10.1016/j.jacep.2024.03.021. Epub 2024 May 15.
BACKGROUND
Pulmonary vein isolation is an effective treatment for atrial fibrillation (AF). Cryoballoon ablation using the Arctic Front cryoballoon (Medtronic) was found to be superior to antiarrhythmic drug treatment. Recently, a novel cryoballoon system was introduced (PolarX, Boston Scientific).
OBJECTIVES
The purpose of this study was to compare the efficacy and safety of the 2 cryoballoons in a randomized controlled trial.
METHODS
Patients with symptomatic paroxysmal AF were enrolled in 2 centers and randomized 1:1 to pulmonary vein isolation using the PolarX or the Arctic Front cryoballoon. All patients received an implantable cardiac monitor. The primary endpoint was first recurrence of atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia [AT]) between days 91 and 365. Procedural safety was assessed by a composite of tamponade, phrenic nerve palsy lasting >24 hours, vascular complications, stroke/transient ischemic attack, atrioesophageal fistula or death up to 30 days.
RESULTS
A total of 201 patients were enrolled. At 1 year, recurrence of atrial tachyarrhythmia had occurred in 41 of 99 patients (41.6%) assigned to the PolarX group and in 48 of 102 patients (47.1%) assigned to the Arctic Front group (HR: 0.85 [95% CI: 0.56-1.30]; P = 0.03 for noninferiority; P = 0.46 for superiority). The safety endpoint occurred in 5 patients (5%) in the PolarX group (n = 5 phrenic nerve palsies lasting >24 hours), whereas no safety endpoints occurred in the Arctic Front group (P = 0.03).
CONCLUSIONS
In this randomized controlled trial using implantable cardiac monitors for continuous rhythm monitoring, the novel PolarX cryoballoon was noninferior compared with the Arctic Front cryoballoon regarding efficacy. However, the PolarX balloon resulted in significantly more phrenic nerve palsies. (Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF [COMPARE-CRYO]; NCT04704986).
背景
肺静脉隔离是治疗心房颤动（AF）的有效方法。使用 Arctic Front 冷冻球囊（美敦力）进行冷冻球囊消融被发现优于抗心律失常药物治疗。最近，引入了一种新型冷冻球囊系统（PolarX，波士顿科学）。
目的
本研究旨在通过随机对照试验比较两种冷冻球囊的疗效和安全性。
方法
将有症状的阵发性 AF 患者纳入 2 个中心，并以 1:1 的比例随机分为使用 PolarX 或 Arctic Front 冷冻球囊进行肺静脉隔离。所有患者均接受植入式心脏监测仪。主要终点是第 91 天至 365 天之间首次复发的房性快速心律失常（AF、心房扑动或房性心动过速[AT]）。通过复合终点评估程序安全性，包括填塞、持续>24 小时的膈神经麻痹、血管并发症、卒中和短暂性脑缺血发作、食-食管瘘或 30 天内死亡。
结果
共纳入 201 例患者。在 1 年时，PolarX 组 99 例患者中有 41 例（41.6%）和 Arctic Front 组 102 例患者中有 48 例（47.1%）发生房性快速心律失常复发（HR：0.85[95%CI：0.56-1.30]；非劣效性 P=0.03；优效性 P=0.46）。PolarX 组有 5 例（5%）发生 5 例膈神经麻痹持续>24 小时的安全性终点事件，而 Arctic Front 组无安全性终点事件（P=0.03）。
结论
在这项使用植入式心脏监测仪进行连续节律监测的随机对照试验中，新型 PolarX 冷冻球囊在疗效方面与 Arctic Front 冷冻球囊相比非劣效。然而，PolarX 球囊导致更多的膈神经麻痹。（比较 PolarX 和 Arctic Front 冷冻球囊在有症状的阵发性 AF 患者中的疗效[COMPARE-CRYO]；NCT04704986）。
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