Catheter Ablation vs Sotalol or Amiodarone for Ventricular Tachycardia: A Substudy of the VANISH2 Trial.

The objective of this prespecified substudy was to compare the outcomes of catheter ablation vs AAD according to drug eligibility stratum.

这项预先设定的子研究的目标是根据药物适应性分层，比较导管消融与AAD的治疗结果。

Methods

Patients were considered eligible to be allocated to sotalol vs ablation if they met all the following criteria: estimated glomerular filtration rate ≥30 mL/min, NYHA functional class I-II, left ventricular ejection fraction ≥20%, qualifying arrhythmia was not VT storm, and no history of torsades de pointes or QT interval prolongation.

如果患者符合以下所有标准，则被认为有资格被分配到索他洛尔与消融组：估算的肾小球滤过率≥30 mL/min，NYHA功能I-II级，左心室射血分数≥20%，符合条件的心律失常不是室速风暴，且无尖端扭转型室性心动过速或QT间期延长的病史。

All other patients were eligible to be randomly allocated to amiodarone vs ablation.

所有其他患者均有资格被随机分配到胺碘酮与消融组。

The primary endpoint was a composite of death, appropriate implantable cardioverter-defibrillator shock, VT storm, or treated sustained VT below the detection limit of the implantable cardioverter-defibrillator >14-days postrandomization.

主要终点是死亡、适当的可植入心律转复除颤器（ICD）电击、室速（VT）风暴或治疗性持续性VT（低于ICD检测限）的复合终点，发生在随机化后14天以上。

Secondary endpoints included safety and the individual components of the primary endpoint.

次要终点包括安全性以及主要终点的各个组成部分。

In this analysis, the primary and secondary outcomes for catheter ablation are compared with those for sotalol and to amiodarone separately.

在这项分析中，导管消融的主要和次要结果分别与索他洛尔和胺碘酮进行了比较。

Results

A total of 416 patients (199 in sotalol and 217 in amiodarone strata) were followed for a median of 4.3 years.

共有416名患者（索他洛尔组199人，胺碘酮组217人）被随访，中位随访时间为4.3年。

In the sotalol stratum, a primary endpoint occurred in 44 of 95 patients (46%) assigned to catheter ablation and in 62 of 104 (59%) assigned to sotalol (HR: 0.64; 95% CI: 0.43-0.94; P = 0.02).

在索他洛尔组中，95名被分配到导管消融的患者中有44名（46%）发生了主要终点事件，而在104名被分配到索他洛尔治疗的患者中有62名（59%）发生了主要终点事件（HR: 0.64; 95% 置信区间: 0.43-0.94; P = 0.02）。

In the amiodarone stratum, a primary endpoint occurred in 59 of 108 (55%) patients assigned to ablation and 67 of 109 (61%) assigned to AAD (HR: 0.86; 95% CI: 0.61-1.22; P = NS).

在胺碘酮组中，108名被分配到消融治疗的患者中有59名（55%）发生了主要终点事件，而在109名被分配到抗心律失常药物治疗的患者中有67名（61%）发生了主要终点事件（HR: 0.86; 95% 置信区间: 0.61-1.22; P = NS）。

In the sotalol stratum, sustained VT below detection occurred in 2 of 95 (2.1%) patients randomized to ablation and 18 of 104 (17.3%) assigned to sotalol (HR: 0.12; 95% CI: 0.03-0.5; P = 0.004).

在索他洛尔组中，持续性室性心动过速的发生率在随机接受消融治疗的95名患者中有2人（2.1%），而在接受索他洛尔治疗的104名患者中有18人（17.3%）（HR: 0.12; 95% 置信区间: 0.03-0.5; P = 0.004）。

In the amiodarone stratum it occurred in 7 of 108 (6.5%) randomized to ablation and 17 of 109 (15.6%) assigned to amiodarone (HR: 0.41; 95% CI: 0.17-0.99; P = 0.048).

在胺碘酮组中，持续性室性心动过速的发生率在随机接受消融治疗的108名患者中有7人（6.5%），而在接受胺碘酮治疗的109名患者中有17人（15.6%）（HR: 0.41; 95% 置信区间: 0.17-0.99; P = 0.048）。

In the amiodarone stratum, patients allocated to drug therapy had a 3-fold increase in noncardiac death (5.6% vs 16.5%), a 2-fold increase in respiratory failure (4.6% vs 11.0%), a 50% increase in heart failure hospitalization (19.4% vs 31.2%), a 65% increase in sepsis (5.6% vs 9.2%), a 3-fold increase in pneumonia (3.7% vs 11.9%), and 4.6% incidenceof pulmonary fibrosis/infiltrate (vs 0%), when compared with patients allocated to ablation.

在胺碘酮组中，接受药物治疗的患者非心脏死亡率增加了3倍（5.6%对比16.5%），呼吸衰竭增加了2倍（4.6%对比11.0%），心力衰竭住院率增加了50%（19.4%对比31.2%），败血症增加了65%（5.6%对比9.2%），肺炎增加了3倍（3.7%对比11.9%），并且出现了4.6%的肺纤维化/浸润发生率（对比0%），与接受消融治疗的患者相比。

Conclusions

In the sotalol-eligible patients, ablation led to lower risk of the primary composite endpoint.

在可接受索他洛尔治疗的患者中，消融治疗导致主要复合终点风险降低。

In the amiodarone-eligible group, efficacy outcomes were comparable between ablation and amiodarone.

在符合胺碘酮治疗条件的患者组中，消融治疗与胺碘酮治疗在疗效结果上相当。

Adverse events were more marked among patients randomized to amiodarone (Antiarrhythmics or Ablation for Ventricular Tachycardia 2 [VANISH2]; NCT02830360).

在被随机分配接受胺碘酮治疗的患者中，不良事件更为显著（抗心律失常药物或消融治疗室性心动过速2 [VANISH2]；NCT02830360）。