Sapp John L, Tang Anthony S L, Parkash Ratika, Stevenson William G, Healey Jeff S, Gula Lorne J, Nair Girish M, Essebag Vidal, Rivard Lena, Roux Jean-Francois, Nery Pablo B, Sarrazin Jean-Francois, Amit Guy, Raymond Jean-Marc, Deyell Marc, Lane Chris, Sacher Frederic, de Chillou Christian, Kuriachan Vikas, AbdelWahab Amir, Nault Isabelle, Dyrda Katia, Wilton Stephen, Jolly Umjeet, Kanagasundram Arvindh, Wells George A
QEII Health Sciences Centre, Dalhousie University, Halifax, NS, Canada.
Western University, London, ON, Canada.
N Engl J Med. 2025 Feb 20;392(8):737-747. doi: 10.1056/NEJMoa2409501. Epub 2024 Nov 16.
Patients with ventricular tachycardia and ischemic cardiomyopathy are at high risk for adverse outcomes. Catheter ablation is commonly used when antiarrhythmic drugs do not suppress ventricular tachycardia. Whether catheter ablation is more effective than antiarrhythmic drugs as a first-line therapy in patients with ventricular tachycardia is uncertain.
In an international trial, we randomly assigned in a 1:1 ratio patients with previous myocardial infarction and clinically significant ventricular tachycardia (defined as ventricular tachycardia storm, receipt of appropriate implantable cardioverter-defibrillator [ICD] shock or antitachycardia pacing, or sustained ventricular tachycardia terminated by emergency treatment) to receive antiarrhythmic drug therapy or to undergo catheter ablation. All the patients had an ICD. Catheter ablation was performed within 14 days after randomization; sotalol or amiodarone was administered as antiarrhythmic drug therapy according to prespecified criteria. The primary end point was a composite of death from any cause during follow-up or, more than 14 days after randomization, ventricular tachycardia storm, appropriate ICD shock, or sustained ventricular tachycardia treated by medical intervention.
A total of 416 patients were followed for a median of 4.3 years. A primary end-point event occurred in 103 of 203 patients (50.7%) assigned to catheter ablation and in 129 of 213 (60.6%) assigned to drug therapy (hazard ratio, 0.75; 95% confidence interval, 0.58 to 0.97; P = 0.03). Among patients in the catheter ablation group, adverse events within 30 days after the procedure included death in 2 patients (1.0%) and nonfatal adverse events in 23 patients (11.3%). Among the patients assigned to drug therapy, adverse events that were attributed to antiarrhythmic drug treatment included death from pulmonary toxic effects in 1 patient (0.5%) and nonfatal adverse events in 46 patients (21.6%).
Among patients with ischemic cardiomyopathy and ventricular tachycardia, an initial strategy of catheter ablation led to a lower risk of a composite primary end-point event than antiarrhythmic drug therapy. (Funded by the Canadian Institutes of Health Research and others; VANISH2 ClinicalTrials.gov number, NCT02830360.).
室性心动过速和缺血性心肌病患者发生不良结局的风险很高。当抗心律失常药物不能抑制室性心动过速时，通常会采用导管消融术。在室性心动过速患者中，导管消融作为一线治疗是否比抗心律失常药物更有效尚不确定。
在一项国际试验中，我们将既往有心肌梗死且有临床意义的室性心动过速（定义为室性心动过速风暴、接受适当的植入式心律转复除颤器[ICD]电击或抗心动过速起搏，或经紧急治疗终止的持续性室性心动过速）患者按1:1比例随机分配，分别接受抗心律失常药物治疗或进行导管消融。所有患者均植入了ICD。导管消融在随机分组后14天内进行；根据预先设定的标准，给予索他洛尔或胺碘酮作为抗心律失常药物治疗。主要终点是随访期间任何原因导致的死亡，或在随机分组14天以上出现的室性心动过速风暴、适当的ICD电击，或经药物干预治疗的持续性室性心动过速。
共对416例患者进行了中位4.3年的随访。在分配接受导管消融的203例患者中，103例（50.7%）发生了主要终点事件；在分配接受药物治疗的213例患者中，129例（60.6%）发生了主要终点事件（风险比，0.75；95%置信区间，0.58至0.97；P = 0.03）。在导管消融组的患者中，术后30天内的不良事件包括2例患者死亡（1.0%）和23例患者发生非致命不良事件（11.3%）。在分配接受药物治疗的患者中，归因于抗心律失常药物治疗的不良事件包括1例患者因肺部毒性作用死亡（0.5%）和46例患者发生非致命不良事件（21.6%）。
在缺血性心肌病和室性心动过速患者中，与抗心律失常药物治疗相比，初始采用导管消融策略可降低复合主要终点事件的风险。（由加拿大卫生研究院等资助；VANISH2临床试验.gov编号，NCT02830360。）
