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Catheter Ablation or Antiarrhythmic Drugs for Ventricular Tachycardia.
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2024-11-16 , DOI: 10.1056/nejmoa2409501 John L Sapp,Anthony S L Tang,Ratika Parkash,William G Stevenson,Jeff S Healey,Lorne J Gula,Girish M Nair,Vidal Essebag,Lena Rivard,Jean-Francois Roux,Pablo B Nery,Jean-Francois Sarrazin,Guy Amit,Jean-Marc Raymond,Marc Deyell,Chris Lane,Frederic Sacher,Christian de Chillou,Vikas Kuriachan,Amir AbdelWahab,Isabelle Nault,Katia Dyrda,Stephen Wilton,Umjeet Jolly,Arvindh Kanagasundram,George A Wells,
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2024-11-16 , DOI: 10.1056/nejmoa2409501 John L Sapp,Anthony S L Tang,Ratika Parkash,William G Stevenson,Jeff S Healey,Lorne J Gula,Girish M Nair,Vidal Essebag,Lena Rivard,Jean-Francois Roux,Pablo B Nery,Jean-Francois Sarrazin,Guy Amit,Jean-Marc Raymond,Marc Deyell,Chris Lane,Frederic Sacher,Christian de Chillou,Vikas Kuriachan,Amir AbdelWahab,Isabelle Nault,Katia Dyrda,Stephen Wilton,Umjeet Jolly,Arvindh Kanagasundram,George A Wells,
BACKGROUND
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.
METHODS
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.
RESULTS
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%).
CONCLUSIONS
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.).
中文翻译:
导管消融术或抗心律失常药物治疗室性心动过速。
背景 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,通常使用导管消融术。对于室性心动过速患者,导管消融术作为一线治疗是否比抗心律失常药物更有效尚不确定。方法 在一项国际试验中,我们以 1:1 的比例随机分配既往心肌梗死和有临床意义的室性心动过速患者 (定义为室性心动过速危象,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)接受抗心律失常药物治疗或接受导管消融术。所有患者都有 ICD。随机分组后 14 天内进行导管消融术;根据预先设定的标准,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或随机分组后超过 14 天、室性心动过速危象、适当的 ICD 休克或经医疗干预治疗的持续性室性心动过速的复合死亡。结果 共 416 例患者接受了中位随访 4.3 年。203 名接受导管消融术的患者中有 103 名 (50.7%) 发生主要终点事件,213 名接受药物治疗的患者中有 129 名 (60.6%) 发生主要终点事件(风险比,0.75;95% 置信区间,0.58 至 0.97;P = 0.03)。导管消融组患者中,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 (11.3%) 的非致死性不良事件。 在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 (0.5%) 死于肺毒性作用,46 例患者 (21.6%) 死于非致命性不良事件。结论 在缺血性心肌病合并室性心动过速患者中,与抗心律失常药物治疗相比,导管消融术的初始策略导致复合原发性终点事件的风险更低。(由加拿大卫生研究院和其他机构资助;VANISH2 ClinicalTrials.gov 号,NCT02830360.)。
更新日期:2024-11-16
中文翻译:
导管消融术或抗心律失常药物治疗室性心动过速。
背景 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,通常使用导管消融术。对于室性心动过速患者,导管消融术作为一线治疗是否比抗心律失常药物更有效尚不确定。方法 在一项国际试验中,我们以 1:1 的比例随机分配既往心肌梗死和有临床意义的室性心动过速患者 (定义为室性心动过速危象,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)接受抗心律失常药物治疗或接受导管消融术。所有患者都有 ICD。随机分组后 14 天内进行导管消融术;根据预先设定的标准,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或随机分组后超过 14 天、室性心动过速危象、适当的 ICD 休克或经医疗干预治疗的持续性室性心动过速的复合死亡。结果 共 416 例患者接受了中位随访 4.3 年。203 名接受导管消融术的患者中有 103 名 (50.7%) 发生主要终点事件,213 名接受药物治疗的患者中有 129 名 (60.6%) 发生主要终点事件(风险比,0.75;95% 置信区间,0.58 至 0.97;P = 0.03)。导管消融组患者中,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 (11.3%) 的非致死性不良事件。 在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 (0.5%) 死于肺毒性作用,46 例患者 (21.6%) 死于非致命性不良事件。结论 在缺血性心肌病合并室性心动过速患者中,与抗心律失常药物治疗相比,导管消融术的初始策略导致复合原发性终点事件的风险更低。(由加拿大卫生研究院和其他机构资助;VANISH2 ClinicalTrials.gov 号,NCT02830360.)。