Pekka Raatikainen, Heikki Mäkynen, Juha Hartikainen, Mats Jensen Urstad, Leena Konkola, Niels C F Sandgaard, Peter Lukac, Arne Johannessen, Anders Jönsson, Peter Schuster, Carina Blomström-Lundqvist, Jussi Kuutti, Piia Lavikainen, Hannu Parikka
{"title":"早期底物导管消融与抗心律失常药物治疗既往心肌梗死患者室性心动过速:MANTRA-VT随机试验","authors":"Pekka Raatikainen, Heikki Mäkynen, Juha Hartikainen, Mats Jensen Urstad, Leena Konkola, Niels C F Sandgaard, Peter Lukac, Arne Johannessen, Anders Jönsson, Peter Schuster, Carina Blomström-Lundqvist, Jussi Kuutti, Piia Lavikainen, Hannu Parikka","doi":"10.1093/europace/euaf236","DOIUrl":null,"url":null,"abstract":"<p><strong>Aims: </strong>Ventricular tachyarrhythmias (VT/VF) are common among patients with prior myocardial infarction (MI). MANTRA-VT trial was designed to compare the efficacy and safety of early substrate-based radiofrequency catheter ablation (RFCA) to antiarrhythmic drug (AAD) therapy for ventricular tachyarrhythmias.</p><p><strong>Methods and results: </strong>We randomly assigned 58 AAD naïve post MI patients with implantable cardioverter defibrillator (ICD) and at least one documented VT/VF episode after the device implantation to an initial treatment strategy of substrate-based RFCA or AAD therapy. The primary endpoint was cumulative number of ventricular tachyarrhythmias (VT/VF burden) at 12 months. The secondary endpoints included all-cause mortality, hospitalization, adverse events, and VT/VF burden at 24 months. Analyses were performed on an intention-to-treat basis. The median number of VT/VF episodes at 12 months was zero in both the RFCA (range 0-3) and the AAD group (range 0-23) (P = 0.454), whereas the rate of appropriate ICD shocks was 7% and 30% in the RFCA and the AAD groups (P = 0.026), respectively. During the extended follow-up, 82% of the patients in the RFCA group and 63% in the AAD group had no ICD therapies (P = 0.012). There was no significant difference between the groups in total mortality (HR 1.02, 95% CI 0.20-5.11, P = 0.86) and hospitalization (HR 1.35, 95% CI 0.36-5.09. P = 0.66) at 24 months. Therapy-related adverse events occurred in 3.6% and 16.7% of the patients in the RFCA and the AAD groups (P = 0.10), respectively.</p><p><strong>Conclusion: </strong>Early substrate-based RFCA was associated with reduced risk of ICD therapies, but with no meaningful difference in VT/VF burden, mortality, hospitalization, and adverse events.</p>","PeriodicalId":11981,"journal":{"name":"Europace","volume":"27 10","pages":""},"PeriodicalIF":7.4000,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12527351/pdf/","citationCount":"0","resultStr":"{\"title\":\"Early substrate-based catheter ablation vs. antiarrhythmic drug therapy for ventricular tachyarrhythmias among patients with prior myocardial infarction: the MANTRA-VT randomized trial.\",\"authors\":\"Pekka Raatikainen, Heikki Mäkynen, Juha Hartikainen, Mats Jensen Urstad, Leena Konkola, Niels C F Sandgaard, Peter Lukac, Arne Johannessen, Anders Jönsson, Peter Schuster, Carina Blomström-Lundqvist, Jussi Kuutti, Piia Lavikainen, Hannu Parikka\",\"doi\":\"10.1093/europace/euaf236\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aims: </strong>Ventricular tachyarrhythmias (VT/VF) are common among patients with prior myocardial infarction (MI). MANTRA-VT trial was designed to compare the efficacy and safety of early substrate-based radiofrequency catheter ablation (RFCA) to antiarrhythmic drug (AAD) therapy for ventricular tachyarrhythmias.</p><p><strong>Methods and results: </strong>We randomly assigned 58 AAD naïve post MI patients with implantable cardioverter defibrillator (ICD) and at least one documented VT/VF episode after the device implantation to an initial treatment strategy of substrate-based RFCA or AAD therapy. The primary endpoint was cumulative number of ventricular tachyarrhythmias (VT/VF burden) at 12 months. The secondary endpoints included all-cause mortality, hospitalization, adverse events, and VT/VF burden at 24 months. Analyses were performed on an intention-to-treat basis. The median number of VT/VF episodes at 12 months was zero in both the RFCA (range 0-3) and the AAD group (range 0-23) (P = 0.454), whereas the rate of appropriate ICD shocks was 7% and 30% in the RFCA and the AAD groups (P = 0.026), respectively. During the extended follow-up, 82% of the patients in the RFCA group and 63% in the AAD group had no ICD therapies (P = 0.012). There was no significant difference between the groups in total mortality (HR 1.02, 95% CI 0.20-5.11, P = 0.86) and hospitalization (HR 1.35, 95% CI 0.36-5.09. P = 0.66) at 24 months. Therapy-related adverse events occurred in 3.6% and 16.7% of the patients in the RFCA and the AAD groups (P = 0.10), respectively.</p><p><strong>Conclusion: </strong>Early substrate-based RFCA was associated with reduced risk of ICD therapies, but with no meaningful difference in VT/VF burden, mortality, hospitalization, and adverse events.</p>\",\"PeriodicalId\":11981,\"journal\":{\"name\":\"Europace\",\"volume\":\"27 10\",\"pages\":\"\"},\"PeriodicalIF\":7.4000,\"publicationDate\":\"2025-10-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12527351/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Europace\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/europace/euaf236\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Europace","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/europace/euaf236","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
目的:室性心动过速(VT/VF)在既往心肌梗死(MI)患者中很常见。MANTRA-VT试验旨在比较早期底物射频导管消融(RFCA)与抗心律失常药物(AAD)治疗室性心动过速的疗效和安全性。方法和结果:我们随机分配58例AAD naïve心肌梗死后患者,植入ICD后至少有一次记录的VT/VF发作,采用基于基质的RFCA或AAD治疗的初始治疗策略。主要终点是12个月室性心动过速的累积次数(VT/VF负担)。次要终点包括24个月时的全因死亡率、住院率、不良事件和VT/VF负担。在意向治疗基础上进行分析。RFCA组(范围0-3)和AAD组(范围0-23)12个月时VT/VF发作的中位数为零(P = 0.454),而RFCA组和AAD组适当的ICD电击率分别为7%和30% (P = 0.026)。在延长随访期间,82%的RFCA组患者和63%的AAD组患者未接受ICD治疗(P = 0.012)。两组总死亡率(HR 1.02, 95% CI 0.20-5.11, P = 0.86)和住院率(HR 1.35, 95% CI 0.36-5.09)无显著差异。P = 0.66)。RFCA组和AAD组治疗相关不良事件发生率分别为3.6%和16.7% (P = 0.10)。结论:早期基于底物的RFCA与ICD治疗风险降低相关,但在VT/VF负担、死亡率、住院率和不良事件方面无显著差异。
Early substrate-based catheter ablation vs. antiarrhythmic drug therapy for ventricular tachyarrhythmias among patients with prior myocardial infarction: the MANTRA-VT randomized trial.
Aims: Ventricular tachyarrhythmias (VT/VF) are common among patients with prior myocardial infarction (MI). MANTRA-VT trial was designed to compare the efficacy and safety of early substrate-based radiofrequency catheter ablation (RFCA) to antiarrhythmic drug (AAD) therapy for ventricular tachyarrhythmias.
Methods and results: We randomly assigned 58 AAD naïve post MI patients with implantable cardioverter defibrillator (ICD) and at least one documented VT/VF episode after the device implantation to an initial treatment strategy of substrate-based RFCA or AAD therapy. The primary endpoint was cumulative number of ventricular tachyarrhythmias (VT/VF burden) at 12 months. The secondary endpoints included all-cause mortality, hospitalization, adverse events, and VT/VF burden at 24 months. Analyses were performed on an intention-to-treat basis. The median number of VT/VF episodes at 12 months was zero in both the RFCA (range 0-3) and the AAD group (range 0-23) (P = 0.454), whereas the rate of appropriate ICD shocks was 7% and 30% in the RFCA and the AAD groups (P = 0.026), respectively. During the extended follow-up, 82% of the patients in the RFCA group and 63% in the AAD group had no ICD therapies (P = 0.012). There was no significant difference between the groups in total mortality (HR 1.02, 95% CI 0.20-5.11, P = 0.86) and hospitalization (HR 1.35, 95% CI 0.36-5.09. P = 0.66) at 24 months. Therapy-related adverse events occurred in 3.6% and 16.7% of the patients in the RFCA and the AAD groups (P = 0.10), respectively.
Conclusion: Early substrate-based RFCA was associated with reduced risk of ICD therapies, but with no meaningful difference in VT/VF burden, mortality, hospitalization, and adverse events.
期刊介绍:
EP - Europace - European Journal of Pacing, Arrhythmias and Cardiac Electrophysiology of the European Heart Rhythm Association of the European Society of Cardiology. The journal aims to provide an avenue of communication of top quality European and international original scientific work and reviews in the fields of Arrhythmias, Pacing and Cellular Electrophysiology. The Journal offers the reader a collection of contemporary original peer-reviewed papers, invited papers and editorial comments together with book reviews and correspondence.