Assessment of Antitachycardia Pacing in Primary Prevention Patients: The APPRAISE ATP Randomized Clinical Trial.

Autor:	Schuger C; Clinical Cardiac Research Center, University of Rochester, Rochester, New York., Joung B; Yonsei University, Severance Hospital, Seoul, South Korea., Ando K; Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan., Mont L; Universitat de Barcelona, Hospital Clinic, Barcelona, Spain., Lambiase PD; Bart's Heart Centre, St Bartholomew's Hospital, London, United Kingdom., O'Hara GE; Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Quebec, Canada., Jennings JM; Heart Center Research, Huntsville, Alabama., Yung D; Scarborough Health Network, Scarborough, Ontario, Canada., Boriani G; Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy., Piccini JP; Duke Clinical Research Institute and Division of Cardiology, Duke University, Durham, North Carolina., Wold N; Boston Scientific Corporation, Saint Paul, Minnesota., Stein KM; Boston Scientific Corporation, Saint Paul, Minnesota., Daubert JP; Duke Clinical Research Institute and Division of Cardiology, Duke University, Durham, North Carolina.
Jazyk:	angličtina
Zdroj:	JAMA [JAMA] 2024 Oct 03. Date of Electronic Publication: 2024 Oct 03.
DOI:	10.1001/jama.2024.16531
Abstrakt:	Importance: The emergence of novel programming guidelines that reduce premature and inappropriate therapies along with the availability of new implantable cardioverter-defibrillator (ICD) technologies lacking traditional endocardial antitachycardia pacing (ATP) capabilities requires the reevaluation of ATP as a first strategy in terminating fast ventricular tachycardias (VTs) in primary prevention ICD recipients. Objective: To assess the role of ATP in terminating fast VTs in primary prevention ICD recipients with contemporary programming. Design, Setting, and Participants: This global, prospective, double-blind, randomized clinical trial had an equivalence design with a relative margin of 35%. Superiority tests were performed at interim analyses and the final analysis if equivalence was not proven. Patients were enrolled between September 2016 and April 2021 at 134 sites in 8 countries, with the last date of follow-up on July 6, 2023. Patients were required to have an indication for a primary prevention ICD, including left ventricular ejection fraction less than or equal to 35%. Interventions: Patients were randomized in a 1:1 ratio to receive ATP plus shock vs shock only. Main Outcomes and Measures: The primary end point was time to first all-cause shock. Secondary end points included time to first appropriate shock, time to first inappropriate shock, all-cause mortality, and the composite of time to first all-cause shock plus all-cause mortality. Results: A total of 2595 patients were randomized (mean age, 63.9 years; 22.4% were females). At a mean follow-up of 38 months, first all-cause shock occurred in 129 participants in the ATP plus shock group and 178 participants in the shock only group. The hazard ratio (HR) for the primary end point was 0.72 (95.9% CI, 0.57-0.92), with P = .005 for superiority of the ATP plus shock group over the shock only group. During follow-up in an intention-to-treat analysis, the total shock burden per 100 patient-years was not statistically different, at 12.3 and 14.9, respectively (P = .70). Conclusions and Relevance: The use of a single burst of ATP prior to shock in primary prevention ICD recipients with modern ICD detection programming prolonged the time to first all-cause ICD shock. Trial Registration: ClinicalTrials.gov Identifier: NCT02923726.
Databáze:	MEDLINE
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