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Multicenter Study
. 2024 Nov 26;332(20):1723-1731.
doi: 10.1001/jama.2024.16531.

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

Claudio Schuger  1 , Boyoung Joung  2 , Kenji Ando  3 , Lluís Mont  4 , Pier D Lambiase  5 , Gilles E O'Hara  6 , John M Jennings  7 , Derek Yung  8 , Giuseppe Boriani  9 , Jonathan P Piccini  10 , Nicholas Wold  11 , Kenneth M Stein  11 , James P Daubert  10 ; APPRAISE ATP Investigators
Collaborators, Affiliations
Multicenter Study

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

Claudio Schuger et al. JAMA. .

Erratum in

  • Error in Table.
    [No authors listed] [No authors listed] JAMA. 2025 Mar 11;333(10):911. doi: 10.1001/jama.2025.1887. JAMA. 2025. PMID: 39960740 Free PMC article. No abstract available.

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Ando reported receiving personal fees from Medtronic Japan, BIOTRONIK Japan, Japan LifeLine, and Abbott Medical Japan outside the submitted work. Dr Mont reported receiving personal fees from Abbott, Boston Scientific, Medtronic, and Biosense Webster and being a shareholder in Galgo Medical and Corify outside the submitted work. Dr Yung reported receiving speakers honoraria from Pfizer and Servier. Dr Boriani reported receiving personal fees from Boston Scientific, Bayer, Daiichi-Sankyo, Sanofi, and Janssen outside the submitted work. Dr Piccini reported receiving grants from Abbott, personal fees from Boston Scientific, personal fees from Medtronic, grants from Philips, and personal fees from UptoDate outside the submitted work. Dr Daubert reported receiving personal fees from Biosense, Cordis, Farapulse, Medtronic, Microport, Phillips, Rocket Pharma, Synaptic Sensation, Syneos, Acutus, and Affera and having patents with McGraw Hill, Wiley, and Springboard with royalties paid for a book. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Recruitment, Randomization, and Follow-Up in the APPRAISE ATP Trial
aThe number of patients approached for enrollment was not recorded. Ventricular tachycardia (VT) zone programming (heart rate, 200-250/min) for ATP shock group: 2 s detection, 12 s therapy delay, ~3 s antitachycardia pacing (ATP), 10 s charge time, deliver shock if necessary. VT zone programming (heart rate, 200-250/min) for shock only group: 2 s detection, 12 s therapy delay, 10 s charge time, deliver shock. Because the trial was conducted to determine whether ATP prolongs the time to first all-cause shock, patient deaths and withdrawals with or without a shock episode are enumerated for both groups. Reasons for withdrawal are detailed in eTable 6 in Supplement 2.
Figure 2.
Figure 2.. Time to First All-Cause Shock Primary End Point Kaplan-Meier Curve
First shock of any kind is shown over the follow-up period. The median (IQR) follow-up time was 38.0 (26.9-52.4) months for the antitachycardia pacing (ATP) plus shock group and 41.0 (27.8-52.9) months for the shock only group. Cox modeling was used to evaluate the impact of randomization groups. The hazard ratio was 0.72 (95.9% CI, 0.57-0.92); P = .005.
Figure 3.
Figure 3.. Primary End Point Across Prespecified Clinical and Demographic Groups
aRemote monitoring through the LATITUDE monitoring system. Forest plot depicts the hazard ratios, 95% CIs, and interaction P values for prespecified subgroup interactions with the primary end point. EF, ejection fraction; MI, myocardial infarction; NYHA, New York Heart Association.
Figure 4.
Figure 4.. Time to First Event Secondary End Point Curves
Differences in appropriate shocks, inappropriate shocks, all-cause death, and the composite of time to first all-cause shocks and all-cause death are depicted between randomization groups. A, Hazard ratio, 0.73 (95% CI, 0.56-0.95). B, Hazard ratio, 0.65 (95% CI, 0.44-0.97). C, Hazard ratio, 1.15 (95% CI, 0.94-1.41). D, Hazard ratio, 0.92 (95% CI, 0.78-1.07). ATP indicates antitachycardia pacing.
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