Health technology assessment (Winchester, England) · 2018
Amaze: a double-blind, multicentre randomised controlled trial to investigate the clinical effectiveness and cost-effectiveness of adding an ablation device-based maze procedure as an adjunct to routine cardiac surgery for patients with pre-existing atrial fibrillation.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАPragmatic Clinical TrialНазвание и аннотация: Перевод в очереди
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Sharples Linda, Everett Colin, Singh Jeshika, Mills Christine, Spyt Tom, Abu-Omar Yasir, Fynn Simon, Thorpe Benjamin, Stoneman Victoria, Goddard Hester, Fox-Rushby Julia, Nashef Samer
Аннотация
BACKGROUND: Atrial fibrillation (AF) can be treated using a maze procedure during planned cardiac surgery, but the effect on clinical patient outcomes, and the cost-effectiveness compared with surgery alone, are uncertain.
OBJECTIVES: To determine whether or not the maze procedure is safe, improves clinical and patient outcomes and is cost-effective for the NHS in patients with AF.
DESIGN: Multicentre, Phase III, pragmatic, double-blind, parallel-arm randomised controlled trial. Patients were randomised on a 1 : 1 basis using random permuted blocks, stratified for surgeon and planned procedure.
SETTING: Eleven acute NHS specialist cardiac surgical centres.
PARTICIPANTS: Patients aged ≥ 18 years, scheduled for elective or in-house urgent cardiac surgery, with a documented history (> 3 months) of AF.
INTERVENTIONS: Routine cardiac surgery with or without an adjunct maze procedure administered by an AF ablation device.
MAIN OUTCOME MEASURES: The primary outcomes were return to sinus rhythm (SR) at 12 months and quality-adjusted life-years (QALYs) over 2 years after randomisation. Secondary outcomes included return to SR at 2 years, overall and stroke-free survival, drug use, quality of life (QoL), cost-effectiveness and safety.
RESULTS: Between 25 February 2009 and 6 March 2014, 352 patients were randomised to the control (n = 176) or experimental (n = 176) arms. The odds ratio (OR) for return to SR at 12 months was 2.06 [95% confidence interval (CI) 1.20 to 3.54; p = 0.0091]. The mean difference (95% CI) in QALYs at 2 years between the two trial arms (maze/control) was -0.025 (95% CI 0.129 to 0.078; p = 0.6319). The OR for SR at 2 years was 3.24 (95% CI 1.76 to 5.96). The number of patients requiring anticoagulant drug use was significantly lower in the maze arm from 6 months after the procedure. There were no significant differences between the two arms in operative or overall survival, stroke-free survival, need for cardioversion or permanent pacemaker implants, New York Heart Association Functional Classification (for heart failure), EuroQol-5 Dimensions, three-level version score and Short Form questionnaire-36 items score at any time point. Sixty per cent of patients in each trial arm had a serious adverse event (p = 1.000); most events were mild, but 71 patients (42.5%) in the maze arm and 84 patients (45.5%) in the control arm had moderately severe events; 31 patients (18.6%) in the maze arm and 38 patients (20.5%) in the control arm had severe events. The mean additional cost of the maze procedure was £3533 (95% CI £1321 to £5746); the mean difference in QALYs was -0.022 (95% CI -0.1231 to 0.0791). The maze procedure was not cost-effective at £30,000 per QALY over 2 years in any analysis. In a small substudy, the active left atrial ejection fraction was smaller than that of the control patients (mean difference of -8.03, 95% CI -12.43 to -3.62), but within the predefined clinically equivalent range.
LIMITATIONS: Low recruitment, early release of trial summaries and intermittent resource-use collection may have introduced bias and imprecise estimates.
CONCLUSIONS: Ablation can be practised safely in routine NHS cardiac surgical settings and increases return to SR rates, but not survival or QoL up to 2 years after surgery. Lower anticoagulant drug use and recovery of left atrial function support anticoagulant drug withdrawal provided that good atrial function is confirmed.
FURTHER WORK: Continued follow-up and long-term clinical effectiveness and cost-effectiveness analysis. Comparison of ablation methods.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN82731440.
FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 19. See the NIHR Journals Library website for further project information.
OBJECTIVES: To determine whether or not the maze procedure is safe, improves clinical and patient outcomes and is cost-effective for the NHS in patients with AF.
DESIGN: Multicentre, Phase III, pragmatic, double-blind, parallel-arm randomised controlled trial. Patients were randomised on a 1 : 1 basis using random permuted blocks, stratified for surgeon and planned procedure.
SETTING: Eleven acute NHS specialist cardiac surgical centres.
PARTICIPANTS: Patients aged ≥ 18 years, scheduled for elective or in-house urgent cardiac surgery, with a documented history (> 3 months) of AF.
INTERVENTIONS: Routine cardiac surgery with or without an adjunct maze procedure administered by an AF ablation device.
MAIN OUTCOME MEASURES: The primary outcomes were return to sinus rhythm (SR) at 12 months and quality-adjusted life-years (QALYs) over 2 years after randomisation. Secondary outcomes included return to SR at 2 years, overall and stroke-free survival, drug use, quality of life (QoL), cost-effectiveness and safety.
RESULTS: Between 25 February 2009 and 6 March 2014, 352 patients were randomised to the control (n = 176) or experimental (n = 176) arms. The odds ratio (OR) for return to SR at 12 months was 2.06 [95% confidence interval (CI) 1.20 to 3.54; p = 0.0091]. The mean difference (95% CI) in QALYs at 2 years between the two trial arms (maze/control) was -0.025 (95% CI 0.129 to 0.078; p = 0.6319). The OR for SR at 2 years was 3.24 (95% CI 1.76 to 5.96). The number of patients requiring anticoagulant drug use was significantly lower in the maze arm from 6 months after the procedure. There were no significant differences between the two arms in operative or overall survival, stroke-free survival, need for cardioversion or permanent pacemaker implants, New York Heart Association Functional Classification (for heart failure), EuroQol-5 Dimensions, three-level version score and Short Form questionnaire-36 items score at any time point. Sixty per cent of patients in each trial arm had a serious adverse event (p = 1.000); most events were mild, but 71 patients (42.5%) in the maze arm and 84 patients (45.5%) in the control arm had moderately severe events; 31 patients (18.6%) in the maze arm and 38 patients (20.5%) in the control arm had severe events. The mean additional cost of the maze procedure was £3533 (95% CI £1321 to £5746); the mean difference in QALYs was -0.022 (95% CI -0.1231 to 0.0791). The maze procedure was not cost-effective at £30,000 per QALY over 2 years in any analysis. In a small substudy, the active left atrial ejection fraction was smaller than that of the control patients (mean difference of -8.03, 95% CI -12.43 to -3.62), but within the predefined clinically equivalent range.
LIMITATIONS: Low recruitment, early release of trial summaries and intermittent resource-use collection may have introduced bias and imprecise estimates.
CONCLUSIONS: Ablation can be practised safely in routine NHS cardiac surgical settings and increases return to SR rates, but not survival or QoL up to 2 years after surgery. Lower anticoagulant drug use and recovery of left atrial function support anticoagulant drug withdrawal provided that good atrial function is confirmed.
FURTHER WORK: Continued follow-up and long-term clinical effectiveness and cost-effectiveness analysis. Comparison of ablation methods.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN82731440.
FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 19. See the NIHR Journals Library website for further project information.
Предметные рубрики MeSH
Ablation TechniquesAgedAged, 80 and overAnticoagulantsAtrial FibrillationCardiac Surgical ProceduresCost-Benefit AnalysisDouble-Blind MethodFemaleHumansMaleMiddle AgedModels, EconometricQuality of LifeQuality-Adjusted Life YearsSeverity of Illness IndexState MedicineTechnology Assessment, BiomedicalUnited Kingdom