University of British Columbia, Vancouver, British Columbia, Canada.
York Health Economics Consortium, York, United Kingdom.
Can J Cardiol. 2024 Apr;40(4):576-584. doi: 10.1016/j.cjca.2023.11.019. Epub 2023 Nov 23.
The EARLY-AF (NCT02825979), STOP AF First (NCT03118518), and Cryo-FIRST (NCT01803438) randomised controlled trials (RCTs) demonstrated that cryoballoon pulmonary vein isolation reduces atrial fibrillation (AF) recurrence compared with antiarrhythmic drugs (AADs) in patients with symptomatic paroxysmal atrial fibrillation (PAF). The present study developed a cost-effectiveness model (CEM) of first-line cryoablation compared with first-line AADs for PAF, from the Canadian health care payer's perspective.
Data from the 3 RCTs were analysed to estimate key CEM parameters. The model structure used a decision tree for the first 12 months and a Markov model with a 3-month cycle length for the remaining lifetime time horizon. Costs were set at 2023 Canadian dollars, health benefits were expressed as quality-adjusted life years (QALYs), and both were discounted 3% annually. Probabilistic sensitivity analysis (PSA) considered parameter uncertainty.
The statistical analysis estimated that first-line cryoablation generates a 47% reduction (P < 0.001) in the rate of AF recurrence, a 73% reduction in the rate of subsequent ablation (P < 0.001), and a 4.3% (P = 0.025) increase in health-related quality of life, compared with first-line AADs. The PSA indicates that an individual treated with first-line cryoablation accrues less costs (-$3,862) and more QALYs (0.19) compared with first-line AADs. Cryoablation is cost-saving in 98.4% of PSA iterations and has a 99.9% probability of being cost-effective at a cost-effectiveness threshold of $50,000 per QALY gained. Cost-effectiveness results were robust to changes in key model parameters.
First-line cryoballoon ablation is cost-effective when compared with AADs for patients with symptomatic PAF.
EARLY-AF(NCT02825979)、STOP AF First(NCT03118518)和 Cryo-FIRST(NCT01803438)这三项随机对照试验(RCT)表明,与抗心律失常药物(AAD)相比,冷冻球囊肺静脉隔离可降低有症状阵发性心房颤动(PAF)患者的房颤(AF)复发率。本研究从加拿大医疗保健支付者的角度,针对有症状 PAF 患者的一线冷冻消融术与一线 AAD 治疗方法,开发了一种成本效益模型(CEM)。
分析这 3 项 RCT 的数据,以估计关键 CEM 参数。模型结构在前 12 个月采用决策树,在剩余的终生时间范围内采用 3 个月周期长度的 Markov 模型。成本设定为 2023 年加拿大元,健康效益表示为质量调整生命年(QALY),两者均按 3%的年率贴现。概率敏感性分析(PSA)考虑了参数不确定性。
统计分析估计,与一线 AAD 相比,一线冷冻消融术可使 AF 复发率降低 47%(P < 0.001),后续消融术的复发率降低 73%(P < 0.001),并使健康相关生活质量提高 4.3%(P=0.025)。PSA 表明,与一线 AAD 相比,接受一线冷冻消融术治疗的个体成本降低(-3862 美元),健康相关生活质量提高(0.19)。在 PSA 的 98.4%迭代中,冷冻消融术具有成本节约效果,在成本效益阈值为每获得一个质量调整生命年(QALY)50000 美元时,其具有 99.9%的概率具有成本效益。成本效益结果对模型关键参数的变化具有稳健性。
与 AAD 相比,对于有症状 PAF 患者,一线冷冻球囊消融术具有成本效益。