Royal Papworth Hospital, Cambridge, UK.
Eur J Cardiothorac Surg. 2022 Oct 4;62(5). doi: 10.1093/ejcts/ezac181.
The Amaze trial showed that adding atrial fibrillation (AF) surgery to cardiac operations increased return to sinus rhythm (SR) without impact on quality of life or survival at 2 years. We report outcomes to 5 years.
In a multicentre, phase III, pragmatic, double-blind, randomized controlled superiority trial, cardiac surgery patients with >3 months of AF were randomized 1:1 to adjunct AF surgery or control. Primary outcomes of 1-year SR restoration and 2-year quality-adjusted survival were already reported. This study reports on rhythm, survival, quality-adjusted survival, stroke, medication and safety to 5 years.
Between 2009 and 2014, 352 patients were randomized. By 5 years 79 died, 58 withdrew, 34 were lost to follow-up and the remaining 182 provided data. AF surgery significantly increased the odds of remaining in SR at 5 years {odds ratio = 2.98 [95% confidence interval (CI) 1.23, 7.17], P = 0.015}. There was a non-significant decrease in stroke incidence [odds ratio = 0.605 (95% CI 0.284, 1.287), P = 0.19], but no improved survival [5-year survival: AF surgery 77.3% (95% CI 71.1%, 83.5%), controls 77.8% (95% CI 71.7%, 84.0%), P = 0.85]. Quality-adjusted survival difference was negligible (-0.03; 95% CI -0.33, 0.27, P = 0.85). The composite of survival free of stroke and AF was better in the AF surgery group [odds ratio = 2.34 (95% CI 1.03, 5.31)]. There were no other differences.
Adjunct AF surgery confers a higher rate of SR to 5 years and a better composite outcome of survival free of stroke and AF but has no impact on overall or quality-adjusted survival or other clinical outcomes.
ISRCTN82731440.
Amaze 试验表明，在心脏手术中加入房颤（AF）手术可增加窦性心律（SR）的恢复率，而对 2 年的生活质量或生存率没有影响。我们报告了 5 年的结果。
在一项多中心、三期、实用、双盲、随机对照优效性试验中，将有 >3 个月房颤史的心脏手术患者以 1:1 的比例随机分为辅助房颤手术组或对照组。1 年 SR 恢复率和 2 年质量调整生存率的主要结果已报告。本研究报告了 5 年时的节律、生存、质量调整生存、卒中和药物以及安全性。
2009 年至 2014 年期间，共纳入 352 例患者。5 年后，79 例死亡，58 例退出，34 例失访，其余 182 例提供了数据。房颤手术组 5 年时 SR 持续的可能性显著增加[优势比=2.98（95%可信区间 1.23 至 7.17），P=0.015]。卒中发生率虽有降低趋势[比值比=0.605（95%可信区间 0.284 至 1.287），P=0.19]，但生存率无改善[5 年生存率：房颤手术组为 77.3%（95%可信区间 71.1%至 83.5%），对照组为 77.8%（95%可信区间 71.7%至 84.0%），P=0.85]。质量调整生存差异可忽略不计（-0.03；95%可信区间-0.33 至 0.27，P=0.85）。房颤手术组的生存和无卒中的复合结果更好[比值比=2.34（95%可信区间 1.03 至 5.31）]。其他方面无差异。
辅助房颤手术可使 5 年时的 SR 率更高，并使生存和无卒中的复合结果更好，但对总生存率或质量调整生存率或其他临床结果无影响。
ISRCTN82731440。
