Abstract：
Use of d,l-sotalol for rhythm control in patients with atrial fibrillation (AF) has raised safety concerns. Previous randomized studies are few and not designed for mortality outcome.
The purpose of this study was to compare the incidences of mortality and ventricular arrhythmias in AF patients treated with d,l-sotalol for rhythm control vs matched control patients treated with cardioselective beta-blockers.
This population-based cohort study included AF patients from the Swedish National Patient Registry (2006-2017) who underwent rhythm control after a second cardioversion. Incidence rates (IRs) and adjusted hazard ratios (aHRs) for mortality and a composite endpoint of cardiac arrest/death and ventricular arrhythmias were calculated for the overall cohort and a 1:1 propensity score matched cohort of d,l-sotalol vs beta-blocker treatment.
Among patient treated with d,l-sotalol (n = 4987) and beta-blocker (n = 27,078) (mean follow-up 458 days), all-cause mortality was lower in patients treated with d,l-sotalol: IR 1.21; 95% confidence interval 0.95-1.52 vs 2.42 (2.26-2.60) deaths per 100 patient-years; aHR 0.66 (0.52-0.83). The difference in mortality persisted in the propensity score matched comparison (n = 4953 in each group): aHR 0.63 (0.48-0.86). No differences were observed in the composite outcome: IR in propensity cohorts 2.13 (1.78-2.52) vs 2.07 (1.73-2.53) events per 100 years; aHR 1.01 (0.78-1.29).
There was no excess mortality with d,l-sotalol compared with cardioselective beta-blockers in patients undergoing rhythm control treatment for AF after a second cardioversion. Our results indicate that the risk associated with d,l-sotalol treatment for AF can be mitigated by careful patient selection and strict adherence to follow-up protocols.
The purpose of this study was to compare the incidences of mortality and ventricular arrhythmias in AF patients treated with d,l-sotalol for rhythm control vs matched control patients treated with cardioselective beta-blockers.
This population-based cohort study included AF patients from the Swedish National Patient Registry (2006-2017) who underwent rhythm control after a second cardioversion. Incidence rates (IRs) and adjusted hazard ratios (aHRs) for mortality and a composite endpoint of cardiac arrest/death and ventricular arrhythmias were calculated for the overall cohort and a 1:1 propensity score matched cohort of d,l-sotalol vs beta-blocker treatment.
Among patient treated with d,l-sotalol (n = 4987) and beta-blocker (n = 27,078) (mean follow-up 458 days), all-cause mortality was lower in patients treated with d,l-sotalol: IR 1.21; 95% confidence interval 0.95-1.52 vs 2.42 (2.26-2.60) deaths per 100 patient-years; aHR 0.66 (0.52-0.83). The difference in mortality persisted in the propensity score matched comparison (n = 4953 in each group): aHR 0.63 (0.48-0.86). No differences were observed in the composite outcome: IR in propensity cohorts 2.13 (1.78-2.52) vs 2.07 (1.73-2.53) events per 100 years; aHR 1.01 (0.78-1.29).
There was no excess mortality with d,l-sotalol compared with cardioselective beta-blockers in patients undergoing rhythm control treatment for AF after a second cardioversion. Our results indicate that the risk associated with d,l-sotalol treatment for AF can be mitigated by careful patient selection and strict adherence to follow-up protocols.
摘要：
背景：使用d，左索他洛尔用于心房颤动（AF）患者的节律控制引起了安全性问题。以前的随机研究很少，也不是针对死亡率结果而设计的。
目的：比较接受d治疗的房颤患者的死亡率和室性心律失常的发生率，左索他洛尔用于心律控制与心脏选择性β受体阻滞剂治疗的匹配对照患者。
方法：这项基于人群的队列研究包括来自瑞典国家患者登记处（2006年至2017年）的房颤患者，这些患者在第二次心脏复律后接受了节律控制。计算总体队列和1：1倾向评分匹配的d队列的死亡率发生率（IR）和调整后的风险比（aHR），以及心脏骤停/死亡和室性心律失常的复合终点。l-索他洛尔vs.β受体阻滞剂治疗。
结果：在d，左索他洛尔（n=4,987）和β受体阻滞剂治疗（n=27,078）患者，平均随访458天，全因死亡率较低，左索他洛尔治疗的患者：IR1.21（95％置信区间：0.95-1.52）与2.42（2.26-2.60）例死亡，每100例患者年，HR0.66(0.52-0.83)。死亡率的差异在倾向匹配比较中仍然存在（每组n=4,953），HR0.63(0.48-0.86)。在复合结局中没有观察到差异，倾向队列中的IR：2.13（1.78-2.52）与每100年发生2.07（1.73-2.53）个事件，aHR1.01(0.78-1.29)。
结论：没有额外的死亡率，左索他洛尔与心脏选择性β受体阻滞剂在第二次心脏复律后使用心律控制策略的房颤患者中的比较。我们的结果表明，与D相关的风险，通过仔细选择患者并严格遵守随访方案，可以减轻左索他洛尔对AF的治疗。
目的：比较接受d治疗的房颤患者的死亡率和室性心律失常的发生率，左索他洛尔用于心律控制与心脏选择性β受体阻滞剂治疗的匹配对照患者。
方法：这项基于人群的队列研究包括来自瑞典国家患者登记处（2006年至2017年）的房颤患者，这些患者在第二次心脏复律后接受了节律控制。计算总体队列和1：1倾向评分匹配的d队列的死亡率发生率（IR）和调整后的风险比（aHR），以及心脏骤停/死亡和室性心律失常的复合终点。l-索他洛尔vs.β受体阻滞剂治疗。
结果：在d，左索他洛尔（n=4,987）和β受体阻滞剂治疗（n=27,078）患者，平均随访458天，全因死亡率较低，左索他洛尔治疗的患者：IR1.21（95％置信区间：0.95-1.52）与2.42（2.26-2.60）例死亡，每100例患者年，HR0.66(0.52-0.83)。死亡率的差异在倾向匹配比较中仍然存在（每组n=4,953），HR0.63(0.48-0.86)。在复合结局中没有观察到差异，倾向队列中的IR：2.13（1.78-2.52）与每100年发生2.07（1.73-2.53）个事件，aHR1.01(0.78-1.29)。
结论：没有额外的死亡率，左索他洛尔与心脏选择性β受体阻滞剂在第二次心脏复律后使用心律控制策略的房颤患者中的比较。我们的结果表明，与D相关的风险，通过仔细选择患者并严格遵守随访方案，可以减轻左索他洛尔对AF的治疗。
