Kumana Cyrus R, Cheung Bernard M Y, Cheung Giselle T Y, Ovedal Tori, Pederson Bjorn, Lauder Ian J
Department of Medicine, The University of Hong Kong, Hong Kong, SAR.
Br J Clin Pharmacol. 2005 Oct;60(4):347-54. doi: 10.1111/j.1365-2125.2005.02449.x.
Whenever feasible, rhythm control of atrial fibrillation (AF) was generally preferred over rate control, in the belief that it offered better symptomatic relief and quality of life, and eliminated the need for anticoagulation. However, recent trials appear to challenge these assumptions.
To explore the desirability of rhythm vs. rate control of AF by systematic review of pertinent, published, randomized controlled trials (RCTs) and a meta-analysis by number needed to treat (NNT) year(-1), with respect to diverse clinically important outcomes.
RCTs of outcome primarily comparing rate vs. rhythm control in patients with spontaneous AF were identified. For each outcome and assuming rhythm control to be the active treatment, relative risk reduction (RRR) and NNT year(-1) were derived for individual trials together with an NNT year(-1) for all trials combined; corresponding 95% confidence intervals (CI) were also calculated. Adverse drug reaction (ADR) and quality of life reporting were also assessed.
In all, data from five suitable RCTs (entailing 5239 patients) were analysed. For hospitalization, available RRRs and NNT year(-1) values were all clinically and statistically significant. Overall, one additional patient was hospitalized for every 35 assigned to rhythm control (95% CI 27, 48). For the endpoints of death, 'ischaemic' stroke and 'non-CNS' bleeding, there was no significant difference. ADRs were significantly more common in rhythm control patients, whereas quality of life assessments revealed no difference. Thromboembolism was associated with cessation of or subtherapeutic anticoagulation, irrespective of treatment assignment.
Reduced risk of hospitalization and non-inferiority for other endpoints all favour rate control, the less costly strategy. If symptoms of AF are not a problem, treatment should target optimizing rate control and more widespread and effective prophylactic anticoagulation.
只要可行,心房颤动(AF)的节律控制通常比心率控制更受青睐,因为人们认为它能更好地缓解症状、提高生活质量,并且无需抗凝治疗。然而,近期的试验似乎对这些假设提出了挑战。
通过系统回顾相关的已发表随机对照试验(RCT),并按治疗所需人数(NNT)年(-1)进行荟萃分析,探讨房颤节律控制与心率控制的可取性,涉及多种临床重要结局。
确定主要比较自发性房颤患者心率控制与节律控制结局的RCT。对于每个结局,并假设节律控制为积极治疗,计算各试验的相对风险降低率(RRR)和NNT年(-1),以及所有试验合并后的NNT年(-1);还计算相应的95%置信区间(CI)。同时评估药物不良反应(ADR)和生活质量报告。
总共分析了5项合适的RCT(涉及5239例患者)的数据。对于住院治疗,可用的RRR和NNT年(-1)值在临床和统计学上均具有显著意义。总体而言,每35名被分配到节律控制组的患者中就有1例额外住院(95%CI 27,48)。对于死亡、“缺血性”卒中及“非中枢神经系统”出血等终点,无显著差异。ADR在节律控制组患者中明显更常见,而生活质量评估显示无差异。血栓栓塞与抗凝治疗的停止或不足有关,与治疗分配无关。
住院风险降低以及其他终点的非劣效性均支持心率控制这一成本较低的策略。如果房颤症状不是问题,治疗应致力于优化心率控制以及更广泛有效的预防性抗凝治疗。