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非瓣膜性持续性心房颤动患者的心率控制与节律控制:波兰如何治疗慢性心房颤动(HOT CAFE)研究结果

Rate control vs rhythm control in patients with nonvalvular persistent atrial fibrillation: the results of the Polish How to Treat Chronic Atrial Fibrillation (HOT CAFE) Study.

作者信息

Opolski Grzegorz, Torbicki Adam, Kosior Dariusz A, Szulc Marcin, Wozakowska-Kaplon Beata, Kolodziej Piotr, Achremczyk Piotr

机构信息

Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.

出版信息

Chest. 2004 Aug;126(2):476-86. doi: 10.1378/chest.126.2.476.

Abstract

STUDY OBJECTIVES

The relative risks and benefits of strategies of rate control vs rhythm control in patients with atrial fibrillation (AF) remain to be fully explored.

DESIGN

The How to Treat Chronic Atrial Fibrillation (HOT CAFE) Polish trial was designed to evaluate in a randomized, multicenter, and prospective manner the feasibility and long-term outcomes of rate control vs rhythm control strategies in patients with persistent AF.

PATIENTS

Our study population comprised 205 patients (134 men and 71 women; mean [+/- SD] age, 60.8 +/- 11.2 years) with a mean AF duration of 273.7 +/- 112.4 days. The mean observation period was 1.7 +/- 0.4 years. One hundred one patients were randomly assigned to the rate control group and received rate-slowing therapy guided by repeated 24-h Holter monitoring. Direct current cardioversion and atrioventricular junctional ablation with pacemaker placement were alternative nonpharmacologic strategies for patients with tachycardia that was resistant to medical therapy. One hundred four patients were randomized to sinus rhythm restoration and maintenance using serial cardioversion supported by a predefined stepwise antiarrhythmic drug regimen (ie, disopyramide, propafenone, sotalol, and amiodarone). In both groups, thromboembolic prophylaxis followed current guidelines.

MEASUREMENTS AND RESULTS

At the end of follow-up, 63.5% of patients in the rhythm control arm remained in sinus rhythm. No significant differences in the composite end point (ie, all-cause mortality, number of thromboembolic events, or major bleeding) were found between the rate control group and the rhythm control group (odds ratio, 1.98; 95% confidence interval, 0.28 to 22.3; p > 0.71). The incidence of hospital admissions was much lower in the rate control arm (12% vs 74%, respectively; p < 0.001). New York Heart Association functional class improved in both study groups, while mean exercise tolerance, as measured by the maximal treadmill workload, improved only in the rhythm control group (5.2 +/- 5.1 vs 7.6 +/- 3.3 metabolic equivalents, respectively; p < 0.001). The rhythm control strategy led to an increased mean left ventricular fractional shortening (29 +/- 7% vs 31 +/- 7%, respectively; p < 0.01). One episode of pulmonary embolism occurred in the rate control group despite oral anticoagulation therapy, while three patients in the rhythm control arm of the study experienced ischemic strokes (not significant).

CONCLUSIONS

The Polish HOT CAFE study revealed no significant differences in major end points between the rate control group and the rhythm control group.

摘要

研究目的

心房颤动(AF)患者心率控制与节律控制策略的相对风险和益处仍有待充分探索。

设计

波兰如何治疗慢性心房颤动(HOT CAFE)试验旨在以随机、多中心和前瞻性的方式评估持续性AF患者心率控制与节律控制策略的可行性和长期结果。

患者

我们的研究人群包括205例患者(134例男性和71例女性;平均[±标准差]年龄为60.8±11.2岁),平均房颤持续时间为273.7±112.4天。平均观察期为1.7±0.4年。101例患者被随机分配到心率控制组,并接受基于重复24小时动态心电图监测指导的心率减慢治疗。直流电复律和房室交界区消融加起搏器植入是对药物治疗无效的心动过速患者的替代非药物策略。104例患者被随机分配至使用预定义的逐步抗心律失常药物方案(即丙吡胺、普罗帕酮、索他洛尔和胺碘酮)支持的系列复律来恢复和维持窦性心律。在两组中,血栓栓塞预防均遵循现行指南。

测量与结果

随访结束时,节律控制组63.5%的患者维持窦性心律。心率控制组和节律控制组在复合终点(即全因死亡率、血栓栓塞事件数量或大出血)方面未发现显著差异(优势比,1.98;95%置信区间,0.28至22.3;p>0.71)。心率控制组的住院率低得多(分别为12%和74%;p<0.001)。两个研究组的纽约心脏协会功能分级均有改善,而通过最大运动平板负荷测量的平均运动耐量仅在节律控制组有所改善(分别为5.2±5.1和7.6±3.3代谢当量;p<0.001)。节律控制策略导致平均左心室缩短分数增加(分别为29±7%和31±7%;p<0.01)。尽管进行了口服抗凝治疗,心率控制组仍发生了1次肺栓塞,而研究的节律控制组有3例患者发生缺血性卒中(无显著性差异)。

结论

波兰HOT CAFE研究显示心率控制组和节律控制组在主要终点方面无显著差异。

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