Chest
Volume 126, Issue 2, August 2004, Pages 476-486
Journal home page for Chest

Clinical Investigations
CARDIOLOGY
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

https://doi.org/10.1378/chest.126.2.476Get rights and content

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.

Section snippets

Materials and Methods

The HOT CAFE study12 was a prospective, randomized, open multicenter clinical trial that was designed to evaluate the effects of rhythm control vs rate control in patients with persistent AF. The study involved six cardiology centers in central Poland, five of which enrolled patients. The study was approved by the institutional review board or ethics committee at those centers, and consecutive, eligible patients provided written informed consent. Recruitment began in March 1997, randomization

Baseline Characteristics

Of 738 screened patients with AF from March 1997 to December 2000, 205 patients (134 men and 71 women) met the inclusion criteria and were enrolled into the study. Valvular heart disease (21%), thyrotoxicosis (13%), and advanced stages of concomitant diseases influencing the natural history of AF (11%) were the main exclusion criteria limiting enrollment. One hundred one consecutive patients were randomly assigned to the heart rate control group. The restoration and maintenance of sinus rhythm

Discussion

The results of the HOT CAFE study have provided data that are relevant to the management of patients with AF. Our study demonstrated that the rate control of AF is as acceptable as sinus rhythm restoration and maintenance. Despite the relatively small number of enrolled patients and the short observation period, our study suggests that, at least with currently available pharmacologic therapy, there is no distinct advantage associated with the rhythm control strategy. Moreover, the control of

Conclusions

The HOT CAFE study suggests that the rate control of persistent AF is equivalent to rhythm control in terms of mortality rate, stroke, and thromboembolic and severe bleeding complications. Therefore, our trial supports the results of other studies, although our population was younger and possibly had AF relatively longer than other populations (for up to 2 years). The HOT CAFE trial, like the PIAF, AFFIRM, RACE, and other trials, showed no significant differences in the two proposed treatment

References (19)

There are more references available in the full text version of this article.

Cited by (0)

The study results were presented at the 24th Congress of the European Society of Cardiology, Berlin, Germany, in October 2002.

The study was supported by Polish Government research grant No. PO5B06012.

View full text