Title of Trial
Randomized Trial of Rate-Control Versus Rhythm Control in Persistent Atrial Fibrillation. The Strategies of Treatment of Atrial Fibrillation (STAF) Study

Date and Citation of Primary Publication(s) or References
Carlsson J. Miketic S. Windeler J. Cuneo A. Haun S. Micus S. Walter S. Tebbe U. STAF Investigators. Randomized trial of rate-control versus rhythm-control in persistent atrial fibrillation: the Strategies of Treatment of Atrial Fibrillation (STAF) study. Journal of the American College of Cardiology. 41(10):1690-6, 2003 May 21

Purpose of the Trial
The purpose of the study was to compare two treatment strategies for the management of persistent atrial fibrillation: rhythm control versus rate control.

Study Category
Atrial Fibrillation. Open, randomized controlled pilot trial.

Patient Population
Not defined

Inclusion Criteria
Ability to give informed consent, 18 years or older, and one or more of the following: AF for >4 weeks, left atrial size>45mm, congestive heart failure (NYHA class II or greater), left ventricular ejection fraction <45% or >1 prior cardioversion with arrhythmia recurrence.

Exclusion Criteria
Permanent AF>2 years, history of paroxysmal AF, left atrial size >70mm, LVEF<20%, Wolff-Parkinson-White syndrome, history of AV node ablation or modification, contraindications to oral anticoagulation, primarily unsuccessful cardioversion within 4 weeks of randomization, pregnancy, or malignant or other disease that would limit life expectancy to <3 years.

Study Design
Patients were randomized by a computer to a strategy of either restoration and maintenance of sinus rhythm or rate control and anticoagulation. If randomized to the rhythm control strategy, patients were cardioverted either externally or internally. Anti-arrhythmic therapy was then prescribed based on the presence of coronary disease and LVEF. In the absence of coronary artery disease or left ventricular dysfunction, patients were given Class I agents or sotalol. Patients with CAD or impaired LV function patients received amiodarone and/or a beta blocker. In case of AF recurrence cardioversion was repeated.

Patients randomized to rate control were prescribed one or more of the following: beta blockers, digitalis, calcium antagonists, or AV node ablation or modification with or without implantation of a permanent pacemaker.

Anticoagulation was given in both arms in accordance to the guidelines of the American College of Chest Physicians.

At baseline and follow up (3,6,12,18,24 and 26 months) patients underwent physical exam, transthoracic echocardiogram, resting electrocardiogram, blood pressure, and quality of life questionnaire.

Primary Endpoints
Combination of death, stroke, transient ischemic attack, systemic embolization, and cardiopulmonary resuscitation.

Secondary Endpoints
Syncope, bleeding (requiring transfusion, hospitalization or both) quality of life, LV end diastolic diameter, LV end systolic diameter, LVEF, left atrial diameter, resting heart rate, maintenance of sinus rhythm at follow up.

Baseline Characteristics

	Rhythm-Control (n=100)	Rate Control (n=100)
Age, mean, yrs	65.3	66.2
Women (%)	41	32
CAD (%)	34	53
Valvular heart disease	10	16
Hypertension	63	62
LA size (mean), cm	4.6	4.6
AF duration, months	6	6

Time of Follow-up
19.5 months in the rhythm-control group and 19.7 months in the rate-control group.

Results
There was no difference in the combined primary endpoint (9/100 in the rhythm-control group and 10/100 in the rate control group, p=0.99).
There was no difference in the secondary endpoints of syncope, bleeding complications, quality of life, symptoms, NYHA functional class, echo parameters, and resting heart rate between the two groups. In the rhythm control group 86% of patients received anti-arrhythmic therapy, which was amiodarone in 42% of patients. At the end of follow up only 23% if the patients in the rhythm control group were in sinus rhythm. Only one of the primary endpoints during follow-up occurred with the patient in sinus rhythm. There were a statistically significantly greater number of days in the hospital in the rhythm control group when compared to the rate control group (449 vs. 314 days, p<0.001)

Sponsor
Medtronic GmbH, Dusseldorf, Germany
Arbeitsgemeinschaft leitender kardiologischer krankernhausarzte (ALKK), Germany

Trial Status: Completed