Author + information
- Received May 17, 2002
- Revision received September 30, 2002
- Accepted October 10, 2002
- Published online May 21, 2003.
- J.örg Carlsson, MD, FESC*,* (, )
- Sinisa Miketic, MD*,
- J.ürgen Windeler, MD†,
- Alessandro Cuneo, MD*,
- Sebastian Haun, MD*,
- Stefan Micus, MD*,
- Sabine Walter, MD*,
- Ulrich Tebbe, MD, FESC*,
- STAF Investigators
- ↵*Reprint requests and correspondence:
Dr. Jörg Carlsson, Medizinische Klinik II, Klinikum Lippe-Detmold, Röntgenstrasse 18, D-32760 Detmold, Germany.
Objectives This study was designed to compare two treatment strategies in patients with atrial fibrillation (AF): rhythm-control (restoration and maintenance of sinus rhythm) and rate-control (pharmacologic or invasive rate-control and anticoagulation).
Background Atrial fibrillation is the most common arrhythmia. It is unclear whether a strategy of rhythm- or rate-control is better in terms of mortality, morbidity, and quality of life.
Methods The Strategies of Treatment of Atrial Fibrillation (STAF) multicenter pilot trial randomized 200 patients (100 per group) with persistent AF to rhythm- or rate-control. The combined primary end point was a combination of death, cardiopulmonary resuscitation, cerebrovascular event, and systemic embolism.
Results After 19.6 ± 8.9 months (range 0 to 36 months) there was no difference in the primary end point between rhythm-control (9/100; 5.54%/year) and rate-control (10/100; 6.09%/year; p = 0.99). The percentage of patients in sinus rhythm in the rhythm-control group after up to four cardioversions during the follow-up period (rate-control group) was 23% (0%) at 36 months. Eighteen primary end points occurred in atrial fibrillation; only one occurred in sinus rhythm (p = 0.049).
Conclusions The STAF pilot study showed no differences between the two treatment strategies in all end points except hospitalizations. These data suggest that there was no benefit in attempting rhythm-control in these patients with a high risk of arrhythmia recurrence. It remains unclear whether the results in the rhythm-control group would have been better if sinus rhythm had been maintained in a higher proportion of patients, as all but one end point occurred during AF.
☆ The study was funded in part by Medtronic GmbH, Düsseldorf, Germany, and by the Arbeitsgemeinschaft leitender kardiologischer Krankenhausärzte (ALKK), Germany.
- Received May 17, 2002.
- Revision received September 30, 2002.
- Accepted October 10, 2002.
- American College of Cardiology Foundation