CLINICAL RESEARCH
Randomized trial of rate-control versus rhythm-control in persistent atrial fibrillation
The Strategies of Treatment of Atrial Fibrillation (STAF) study
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
* Department of Internal Medicine II, Klinikum Lippe, Detmold, Germany
Department of Evidence-Based Medicine, Medizinischer Dienst der Spitzenverbände der Krankenkassen e.V., Essen, Germany
Manuscript received May 17, 2002;
revised manuscript received September 30, 2002,
accepted October 10, 2002.
* Reprint requests and correspondence: Dr. Jörg Carlsson, Medizinische Klinik II, Klinikum Lippe-Detmold, Röntgenstrasse 18, D-32760 Detmold, Germany.
Joerg.Carlsson{at}Klinikum-Lippe.de
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.
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Abbreviations and Acronyms
| | AF | | atrial fibrillation | | AFFIRM | | Atrial Fibrillation Follow-up Investigation of Rhythm Management | | AV | | atrioventricular | | INR | | international normalized ratio | | LV | | left ventricular | | LVEF | | left ventricular ejection fraction | | NYHA | | New York Heart Association | | PIAF | | Pharmacological Intervention in Atrial Fibrillation | | SPAF | | Stroke Prevention in Atrial Fibrillation | | STAF | | Strategies of Treatment of Atrial Fibrillation |
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Additional Information
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