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AFFIRM TRIAL |
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|---|---|
| Problem | Atrial fibrillation |
| Format | Multi-center RCT |
| Treatment | Rhythm vs. rate control |
| Control | NA |
| Population | 4060 patients |
| Inclusion criteria | Only patients with recurrent persistent atrial fibrillation or flutter, in whom oral anticoagulation was not contraindicated, were included. |
| Exclusion criteria | Patients were excluded if arrhythmia had lasted longer than one year. In addition to the usual exclusion criteria for studies of electrical cardioversion, we also excluded patients with New York Heart Association class IV heart failure, current or previous treatment with amiodarone, or a pacemaker. Patients were required to have undergone one electrical cardioversion during the previous two years, with a maximum of two. |
| Follow-up | Mean 3.5 years |
| Primary endpoint | Composite of death from cardiovascular causes, heart failure, thromboembolic complications, bleeding, the need for implantation of a pacemaker, or severe adverse effects of antiarrhythmic drugs. |
| Secondary endpoint(s) | The components of the primary end point are reported as secondary end points. |
| Details | Enrolled patients aged ≥65 years old or who had other risk factors for stroke or death 38.2% with coronary heart disease, 70.8% hypertension Rate control with b-blockers/Diltiazem/Verapamil & warfarin Rhythm control to choice of physician +- cardioversion. Warfarin encouraged but optional if in sinus rhythm for > 4 days |
| Brief summary: | Rate control non-inferior to rhythm control and possibly superior in elderly and co-morbid patients |
| PAPER: A comparison of rate control and rhythm control in patients with atrial fibrillation | |
|---|---|
| Date | 5 Dec 2002 |
| Journal | N Engl J Med. 2002 Dec 5;347(23):1825-33. |
| Information | No significant difference between groups -Trend favoured rate control, p=0.08 -Greater crossover (~25%) rhythm -> rate control Subgroup analysis showing higher mortality for -Rhythm control in elderly -Rhythm control in CAD -Rhythm control in CCF Recommended anticoagulation for all patients, regardless of control |
| PAPER: A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation | |
|---|---|
| Date | 5 Dec 2002 |
| Journal | N Engl J Med. 2002 Dec 5;347(23):1834-40. |
| Information | Non-inferiority study in 522 patients with persistent AF following D/C cardioversion Group 1 - rate control & anti-coag Group 2 - rhythm control & further D/C cardioversion Composite end-point (CV death, heart failure, thromboembolism, bleeding, pacemaker implantation, and severe adverse effects of drugs) -In 17.2% of rate control -In 22.6% of rhythm control Concluded rate control not inferior in patients with AF following D/C cardioversion |