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RACE-II TRIAL |
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|---|---|
| Problem | Atrial fibrillation |
| Format | - |
| Treatment | Lenient rate control (HR<110) |
| Control | Strict rate control (HR<80) |
| Population | 614 patients |
| Inclusion criteria | Permanent atrial fibrillation for up to 12 months Age of 80 years or younger Mean resting heart rate above 80 beats per minute Current use of oral anticoagulation therapy (or aspirin, if no risk factors for thromboembolic complications were present) |
| Exclusion criteria | - |
| Follow-up | 2-3 years |
| Primary endpoint | Composite of -Death from cardiovascular causes -Hospitalization for heart failure -Stroke -Systemic embolism -Bleeding -Life-threatening arrhythmic events |
| Secondary endpoint(s) | Components of the primary outcome Death from any cause Symptoms Functional status |
| Details | Paroxysmal AF Known contraindications for either strict or lenient rate control (eg, previous adverse effects on negative chronotropic drugs) Unstable heart failure defined as NYHA IV heart failure or heart failure necessitating hospital admission within 3 months before inclusion Cardiac surgery within 3 months Any stroke, Current or foreseen pacemaker Internal cardioverter defibrillator, and/or cardiac resynchronization therapy, Signs of sick sinus syndrome or AV conduction disturbances (ie, symptomatic bradycardia or asystole >3 seconds or escape rate b40 bpm in awake symptom-free patients) Untreated hyperthyroidism or <3 months euthyroidism Inability to walk or bike. Discontinuation of rate control drugs before inclusion to meet the inclusion criteria is not allowed. |
| Brief summary: | Strict rate control (<80) no better than lenient (<110) control |
| PAPER: Lenient versus strict rate control in patients with atrial fibrillation. | |
|---|---|
| Date | 15 Apr 2010 |
| Journal | N Engl J Med. 2010 Apr 15;362(15):1363-73. Epub 2010 Mar 15. |
| Information | Lenient (resting HR<110) vs. strict (resting HR<80; mod. exercise HR<110) -Lenient rate control non-inferior to strict control (p<0.001) -Components of outcome similar in 2 groups -Decreased clinic visits for lenient control |