Table 1.
Characteristics of rhythm control and rate control trials in patients with atrial fibrillation (adapted from Camm et al. with permission)1
| Patients reaching primary endpoint (n) |
||||||||
|---|---|---|---|---|---|---|---|---|
| Trial | Patients (n) | Mean age (years) | Mean length of follow-up (years) | Inclusion criteria | Primary endpoint | Rate control | Rhythm control | P |
| PIAF8 | 252 | 61.0 | 1.0 | Persistent AF (7–360 days) | Symptomatic improvement | 76/125 (60.8%) | 70/127 (55.1%) | 0.32 |
| AFFIRM6 | 4060 | 69.7 | 3.5 | Paroxysmal AF or persistent AF, age 65 years or older, or risk of stroke or death | All-cause mortality | 310/2027 (25.9%) | 356/2033 (26.7%) | 0.08 |
| RACE7 | 522 | 68.0 | 2.3 | Persistent AF or flutter for <1 year and 1 to 2 cardioversions >2 years and oral anticoagulation | Composite: cardiovascular death, CHF, severe bleeding, PM implantation, thromboembolic events, severe adverse effects of antiarrhythmic drugs | 44/256 (17.2%) | 60/266 (22.6%) | 0.11 |
| STAF9 | 200 | 66.0 | 1.6 | Persistent AF (>4 weeks and <2years), left atrial size >45 mm, CHF NYHA II–IV, LVEF <45% | Composite: overall mortality, cerebrovascular complications, CPR, embolic events | 10/100 (10.0%) | 9/100 (9.0%) | 0.99 |
| HOT CAFÉ10 | 205 | 60.8 | 1.7 | First clinically overt persistent AF (≥7 and <2 years), 50–75-year old | Composite: death, thromboembolic events; intracranial/ major haemorrhage | 1/101 (1.0%) | 4/104 (3.9%) | >0.71 |
| AF-CHF11 | 1376 | 66 | 3.1 | LVEF≤35%, symptoms of CHF, history of AF (≥6 h or ECV <last 6 months) | Cardiovascular death | 175/1376 (25%) | 182/1376 (27%) | 0.59 |
AF, atrial fibrillation; AFFIRM, atrial fibrillation follow-up investigation of rhythm management; CHF, congestive heart failure; CPR, cardiopulmonary resuscitation; ECV, electrical cardioversion; HOT CAFE, how to treat chronic atrial fibrillation; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; PIAF, pharmacological intervention in atrial fibrillation; PM, pacemaker; RACE, rate control versus electrical cardioversion for persistent atrial fibrillation; STAF, strategies of treatment of atrial fibrillation.