The burden of atrial fibrillation (AF) and the lack of data on AF and its management in the Asia Pacific highlight the need for a comprehensive prospective study of AF management in this region. To address this need, the REgistry on Cardiac rhythm disORDers (RecordAF-Asia Pacific [AP]) has been initiated to assess the management of AF in 8 countries across the Asia Pacific. RecordAF-AP is a prospective, observational survey of the management of recently diagnosed AF with 1 year of follow-up. Eligible patients with AF, treated or not, were included in the registry; with data recorded prospectively during the follow-up visits at 6 and 12 months. A total of 2,721 patients with AF were recruited, of whom 2,629 were eligible for evaluation (intent-to-treat population). At study inclusion, rhythm- and rate-control strategies were applied to 37% (n = 959) and 62% (n = 1,610) of the patients, respectively. At baseline, the rhythm-control patients were mainly prescribed class III agents (49%), class Ic agents (39%), or β blockers (except for sotalol; 35%). The rate-control patients were mainly prescribed β blockers (except for sotalol; 57%) or cardiac glycosides (32%). Patients receiving rate-control strategies were more likely to have a history of heart failure or valvular heart disease and persistent AF. In contrast, those receiving rhythm-control strategies were more likely to have recently diagnosed or paroxysmal AF. In conclusion, RecordAF-AP will provide much needed insight into the real-life management of patients with AF in the Asia Pacific region.
The burden of atrial fibrillation (AF) and the lack of data on AF in Asia Pacific highlight the need for a comprehensive prospective study of AF in the day-to-day practice in this region. To address this need, the REgistry on Cardiac rhythm disORDers (RecordAF-Asia Pacific [AP]) has been initiated in 8 countries across the Asia Pacific. In the present study, we report the baseline data from patients enrolled in the RecordAF-AP registry.
Methods
The RecordAF-AP is prospective, observational, survey of the management of patients with recently diagnosed AF with 1 year of follow-up. The primary objective of the present was to prospectively assess AF control during a 1-year period for patients attending a general or specialist practice to compare the clinical outcomes for rhythm- versus rate-control strategies.
The study was conducted at multiple hospital sites in 8 countries across the Asia Pacific (Australia [20 sites], China [20 sites], Hong Kong [3 sites], Korea [20 sites], Malaysia [5 sites], the Philippines [4 sites], Taiwan [15 sites], and Thailand [30 sites]). The method complied with the Declaration of Helsinki (as amended in 2004), the Guidelines for Good Epidemiological Practice, and the local regulations. The full details of the study method have been published previously in a design report.
Results
In the 16 months from April 2009 to July 2010, 2,721 patients from 8 countries were enrolled in the present study, of whom 2,629 were eligible for evaluation (intent-to-treat population). The population exceeded the minimum requirements previously determined in the sample size calculations. Overall, the mean age was 64 ± 13 years (range 19 to 100), and 60% of the patients were men. The baseline demographic characteristics of the study population are listed in Table 1 .
| Variable | Rhythm-Control Strategy (n = 959) | Rate-Control Strategy (n = 1,670) | Total (n = 2,629) |
|---|---|---|---|
| Age (years) | 63 ± 13 | 65 ± 13 | 64 ± 13 |
| Men | 591 (62%) | 997 (60%) | 1,588 (60%) |
| Ethnicity | |||
| Chinese | 420 (44%) ⁎ | 531 (32%) ⁎ | 951 (36%) |
| Korean | 240 (25%) ⁎ | 213 (13%) ⁎ | 453 (17%) |
| White | 176 (18%) | 270 (16%) | 446 (17%) |
| Thai | 42 (4%) ⁎ | 472 (28%) ⁎ | 515 (20%) |
| Other | 81 (8%) | 184 (11%) | 264 (10%) |
| Body mass index (kg/m 2 ) | 25.73 ± 4.6 (n = 935) | 25.39 ± 5.1 (n = 1,631) | 25.5 ± 4.9 |
| Waist circumference (cm) | 89.9 ± 11.9 (n = 891) | 89.4 ± 13.2 (n = 1,584) | 89.9 ± 12.7 |
⁎ Statistically significant difference (p <0.05) based on 2-tailed z test comparing rhythm control and rate control.
A history of hypertension was the most prevalent concomitant disease, present in 1,530 patients (58%; Table 2 ), followed by dyslipidemia (37%), heart failure (25%), and valvular heart disease (23%). Among those patients with heart failure, 74% were in New York Heart Association functional class I or II. Left ventricular (LV) function was assessed in 1,969 patients (75%). A lower LV ejection fraction was observed more frequently in patients assigned to a rate-control strategy compared to those assigned to a rhythm-control strategy; 4% versus 1% had an LV ejection fraction of <30%, respectively. In contrast, more patients in the rhythm-control group had an LV ejection fraction of >50% (88% vs 76%; p <0.05). The details of other concomitant diseases are listed in Table 2 . More than one half (56%) of the patients had never smoked, and only 13% were current smokers at baseline.
| Concomitant Disease | Rhythm-Control Strategy (n = 959) | Rate-Control Strategy (n = 1,670) | Total (n = 2,629) |
|---|---|---|---|
| History of hypertension | 549 (57%) | 981 (59%) | 1,530 (58%) |
| History of coronary artery disease | 197 (21%) | 310 (19%) | 507 (19%) |
| History of myocardial infarction | 46 (5%) | 119 (7%) | 165 (6%) |
| History of stroke | 65 (7%) | 158 (10%) | 223 (9%) |
| History of transient ischemic attack | 23 (2%) | 68 (4%) | 91 (4%) |
| Symptomatic peripheral artery disease | 17 (2%) | 35 (2%) | 52 (2%) |
| Heart failure | 136 (14%) | 519 (31%) | 655 (25%) |
| New York Heart Association class I | 45 (33%) | 113 (22%) | 158 (24%) |
| New York Heart Association class II | 60 (44%) | 265 (51%) | 325 (50%) |
| New York Heart Association class III | 23 (17%) | 114 (22%) | 137 (21%) |
| New York Heart Association class IV | 8 (6%) | 24 (5%) | 32 (5%) |
| Diabetes | 145 (15%) | 317 (19%) | 462 (18%) |
| Valvular heart disease | 145 (15%) | 449 (27%) | 594 (23%) |
| Mitral | 114 (79%) | 384 (86%) | 498 (84%) |
| Aortic | 49 (34%) | 131 (29%) | 180 (30%) |
| Other | 32 (22%) | 72 (16%) | 104 (18%) |
| Hyperthyroidism | 55 (6%) | 80 (5%) | 135 (5%) |
| Peripheral embolic events | 14 (2%) | 36 (2%) | 50 (2%) |
| Renal disease | 64 (7%) | 105 (6%) | 169 (6%) |
| Arrhythmia other than atrial fibrillation | 191 (20%) | 234 (14%) | 425 (16%) |
| Cardiac or vascular intervention | 88 (9%) | 150 (9%) | 238 (9%) |
| Percutaneous coronary intervention | 51 (58%) | 99 (66%) | 150 (63%) |
| Coronary artery bypass graft | 25 (28%) | 34 (23%) | 59 (25%) |
| Valvular surgery | 9 (10%) | 15 (10%) | 24 (10%) |
| Carotid intervention | 1 (1%) | 3 (2%) | 4 (2%) |
| Other cardiac or vascular surgery | 7 (8%) | 11 (7%) | 18 (8%) |
| Risk factor | |||
| Family history of premature cardiovascular disease ⁎ | 143 (15%) | 194 (12%) | 337 (13%) |
| Current smoker | 132 (14%) | 210 (13%) | 342 (13%) |
| Dyslipidemia † | 336 (35%) | 623 (37%) | 959 (37%) |
⁎ Fatal or nonfatal myocardial infarction and/or stroke occurring before age 55 years for men and 65 years for women who are first-degree relatives (mother, father, sibling, or offspring) of the subject.
† Low-density lipoprotein >155 mg/dl and high-density lipoprotein <40 mg/dl in men and <48 mg/dl in women.
At baseline, a history of stroke was recorded in 223 patients (9%), and the etiology was predominantly documented to be ischemic (172 patients). A history of transient ischemic attack was recorded in 91 patients (4%). International normalization ratio measurements were performed within 6 months of study inclusion in 1,098 patients (42%).
At the baseline visit, 775 (81%) of the rhythm-control patients and 1,465 (88%) of the rate-control patients were prescribed thromboembolic prevention therapy. Among these patients, significantly more in the rate-control group received a vitamin K antagonist (47% vs 35%; p <0.001) and significantly more rhythm-control patients received acetylsalicylic acid (66% vs 56%, p <0.05). International normalization ratio monitoring and adjustment in response to these measurements was undertaken predominantly by a physician or clinic (n = 871; 79%). The differences in anticoagulation control between the rate- and rhythm-control groups were not significant.
The baseline AF characteristics are listed in Table 3 . At study inclusion, 872 patients (39%) were in sinus rhythm, 1,365 (61%) had AF, and a family history of AF was reported in 128 (5%). At baseline, the symptoms were present in 756 patients (29%). Those patients who were allocated to rhythm control tended to be more symptomatic than those who received rate control (33% vs 26%). At inclusion, the patients allocated to rate control more often had persistent AF (47% vs 17%) and tended to be in AF at baseline. In contrast, those allocated to rhythm control more often had paroxysmal AF (70% vs 38%) and were more often in sinus rhythm at inclusion.
| Variable | Rhythm-Control Strategy (n = 959) | Rate-Control Strategy (n = 1,670) | Total (n = 2,629) |
|---|---|---|---|
| Atrial fibrillation type | |||
| First diagnosis | 188 (20%) | 367 (22%) | 555 (21%) |
| Symptomatic | 61 (32%) | 98 (27%) | 159 (29%) |
| Asymptomatic | 127 (68%) | 269 (73%) | 396 (71%) |
| Paroxysmal | 664 (69%) | 628 (38%) | 1,292 (49%) |
| Symptomatic | 244 (37%) | 171 (27%) | 415 (32%) |
| Asymptomatic | 420 (63%) | 457 (73%) | 877 (68%) |
| Persistent | 166 (17%) | 784 (47%) | 950 (36%) |
| Symptomatic | 31 (19%) | 202 (26%) | 233 (25%) |
| Asymptomatic | 135 (81%) | 582 (74%) | 717 (76%) |
| Symptomatic | 316 (33%) | 440 (26%) | 756 (29%) |
| Number of symptomatic episodes during previous year | 25.5 ± 94.4 | 21.1 ± 66.8 | 22.8 ± 78.8 |
| Atrial fibrillation at inclusion | 316 (39%) | 1,049 (74%) | 1,365 (61%) |
| Sinus rhythm at inclusion | 494 (61%) | 378 (27%) | 872 (39%) |
| Family history of atrial fibrillation | 47 (5%) | 81 (5%) | 128 (5%) |
| Interventions during previous year | |||
| Pharmacologic conversion | 323 (45%) | 240 (20%) | 563 (30%) |
| Number of pharmacologic conversions | 2.0 ± 4.1 | 1.9 ± 2.3 | 2.0 ± 3.4 |
| Electrical cardioversion | 52 (7%) | 40 (3%) | 92 (5%) |
| Number of electrical cardioversions | 1.3 ± 0.63 | 1.4 ± 0.78 | 1.3 ± 0.70 |
| Catheter ablation | 6 (0.8%) | 7 (0.6%) | 13 (0.7%) |
| Surgical therapy for atrial fibrillation | 12 (2%) | 15 (1%) | 27 (1%) |
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