The Atrial Fibrillation: Focus on Effective Clinical Treatment Strategies (AFFECTS) Registry was designed to examine atrial fibrillation (AF) treatment by United States cardiologists in the context of the American College of Cardiology, American Heart Association, and European Society of Cardiology guidelines after recent landmark clinical trials. Most patients in AFFECTS had AF without clinically significant structural heart disease or only uncomplicated hypertension. Among the all-enrolled population (n = 1,461), initial treatment strategies assigned were rhythm control in 64% and rate control in 36%. Among patients with either paroxysmal (n = 1,165) or persistent (n = 273) AF, 67% and 55%, respectively, were assigned rhythm control. The trend to assign rhythm control as the initial treatment goal decreased with age. In the rhythm-control group, most patients (74%) also received a rate-control agent during the registry, while 25% of those assigned to rate control received antiarrhythmic drugs. Most first prescriptions of antiarrhythmic drugs were for first-line therapy compliant with 2001 (76%) and 2006 (86%) guidelines. Most second prescriptions were for first-line therapies as well. Rates of serious adverse events were low. In conclusion, data from this study provide insight into community treatment patterns in patients with AF, most without clinically significant structural heart disease or with only uncomplicated hypertension.
The Atrial Fibrillation: Focus on Effective Clinical Treatment Strategies (AFFECTS) Registry was designed to examine treatment patterns of atrial fibrillation (AF) among United States cardiologists in the context of the American Heart Association/American College of Cardiology/European Society of Cardiology (AHA/ACC/ESC) guidelines developed before (2001) and revised after (2006) the publication of recent landmark clinical trials, such as Rate Control Versus Electrical Cardioversion for Persistent Atrial Fibrillation (RACE) and Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM), trials that appeared to suggest no survival benefit from antiarrhythmic drugs (AADs) in the enrolled populations, which encompassed primarily patients with structural heart disease (SHD). The registry was also expected to generate data to assess the comparative safety, tolerability, and effectiveness of AAD therapies in patients with lone, recurrent paroxysmal AF (PAF) or persistent AF (PerAF) and those with AF and uncomplicated hypertension (this will be the subject of a later report). A companion report in this issue focuses on anticoagulation use observed during this registry.
Methods
AFFECTS, a multicenter, open-label, prospective registry, was designed to provide insight into current AF management practices in the United States. Cardiology physicians or practices were recruited from March 2005 through December 2007, with a recruitment goal of 500 sites. Potential sites were identified on the basis of the investigator directory system of the clinical research organization PPD, Inc. (Wilmington, North Carolina), inquiries through the AFFECTS Web site or toll-free number, or referrals from other sites. Some were identified through interest expressed to the sponsors (see “Acknowledgment”). Sponsor sales representatives were directed to advise any physician who inquired about the registry to go to the Web site, call the toll-free number, or speak to a medical liaison representative to obtain further information and were prohibited from any involvement with site selection or patient recruitment, under risk for disciplinary action, including termination. Of 14,804 potential sites identified, 633 expressed interest in participating; 455 received independent review board approval, 322 were activated, and 248 enrolled ≥1 patient. Patients meeting protocol entry criteria were provided with an overview of the registry and informed consent forms to sign for enrollment. Before any patient enrollment, each physician participated in training on the ACC/AHA/ESC guidelines current at time of recruitment (2001 or 2006 ). All-enrolled patients were expected to be seen regularly by their enrolling physicians according to those physicians’ standard of care. No specific therapy was protocol driven. Data were to be collected on each patient at the enrollment (baseline) visit, then quarterly for 1 year after enrollment, with a total of 5 visits. Blood tests, electrocardiograms, echocardiograms, x-rays, stress tests, or other medical tests during a registry visit were on the basis of physician judgment or standard of care and were not part of registry protocol. All data were entered into case report forms (paper or electronic).
Eligible patients were to be ≥18 years of age, have AF without clinically significant SHD or AF with hypertension but neither left ventricular hypertrophy nor coronary artery disease, were not previously treated with Vaughan-Williams class I or III AADs up to 7 days before enrollment, were willing to participate for the duration of the 1-year follow-up period, and provided written informed consent. Exclusion criteria included a diagnosis or history of ventricular pathophysiology leading to a proarrhythmic event; AF within 8 weeks of cardiac surgery, during pregnancy, or in association with a myocardial infarction; hyperthyroidism; acute pulmonary disease; acute myocarditis or pericarditis; permanent AF; ischemia by stress test and/or angiography; or participation in a clinical trial in which they received investigational products. At enrollment, physicians indicated their primary therapy goal for each subject, either pursuit of sinus rhythm (rhythm control) or control of heart rate (rate control). The therapy goal for each patient was selected only at baseline (intention-to-treat approach) but did not restrict a physician’s therapeutic options during study. Choice of medications for AF management was solely at the physician’s discretion, and no reimbursements for medication costs were provided.
AAD prescription orders during the registry were examined in comparison to the 2001/06 ACC/AHA/ESC guidelines. The effectiveness of therapy was measured by the proportion of patients in normal sinus rhythm recorded by electrocardiography or Holter monitoring and the ventricular rates of patients at each registry visit. Safety measures assessed were the incidence of serious adverse events (SAEs), vital signs, and physical examinations. Hospitalization for AF-related inpatient procedures, such as cardioversion or initiation of treatment with an AAD, was recorded as an SAE using the United States Food and Drug Administration’s reporting requirements.
Results
Of 1,535 patients enrolled, 1,461 had analyzable data ( Figure 1 ) and constituted the all-enrolled population, 50% of which came from 50 of the 248 participating sites. The per-protocol cohort consisted of 1,110 patients (76%) from the all-enrolled population who met all inclusion and exclusion criteria. Among the all-enrolled population, 804 (55%) completed the 1-year follow-up visit. Of those who discontinued prematurely, 31% did not have a fifth visit, 15% were lost to follow-up, 14% violated exclusion or inclusion criteria (16% for rhythm control and 9% for rate control), and 10% withdrew consent. Figure 1 shows the flow of patients through the study along with a breakdown of specific reasons classified as “other” for premature discontinuation. Table 1 lists patient characteristics for the all-enrolled cohort. Overall, 34% of patients had newly diagnosed AF, and 80% had PAF. Symptoms were present in 71% of patients with PerAF, while 77% of patients with PAF reported symptoms. In patients with symptoms, PerAF was more likely than PAF to be associated with dyspnea (55% vs 43%), fatigue (51% vs 41%), and exercise intolerance (29% vs 19%). PAF was more likely than PerAF to be associated with palpitations (70% vs 50%) and/or chest discomfort (23% vs 16%).
| Variable | Rhythm Control (n = 942) | Rate Control (n = 519) | Total (n = 1,461) |
|---|---|---|---|
| Age (years) | |||
| Mean ± SD | 65.4 ± 13.18 | 67.9 ± 13.25 | 66.2 ± 13.25 |
| Range | 23–94 | 20–95 | 20–95 |
| 18–44 | 76 (8.1%) | 32 (6.2%) | 108 (7.4%) |
| 45–64 | 321 (34.1%) | 146 (28.1%) | 467 (32.0%) |
| 65–79 | 416 (44.2%) | 250 (48.2%) | 666 (45.6%) |
| ≥80 | 129 (13.7%) | 91 (17.5%) | 220 (15.1%) |
| Men | 513 (54.5%) | 271 (52.2%) | 784 (53.7%) |
| Women | 429 (45.5%) | 248 (47.8%) | 677 (46.3%) |
| Race | |||
| Caucasian/white | 858 (91.1%) | 467 (90.0%) | 1,325 (90.7%) |
| African American | 41 (4.4%) | 17 (3.3%) | 58 (4.0%) |
| Hispanic | 26 (2.8%) | 16 (3.1%) | 42 (2.9%) |
| Asian/Pacific Islander | 6 (0.6%) | 12 (2.3%) | 18 (1.2%) |
| Native American | 1 (0.1%) | 4 (0.8%) | 5 (0.3%) |
| Other | 10 (1.1%) | 3 (0.6%) | 13 (0.9%) |
| Duration of AF (months) | |||
| Mean ± SD | 22.8 ± 54.56 | 31.1 ± 65.04 | 25.8 ± 58.61 |
| Median | 1.9 | 6.4 | 3.1 |
| Range | 0.0–776.4 | 0.0–729.2 | 0.0–776.4 |
| Duration categories of AF (months) | |||
| <3 | 516 (54.8%) | 208 (40.1%) | 724 (49.6%) |
| ≤3 and <12 | 128 (13.6%) | 86 (16.6%) | 214 (14.6%) |
| ≥12 | 298 (31.6%) | 225 (43.4%) | 523 (35.8%) |
| AF types (not mutually exclusive) | |||
| Lone AF | 158 (16.8%) | 68 (13.1%) | 226 (15.5%) |
| AF with hypertension | 240 (25.5%) | 148 (28.5%) | 388 (26.6%) |
| Newly diagnosed | 347 (36.8%) | 148 (28.5%) | 495 (33.9%) |
| Recurrent paroxysmal | 775 (82.3%) | 390 (75.1%) | 1,165 (79.7%) |
| Recurrent persistent | 149 (15.8%) | 124 (23.9%) | 273 (18.7%) |
| Other | 16 (1.7%) | 8 (1.5%) | 24 (1.6%) |
| PAF | n = 775 | n = 390 | n = 1,165 |
| Symptomatic | 606 (78.2%) | 290 (74.4%) | 896 (76.9%) |
| Asymptomatic | 169 (21.8%) | 100 (25.6%) | 269 (23.1%) |
| PerAF ⁎ | n = 149 | n = 142 | n = 273 |
| Symptomatic | 117 (78.5%) | 77 (62.1%) | 194 (71.1%) |
| Asymptomatic | 32 (21.5%) | 47 (37.9%) | 79 (28.9%) |
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