Экстрасистолы? Ну и что? Большое дело!

[Gilarov]

Все что мне известно об AFFIRM:
Protocol Summary
The purpose of this study was to compare two standard treatment strategies for atrial fibrillation (AF): ventricular rate control plus anticoagulation versus rhythm control plus anticoagulation.

Disease or Condition
Atrial Fibrillation

Interventions
Patients were treated with warfarin and then randomly assigned to one of two groups: rhythm control or rate control.

Among patients randomized to the rhythm control strategy, the choice of anti-arrhythmic drug was left to the discretion of the primary treating physician. Changes in doses and/or classes of agents were permitted, and repeat cardioversion(s), focal AF ablations, and pacemakers were allowed. The most common anti-arrhythmic drugs used were amiodarone (39%), sotalol (33%), and propafenone (10%). There were frequent changes in the anti-arrhythmic drug regimen, and amiodarone was ultimately administered to 60% of study patients. Anticoagulation could be discontinued if sinus rhythm was maintained for one month.

Among patients randomized to the rate control strategy, therapy consisted primarily of digoxin (51%), beta-blockers (49%), and calcium-channel antagonists (41%).

Gender: Male/Female

Eligibility Criteria
Patients with atrial fibrillation at high risk for stroke (greater than 65 years of age) or patients less than 65 with one or more other risk factors for stroke (such as systemic hypertension, diabetes mellitus, congestive heart failure, transient ischemic attack, or prior cerebral vascular accident) were enrolled. Cardioversion was permitted prior to randomization; patients were excluded if it was unsuccessful.

Study Type: Clinical Trial
Study Design: Prospective, Randomized, Controlled, Multicenter
Study Phase: III

Study Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Locations/Contact
Dr. D. George Wyse, Lead Investigator
Professor of Medicine, Division of Cardiology
University of Calgary
Calgary, AB, Canada
[Ссылки доступны только зарегистрированным пользователям ]

H. Leon Greene, Study Chair
Statistics and Epidemiology Research Corporation (SERC)
Seattle, Washington

Start Date: 31-MAR-1995
End Date: 30-SEP-2002

Recruiting Status: This study is no longer recruiting patients.

Study ID: 100

Study Results
Results of this study were presented on March 18th, 2002 at the American College of Cardiology 51st Annual Scientific Sessions in Atlanta, Georgia.

The AFFIRM trial enrolled 4060 patients (mean age 69.7, 39% female). Seventy-one percent had a history of hypertension, 38% had coronary artery disease, 17% had a previous myocardial infarction, 23% had a history of congestive heart failure, and 24% had abnormal left ventricular (LV) function. 90% of patients in the rate control group and 70% of patients in the rhythm control group remained on warfarin throughout the study.

The primary end point was total mortality, analyzed by intention-to-treat. Secondary end points included composite end points (total mortality, disabling intracranial bleed [subdural and/or subarachnoid hemorrhage], stroke [embolus, thrombosis, hemorrhage], disabling anoxic encephalopathy, cardiac arrest, major noncentral nervous system bleed), cost of therapy, and quality of life. Mean followup was 5 years.

At the end of follow-up, 60% of patients in the rhythm control arm and 35% of patients in the rate control arm were in sinus rhythm. Successful rate control was achieved in 80% of patients in the rate control arm.

In the rhythm control group, crossover rates were 15% during the first year and 5% each following year. In the rate control group, the crossover rate was 5% each year. 302 patients in the rate control group died, compared with 353 patients in the rhythm group. This translates into a 76% survival in the rhythm group and a 79% survival in the rate control group.

Seventy percent of strokes in the rate control arm and 80% of strokes in the rhythm control arm occurred in patients who either stopped warfarin or had an INR below 2.0. The number of strokes in the rhythm control was slightly, but not significantly, greater than that in the rate control arm.

There were more hospitalizations in the rhythm control arm. There were 15 episodes of Torsade de pointes, significantly more in the rhythm control arm (13 versus 2). In addition, there were also a 17 episodes of bradycardic cardiac arrests and these were also more frequent in the rhythm control arm (14 versus 3). There was no difference between groups in the number of cardiac arrests due to ventricular tachycardia or fibrillation.

There was no significant difference between groups in the composite endpoint of death plus disabling stroke, anoxic encephalopathy, resuscitated cardiac arrest and major bleeding to death.

Baseline characteristics: More than 7,400 patients at more than 200 North American hospitals and clinics qualified for enrollment in the AFFIRM Study. A total of 4,060 patients were enrolled in the AFFIRM Study. The average age of patients enrolled was 70 years, with 39% female and 89% white. Hypertension was present in 71%. Coronary artery disease was present in 38%. Echocardiography was performed in 3311 patients, and results showed normal ventricular function in 68% and normal left atrial size in 33%. Most patients with recurrent episodes had symptoms with atrial fibrillation. Approximately one third of patients were enrolled with a first episode of atrial fibrillation.

Investigators conclude that the patients in the AFFIRM Study were representative of patients at high risk for complications from atrial fibrillation, which indicates that the results of this large clinical trial will be relevant to patient care (Am Heart J 2002;143:991-1001)

Commentary
Commentator: Benjamin Trichon, MD
There are now two prospective, randomized studies (AFFIRM and RACE) that provide important information to guide the clinician in managing patients with AF. Both studies suggest that a strategy of rate control with anticoagulation is acceptable and safe and is at least equivalent to the strategy of cardioversion and maintenance of sinus rhythm with anti-arrhythmic medications. The latter strategy may be associated with a higher rate of stroke, likely related to the discontinuation of therapeutic anticoagulation therapy after restoration of sinus rhythm.

In the past, reasons for restoration and maintenance of sinus rhythm among patients with AF included the relief of symptoms, prevention of embolism, improvement in quality of life, and prevention of LV dysfunction related to the tachycardia. The results of these trials suggest no advantage (and possible harm) with this strategy, with a similar quality of life and lower rate of thromboembolism among patients receiving rate control and anticoagulation.

These results may be less applicable to younger patients and those with intolerable symptoms related to their AF. Refractory symptoms and the prospect of very long-term anticoagulation may make the strategy of restoration of sinus rhythm more attractive in these patient groups. However, both studies suggest that long-term anticoagulation is necessary to prevent thromboembolic events among patients in whom sinus rhythm is restored. The optimal duration of this anticoagulation is unknown. For patients with AF, the strategy of rate control and anticoagulation is safe and effective and does not appear to be associated with a poor quality of life and an excessive rate of thromboembolism. For patients who are eligible for both rate control and rhythm control strategies, the use of rate control and anticoagulation is supported by the findings of these trials. March 2002

Reproduced with permission of the American Heart Journal.

Publications
Wyse DG, Anderson JL, Antman EM, et al. Atrial fibrillation follow-up investigation of rhythm management. The AFFIRM study design. Am J Cardiol 1997;79:1198-1202.

Waldo AL for the AFFIRM Investigators: Management of Atrial Fibrillation: The Need for AFFIRMative Action. Am J Cardiol 1999;84:698-700.

Wyse DG: The AFFIRM Trial: Main Trial and Substudies-What Can We Expect? J Interv Card Electrophysiol 2000;4 Suppl 1:171-176.

Highlights from the American College of Cardiology Annual Scientific Sessions 2002: March 17 to 20, 2002. Am Heart J 2002;In Press.

The AFFIRM Investigators. Baseline characteristics of patients with atrial fibrillation: the AFFIRM Study. Am Heart J 2002;143(6):991-1001

[Участковый]

На странице 122 в "Progress in Cardiovascular Diseases" доказывается преимущество электрокардиоверсии над фармакологической?

[Gilarov]

Наоборот. Там, правда, не то чтобы доказывается, а скорее просто говорится, что медикаментозный метод лучше.

[Участковый]

Не могли бы Вы привести цитату?

Надо ехать в больницу. Поступил пациент с инсультом. Пока.

[Gilarov]

Based on American, European, and recent international consensus guidelines, emergent DCC is the conversion method of choice in hemodynamically unstable AF patients with serious signs or symptoms such as presyncope, hypotension, pulmonary edema, or an acute coronary syndrome.[8] [10] DCC is associated with efficacy rates of 67% to 94%.[11] Lower conversion rates have been reported in older patients with a longer duration of AF and/or dilated left atrium.[12] [13] However, potential drawbacks of DCC are the need for anesthesia; adverse cardiovascular effects, such as hypotension, sinus arrest, heart block, bradycardia, ventricular tachycardia or fibrillation, and pacemaker malfunction; skin burns; pain; aspiration risk; or pulmonary edema.[11] Thus, for elective cardioversion, drug therapy may be preferred.

[Участковый]

Возможно Вы правы, при элективной кардиоверсии можно предпочесть медикаментозный метод. Это хороший источник. Наверное, многое зависит и от индивидуального опыта кардиолога.

[Участковый]

Значит, согласно AFFIRM, контроль ЧСС с варфарином при мерцательной аритмии несколько лучше поддержки синусового ритма кордароном/соталолом.

То есть только с молодыми можно попытаться восстановить ритм, да и то, все равно, продолжать варфарин.

Гм.

[Участковый]

Как раз попался случай, когда надо избавиться от кордарона у матери Татьяны в разделе "Форумы по специальностям > Заболевания щитовидной железы > Вопросы и ответы по заболеваниям щитовидной железы > Узловатый зоб щитовидной железы"