Experiencing the EAST – AFNET 4 trial - Perspective of a patient

“Your heart is beating completely irregularly and at almost 110 times per minute. We must record an ECG,” Frank W.’s GP found when he examined him in January. The 58-year-old was surprised, as he had come to the doctor’s office because of an erectile dysfunction which had recently started to bother him. By then, he had not noticed any heart problems. He didn’t feel any shortness of breath, pain or weakness. Only his physical work as a carpenter was tiring him somewhat more than usual. The ECG confirmed the GP’s suspicion: atrial fibrillation, the most common type of arrhythmia. Further medical examinations revealed high blood pressure and an enlarged left atrium.

In atrial fibrillation, the heart suddenly loses its rhythm. The arrhythmia is not directly life-threatening, but it can cause severe complications. When atrial fibrillation is present, the blood in the left atrium is not mixed well and blood clots may form. If such a blood clot travels through the blood stream into the brain, it may there block a blood vessel - causing a stroke.

His GP prescribed Frank W. the anticoagulant Warfarin and additionally a beta blocker to lower his blood pressure and to control his heart rate. Most patients during atrial fibrillation have a heartbeat that is not only irregular but also much too fast. As long-standing tachycardia can damage the myocardium, the heart rate must be controlled by medication to keep it within the normal range – a resting heart rate below 100 beats per minute. “This does not stop the fibrillation. But many patients live well with atrial fibrillation, if the main risks are eliminated this way,” the physician explained.

And Frank W. is not alone. Several million people in Europe are affected by atrial fibrillation. And the number of patients is rising. In many cases, if the symptoms caused by atrial fibrillation are not too severe, therapy mainly consists of the following: anticoagulant treatment to reduce the risk of stroke, treatment of possible concomitant diseases such as high blood pressure, and a rate control therapy to protect the cardiac muscle – as recommended in the current guidelines for the treatment of atrial fibrillation.

However, many experts are not content with this approach, as the data are alarming. Atrial fibrillation is associated with an increased risk of death, not only if the arrhythmia is left untreated, but even if it is treated according to the guidelines. While for most other heart diseases, for example heart attack, the number of deaths has declined over the past years due to better treatments, patients with atrial fibrillation still have an increased risk to die earlier.
Here it is where the EAST – AFNET 4 trial comes in and puts the treatment strategy recommended so far to the test. EAST – AFNET 4 stands for Early treatment of Atrial fibrillation for Stroke prevention Trial. The study evaluates whether an early restoration of the sinus rhythm in addition to anticoagulation can prevent complications more effectively than usual care.
Since he was first diagnosed with atrial fibrillation, Frank W. has been seeing his GP routinely. As with all warfarin patients, his blood coagulation value (INR) had to be checked at regular intervals. In the meantime he has become familiar with INR self-testing – the most reliable way to achieve good INR control. His blood pressure and his heart rate were well controlled by the beta blocker. Frank W., however, was a bit worried, as his atrial fibrillation was still present, at least sometimes.

In May he consulted a cardiologist to get information about further treatment options. “You can participate in the EAST – AFNET 4 trial. This study is to test the benefit of an early and comprehensive treatment and needs people like you who have experienced atrial fibrillation only for a short time, that is to say, no longer than one year,” the cardiologist suggested and explained to him what is involved in participating in the trial.

The first step is that all patients are randomized into one of two groups, either receiving early rhythm control therapy or usual care. Usual care normally covers the kind of treatment Frank W.’s had received so far. Only if symptoms of atrial fibrillation, such as chest pain or shortness of breath, are seriously affecting the patient’s wellbeing, additional measures are taken. In contrast, in the early rhythm control therapy group the study doctor uses all available treatment options to stop atrial fibrillation as early as possible and to restore the normal heart rhythm and maintain it permanently, if possible. When patients are assigned to this study group, their atrial fibrillations will be terminated by cardioversion – an electric shock produced by a defibrillator – or by an antiarrhythmic drug.

During the study, all patients of this group are equipped with a card-sized ECG telemetry device which enables them to daily record an ECG and to transmit it over the phone to the central trial office for analysis. In this way, it is ensured that any recurrence of atrial fibrillation is soon detected. In the case of recurrence, further treatment measures are initiated immediately to restore the normal heart rhythm. If, for example, an antiarrhythmic drug becomes less effective over time, the patient promptly receives another more efficient medicine. In some patients, early catheter ablation may be performed, if necessary. During this procedure, the area of heart tissue where the arrhythmia starts is destroyed.
“Antiarrhythmic drug treatment and ablation are associated with complications. But these treatments can eliminate atrial fibrillation or at least suppress it for some time and, in doing so, may prevent severe secondary diseases. The shorter atrial fibrillation exists, the higher the chance of success,” the cardiologist explains.

Frank W., with new hope to get rid of his atrial fibrillation, decides to participate in the EAST – AFNET 4 trial and, by sheer coincidence, is assigned to the early rhythm control group. Following a thorough medical examination, which confirms that he is currently experiencing atrial fibrillation, he undergoes cardioversion with concomitant antiarrhythmic therapy with flecainide. Unfortunately, the intervention is not successful and his atrial fibrillation soon recurs. He then receives the more efficient antiarrhythmic drug amiodarone. This time, the treatment is successful, finally putting an end to his atrial fibrillation.

Like all EAST – AFNET 4 patients, Frank W. is going to be monitored for a period of several years, with scheduled follow-up examinations once every year. So far, his atrial fibrillation has not returned. He is doing well and even his erectile dysfunction has improved. “Should the arterial fibrillation come back one day,  I'll be more than willing to undergo further treatments, maybe ablation too.“

The EAST – AFNET 4 trial started in July 2011. About 200 hospitals and practices are participating in 11 European countries. The EAST – AFNET 4 trial is conducted by the German Atrial Fibrillation NETwork (AFNET) in cooperation with the European Heart Rhythm Association (EHRA) as a scientific partner and with financial support of the companies Sanofi and St. Jude Medical and the German Heart Foundation. www.easttrial.org

For the EAST – AFNET 4 trial more patients are still in demand. Study participation will offer them an intense and close monitoring. If you recently started having atrial fibrillation and you are interested in participating in the trial, please contact the following address:

Phone: +49 251 980 1330