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Patients who took ≤3 drugs had fewer complications than patients who took more (4.3% versus 24.4%/100 patient-years; It is unknown, however, whether the risk factor by itself or other factors, such as additional drug intake, drug interaction, or other problems, are responsible for the increased complication rate.

Therefore, the present study on outpatients with AF and OAC was performed to assess (1) whether the complication rate is influenced by the presence or absence of the risk factors age 65 years, arterial hypertension, diabetes, and previous stroke; (2) whether the complication rate is influenced by the number of additional drugs and their interactions with OAC; and (3) whether the occurrence of problems and interventions during long-term OAC differs between patients with complications and patients without complications.

The present study is a substudy of the Safety in the Therapy With Oral Anticoagulants (STOA) study, an observational trial that seeks to assess problems occurring long-term OAC therapy (C. The study took place in the outpatient clinic of the Second Medical Department of the KA Rudolfstiftung.

The patients were referred for control of OAC either at discharge from the hospital or by their general practitioners or internists.

In these patients, OAC was started only if it was deemed safe by the gastroenterologist or urologist.

At each appointment the international normalized ratio (INR) value was determined in the hospital laboratory of the KA Rudolfstiftung with the use of the Thrombotest (Nycomed) and a KC 4A test (Amelung).

Immediately after the actual INR value was obtained, the patient had a personal appointment with a physician who registered in the patient’s “OAC passport” the INR value, prescribed the OAC dosage, set the date of the next appointment, and asked for problems and complications (Tables 2 and 3).

If needed, interventions and investigations were initiated by the physician.

The study period was between July 1998 and August 2000.

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