Results of the EPICA Study (Elderly Patients followed by Italian Centres for Anticoagulation Study), were presented at the ESC Congress 2011 today. This is the largest study on very old patients anticoagulated with Vitamin K antagonists for the prevention of venous thromboembolism and, for the major part (75%), for the prevention of stroke because affected by atrial fibrillation.
All studied patients started the anticoagulant treatment after the age of 80 years, and the median age of studied patients was 84 years, ranging from 80 to 102 years. Fear of bleeding is the major concern for Vitamin K antagonist prescription, in particular in very old patients who carry many risk factors for bleeding. This study demonstrates a low rate of bleeding complications, notwithstanding the particularly advanced age of the patients, suggesting that age in itself should not be considered a contraindication to this treatment.
The prevalence of atrial fibrillation is strongly dependent on age and is present in nearly 10% of subjects after the age of 80 years. Given the aging of the population in western countries, the number of individuals with AF is likely to increase substantially in the next few years. Atrial fibrillation increases the risk of stroke 4 -fold, across all age groups, and it is estimated that the percentage of stroke attributable to atrial fibrillation rose up to 23.5% in the age group of 80 to 89 year-olds.
In the EPICA study, all patients were followed-up for anticoagulation management by specifically devoted Centres and showed a good quality of anticoagulation. Centres in this study, routinely practiced patient education, including explaining the purposes of treatment, risk of complications and information about laboratory controls.
"Actually, we know that well informed patients carry a lower risk for adverse events during anticoagulant treatment. Family members and care givers are also involved in the education programme. Due to the variable effect of oral anticoagulants that is present among the individuals and over time also for the single subject, patients receive a detailed prescription of daily dosages and the indication for the subsequent visits. The good management of anticoagulation probably explains the low bleeding risk recorded in this study," explained Dr Daniela Poli, from Thrombosis Centre AOU Careggi Firenze –Italy.
The EPICA study shows that the use of the 'old' Vitamin K antagonists is beneficial for very old people. "This is interesting especially now, because we are waiting for the 'new' oral anticoagulant drugs, that will be marketed in Europe in the next few months. No information is available at the moment for their use in very old people. In addition, it should be noted that renal failure is one of the main risk factors for bleeding and our study outlined also that the major part of very old patients have a severe or moderate renal insufficiency, that is known to get worse with age. Unlike 'old' anticoagulants, the 'new' ones have a prevalent renal route of excretion and are contraindicated in renal failure. Therefore, a large group of old patients should be carefully monitored over time to detect worsening of renal function that not infrequently happens for intercurrent illnesses, such as infection or heart failure," said Dr Poli.
This large study on very old patients on VKA treatment, showed that the rate of bleeding complications was low, suggesting that age in itself should not be considered a contraindication to treatment. An adequate management of VKA therapy with the careful monitoring of patients, in specifically trained Centres, allows very old and frail patients to benefit from VKA thromboprophylaxis.