Residual thrombosis on ultrasonography to guide the duration of anticoagulation in patients with deep venous thrombosis: a randomized trial.

BACKGROUND: The optimal duration of oral anticoagulant therapy in patients with deep venous thrombosis (DVT) of the lower extremities remains uncertain. OBJECTIVE: To assess whether tailoring the duration of anticoagulation on the basis of the persistence of residual thrombi on ultrasonography reduces the rate of recurrent venous thromboembolism (VTE) compared with the administration of conventional fixed-duration treatment in adults with proximal DVT. DESIGN: Parallel, randomized trial from 1999 to 2006. Trained physicians who assessed outcomes were blinded to patient assignment status, but patients and providers were not. SETTING: 9 university or hospital centers in Italy. PATIENTS: 538 consecutive outpatients with a first episode of acute proximal DVT at completion of an uneventful 3-month period of anticoagulation. INTERVENTION: Patients were randomly assigned (stratified by center and secondary vs. unprovoked DVT by using a computer-generated list that was accessible only to a trial nurse) to fixed-duration anticoagulation (no further anticoagulation for secondary thrombosis and an extra 3 months for unprovoked thrombosis) or flexible-duration, ultrasonography-guided anticoagulation (no further anticoagulation in patients with recanalized veins and continued anticoagulation in all other patients for up to 9 months for secondary DVT and up to 21 months for unprovoked thrombosis). For the primary outcome assessment, 530 patients completed the trial. MEASUREMENTS: The rate of confirmed recurrent VTE during 33 months of follow-up. RESULTS: Overall, 46 (17.2%) of 268 patients allocated to fixed-duration anticoagulation and 32 (11.9%) of 270 patients allocated to flexible-duration anticoagulation developed recurrent VTE (adjusted hazard ratio [HR], 0.64 [95% CI, 0.39 to 0.99]). For patients with unprovoked DVT, the adjusted HR was 0.61 (CI, 0.36 to 1.02) and 0.81 (CI, 0.32 to 2.06) for those with secondary DVT. Major bleeding occurred in 2 (0.7%) patients in the fixed-duration group and 4 (1.5%) patients in the flexible-duration group (P = 0.67). LIMITATIONS: The trial lacked a double-blind design. The sample size was not powered to detect differences in bleeding between groups and to detect effectiveness of the intervention in the subgroups of patients with unprovoked and secondary DVT. Patients with previous thromboembolism, permanent risk factors for thrombosis, and thrombophilic abnormalities other than factor V Leiden and prothrombin mutation were excluded. CONCLUSION: Tailoring the duration of anticoagulation on the basis of ultrasonography findings reduces the rate of recurrent VTE in adults with proximal DVT. PRIMARY FUNDING SOURCE: None.

Blood pressure is insufficiently controlled in European patients with established coronary heart disease.

BACKGROUND: Elevated blood pressure is associated with an impaired prognosis in patients with established coronary heart disease. Adequate blood pressure control is therefore of utmost importance. We report on two successive European surveys that evaluated whether the goals given in recommendations on secondary prevention are achieved. METHODS: The first European Action on Secondary Prevention through Intervention to Reduce Events (EUROASPIRE I) survey was conducted during 1995-1996 in 21 hospitals in nine European countries. The second survey (EUROASPIRE II) was conducted during 1999-2000 in 47 hospitals (including 20 hospitals that participated in EUROASPIRE I) in 15 Europeans countries. Consecutive patients (aged < 71 years) were identified from hospital records after coronary artery bypass grafting, percutaneous coronary intervention, myocardial infarction, or myocardial ischaemia. Patients were invited for an interview and examination at least 6 months after hospitalization. During the interview, blood pressure was measured in a standardized fashion. Systolic blood pressure >/= 140 mmHg and/or a diastolic blood pressure >/= 90 mmHg were considered as elevated blood pressure. EUROASPIRE II provides a more comprehensive view on the actual management of patients with established coronary disease. Therefore, we decided to concentrate mainly on the EUROASPIRE II data, and to use EUROASPIRE I for the evaluation of time trends. RESULTS: In EUROASPIRE II, 5556 patients were interviewed, and 51% were diagnosed with elevated blood pressure. Large regional variations in the prevalence of elevated blood pressure were observed, with values ranging from 37 to 64%. Twenty-five per cent (1401) of patients were on a diet to reduce blood pressure, and among these 61% had elevated blood pressure. The prevalence of elevated blood pressure among the 4827 (87%) patients taking blood pressure-lowering medication (which was not necessarily taken as an antihypertensive treatment) was 51%. Patients with elevated blood pressure were more likely to be diabetic, hypercholesterolemic, and obese than normotensive patients. The proportion of patients who reported being aware of their hypertensive status was somewhat higher in EUROASPIRE II than in EUROASPIRE I (71 versus 67%), and the use of blood pressure-lowering medication was intensified (91 versus 85%). However, these changes were not accompanied by a decrease in the prevalence of elevated blood pressure (54 versus 55% in centres that participated in both surveys). CONCLUSION: During 1995-2000 the prevalence of elevated blood pressure in patients with established coronary heart disease remained at an unacceptably high level. Throughout Europe, still about half of coronary patients require more intensive blood pressure management.

Residual risk of cardiovascular mortality in patients with coronary heart disease: the EUROASPIRE risk categories.

BACKGROUND: The EUROASPIRE I, II and III surveys revealed high prevalences of modifiable risk factors in the high priority group of coronary patients all over Europe. The potential to further reduce coronary heart disease (CHD) morbidity and mortality rates is still considerable. We report here on the relative risk of cardiovascular disease (CVD) death associated with common modifiable risk factor levels based on the mortality follow-up of patients participating in the first two EUROASPIRE surveys. We also present a novel simple risk classification system (ERC) that can be used in the management of patients with existing CHD. METHODS: The study cohort consisted of a consecutive sample of CHD patients aged ≤ 70 years from 12 European countries. Baseline data gathered in 1995-2000 through standardized methods, were linked to cardiovascular mortality in 5216 patients according to an accelerated failure time model. RESULTS: During 28,143 person-years of follow-up, 332 patients died from cardiovascular disease denoting a CVD mortality risk of 12.3 per 1000 person-years in men and 10.2 per 1000 person-years in women. In multivariate analysis, fasting glucose, total cholesterol and smoking emerged as the strongest independent modifiable predictors of cardiovascular mortality. CONCLUSIONS: The results of the mortality follow-up of the EUROASPIRE I and II CHD patients emphasize the continuing risk from elevated glucose and total cholesterol levels and underline the importance of smoking cessation in secondary prevention. The ERC risk tool that we developed may prove helpful to obtain these goals in the setting of secondary prevention.