Bleeding complications during warfarin treatment in primary healthcare centres compared with anticoagulation clinics.

OBJECTIVES

To examine determinants of bleeding complications during warfarin treatment in an unselected patient population and evaluate possible differences in safety between specialized anticoagulation clinics and primary healthcare centres.

DESIGN

Prospective cohort study. Data were collected with an admission form and medical records were scrutinized in order to pursue all adverse events. Differences between groups were estimated with a t-test and chi-squared test, and univariate and multivariate Cox regression analysis.

SETTING

All patients treated and monitored with oral anticoagulation in primary healthcare centres and specialized anticoagulation clinics in the Sundsvall and Skellefteå region (northern Sweden) during a five-year period.

SUBJECTS

A total of 2731 patients corresponding to 5044 treatment years.

MAIN OUTCOME MEASURES

Bleedings were classified as fatal or major. Major bleedings were defined as an event causing admission, prolonged in-hospital care or death.

RESULTS

In total 195 major bleedings occurred corresponding to 3.9% per treatment year, including 34 fatal events (0.67% per treatment year). Patients monitored at the two specialized anticoagulation clinics combined had a major bleeding frequency of 4.1% as compared with 3.9% at primary healthcare units. The frequency of fatal haemorrhage was 0.57% and 0.76%, respectively. The rate of major and fatal bleeding was age related with an increase of 4% and 5%, respectively, per year.

CONCLUSIONS

There was no difference in bleeding complications between patients monitored at primary healthcare centres and specialized anticoagulation clinics. Age was continuously and independently associated with bleeding risk. These study data indicate the need to exercise caution in treatment of the elderly.