In this randomized, prospective and multicentre trial 897 adult patients of both sexes suffering from
unstable angina were included. All patients also received oral
aspirin and adequate anti-anginal treatment as per their individual needs. Patients in
unfractionated heparin group received
unfractionated heparin as an intravenous bolus of 5000 IU followed by an
intravenous infusion of 800 to 1000 IU/hour for 48 hours, followed by 5000 IU subcutaneously every 6 hours for 5 days. The patients in the other group were treated with
parnaparin sodium 6400 IU subcutaneously once daily for 7 days. In the
unfractionated heparin group there were 446 patients (310 males, 136 females) with a mean age of 55.9 + 12.27 years and in
parnaparin group 451 patients (312 males, 139 females) with a mean age of 57.6 +/- 11.19 years. Both the groups were similar with respect to age and sex (p = 0.89 and 0.068, respectively). The associated cardiovascular risk factors such as diabetes,
hypertension,
dyslipidemia, previous
myocardial infarction and previous
coronary artery bypass grafting/percutaneous transluminal coronary angioplasty were similar in both the groups. At the end of 7 days, the primary end points (death,
myocardial infarction, or need for
myocardial revascularization) were reported in 33 (7.32%) patients in
parnaparin group and 51 (11.43%) patients in
unfractionated heparin group. This difference was statistically significant. At the end of 30 days, data from 330 patients from
parnaparin group and 334 patients from
unfractionated heparin group was available for analysis. The cumulative event rate of primary end points at the end of 30 days was reported in 40 (12.12%) patients in
parnaparin group and in 73 (21.86%) patients in
unfractionated heparin group. This difference was statistically significant. Two episodes of major
bleeding each were reported in both the groups. Minor
bleeding was reported by 12 (2.66%) patients in
parnaparin group and by 115 (25.8%) patients in
unfractionated heparin group. This difference was statistically significant.
CONCLUSIONS: