PTCA: 2 studies, of which one was a small pilot study (number of patients not given) and the other included more than 2,000 patients.
Unstable angina: one pilot study (number of patients not given).
MI: one study with 60 patients.
PTCA: the small pilot study suggested that abciximab reduced the incidence of restenosis following PTCA. The large trial showed that abciximab was associated with a 35% reduction in deaths and cardiac events within 30 days (p=0.008). There are 3 comparison groups in the large trial: placebo (n=696), abciximab bolus alone (n=695), and abciximab bolus plus infusion group (n=708). The death rate within 30 days did not differ significantly between groups (1.7 versus 1.3 versus 1.7%). The difference between the placebo and the abciximab bolus alone groups was not statistically significant for nonfatal MI (8.6 versus 6.2%), rate of repeat PTCA (4.5 versus 3.6%) and coronary artery bypass graft (3.6 versus 2.3%). Compared with the placebo group, the abciximab bolus plus infusion group had a significantly lower rate of nonfatal MI (8.6 versus 5.2%, p<0.05) and PTCA (4.5 versus 0.8%, p<0.05).
Unstable angina: the pilot study showed a lower incidence of ischaemia with intravenous abciximab (p=0.06).
MI: the single study found a lower incidence of ischaemia in patients receiving m7E3 Fab, with a similar risk of bleeding in the two groups.
Adverse effects: in the MI trial, treatment with abciximab was associated with an increased risk of bleeding and an increased need for transfusions. Thrombocytopenia was also more common, as was the need for platelet infusions (p<0.001). Human antimurine antibody production was more frequent with m7E3 Fab fragments than with abciximab.