June 1, 1997
Clinical Brief
Two Trials of a New Platelet Receptor Inhibitor
The results of the platelet receptor inhibition for Ischemic Syndrome Management
(PRISM) trial and PRISM in Patients Limited to very Unstable Signs and
symptoms (PRISM-PLUS) trial were presented on March 17, 1997, at the ACC
Annual Scientific Sessions. PRISM compared 1615 patients with unstable
angina (including non-Q MI) treated with 48 hours of intravenous tirofiban
(glycoprotein IIB/IIIa blocker) to 1616 heparin treated patients. All patients
also received aspirin. PRISM patients had to have either ECG changes or
increased cardiac enzymes or a history of coronary artery disease. After
48, hours the tirofiban-treated patients exhibited a 36% reduction in the
combined primary end point of death, MI, and refractory ischemia (3.8%
tirofiban vs 5.3% on heparin). At 30 days, mortality was 39% less on tirofiban.
PRISM-PLUS patients had ECG changes or elevated cardiac enzymes. All patients
received aspirin, and 773 received tirofiban intravenously for 96 hours
vs. 797 who received only heparin. Tirofiban reduced the combined primary
end point of death, MI, and refractory ischemia at seven days by 34% and
at 30 days by 31%. Also, it decreased the risk of death and MI at seven
days by 44% and the risk of MI at seven days by 47%. The authors of both
studies concluded that tirofiban’s beneficial effect in unstable angina
was better than expected and a tremendous advance. Clearly, this is more
highly positive data on this new class of agents. While some of these agents
are available now for intravenous use in high-risk patients, their full
potential will not be realized until an oral agent is developed. —mhc