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Brief Description

The Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) study was an international multi-center double-blind randomized placebo-controlled study evaluating the 180/2.0 regimen of INTEGRILIN in 10,948 patients. INTEGRILIN was added to aspirin and heparin and continued until hospital discharge or for up to 72 hours (or up to 96 hours if a coronary intervention was performed towards the end of the 72 hour period). The primary composite endpoint of death or MI at 30 days was significantly reduced in patients randomized to receive INTEGRILIN therapy (14.2% in INTEGRILIN treated patients versus 15.7% in the placebo-treated patients, p=0.04).

Subsequent analysis of the PCI population from PURSUIT has provided some encouraging results to support the use of higher doses of INTEGRILIN during PCI. In PURSUIT, PCI was performed according to physician practices. For patients undergoing PCI within 72 h ours after randomization (n=1,250), there was a 5% absolute reduction in the 30-day incidence of the primary composite endpoint among those treated with INTEGRILIN, as compared with placebo (11.8% versus 16.8%, p=0.01).(16) These results suggest that INTEGRILIN is effective when administered in the PURSUIT 180/2.0 regimen in patients undergoing PCI. However, it is important to interpret these results with caution; this subset was defined based on a post-randomization, so the analysis may be subject to selection bias.

Power calculation

The maximum sample size is 4691 patients per arm (9382 total). This will provide 80% power to detect a difference between the control group event incidence (MI or death) of 8.0% and an Integrilin group incidence of 6.4%, a relative reduction of 20%.

References

The PURSUIT Trial Investigators. Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes without persistent ST-segment elevation. N Engl J Med. 1998; 339:436-443. (You can obtain a copy by going to www.nejm.org and registering.)