Early Initiation Of INTEGRILIN(R) (Eptifibatide) for Heart-Attack Patients in Emergency Department Achieved Superior Coronary Artery Blood Flow
Saturday November 12, 3:14 pm ET
DALLAS, Nov. 12 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) today announced that results from the Time to Integrilin Therapy in Acute Myocardial InfarctioN -Thrombolysis In Myocardial Infarction (TITAN)- TIMI-34 study, indicated that the early initiation of INTEGRILIN® in the emergency department prior to percutaneous coronary intervention (PCI) for acute ST-segment-elevation myocardial infarction (STEMI) yielded superior coronary artery blood flow, as assessed by TIMI frame counts, the study's primary endpoint. Also, superior myocardial perfusion, as assessed by TIMI myocardial perfusion grade, was found by early initiation of INTEGRILIN, compared to initiation in the cardiac catheterization laboratory. Results from the study were presented during a symposium hosted by the Texas Heart Institute, on Saturday, Nov. 12, 2005.
"The longer a patient has poor blood flow to the heart, the higher the risk of cardiovascular damage," said C. Michael Gibson, MD, Brigham and Women's Hospital and principal investigator in the TITAN-TIMI-34 study. "Since delays in restoring blood flow via angioplasty are frequent, this trial demonstrated that the strategy of early intervention in the emergency department with INTEGRILIN improved blood flow prior to angioplasty," added Dr. Gibson.
INTEGRILIN is approved for use in ACS (UA/NSTEMI), and patients undergoing PCI, but is not approved for use in STEMI patients.
Time to Integrilin Therapy in Acute Myocardial InfarctioN (TITAN)-TIMI-34 study
TITAN was a Phase IV, randomized, open-label, multicenter trial designed to evaluate the efficacy of early initiation of INTEGRILIN in 343 patients undergoing primary PCI for acute STEMI. The primary endpoint of the trial was the Corrected TIMI Frame Count (CTFC).
The study demonstrated that early initiation of INTEGRILIN in the emergency department prior to primary PCI for STEMI, produced statistically significant faster blood flow through the blocked artery. The time required for blood to go through the artery, as assessed by TIMI Frame Count, sped up significantly from 84.3 frames among those treated later in the catheterization lab to 77.5 frames (p=0.049) among those treated early in the emergency department. In addition, the percentage of patients with normal blood flow into the heart muscle itself (normal TIMI myocardial perfusion grade) improved from 14.2 percent among patients treated later in the catheterization laboratory to 24.3 percent (p=0.026) among those treated earlier in the emergency department.
These improvements in blood flow and perfusion did not come at the expense of any increase in TIMI major or minor bleeding, which was 6.9 percent among those treated early in the emergency department versus 7.8 percent among those treated later in the catheterization laboratory. Specifically, in this study, there were no strokes or intracranial hemorrhages.
"These study results add to a growing body of evidence about the potential value of early initiation of INTEGRILIN in ACS patients," said Robert J. Spiegel, MD, chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.
The Texas Heart Institute symposium was supported, in part, by an unrestricted educational grant from Schering-Plough. |
