June 15, 1995Circulation
Bleeding Complications With the Chimeric Antibody to Platelet Glycoprotein IIb/IIIa Integrin in Patients Undergoing Percutaneous Coronary Intervention
Key result
c7E3 Fab therapy increases major bleeding ~221% vs placebo during high-risk angioplasty.
- P<.001
- n=2,099
Why the study?
Does c7E3 Fab increase bleeding complications in patients undergoing high-risk percutaneous coronary intervention?
Population
2099 patients with high-risk clinical or lesion morphological characteristics undergoing percutaneous…
Comparison
c7E3 Fab bolus plus placebo infusion, or c7E3… vs Placebo bolus plus placebo infusion, with…
Design
RCT, randomized to receive placebo bolus plus placebo infusion, c7E3 Fab bolus…
Authors
Discussion
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Implication
Elevates bleeding risk awareness for c7E3 Fab in high-risk PCI; confirms the ischemic benefit-safety trade-off in EPIC.
Study Design
Type
RCT (n=2,099)
Randomization
Randomized
Structured PICO
Does c7E3 Fab increase bleeding complications in patients undergoing high-risk percutaneous coronary intervention?
P
Population
2099 patients with high-risk clinical or lesion morphological characteristics undergoing percutaneous coronary revascularization
I
Intervention
c7E3 Fab bolus plus placebo infusion, or c7E3 Fab bolus plus c7E3 Fab infusion, with periprocedural aspirin and intravenous heparin continued for a minimum of 12 hours after the procedure
C
Comparator
Placebo bolus plus placebo infusion, with periprocedural aspirin and intravenous heparin continued for a minimum of 12 hours after the procedure
O
Outcome
Bleeding complications (transfusions, decreased hemoglobin, and an index including both parameters)safety
Main Result
Absolute Event Rate: 10.6% vs 3.3%
p-value: p=<.001
The use of c7E3 Fab during high-risk PCI significantly increases periprocedural bleeding complications compared to placebo, though most are transient and well tolerated.
Cite This Study
Aguirre et al. (1995) conducted an RCT in High-risk percutaneous coronary revascularization (n=2,099). c7E3 Fab vs. Placebo bolus plus placebo infusion was evaluated on Major bleeding complications unrelated to bypass surgery (p=<.001). c7E3 Fab therapy during high-risk angioplasty significantly increased major bleeding complications compared to placebo (10.6% for bolus plus infusion vs 3.3% for placebo, P<0.001).