Sustained suppression of ischemic complications of coronary intervention by platelet GP IIb/IIIa blockade with abciximab: one-year outcome in the EPILOG trial. Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade.
BACKGROUND
Blockade of the platelet glycoprotein IIb/IIIa receptor with the monoclonal antibody fragment abciximab was shown in a placebo-controlled randomized trial to reduce the incidence of acute ischemic complications within 30 days among a broad spectrum of patients undergoing percutaneous coronary revascularization. The durability of clinical benefit in this setting has not been established.


RESULTS
A total of 2792 patients enrolled in the Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade (EPILOG) trial were followed with maintenance of double-blinding for 1 year. Patients had been assigned at the time of their index coronary interventional procedure to receive placebo with standard-dose, weight-adjusted heparin (100 U/kg initial bolus), abciximab with standard-dose, weight-adjusted heparin, or abciximab with low-dose, weight-adjusted heparin (70 U/kg initial bolus). The primary outcome was the composite of death, myocardial infarction, or urgent repeat revascularization by 30 days; this composite end point and its individual components were also assessed at 6 months and 1 year. Rates of any repeat revascularization (urgent or elective), target vessel revascularization, and a composite of death, myocardial infarction, or any repeat revascularization were also reported. Follow-up at 1 year was 99% complete for survival status and 97% complete for other end points. By 1 year, the incidence of the primary composite end point was 16.1% in the placebo group, 9.6% in the abciximab with low-dose heparin group (P<0.001), and 9.5% in the abciximab with standard-dose heparin group (P<0.001). Each of the components of this composite end point was reduced to a similar extent. Nonurgent or target vessel repeat revascularization rates were not significantly decreased by abciximab therapy. Mortality rates over 1 year increased with increasing levels of periprocedural creatine kinase MB fraction elevation.


CONCLUSIONS
Acute reductions in ischemic events after percutaneous coronary intervention by abciximab are sustained over follow-up to at least 1 year. Early periprocedural myocardial infarctions suppressed by this therapy are associated with long-term mortality rates.
Lincoff
A M
AM
Departments of Cardiology or Biostatistics and Epidemiology, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
Tcheng
J E
JE
Califf
R M
RM
Kereiakes
D J
DJ
Kelly
T A
TA
Timmis
G C
GC
Kleiman
N S
NS
Booth
J E
JE
Balog
C
C
Cabot
C F
CF
Anderson
K M
KM
Weisman
H F
HF
Topol
E J
EJ
D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000706:statistics & numerical data; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D015415:Biomarkers; D002423:Cause of Death; D003131:Combined Modality Therapy; D001026:Coronary Artery Bypass / Q000706:statistics & numerical data; D003327:Coronary Disease / Q000150:complications / Q000201:enzymology / Q000628:therapy*; D003402:Creatine Kinase / Q000097:blood; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004630:Emergencies; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D015994:Incidence; D007527:Isoenzymes; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000517:prevention & control; D017202:Myocardial Ischemia / Q000401:mortality / Q000517:prevention & control*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011446:Prospective Studies; D012008:Recurrence; D016019:Survival Analysis; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D015415:Biomarkers; D007140:Immunoglobulin Fab Fragments; D007527:Isoenzymes; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D006493:Heparin; D003402:Creatine Kinase; D000077284:Abciximab