title: Multi-year follow-up of abciximab therapy in three randomized, placebo-controlled trials of percutaneous coronary revascularization.
abstract: There is considerable evidence supporting the use of platelet glycoprotein IIb/IIIa inhibitors to reduce ischemic complications of percutaneous coronary revascularization. However, long-term follow-up has been limited. In three large-scale randomized trials that tested abciximab at a uniform bolus dose and 12-hour infusion against placebo, in a double-blind fashion, a total of 5799 patients had their long-term follow-up vital status determined at a minimum of 7 years (EPIC), 4.5 years (EPILOG), or 3 years (EPISTENT) after randomization (median, 4.8 years). The prespecified primary endpoint was all-cause mortality by intention-to-treat analysis at 3 years in patients randomly assigned to a common intervention. Follow-up for 5603 of the 5799 patients was 96.6% complete at 3 years; 320 deaths had occurred by that time. After 3 years of follow-up, mortality was 6.4% in the placebo groups and 5.0% in the abciximab groups (hazard ratio [HR] = 0.78; 95% confidence interval [CI]: 0.63 to 0.98; P = 0.03). A similar reduction in mortality was observed on an intention-to-treat basis when all follow-up information was utilized after a median of 4.8 years of follow-up (n = 652 deaths): 12.6% in the placebo groups and 10.2% in the abciximab groups (HR = 0.82; 95% CI: 0.70 to 0.96; P = 0.01).Abciximab treatment reduced all-cause mortality by about 20% during long-term follow-up after percutaneous coronary intervention. The findings were similar in magnitude and consistent in direction for each of the three trials, and the absolute survival benefit appeared to increase over time. Brief intervention with this monoclonal antibody during percutaneous coronary revascularization is associated with significant improvement of long-term survival.
authors.affiliation: Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA. topole@ccf.org
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.forename: Eric A
authors.initials: EA
authors.lastname: Cohen
authors.forename: James J
authors.initials: JJ
authors.lastname: Ferguson
authors.forename: James E
authors.initials: JE
authors.lastname: Tcheng
authors.forename: Shelly
authors.initials: S
authors.lastname: Sapp
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D000077284:Abciximab; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000517:prevention & control*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016019:Survival Analysis
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D000077284:Abciximab