1017-68 Influence of Platelet GP IIb/IIIa Receptor Inhibition with c7E3 on the Sequelae of Dissection During Percutaneous Coronary Revascularization

Abstract

The EPIC Trial tested the efficacy of the c7E3 monoclonal antibody to the platelet GP IIbIIIa receptor in preventing ischemic events during “high-risk” PTCA or atherectomy by randomizing 2099 pts to receive placebo (PL), c7E3 bolus (BO), or c7E3 bolus + 12 hr infusion (BO + IN). BO + IN of c7E3 produced a 35% reduction in the 30-day composite primary endpoint (death, MI, urgent CABG, or re-PTCA) from 12.8% to 8.3% (p = 0.009) compared with placebo. Although c7E3 would not be expected to prevent the mechanical complication of coronary dissection, this agent may limit subsequent thrombus formation at dissection sites and thereby prevent progression to overt closure, embolization, or ischemic clinical events. The influence of c7E3 on adverse sequelae among pts who sustained dissection during EPIC was therefore investigated. Moderate (2–10 mm) or long (> 10 mm) dissections, as determined by Angiographic Core Laboratory analysis, occurred in 40.1%, 39,3%, and 42.5% of pts randomized to PL, BO, or BO + IN, respectively. Event PL (N = 278) BO IN = 273) BO + IN (N = 301) p-value Abrupt Closure 13% 7% 10% 0.080 Embolization < 1% 1% 1% 0.693 Primary Composite Endpoint 17% 12% 10% 0.025 Death 3% 1% 1% 0.510 Myocardial Infarction 12% 6% 7% 0.013 Emergency Re-PTCA 6% 5% 1% 0.002 Emergency CABG 5% 3% 3% 0.350 Although c7E3 did not significantly diminish the risk of abrupt closure or embolization among pts with moderate or long coronary dissections, potent reduction in the incidences of MI and emergency repeat revascularization may reflect ultimate stabilization of disrupted vascular segments during the post-procedural period. Further study is warranted to investigate a strategy of administration of c7E3 after coronary dissection has occurred.