OBJECTIVE: Whether patients with renal insufficiency (RI) undergoing percutaneous coronary interventions (PCI) benefit fromabciximab added to clopidogrel plus aspirin is unknown. METHODS: The study included 2,159 patients with coronary artery disease undergoing elective PCI. RI was assessed using glomerular filtration rate (GFR) cutoff values: moderate-to-severe RI (GFR <or=60 ml/min), mild RI (GFR >60 to <or=90 ml/min) and no RI (GFR >90 ml/min). The 30-day incidence of major adverse cardiac events (MACE) and bleeding were the primary outcome analyses. RESULTS: In patients with moderate-to-severe RI, mild RI and no RI, MACE occurred in 5.2, 5 and 2.9%, respectively, in the abciximab group (p = 0.14) and in 4.2, 3.8 and 4.0%, respectively, in the placebo group (p = 0.96). In the abciximab group, bleeding complications occurred in 8.9% of patients with moderate-to-severe RI, in 2.0% with mild RI and in 2.1% with no RI (p < 0.001). Multivariable analysis identified GFR as an independent correlate of MACE (p = 0.03) and bleeding (p = 0.001) with a trend for an interaction between GFR and abciximab regarding major bleeding (p = 0.22). CONCLUSIONS: In patients with RI undergoing PCI, addingabciximab to clopidogrel plus aspirin increases the risk of bleeding without benefit in reducing the risk of ischemic complications within the first 30 days. Copyright 2008 S. Karger AG, Basel.
RCT Entities:
OBJECTIVE: Whether patients with renal insufficiency (RI) undergoing percutaneous coronary interventions (PCI) benefit from abciximab added to clopidogrel plus aspirin is unknown. METHODS: The study included 2,159 patients with coronary artery disease undergoing elective PCI. RI was assessed using glomerular filtration rate (GFR) cutoff values: moderate-to-severe RI (GFR <or=60 ml/min), mild RI (GFR >60 to <or=90 ml/min) and no RI (GFR >90 ml/min). The 30-day incidence of major adverse cardiac events (MACE) and bleeding were the primary outcome analyses. RESULTS: In patients with moderate-to-severe RI, mild RI and no RI, MACE occurred in 5.2, 5 and 2.9%, respectively, in the abciximab group (p = 0.14) and in 4.2, 3.8 and 4.0%, respectively, in the placebo group (p = 0.96). In the abciximab group, bleeding complications occurred in 8.9% of patients with moderate-to-severe RI, in 2.0% with mild RI and in 2.1% with no RI (p < 0.001). Multivariable analysis identified GFR as an independent correlate of MACE (p = 0.03) and bleeding (p = 0.001) with a trend for an interaction between GFR and abciximab regarding major bleeding (p = 0.22). CONCLUSIONS: In patients with RI undergoing PCI, adding abciximab to clopidogrel plus aspirin increases the risk of bleeding without benefit in reducing the risk of ischemic complications within the first 30 days. Copyright 2008 S. Karger AG, Basel.