Stenting combined with abciximab significantly reduced the 6-month rate of death, MI, or target-vessel revascularization to 13.0% compared with 25.2% for stent-placebo (P=0.005).
RCT (n=491)
Yes
Does stenting combined with abciximab reduce the 6-month composite of death, MI, or TVR compared to stenting with placebo or balloon angioplasty with abciximab in diabetic patients?
The combination of stenting and abciximab significantly reduces 6-month rates of death, MI, and TVR in diabetic patients compared to stenting alone or balloon angioplasty with abciximab.
Absolute Event Rate: 13% vs 25.2%
p-value: p=0.005
BACKGROUND: Stenting likely decreases the need for target-vessel revascularization procedures in diabetic patients compared with balloon angioplasty. However, the efficacy of stenting with platelet glycoprotein IIb/IIIa blockade has not yet been assessed in diabetics. METHODS AND RESULTS: We analyzed the outcomes of 491 diabetic patients within the multicenter Evaluation of Platelet IIb/IIIa Inhibitor for Stenting Trial (EPISTENT). Diabetic patients were a prospectively defined subset: 173 were randomized to stent-placebo, 162 to stent-abciximab, and 156 to balloon angioplasty-abciximab. The main end point for this analysis was combined 6-month death, myocardial infarction (MI), or target-vessel revascularization (TVR). The composite end point occurred in 25.2% of stent-placebo, 23.4% of balloon-abciximab, and 13.0% of stent-abciximab patients (P=0.005). Abciximab therapy, irrespective of revascularization strategy (stent or balloon angioplasty), resulted in a significant reduction in the 6-month death or MI rate: 12.7% for stent-placebo, 7.8% for balloon angioplasty-abciximab, and 6.2% for the stent-abciximab group (P=0.029). The 6-month TVR rate was 16.6% for stent-placebo, 18.4% for balloon-abciximab, and 8.1% for stent-abciximab (P=0.021). Compared with stent-placebo, stent-abciximab therapy was associated with a significant increase in angiographic net gain (0.88 versus 0.55 mm; P=0.011) and a decrease in the late loss index (0.40 versus 0.60 mm; P=0.061). The 1-year mortality rate for diabetics was 4.1% for stent-placebo and 1. 2% for stent-abciximab patients (P=0.11). CONCLUSIONS: The combination of stenting and abciximab therapy among diabetics resulted in a significant reduction in 6-month rates of death, MI, and TVR compared with stent-placebo or balloon-abciximab therapy.
Marso et al. (Tue,) conducted a rct in Diabetes Mellitus (n=491). Stent-abciximab vs. Stent-placebo and balloon angioplasty-abciximab was evaluated on Combined 6-month death, myocardial infarction (MI), or target-vessel revascularization (TVR) (p=0.005). Stenting combined with abciximab significantly reduced the 6-month rate of death, MI, or target-vessel revascularization to 13.0% compared with 25.2% for stent-placebo (P=0.005).