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Multi-year follow-up of abciximab therapy in three randomized, placebo-controlled trials of percutaneous coronary
Eric J Topol1, A Michael Lincoff, Dean J Kereiakes
1Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA. topole@ccf.org
Insights
Platelet glycoprotein IIb/IIIa inhibitors like abciximab significantly reduce long-term mortality after percutaneous coronary intervention. This monoclonal antibody treatment offers a sustained survival benefit, improving outcomes for patients undergoing coronary procedures.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Platelet glycoprotein IIb/IIIa inhibitors are used to reduce ischemic complications during percutaneous coronary revascularization.
- Long-term follow-up data on the efficacy of these inhibitors, specifically abciximab, have been limited.
- Assessing the long-term impact on mortality is crucial for understanding the full benefit of abciximab treatment.
Purpose of the Study:
- To evaluate the long-term effects of abciximab on all-cause mortality in patients undergoing percutaneous coronary revascularization.
- To analyze data from three large-scale randomized trials (EPIC, EPILOG, EPISTENT) with extended follow-up periods.
- To determine if the observed reduction in mortality persists and potentially increases over time.
Main Methods:
- Analysis of data from 5799 patients across three double-blind, placebo-controlled randomized trials.
- Patients received either abciximab (bolus dose and 12-hour infusion) or placebo during percutaneous coronary revascularization.
- Long-term vital status follow-up was conducted for a median of 4.8 years, with primary endpoint assessed at 3 years.
Main Results:
- At 3 years, all-cause mortality was 5.0% in the abciximab group versus 6.4% in the placebo group (HR=0.78, P=0.03).
- Over a median of 4.8 years, mortality was 10.2% with abciximab compared to 12.6% with placebo (HR=0.82, P=0.01).
- Abciximab treatment demonstrated a consistent and significant reduction in all-cause mortality, approximately 20%, with an increasing absolute survival benefit over time.
Conclusions:
- Brief treatment with abciximab during percutaneous coronary intervention is associated with a significant improvement in long-term survival.
- The survival benefit of abciximab appears to increase over the extended follow-up period.
- These findings support the continued use of abciximab for reducing mortality after 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.
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