1. Long-term protection from myocardial ischemic events in a randomized trial of brief integrin beta-3 blockade with percutaneous coronary intervention
- Author
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Topol, Eric J., Ferguson, James J., Weisman, Harlan F., Tcheng, James E., Ellis, Stephen G., Kleiman, Neal S., Ivanhoe, Russell J., Wang, Ann L., Miller, David P., Anderson, Keaven M., and Califf, Robert M.
- Subjects
Transluminal angioplasty -- Health aspects ,Heart attack -- Prevention ,Coronary heart disease -- Prognosis ,Monoclonal antibodies -- Health aspects - Abstract
Abciximab appears to lower the risk of heart attack, death, and additional angioplasty in patients undergoing angioplasty to open clogged coronary arteries. Abciximab is a monoclonal antibody that blocks platelet aggregation, which is one of the steps in blood clot formation. A 2- to 3-year follow-up of 2,099 patients who were given abciximab or placebo during angioplasty found that abciximab significantly reduced the rate of heart attack, death or additional angioplasty. This is important because many patients treated with angioplasty often experience a recurrence of atherosclerosis., Context. -- Abciximab, a monoclonal antibody fragment against the platelet receptor [alpha.subllb.beta.sub.3] integrin, prevents platelet aggregation. A randomized, placebo-controlled study showed that abciximab improves outcomes for patients undergoing percutaneous coronary angioplasty at 30 days and at 6 months. Objective. -- To determine whether abciximab improves outcomes 3 years after coronary angioplasty. Design. -- Double-blind, placebo-controlled, randomized trial. Setting. -- a total of 56 academic and community hospitals in the United States. Patients. -- a total of 2099 high-risk patients undergoing coronary angioplasty were randomized. Sufficient time elapsed for 2.5 years of follow-up among 2001 patients and for 3 years of follow-up among 1599 patients. Interventions. -- abciximab bolus of 0.25 mg/kg followed by infusion at 10 [mu]g/min for 12 hours; abciximab bolus of 0.25 mg/kg followed by placebo infusion; or placebo bolus followed by placebo infusion. Main Outcomes Measures. -- The primary outcome was the composite of death, myocardial infarction, or coronary revascularization. Secondary outcomes were death, myocardial infarction, or coronary revascularization individually. Subgroups having. refractory unstable angina or evolving myocardial infarction and having different elevations of creatine kinase during initial angioplasty were analyzed. Results. -- at 3 years, composite end points occurred in 41.1% of those receiving abciximab bolus plus infusion; 47.4% of those receiving abciximab bolus only; and 47.2% of those receiving placebo only (for abciximab bolus plus infusion vs placebo, P=.009). Death occurred in 6.8%, 8.0%, and 8.6%, respectively (for abciximab bolus plus infusion vs placebo, P=.20); myocardial infarction in 10.7%, 12.2%, and 13.6%, respectively (for abciximab bolus plus infusion vs placebo, P=.08); and revascularization in 34.8%, 38.6%, and 40.1%, respectively (for abciximab bolus plus infusion vs placebo, P=.02). Among those with refractory unstable angina or evolving myocardial infarction, death occurred in 5.1%, 9.2%, and 12.7%, respectively (for abciximab bolus plus infusion vs placebo, P=.01). Death rates increased as periprocedural creatine kinase levels increased. Conclusions. -- abciximab bolus with infusion given at the time of coronary angioplasty improves outcomes as long as 3 years after the procedure. JAMA. 1997;278:479-484
- Published
- 1997