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A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel
Adnan Kastrati1, Julinda Mehilli, Helmut Schühlen
1Deutsches Herzzentrum, Munich, Germany. kastrati@dhm.mhn.de
Insights
Abciximab did not show a clinical benefit for patients undergoing elective percutaneous coronary intervention after clopidogrel pretreatment. The study found no significant difference in major adverse events between the abciximab and placebo groups.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Assessing the efficacy of glycoprotein IIb/IIIa inhibitors in percutaneous coronary intervention (PCI).
- Evaluating abciximab's role in elective PCI following clopidogrel pretreatment.
Purpose of the Study:
- To determine if abciximab provides additional benefit in patients undergoing elective PCI pretreated with clopidogrel.
- To compare the incidence of major adverse cardiac events in patients receiving abciximab versus placebo.
Main Methods:
- A double-blind, randomized trial involving 2159 patients undergoing PCI.
- Patients received either abciximab or placebo, with all pretreated with a 600-mg dose of clopidogrel.
- Primary endpoint: composite of death, myocardial infarction, or urgent target-vessel revascularization within 30 days.
Main Results:
- No significant difference in the primary endpoint between abciximab and placebo groups (4% vs. 4%, P=0.82).
- Similar rates of myocardial infarction and major bleeding complications.
- Increased incidence of profound thrombocytopenia in the abciximab group (1% vs. 0%, P=0.002).
Conclusions:
- Abciximab offers no measurable clinical benefit within 30 days for low-to-intermediate risk patients undergoing elective PCI after high-dose clopidogrel pretreatment.
- The findings suggest routine use of abciximab in this specific patient population may not be warranted.
Background:
Whether the glycoprotein IIb/IIIa inhibitor abciximab is beneficial in patients undergoing elective percutaneous coronary intervention after pretreatment with clopidogrel is unknown.
Methods:
We enrolled 2159 patients with coronary artery disease who underwent a percutaneous coronary intervention: 1079 patients were randomly assigned in a double-blind manner to receive abciximab and 1080 patients to receive placebo. All patients were pretreated with a 600-mg dose of clopidogrel at least two hours before the procedure. The primary end point of the trial was the composite of death, myocardial infarction, and urgent target-vessel revascularization within 30 days after randomization.
Results:
The incidence of the primary end point was 4 percent (45 patients) in the abciximab group, as compared with 4 percent (43 patients) in the placebo group (relative risk, 1.05; 95 percent confidence interval, 0.69 to 1.59; P=0.82). Most adverse events were myocardial infarctions: the incidence was 4 percent (40 patients) in the abciximab group and 4 percent (41 patients) in the placebo group (P=0.91). Twelve patients (1 percent) in the abciximab group and eight patients (1 percent) in the placebo group had major bleeding complications (P=0.37). Profound thrombocytopenia occurred in 10 patients (1 percent) in the abciximab group but in none in the placebo group (P=0.002).
Conclusions:
Our data suggest that in patients at low-to-intermediate risk who undergo elective percutaneous coronary intervention after pretreatment with a high loading dose of clopidogrel, abciximab is associated with no clinically measurable benefit within the first 30 days.
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