PCI with and without Abciximab after Upstream Eptifibatide Use: Outcomes in High-Risk Patients
- Volume 18 - Issue 12 - December, 2006
- Posted on: 8/1/08
- 1 Comments
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There was a significantly higher percentage of patients with acute or MI (within 7 days before the index PCI) in the EA group compared to the EE group: 80% versus 53%; p < 0.001. Meaningful differences in procedural characteristics between the two treatment groups included a greater degree of lesion complexity, including a greater number of ACC Type-B2 and C lesions, and lesions containing thrombus in the EA group compared to the EE group. The clinical and procedural characteristics of the two groups stratified by clinical presentation are shown in Table 1. Significant differences in baseline patient and procedural characteristics between the two treatment groups were present in the unstable angina patients, reflecting the strategy of use of abciximab in patients with higher-risk lesion and procedural characteristics. Baseline characteristics in the subgroup of patients with MI were reasonably similar between the two treatment groups.
For the entire study population, the change in overall platelet count from baseline to after PCI was not statistically different for either treatment group. The average decrease in hemoglobin postprocedure was 1.0 g/dl in both treatment groups; p = 0.284. TIMI bleeding rates were similar for the two treatment groups: 4.1% EA versus 2.6% EE; p = 0.25. The incidence of any vascular complications was comparable for the two treatment groups. No adverse events occurred in-lab for either of the two treatment groups. The in-hospital outcomes for patients stratified by clinical presentation are shown in Table 2. In-hospital outcomes for both treatment groups in patients with unstable angina paralleled the overall outcomes outlined above and were not significantly different. For the MI subgroup, overall MACE was lower for EA, 0.9%, than for EE, 4.3%; p = 0.017.
For the entire study population, overall MACE at 30 days was 4.8% for the EE group and 4.2% for the EA group (p = 0.66), and at 1 year, overall MACE rates were similar (25.2% for the EE group and 26.0% for the EA group; p = 0.82). The early and late clinical outcomes following PCI stratified by clinical presentation are shown in Table 3. Kaplan-Meier plots of MACE-free, MI or death-free and revascularization-free survival for patients stratified by clinical presentation and treatment group are shown in Figure 2. In patients with unstable angina, overall MACE at 30 days was lower for the EE group (3.4%) than for the EA group (10.0%) because of a significantly higher rate of nontarget revascularization in the EA group compared to the EE group. At 1 year, overall MACE remained lower in the EE group than the EA group (23.9% vs. 41.7%, respectively; p = 0.013), primarily because of a lower rate of revascularization during follow up in the EE group than in the EA group (20.3% vs. 33.3%, respectively; p = 0.054). In patients with MI, overall MACE was similar at 30 days in the two treatment groups, although recurrent MI or death was lower in the EA group than in the EE group (0.9% vs. 4.4%, respectively; p = 0.017). At 1 year, overall MACE was nonsignificantly lower in the EA group than in the EE group (21.7% vs. 26.3%, respectively; p = 0.285). At 1 year, there was a significantly lower incidence of recurrent MI or death in the EA group than in the EE group (6.9% vs. 15.6%, respectively; p = 0.007).