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Benefits and Risks of Abciximab Use in Primary Angioplasty for Acute Myocardial Infarction: The Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) Trial

J. E. Tcheng, DE Kandzari, CL Grines, DA Cox, MB Effron, E Garcia, JJ Griffin, G Guagliumi, T Stuckey, M Turco, M Fahy, AJ Lansky, R Mehran, GW Stone

Circulation 2003;108:1316-1323

The Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial was a large, randomized, open-label, multicenter study that examined the efficacy and safety of abciximab (ReoPro, Centocor and Eli Lilly) and coronary stenting in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (MI). The authors present the abciximab-specific end point results at 30 days (as defined in the protocol) and extend these observations to 1 year. 2082 patients sustaining an acute MI were randomized to receive 1 of 4 reperfusion strategies: (1) balloon percutaneous transluminal coronary angioplasty (PTCA), (2) PTCA with abciximab, (3) MultiLink stent implantation (Guidant Corporation), or (4) MultiLink stent implantation with abciximab.
In a multivariable Cox regression model that examined 30-day and 1-year major adverse cardiac events (MACE), there was no significant interaction between stenting and abciximab treatment (p=0.4 for 30 days; p=0.9 for 1 year). At 30 days, the primary abciximab composite end point was reduced from 7.0% to 4.6% with abciximab treatment (p<0.0001 for noninferiority; p=0.01 for superiority). Abciximab significantly reduced the rates of recurrent ischemia, subacute thrombosis, ischemic target vessel revascularization (TVR), and all TVR within 30 days. Among the 4 treatment groups, ischemic TVR within 30 days was required in 5.6% of patients after PTCA alone, 3.2% after stenting alone, 3.4% after PTCA with abciximab, and 1.6% with stenting with abciximab (4-way p=0.004; compared with stenting with abciximab, p<0.001 versus PTCA alone and p<0.05 versus PTCA with abciximab). Abciximab also reduced the 30-day incidence of subacute thrombosis (2.0% after PTCA only, 1.0% after stenting only, 0.8% after PTCA with abciximab, and 0.0% after stenting with abciximab [p=0.01]). The 30-day rates of the component events (death, reinfarction, or disabling stroke) did not differ significantly among the 4 treatment strategies relative to abciximab therapy.

Results were similar, but somewhat less strong, when analysis was performed by actual treatment received. By 12 months, abciximab was no longer associated with significant differences in the composite incidence of MACE (16.9% with abciximab versus 18.4% with control, p=0.3) because late events accrued almost equally in both groups. A weak trend was still present for fewer TVR procedures in abciximab-assigned patients; the absolute difference in TVR rates between the 2 treatment groups at 30 days (1.9% by intention-to-treat analysis) persisted at 1 year (2.2%). No major subgroups seemed to benefit preferentially from abciximab treatment, except for possibly patients with right coronary artery MI. In a logistic regression model for 1-year MACE that incorporated infarct size, abciximab treatment, and their interaction term, this benefit remained statistically significant (p=0.0485).

Abciximab therapy was safe; no patient sustained an intracranial hemorrhage, and moderate or major bleeding was not increased. Mild thrombocytopenia was increased by abciximab treatment. Transfusion requirements were increased with abciximab treatment in the as-treated analysis, possibly related to the use of bailout abciximab in patients treated with higher levels of heparin anticoagulation, but not by intention to treat. Of 900 patients eligible for follow-up protocol angiography at 7 months, 656 (73%) underwent the procedure. Compared with patients not randomized to abciximab, the rates of restenosis, infarct artery reocclusion, and degree of myocardial salvage were unaffected by abciximab treatment.

The authors conclude: "In conclusion, when abciximab is started immediately before primary PCI in acute MI, the likelihood of a successful procedural outcome and freedom from 30-day MACE is enhanced. The predominant effect of abciximab is in reducing early ischemia, abrupt vessel closure, and subacute thrombosis over the short term. Because the late composite event rate is dominated by restenosis, the relative benefit of this early, fixed treatment effect diminishes over time with a consequent loss of statistical significance; between 1 and 12 months, TVR events in both treatment arms predominate and are not affected by abciximab treatment. The absolute benefits are nonetheless maintained over longer-term follow-up). Accordingly, these results confirm and clarify the complementary effects of coronary stenting and adjunctive GP IIb/IIIa inhibition with abciximab in reducing adverse events after primary PCI."

Autor: J. E. Tcheng, DE Kandzari, CL Grines, DA Cox, MB Effron, E Garcia, JJ Griffin, G Guagliumi, T Stuckey, M Turco, M Fahy, AJ Lansky, R Mehran, GW Stone

Fuente: Circulation 2003;108:1316-1323

Ultima actualizacion: 28 DE ENERO DE 2004

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