RESUMEN
Abciximab therapy during primary percutaneous coronary intervention (PCI) has shown to ameliorate left ventricular (LV) function recovery in patients with ST elevated myocardial infarction. High-dose bolus tirofiban has similar effect on platelet inhibition. Whether this is associated with comparable efficacy on LV function recovery remains unclear. We sought to evaluate the impact on LV function of high-dose bolus tirofiban or abciximab in patients undergoing primary PCI with the predictors of favorable (> or = 50%) LV ejection fraction (EF) and LV function recovery at 30 days. We studied 314 patients (abciximab n = 154; tirofiban n = 160) undergoing primary PCI in the randomized Facilitated Angioplasty with Tirofiban or Abciximab (FATA) Trial. LVEF was assessed within 48 hours and at 30 days after primary PCI. In patients with systolic dysfunction at baseline, LV function recovery was defined by either increase of LVEF > or = 10% compared with baseline or LVEF > or = 50%. Similar LVEF was observed in the 2 groups postprocedure (abciximab 49.7 +/- 10.1% vs tirofiban 49.3 +/- 10.1%, p = 0.9) and at 30 days (abciximab 53.1 +/- 9.8% vs tirofiban 52.5 +/- 10.2%, p = 0.6). Independent predictors of 30-day LVEF > or = 50% were preprocedure Thrombolysis In Myocardial Infarction flow class >0 (odds ratio = 2.4, 95% confidence interval 1.32 to 4.34), anterior location (odds ratio = 0.25, 95% confidence interval 0.15 to 0.42), and age (odds ratio = 0.97, 95% confidence interval 0.95 to 0.99). Preprocedure Thrombolysis In Myocardial Infarction flow grade >0 was the only predictor of LV function recovery (odds ratio = 6.73, 95% confidence interval 2.69 to 16.88). In conclusion, this study showed no difference in LV function recovery in patients undergoing primary PCI treated either with abciximab or high-dose bolus tirofiban. Preprocedure Thrombolysis In Myocardial Infarction flow grade >0 seems to be the most important predictor of favorable LVEF and LV function recovery at 30 days.
Asunto(s)
Angioplastia Coronaria con Balón , Anticuerpos Monoclonales/farmacología , Fragmentos Fab de Inmunoglobulinas/farmacología , Infarto del Miocardio/terapia , Inhibidores de Agregación Plaquetaria/farmacología , Tirosina/análogos & derivados , Función Ventricular Izquierda/efectos de los fármacos , Abciximab , Anciano , Anticuerpos Monoclonales/uso terapéutico , Terapia Combinada , Electrocardiografía , Femenino , Humanos , Fragmentos Fab de Inmunoglobulinas/uso terapéutico , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Tirofibán , Resultado del Tratamiento , Tirosina/farmacología , Tirosina/uso terapéuticoRESUMEN
AIMS: To test the equivalence of high-dose bolus (HDB) tirofiban vs. abciximab during primary percutaneous coronary intervention (PPCI) in terms of ST-segment resolution (STR). METHODS AND RESULTS: The FATA trial (Facilitated Angioplasty with Tirofiban or Abciximab) was a prospective, multicentre, open-label trial that enrolled 692 patients with ST-segment elevation myocardial infarction (STEMI) undergoing PPCI. Patients were randomized 1:1 to receive abciximab (n = 341) or HDB tirofiban (n = 351). Primary endpoint was the rate of complete (> or =70%) STR 90 min after first balloon inflation. Thirty-day incidence of major bleedings, death, re-infarction and new revascularizations was also evaluated. Baseline characteristics of the two groups were well-balanced, with the exception of previous MI rates (tirofiban 6% vs. abciximab 2.6%, P = 0.03). The procedure was successful in 96.7% of the abciximab and in 96.6% of the tirofiban cohort (P = 0.94). Complete STR was obtained in 67.05% of the tirofiban and 70.45% of the abciximab group (Delta -3.4%, 95% confidence interval -10.35 to +3.56), which falls beyond the predefined Delta +/- 10% equivalence boundaries. Rates of secondary endpoints were similar between the two groups. CONCLUSION: This study failed to show the equivalence of HBD of tirofiban and abciximab as adjunctive therapy to PPCI.