Abstract 3009: Major Subgroup Analyses from the FINESSE Trial: Evaluation of Abciximab + Half -Dose Reteplase, Abciximab Alone, or Placebo for Facilitation of Primary PCI for ST Segment Elevation MI
Introduction: Whereas primary PCI is the preferred reperfusion strategy for acute ST elevation MI if performed promptly, treatment delays are common.
Methods: We tested the hypothesis in a randomized placebo-controlled double-blind trial of 2452 subjects from 20 countries that early pharmacologic therapy with half dose reteplase and abciximab, followed by PCI would improve the outcome in ST elevation MI patients presenting within 6 hours of symptom onset with anticipated first medical contact to catheterization time of 1– 4 hours, relative to patients receiving abciximab at the time of primary PCI; with a third randomized arm of early abciximab to better evaluate the contribution of reteplase to the combination therapy. The primary study endpoint was a composite of all cause mortality, ventricular fibrillation beyond 48 hours, cardiogenic shock or heart failure requiring re-hospitalization or an emergency room visit within 90 days. A major secondary endpoint was % ST segment resolution (>70%) 60 –90 min after randomization. Final patient enrollment was completed December 30, 2006, and 90 day follow up results will be available fall 2007.
Results: Enrollment demographics are as follows: mean age = 62 years (16% ≥75), 26% female, 10% Killip II-IV, 11% prior MI, 16% diabetics, 48% anterior MI and 61% enrolled ≤ 3h after symptom onset. The median times from symptom onset to randomization, and randomization to first balloon inflation by tertiles were 1.5, 2.6, and 4.4 hours and 1.2, 1.8, and 2.6 hours, respectively. Pre specified subgroup analyses for the primary and major secondary study endpoints included time from symptom onset to randomization (≥3 vs >3 hours), randomization time to first balloon inflation (by tertiles), Killip Class (I vs II-IV), gender, age (<75 vs ≤75 years), history of prior MI, diabetes, and anterior vs non-anterior MI.
Conclusion: The findings from these analyses will supplement the primary study results from this, the largest randomized trial of facilitated angioplasty, to help define the proper management of this important group of high-risk patients.