Abstract 2146: Drug Eluting Stents (DES) in AMI patients. Insights from FINESSE
Introduction: The use of DES in acute MI patients remains controversial. In previous smaller trials of primary PCI the outcome was somewhat variable and the possible interaction of DES with medications for facilitated PCI has not been evaluated.
Methods: FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) was a randomized, placebo-controlled, double-blind study in patients with ST elevation AMI comparing: early pharmacologic therapy with half dose reteplase and abciximab followed by PCI; early abciximab followed by PCI, or primary PCI with abciximab administered in the catheterization lab. This substudy provides unique data on outcomes of patients who received DES versus those who received bare metal stents (BMS). The primary endpoint was the composite of all cause mortality, ventricular fibrillation (beyond 48 hrs), cardiogenic shock or congestive heart failure requiring re-hospitalization or an emergency room visit within 90 days.
Results: Between August 2002 and December 2006, 2452 patients were enrolled. Overall baseline demographics were: 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. Of 2131 patients with a stent placed in the index lesion, 414 (18.2%) received a DES (sirolimus, paclitaxel or other) while 1717 (80.6%) received a BMS; heparin coated stents were used in 27 (1.3%). Overall and treatment group specific data will be presented on 90 day outcomes of patients who received DES vs BMS including data related to stent thrombosis, including reinfarction and death associated with acute and sub-acute stent thrombosis.
Conclusion: This large trial of facilitated angioplasty in AMI patients provides new important information on the safety and efficacy of DES in conjunction with various pharmacologic regimens.