Results of the TRANSFER AMI study published in NEJM

June 25, 2009: The TRANSFER-AMI Trial Investigators reported today in the New England Journal of Medicine that among ST-segment elevation myocardial infarction (STEMI) patients treated with fibrinolysis, routine early adjunctive PCI is superior to delayed rescue angioplasty.

While in many community hospitals without cardiac catheterization facilities fibrinolytic therapy is the standard of care , the Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI Trial) sought to investigate the safety and efficacy of transferring high risk STEMI patients to angioplasty centers within 6 hours of drug treatment. It should be noted that this was not a trial of facilitated PCI: in a trial of facilitated PCI all patients would be treated with PCI and the trial would test whether adjunctive therapy prior to the PCI improved outcomes. This was a trial instead in which all patients received fibrinolysis, and the question was whether an early PCI could improve the outcomes with a lytic agent. PCI was performed either early in all patients (routine adjunctive PCI) or late in only those select patients who failed fibrinolysis (rescue angioplasty).

In this open label, active control, parallel assignment, safety/efficacy study, 1059 high risk STEMI patients presenting at Canadian hospitals unable to perform PCI were randomized either to immediate transfer for routine PCI within 6 hours after fibrinolysis (routine early adjunctive PCI arm, n=537) or to rescue or delayed PCI only when fibrinolytic therapy failed (standard therapy arm, n=532). Patients in both treatment strategy arms were administered tenecteplase, aspirin and unfractionated heparin or enoxaparin prior at presentation in the emergency department. The primary endpoint was a 30 day composite of all cause death, reinfarction, recurrent ischemia, heart failure or cardiogenic shock. The secondary endpoint was incidence of major/severe bleeding (according to TIMI and GUSTO classifications) within 30 days.

Compared to standard treatment, routine early adjunctive PCI was associated with an absolute reduction in the primary endpoint from 17.2% (n=90) to 11.0% (n=59), which translates to a relative risk reduction of 0.64 (95% Confidence Interval [CI]: 0.47 – 0.87, p=0.004). Rates of TIMI major or severe GUSTO bleeding did not significantly differ between treatment strategy arms (6.1% versus 7.4% for standard and routine early PCI groups respectively, p=0.39). While much of the benefit in the composite endpoint was driven by a reduction in recurrent ischemia, there was also a reduction in new onset heart failure. There were trends toward a benefit in recurrent MI.

This trial adds to a growing body of literature that demonstrates that among patients treated with fibrinolysis for STEMI, routine, early transfer of all patients for adjunctive PCI is superior to a strategy of delayed transfer for rescue PCI among those select patients who have failed fibrinolysis.

Slides

For the slides presented at ACC 2008, click here.