Abstract 6178: Trial of Routine ANgioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) - Six Month Outcomes
Patients who present with ST-elevation myocardial infarction to hospitals without percutaneous coronary intervention (PCI) often cannot undergo primary PCI in a timely manner and therefore receive fibrinolysis. The role and optimal timing of routine PCI after fibrinolysis, using contemporary stents and pharmacotherapy, has not been studied in a large adequately powered randomized trial. To compare a pharmacoinvasive strategy of transfer for routine PCI within 6 hrs after fibrinolysis with standard treatment after fibrinolysis (including predefined criteria for rescue PCI). Pts presenting to non-PCI centres with STEMI within 12 hrs of symptom onset and with high-risk features were randomized to a pharmacoinvasive strategy (transfer for PCI within 6 hrs of fibrinolysis) or to standard treatment after fibrinolysis (which included rescue PCI as required for ongoing chest pain and < 50% resolution of ST-elevation at 60 –90 minutes). For standard treatment pts who did not require rescue PCI, cardiac catheterization was encouraged beyond 24 hrs. All pts received ASA and antithrombin therapy (unfractionated heparin or enoxaparin for age <75 yrs); use of upfront clopidogrel was strongly encouraged; all other therapies were left to the discretion of the treating physician. The primary endpoint was the 30-day composite of death, reinfarction, recurrent ischemia, heart failure or shock. All patients were contacted at 6-months and 1-year for death and reinfarction, and all events were independently adjudicated. 1,059 pts were enrolled as of December 31, 2007. The preliminary 30-day results were recently presented, showing a 45% reduction in the primary endpoint with the pharmacoinvasive strategy (10.6% vs. 16.6%, p=0.01), with no difference in major bleeding complications. This study is the largest randomized trial to date comparing a pharmacoinvasive strategy with standard care after fibrinolysis. The 6-month outcomes will demonstrate whether the significantly lower rates of ischemic complications seen with the pharmacoinvasive strategy at 30-days are sustained and translate into lower rates of death or reinfarction at 6 months.