The Trial of Routine ANgioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) compared the outcome of a pharmacoinvasive strategy (transfer to a PCI centre for routine early PCI within 6 h) and a standard treatment (early transfer only for failed reperfusion, otherwise catheterisation >24 h) for high-risk STEMI patients receiving thrombolysis at non-PCI centres.
A total of 1,059 patients with high-risk ST-segment elevation myocardial infarction (STEMI), presenting at non-PCI centres within 12 h of onset of symptoms, were randomised to a pharmacoinvasive strategy (transfer for routine PCI within 6 h of fibrinolysis; n=537) or to standard treatment after fibrinolysis (n=522). All patients received aspirin, tenecteplase, and heparin or enoxaparin; concomitant clopidogrel was recommended.
Patients were transferred urgently by land or air ambulance to a participating PCI centre as soon as possible and underwent coronary angiography and PCI of the infarct-related artery within 6 h of fibrinolysis, regardless of chest pain, ST-elevation, or coronary flow.
Patients had a repeat electrocardiogram 60 to 90 min after randomisation and were transferred for rescue PCI only if they had persistent chest pain and <50% ST-segment resolution, or if they became haemodynamically unstable. Otherwise, patients remained at the enrolling hospital and did not undergo cardiac catheterisation within the first 24 h. Elective cardiac catheterisation within the first 2 weeks was encouraged but not mandated.
TRANSFER-AMI: Study design
The 30-day primary endpoint was a composite of death, re-infarction, recurrent ischaemia, new or worsening congestive heart failure (CGF), and cardiogenic shock.
The secondary endpoints included death or re-infarction at 6 months.
The 30-day clinical outcomes support the "pharmacoinvasive" strategy over the standard "wait-and-see" strategy for high-risk STEMI patients receiving thrombolysis at non-PCI centres.
The early routine PCI group was associated with a significant reduction in the primary endpoint (11.0% versus 17.2% for standard treatment; relative risk 0.64; 95% confidence interval [CI] 0.47 to 0.87; p=0.004). There were reductions in re-infarction, recurrent ischaemia and new or worsening congestive heart failure (CHF) in the early routine PCI group; however the study was not powered to detect these differences.
There were more mild bleeding events (according to GUSTO criteria) in the early PCI group (13.0% versus 9.0%, p=0.04) but no differences in moderate or severe bleeding. There were no differences in major or minor bleeding events as assessed by the TIMI criteria.
At 6 months, the rates of re-infarction and death did not differ significantly between the two groups.
TRANSFER-AMI: Primary endpoint at 30 days
TRANSFER-AMI: secondary outcomes at 30 days
- For high-risk STEMI patients receiving thrombolysis at non-PCI centres, routine transfer and PCI within 6 h was associated with a reduction in the primary endpoint, a 30-day composite of death, re-infarction, recurrent ischaemia, new or worsening congestive heart failure (CHF), and cardiogenic shock.
- Transfer to PCI centres should be initiated immediately after thrombolysis without waiting to see whether reperfusion is successful.
- Regional systems should be developed to ensure timely transfers of STEMI patients to PCI centres.
- Cantor, WJ, Fitchett, D, Borgundvaag, B, et al. Routine early angioplasty after fibrinolysis for acute myocardial infarction. N Engl J Med 2009;360:2705-2718.
- Cantor, WJ, Fitchett, D, Borgundvaag, B, et al. Rationale and design of the Trial of Routine ANgioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI). Am Heart J 2008;155:19-25.