CHICAGO—For high-risk STEMI patients receiving thrombolysis at non-PCI centers, urgent transfer and PCI within six hours is associated with significantly less ischemic complications and no excess in bleeding, according to the preliminary results of TRANSFER-AMI (Trial of Routine ANgioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute MI), which were presented on Sunday during the SCAI-ACCi2 Late Breaking Clinical Trials at the 2008 American College of Cardiology (ACC) Scientific Sessions.
Warren J. Cantor, MD, medical director of the interventional and invasive program at the Southlake Regional Health Centre in Newmarket, Ontario, and colleagues undertook the study to compare a pharmacoinvasive strategy of transfer for routine PCI within six hours after fibrinolysis with standard treatment after fibrinolysis, including predefined criteria for rescue PCI.
“There’s good reason to believe that performing PCI after thrombolytic therapy is safer and more effective now than in previous studies,” said Cantor. “It’s an important question, because more than 75 percent of hospitals in North America don’t have PCI facilities.”
TRANSFER-AMI is the largest randomized trial to investigate this question, according to Cantor.
For the study, Cantor and his colleagues enrolled 1,060 high-risk patients with STEMI. All patients initially sought treatment at a hospital without PCI capability and were treated with tenecteplase. These patients were then randomly assigned to urgent transfer for PCI within six hours, or to standard therapy, consisting of observation for 60 to 90 minutes, with transfer for PCI only in the case of continuing chest pain or other evidence of treatment failure.
For the primary endpoint of 30-day death, re-MI, congestive heart failure, severe recurrent ischemia and shock, the preliminary results found that the standard treatment arm (496 patients) has 16.6 patients experienced these events, while in the pharmacoinvasive arm (508 patients) 10.6 patients experienced.
The study will continue to evaluate 30-day combined rates of death, repeat heart attack, recurring ischemia, heart failure and shock in the two groups of patients.
“Many hospitals have difficulty getting patients to the cath lab within the recommended 90 minutes, but six hours is a much more realistic goal,” Cantor said. “If routine PCI is clearly superior to standard therapy in the TRANSFER-AMI trial, then all institutions that use thrombolysis for treating STEMI will need to develop strategies to get those patients to a cardiac catheterization laboratory within six hours.”
Cantor concluded that transfers to PCI centers should be initiated immediately after thrombolysis without waiting to see whether reperfusion is successful.
He also said that “regional systems should be developed to ensure timely transfers of STEMI patients to PCI centers.”