Primary percutaneous coronary intervention ( PCI ) is more effective than fibrinolytic therapy for ST-segment elevation acute myocardial infarction ( STEMI ), but time to intervention can be considerable.
Researchers investigated whether the administration of full-dose Tenecteplase ( Metalyse/ TNKase ) before a delayed PCI could mitigate the negative effect of this delay.
The patients with STEMI of less than 6 h duration ( scheduled to undergo primary PCI with an anticipated delay of 1-3 h ) were assigned to standard PCI ( n=838 ) or PCI preceded by administration of full-dose Tenecteplase ( n=829 ).
All patients received Aspirin and a bolus, without an infusion, of unfractionated Heparin.
The primary endpoint was death or congestive heart failure or shock within 90 days.
Researchers planned to enroll 4000 patients, but early cessation of enrollment was recommended by the Data and Safety Monitoring Board because of a higher in-hospital mortality in the facilitated than in the standard PCI group ( 6% vs 3%, p=0.0105 ).
Of those enrolled, six were lost to follow-up in the facilitated PCI group and seven in the other group.
Median time from randomisation to first balloon inflation was similar in both groups.
The median time from bolus Tenecteplase to first balloon inflation was 104 min.
The primary endpoint was achieved in 19% of patients assigned facilitated PCI versus 13% of those randomised to primary PCI ( relative risk 1.39; p=0.0045 ).
During hospital stay, significantly more strokes ( 1.8% vs 0, p