Clinical question
Is early fibrinolysis followed by angiography an effective strategy for patients with STEMI presenting to hospitals without the capability to perform percutaneous coronary intervention?
Bottom line
Current guidelines recommend primary percutaneous coronary intervention (PCI) with a door-to-balloon time of 90 minutes for patients presenting with ST-segment elevation myocardial infarction (STEMI). However, this can be difficult to achieve, especially in remote areas without prompt access to PCI. This study finds that early fibrinolysis plus adjunctive antiplatelet and anticoagulant therapy followed by coronary angiography within 24 hours is effective in preventing adverse outcomes in patients presenting with recent onset symptoms of STEMI in whom PCI within 1 hour is not feasible. However, fibrinolysis therapy leads to a higher rate of ischemic strokes and intracranial bleeding, suggesting that timely PCI is still the optimal therapy for these patients. (LOE = 1b)
Reference
Study design
Randomized controlled trial (nonblinded)
Funding source
Industry
Allocation
Concealed
Setting
Inpatient (any location) with outpatient follow-up
Synopsis
Using concealed allocation, these investigators randomized 1892 patients who presented within 3 hours after onset of symptoms of STEMI but could not undergo PCI within 1 hour to receive 1 of 2 interventions: immediate transfer to a PCI-capable facility, or initial fibrinolysis treatment with tenecteplase followed by angiography within 24 hours. The fibrinolysis group also received enoxaparin and clopidogrel as adjunctive therapy. The primary endpoint was the composite of all-cause mortality, shock, congestive heart failure, or reinfarction at 30 days. Baseline characteristics were similar in the 2 groups, except for a higher frequency of previous congestive heart failure in the PCI group. Partway through the trial, the dose of tenecteplase was halved in patients 75 years or older because of a higher frequency of intracranial bleeds in this group. The median time from symptom onset to start of reperfusion therapy (either initiation of fibrinolysis or arterial sheath insertion for PCI) was shorter in the fibrinolysis group (100 minutes vs 178 minutes; P < .0001). However, one third of the patients in the fibrinolysis group required rescue PCI because of failed reperfusion. Overall, there were no significant differences detected between the 2 groups in either the primary endpoint or in the individual components of the endpoint. The fibrinolysis group had a higher rate of total hemorrhagic and ischemic strokes (1.6% vs 0.5%; P = .03).
Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.