Double-blind randomized trial of alteplase versus placebo in patients with chest pain at rest
M J Roberts1, A J McNeill, G W Dalzell
1Regional Medical Cardiology Centre, Royal Victoria Hospital, Belfast, N. Ireland.
Insights
Early treatment with alteplase for rest chest pain did not improve vessel patency or reduce cardiac events. This study found no significant benefit of thrombolytic therapy in patients with acute myocardial infarction symptoms.
Area of Science:
- Cardiology
- Thrombotic Therapy
- Acute Coronary Syndromes
Background:
- Rest chest pain indicates a high risk of myocardial infarction and sudden death.
- Early thrombolytic treatment efficacy for rest pain remains unproven.
- Standard care involves screening before entering trials for rest angina.
Purpose of the Study:
- To evaluate the clinical efficacy of early thrombolytic treatment with alteplase in patients experiencing chest pain at rest.
- To assess the impact of alteplase on vessel patency, lesion morphology, and in-hospital cardiac events.
Main Methods:
- Eighty patients with rest chest pain and ST depression were randomized to alteplase or placebo.
- All patients received concomitant heparin and aspirin therapy.
- Coronary angiography was performed within 72 hours for patency and lesion assessment.
Main Results:
- Alteplase treatment did not significantly increase ischaemia-related vessel patency (81% vs 78%).
- Culprit lesion morphology was more concentric in the alteplase group (84% vs 56%), but stenosis severity was not reduced.
- No significant difference in in-hospital cardiac events (death, myocardial infarction, revascularization) was observed between groups.
Conclusions:
- Early thrombolytic treatment with alteplase did not demonstrate significant clinical benefits in patients with rest chest pain and ECG changes.
- The study suggests that alteplase may not be superior to placebo in improving angiographic outcomes or reducing short-term cardiac events in this patient population.
Abstract:
Patients who have chest pain occurring at rest are at a significant risk of myocardial infarction and or sudden death. Most trials enter patients with anginal rest pain after an initial screening period. Thus, the clinical efficacy of early thrombolytic treatment for patients with rest pain remains unproven. Eighty patients with chest pain at rest and with ECG changes of ST depression of at least 1 mm in any ECG lead, were randomized to alteplase 100 mg infused over 3 h, or placebo. Concomitantly, all patients received intravenous heparin and 300 mg of aspirin daily (unless contra-indicated). Seventy-four patients had coronary angiography (the majority within 72 h of admission) of which 73 were assessable. The patency of the ischaemia-related vessel was not significantly greater in the alteplase treated group (81% vs 78%, P = 0.82). The culprit lesion morphology tended to be more concentric in the alteplase treated group (84% vs 56%, P = 0.06) although alteplase treatment was not associated with a significant reduction in the severity of the culprit lesion stenosis. Intra-coronary thrombi were detected in 7% of patients (3% placebo, 11% alteplase, P = 0.35). The mean left ventricular ejection fraction or the alteplase-treated group was 49 +/- 3% and for the placebo-treated patients 56 +/- 3% (P = 0.05). There was no difference in the total in-hospital cardiac event rate i.e. cardiac death, myocardial infarction and coronary revascularization between patients receiving alteplase (10%, 63%, and 38%) and those receiving placebo (8%, 65%, and 30%) respectively.(ABSTRACT TRUNCATED AT 250 WORDS)
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