Copyright © 1993 by the European Society of Cardiology.
© 1993 The European Society of Cardiology
Double-blind randomized trial of alteplase versus placebo in patients with chest pain at rest
Regional Medical Cardiology Centre, Royal Victoria Hospital Belfast BT12 6BA, N. Ireland
Received 8 December 1992; revised 17 May 1993; .
Correspondence Professor A A J Adgey, Regional Medical Cardiology Centre, Royal Victoria Hospital, Belfast BT12 6BA, N. Ireland
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 for 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.
At 6-month follow-up, 17 patients were readmitted to hospital with cardiac causes (eight in the alteplase-treated group and nine in the placebo-treated group). A further two patients died before 6-month review, one in the alteplase group and one in the placebo group.
Alteplase treatment for patients with chest pain at rest does not significantly improve culprit vessel patency or reduce in-hospital or long-term cardiac event rates. Thus, alteplase cannot be recommended as an adjuvant to conventional therapy in patients presenting with rest pain and EGG changes of ST segment depression.
Key Words: Chest pain at rest • thrombolytic therapy
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