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Randomized trial comparing stenting within 24 hours of thrombolysis versus ischemia-guided approach to thrombolysed acute myocardial infarction with ST elevation - GRACIA I
Description:
This randomized trial compared revascularization within 24 hours to ischemia-guided reperfusion therapy in patients treated with thrombolytics for acute myocardial infarction (AMI).
Hypothesis:
Ischemia-guided reperfusion therapy after thrombolytic therapy for AMI would be inferior to routine revascularization within 24 hours of thrombolytic administration.
Study Design
Study Design:
Patients Enrolled: 500
Mean Follow Up: One year
Mean Patient Age: Mean 60 ± 12 years
Female: 14
Patient Populations:
Acute ST-segment elevation MI within 12 hours and treated with fibrin-specific thrombolytic agents (accelerated dose of alteplase)
Exclusions:
Cardiogenic shock; suspicion or evidence of mechanical complication; noncardiac condition with expected survival less than one year; women with positive pregnancy test; current use of warfarin or other anticoagulant drug; active bleeding or major surgery within the past two weeks, prohibiting the use of heparin or antiplatelet therapy; aspirin, ticlopidine, clopidogrel, or heparin contraindication; known renal failure; any stroke in the past year or hemorrhagic stroke ever; inclusion in other clinical trial; known multivessel coronary artery disease not suitable for revascularization; major surgery pending in the coming year; and peripheral vascular disease prohibiting catheterization
Primary Endpoints:
Composite of death, reinfarction, or revascularization by 12 months
Secondary Endpoints:
Revascularization induced by spontaneous recurrence of ischemia during the index hospitalization; rate of ischemia-induced revascularization from discharge to one year; mortality at one year; death or reinfarction at one year; and rate of ischemia-induced readmission at one year
Drug/Procedures Used:
Patients were randomized to angiography and intervention (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) if indicated within 24 hours of thrombolysis (n=248), or to an ischemia-guided conservative approach (n=252).
Concomitant Medications:
Aspirin, beta-blockers, and heparin. Abciximab was administered in 27% of patients if visible thrombus was present.
Principal Findings:
In the interventional arm, 80% underwent stenting of the infarct-related artery. CABG was used for revascularization in 2%, and 16% were treated medically. A total of 21% of medical patients underwent angiography, and 19% underwent PCI.
The primary endpoint was lower in the interventional arm (9% vs. 21%; risk ratio [RR] 0.44, p=0.0008), with much of the reduction driven by a lower revascularization rate in the intervention arm (4% vs. 12%, RR 0.30, p=0.001), but trends in reduction of death (4% vs. 6%, RR 0.55, p=0.16) and MI (4% vs. 6%, RR 0.60, p=0.22). Length of stay was shorter in the interventional arm (7.1 days vs. 10.5 days; p=0.0001). There was no difference in the rate of major bleeding during the index hospitalization by treatment group (1.6% in each group).
Interpretation:
Among patients with ST elevation MI treated with thrombolytic therapy, routine coronary angiography and revascularization was associated with a reduction in the primary endpoint of death, MI, or revascularization at one year compared with a more conservative, ischemia-driven approach.
Earlier studies of thrombolytic therapy followed by balloon angioplasty such as TIMI II and SWIFT did not show a benefit with an invasive approach. However, these studies predated the widespread use of stents and newer antiplatelet treatments.
A concern raised by these earlier studies was a potential for increased bleeding associated with the invasive strategy. However, bleeding rates in the present trial were identical, but the number of patients was small, limiting the conclusions that can be drawn regarding safety.
References:
Fernandez-Aviles F, Alonso JJ, Castro-Beiras A, et al. Routine invasive strategy within 24 hours of thrombolysis versus ischaemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1): a randomised controlled trial. Lancet 2004;364:1045–53.
Presented by F. Fernandez-Aviles at the Annual Meeting of the European Society of Cardiology, August 31, 2002.
Keywords: Thrombolytic Therapy, Myocardial Infarction, Coronary Angiography, Fibrinolytic Agents, Tissue Plasminogen Activator, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Stents, Length of Stay
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