ST段抬高的急性心肌梗死溶栓后24h内常规介入治疗与缺血指导下的保守治疗的比较(GRACIA-1):随机对照试验

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Background In patients with ST segment elevated myocardial infarction (STEMI) , early post thrombolysis routine angioplasty has been discouraged because of i ts association with high incidence of events. The GRACIA 1 trial was designed t o reassess the benefits of an early postthrombolysis interventional approach in the era of stents and new antiplatelet agents. Methods 500 patients with thrombo lysed STEMI (with recombinant tissue plasminogen activator) were randomly assign ed to angiography and intervention if indicated within 24 h of thrombolysis, or to an ischaemia guided conservative approach. The primary endpoint was the comb ined rate of death, reinfarction, or revascularisation at 12 months. Analysis wa s by intention to treat. Findings Invasive treatment included stenting of the cu lprit artery in 80%(199 of 248) patients, bypass surgery in six (2%), non cul prit artery stenting in three, and no intervention in 40 (16%). Predischarge re vascularisation was needed in 51 of 252 patients in the conservative group. By c omparison with patients receiving conservative treatment, by 1 year, patients in the invasive group had lower frequency of primary endpoint (23 [9%] vs 51 [ 21 %], risk ratio 0.44 [95%CI 0.28-0.70], p=0.0008), and they tended to have red uced rate of death or reinfarction (7%vs 12%, 0.59 [0.33-1.05], p=0.07). In de x time in hospital was shorter in the invasive group, with no differences in maj or bleeding or vascular complications. At 30 days both groups had a similar inci dence of cardiac events. In hospital incidence of revascularisation induced by spontaneous recurrence of ischaemia was higher in patients in the conservative g roup than in those in the invasive group. Interpretation In patients with STEMI, early post thrombolysis catheterisation and appropriate intervention is safe a nd might be preferable to a conservative strategy since it reduces the need for unplanned in hospital revascularisation, and improves 1-year clinical outcome. Background In patients with ST segment elevated myocardial infarction (STEMI), early postthrombolysis routine angioplasty has been discouraged because of i ts association with high incidence of events. The GRACIA 1 trial was designed to reassess the benefits of an early postthrombolysis interventional approach in the era of stents and new antiplatelet agents. Methods 500 patients with thrombo lysed STEMI (with recombinant tissue plasminogen activator) were randomly assigned ed to angiography and intervention if indicated within 24 h of thrombolysis, or to an ischaemia guided conservative approach. The primary endpoint was the combined rate of death, reinfarction, or revascularisation at 12 months. Analysis of the treatment by stenting of the cu lprit artery in 80% (199 of 248) patients, bypass surgery in six (2% ), non cul prit artery stenting in three, and no intervention in 40 (16%). Predischarge re vascularisation was needed in 51 of 252 patients in the conservative group. By c omparison with patients receiving conservative treatment, by 1 year, patients in the invasive group had lower frequency of primary endpoint (23 [9%] vs 51 [21%], risk ratio 0.44 [95% CI 0.28-0.70], p = 0.0008), and they tended to have red uced rate of death or reinfarction (7% vs 12%, 0.59 [0.33-1.05], p = 0.07) the invasive group, with no differences in maj or bleeding or vascular complications. At 30 days both groups had a similar inci dence of cardiac events. In hospital incidence of revascularisation induced by spontaneous recurrence of ischaemia was higher in patients in the conservative g roup than in those in the invasive group. Interpretation In patients with STEMI, early post thrombolysis catheterisation and appropriate intervention is safe a nd might be preferable to a reduces the need for unplanned in hospital revascularisation, and improves 1-year clinical outcome.
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