2049 Early invasive management of acute coronary syndromes without ST-elevation does not improve long-term mortality: Insights from the randomized trials

Background Randomized trials evaluating an early invasive against a conservative strategy show a benefit over a conservative approach in the composite of death, MI and revascularisation/recurrent ischemia. However, the rate of invasive therapies differed significantly in the trials. Moreover, there were also large differences in the rate of invasive therapies in the invasive versus the conservative arms ( cross-over rate) in the different studies. Therefore we studied the differences in rate of invasive therapy in the study arms of the above trials, and correlated them with the benefit of the invasive therapy with regard to the very long-term mortality as recently published. Methods and Results We analyzed very long-term mortality (30,932 patient-years) in the 9 trials carried out between 1996 and 2004, which randomized 10,558 patients with non-ST-elevation acute coronary syndromes to an early invasive or an ischemia-guided conservative strategy. Differences in the revascularization rate between the invasive and conservative strategies in the trials ranged between 10% and 39%. There was no relation of the differences in revascularization between invasive and conservative strategies and the benefit on mortality whatsoever (see figure ). Conclusion Although most trials on non ST-elevation ACS reported a reduction in the composite of death, MI and revascularisation/ recurrent ischemia, an early invasive strategy does not lead to improved survival on the very long-term. There seems no relation between the difference in revascularisation rate and benefit on the very long term, which may explain the lack of efficacy of early intervention on very long-term mortality.

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Abstract 3210: Early Invasive Management of Acute Coronary Syndromes without ST-elevation does not Improve Long-term Mortality: insights from the Randomized Trials with the most Recent Follow-up Data

Circulation ◽

10.1161/circ.116.suppl_16.ii_722 ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

Freek W Verheugt ◽

Marc A Brouwer

Keyword(s):

Acute Coronary Syndromes ◽

Randomized Trials ◽

Conservative Strategy ◽

Coronary Syndromes ◽

St Elevation ◽

Early Invasive Strategy ◽

Recurrent Ischemia ◽

Long Term Mortality

Background Randomized trials evaluating an early invasive against a conservative strategy show a benefit over a conservative approach in the composite of death, MI and revascularisation/recurrent ischemia. However, by the necessarily open design MI and revascularisation/ recurrent ischemia are relatively weak endpoints. Since MI is both an entry criterion and an endpoint, it is difficult to evaluate, since it may be induced by intervention and, therefore, its definition in the trials is cumbersome. Thus, long-term mortality is the best outcome parameter to evaluate the above strategies. Recently, the very long follow-up data of 3 major trials RITA-3, FRISC-2 and ICTUS have been published. Methods and Results We analyzed the 9 trials carried out between 1996 and 2004, which randomized 10,558 patients with non-ST-elevation acute coronary syndromes to an early invasive or an ischemia-guided conservative strategy. F/U ranged from 6 months to 5 years with a total of 30,932 patients-years. RR for long-term mortality is for invasive versus conservative from completed follow-up data is 0.94 (95%CI 0.83–1.06, p = 0.32, see figure ). Conclusion Although most trials on non ST-elevation ACS reported a reduction in the composite of death, MI and revascularisation/recurrent ischemia, an early invasive strategy does not lead to improved survival on the very long-term. These findings should be mentioned in future guidelines.

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