Early invasive versus selectively invasive management for acute coronary syndromes
Robbert J de Winter1, Fons Windhausen, Jan Hein Cornel
1Academisch Medisch Centrum, Amsterdam, Netherlands. r.j.dewinter@amc.uva.nl
Insights
An early invasive strategy did not significantly improve outcomes for acute coronary syndromes without ST-segment elevation. While myocardial infarction rates were higher, rehospitalization was lower in the invasive group, with no difference in mortality.
Area of Science:
- Cardiology
- Clinical Trials
- Acute Coronary Syndromes
Background:
- Current guidelines suggest early invasive strategy for acute coronary syndromes (ACS) without ST-segment elevation and elevated cardiac troponin T.
- However, prior randomized trials show inconsistent benefits in mortality and myocardial infarction (MI) rates.
Purpose of the Study:
- To compare an early invasive strategy versus a selectively invasive strategy in patients with ACS without ST-segment elevation and elevated troponin T.
- To evaluate the composite endpoint of death, nonfatal MI, or rehospitalization for anginal symptoms within one year.
Main Methods:
- 1200 patients with ACS without ST-segment elevation and elevated troponin T were randomized to early invasive or selectively invasive strategies.
- All patients received aspirin, enoxaparin, and recommended clopidogrel and intensive lipid-lowering therapy.
- Primary endpoint: composite of death, nonfatal MI, or rehospitalization for angina at one year.
Main Results:
- The primary endpoint occurred in 22.7% of the early invasive group and 21.2% of the selectively invasive group (P=0.33).
- Mortality rates were similar (2.5%) in both groups.
- Myocardial infarction was significantly higher in the early invasive group (15.0% vs. 10.0%, P=0.005), but rehospitalization was lower (7.4% vs. 10.9%, P=0.04).
Conclusions:
- An early invasive strategy was not demonstrated to be superior to a selectively invasive strategy in this patient population with optimized medical therapy.
- The findings suggest that a less aggressive approach may be suitable for selected patients with non-ST-elevation acute coronary syndromes and elevated troponin T.
Background:
Current guidelines recommend an early invasive strategy for patients who have acute coronary syndromes without ST-segment elevation and with an elevated cardiac troponin T level. However, randomized trials have not shown an overall reduction in mortality, and the reduction in the rate of myocardial infarction in previous trials has varied depending on the definition of myocardial infarction.
Methods:
We randomly assigned 1200 patients with acute coronary syndrome without ST-segment elevation who had chest pain, an elevated cardiac troponin T level (> or =0.03 mug per liter), and either electrocardiographic evidence of ischemia at admission or a documented history of coronary disease to an early invasive strategy or to a more conservative (selectively invasive) strategy. Patients received aspirin daily, enoxaparin for 48 hours, and abciximab at the time of percutaneous coronary intervention. The use of clopidogrel and intensive lipid-lowering therapy was recommended. The primary end point was a composite of death, nonfatal myocardial infarction, or rehospitalization for anginal symptoms within one year after randomization.
Results:
The estimated cumulative rate of the primary end point was 22.7 percent in the group assigned to early invasive management and 21.2 percent in the group assigned to selectively invasive management (relative risk, 1.07; 95 percent confidence interval, 0.87 to 1.33; P=0.33). The mortality rate was the same in the two groups (2.5 percent). Myocardial infarction was significantly more frequent in the group assigned to early invasive management (15.0 percent vs. 10.0 percent, P=0.005), but rehospitalization was less frequent in that group (7.4 percent vs. 10.9 percent, P=0.04).
Conclusions:
We could not demonstrate that, given optimized medical therapy, an early invasive strategy was superior to a selectively invasive strategy in patients with acute coronary syndromes without ST-segment elevation and with an elevated cardiac troponin T level.
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