Early invasive strategy, recommended by the current guidelines in the treatment of patients with acute coronary syndromes (ACS), did not excel when compared with its more conservative alternative in a randomized study published in the New England Journal of Medicine.
Early invasive strategy, recommended by the current guidelines in the treatment of patients with acute coronary syndromes (ACS), did not excel when compared with its more conservative alternative in a randomized study published in the New England Journal of Medicine.
Researchers could not demonstrate that an early invasive strategy was superior to a selectively invasive strategy in patients with ACS who did not have ST-segment elevation and who had an elevated cardiac troponin T level.
The study involved 1,200 patients with ACS without ST-segment elevation. Patients had chest pain, an elevated cardiac troponin level (≥0.03 mcg/L), and either electrocardiographic evidence of ischemia at admission or a documented history of coronary disease and were randomized to an early invasive strategy or the more conservative selectively invasive strategy.
The primary end point was a composite of death, nonfatal myocardial infarction, or rehospitalization for anginal symptoms within 1 year after randomization.
The incidence of the primary end point was 22.7% in the early invasive strategy group and 21.2% in the selectively assigned group (relative risk, 1.07; 95% CI, 0.87 to 1.33, P=.33).
"We did not find the expected 25% reduction in the cumulative rate of the primary end point with an early invasive strategy as compared with a selectively invasive strategy," the researchers stated. "As a result, the confidence interval around the relative risk of the composite end point of death, myocardial infarction or rehospitalization for angina was 0.87 to 1.33, corresponding to a possible reduction in risk of 13% (or an increase in risk of 33%) with an early invasive strategy.
"However, the point estimate for the relative risk (1.07) actually favors the selectively invasive approach, and even the most substantial advantage of early invasive management consistent with our data is much less than that estimated in previous large trials."
Confirming earlier findings that there is a hazard associated with early revascularization, the incidence of myocardial infarction was significantly higher in the early invasive strategy group (15% vs 10%, P=.005), but hospitalization was less frequent in the group (7.4% vs 10.9%, P=.04).
Mortality within 1 year was low (2.5%) in both groups despite the fact that all the patients had been considered high risk.
No significant difference in the frequency of the primary end point was seen among subgroups defined according to age, sex, the presence or absence of diabetes mellitus, the presence or absence of ST-segment deviation, or the level of cardiac troponin T.
SOURCE de Winter RJ, Windhausen F, Hein Cornel J, et al. Early invasive versus selectively invasive management for acute coronary syndromes. N Engl J Med. 353;11:1095–1104.
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