Safety of Routine Invasive Versus Selective Invasive Therapy in Women with Non-ST-Elevation Acute Coronary Syndrome

Abstract

IntroductionPrior studies suggested that a routine invasive approach in the management of non-ST-elevation acute coronary syndrome (NSTE-ACS) is beneficial in men, but the data are less conclusive in women. One study conducted exclusively in women found that routine invasive therapy was associated with a markedly increased risk of major bleeding. This pilot randomized controlled trial compared the safety of a routine invasive versus a selective invasive strategy among women.MethodsWomen with NSTE-ACS and an additional high-risk characteristic were randomized to a routine invasive versus a selective invasive strategy. The primary outcome was the risk of major bleeding. The secondary outcome was the first occurrence of all-cause death, myocardial infarction, stroke, re-hospitalization for ACS, or major bleeding within 6 months.ResultsTwenty-three women were assigned to routine invasive therapy and 17 to selective invasive therapy. Twenty-seven women (68%) had elevated troponin T (mean 0.33 ng/mL) and/or creatinine kinase-MB (mean 23 ng/mL). The risk of major bleeding was similar with both approaches (P = 0.99). At 6 months, the secondary outcome occurred in 9% of the routine invasive group versus 18% of the selective invasive group (risk ratio = 0.49, 95% confidence interval 0.09–2.63, P = 0.63).ConclusionThis pilot study demonstrated that a routine invasive approach is safe in women. There was suggestion of benefit from routine invasive therapy compared with selective invasive therapy. These data could be used to design an appropriately powered trial to determine the optimal management strategy among women with NSTE-ACS.Electronic supplementary materialThe online version of this article (doi:10.1007/s40119-015-0055-x) contains supplementary material, which is available to authorized users.

Routine invasive versus selective invasive strategies for Non‐ST‐elevation acute coronary syndromes: An Updated meta‐analysis of randomized trials

“…The composite of all‐cause mortality or MI was reported by 10 trials . Compared with a selective invasive strategy, a routine invasive strategy was associated with a significant reduction in the composite of all‐cause mortality or MI (15.5% vs. 17.5%; OR: 0.86, 95% CI: 0.77‐0.96, P = 0.009) at a mean of 39 ± 12 months (Fig.…”

“…1). A total of 12 trials with 9,650 patients were included in the final analysis . Four of the included studies reported outcomes at both the intermediate and long‐term follow‐up periods .…”

“…In Table , we summarize the baseline characteristics, medications, and the interventions of the included studies. All the studies were conducted in multiple centers except for the Lady‐Gator pilot study, which was a single center study . In general; all studies were classified as low risk for bias.…”

“…Some of these analyses included studies that predated the current era of stents and contemporary antiplatelet therapy which may not adequately represent current practice . Moreover, additional studies comparing these strategies have been reported . In a patient level meta‐analysis of the largest three trials comparing these strategies (i.e., FRISC II, RITA‐3, and ICTUS), the authors had concluded that a routine invasive strategy reduced the risk of cardiovascular mortality or myocardial infarction (MI) .…”

Early Invasive Versus Initial Conservative Strategies for Women with Non–ST-Elevation Acute Coronary Syndromes: A Nationwide Analysis

“…7 In our study, with an OR of 0.55 and an event rate of 3.8% in the control arm, we estimated that 2635 women would be needed in each group to achieve 80% power for in-hospital mortality, which is almost double the number of women enrolled in that patient-level analysis. 7 To date, only 2 randomized trials have attempted to compare both strategies exclusively in women 9,14 ; one of these trials was relatively small (ie, enrolled only 40 women) and showed no difference in clinical outcomes. 14 In the Organization to Assess Strategies in Acute Ischemic Syndromes 5 substudy in women, an early invasive strategy was associated with a higher risk of mortality at 1 year, which could have been driven by the increased risk of major bleeding at 30 days.…”