Key result
Xa inhibitors did not significantly improve primary efficacy outcomes compared to control (RR 0.82, P=0.06 for 2.5 mg) but significantly increased the risk of primary safety outcomes.
Why the study?
The study was conducted to evaluate the efficacy and safety of Xa inhibitors in patients with heart failure and coronary artery disease or peripheral artery disease.
Do Factor Xa inhibitors improve efficacy outcomes and safety in patients with heart failure and coronary or peripheral artery disease?
Meta-Analysis (n=14,694)
Do Factor Xa inhibitors improve efficacy outcomes and safety in patients with heart failure and coronary or peripheral artery disease?
Effect estimate: RR 0.82 (2.5 mg); RR 0.86 (5 mg) (95% CI 0.66-1.01 (2.5 mg); 0.73-1.02 (5 mg))
p-value: p=0.06 (2.5 mg); 0.08 (5 mg)
In patients with heart failure and CAD or PAD, Factor Xa inhibitors do not significantly improve primary efficacy outcomes but significantly increase the risk of adverse safety events.
Net harm from Xa inhibitors in HF with CAD/PAD warrants avoidance; challenges assumptions of net benefit from prior data.
BACKGROUND: To evaluate the efficacy and safety of Xa inhibitors in patients with heart failure (HF) and coronary artery disease (CAD) or peripheral artery disease (PAD). METHODS: A systematic electronic literature search was performed using the PubMed, Web of Science, EMBASE, and Cochrane Library databases from inception to June 26, 2019. A total of four randomized controlled trials involving 14,694 patients were included in this meta-analysis. RESULTS: The meta-analysis showed that there was no statistical difference between the Xa inhibitor and control group regarding the primary efficacy outcome [rivaroxaban 2.5 mg group: relative risk (RR) 0.82, 95% CI: 0.66-1.01, P=0.06; rivaroxaban 5 mg group: RR 0.86, 95% CI: 0.73-1.02, P=0.08]. The risk of the primary safety outcome was significantly increased among patients who received Xa inhibitors compared with the control group (rivaroxaban 2.5 mg group: RR 1.55, 95% CI: 1.21-1.98, P=0.0006; rivaroxaban 5 mg group: RR 1.66, 95% CI: 1.30-2.12, P<0.0001). There was no significant difference in the risk of cardiovascular death between the Xa inhibitor and control group (rivaroxaban 2.5 mg group: RR 0.79, 95% CI: 0.54-1.14, P=0.21; rivaroxaban 5 mg group: RR 0.89, 95% CI: 0.73-1.08, P=0.24). The risk of myocardial infarction (MI) in the rivaroxaban 5 mg group was significantly lower than that of the control group (RR 0.83, 95% CI: 0.69-0.99, P=0.04). However, the risk of MI in the rivaroxaban 2.5 mg group was similar to that of the control group (RR 0.85, 95% CI: 0.71-1.01, P=0.07). DISCUSSION: Xa inhibitors were associated with a higher risk of major adverse cardiovascular events and bleeding among HF and CAD or PAD patients. Therefore, Xa inhibitors should be used cautiously in patients with HF and CAD or PAD.
No takes yet. Share an insight, caveat, or question.
Chen et al. (2021) conducted a meta-analysis in Heart failure and coronary or peripheral artery disease (n=14,694). Xa inhibitors (rivaroxaban) vs. Control group was evaluated on Primary efficacy outcome (RR 0.82 (2.5 mg); RR 0.86 (5 mg), 95% CI 0.66-1.01 (2.5 mg); 0.73-1.02 (5 mg), p=0.06 (2.5 mg); 0.08 (5 mg)). Xa inhibitors did not significantly improve primary efficacy outcomes compared to control (RR 0.82, P=0.06 for 2.5 mg) but significantly increased the risk of primary safety outcomes.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: