Data from Antithrombosis News - Curated by EPG Health - Last updated 29 August 2018
ESC 2018: Antithrombosis News congress highlights
Throughout this year’s congress we have discussed a series of studies – large and small – regarding antithrombotic use. As a wrap up, we share here headline results from a series of important trials presented in the hotline sessions, not covered in our previous posts.
MARINER trial – Medically Ill Patient Assessment of Rivaroxaban Versus Placebo IN Reducing Post-Discharge Venous Thrombo-Embolism Risk
This randomised, double-blinded trial looked at patients hospitalised for medical illness, who remained at risk of venous thromboembolism after discharge and whether they would benefit from extended thromboprophylaxis.
Patients were randomised to receive rivaroxaban 10mg OD or placebo for 45 days. The primary endpoint was a composite of symptomatic venous thromboembolism or death due to venous thromboembolism.
12,024 patients were randomised, with the primary endpoint met in 50 of 6,007 in the treatment arm vs 66 of 6,012 in the placebo arm (hazard ratio, 0.76; 95% confidence interval [CI], 0.52 to 1.09; P=0.14).
Low dose rivaroxaban was not considered to have had an impact on post discharge VTE.
COMMANDER HF – Rivaroxaban in Patients with Heart Failure, Sinus Rhythm and Coronary Artery Disease
The trial’s rationale was, heart failure is associated with activation of thrombin-related pathways, an indicator of poor prognosis. It was hypothesised that treatment with rivaroxaban would reduce thrombin generation and improve outcomes for patients with worsening chronic heart failure and underlying coronary disease.
5,022 patients with an LVEF<40%, coronary disease, elevated BNP levels and not in AF, were randomised to receive rivaroxaban 2.5mg BD or placebo, alongside normal HF care in patients recently acutely hospitalised for heart failure. The primary outcome was composite of death from any cause, myocardial infarction, or stroke. Mean follow up was 21.1 months.
The primary endpoint was met in 25% of the rivaroxaban group and 26.2% of the placebo group: a non-significant result (hazard ratio, 0.94; 95% confidence interval [CI], 0.84 to 1.05; P=0.27).
In summary, low dose rivaroxaban was not associated with a significantly lower rate of death, MI or stroke compared with placebo in those with worsening chronic heart failure.
ASCEND – Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus
Aspirin’s role in the secondary prevention of cardiovascular events is well-established; however, debate continues regarding its use in patients with diabetes due to an increased risk of bleeding.
This trial aimed to establish whether the risks outweigh the benefits for aspirin use as primary prevention of serious vascular ischaemic events in patients with diabetes.
Adult patients with diabetes and no evident cardiovascular disease were randomised to receive aspirin [100 mg daily] or matching placebo. The primary outcome was the first serious vascular ischaemic event, with the primary safety outcome being major bleeding. A total of 15,480 patients were randomised, with a mean follow up of 7.4 years.
Results showed a significant reduction in serious vascular events 658 participants [8.5%] vs. 743 [9.6%]; rate ratio, 0.88; 95% confidence interval [CI], 0.79 to 0.97; P=0.01). In contrast, major bleeding events occurred in 314 participants (4.1%) in the aspirin group compared with 245 (3.2%) in the placebo group (rate ratio, 1.29; 95% CI, 1.09 to 1.52; P=0.003).
The below graph shows the benefit of risk reduction of the primary outcome in patients given aspirin is largely counterbalanced by the risk of major bleeding.
Thank you for following our blogs during ESC 2018. We hope you have found them valuable.