The GEMINI-ACS study, which was simultaneously presented at the 2017 scientific sessions of the American College of Cardiology (ACC; 17–19 March, Washington, DC, USA) and published in The Lancet, indicated that combining rivaroxaban (Xarelto, Bayer) and a PY12 inhibitor in patients who have experienced an acute coronary syndrome was associated with similar rate of bleeding as dual antiplatelet therapy (DAPT). Study author E Magnus Ohman (Duke Clinical Research Institute, Duke University School of Medicine, Durham, USA) talks to Cardiovascular News about the implications of the study.
Prior to this study, what was the evidence base for using a non-vitamin K antagonist in patients with acute coronary syndromes?
Aspirin has been foundational therapy for managing acute coronary syndromes for several decades and, later, the combination of aspirin and a PY12 inhibitor (ie. DAPT) led to further improved outcomes for patients with acute coronary syndromes.
However, we have known for a long time that a clot is formed from a combination of activated platelets and the coagulation system. For example, triple therapy with DAPT and rivaroxaban is associated with improved outcomes (compared with DAPT alone) but with high bleeding rates. We sought to evaluate whether exchanging aspirin for rivaroxaban could create a dual-pathway strategy (PY12 inhibitor plus Xa inhibitor) that could perform similar to a DAPT strategy.
What were your key findings?
We found similar bleeding outcomes between these two strategies
Based on the available data, do you believe a rivaroxaban/PY12 inhibitor approach has the potential to reduce more ischaemic events than a DAPT approach?
No. We are not able to determine that as this was a phase 2 trial
What further studies in this area are needed?
This study, while being a phase 2 trial, offers new insight that you may be able to substitute aspirin for rivaroxaban in the acute coronary syndrome setting. This needs to be confirmed in a large phase 3 trial