Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial

Abstract

SummaryBackground Dual antiplatelet therapy (DAPT), aspirin plus a P2Y12 inhibitor, is the standard antithrombotic treatment following acute coronary syndromes. The factor Xa inhibitor rivaroxaban reduced mortality and ischaemic events when added to DAPT, but caused increased bleeding. The safety of a dual pathway antithrombotic therapy approach combining low-dose rivaroxaban (in place of aspirin) with a P2Y12 inhibitor has not been assesssed in acute coronary syndromes. We aimed to assess rivaroxaban 2·5 mg twice daily versus aspirin 100 mg daily, in addition to clopidogrel or ticagrelor (chosen at investigator discretion before randomisation), for patients with acute coronary syndromes started within 10 days after presentation and continued for 6-12 months.

Management of patients after primary percutaneous coronary intervention for myocardial infarction

“…24 25 Most patients who are asymptomatic with mild to moderate physical activity-walking two flights of stairs or walking briskly for a few minutes-should be able to resume sexual activity around a week after an uncomplicated myocardial infarction. [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] Information about sexual activity is usually included in cardiac rehabilitation programmes.…”

More, More, More: Reducing Thrombosis in Acute Coronary Syndromes Beyond Dual Antiplatelet Therapy—Current Data and Future Directions

“…The more recently published GEMINI ACS 1 (A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome) study was a phase II randomized trial of 3037 patients with ACS comparing aspirin or rivaroxaban 2.5 mg BID in addition to clopidogrel or ticagrelor 27. The primary end point was non–coronary artery bypass grafting–related TIMI clinically significant bleeding.…”

Triple antithrombotic therapy after ACS and PCI in patients on chronic oral anticoagulation: update

“…Conversely, in the Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome (ATLAS-ACS-2) study, a very low-dose of rivaroxaban (2.5 mg twice daily) resulted in significantly less ischaemic events at the price of increased major and intracranial bleeding 19. In further scrutiny of a safer rivaroxaban-based strategy for patients with ACS, a phase II study recently reported the same risk of clinically significant bleeding with very low-dose rivaroxaban and a P2Y 12 inhibitor (ie, without aspirin) compared with DAPT, but whether this strategy is also similarly effective remains uncertain 20. Rivaroxaban is currently indicated by the European Medical Agency for the prevention of atherothrombotic events in patients with ACS and elevated cardiac biomarkers and is given by clinical practice guidelines a class IIb recommendation for combination therapy with DAPT 21.…”