Rivaroxaban in Patients with a Recent Acute Coronary Syndrome

Abstract

In patients with a recent acute coronary syndrome, rivaroxaban reduced the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke. Rivaroxaban increased the risk of major bleeding and intracranial hemorrhage but not the risk of fatal bleeding. (Funded by Johnson & Johnson and Bayer Healthcare; ATLAS ACS 2-TIMI 51 ClinicalTrials.gov number, NCT00809965.).

2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient Management and Follow-up, Definitions, Endpoints, and Research Trial Design

“…First, a direct thrombin or Factor Xa inhibitor can be administered several hours following ablation. 826,827,853,854 Second, low molecular weight heparin (enoxaparin 0.5–1.0 mg per kg twice daily) or intravenous heparin can be used as a bridge to resumption of INR 2.0–3.0. For most patients, other than those with prosthetic valves who will need to remain indefinitely on warfarin, initiation of a NOAC postablation is a preferred strategy to use instead of heparin or low molecular weight heparin due to the increased bleeding risk with these agents.…”

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

“…10 Subsequent trials of post-acute coronary syndromes have explored triple antithrombotic therapy, adding an oral anticoagulant to DAPT with aspirin plus clopidogrel. 11,12 Although low-dose rivaroxaban reduced the composite endpoint of cardiovascular death, myocardial infarction, and stroke, 11 no benefits were noted with standard-dose apixaban in this setting, 12 and both studies showed a significant three-fold to four-fold increase in major bleeding, suggesting that a ceiling might have been reached for adding antithrombotic therapies in the post-acute coronary syndromes setting. Notwithstanding these observations, recent trials assessing patients with an indication for full-dose oral anticoagulation undergoing percutaneous coronary intervention (PCI), where triple antithrombotic therapy (aspirin plus clopidogrel together with standard doses of oral anticoagulants) has been the standard of care, have suggested that withholding aspirin has not caused a significant increase in ischaemic events and showed a lower risk of major bleeding events.…”

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

“…The control arms in the reported trials, against which TT was compared, have mostly included patients receiving a combination of aspirin and clopidogrel,21, 22, 23, 28, 29, 30, 31, 45 but current guidelines recommend ticagrelor or prasugrel over clopidogrel in ACS 15, 20, 26, 38. Consequently, any new combination regimen should be compared with “current best.” The combination of a non–vitamin K oral anticoagulant with DAPT that includes these more effective P2Y 12 inhibitors may increase bleeding compared with clopidogrel, but this has never been tested.…”

“…Subgroup analysis showed that rivaroxaban reduced the primary efficacy end point in STEMI patients (8.4% versus 10.6%, P =0.019)24 and reduced stent thrombosis compared with placebo (1.9% versus 1.5%, P= 0.017),25 and the reduction in the primary efficacy end point in patients with STEMI appeared to become apparent as early as 30 days after the index event 24. Rivaroxaban combined doses, compared with placebo, significantly increased the rate of non–coronary artery bypass grafting–related TIMI major bleeding (2.1% versus 0.6%, P <0.001) and intracranial bleeding (0.6% versus 0.2%, P =0.009) but not fatal bleeding (0.3% versus 0.2%, P =0.66),21 and the rates of non–coronary artery bypass grafting–related TIMI major bleeding were similar with the 2.5‐ and 5‐mg BID doses (1.8% versus 2.4%, P =0.12).…”

“…Bleeding complications increased in a dose‐dependent manner in all TT groups ( P< 0.0001). The subsequent ATLAS ACS 2‐TIMI 51 (Anti‐Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects With Acute Coronary Syndrome–Thrombolysis in Myocardial Infarction 51) study—a phase III, double‐blind, randomized, placebo‐controlled trial—compared the addition of 2.5 or 5 mg BID rivaroxaban to DAPT with clopidogrel in 15 526 patients with ACS 21. The 1‐year primary efficacy end point, a composite of cardiovascular death, MI, and stroke, was significantly reduced by the combined doses of rivaroxaban (8.9% versus 10.7%, P =0.008) and each dose alone (2.5 mg: 9.1% versus 10.7%, P =0.02; 5 mg: 8.8% versus 10.7%, P =0.03) compared with placebo (Figure 2).…”