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In this clinical trial, rivaroxaban, an oral factor Xa inhibitor, was effective in the initial and continued treatment of symptomatic venous thromboembolism; it may become part of the treatment armamentarium for this common clinical problem. Acute venous thromboembolism (i.e., deep-vein thrombosis [DVT] or pulmonary embolism) is a common disorder with an annual incidence of approximately 1 or 2 cases per 1000 persons in the general population. 1 , 2 Short-term treatment is effective, with the risk of recurrent disease — the major complication — reduced from an estimated 25% to about 3% during the first 6 to 12 months of therapy. 3 The risk of recurrence remains after treatment ends and can reach 5 to 10% during the first year. 4 , 5 Standard treatment for acute venous thromboembolism is limited by the need for parenteral heparin initially, with overlapping . . .

In this trial, dabigatran plus a P2Y 12 inhibitor was compared with warfarin plus a P2Y 12 inhibitor and aspirin after PCI in patients with atrial fibrillation. The risk of bleeding was lower with dabigatran therapy; prevention of thromboembolic events was similar with the two strategies.

In this multicenter trial, the oral factor Xa inhibitor apixaban was compared with enoxaparin and warfarin for the treatment of acute venous thromboembolism. Apixaban was noninferior to enoxaparin and warfarin with respect to efficacy and superior with respect to safety. Venous thromboembolism, with an annual incidence of 1 to 2 cases per 1000 persons in the general population, is the third most common cause of vascular death after myocardial infarction and stroke. 1 Conventional treatment consists of a parenteral anticoagulant, such as enoxaparin, for at least 5 days, and warfarin begun during this time and continued for at least 3 months. 2 Although effective, this regimen presents a challenge because enoxaparin requires daily subcutaneous injections, and warfarin therapy requires coagulation monitoring and dose adjustment. Apixaban is an oral factor Xa inhibitor with a rapid onset of action and predictable pharmacokinetics that allow . . .

Among patients with rheumatic heart disease and atrial fibrillation who received a vitamin K antagonist or rivaroxaban, the rate of stroke, systemic embolism, MI, or death from vascular or unknown causes was lower with a VKA, without increased bleeding.

In this randomized trial comparing rivaroxaban with dose-adjusted warfarin in patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months.

Four new oral anticoagulants compare favourably with warfarin for stroke prevention in patients with atrial fibrillation; however, the balance between efficacy and safety in subgroups needs better definition. We aimed to assess the relative benefit of new oral anticoagulants in key subgroups, and the effects on important secondary outcomes. We searched Medline from Jan 1, 2009, to Nov 19, 2013, limiting searches to phase 3, randomised trials of patients with atrial fibrillation who were randomised to receive new oral anticoagulants or warfarin, and trials in which both efficacy and safety outcomes were reported. We did a prespecified meta-analysis of all 71 683 participants included in the RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE AF–TIMI 48 trials. The main outcomes were stroke and systemic embolic events, ischaemic stroke, haemorrhagic stroke, all-cause mortality, myocardial infarction, major bleeding, intracranial haemorrhage, and gastrointestinal bleeding. We calculated relative risks (RRs) and 95% CIs for each outcome. We did subgroup analyses to assess whether differences in patient and trial characteristics affected outcomes. We used a random-effects model to compare pooled outcomes and tested for heterogeneity. 42 411 participants received a new oral anticoagulant and 29 272 participants received warfarin. New oral anticoagulants significantly reduced stroke or systemic embolic events by 19% compared with warfarin (RR 0·81, 95% CI 0·73–0·91; p<0·0001), mainly driven by a reduction in haemorrhagic stroke (0·49, 0·38–0·64; p<0·0001). New oral anticoagulants also significantly reduced all-cause mortality (0·90, 0·85–0·95; p=0·0003) and intracranial haemorrhage (0·48, 0·39–0·59; p<0·0001), but increased gastrointestinal bleeding (1·25, 1·01–1·55; p=0·04). We noted no heterogeneity for stroke or systemic embolic events in important subgroups, but there was a greater relative reduction in major bleeding with new oral anticoagulants when the centre-based time in therapeutic range was less than 66% than when it was 66% or more (0·69, 0·59–0·81 vs 0·93, 0·76–1·13; p for interaction 0·022). Low-dose new oral anticoagulant regimens showed similar overall reductions in stroke or systemic embolic events to warfarin (1·03, 0·84–1·27; p=0·74), and a more favourable bleeding profile (0·65, 0·43–1·00; p=0·05), but significantly more ischaemic strokes (1·28, 1·02–1·60; p=0·045). This meta-analysis is the first to include data for all four new oral anticoagulants studied in the pivotal phase 3 clinical trials for stroke prevention or systemic embolic events in patients with atrial fibrillation. New oral anticoagulants had a favourable risk–benefit profile, with significant reductions in stroke, intracranial haemorrhage, and mortality, and with similar major bleeding as for warfarin, but increased gastrointestinal bleeding. The relative efficacy and safety of new oral anticoagulants was consistent across a wide range of patients. Our findings offer clinicians a more comprehensive picture of the new oral anticoagulants as a therapeutic option to reduce the risk of stroke in this patient population. None.

In this trial, patients with atrial fibrillation who required warfarin interruption for an elective procedure were assigned to either bridging anticoagulation or placebo. Forgoing bridging was noninferior to bridging for arterial thromboembolism and superior for major bleeding. For patients with atrial fibrillation who are receiving warfarin and require an elective operation or other elective invasive procedure, the need for bridging anticoagulation during perioperative interruption of warfarin treatment has long been uncertain. 1 – 3 Each year, this common clinical scenario affects approximately one in six warfarin-treated patients with atrial fibrillation. 4 , 5 Warfarin treatment is typically stopped 5 days before an elective procedure to allow its anticoagulant effect to wane; it is resumed after the procedure, when hemostasis is secured, at which point 5 to 10 days of treatment is required to attain therapeutic anticoagulation. 6 , 7 During the interruption of . . .

Edoxaban, an oral factor Xa inhibitor, is non-inferior for prevention of stroke and systemic embolism in patients with atrial fibrillation and is associated with less bleeding than well controlled warfarin therapy. Few safety data about edoxaban in patients undergoing electrical cardioversion are available. We did a multicentre, prospective, randomised, open-label, blinded-endpoint evaluation trial in 19 countries with 239 sites comparing edoxaban 60 mg per day with enoxaparin–warfarin in patients undergoing electrical cardioversion of non-valvular atrial fibrillation. The dose of edoxaban was reduced to 30 mg per day if one or more factors (creatinine clearance 15–50 mL/min, low bodyweight [≤60 kg], or concomitant use of P-glycoprotein inhibitors) were present. Block randomisation (block size four)—stratified by cardioversion approach (transoesophageal echocardiography [TEE] or not), anticoagulant experience, selected edoxaban dose, and region—was done through a voice-web system. The primary efficacy endpoint was a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular mortality, analysed by intention to treat. The primary safety endpoint was major and clinically relevant non-major (CRNM) bleeding in patients who received at least one dose of study drug. Follow-up was 28 days on study drug after cardioversion plus 30 days to assess safety. This trial is registered with ClinicalTrials.gov, number NCT02072434. Between March 25, 2014, and Oct 28, 2015, 2199 patients were enrolled and randomly assigned to receive edoxaban (n=1095) or enoxaparin–warfarin (n=1104). The mean age was 64 years (SD 10·54) and mean CHA2DS2-VASc score was 2·6 (SD 1·4). Mean time in therapeutic range on warfarin was 70·8% (SD 27·4). The primary efficacy endpoint occurred in five (<1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin–warfarin group (odds ratio [OR] 0·46, 95% CI 0·12–1·43). The primary safety endpoint occurred in 16 (1%) of 1067 patients given edoxaban versus 11 (1%) of 1082 patients given enoxaparin–warfarin (OR 1·48, 95% CI 0·64–3·55). The results were independent of the TEE-guided strategy and anticoagulation status. ENSURE-AF is the largest prospective randomised clinical trial of anticoagulation for cardioversion of patients with non-valvular atrial fibrillation. Rates of major and CRNM bleeding and thromboembolism were low in the two treatment groups. Daiichi Sankyo provided financial support for the study.

In this trial, 14,264 patients with atrial fibrillation were randomly assigned to receive either rivaroxaban or warfarin. In a per-protocol, as-treated analysis, rivaroxaban was noninferior to warfarin with respect to the primary end point of stroke or systemic embolism. Atrial fibrillation is associated with an increase in the risk of ischemic stroke by a factor of four to five 1 and accounts for up to 15% of strokes in persons of all ages and 30% in persons over the age of 80 years. 2 The use of vitamin K antagonists is highly effective for stroke prevention in patients with nonvalvular atrial fibrillation and is recommended for persons at increased risk. 3 – 5 However, food and drug interactions necessitate frequent coagulation monitoring and dose adjustments, requirements that make it difficult for many patients to use such drugs in clinical practice. 6 – 8 Rivaroxaban is . . .

Edoxaban, an oral factor Xa inhibitor, was noninferior to warfarin in the prevention of stroke or systemic embolism in patients with atrial fibrillation. There was less bleeding with edoxaban than with warfarin. Edoxaban is an oral, reversible, direct factor Xa inhibitor with a linear and predictable pharmacokinetic profile and 62% oral bioavailability. 1 It achieves maximum concentrations within 1 to 2 hours, and 50% is excreted by the kidney. 2 A randomized, dose-ranging, warfarin-controlled, phase 2 study involving 1146 patients with atrial fibrillation showed that once-daily doses of edoxaban (60 mg or 30 mg) were safer than twice-daily doses. 3 Pharmacokinetic modeling and simulation showed that patients with low body weight, moderate-to-severe renal dysfunction, or concomitant use of a potent P-glycoprotein inhibitor should have the edoxaban dose reduced by 50%. 4 A phase 3 study involving . . .