Characteristics of the included studies
| Study . | Population . | Duration of treatment . | Patients randomized (n) . | Funding . | |
|---|---|---|---|---|---|
| Intervention . | Control . | ||||
| 1. RE-COVER,7 2009 | Proximal DVT of PE | 6 mo | UFH or LMWH for 5 d, followed by dabigatran 150 mg bid (1273) | UFH or LMWH for at least 5 d with warfarin, INR 2-3 (1266) | Boehringer Ingelheim |
| 2. RE-LY,12 2009 | AF, ≥1 risk factors (previous stroke or TIA, LVEF <40%, NYHA class II or higher, CHF and age ≥75 y or an age of 65-74 y plus DM, HTN, or CAD) | Median 2 y | Dabigatran 100 mg bid (6015) or 150 mg bid (6076) | Warfarin, INR 2-3 (6022) | Boehringer Ingelheim |
| 3. EINSTEIN-DVT,16 2010 | Proximal DVT without symptomatic PE | 3/6/12 mo | Rivaroxaban 15 mg bid for 3 wk, followed by 20 mg OD (1731) | Subcutaneous enoxaparin for at least 5 d with warfarin, INR 2-3 (1718) | Bayer Schering Pharma and Ortho-McNeil |
| 4. ARISTOTLE,13 2011 | AF, ≥1 risk factors (age ≥75, previous stroke/TIA, or systemic embolism, CHF within the previous 3 mo or LVEF ≤40%, DM, HTN) | Median 1.8 y | Apixaban 5 mg bid (9120) | Warfarin, INR 2-3 (9081) | Bristol-Myers Squibb and Pfizer |
| 5. ROCKET AF,14 2012 | NVAF, CHADS2 score ≥2 | Median 590 d | Rivaroxaban 20 mg OD (7131) | Warfarin, INR 2-3 (7133) | Johnson & Johnson and Bayer |
| 6. EINSTEIN-PE,29 2012 | Acute PE | 3/6/12 mo | Rivaroxaban 15 mg bid for 3 wk, followed by 20 mg OD (1731) | Subcutaneous enoxaparin at least 5 d with warfarin, INR 2-3 (1718) | Bayer HealthCare and Janssen Pharmaceuticals |
| 7. J-ROCKET AF,28 2012 | NVAF, ≥2 risk factors (CHF and/or LVEF ≤35%, HTN, DM) | Median: 71 wk (rivaroxaban), 69 wk (warfarin) | Rivaroxaban 15 mg OD (639) | Warfarin, INR 2-3 (639) | Bayer Yakuhin Ltd. |
| 8. AMPLIFY,8 2013 | Proximal DVT or PE | 6 mo | Apixaban 10 mg bid for 7 d, followed by 5 mg bid (2691) | Subcutaneous enoxaparin for at least 5 d with warfarin, INR 2-3 (2704) | Pfizer and Bristol-Myers Squibb |
| 9. ENGAGE-AF-TIMI- 48,15 2013 | AF, CHADS2 score ≥2 | Median 907 d | Edoxaban 30 mg OD (7034) or edoxaban 60 mg OD (7035) | Warfarin, INR 2-3 (7036) | Daiichi Sankyo Pharma Development |
| 10. RE-MEDY,11 2013 | Proximal DVT or PE | 6-36 mo | Dabigatran 150 mg bid (1430) | Warfarin, INR 2-3 (1426) | Boehringer Ingelheim |
| 11. HOKUSAI-VTE,9 2013 | Proximal DVT or PE | 3-12 mo | UFH or LMWH for at least 5 d, followed by edoxaban 60 mg OD (4122) | UFH or LMWH for at least 5 d, followed by warfarin, INR 2-3 (4122) | Daiichi Sankyo Pharma Development |
| 12. RE-COVER II,27 2014 | Proximal DVT or PE | 6 mo | UFH or LMWH for 5 d, followed by dabigatran 150 mg bid (1273) | UFH or LMWH for at least 5 d with warfarin, INR 2-3 (1266) | Boehringer Ingelheim |
| Study . | Population . | Duration of treatment . | Patients randomized (n) . | Funding . | |
|---|---|---|---|---|---|
| Intervention . | Control . | ||||
| 1. RE-COVER,7 2009 | Proximal DVT of PE | 6 mo | UFH or LMWH for 5 d, followed by dabigatran 150 mg bid (1273) | UFH or LMWH for at least 5 d with warfarin, INR 2-3 (1266) | Boehringer Ingelheim |
| 2. RE-LY,12 2009 | AF, ≥1 risk factors (previous stroke or TIA, LVEF <40%, NYHA class II or higher, CHF and age ≥75 y or an age of 65-74 y plus DM, HTN, or CAD) | Median 2 y | Dabigatran 100 mg bid (6015) or 150 mg bid (6076) | Warfarin, INR 2-3 (6022) | Boehringer Ingelheim |
| 3. EINSTEIN-DVT,16 2010 | Proximal DVT without symptomatic PE | 3/6/12 mo | Rivaroxaban 15 mg bid for 3 wk, followed by 20 mg OD (1731) | Subcutaneous enoxaparin for at least 5 d with warfarin, INR 2-3 (1718) | Bayer Schering Pharma and Ortho-McNeil |
| 4. ARISTOTLE,13 2011 | AF, ≥1 risk factors (age ≥75, previous stroke/TIA, or systemic embolism, CHF within the previous 3 mo or LVEF ≤40%, DM, HTN) | Median 1.8 y | Apixaban 5 mg bid (9120) | Warfarin, INR 2-3 (9081) | Bristol-Myers Squibb and Pfizer |
| 5. ROCKET AF,14 2012 | NVAF, CHADS2 score ≥2 | Median 590 d | Rivaroxaban 20 mg OD (7131) | Warfarin, INR 2-3 (7133) | Johnson & Johnson and Bayer |
| 6. EINSTEIN-PE,29 2012 | Acute PE | 3/6/12 mo | Rivaroxaban 15 mg bid for 3 wk, followed by 20 mg OD (1731) | Subcutaneous enoxaparin at least 5 d with warfarin, INR 2-3 (1718) | Bayer HealthCare and Janssen Pharmaceuticals |
| 7. J-ROCKET AF,28 2012 | NVAF, ≥2 risk factors (CHF and/or LVEF ≤35%, HTN, DM) | Median: 71 wk (rivaroxaban), 69 wk (warfarin) | Rivaroxaban 15 mg OD (639) | Warfarin, INR 2-3 (639) | Bayer Yakuhin Ltd. |
| 8. AMPLIFY,8 2013 | Proximal DVT or PE | 6 mo | Apixaban 10 mg bid for 7 d, followed by 5 mg bid (2691) | Subcutaneous enoxaparin for at least 5 d with warfarin, INR 2-3 (2704) | Pfizer and Bristol-Myers Squibb |
| 9. ENGAGE-AF-TIMI- 48,15 2013 | AF, CHADS2 score ≥2 | Median 907 d | Edoxaban 30 mg OD (7034) or edoxaban 60 mg OD (7035) | Warfarin, INR 2-3 (7036) | Daiichi Sankyo Pharma Development |
| 10. RE-MEDY,11 2013 | Proximal DVT or PE | 6-36 mo | Dabigatran 150 mg bid (1430) | Warfarin, INR 2-3 (1426) | Boehringer Ingelheim |
| 11. HOKUSAI-VTE,9 2013 | Proximal DVT or PE | 3-12 mo | UFH or LMWH for at least 5 d, followed by edoxaban 60 mg OD (4122) | UFH or LMWH for at least 5 d, followed by warfarin, INR 2-3 (4122) | Daiichi Sankyo Pharma Development |
| 12. RE-COVER II,27 2014 | Proximal DVT or PE | 6 mo | UFH or LMWH for 5 d, followed by dabigatran 150 mg bid (1273) | UFH or LMWH for at least 5 d with warfarin, INR 2-3 (1266) | Boehringer Ingelheim |
CHADS2 score, 1 is given for point for CHF, HTN, age ≥75 y, and DM; 2 points are given for previous stroke or TIA, and systemic embolism.
AMPLIFY, Apixaban for the initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy; ARISTOTLE, Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; bid, twice daily; CAD, coronary artery disease; CHADS2 score, a HYPERLINK “http://en.wikipedia.org/wiki/Clinical_prediction_rule” \o “Clinical prediction rule” clinical prediction rule for estimating the risk of HYPERLINK “http://en.wikipedia.org/wiki/Stroke” \o “Stroke” stroke in patients with HYPERLINK “http://en.wikipedia.org/wiki/Rheumatic_fever” \o “Rheumatic fever” nonrheumatic AF; CHF, congestive heart failure; d, day; DM, diabetic mellitus (2 points are given for previous stroke or TIA); EINSTEIN-DVT, Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis; ENGAGE-AF TIMI 48, Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation–Thrombolysis in Myocardial Infarction 48; EINSTEIN-PE, Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism; HOKUSAI-VTE, Edoxaban vs Warfarin for the Treatment of Symptomatic Venous Thromboembolism; HTN, hypertension (age ≥75 y); INR, international normalized ratio; J-ROCKET-AF, An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With NonValvular Atrial Fibrillation in Japan; LVEF, left ventricular ejection fraction; mo, month; NVAF, nonvalvular AF; NYHA, New York Heart Association; OD, once daily; RE-COVER I, Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism I; RE-COVER II, Efficacy and Safety of Dabigatran Compared to Warfarin for 6-Month Treatment of Acute Symptomatic Venous Thromboembolism II; RE-LY, Randomized Evaluation of Long-Term Anticoagulation Therapy study; RE-MEDY, A phase III, randomised, multi-center, double-blind, parallel-group, active controlled study to evaluate the efficacy and safety of oral dabigatran etexilate compared to warfarin (INR 2.0-3.0) for the secondary prevention of venous thromboembolism; ROCKET-AF; Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; TIA, transient ischemic attack; UFH, unfractionated heparin; y, year.