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. 2021 Mar 19;100(11):e25216. doi: 10.1097/MD.0000000000025216

Table 1.

Baseline characteristics and results of included trials.

Study (patients) Study design Source of participant Study Period Intervention Conventional treatment Major GI bleeding, n/N NOAC vs n/N conventional treatment group
Atrial Fibrillation (11 studies)
 Granger2011 Double blind randomized North America, South America, Europe, Asian Pacific 2006–2010 Apixaban (2.5 mg twice) Warfarin 150/9120 vs 119/9081
 Giugliano2013 Double blind randomized North America, South America, Europe, Asian Pacific 2008–2010 Edoxaban (60 mg, 30mg) Warfarin 361/14069 vs 190/7036
 Hori2013 Double blind randomized Asia 2007–2010 Rivaroxaban (15mg) Warfarin 8/639 vs 15/639
 Connolly2009 Open-label randomized North America, South America, Europe, Asian Pacific 2005–2007 Dabigatran (150 mg, 110mg) Warfarin 315/1291 vs 120/6022
 Patel 2011 Double blind randomized North America, South America, Europe, Asian Pacific 2006–2009 Rivaroxaban (20mg) Warfarin 224/7131 vs 154/7133
 Connolly2011 Double blind randomized North America, South America, Europe, Asian Pacific, South Africa 2007–2009 Apixaban (2.5 mg twice) Aspirin (81–324mg) 12/2808 vs 14/2791
 Chung 2011 Double blind randomized Asian countries (Taiwan, South Korea, Hong Kong and Singapore) 2007–2008 Edoxaban (60 mg, 30mg) Warfarin 0/159 vs 1/75
 Ogawa 2011 Double blind randomized Japan Apixaban (2.5 mg twice,5 mg twice) Warfarin 0/75 vs 2/143
 Abraham 2017 Retrospective, propensity matched cohort study. US, Optum Data Warehouse 2010–2015 Apixaban Dabigatran Rivaroxaban None 33/6542 222/15787 215/15787
 Abraham 2015 Retrospective, propensity matched cohort study. US, Optum Data Warehouse 2010–2013 Dabigatran Rivaroxaban Warfarin 18/7749 vs 22/7749 15/5166 vs 16/5166
 Graham 2016 Retrospective, propensity matched cohort study. US, fee-for-service Medicare 2011–2014 Dabigatran, 150 mg, twice daily; Rivaroxaban, 20 mg, once daily. None 362/52 240 656/66 651
 Yao 2016 Retrospective, propensity matched cohort study. US insurance database 2010–2015 Apixaban Dabigatran Rivaroxaban Warfarin 14/7695 vs 23/7695 28/14307 vs 28/14307 53/16175 vs 40/16175
Venous thromboembolism or Pulmonary embolism (11 studies)
 Bauersachs 2010 Double blind randomized 2007–2009 Rivaroxaban (20mg) Placebo 3/598 vs 0/590
 Buller 2012 Open-label, randomized 2007–2011 Rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily Enoxaparin 1/2420 vs 2/2413
 Yamada 2015 Double blind randomized Japan 2012–2013 Rivaroxaban (15 or 10 mg twice) warfarin 0/77 vs 0/19
 Agnelli 2013 (acute VTE) Double blind randomized North America, South America, Europe, Asian Pacific 2008–2012 Apixaban (5 mg twice) Enoxaparin (1 mg/kilogram of body weight, 12 h) 8/2676 vs 19/2689
 Agnelli 2013Ext Double blind randomized North America, South America, Europe, Asian Pacific 2008–2011 Apixaban (2.5 mg, 5mg) Placebo 1/1635 vs 1/829
 Nakamura 2015 Double blind randomized Japan NA Apixaban (10 mg twice) Warfarin 0/40 vs 0/40
 Buller 2013 Double blind randomized Europe 2010–2012 Edoxaban (60mg) Warfarin 27/4118 vs 18/4122
 Schulman 2009 Double blind randomized Europe, North America 2006–2008 Dabigatran (150mg) Warfarin 53/1274 vs 35/1265
 Schulman 2014 Double blind randomized Europe, North America 2008–2010 Dabigatran (150 mg twice) Warfarin 48/1279 vs 33/1289
 Schulman 2013 (RE-MEDY) Double blind randomized North America, South America, Europe, Asian Pacific 2006–2010 Dabigatran (150 mg twice) Warfarin 5/1430 vs 8/1426
 Schulman 2013 (RE-SONATE) Double blind randomized North America, South America, Europe, Asian Pacific 2007–2010 Dabigatran (150 mg twice) Placebo 2/681 vs 0/662
Post-surgical prophylaxis of venous thromboembolism (11 studies)
 Lassen 2009 Double blind randomized Europe NA Apixaban (2.5 mg twice) Enoxaparin (30mg) 1/1596 vs 6/1588
 Lassen 2010K Double blind randomized Europe 2007–2008 Apixaban (2.5 mg twice) Enoxaparin (40mg) 2/1501 vs 2/1508
 Lassen 2010H Double blind randomized Europe 2007–2009 Apixaban (2.5 mg twice) Enoxaparin (40mg) 4/2673 vs 0/2659
 Fuji 2014K Double blind randomized Japan 2009 Edoxaban (30mg) Enoxaparin (2000IU) 1/354 vs 0/349
 Fuji 2015 Double blind randomized Japan 2009–2010 Edoxaban (30mg) Enoxaparin (2000IU) 0/303 vs 2/301
 Fuji 2014H Double blind randomized Japan 2008–2009 Edoxaban (30mg) Enoxaparin (2000IU) 1/59 vs 0/29
 Eriksson 2007 Double blind randomized Europe 2004–2006 Dabigatran (150 mg or 220mg) Enoxaparin 1/2309 vs 0/1154
 Eriksson 2008 Double blind randomized Europe 2006–2007 Rivaroxaban (10mg) Enoxaparin (40mg) 2/2209 vs 1/2224
 Kakkar 2008 Double blind randomized Europe 2006–2007 Rivaroxaban (10mg) Enoxaparin (40mg) 1/1228 vs 0/1229
 Turpie 2009 Double blind randomized North America, Europe 2006–2007 Rivaroxaban (10mg) Enoxaparin (30mg) 1/1526 vs 0/1508
 Lassen 2008 Double blind randomized Europe 2006 Rivaroxaban 10mg Enoxaparin (40mg) 7/12,20 vs 6/1,239

NA = non-available.