Ectiveness and Safety of NOACs vs WarfarinYao et alORIGINAL RESEARCHTable 5. Subgroup
Ectiveness and Security of NOACs vs WarfarinYao et alORIGINAL RESEARCHTable five. Subgroup Analysis in Propensity Score atched Rivaroxaban Versus G-CSF, Human (CHO) Warfarin UsersRivaroxaban (n=16 175) Event RateWarfarin (n=16 175) Occasion RateRivaroxaban vs Warfarin (n=32 350) HR (95 CI) P ValueStroke or systemic embolism CHA2DS2-VASc 0 2 four HAS-BLED 0 3 Warfarin seasoned No Yes Dose Decreased Common Main bleeding CHA2DS2-VASc 0 two four HAS-BLED 0 three Warfarin seasoned No Yes Dose Reduced Frequent 6.42 three.46 three.98 3.54 1.15 (0.87.51) 1.01 (0.85.21) 3.80 four.66 4.23 2.45 0.94 (0.79.12) 1.48 (1.12.95) 0.45 two.66 6.32 2.03 6.28 1.22 (0.96.54) 0.95 (0.79.14) 0.01 0.89 2.35 five.85 1.26 two.53 4.86 0.65 (0.27.55) 0.86 (0.64.16) 1.13 (0.95.34) 0.ten 0.17 two.21 1.03 1.31 1.29 1.21 (0.76.92) 0.84 (0.62.14) 1.09 1.70 1.55 0.77 0.77 (0.57.04) 1.63 (1.01.62) 0.20 0.78 2.06 0.74 two.18 0.98 (0.65.48) 0.90 (0.66.24) 0.01 0.33 0.48 two.00 0.18 0.70 1.91 1.72 (0.290.21) 0.65 (0.35.21) 0.99 (0.75.31) 0.76 0.P worth inside the table is for interaction. HR indicates hazard ratio. P0.05. P0.01. Event rate is expressed per 100 person-years.for the trial population; consequently, rivaroxaban might be prescribed far more commonly in for elderly individuals due to the fact ROCKET-AF integrated a largely elderly high-risk population. Amongst the 3 studied NOACs, dabigatran 150 mg (110 mg was not authorized within the Usa) and rivaroxaban have been each associated to a larger risk of gastrointestinal bleeding, whereas apixaban was associated to a nonsignificant numerically decrease threat of gastrointestinal bleeding.six The lower bleeding risk of apixaban might explain why it has been prescribed for many elderly patients. A bigger percentage of dabigatran patients had applied warfarin previously. That is probably becauseDOI: 10.1161/JAHA.116.dabigatran was the first NOAC towards the market. Quite a few insurance coverage plans call for individuals to have a documented trial of warfarin before employing NOACs, and this requirement may be less prevalent within the latter portion of the study period. The results of apixaban and rivaroxaban were constant using the pivotal GDF-11/BMP-11, Human (HEK293) clinical trials. Inside the ARISTOTLE trial comparing apixaban and warfarin, apixaban was superior to warfarin in stopping stroke or systemic embolism and brought on significantly less bleeding.8 In the ROCKET-AF trial comparing rivaroxaban and warfarin, rivaroxaban was noninferior to warfarin for both principal effectiveness and safety endJournal in the American Heart AssociationEffectiveness and Safety of NOACs vs WarfarinYao et alORIGINAL RESEARCHTable six. Sensitivity Test Primarily based on Intent-to-Treat ApproachApixaban vs Warfarin (n=15 390) Dabigatran vs Warfarin (n=28 614) Rivaroxaban vs Warfarin (n=32 350)Stroke or systemic embolism Ischemic stroke Hemorrhagic strokeP0.05. P0.01.0.72 (0.55.95) 0.73 (0.53.00) 0.69 (0.36.32)1.01 (0.87.16) 1.ten (0.94.30) 0.61 (0.42.87)1.04 (0.89.21) 1.14 (0.95.37) 0.63 (0.43.91)points.7 There happen to be issues relating to the validity of ROCKET-AF. The device utilised to monitor INR has been topic to a recall simply because it could deliver clinically drastically reduced values than a laboratory INR system.47 The anticoagulation control in the warfarin-treated arm was also suboptimal. The imply TTR was only 55 compared with 64 inside the dabigatran trial and 62 within the apixaban trial.six Additionally, lack of lowrisk patients inside the ROCKET-AF raised a question relating to its effectiveness and security in reduced threat patients. Our study, consistent having a preceding French study comparing rivaroxaban and warfarin21 and observations fro.
