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Classical Hematology

ROCKET AF trial, rivaroxaban vs warfarin in Afib
2011
Classical Hematology - Anticoagulation
TRAPS trail Rivaroxaban vs warfarin in high-risk APLS
2018
Classical Hematology - Anticoagulation
Rivaroxaban vs warfarin in APS trial
2019
Classical Hematology - Anticoagulation
HAVEN 1 trial, emicizumab, with inhibitor ≥12y/o
2017
Classical Hematology - Hemophilia
HAVEN 3 trial, emicizumab, no inhibitor ≥12y/o
2018
Classical Hematology - Hemophilia
HAVEN 2 trial, emicizumab, with inhibitor ≤12y/o
2019
Classical Hematology - Hemophilia
TITAN trial
2016
Classical Hematology - TTP
HERCULES trial
2019
Classical Hematology - TTP

ROCKET AF trial, rivaroxaban vs warfarin in Afib
Patel MR et al, NEJM, 2011, PMID: 21830957

Classical Hematology - Anticoagulation

Background: noninferiority phase III RCT included 14,264 patients with nonvalvular atrial fibrillation with patients at least 2/3 following criteria: HF with EF ≤35%, ≥75y/o or DM (i.e., a CHADS2 ≥2/6 indicating a greater risk of stroke). Important exclusions: CrCl <30 mL/min, liver disease or ALT >3x ULN, hemodynamically significant MV stenosis, prosthetic heart valve, atrial myxoma, LV thrombus CVA in <15days, TIA <3days

Arm A: rivaroxaban 20 mg daily (15 mg daily if CrCL 30-50ml/min)
Arm B: warfarin INR 2.0-3.0

Primary end point: composite of stroke (ischemic or hemorrhagic) and systemic embolism.
mFollow up: 707 days

 

ITT stroke or systemic embolism: 188 evets (2.1events/yr) vs 241 (2.4 events/yr), HR 0.88 95%CI 0.75-1.03, P<.001 for noninferiority)
Per-protocol stroke or systemic embolism: 188 evets (1.7 events/yr) vs 241 events (2.2 events/yer), HR 0.79 95%CI 0.66-0.96; P<.001 for noninferiority)

MI: 0.9 vs 1.1 events per 100 patient-years, HR 0.81; 95%CI 0.63-1.06, P=.12

All-cause mortality:
1.9 vs 2.2 events per 100 patient-years
Adverse Events. Major and non-major clinically-relevant bleeding: 20.7% vs 20.3%, major bleeding (5.6% vs 5.4%), drug discontinuation (23.7% vs 22.2%)

 

Conclusions: rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation.

 

Summarized by Veli Bakalov, MD and reviewed by Deep Shah, MD 

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