NVAF Flashcards
(17 cards)
HAS-BLED
HTN
Abnormal liver or renal disease (Scr of at least 2.3; Bili >2x ULN or AST/ALT >3x ULN) - COULD GET 2 POINTS
Stroke
Bleed History (or predisposition such as anemia)
Labile INR (TTR <60%)
Elderly (Age >65)
Drugs/ETOH (antiplatelets, NSAIDS, >3 drinks/week) - COULD GET 2 POINTS
CHA2DS2-VAS
C- CHF (+1) H - HTN (+1) A - Age >75 (+2) D - DM (+1) S - Stroke, TIA, TE (+2)
V - Prior MI, PAD, Aortic plaque (+1)
A - Age 65-74 (+1)
S - Female sex (+1)
ARISTOPHANES
Meta-Analysis using Medicare, Medicaid, Optum, Humana, Marketscan, Pharmetrics databases
To prevent Stroke/SE:
Apixaban>Rivaroxaban>Dabigatran>warfarin
To prevent Ischemic Stroke:
Apixaban>Rivaroxaban>Dabigatran=warfarin
To prevent Systemic Embolism:
Apixaban~Dabigatran>Rivaroxaban>warfarin
For major bleeding
Apixaban is better than dabigatran which is better than warfarin which is better than rivaroxaban
For Hemorrhagic Stroke:
Dabigatran is slightly better than apixaban which is better than rivaroxaban which is better than warfarin
ARISTOTLE
PURPOSE/COMPARATORS
N
MAIN RESULTS
APIXABAN VS WARFARIN FOR SPAF
N >18,000
○ Stroke/SE = 1.27% per year Apixaban vs 1.6% Warfarin (p<0.001 for noninferiority; p=0.01 superiority) § Absolute Risk Reduction of 0.33; Relative Risk Reduction of 21% ○ ISTH Major Bleeding or CRNM = 2.13% per year Apixaban vs 3.09% per year Warfarin (p<0.001) § ARR of 0.96%; RRR = 31% • Key Secondary Outcomes: ○ All-cause mortality = 3.52% Apixaban vs 3.94% Warfarin 11% RRR (p=0.047) ○ Secondary outcome was also superiority of apixaban vs warfarin for the primary outcome and this was met
AUGUSTUS
N
PURPOSE
RESULTS
N = 4615
APIXABAN VS WARFARIN IN SPAF S/P PCI OR RECENT ACS
ALSO WAS TAKING P2Y INHIBITORS
Results:
31% reduction in primary outcome with apixaban compared to warfarin (superior) at 6 months
17% reduction in death+hospitalization with apixaban (primarily driven by reduction in all-cause hospitalization)
Conclusion:
Apixaban showed significantly less bleeding and fewer deaths or hospitalizations. There was a similar rate of death or ischemic events between apixaban and warfarin
AVERROES
N
PURPOSE/COMPARATORS/RESULTS
• N=5599
Apixaban vs ASA in NVAF stroke prevention in patients who failed or have demonstrated or were expected to be unsuitable for VKAs
Stopped early due to significant reduction in stroke and systemic embolism for apixaban compared to ASA without significant increase in major bleeding
○ Treatment benefit >4 standard deviations in favor of apixaban
○ Median follow up 1.1 years
○ Fewer patient in apixaban group D/C study drug before end of study
EMANATE
N=1500
Apixaban vs VKA/Heparin for Cardioversion
• Results - NOTHING WAS STATISTICALLY SIGNIFICANT:
○ ITT population, ZERO patients in apixaban (n=753) had stroke, compared to 6 in the VKA/heparin (n=747) group
§ But was not powered to detect, and confidence intervals in VKA/heparin group was 0.3-1.7)
○ There were no SE events in either group
○ There were 2 deaths in the apixaban arm, and 1 in the VKA/heparin group
○ Major bleeding: 3 patients in apixaban group vs 6 patients in VKA/heparin group
○ CRNM bleeding: 11 patients in apixaban group vs 13 in VKA/heparin group
• Conclusions - low stroke, SE, death, and bleeding in both groups
RE-LY
n >18,000
Dabigatran 110 mg and 150 mg vs warfarin in AF
• 110 mg dose:
○ non-inferior to warfarin for stroke/SE and bleeding risk
• 150 mg dose:
superior to warfarin for stroke/SE; non-inferior bleeding risk
ROCKET-AF
Rivaroxaban vs warfarin in AF
• Rivaroxaban was non-inferior to warfarin for stroke/SE
• Major+CRNM bleeding =14.9% riv vs 14.5% warfarin (same statistically)
Riv had a slight but statistically significant reduction in ICH (0.5% vs 0.7%) and fatal bleeding (0.2% vs 0.5%)
ENGAGE-AF-TIMI 48
Edoxaban 30 mg vs 60 mg vs warfarin for superiority
Edoxaban at both doses was NOT found superior based on original criteria of study, but a modified analysis found that the 60 mg dose was superior to warfarin in some respects
End conclusion was that bleeding was less in both edox groups, but only the 60 mg dose appeared to be as good or possibly superior in stroke prevention compared to warfarin.
X-VeRT
Rivaroxaban vs warfarin in AF before cardioversion showed similar rates of stroke/TE and bleeding with both groups
ENSURE-AF
Edoxaban vs warfarin in AF before cardioversion showed similar rates of stroke/TE and bleeding with both groups
AEIOU
uninterrupted vs minimally interrupted Apixaban for ablation procedures
• Apixaban for at least 21 days prior to ablation (both groups received heparin bolus prior to procedure)
○ Uninterrupted - Skipped no dose of apixaban at all (i.e., took dose the morning of procedure) - n=150
○ Minimally interrupted - Skipped only one dose the morning of ablation - n=150
○ These were compared to a retrospective analysis of similarly-matched warfarin patients - n=295
• Results:
○ There were no strokes/SE in any group
○ Bleeding was similar
○ Overall conclusion: all 3 strategies are reasonable.
AXAFA-AFNET 5
Apixaban vs warfarin for ablation in AF
• N=633
• Apixaban x 30 days (no TEE) or Apixaban min. of 2 doses (with TEE) compared to warfarin x 30 days (no TEE) OR warfarin to INR 1.8 (with TEE)
• Primary outcome = composite of death, stroke, major bleeding (BARC ≥2)
• Results: continuous apixaban has similar outcomes to VKA for ablation with respect to stroke, major bleeding, cognitive function, and MRI-detected brain lesions
AEGEAN
Assesed the impact of an education program on adherence in patients taking apixaban for SPAF (Stroke prevention in AF) at 24 weeks (48 weeks as a secondary endpoint)
• Education = ○ Additional educational booklet explaining AF and AC treatment for stroke prevention ○ Reminder tools (key ring, SMS texts or smartphone App) ○ Access to virtual clinic organized at country level utilizing ATS staff • At 24 weeks, half of the patients in the education arm were again randomized to usual standard of care, and half went into continued education • Results - endpoints look essentially identical in all groups; no benefit from educational programs
ATLANTIS
• Investigated SUPERIORITY of Apixaban vs standard of care (SOC) after Trans-aortic valve implantation for aortic stenosis
• n=1,500
○ DAPT or
○ SAPT or
○ Warfarin if other indication for OAC
• Apixaban 5 mg BID x 12 months (reduced dose as usual for ≥2 reduction factors)
• Control arm received either DAPT or SAPT, depending on their bleeding risk profile
○ If DAPT, continued for as long as prescriber wished
○ If SAPT, lifelong treatment
• Results:
• Primary Endpoint in ITT ○ 151 events in SOC vs 138 events in apixaban group (not statistically different) • Secondary Endpoints: ○ No differences in bleeding at all • Secondary outcomes in group that REQUIRED OAC (i.e., apixaban or warfarin) ○ No differences in any secondary endpoint • Secondary outcomes in group that DID NOT REQUIRE OAC (i.e., apixaban vs DAPT or SAPT) ○ Found non-statistical difference (BUT CONFIDENCE INTERVALS INDICATE CONCERN) § Increase in risk of death (mainly non-cardiovascular death) with APIXABAN compared to warfarin § But a Decrease risk of any valve thrombosis with apixaban
PCI-involved Apixaban trials
AUGUSTUS
