nuovi anticoagulanti orali: dai criteri di scelta all’esperienza sul campo rivaroxaban dr....
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Nuovi Anticoagulanti orali: dai criteri di scelta all’esperienza sul campo
RIVAROXABAN
Dr. Elisabetta TosoSOC Cardiologia
Ospedale Cardinal Massaia - Asti
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2011-2012Years
1980-1990
Xabans i.v.
THE RIVAROXABAN HISTORY
1905-1980
Antistasin(FXa inhibitor)
2000
Oral Inhibitors
Rivaroxaban
FDA Approves Rivaroxaban
For NVAF, DVT and PE
ROCKET-AF
EINSTEIN-DVT
EINSTEIN-PE
2013
ATLAS TMI 51 ACS
EUROPE Approves Rivaroxaban
For ACS
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Indications
Prophylaxis Treatment
NVAF15 or 20 mg od
VTE10 mg od
ACS2.5 mg bid +antiplatelets
VTE15 mg bid 21 days
20 mg od
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Warfarin Warfarin (2.4%/y)(2.4%/y)
RivaroxabanRivaroxaban(2.1%/y)(2.1%/y)
14264 patientsMean age 73 y, 80% persistent AF, mean CHADS2 score 3.5
Patel et al. NEJM 2011Patel et al. NEJM 2011
ROCKET AFROCKET AF
DaysDays
Stroke or systemic embolism
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ROCKET AF – all-cause mortality
Safety population – on-treatment analysis
Hazard ratio and 95% CIs
0.2 0.5 1 2 5Favours
rivaroxabanFavours warfarin
Endpoints
Rivaroxaban (N=7,061)
Warfarin (N=7,082)
Hazard ratio (95% CI)
n(% per year)
n(% per year)
All-cause mortality 208 (1.9) 250 (2.2) 0.85 (0.70,1.02)
Vascular death 170 (1.5) 193 (1.7) 0.89 (0.73, 1.10)
Non-vascular death 21 (0.2) 34 (0.3) 0.63 (0.36, 1.08)
Unknown cause 17 (0.2) 23 (0.2) 0.75 (0.40, 1.41)
Patel MR et al, NEJM 2011.Patel MR et al, NEJM 2011.
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Parameter
Rivaroxaban (N=7,111)
Warfarin (N=7,125)
Hazard ratio (95% CI)n (% per year) n (% per year)
Principal safety endpoint
1,475 (14.9) 1,449 (14.5) 1.03 (0.96,1.11)
Major bleeding 395 (3.6) 386 (3.4) 1.04 (0.90,1.20)
Haemoglobin drop (≥2 g/dl)
305 (2.8) 254 (2.3) 1.22 (1.03,1.44)*
Transfusion 183 (1.6) 149 (1.3) 1.25 (1.01,1.55)*
Critical organ bleeding 91 (0.8) 133 (1.2) 0.69 (0.53,0.91)*
Intracranial haemorrhage
55 (0.5) 84 (0.7) 0.67 (0.47,0.93)*
Fatal bleeding 27 (0.2) 55 (0.5) 0.50 (0.31,0.79)*
Non-major clinically relevant bleeding
1,185 (11.8) 1,151 (11.4) 1.04 (0.96,1.13)
Safety population – on-treatment analysis; *Statistically significant
ROCKET AF – bleeding analysis
Major bleeding from gastrointestinal site (upper, lower and rectal): rivaroxaban=224 events (3.2%); warfarin=154 events (2.2%); p<0.001*
Hazard ratio and 95% CIs
0.2 0.5 1 2 5Favours
rivaroxabanFavours warfarin
Patel MR et al, NEJM 2011.Patel MR et al, NEJM 2011.
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What about Rivaroxaban and..
VALVULAR HEART DISEASEHYPERTROPHIC CARDIOMYOPATHY
ELECTRICAL CARDIOVERSION
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NOACs for VALVULAR HD
ESC AF Guidelines European Heart Journal 2012
Patients with prosthetic heart valves should not take dabigatran/rivaroxaban/apixaban
nor should pts with AF that is caused by a heart valve problem.
www.fda.gov
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Breithardt G. et al Eur Heart Journal 2014
Valvular Heart Disease 1992 pts (14%)90% mitral regurgitation (only 3% post-rheumatic)
Stroke or SE Major Bleedings
P 0,76
• Rivaroxaban • Warfarin
P 0,01
% E
vent
s/10
0 pt
s/y
2,01
2,43
6,14
4,20
% E
vent
s/10
0 pt
s/y
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• In HCM pts CHA2DS2VASC score to calculate stroke risk is not recommended
• There are no data on the use of NOACs in HCM pts
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What about Rivaroxaban and..
VALVULAR HEART DISEASEHYPERTROPHIC CARDIOMYOPATHY
ELECTRICAL CARDIOVERSION
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Electrical Cardioversion on warfarin
664 pts1841 pts 521 pts 275 pts 1946 pts
0.7%
0.5%
0.4%0.3%
0
13/ 5247 pts0.24%
Sintomatic cerebrovascular complications
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Electrical Cardioversion on NOACs
647 pts 672 pts
0.8%
265 pts
0.30%
0
Sintomatic cerebrovascular complications
Flaker G. et al JACC 2014Nagarakanti R et al Circulation 2011
265 pts
1.6%
Piccinini et al JACC 2013
9/1708 pts0,52%
CHADS 2.1-2.2
CHADS 2.1
CHADS 3.5
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Cappato R. et al. Eur Heart Journal 2014
X-VERT Trial1504 patients, 141 Centres across 16 countries
GermanyFrance
Netherlands
UK
South Africa
Canada Belgium
China
Denmark
Finland
SpainPortugal
USA
Singapore
Greece
Italy:•Botto GL •Calò L•Cappato R •Capucci A•Gaita F•Grimaldi M•Gulizia MM•Themistoclakis S
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30-day follow-up
OAC
Randomized, open-label, parallel-group, active-controlled multicentre study
Early#
Delayed
Cardioversionstrategy
1–5 daysR
Rivaroxaban 20 mg od*
VKA2:1
2:1
≥21 days(max. 56 days)
Rivaroxaban 20 mg od*
VKA
R
Inclusion criteria:Age ≥18 years, non-valvular AF lasting >48 h or unknown duration, scheduled for cardioversion
Ezekowitz MD et al. Am Heart J 2014;167:646–652;
*15 mg if CrCl 30–49 ml/min; VKA with INR 2.0–3.0; #protocol recommended only if adequate anticoagulation or immediate TEE
42 days
42 days
Rivaroxaban 20 mg od*
VKA
Rivaroxaban 20 mg od*
VKA
End
of
stud
y tr
eatm
ent
Car
dio
vers
ion
Car
dio
vers
ion
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Total(N=1504)
Rivaroxaban(n=1002)
VKA(n=502)
Age, mean SD, years 64.9 ±10 64.9±10 64.7±10
Male, % 72.7 72.6 73.1
Persistent 53.9 55.9 50.0
Hypertension, % 66.2 65.0 68.7
Renal function/CrCI, % ≥80 ml/min
60.2 61.5 57.6
Prior OAC use for ≥6 weeks, % 42.8 42.3 43.8
Previous stroke/TIA or SE, % 7.7 6.7 9.8
CHADS2 score, mean SD 1.4±1.1 1.3±1.1 1.4±1.1
CHA2DS2-VASc score, mean SD 2.3±1.6 2.3±1.6 2.3±1.6Cappato R et al. Eur Heart J 2014
X-VeRT: clinical characteristics
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X-VeRT: Stroke or TIA
768/872 early CV performed
567 pts
0.7%
277 pts
1,08%
399/632 delayed CV performed
321 pts
0.2%
78 pts
0,9%
Cappato R et al. Eur Heart J 2014
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p<0.001
1 patient with inadequate
anticoagulation
95 patients with inadequate
anticoagulation
Patients cardioverted as scheduled
X-VeRT: time to cardioversion
Cappato R et al. Eur Heart J 2014
Rivaroxaban: 841/1002 pts (84%)Warfarin: 385/502 pts (77%)
Pati
ents
(%
)
Delayed cardioversion
Rivaroxaban: 321/417 pts (77%)Warfarin: 78/215 pts (36.3%)
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Median time to cardioversion
Day
s
0
20
40
60
80
100
Early Delayed
p=0.628
p<0.001
RivaroxabanVKA
22 days
30 days
X-VeRT: time to cardioversion
Cappato R et al. Eur Heart J 2014
The time between randomization and CV was similar or shorter in Rivaroxaban vs Warfarin Early median 1 (1-2 ) vs 1 (1-3)
Delayed 22 (21-26) vs 30 (23-42)
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Thrombosis Research Global Forum 2014, Berlin 6-8 November
Thanks for your attention!