Introduccin
Introduccin
Recomendaciones:
Mtodos
Objetivo ISAR-TRIPLE:
Diseo:
Mtodos; Diseo
Mtodos; Diseo
Asignacin Aleatoria:
Tratamiento:
Mtodos; Diseo
Evaluacin y seguimiento
Hiptesis:
Tratamiento 6 semana superior a 6 meses. Incidencia variable
principal de valoracin: 10% con 6 meses de tratamiento triple.
60% Reduccin del riesgo con 6 semanas de tratamiento
Poder 80%, con nivel: 0,05
Fisher,
Variables continuas: resumidas con promedios y DS y
medianas comparadas con T-student o Prueba de los rangos
con signo de Wilcoxon
Riesgos estimados con anlisis de Cox
Mtodo de Kaplan Meyer para las curvas de eventos
Mtodos: Diseo
R-TRResultados
IPLE: StudyEstudio
Organization
ISAR-TRIPLE
:
6-month therapy;
10%, Risk reduction
herapy; Power =80%,
patients per group
NT:
ial infarction, definite
s, stroke or TIMI
at 9 months
OINTS:
cations: Cardiac
ial infarction, definite
s or ischemic stroke
cations (TIMI major)
6-week
Clopidogrel
(n=307)
6-month
Clopidogrel
(n=307)
*p = 0.03
p = 0.03.
Antithrombotictherapy
Resultados
Estudio ISAR-TRIPLE
ASTerapia
PIRIN:
Antitrombtica
75-200
mg per day
Aspirina:
75-200 mg da
CLOPIDOGREL:
75mg
per day
Clopidrogrel:
75 mg da
PHENP
ROCOUMON or WARFARIN:
Warfarina
o Fenprucumn
Target INR 2.0 or 2.5 in patients with
(vlvulas
mechanical
valvesmecnicas)
Compliance
6-weekFU
6-month FU
9-monthFU
Aspirin*
97 %
95 %
96 %
OAC*
INR(median)*
Time in therapeuticrange*
94 %
2.2
64 %
91 %
2.3
69 %
88 %
2.3
66 %
Clopidogrel 6-weekgroup
Clopidogrel 6-month group
97 %
98 %
P=0.56
26 %
87 %
P<0.001
23 %
35 %
P<0.001
S
tent
type
Tipos Stent
6-weekgroup
(417 lesions)
6-monthgroup
(409 lesions)
203 (48.7)
206 (50.4)
Biodegradablepolymer DES
131 (31.4)
134 (32.8)
45 (10.8)
46 (11.2)
29 (6.9)
16 (3.9)
BVS
4 (1.0)
3 (0.7)
BMS*
2 (0.5)
DEB/PTCA**
3 (0.7)
4 (1.0)
DES =Drug-eluting stent; BMS =Bare-metal stent; BVS =Bioresorbablevascular scaffold; DEB =Drug-eluting balloon; *One patient
had 1 DES and 1 BMS and 1 patient had 1 BMS only. ** These patients were treated with drug eluting balloons (DEB) except for 1
patient in the 6-week group and 1 patient in the 6-month group.
Resultados
Estudio ISAR-TRIPLE
Primary Endpoint
Variable
Primaria Valoracin
20
Death, myocardial infarction, stentthrombosis,
eorTIMI
majorbleeding
20strok
Death,
myocardial
infarction, stentthrombosis,
strokeorTIMI majorbleeding
HR 1.14 (95%, CI 0.68 1.91), p=0.63
15
Primary Endpoint
15
9.8%
10
9.8 %
10
8.8 %
8.8 %
6-m
onth
group
6-m
onth
group
6-week
group
6-week
group
0 1
1 2
2 3
3 4 4
5 5 6 6 7 7
Months
After
Randomization
Months
After
Randomization
8 8
99
SecondaryEndpoints
SecondaryEndpoints
20
15
10
5
0
TIMI majorbleeding
20
15
20
15
15
10
10
4.3 %
4.3 %
5
0
TIMI majorbleeding
HR1.35 (0.64 - 2.84), p=0.44
4.0 %
0
10
5.3 %5.3 %
4.0 %4.0 %
4.0 %
8
0 1 Months
2 3After4Randomization
5 6 7 8
1 2 3 4 Months
5 After
6 7Randomization
8 9
Months After Randomization
Months After Randomization
6-month group
6-week
group
6-month
group
6-week group
Resultados
Results Estudio ISAR-TRIPLE
Death
Cardiac death
5 (1.7)
9 (3.0)
0.29
Myocardial infarction
6 (2.0)
0.03
2 (0.7)
0.50
Stroke
4 (1.3)
6 (2.0)
0.75
Ischemicstroke
3 (1.0)
4 (1.3)
0.99
Definiciones Sangrado
BARC:
TIMI:
AnyBARC Bleeding(type
1-5)
Resultados
Estudio ISAR-TRIPLE
SecondaryEndpoints
Post-hoc landmarkanalysisof anyBARC
AnyBARCBleeding
50
40
30
20
10
0
Bleedingbeforeandafter 6 weeks(6w)
20
15
30
37.6 %
20
10
4.3 %
5
4.0 %
0
1 2 30 14 2 5 3 64 75 68 7 9 8 9
Months After
Randomization
Months
After Randomization
TIMI majorbleeding
HR 0.68 (0.47 0.98), p=0.04
20
6w
HR 1.35 (0.64 - 2.84), p=0.44
27.9 %
15
10
10 5
5.3
% %
20.5
4.0 %
0 0
0 0 1 1 22 3
3 44 5 5 6 67 78 98
Months
Randomization
Months After
After Randomization
6-month
group
6-month
group
6-week
6-week
group
group