Transcript Clinical end points

Comparison of AngioJET Rheolytic
Thrombectomy
Before Direct Infarct Artery
STENTing with Direct Stenting Alone
in Patients with Acute Myocardial
Infarction:
the JETSTENT trial
David Antoniucci on behalf of the JETSTENT Investigators
Co-Principal Investigators
• David Antoniucci, MD; Florence
• Antonio Colombo, MD; Milan
Steering Committe
D Antoniucci, A Colombo, F-J Neumann,
A Rodriguez, A Stabile, J Gustafson
Sponsor: Medrad Interventional/Possis
Clinical Event Adjudication Committee
ECG Core Laboratory
• Serenella Castelvecchio, M.D. Mediolanum Cardio Research, Milan
• Issam Moussa, M.D.,
Weill Cornell Medical Center, NYC
Nuclear Scan Core Laboratory
• Prof. Roberto Sciagrà, University of Florence, Florence
• Gian Battista Danzi, M.D., Ospedale
Maggiore , University of Milan, Milan
Angiographic Core Laboratory
• Maria Antonietta Bonardi, M.D. Mediolanum Cardio Research, Milan
•Carlo Di Mario, M.D., PhD,
Royal Brompton Hospital, London
Data Management and Monitoring
• Director: Maria Cristina Jori, M.D. Mediolanum Cardio Research, Milan
Study Design
Pts with STEMI admitted within 12 hours from symptom onset
 Lysis
 Stroke < 30 days
 Surgery < 6 weeks
 Pre-stented IRA
After angiography and IRA wiring: thrombus grade 3 to 5
Randomization 1:1
N = 500
Direct Stenting (DS)
Rheolytic Thrombectomy +DS
Technique for AngioJet Use and DS
• Single pass anterograde technique
(activate AngioJet proximal to thrombus)
• Angiographic check after first AngioJet pass.
•
Temporary pacemaker strongly discouraged.
• Balloon pre-dilation strongly discouraged.
• DS had to be attempted in all cases in
both arms.
• Routine Abciximab in both arms.
JETSTENT TRIAL
 Primary surrogate end points:
• Early ST-segment resolution
(≥ 50% ST segment elevation reduction at 30 minutes)
• Infarct size (1-month 99mTc sestamibi scintigraphy)
 Clinical end points:
• MACE at 1, 6, and 12 months
• Death and Readmission for CHF at 12 months
 Secondary surrogate end points:
• TIMI flow, cTFC, and TIMI blush
Baseline Characteristics
 Age (yrs)
 Sex (male)
 Hypertension
 Dyslipidemia
 Diabetes mellitus
 Previous MI
 Anterior MI
 Cardiogenic shock
 ST elevation (mm)
 Symptom-ER (min)
RT
DS
n=256
63.0 ± 12.3
195 (76)
120 (47)
77 (30)
36 (14)
10 (3.9)
101 (39)
7 (2.7)
3.98 ± 2.49
125 [85-221]
n=245
64.3 ± 11.5
199 (81)
116 (47)
85 (35)
37 (15)
12 (4.9)
91 (37)
13 (5.3)
4.02 ± 2.69
135 [86-227]
p value
.208
.168
.916
.270
.742
.588
.595
.142
.886
.853
Baseline Angiographic Characteristics
RT
DS
n=256
114 (44)
n=245
95 (39)
LAD
107 (42)
91 (37)
RCA
112 (44)
120 (49)
LCx
 RVD (mm)
37 (14)
2.94 [2.67-3.24]
34 (14)
2.91 [2.62-3.25]
.670
 Pre-wiring TIMI flow 0-1
212/254 (83.5)
203/242 (83.9)
.899
 Post-wiring TIMI flow 0-1
142/231 (61.5)
129/222 (58.1)
.465
 Multivessel disease
 IRA
 Thrombus grade
1-2
3
4
5
p value
.192
.483
.640
3 (1.4)
73 (32.5)
83 (37.4)
63 (28.4)
3 (1.4)
80 (37.4)
79 (36.9)
52 (24.3)
Procedural Characteristics
RT
DS
n=256
n=245
34 [15-67]
31 [18-60]
.727
 Procedural time (min)
59.5 [44.7-70]
46 [35-60]
<.001
 Predilation before RT
5/246 (2)
25 (9.8)
34 (13.9)
.149
 Stent per pt
1.26 ± 0.54
1.40 ± 0.73
.022
 Mean stent length (mm)
23.7 ± 10.9
25.9 ± 14.1
.050
 Abciximab
249 (97)
239 (98)
.841
 Procedural success
237 (93)
229 (93)
.696
 ER-PCI (min)
 TIMI flow 3 after RT
 Predilation before stenting
p value
159/ 222 (72)
Complications
RT
DS
n=256
n=245
p value
 Major bleeding (TIMI criteria)
10 (3.9)
4 (1.6)
.123
 RT related pacing
2 (0.08)
-
.165
0
1* (0.04)
.327
 Perforation
*Covered stent.
Surrogate Endpoints
STR ≥ 50% at 30 min
Infarct Size (%)
RT
DS
n=246
n=240
211 (85.8)
189 (78.8)
n=217
n=208
11.8 [3.1-23.7] 12.7 [4.7-23.3]
n=252
Final TIMI 3 flow
203 (80.6)
n=228
cTFC
20 [15.0-27.2]
n=215
p value
.043
.398
n=241
207 (85.9)
.113
n=216
20 [14.0-25.7]
.357
n=211
Blush grade
.207
0-1
2
17 (8)
43 (20)
11 (5)
33 (16)
3
155 (72)
167 (79)
Early ST Resolution and MACE
Non-STR
STR
n=86
n=400
Death
6 (7.0)
5 (1.3)
.001
MACE
10 (11.6)
15 (3.8)
.003
n=80
n=365
Death
8 (10.0)
10 (2.7)
.003
MACE
22 (27.5)
53 (14.5)
.005
1-month
6-months
p value
One-Month Outcome
P = 0.050
6-Month Outcome
RT
DS
Predictors of ST-Segment Resolution and 6-Month MACE
30 min. ST
Reduction ≥ 50%
OR
95%CI
p value
 Randomization to RT
1.70
1.03 – 2.82
.039
 Anterior AMI
0.29
0.17 – 0.47
<.001
 Final TIMI 3 flow
2.10
1.17 - 3.80
.013
HR
95%CI
p value
 Randomization to RT
0.50
0.31 – 0.82
.006
 Age (yrs)
1.02
1.01 – 1.04
.023
 Bleeding
4.33
1.80 – 10.42
.001
6-month MACE
Six-month MACE Kaplan-Meier Estimate
100
80.7 ± 4.1
(%)
90
N=464
Events
RT = 28
DS = 47
80
Log-rank test
p=0.007
70
RT
64.1 ± 6.0
DS
60
Time (days)
50
0
30
60
90
120
150
180
210
240
Conclusions
 AngioJet rheolytic thrombectomy before direct IRA
stenting as compared to direct stenting alone is
associated with:
o Better myocardial reperfusion
(higher rate of early STR)
o Improved 6-month clinical outcome
(lower MACE rate)
 The results of the JETSTENT trial support the routine
use of AngioJet rheolytic thrombectomy in AMI patients
with evidence of thrombus.