Comparison of AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing in Patients with...
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Transcript of Comparison of AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing in Patients with...
Comparison of AngioComparison of AngioJETJET Rheolytic Rheolytic ThrombectomyThrombectomy
Before Direct Infarct Artery Before Direct Infarct Artery STENTSTENTing in Patients with Acute ing in Patients with Acute
Myocardial Infarction: Myocardial Infarction: the the JETSTENT trialJETSTENT trial
David Antoniucci on behalf of the JETSTENT Investigators
Co-Principal Investigators
• David Antoniucci, MD; Florence
• Antonio Colombo, MD; Milan
Clinical Event Adjudication Committee
• Isaam Moussa, M.D., Chairman Weill Cornell Medical Center, NYC
• Gian Battista Danzi, M.D., Ospedale Maggiore Policlinico University of Milan, Milan
• Carlo DiMario, M.D., PhD, Royal Brompton Hospital, London Data Management and Monitoring
• Director: Maria Cristina Jori, M.D. Mediolanum Cardio Research, Milan
ECG Core Laboratory• Serenella Castelvecchio, M.D. Mediolanum Cardio Research, Milan
Angiographic Core Laboratory• Maria Antonietta Bonardi, M.D. Mediolanum Cardio Research, Milan
Nuclear Scan Core Laboratory• Prof. Roberto Sciagrà, University of Florence, Florence
Steering Committe D Antoniucci, A Colombo, F-J
Neumann, A Rodriguez, A Stabile, J Gustafson
Sponsor: Medrad Interventional/Possis
After angiography and IRA wiring: thrombus grade 3 to 5Randomization 1:1
Pts with STEMI admitted within 12 hours from symptom onset
Lysis Stroke < 30 days Surgery < 6 weeks Pre-stented IRA
Rheolytic Thrombectomy +DSDirect Stenting (DS)
Study Design
N = 500
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 HCF at 12 months
Secondary surrogate end points: • TIMI flow, cTFC, and TIMI blush
Baseline CharacteristicsBaseline Characteristics
RT DS
n=256 n=245 p value Age (yrs) 63.0 ± 12.3 64.3 ± 11.5 .208 Sex (male) 195 (76) 199 (81) .168 Hypertension 120 (47) 116 (47) .916 Dyslipidemia 77 (30) 85 (35) .270 Diabetes mellitus 36 (14) 37 (15) .742 Previous MI 10 (3.9) 12 (4.9) .588 Anterior MI 101 (39) 91 (37) .595 Cardiogenic shock 7 (2.7) 13 (5.3) .142 ST elevation (mm) 3.98 ± 2.49 4.02 ± 2.69 .886 Symptom-ER (min) 125 [85-221] 135 [86-227] .853
Baseline Angiographic Characteristics Baseline Angiographic Characteristics RT DS
n=256 n=245 p value Multivessel disease 114 (44) 95 (39) .192 IRA .483
LAD 107 (42) 91 (37)
RCA 112 (44) 120 (49)
LCx 37 (14) 34 (14) RVD (mm) 2.94 [2.67-3.24] 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
Thrombus grade .6401-2 3 (1.4) 3 (1.4)3 73 (32.5) 80 (37.4)4 83 (37.4) 79 (36.9)5 63 (28.4) 52 (24.3)
RT DS
n=256 n=245 p
value
ER-PCI (min) 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)
TIMI flow 3 after RT 159/ 222 (72)
Predilation before stenting 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
Procedural Characteristics Procedural Characteristics
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
Perforation 0 1* (0.04) .327
*Covered stent.
Complications Complications
Surrogate End PointsSurrogate End Points
RT DS
n=246 n=240
STR ≥ 50% at 30 min 211 (85.8) 189 (78.8).043
n=217 n=208
Infarct Size (%) 11.8 [3.1-23.7] 12.7 [4.7-23.3]
.398 n=252 n=241
Final TIMI 3 flow 203 (80.6) 207 (85.9) .113
n=228 n=216
cTFC 20 [15.0-27.2] 20 [14.0-25.7] .357 n=215 n=211
Blush grade .2070-1 17 (8) 11
(5)2 43 (20) 33
(16)3 155 (72) 167
(79)
Early ST Resolution and MACEEarly ST Resolution and MACE
Non-STR STR p value
1-month n=86 n=400
Death 6 (7.0) 5 (1.3) .001
MACE 10 (11.6) 15 (3.8) .003
6-months n=80 n=365
Death 8 (10.0) 10 (2.7) .003
MACE 22 (27.5) 53 (14.5) .005
One-Month Outcome
P = 0.050
6-Month Outcome6-Month Outcome
RT DS
Predictors of ST-Segment Resolution and 6-Month MACEPredictors of ST-Segment Resolution and 6-Month MACE
6-month MACE 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
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
N=464
Events RT = 28Events DS = 47
Log-rank testp=0.007
80.7 ± 4.1
64.1 ± 6.0
Time (days)
2402101801501209060300
100
90
80
70
60
50
Six-month MACE Kaplan-Meier EstimateSix-month MACE Kaplan-Meier Estimate
RT
DS
(%)
ConclusionsConclusions Rheolytic thrombectomy before direct IRA
stenting as compared to direct IRA stenting alone is associated with a better myocardial reperfusion (higher early ST-segment resolution rate) and improved 6-month clinical outcome (lower MACCE rate).
The results of the JETSTENT trial support the routine use of rheolytic thrombectomy in STEMI patients with evidence of thrombus.
30 min. ST Reduction ≥ 50% (n=471) OR 95%CI p value
Randomization to RT 1.81 1.09 – 3.00 .022
Anterior AMI 0.28 0.17 – 0.46 <.001
Abciximab 4.28 1.22 – 14.95 .023
TIMI 3 flow 2.10 1.17 - 3.80 .013
Predictors of ST-segment resolution and 1-month MACELogistic regression (forward stepwise)
1-month MACE (n=486) OR 95%CI p value
Randomization to RT 0.30 0.11 – 0.80 .017
Abciximab 0.10 0.02 – 0.43 .002
TIMI 3 flow 0.16 0.06 – 0.41 <.001 Major bleeding 9.11 2.17 – 38.17 .003