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