Comparison of AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing 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 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 5 Randomization 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 99m Tc 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 Characteristics RTDS n=256 n=245 p value  Age (yrs)63.0 ± ±  Sex (male) 195 (76)199 (81).168  Hypertension 120 (47)116 (47).916  Dyslipidemia77 (30)85 (35).270  Diabetes mellitus36 (14)37 (15).742  Previous MI10 (3.9)12 (4.9).588  Anterior MI101 (39)91 (37).595  Cardiogenic shock7 (2.7)13 (5.3).142  ST elevation (mm) 3.98 ± ±  Symptom-ER (min) 125 [85-221] 135 [86-227].853

Baseline Angiographic Characteristics RTDS n=256 n=245 p value  Multivessel disease114 (44)95 (39).192  IRA.483 LAD107 (42)91 (37) RCA112 (44)120 (49) LCx37 (14)34 (14)  RVD (mm)2.94 [ ] 2.91 [ ].670  Pre-wiring TIMI flow /254 (83.5)203/242 (83.9).899  Post-wiring TIMI flow /231 (61.5) 129/222 (58.1).465  Thrombus grade (1.4)3 (1.4) 373 (32.5)80 (37.4) 483 (37.4)79 (36.9) 563 (28.4)52 (24.3)

RTDS n=256n=245 p value  ER-PCI (min)34 [15-67]31 [18-60].727  Procedural time (min) 59.5 [ ] 46 [35-60] <.001  Predilation before RT5/246 (2)  TIMI flow 3 after RT159/ 222 (72)  Predilation before stenting25 (9.8)34 (13.9).149  Stent per pt 1.26 ± ±  Mean stent length (mm) 23.7 ± ±  Abciximab249 (97)239 (98).841  Procedural success237 (93)229 (93).696 Procedural Characteristics

RTDS n=256n=245 p value  Major bleeding (TIMI criteria) 10 (3.9)4 (1.6).123  RT related pacing2 (0.08)-.165  Perforation0 1* (0.04).327 * Covered stent. Complications Complications

Surrogate End Points RTDS n=246n=240  STR ≥ 50% at 30 min 211 (85.8)189 (78.8).043 n=217n=208  Infarct Size (%)11.8 [ ] 12.7 [ ].398 n=252n=241  Final TIMI 3 flow 203 (80.6) 207 (85.9).113 n=228n=216  cTFC 20 [ ] 20 [ ].357 n=215n=211  Blush grade (8)11 (5) 243 (20)33 (16) (72)167 (79)

Early ST Resolution and MACE Non-STR STR p value 1-month n=86n=400  Death6 (7.0)5 (1.3).001  MACE10 (11.6)15 (3.8) months n=80n=365  Death8 (10.0)10 (2.7).003  MACE22 (27.5)53 (14.5).005

One-Month Outcome P = 0.050

6-Month Outcome RT DS

Predictors of ST-Segment Resolution and 6-Month MACE 6-month MACEHR95%CIp value  Randomization to RT –  Age (yrs) –  Bleeding – min. ST Reduction ≥ 50% OR95%CIp value  Randomization to RT –  Anterior AMI – 0.47<.001  Final TIMI 3 flow

N=464 Events RT = 28 Events DS = 47 Log-rank test p= ± ± 6.0 Time (days) Six-month MACE Kaplan-Meier Estimate RT DS (%)

Conclusions  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) OR95%CIp value Randomization to RT – Anterior AMI – 0.46<.001 Abciximab – TIMI 3 flow Predictors of ST-segment resolution and 1-month MACE Logistic regression (forward stepwise) 1-month MACE (n=486) OR95%CIp value Randomization to RT – Abciximab – TIMI 3 flow – 0.41<.001 Major bleeding –