1. 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

2. Co-Principal Investigators David Antoniucci, MD; Florence Antonio Colombo, MD; Milan Clinical Event Adjudication Committee Issam Moussa, M.D., Weill Cornell Medical Center, NYC Gian Battista Danzi, M.D., Ospedale Maggiore, University of Milan, 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 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

3. After angiography and IRA wiring: thrombus grade 3 to 5 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 Randomization 1:1 N = 500

4. 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.

5. 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 CHF at 12 months Secondary surrogate end points: TIMI flow, cTFC, and TIMI blush

6. Baseline Characteristics RTDS n=256 n=245 p value Age (yrs)63.0 ± 12.364.3 ± 11.5.208 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 ± 2.494.02 ± 2.69.886 Symptom-ER (min) 125 [85-221] 135 [86-227].853

7. 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 [2.67-3.24] 2.91 [2.62-3.25].670 Pre-wiring TIMI flow 0-1212/254 (83.5)203/242 (83.9).899 Post-wiring TIMI flow 0-1 142/231 (61.5) 129/222 (58.1).465 Thrombus grade.640 1-23 (1.4)3 (1.4) 373 (32.5)80 (37.4) 483 (37.4)79 (36.9) 563 (28.4)52 (24.3)

8. RTDS n=256n=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 RT5/246 (2) TIMI flow 3 after RT159/ 222 (72) Predilation before stenting25 (9.8)34 (13.9).149 Stent per pt 1.26 ± 0.541.40 ± 0.73.022 Mean stent length (mm) 23.7 ± 10.925.9 ± 14.1.050 Abciximab249 (97)239 (98).841 Procedural success237 (93)229 (93).696 Procedural Characteristics

9. 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

10. Surrogate Endpoints RT DS p value n=246n=240 STR 50% at 30 min 211 (85.8)189 (78.8).043 n=217n=208 Infarct Size (%)11.8 [3.1-23.7] 12.7 [4.7-23.3].398 n=252n=241 Final TIMI 3 flow 203 (80.6) 207 (85.9).113 n=228n=216 cTFC 20 [15.0-27.2] 20 [14.0-25.7].357 n=215n=211 Blush grade.207 0-117 (8)11 (5) 243 (20)33 (16) 3 155 (72)167 (79)

11. 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).003 6-months n=80n=365 Death8 (10.0)10 (2.7).003 MACE22 (27.5)53 (14.5).005

12. One-Month Outcome P = 0.050

13. 6-Month Outcome RT DS

14. Predictors of ST-Segment Resolution and 6-Month MACE 6-month MACEHR95%CIp value Randomization to RT0.500.31 – 0.82.006 Age (yrs)1.021.01 – 1.04.023 Bleeding4.331.80 – 10.42.001 30 min. ST Reduction 50% OR95%CIp value Randomization to RT 1.701.03 – 2.82.039 Anterior AMI0.290.17 – 0.47<.001 Final TIMI 3 flow2.101.17 - 3.80.013

15. N=464 Events RT = 28 DS = 47 Log-rank test p=0.007 80.7 ± 4.1 64.1 ± 6.0 Time (days) 2402101801501209060300 100 90 80 70 60 50 Six-month MACE Kaplan-Meier Estimate RT DS (%)

16. 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.