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Comparison of Angio JET Rheolytic Thrombectomy Before Direct Infarct Artery STENT ing in Patients with Acute Myocard

Comparison of Angio JET Rheolytic Thrombectomy Before Direct Infarct Artery STENT ing in Patients with Acute Myocardial Infarction : the JETSTENT trial. David Antoniucci on behalf of the JETSTENT Investigators. Co-Principal Investigators David Antoniucci, MD; Florence

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Comparison of Angio JET Rheolytic Thrombectomy Before Direct Infarct Artery STENT ing in Patients with Acute Myocard

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  1. ComparisonofAngioJETRheolyticThrombectomy BeforeDirectInfarctArterySTENTing in Patientswith Acute MyocardialInfarction: the JETSTENT trial David Antoniucci on behalf of the JETSTENT Investigators

  2. 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 • 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 • ECG Core Laboratory • Serenella Castelvecchio, M.D. Mediolanum Cardio Research, Milan • Nuclear Scan Core Laboratory • Prof. Roberto Sciagrà, University of Florence, Florence • Angiographic Core Laboratory • Maria Antonietta Bonardi, M.D.Mediolanum Cardio Research, Milan • Data Management and Monitoring • Director: Maria Cristina Jori, M.D.Mediolanum Cardio Research, Milan

  3. 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 Direct Stenting (DS) Rheolytic Thrombectomy +DS N = 500

  4. 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

  5. Baseline Characteristics • RT DS • n=256n=245p 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

  6. Baseline Angiographic Characteristics • RT DS • n=256n=245p 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 • Thrombusgrade.640 • 1-2 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)

  7. ProceduralCharacteristics • RT DS • 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 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

  8. Complications • RT DS • n=256n=245p 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.

  9. Surrogate 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 .207 • 0-1 17 (8) 11 (5) • 2 43 (20) 33 (16) • 3 155 (72) 167 (79)

  10. Early ST Resolution and MACE • Non-STRSTR p value • 1-monthn=86 n=400 • Death 6 (7.0) 5 (1.3) .001 • MACE 10 (11.6) 15 (3.8) .003 • 6-monthsn=80 n=365 • Death 8 (10.0) 10 (2.7) .003 • MACE 22 (27.5) 53 (14.5) .005

  11. One-Month Outcome P = 0.050

  12. 6-Month Outcome RT DS

  13. PredictorsofST-SegmentResolution 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 • 6-month MACEHR 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

  14. Six-monthMACE Kaplan-Meier Estimate 100 80.7 ± 4.1 (%) 90 Log-rank test p=0.007 N=464 EventsRT = 28 EventsDS = 47 80 70 RT 64.1 ± 6.0 DS 60 Time (days) 50 0 30 60 90 120 150 180 210 240

  15. Conclusions • Rheolyticthrombectomy 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 rheolyticthrombectomy in STEMI patients with evidence of thrombus.

  16. Predictors of ST-segment resolution and 1-month MACE Logistic regression (forward stepwise) • 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 • 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

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