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Comparison of Angio JET Rheolytic Thrombectomy

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

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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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