1 / 16

Comparison of Angio JET Rheolytic Thrombectomy

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

yuval
Download Presentation

Comparison of Angio JET Rheolytic Thrombectomy

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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 Steering Committe D Antoniucci, A Colombo, F-J Neumann, A Rodriguez, A Stabile, J Gustafson Sponsor: Medrad Interventional/Possis • 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 • 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 N = 500 Direct Stenting (DS) Rheolytic Thrombectomy +DS

  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 99mTc 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 • 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

  7. 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)

  8. 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

  9. 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.

  10. Surrogate Endpoints RT DS p value n=246 n=240 STR ≥ 50% at 30 min 211 (85.8) 189 (78.8) .043 n=217 n=208 InfarctSize (%) 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)

  11. Early ST Resolution and MACE • Non-STR STR 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

  12. One-Month Outcome P = 0.050

  13. 6-Month Outcome RT DS

  14. 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

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

  16. Conclusions • AngioJet rheolytic thrombectomy before direct IRA stenting as compared to direct stenting alone is associated with: • Better myocardial reperfusion (higher rate of early STR) • 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.

More Related