Presentation on theme: "Comparison of AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing with Direct Stenting Alone in Patients with Acute Myocardial Infarction:"— Presentation transcript:
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
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
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
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.
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
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
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.