Comparison of AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing in Patients with Acute Myocardial Infarction: the JETSTENT trial David.

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Comparison of AngioJET Rheolytic Thrombectomy Before Direct Infarct Artery STENTing in Patients with Acute Myocardial Infarction: the JETSTENT trial David Antoniucci on behalf of the JETSTENT Investigators

JETSTENT TRIAL Steering Committe: D Antoniucci (PI), A Colombo (PI), F-J Neumann, A Rodriguez, A Stabile, J Gustafson Data monitoring and management and Core Labs: MCR (EKG, Angio), Florence University (Nuclear) Clinical event adjudication committee: GB Danzi (I), C Di Mario (UK), and I Moussa (USA) Country sites: Italy (4); Argentina (1); Germany (1); Poland (3). Sponsor: Medrad Interventional/Possis

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

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: MACCE at 1, 6, and 12 months, Death and Readmission for HCF at 12 months  Secondary surrogate end points: TIMI flow, cTFC, and TIMI blush

Baseline Characteristics RTDS n=256 n=245 p value  Age (yrs)63.0 ± ±  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 ± ±  Symptom-ER (min) 125 [ ] 135 [ ].853

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 [ ] 2.91 [ ].670  Pre-wiring TIMI flow /254 (83.5)203/242 (83.9).899  Post-wiring TIMI flow /231 (61.4) 129/222 (58.1).465  Thrombus grade (1.4)3 (1.4) 373 (32.5)80 (37.4) 483 (37.4)79 (36.9) 563 (28.4)52 (24.3)

RTDS n=256n=245 p value  ER-PCI (min)34 [15-67]31 [18-60].727  Procedural time (min) 59.5 [ ] 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 ± ±  Mean stent length (mm) 23.7 ± ±  Abciximab249 (97)239 (98).841  Procedural success237 (93)229 (93).696 Procedural Characteristics

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

Surrogate Endpoints RTDS n=246n=240  ST ≥ 50% at 30 min 85.8%78.8%.043 n=217n=208  Infarct Size (%)11.8 [ ] 12.7 [ ].398 n=252n=241  Final TIMI 3 flow 203 (80.6) 207 (85.9).113 n=228n=216  cTFC 20 [ ] 20 [ ].357 n=215n=211  Blush grade (8)11 (5) 243 (20)33 (16) 3155 (72)167 (79)

Early ST Resolution and MACCE Non-STR STR p value 1-month n=86n=400  Death6 (7.0)5 (1.3).001  MACCE10 (11.6)15 (3.8) months n=80n=365  Death8 (10.0)10 (2.7).003  MACCE22 (27.5)53 (14.5).005

One-Month Outcome P = 0.050

6-Month Outcome RT DS

30 min. ST Reduction ≥ 50% (n=471) OR95%CIp value Randomization to RT – Anterior AMI – 0.46<.001 Abciximab – TIMI 3 flow Predictors of ST-segment Resolution and 1-month MACCE Logistic regression (forward stepwise) 1-month MACCE (n=486) OR95%CIp value Randomization to RT – Abciximab – TIMI 3 flow – 0.41<.001 Bleeding –

N=464 Events RT = 28 Events DS = 47 Log-rank test p= ± ± 6.0 Time (days) Six-month MACCE Kaplan-Meier Estimate RT DS (%)

Conclusions  Rheolytic thrombectomy 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 6-month clinical outcome (lower MACCE rate).  The results of the JETSTENT trial support the routine use of rheolytic thrombectomy in STEMI patients with evidence of thrombus.