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Impact of Thromboaspiration during Primary PCI on Microvascular Damage and Infarct Size: Acute and Long term CE-MRI Eva

Impact of Thromboaspiration during Primary PCI on Microvascular Damage and Infarct Size: Acute and Long term CE-MRI Evaluation. GENNARO SARDELLA, MD, FACC ,FESC; . MASSIMO MANCONE, MD; RAFFAELE SCARDALA, MD; CHIARA BUCCIARELLI DUCCI,MD;ANGELO DI ROMA,MD; IACOPO CARBONE,MD*;GIULIA BENEDETTI

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Impact of Thromboaspiration during Primary PCI on Microvascular Damage and Infarct Size: Acute and Long term CE-MRI Eva

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  1. Impact of Thromboaspiration during Primary PCI on Microvascular Damage and Infarct Size: Acute and Long term CE-MRI Evaluation. GENNARO SARDELLA, MD, FACC ,FESC; MASSIMO MANCONE, MD; RAFFAELE SCARDALA, MD; CHIARA BUCCIARELLI DUCCI,MD;ANGELO DI ROMA,MD; IACOPO CARBONE,MD*;GIULIA BENEDETTI GIULIA CONTI,MD ; FRANCESCO FEDELE, MD. O.U. of Invasive Cardiology, Dept. of Cardiovascular Sciences *Dept.of Radiology Policlinico Umberto I - University “La Sapienza ROME

  2. GENNARO SARDELLA,MD; MASSIMO MANCONE,MD; RAFFAELE SCARDALA, MD; CHIARA BUCCIARELLI DUCCI,MD; ANGELO DI ROMA,MD; IACOPO CARBONE,MD*; GIULIA BENEDETTI MD, GIULIA CONTI,MD; FRANCESCO FEDELE, MD. • No relationship to disclose

  3. Final Blush Score (patients with final TIMI 3 flow) 100 95 3 90 Cumulative Survival(%) 2 85 Blush 1-Year Mortality 0/1 3 6.8% 80 P=0.004 2 13.2% 0/1 18.3% 75 0 2 4 6 8 10 12 ( Courtesy of M.Gibson) Background Myocardial Perfusion After Primary PCI is Strongest Predictor of Mortality independently from IRA reopening PPCI Hardest point “ Open Artery ...but Closed Myocardium !! Stone GW, et al. J Am Coll Cardiol. 2002;39:591-597.

  4. Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI ( EXPIRA Trial ). (G.Sardella et al presented at TCT 2007) 256 pts. (STEMI, at 6.8 ± 2.3 h from symptoms onset) Design • Prospective, randomized, • double-arm, mono-centric study. • Primary end-point : • Final MBG ≥ 2 ; • 90’ ST resolution • (> 70% decrease of ST segment after PCI) • Secondary end-point : • MACE at 9 month clinical f-u • Principal investigator • G.Sardella MD 175 pts. eligible for 1:1 randomization 81 pts.excluded: • Cardiogenic shock • 3-vessel / Left Main • TIMI >0-1 • TS < 3 • Contra to GPIIb/IIIa (Heparin 7.500 U/I, GPIIb/IIIa, Aspirin, Clopidogrel 300 mg) 87 pts randomized to Standard PCI 88 pts randomized to Thrombectomy + PCI 9 months clinical f-u

  5. Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI ( EXPIRA Trial ). MYOCARDIAL BLUSH GRADE Procedural Results *p=<0.0001 28.7* % 70.3* 39.5* 11.8* Post- POBA CONVENTIONAL GROUP EXPORT GROUP (G.Sardella et al ,TCT 2007)

  6. Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI ( EXPIRA Trial ). 90’ ST resolution after PCI (%) ( > 70% decrease of ST segment) p=<0.01 100 OR 6.36 (95% CI 3.23-12.50) 90 80 80.0 70 60 % 50 40 30 37.5 20 10 0 CONVENTIONAL GROUP EXPORT GROUP (G.Sardella et al ,TCT 2007)

  7. Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI ( EXPIRA Trial ). 9 months Composite Cardiac Event Rates p=ns p=0.059 Pts % (G.Sardella et al ,TCT 2007)

  8. Aim of the Study • We sought to evaluate the impact of thromboaspiration on procedural and long term outcomes in terms of microascular damage and infarct size by contrast enhanced-MRI (ce-MRI) ascompared to conventional primary PCI. Export® aspiration catheter (Medtronic, Minneapolis, Minnesota)

  9. Methods Design 75 patients eligible for 1:1 randomization (Anterior STEMI, at 6.8 + 2.3 h from symptoms onset) • Prospective, randomized, • double-arm, mono-centric study. • End-points (MRI evaluation) • Microvascular damage (grams/g) in terms of Hypoenhancement . • Infarct size (grams/g) in terms of • Hyperenhancement. (Heparin 7.500 U/I, GPIIb/IIIa, Aspirin, Clopidogrel 300 mg) 37 pts randomized to Standard PCI 38 pts randomized to Thrombectomy + PCI 3 – 90 Day MRI follow-up • Microvascular damage • Infarct size

  10. Methods Methods Inclusion Criteria Exclusion Criteria • Previous AMI or CABG • Cardiogenic shock • 3-vessel / Left Main CAD • Severe valvular heart disease • Unsuccessful PCI (no antegrade • flow or 50% residual stenosis in the IRA) • Rescue / Facilitaded PCI • Contraindication to GP IIb/IIIa inhibitors • Age >18 yrs • STEMI within 9 hrs from symptoms onset • “De novo” coronary artery lesions • Native IRA ≥2.5 mm diameter • Angiographically identifiable occlusive thrombus (TS grade ≥ 3) • TIMI 0-1 at time of initial angiography

  11. Thrombectomy Group (n=38) Conventional Group (n=37) Total Population (n=75) Age, yrs±SD 65.813.1 67.414.1 66.310.6 Males (%) 47 (62.7) 24 (64.7) 23 (60.5) Risk factors Hypertension (%) Diabetes (%) Smoking (%) Obesity (%) Family History of CAD (%) Cholesterol (mg/dl±SD) Triglycerides (mg/dl±SD) 24 (64.9) 9 (24.3) 11 (29.8) 2 (5.4) 12 (32.4) 16510 12223 19 (50.0) 8 (21.1) 15 (39.5) 0 15 (39.5) 16311 12127 43 (57.8) 17 (22.7) 26 (34.7) 2 (2.7) 27 (36.0) 16413 12035 Renal Failure (%) 4 (5.3) 3 (8.1) 1 (2.6) Killip class III (%) 19 (25.3) 12 (32.4) 7 (18.4) Previous PCI (%) 10 (13.3) 4 (10.8) 6 (15.8) 7.90.7 7.71.2 6.51.4 Symptoms to balloon, (hrs±SD) LVEF (%±SD) 43.1 ±12 40.8 ±7.5 41.9 ±0.9 CLINICAL CHARACTERISTICS

  12. Total Population (n=75) Conventional Group (n=37) Thrombectomy Group (n=38) 7 (9.3) 4 (10.8) 3 (7.9) IABP (%) 14.15.6 14.94.9 Lesion length, mm±SD 13.85.7 2.90.6 2.80.5 Vessel size, mm±SD 2.90.6 PROCEDURAL CHARACTERISTICS 1 0.90.4 0.70.3 MLD pre, mm±SD 0.80.4 GPIIb/IIIa Inhibhitors Direct stenting Post-dilatation 75 (100) 37 (100) 38 (100) 28 (74.3)§ 4 (10.5) 2 (5.4)*§ 3 (8.1) 32 (42.6) 7 (9.3) MLD post, mm±SD 2.90.7 2.80.5 2.90.3 Post-PCI diameter stenosis, (%±SD) 3.53.9 3.45.4 3.45.2 29 (38.7) 46 (61.3) 12 (31.5) 26 (68.4) Stent Type (%) Bare-metal Stent Drug-eluting Stent 17 (45.9) 20 (54.0) * 2 pts with recanalized IRA after guide-wire placement § p= <.0001

  13. PROCEDURAL RESULTS 1 TIMI FLOW GRADE p=ns p=0.0005 45.9 % 97.8 CONVENTIONAL GROUP THROMBECTOMY GROUP

  14. PROCEDURAL RESULTS 2 MYOCARDIAL BLUSH GRADE *p=<0.0001 32.4* % 76.3* Post- POBA CONVENTIONAL GROUP THROMBECTOMY GROUP

  15. In-Hospital Outcome 90’ ST resolution after PCI ( > 70% decrease of ST segment) p=.0001 OR 7.2 (95% CI 2.5-20.9) 100 90 80 84.2 70 60 % 50 40 30 40.5 20 10 0 CONVENTIONAL GROUP THROMBECTOMY GROUP

  16. MRI Results-1 Thrombectomy (n=38) p Standard PCI (n=37) MRI evaluation Hypoenhancement (gr) 3 d 3 m 3 d 3 m Hyperenhancement (gr) ╪ * * ╪ <.001 2.7±2.3 4.04±5.87 3.7±5.04 0.12±0.4 § § 14.02±7.5 13.6+ 12,7 17.39±15.6 11.01±8.07 ╪ p=.001 between the groups * § p=.004 within the same group within the same group p=.004

  17. MRI Results-2 g p=0.004 P<0.001 17.39 p=0.004 gr 11.01 4.04 2.7 0.12 Hypo 3 Days Hypo 3 Months Hyper 3 Days Hyper 3 Months

  18. Conclusion • In this study Thrombectomy has been demonstrated to be safe and effective in AMI setting during Primary PCI. • Compared with conventional stenting, in patients with intracoronary visible and occlusive thrombus, pretreatment with manual aspiration thrombectomy during primary PCI improves acutely the parameters of myocardial tissue perfusion and ST resolution in a well selected population. • MRI long term evaluation showed a reduction of microvascular damage in the Thrombectomy group compared with the Control group. • In the Thrombectomy group setting resulted a reduction of microvascular damage and infarct size in long term compared with acute evaluation.

  19. Thank You !

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