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The PREPARE Trial

A Prospective Randomized Trial of Proximal Microcirculatory Protection in Patients with Acute Myocardial Infarction Undergoing Primary PCI. The PREPARE Trial PR oximal E mbolic P rotection in A cute MI and R esolution of ST- E levation. Karel T. Koch

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The PREPARE Trial

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  1. A Prospective Randomized Trial of Proximal Microcirculatory Protection in Patients with Acute Myocardial Infarction Undergoing Primary PCI The PREPARE Trial PRoximal Embolic Protection in Acute MI and Resolution of ST-Elevation Karel T. Koch Joost D.E. Haeck, Jan G.P. Tijssen, Luc Bilodeau*, René J. van der Schaaf, José P.S. Henriques, Allard van der Wal, Jan Baan Jr., Marije M. Vis, Jan J. Piek, Mitchell W. Krucoff†, Robbert J. de Winter. Academic Medical Center - University of Amsterdam, The Netherlands *Institut de Cardiologie de Montréal, QC, Canada †Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA

  2. Disclosure statement of financial interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial RelationshipCompany Grant/Research Support: Educational Grant St. Jude Medical

  3. Background Inadequate myocardial reperfusion relates to prognosis, even in the presence of adequate epicardial flow. Embolization of atherothrombotic material plays a crucial role in microvascular obstruction and impaired myocardial perfusion. The Proxis™ device is a combined system of proximal embolic protection and thrombus aspiration. The device has been shown feasible and safe in primary PCI*. The PREPARE Trial was designed to evaluate primary PCI with the Proxis system compared to primary PCI alone. *Koch KT et al. Rev Cardiovasc Med. 2007;8(3): 160-6

  4. Proxis embolic protection system Full length flexible catheter 6F and 7F GC compatible Sealing balloon at the tip CO2 based inflation device Deployed proximal to target lesion before crossing Inflation of balloon suspends antegrade flow during lesion intervention Stagnated blood and emboli liberated during intervention are retrieved by gentle aspiration Proxis™ embolic protection system (St. Jude Medical, St. Paul, MN, USA)

  5. PREPARE Trial • PRoximal Embolic Protection in Acute MI and Resolution of ST-Elevation • Investigator-initiated randomized trial • Comparison of primary PCI with Proxis system versus primary PCI alone • Open trial with blinded evaluation of end points • Participation of 2 centers • 140 patients in each study arm

  6. Patient selection • Inclusion criteria • Consecutive STEMI patients ≤ 6 h • ST-segment elevation ≥ 2 mm in ≥ 2 leads • TIMI flow grade 0 to 1 at first angiogram • Coronary anatomy suitable for Proxis • ECG suitable for ST-segment resolution evaluation • Exclusion criteria • Recurrence of MI in same area • Prior CABG or lytics

  7. PREPARE Trial Study flow chart STEMI ≤ 6 h UFH 70 U/kg ASA 300 mg Clopidogrel 600 mg Continuous ST Holter Coronary angiogram R 24 h Primary PCI with Proxis Primary PCI alone Clinical follow up at 30 days

  8. End points • Primary end point • ST-segment elevation resolution (STR) over time* • Secondary end points • TIMI graded flow • Myocardial blush grade • Angiographic signs of distal embolization • Composite of death, MI, TVR, and stroke at 30 days *Duke Clinical Research Institute Core Lab

  9. Patient characteristics Proxis n = 141 Control n = 143 Age 62 ± 11 59 ± 11 Male 80% 80% Family history CAD 35% 38% Hypercholesterolemia 21% 13% Current smoking 50% 65% Hypertension 31% 23% Diabetes 12% 6% Previous MI 6% 9% Multivessel disease 33% 31% Symptoms to balloon (min) 170 153

  10. Lesion characteristics Proxis n = 141 Control n = 143 Infarct related artery RCA 61% 60% LAD 29% 29% LCx 10% 11% Pre-PCI TIMI graded flow 0 90% 89% 1 9% 8% 2 1% 4%

  11. Procedural characteristics Proxis n = 141 Control n = 143 Procedural success 100% 99% Proxis placed 94% ─ Predilatation and stenting 87% 76% Direct stenting 11% 19% Balloon angioplasty 3% 6% GP IIb/IIIa receptor antagonists 43% 35% Additional thrombus aspiration 6% 6% Pathology confirmed thrombus 75% ─ Puncture to balloon (min) Median 1714* IQR 13-23 10-18 * *P<0.05; IQR interquartile range

  12. Complete (>70%) STR Proxis n = 141 Control n = 143 P-value *Primary endpoint (Fisher’s Exact Test)

  13. Complete (>70%) STR Proxis n = 141 Control n = 143 P-value Immediate 66%(85/129)50% (67/135) 0.009 *Primary endpoint (Fisher’s Exact Test)

  14. Complete (>70%) STR Proxis n = 141 Control n = 143 P-value Immediate 66%(85/129)50% (67/135) 0.009 30 min75%(91/122)66%(86/130)0.17 60 min80%(101/126)72%(93/129) 0.14 90 min81%(100/124)74%(97/131) 0.23 120 min78% (98/126)76%(100/131) 0.88 (Fisher’s Exact Test)

  15. Complete STR over time 90 P=0.009 80 70 Patients with complete STR, % Proxis 60 Control 50 40 Last contrast 90 120 30 60 Time after last contrast, min

  16. Mean % STR Proxis n = 141 Control n = 143 P-value* Immediate 73 ± 27 63 ± 32 0.009 30 min 79 ± 21 75 ± 23 0.30 60 min 82 ± 20 78 ± 21 0.27 90 min 82 ± 19 80 ± 21 0.17 120 min 82 ± 19 81 ± 20 0.48 Mean (SD); *T-Test

  17. Angiographic parameters Proxis n = 141 Control n = 143 P-value Post-PCI TIMI graded flow 3 93% 87% 2 7% 11% 0.06* 0-1 0% 2% Myocardial blush grade 3 81% 83% 2 16% 11% 0.93* 0-1 4% 6% Distal embolization (yes/no)10% 14%0.36† *Cochran-Armitage Test †Fisher’s Exact Test

  18. Clinical events at 30 days Proxis n = 141 Control n = 143 Death22 MI23 TVR36 Stroke01 MACCE*6(4%)10(7%) no complications at Proxis landing zone For descriptive purposes only; no statistical comparisons done *ARC MACCE definition Circ. 2007; 115: 2344–2351

  19. In conclusion The Proxis system is feasible and safe in the setting of STEMI, and effectively retrieves embolic debris in most patients.

  20. In conclusion The Proxis system is feasible and safe in the setting of STEMI, and effectively retrieves embolic debris in most patients. Complete STR was better in Proxistreated patients compared to control patients. The difference in STR immediately after PCI was highly statistically significant (p=0.009).

  21. In conclusion The Proxis system is feasible and safe in the setting of STEMI, and effectively retrieves embolic debris in most patients. Complete STR was better in Proxistreated patients compared to control patients. The difference in STR immediately after PCI was highly statistically significant (p=0.009). The results of the PREPARE trial suggest that primary PCI with combined proximal embolic protection and aspiration leads tobetter immediate microvascular flow in STEMI patients.

  22. PREPARE Trial PRoximal Embolic Protection in Acute MI and Resolution of ST-Elevation Thank you for your attention k.t.koch@amc.uva.nl

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