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Disclosure statement of financial interest

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  1. Disclosure statement of financial interest Within the past 12 months, our institution has had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial RelationshipCompany Grant/Research Support: Unrestricted educational grant St. Jude Medical

  2. Randomized Comparison of Primary PCI with Combined Proximal Embolic Protection and Thrombus Aspiration versus Primary PCI Alone in STEMI The PREPARE Trial PRoximal Embolic Protection in Acute MI and Resolution of ST-Elevation Joost D.E. Haeck Karel T. Koch, Luc Bilodeau*, Jan G.P. Tijssen, René J. van derSchaaf, José P.S. Henriques, Wim. J. Rohling, Allard van derWal, Jan Baan Jr., Marije M. Vis, Jan J. Piek, Mitchell W. Krucoff†, Robbert J. de Winter. Academic Medical Center - University of Amsterdam, The Netherlands *Montréal Heart Institute, QC, Canada †Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA

  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 • ST-segment curve area • 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 * * *p≤0.03

  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 Proxis n = 141 Control n = 143 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 Immediate 66%(85/129)50% (67/135) 0.009 30 min74%(96/130)64%(87/135)0.11 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)

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

  14. Continuous ST-recovery parameters Proxis n = 141 Control n = 143 P-value* ST- resolution % Immediate 73 ± 27 63 ± 32 0.009 30 min 78 ± 21 74 ± 24 0.18 60 min 82 ± 20 78 ± 21 0.27 90 min 82 ± 19 80 ± 21 0.17 120 min 82 ± 19 81 ± 20 0.48 ST- curve area**(µV/min) Median 5192 6250 0.037 IQR (3793-7626) (4221-9186) * *Area under ST-deviation versus time trend curve is from last contrast to 3 hours after procedure Mean (SD); *T-Test

  15. Procedural 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† Infarct size by peak CK-MB (μg/L) Median 204 246 0.22‡ IQR 136-378 154-413 *Cochran-Armitage Test †Fisher’s Exact Test ‡Mann Whitney U Test

  16. Pathology results Proxis n = 112 Debris confirmed by pathology 75% (84/112) Before stenting 87% (73/84) Both before and after stenting 35% (29/84) Only after stenting 13% (11/84) Only thrombus 50% (42/84) Thrombus and plaque-components 49% (41/84) Only plaque-components 1% (1/84)

  17. 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

  18. Subgroup analysis complete STR at last contrast Proxis n = 129 Control n = 135 P-value All patients 66%(85/129)50% (67/135)0.009 Infarct-related artery Anterior 42% (16/38)18% (7/40) 0.03 Non-anterior 76% (69/91) 63% (60/95) 0.08 Baseline thrombus Yes 65% (64/98)50% (46/92)0.04 No 68% (21/31)49% (21/43)0.15 Symptom onset to balloon < 3 hours 68% (47/69) 49% (43/87) 0.02 ≥ 3 hours 63% (38/60)50% (24/48) 0.18 GP IIb/IIIa antagonists Yes 56% (29/52)28% (13/46) 0.008 No 72% (56/77)61% (54/89) 0.14 (Fisher’s Exact Test)

  19. 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 faster and more frequent in Proxistreated patients, withreduction of ECG injury current over time, compared to control patients. 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.

  20. PREPARE Trial PRoximal Embolic Protection in Acute MI and Resolution of ST-Elevation Thank you for your attention K.T.Koch@amc.uva.nl