Within the past 12 months, our institution has had a financial interest/arrangement or affiliation with the organization(s...
Randomized Comparison of Primary PCI with Combined Proximal Embolic Protection and Thrombus Aspiration versus Primary PCI ...
Background Inadequate myocardial reperfusion relates to prognosis, even in the presence of adequate epicardial flow. Embol...
Proxis embolic protection system Full length flexible catheter 6F and 7F GC compatible Sealing balloon at the tip CO 2  ba...
PREPARE Trial <ul><li>PR oximal  E mbolic  P rotection in  A cute MI and  R esolution of ST- E levation </li></ul><ul><li>...
Patient selection <ul><li>Inclusion criteria </li></ul><ul><ul><li>Consecutive STEMI patients  ≤ 6 h </li></ul></ul><ul><u...
UFH 70 U/kg ASA 300 mg Clopidogrel 600 mg Continuous  ST Holter Coronary angiogram STEMI ≤ 6 h Primary PCI alone Clinical ...
End points <ul><li>Primary end point   </li></ul><ul><li>ST-segment elevation resolution (STR) over time* </li></ul><ul><l...
Patient characteristics Age 62 ± 11   59 ± 11 Male   80% 80% Family history CAD 35% 38% Hypercholesterolemia 21% 13% Curre...
Lesion characteristics Proxis n = 141 Control n = 143 Infarct related artery RCA 61% 60% LAD 29% 29% LCx 10% 11% Pre-PCI T...
Procedural characteristics Proxis n = 141 Control n = 143 *P<0.05; IQR interquartile range Procedural success 100% 99% Pro...
Immediate 66% (85/129) 50% (67/135) 0.009 30 min 74% (96/130) 64% (87/135) 0.11 60 min 80% (101/126) 72% (93/129) 0.14 90 ...
Complete STR over time Last  contrast 40 50 60 70 80 90 30 60 90 120 Time after last contrast, min Patients with complete ...
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...
Procedural parameters Proxis n = 141 Control n = 143 *Cochran-Armitage Test † Fisher’s Exact Test ‡ Mann Whitney U Test Po...
Pathology results Debris confirmed by pathology 75% (84/112) Before stenting 87% (73/84) Both before and after stenting 35...
Death 2 2 MI 2 3 TVR 3 6 Stroke 0 1 MACCE * 6   (4%) 10 (7%) no complications at Proxis landing zone Clinical events at 30...
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% ...
In conclusion The Proxis system is  feasible  and  safe  in the setting of STEMI,  and effectively retrieves embolic debri...
PREPARE Trial PR oximal  E mbolic  P rotection in  A cute MI and  R esolution of ST- E levation Thank you for your attenti...
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  1. 1. Within the past 12 months, our institution has had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support: Unrestricted educational grant St. Jude Medical Disclosure statement of financial interest
  2. 2. Randomized Comparison of Primary PCI with Combined Proximal Embolic Protection and Thrombus Aspiration versus Primary PCI Alone in STEMI The PREPARE Trial PR oximal E mbolic P rotection in A cute MI and R esolution of ST- E levation Joost D.E. Haeck Karel T. Koch, Luc Bilodeau*, Jan G.P. Tijssen, René J. van der Schaaf, José P.S. Henriques, Wim. J. Rohling, 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 *Montréal Heart Institute, QC, Canada † Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA
  3. 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. 4. Proxis embolic protection system Full length flexible catheter 6F and 7F GC compatible Sealing balloon at the tip CO 2 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. 5. PREPARE Trial <ul><li>PR oximal E mbolic P rotection in A cute MI and R esolution of ST- E levation </li></ul><ul><li>Investigator-initiated randomized trial </li></ul><ul><li>Comparison of primary PCI with Proxis system versus primary PCI alone </li></ul><ul><li>Open trial with blinded evaluation of end points </li></ul><ul><li>Participation of 2 centers </li></ul><ul><li>140 patients in each study arm </li></ul>
  6. 6. Patient selection <ul><li>Inclusion criteria </li></ul><ul><ul><li>Consecutive STEMI patients ≤ 6 h </li></ul></ul><ul><ul><li>ST-segment elevation ≥ 2 mm in ≥ 2 leads </li></ul></ul><ul><ul><li>TIMI flow grade 0 to 1 at first angiogram </li></ul></ul><ul><ul><li>Coronary anatomy suitable for Proxis </li></ul></ul><ul><ul><li>ECG suitable for ST-segment resolution evaluation </li></ul></ul><ul><li>Exclusion criteria </li></ul><ul><ul><li>Recurrence of MI in same area </li></ul></ul><ul><ul><li>Prior CABG or lytics </li></ul></ul>
  7. 7. UFH 70 U/kg ASA 300 mg Clopidogrel 600 mg Continuous ST Holter Coronary angiogram STEMI ≤ 6 h Primary PCI alone Clinical follow up at 30 days Primary PCI with Proxis PREPARE Trial Study flow chart R 24 h
  8. 8. End points <ul><li>Primary end point </li></ul><ul><li>ST-segment elevation resolution (STR) over time* </li></ul><ul><li>Secondary end points </li></ul><ul><li>ST-segment curve area </li></ul><ul><li>TIMI graded flow </li></ul><ul><li>Myocardial blush grade </li></ul><ul><li>Angiographic signs of distal embolization </li></ul><ul><li>Composite of death, MI, TVR, and stroke at 30 days </li></ul>*Duke Clinical Research Institute Core Lab
  9. 9. Patient characteristics 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 Proxis n = 141 Control n = 143 * * *p ≤ 0.03
  10. 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. 11. Procedural characteristics Proxis n = 141 Control n = 143 *P<0.05; IQR interquartile range 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 17 14* IQR 13-23 10-18 * Proxis n = 141 Control n = 143
  12. 12. Immediate 66% (85/129) 50% (67/135) 0.009 30 min 74% (96/130) 64% (87/135) 0.11 60 min 80% (101/126) 72% (93/129) 0.14 90 min 81% (100/124) 74% (97/131) 0.23 120 min 78% (98/126) 76% (100/131) 0.88 Complete ( ≥ 70%) STR (Fisher’s Exact Test) Proxis n = 141 Control n = 143 P-value
  13. 13. Complete STR over time Last contrast 40 50 60 70 80 90 30 60 90 120 Time after last contrast, min Patients with complete STR, % P=0.009 Control Proxis
  14. 14. 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) Continuous ST-recovery parameters P-value * Proxis n = 141 Control n = 143 Mean (SD); * T-Test * * Area under ST-deviation versus time trend curve is from last contrast to 3 hours after procedure
  15. 15. Procedural parameters Proxis n = 141 Control n = 143 *Cochran-Armitage Test † Fisher’s Exact Test ‡ Mann Whitney U Test 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 ( μ g/L) Median 204 246 0.22 ‡ IQR 136-378 154-413 P-value †
  16. 16. Pathology results 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) Proxis n = 112
  17. 17. Death 2 2 MI 2 3 TVR 3 6 Stroke 0 1 MACCE * 6 (4%) 10 (7%) no complications at Proxis landing zone Clinical events at 30 days Proxis n = 141 Control n = 143 For descriptive purposes only; no statistical comparisons done *ARC MACCE definition Circ. 2007; 115: 2344–2351
  18. 18. 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 P-value Proxis n = 129 Control n = 135 (Fisher’s Exact Test) Subgroup analysis complete STR at last contrast
  19. 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 Proxis treated patients , with reduction 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 to better immediate microvascular flow in STEMI patients.
  20. 20. PREPARE Trial PR oximal E mbolic P rotection in A cute MI and R esolution of ST- E levation Thank you for your attention [email_address]

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