Evidence/Practice
Intersection: How I Approach
Thrombus in My Daily Clinical
Practice (and Why)
SOLACI in Partnership with...
I, Ricardo A. Costa DO NOT have a
financial interest/arrangement or affiliation
with one or more organizations that could
...
Thrombotic Lesions
Thrombotic Lesions
No-Reflow: A Multifactorial
Phenomenon
Vasoconstrictor Thrombotic Mechanical
Serotonin Release
Vasoconstriction
• Aggregat...
Distal Embolization in STEMI
Distal Embolization occurs in approximately 14%
of patients who underwent primary angioplasty...
Importance of TIMI-3 Flow
Stone GW, et al. Circulation. 2001;104:636
What is the best therapy to prevent
distal embolization?
• Pharmacotherapy
• Distal Protection
• Thromboaspiration
• New D...
What is the best therapy to prevent
distal embolization?
• Pharmacotherapy
• Distal Protection
• Thromboaspiration
• New D...
Impact of Time to Therapy and Reperfusion
Modality on the Efficacy of Adenosine in Acute MI:
AMISTAD -2 Trial
Kloner RA et...
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3,949 pts with AMI w/i 12h undergoing primary (7)
or rescue (1) PCI random...
Abciximab in Primary PCI Meta-Analysis
8 RCTs - 3,949 pts with AMI w/i 12h undergoing primary (7)
or rescue (1) PCI rand t...
Intracoronary vs. Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H, et al. Circulation. 2008;...
Intracoronary vs. Intravenous Bolus Abciximab in
Pts with STEMI Undergoing Primary PCI
Thiele H, et al. Circulation. 2008;...
What is the best therapy to prevent
distal embolization?
• Pharmacotherapy
• Distal Protection
• Thromboaspiration
• New D...
Distal Protection Devices
Distal occlusion
Distal Filter
Proximal occlusion/ reverse flow
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
501 pts with AMI < 6h Sx onset, undergoing pr...
Distal Microcirculatory Protection During PCI in
Acute STEMI - EMERALD Trial
6-Month Clinical End-Points
Stone GW, et al. ...
%
Randomized Comparison of Distal Protection
Versus Conventional Treatment in Primary PCI:
DEDICATION Trial
Kelbaek H, et ...
What is the best therapy to prevent
distal embolization?
• Pharmacotherapy
• Distal Protection
• Thromboaspiration
• New D...
X-Sizer for Thrombectomy in AMI Improves
ST Segment Resolution: X AMINE ST Trial
201 pts with STEMI < 12h randomized to Th...
Thrombus Aspiration Before Primary Angioplasty
Improves Myocardial Reperfusion in AMI: DEAR-MI
Silva-Orrego P, et al. J Am...
Thrombus Aspiration During PCI in
AMI Study: TAPAS
Svillas T, et al. N Engl J Med 2008;358:557-567
1071 STEMI
pts
Thrombus...
Thrombus Aspiration During PCI
in AMI Study: TAPAS
Svillas T, et al. N Engl J Med 2008;358:557-567
Patients(%)
Thrombus as...
Thrombus Aspiration During PCI in
AMI Study: TAPAS
Svillas T, et al. N Engl J Med 2008;358:557-567
Time (days)
0 100 200 3...
Role of Adjunctive Thrombectomy and
Embolic Protection Devices in AMI
Meta-Analysis of Randomized Trials
Bavry AA, et al. ...
What is the best therapy to prevent
distal embolization?
• Pharmacotherapy
• Distal Protection
• Thromboaspiration
• New D...
ClearWayTM Perfusion Balloon
• What is ClearWay RX?
– Rapid Exchange therapeutic infusion
catheter
101.9
80
105.4
68.5
91.2
85.5
0
20
40
60
80
100
120
Total Clearway Inf. Guid. Cath.
Inf.
Basal Post Abcix.
Basal and FU Th...
MGuard™ Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
• Bare metal stent (stainless
steel) - Strut width 100 µm
• Balloon-expandable
• Protection net (mesh sleeve
fibers of
pol...
INSPIRE trial
Brazilian Experience
Primary
Endpoint:
30-day MACE
Secondary endpoints
Device success
Procedure success
6-12...
In-Hospital Results
50% SVG, 35% of lesions w/ visible thrombus
0
10
20
30
40
50
60
70
80
90
100
TIMI3
flow
MBG 3 ck-mb >
...
CASE # 1
WP
OCLUSÃO PÓS IAM
Aspiration
WP
After aspiration
WP
Pre Final result
PRÉ PÓS
CASE # 2
Baseline Angiogram
• Premedication (ASA + Clop + UFH)
• Thrombus aspiration - Export®
• GP IIb/IIIa – Abciximab
• No predilatation
• Stent MG...
• Export® AP Aspiration catheter
large thrombus burden
Results post-aspiration
• MGuardstent 3.0 x 15 mm
Results post stent
CASE # 3
Baseline Angiogram
Baseline Angiogram
• Premedication (ASA + Clopidogrel)
• Anti-thrombin with Enoxaparin for 7 days
• Repeat coronary angiography and PCI to SV...
7 DAYS AFTER
• MGuard stent 3.5 x 29 mm
Results post stent
Conclusions / Recomendations
• Pharmacotherapy:
IC injection of Abciximab and Adenosine
• Distal Protection:
No significan...
Practice Intersection: How I Approach Thrombus in My Daily Clinical Practice
Practice Intersection: How I Approach Thrombus in My Daily Clinical Practice
Practice Intersection: How I Approach Thrombus in My Daily Clinical Practice
Upcoming SlideShare
Loading in …5
×

Practice Intersection: How I Approach Thrombus in My Daily Clinical Practice

987 views

Published on

Alexandre Abizaid. TCT 2012 Congress. Find more presentations on our web site.

Published in: Health & Medicine
  • Be the first to comment

Practice Intersection: How I Approach Thrombus in My Daily Clinical Practice

  1. 1. Evidence/Practice Intersection: How I Approach Thrombus in My Daily Clinical Practice (and Why) SOLACI in Partnership with TCT: Snapshot of Latin America Practice and Research Room D235-236 Ricardo A. Costa Alexandre Abizaid Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil Monday, October 21st, 2012 – From 6:13 to 6:25 pm
  2. 2. I, Ricardo A. Costa DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation DISCLOSURE STATEMENT
  3. 3. Thrombotic Lesions
  4. 4. Thrombotic Lesions
  5. 5. No-Reflow: A Multifactorial Phenomenon Vasoconstrictor Thrombotic Mechanical Serotonin Release Vasoconstriction • Aggregates of Platelets, Neutrophils, Red Blood Cells • Cellular and Intersticial edema Microvascular Occlusion Distal Embolization • Spontaneous • During reperfusion Tx Mechanical Occlusion
  6. 6. Distal Embolization in STEMI Distal Embolization occurs in approximately 14% of patients who underwent primary angioplasty No DE N=167 (86.1%) DE N=27 (13.9%) P value Patency 151 (92) 19 (73) 0.009 LVEF (%) 51 ± 9 42 ± 14 0.005 LDH (Q72) 847 ± 631 1612 ± 1008 0.001 Mortality 15 (9) 12 (44) < 0.001 Death/Re-MI 23.9 21.5 0.48 Proximal LCx filling defect at primary PCI site Distal Thromboemboli Henriques JPS, et al. Eur Heart J. 2002;23:1112-1117
  7. 7. Importance of TIMI-3 Flow Stone GW, et al. Circulation. 2001;104:636
  8. 8. What is the best therapy to prevent distal embolization? • Pharmacotherapy • Distal Protection • Thromboaspiration • New Devices
  9. 9. What is the best therapy to prevent distal embolization? • Pharmacotherapy • Distal Protection • Thromboaspiration • New Devices
  10. 10. Impact of Time to Therapy and Reperfusion Modality on the Efficacy of Adenosine in Acute MI: AMISTAD -2 Trial Kloner RA et al. Eur Heart J. 2006;27:2400-2405 2118 Patients with Anterior STEMI & Reperfusion Therapy within 6 Hrs of Symptoms Placebo Adenosine 50 μg/Kg/min X 3h Fibrinolysis or PTCA Follow-up for 6 months Infarct size (5 d) (243 patients) Adenosine 70 μg/Kg/min X 3h 26% 23% 11% P=0.028 P=NS 57%
  11. 11. Abciximab in Primary PCI Meta-Analysis 8 RCTs - 3,949 pts with AMI w/i 12h undergoing primary (7) or rescue (1) PCI random. to abciximab vs. placebo or control 30-DayEvents,(%) 3.4% 2.4% 1.9% 1.0% 4.1% 4.7% 0.11% 0.06% p=0.047 OR 0.68 [0.47,0.99] p=0.03 OR 0.56 [0.33,0.94] P=0.36 OR 1.16 [0.85,1.59] P=0.96 OR 0.97 [0.31,3.01] De Luca G, et al. JAMA 2005;293:1759-1765
  12. 12. Abciximab in Primary PCI Meta-Analysis 8 RCTs - 3,949 pts with AMI w/i 12h undergoing primary (7) or rescue (1) PCI rand to abciximab vs. placebo or control De Luca G, et al. JAMA 2005;293:1759-1765 Mortality 3.4% 2.4% 6.2% 4.4% p=0.047 OR 0.68 [0.47, 0.99] P=0.01 OR 0.69 [0.52, 0.92]
  13. 13. Intracoronary vs. Intravenous Bolus Abciximab in Pts with STEMI Undergoing Primary PCI Thiele H, et al. Circulation. 2008;118:49-57 154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus (n=77) Abciximab followed by 12-hour infusion % %ofLV Assessed by Delayed MRI Primary End-Points 15.1 23.4 1.1 1.1 0.1 3.4 P=0.02 P=0.01 P=0.006 IV AbciximabIC Abciximab
  14. 14. Intracoronary vs. Intravenous Bolus Abciximab in Pts with STEMI Undergoing Primary PCI Thiele H, et al. Circulation. 2008;118:49-57 P=0.06 30-Day MACE
  15. 15. What is the best therapy to prevent distal embolization? • Pharmacotherapy • Distal Protection • Thromboaspiration • New Devices
  16. 16. Distal Protection Devices Distal occlusion Distal Filter Proximal occlusion/ reverse flow
  17. 17. Distal Microcirculatory Protection During PCI in Acute STEMI - EMERALD Trial 501 pts with AMI < 6h Sx onset, undergoing primary or rescue PCI, rand to: PCI with balloon occlusion and aspiration distal protection (Guardwire Plus; n=252) or PCI without distal protection (n=249) Stone GW, et al. JAMA 2005;293:1063-1072 % P=0.40 P=0.14 Rates of Complete (> 70%) STR at Different Time Points
  18. 18. Distal Microcirculatory Protection During PCI in Acute STEMI - EMERALD Trial 6-Month Clinical End-Points Stone GW, et al. JAMA 2005;293:1063-1072 3.4 3.3 2.4 1.3 2.1 0.4 2.5 3.9 6.3 5.8 0.9 1.7 16.1 14.3 10 11 % P = NS for all comparisons
  19. 19. % Randomized Comparison of Distal Protection Versus Conventional Treatment in Primary PCI: DEDICATION Trial Kelbaek H, et al. J Am Coll Cardiol. 2008;51:899-905 % 5.4 3.2 2.6 2.5 1.6 0.3 1.9 0.6 1.0 0.6 76 72 P=NS Conventional PCI (n=301)Distal Protection (Filterwire) (n=302) P=NS for all comparisons Conclusion: Distal protection failed to significantly improve ST-segment resolution 90 min. after PCI compared to PCI alone in patients with large STEMI.
  20. 20. What is the best therapy to prevent distal embolization? • Pharmacotherapy • Distal Protection • Thromboaspiration • New Devices
  21. 21. X-Sizer for Thrombectomy in AMI Improves ST Segment Resolution: X AMINE ST Trial 201 pts with STEMI < 12h randomized to Thrombectomy (X-Sizer) prior to stent implantation vs. Standard PCI with no thrombectomy mm % 7.5 4.9 67.8 52.6 96 89 30 31 P = 0.033 P = 0.037 P = NS P = NSPrimary End-Point Predictors of STR > 50% by Multivariate Analysis  Younger Age  Non Anterior MI  Use of X-Sizer thrombus aspiration device  Short time from Symptoms Onset Lefèvre T, et al. J Am Coll Cardiol. 2005;46:246-252
  22. 22. Thrombus Aspiration Before Primary Angioplasty Improves Myocardial Reperfusion in AMI: DEAR-MI Silva-Orrego P, et al. J Am Coll Cardiol. 2006;48:1552-1559 148 consecutive STEMI Pts with Sx < 12h randomized to: PPCI (n=74) or Thrombus Aspiration (Pronto Catheter) before PPCI (n=74) % 68% 50% 88% 44% 89% 78% 790 ± 132 910 ± 128 P<0.05 P<0.0001 P=NS P<0.0001 PPCIThrombus Aspiration + PPCI
  23. 23. Thrombus Aspiration During PCI in AMI Study: TAPAS Svillas T, et al. N Engl J Med 2008;358:557-567 1071 STEMI pts Thrombus Aspiration (n=535) Conventional PCI (n=536) Thrombus Aspiration (n=530) Conventional PCI (n=530) R 1-Year FU P < 0.001 Patients(%) Thrombus Aspiration Conventional PCI Primary End-Point: Myocardial Blush Grade
  24. 24. Thrombus Aspiration During PCI in AMI Study: TAPAS Svillas T, et al. N Engl J Med 2008;358:557-567 Patients(%) Thrombus aspiration Conventional PCI P < 0.001 ST-Segment Elevation Resolution
  25. 25. Thrombus Aspiration During PCI in AMI Study: TAPAS Svillas T, et al. N Engl J Med 2008;358:557-567 Time (days) 0 100 200 300 400 Mortality(%) 0 2 4 6 8 10 12 Conventional PCI Thrombus-Aspiration Log-Rank p = 0.040 30 days 4.0% vs. 2.1%, P=0.07 1-Year Mortality
  26. 26. Role of Adjunctive Thrombectomy and Embolic Protection Devices in AMI Meta-Analysis of Randomized Trials Bavry AA, et al. Eur Heart J 2008;29:2989-3001 2.7% 4.4% 5.3% 2.8% 3.1% 3.4% Incidence of Mortality According to the Type of Device Used
  27. 27. What is the best therapy to prevent distal embolization? • Pharmacotherapy • Distal Protection • Thromboaspiration • New Devices
  28. 28. ClearWayTM Perfusion Balloon • What is ClearWay RX? – Rapid Exchange therapeutic infusion catheter
  29. 29. 101.9 80 105.4 68.5 91.2 85.5 0 20 40 60 80 100 120 Total Clearway Inf. Guid. Cath. Inf. Basal Post Abcix. Basal and FU Thrombus score by OCT p=0.0015 p= NS
  30. 30. MGuard™ Concept STENT + EMBOLIC PROTECTION STENT + EMBOLIC PROTECTION
  31. 31. • Bare metal stent (stainless steel) - Strut width 100 µm • Balloon-expandable • Protection net (mesh sleeve fibers of poliethyleneterephthalate) Fiber width 20 µm • Net aperture size (150x180 µm) 2.0 – 4.0mm diameter (every 0.25) 10 – 38mm length MGuard™ Stent
  32. 32. INSPIRE trial Brazilian Experience Primary Endpoint: 30-day MACE Secondary endpoints Device success Procedure success 6-12month MACE Late loss 6-month FU QCA+ IVUS IVUS + QCA Subset analysis QCA post stent Flow wire PRE & POST stent Myocardial blush TIMI frame count TIMI frame count Myocardial blush Register: 30 pts w/ de novo lesions in SVG or native coronaries w/ potential to flow disturbance + 30 pts w/ the same profile
  33. 33. In-Hospital Results 50% SVG, 35% of lesions w/ visible thrombus 0 10 20 30 40 50 60 70 80 90 100 TIMI3 flow MBG 3 ck-mb > 3x MACE
  34. 34. CASE # 1
  35. 35. WP OCLUSÃO PÓS IAM
  36. 36. Aspiration WP
  37. 37. After aspiration WP
  38. 38. Pre Final result PRÉ PÓS
  39. 39. CASE # 2
  40. 40. Baseline Angiogram
  41. 41. • Premedication (ASA + Clop + UFH) • Thrombus aspiration - Export® • GP IIb/IIIa – Abciximab • No predilatation • Stent MGuard® • No postdilatation Strategy
  42. 42. • Export® AP Aspiration catheter
  43. 43. large thrombus burden
  44. 44. Results post-aspiration
  45. 45. • MGuardstent 3.0 x 15 mm
  46. 46. Results post stent
  47. 47. CASE # 3
  48. 48. Baseline Angiogram
  49. 49. Baseline Angiogram
  50. 50. • Premedication (ASA + Clopidogrel) • Anti-thrombin with Enoxaparin for 7 days • Repeat coronary angiography and PCI to SVG Strategy
  51. 51. 7 DAYS AFTER
  52. 52. • MGuard stent 3.5 x 29 mm
  53. 53. Results post stent
  54. 54. Conclusions / Recomendations • Pharmacotherapy: IC injection of Abciximab and Adenosine • Distal Protection: No significant advantages in acute MI • Thromboaspiration: Most cases significant improvement • New Devices: promising data

×