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

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

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

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

  • SOLACI in Partnership with TCT: Snapshot of Latin America Practice and Research Room D235-236 Evidence/PracticeIntersection: How I ApproachThrombus in My Daily Clinical Practice (and Why) Ricardo A. Costa Alexandre Abizaid Instituto Dante Pazzanese de Cardiologia Sao Paulo, Brazil Monday, October 21st, 2012 – From 6:13 to 6:25 pm
  • DISCLOSURE STATEMENTI, Ricardo A. Costa DO NOT have afinancial interest/arrangement or affiliationwith one or more organizations that couldbe perceived as a real or apparent conflictof interest in the context of the subject ofthis presentation
  • Thrombotic Lesions View slide
  • Thrombotic Lesions View slide
  • No-Reflow: A Multifactorial PhenomenonVasoconstrictor Thrombotic MechanicalSerotonin Release • Aggregates of Distal Platelets, Embolization Neutrophils, Red • Spontaneous Blood Cells • Cellular and • During Intersticial edema reperfusion Tx Microvascular Mechanical Vasoconstriction Occlusion Occlusion
  • Distal Embolization in STEMIDistal Embolization occurs in approximately 14%of patients who underwent primary angioplasty Proximal LCx No DE DE P value filling defect at N=167 (86.1%) N=27 (13.9%) primary PCI site 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 Distal Thromboemboli Henriques JPS, et al. Eur Heart J. 2002;23:1112-1117
  • 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 Devices
  • What is the best therapy to prevent distal embolization? • Pharmacotherapy • Distal Protection • Thromboaspiration • New Devices
  • Impact of Time to Therapy and Reperfusion Modality on the Efficacy of Adenosine in Acute MI: AMISTAD -2 Trial 2118 Patients with Anterior STEMI & Reperfusion Therapy within 6 Hrs of Symptoms P=0.028 P=NS Adenosine Adenosine 26%Placebo 50 μg/Kg/min 70 μg/Kg/min 23% 57% X 3h X 3h 11% Fibrinolysis or PTCA Infarct size (5 d) (243 patients) Follow-up for 6 months Kloner RA et al. Eur Heart J. 2006;27:2400-2405
  • 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 p=0.047 p=0.03 P=0.36 P=0.96 OR 0.68 OR 0.56 OR 1.16 OR 0.97 30-Day Events, (%) [0.47,0.99] [0.33,0.94] [0.85,1.59] [0.31,3.01] 4.7% 4.1% 3.4% 2.4% 1.9% 1.0% 0.11% 0.06% De Luca G, et al. JAMA 2005;293:1759-1765
  • Abciximab in Primary PCI Meta-Analysis8 RCTs - 3,949 pts with AMI w/i 12h undergoing primary (7) or rescue (1) PCI rand to abciximab vs. placebo or control p=0.047 P=0.01 OR 0.68 6.2% OR 0.69Mortality [0.47, 0.99] [0.52, 0.92] 4.4% 3.4% 2.4% De Luca G, et al. JAMA 2005;293:1759-1765
  • Intracoronary vs. Intravenous Bolus Abciximab in Pts with STEMI Undergoing Primary PCI154 pts with STEMI for primary PCI randomized to IC bolus (n=77) or IV bolus (n=77) Abciximab followed by 12-hour infusion IC Abciximab IV Abciximab Primary End-Points 23.4 3.4 15.1 % % of LV P=0.02 P=0.006 1.1 1.1 P=0.01 0.1 Assessed by Delayed MRI Thiele H, et al. Circulation. 2008;118:49-57
  • Intracoronary vs. Intravenous Bolus Abciximab in Pts with STEMI Undergoing Primary PCI 30-Day MACE P=0.06 Thiele H, et al. Circulation. 2008;118:49-57
  • What is the best therapy to prevent distal embolization? • Pharmacotherapy • Distal Protection • Thromboaspiration • New Devices
  • Distal Protection DevicesDistal 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 primary or rescue PCI, rand to: PCI with balloonocclusion and aspiration distal protection (Guardwire Plus; n=252) or PCI without distal protection (n=249) Rates of Complete (> 70%) STR at Different Time Points% P=0.40 P=0.14 Stone GW, et al. JAMA 2005;293:1063-1072
  • Distal Microcirculatory Protection During PCI in Acute STEMI - EMERALD Trial 6-Month Clinical End-Points 16.1 14.3 P = NS for all comparisons 11 10% 6.3 5.8 3.4 3.3 3.9 2.4 2.1 2.5 1.3 1.7 0.4 0.9 Stone GW, et al. JAMA 2005;293:1063-1072
  • Randomized Comparison of Distal Protection Versus Conventional Treatment in Primary PCI: DEDICATION Trial Distal Protection (Filterwire) (n=302) Conventional PCI (n=301) 5.4 P=NS for all comparisons 76 72% 3.2 % 2.6 2.5 1.9 1.6 P=NS 1.0 0.6 0.6 0.3 Conclusion: Distal protection failed to significantly improve ST-segment resolution 90 min. after PCI compared to PCI alone in patients with large STEMI. Kelbaek H, et al. J Am Coll Cardiol. 2008;51:899-905
  • What is the best therapy to prevent distal embolization? • Pharmacotherapy • Distal Protection • Thromboaspiration • New Devices
  • 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 Primary End-Point P = 0.037 P = NS P = NS 96 7.5 89 P = 0.033 67.8 4.9mm % 52.6 30 31 Predictors of STR > 50% by  Younger Age Multivariate Analysis  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
  • Thrombus Aspiration Before Primary Angioplasty Improves Myocardial Reperfusion in AMI: DEAR-MI 148 consecutive STEMI Pts with Sx < 12h randomized to: PPCI (n=74) or Thrombus Aspiration (Pronto Catheter) before PPCI (n=74) Thrombus Aspiration + PPCI PPCI 88% 89% 910 ± 128 78% 790 ± 132 68% 50%% 44% P<0.05 P<0.0001 P=NS P<0.0001 Silva-Orrego P, et al. J Am Coll Cardiol. 2006;48:1552-1559
  • Thrombus Aspiration During PCI in AMI Study: TAPAS Thrombus Aspiration Thrombus Aspiration (n=535) (n=530)1071 STEMI pts R 1-Year FU Conventional PCI Conventional PCI (n=536) (n=530) Primary End-Point: Myocardial Blush Grade P < 0.001Patients (%) Thrombus Aspiration Conventional PCI Svillas T, et al. N Engl J Med 2008;358:557-567
  • Thrombus Aspiration During PCI in AMI Study: TAPAS ST-Segment Elevation Resolution P < 0.001Patients (%) Thrombus aspiration Conventional PCI Svillas T, et al. N Engl J Med 2008;358:557-567
  • Thrombus Aspiration During PCI in AMI Study: TAPAS 1-Year Mortality 12 Conventional PCI Thrombus-Aspiration 10 30 days 8 4.0% vs. 2.1%, P=0.07Mortality (%) Log-Rank p = 6 0.040 4 2 0 0 100 200 300 400 Time (days) Svillas T, et al. N Engl J Med 2008;358:557-567
  • Role of Adjunctive Thrombectomy and Embolic Protection Devices in AMI Meta-Analysis of Randomized TrialsIncidence of Mortality According to the Type of Device Used 5.3% 4.4% 3.4% 3.1% 2.7% 2.8% Bavry AA, et al. Eur Heart J 2008;29:2989-3001
  • What is the best therapy to prevent distal embolization? • Pharmacotherapy • Distal Protection • Thromboaspiration • New Devices
  • ClearWayTM Perfusion Balloon• What is ClearWay RX? – Rapid Exchange therapeutic infusion catheter
  • Basal and FU Thrombus score by OCT p=0.0015 p= NS 120 101.9 105.4 100 91.2 80 85.5 80 68.5 60 40 20 0 Total Clearway Inf. Guid. Cath. Inf. Basal Post Abcix.
  • MGuard™ Concept STENT STENT + + EMBOLICEMBOLIC PROTECTION PROTECTION
  • MGuard™ Stent• 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
  • INSPIRE trial Brazilian Experience Register: 30 pts w/ de novo lesions + 30 pts w/ in SVG or native coronaries the same profile w/ potential to flow disturbanceIVUS + QCA Primary QCA post Subset Endpoint: stent analysis TIMI frameMyocardial 30-day MACE count blush Myocardial blushTIMI frame Secondary endpoints count Device success Procedure success Flow wire 6-12month MACE PRE & POST Late loss stent 6-month FU QCA+ IVUS
  • In-Hospital Results50% SVG, 35% of lesions w/ visible thrombus 100 90 80 70 60 50 40 30 20 10 0 TIMI3 MBG 3 ck-mb > MACE flow 3x
  • CASE # 1
  • OCLUSÃO PÓS IAM WP
  • Aspiration WP
  • After aspiration WP
  • Pre Final result PRÉ PÓS
  • CASE # 2
  • Baseline Angiogram
  • Strategy• Premedication (ASA + Clop + UFH)• Thrombus aspiration - Export®• GP IIb/IIIa – Abciximab• No predilatation• Stent MGuard®• No postdilatation
  • • 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
  • Strategy• Premedication (ASA + Clopidogrel)• Anti-thrombin with Enoxaparin for 7 days• Repeat coronary angiography and PCI to SVG
  • 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 significant advantages in acute MI• Thromboaspiration: Most cases significant improvement• New Devices: promising data