1. Thrombus Management in the Cath Lab
David A. Cox, MD FSCAI FACC
Lehigh Valley Health Network
Director, Cardiovascular Research Institute
Associate Director of Cardiac Catheterization Laboratory
Allentown, PA
CRT 2017

2. Disclosures
Advisory Board: Abbott Vascular Medtronic,Inc Boston Scientific
Speaker: Medicure

3. We All Agree Dealing with thrombus still a real challenge
“Why are trials negative? I do thrombectomy and it works!”
Doctor feels good, any benefit for patient?

4. What PCI doc’s already know
Is the size and amount of thrombus really that important?
YES!
WE ALL WANT LESS DISTAL EMBOLI, NO-REFLOW, AND STENT THROMBOSIS

5. Lots of papers in this area

8. Inaba Yet al. Eurointervention; 2009;5:375-83
Embolic Protection During Primary PCI: Impact of single vs. multicenter studies
25 RCTs, 5919 pts
2460 pts in single center trials, 3459 pts in multicenter trials
Study design
Single center
Multicenter
Overall (I2=0, P=0.51)
RR (95%)
0.58 (0.37, 0.90)
1.01 (0.67, 1.54)
0.81 (0.72, 0.91)
Predictors of
mortality
Study design
Single center
Multicenter
Overall (I2=84.8%, p<0.001)
RR (95%)
0.58 (0.37, 0.90)
1.01 (0.67, 1.54)
0.75 (0.72, 0.79) 2 1 4
Predictors of
ST resolution
0.3 1 2
Inaba Yet al. Eurointervention; 2009;5:375-83

9. Filters…no data for use

10. Some exceptions
Massive thrombus in proximal vessel……. Run manual thrombectomy device over filter placed distally. OR Some reports of literally catching the clot with the filter as a butterfly net!!! DATA-FREE ZONE!

11. What’s new in embolic protection?

12. MGuard Concept
STENT +
EMBOLIC PROTECTION
STENT +
EMBOLIC PROTECTION

13. The MGuard and MGuard Prime Embolic Protection Stent (EPS)
MGuard MGuard Prime
Metallic frame 316L stainless steel L605 cobalt chromium
Strut width 100 µm 80 µm
Crossing profile 1.1 – 1.3 mm 1.0 – 1.2 mm
Shaft dimensions – 0.86 mm – 0.86 mm
Mesh sleeve PET** PET**
- Fiber width 20 µm 20 µm
- Net aperture size µm µm
*InspireMD, Tel Aviv, Israel; **Polyethyleneterephthalate

14. MGUARD for Acute ST Elevation Reperfusion II The MASTER II Trial
STEMI with symptom onset within 12 hours
- 1,114 pts at 70 sites in 11 countries - R
Stratified by LAD vs. non-LAD
infarct vessel and
intended DES vs BMS
PCI with BMS or DES
PCI with MGuard Prime
Follow-up: 30 days, 6 months, 1 year, 2 years, 3 years
1 efficacy endpoint: ST-segment resolution at minutes (Sup)
1 safety endpoint: Death or reinfarction at 365 days (NI)
2 efficacy endpoint: Infarct size day 3-7 MRI (n=352 P/MLAD) (Sup)
2 safety endpoint: In-stent late loss 12 months (n=200 BMS strata, NI)

15. MASTER II Primary Endpoint Complete ST-segment resolution
MGuard Prime (n=144)
Control (n=145)
10.4%
11.0%
Difference [95%CI] = -2.4% [-14.5,9.7]
P=0.68
59.3%
56.9%
29.7%
32.6%

16. AngioJet Rheolytic Thrombectomy16

18. Why Angiojet Rarely Used?
Set up more complex
Heart Block, hypotension
Deaths in AiMI often related to procedural complications
Manual Aspiration…must be better

19. Manual Thrombectomy

20. Tale of 4 Trials
TAPAS
INFUSE AMI
TASTE
TOTAL

21. Why might manual aspiration work?
Easy to use
Can chase clot down artery
Direct Stenting?
Why not? Technique not defined, thrombus often left, catheters not ideal

22. TAPAS: 1,071 pts with STEMI undergoing PCI randomized in the ER to aspiration (Export) vs. control
Myocardial Blush (1 EP)
ST-segment Resolution
P<0.001
P<0.001
Thrombus
aspiration
Conventional
PCI
Thrombus
aspiration
Conventional
PCI
Svilaas T et al. NEJM 2008;358;

23. TAPAS: 1,071 pts with STEMI undergoing primary PCI randomized in the ER to manual aspiration (Export) vs. control
30 days
4.0% vs. 2.1% P=0.07
Time (days)
Mortality (%)
Conventional PCI
Thrombus-Aspiration
100
200
300
400 2 4 6 8 10 12
1 year
7.6% vs. 4.0%
P=0.04
Vlaar et al. Lancet 2008;371:

24. INFUSE-AMI Ant MI 452 pts PCI <6 hrs after symptoms
Manual aspiration vs.
no aspiration
Pooled across the abciximab randomization

25. INFUSE-AMI: STR 60 minutes post-PCI*
[55.8, 87.4]
[45.2, 87.2]
ST-segment resolution (%)
*Core laboratory assessed

27. Ole Fröbert, MD, PhD - on behalf of the TASTE investigators
UCR
Uppsala Clinical Research Center
Thrombus Aspiration in ST- Elevation myocardial infarction in Scandinavia (TASTE trial):
Results and Methodology of a Registry based Randomized Clinical Trial (RRCT)
Ole Fröbert, MD, PhD - on behalf of the TASTE investigators
Departement of Cardiology
Örebro University Hospital
Sweden

28. TASTE and previous studies

29. All-cause mortality at 30 days
HR 0.94 ( ), P=0.63
Per protocol analysis based on actual treatment:
HR 0.88 ( ), P=0.38
Fröbert, O. et al. N Engl J Med 2013; 369:

30. Additional results

31. TASTE vs. TAPAS

32. TASTE 12 mo: NO BENEFIT

33. TOTAL Trial Flow and Adherence
10,732 enrolled and randomized
Cross-over to Thrombectomy as initial strategy in 70 (1.4%)
Bailout Thrombectomy
in 354 (7%)
Crossover to PCI alone
in 231 (4.6%)
TOTAL
5035 Manual Thrombectomy
5029 PCI Alone
5029 included in analysis
5035 included in analysis
10,064 underwent PCI for STEMI

34. Primary Outcome (CV death, MI, Shock or CHF) at 1 year

35. Primary Outcome at 1 year
Thrombectomy
(N=5033) (%)
PCI alone
(N=5030) (%) HR
95% CI p
CV death, MI, shock or
class IV heart failure
395 (7.8)
394 (7.8)
1.00
(0.87 – 1.15)
0.99
CV death
179 (3.6)
192 (3.8)
0.93
(0.76 – 1.14)
0.48
Recurrent MI
125 (2.5)
118 (2.3)
1.05
( )
0.68
Cardiogenic Shock
95 (1.9)
105 (2.1)
0.90
(0.68 – 1.19)
0.47
Class IV heart failure
106 (2.1)
96 (1.9)
1.01
(0.83 – 1.45)
0.50

36. Safety Outcomes at 1 year
Thrombectomy
(N=5033) (%)
PCI alone
(N=5030) (%) HR
95% CI p
Stroke at 1 year
60 (1.2)
36 (0.7)
1.66
(1.10 – 2.51)
0.015
Stroke or TIA at 1 year
73 (1.4)
44 (0.9)
1.6 5
(1.14 – 2.40)
0.008
Landmark Analyses
Stroke 180 days to 1 year
7 (0.1)
10 (0.2)
0.7 0
(0.27 – 1.83)
0.46

37. TOTAL one year: subgroups
Jolly et al. Lancet 2016; 387(10014): 127

38. 2015 ACC/AHA/SCAI Focused Update on Primary PCI for Patients with STEMI: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction
Developed in Collaboration with the American College of Emergency Physicians
© American College of Cardiology Foundation, American Heart Association, and Society for Cardiovascular Angiography and Interventions

39. Aspiration Thrombectomy
COR
LOE
Recommendations
IIb
C-LD
The usefulness of selective and bailout aspiration thrombectomy in patients undergoing primary PCI is not well established.1
III: No Benefit A
Routine aspiration thrombectomy before primary PCI is not useful.2
1. Modified recommendation from 2013 guideline (Class changed from IIa to IIb for selective and bailout aspiration thrombectomy before PCI)
2. New recommendation

40. Thomas Stiermaier, MD; Suzanne de Waha, MD;
Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset
Steffen Desch, MD
Thomas Stiermaier, MD; Suzanne de Waha, MD;
Philipp Lurz, MD, PhD; Matthias Gutberlet, MD; Marcus Sandri, MD; Norman Mangner, MD; Enno Boudriot, MD;
Michael Woinke, MD; Sandra Erbs, MD; Gerhard Schuler, MD; Georg Fuernau, MD; Ingo Eitel, MD; Holger Thiele, MD

41. Background Hypothesis Design
Routine thrombus aspiration reduces microvascular obstruction (MVO) assessed by cardiac magnetic resonance imaging (CMR) in patients with subacute STEMI presenting between 12 and 48 hours after symptom onset.
Design
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Prospective, randomized, controlled, single-blind
Single-center 41

42. Primary Endpoint: Microvascular Obstruction
Results
Primary Endpoint: Microvascular Obstruction
on MRI Day 1-4
Thrombus
aspiration
Microvascular obstruction, %LV
Standard PCI
only
p=0.47 5 4 3 1 2
3.1 ± 4.4
2.5 ± 4.0
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43. The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: DEFERred stent implantation in connection with primary PCI: DANAMI 3-DEFER

44. Aim of DANAMI-3-DEFER study
To evaluate whether the prognosis of
STEMI patients treated with pPCI can be
improved by deferred stent implantation

45. Methods N=1207
DEFER:
Minimal acute manipulation to restore stable flow in IRA
Stent implantation 48 hours later
Conventional PCI:
Immediate stent implantation

46. Primary endpoint

47. Components of the primary endpoint

48. Routine deferred stenting was associated with an
increased rate of target vessel revascularisation, mainly due to premature stent implantation but
Slight improvement in EF (3% pts)

49. A prospective, randomized trial of
TATORT-NSTEMI:
A prospective, randomized trial of
Thrombus Aspiration in ThrOmbus containing culPriT lesions in
Non-ST-Segment Elevation Myocardial Infarction
Holger Thiele, MD
Ingo Eitel, MD; Suzanne de Waha, MD; Steffen Desch, MD;
Bruno Scheller, MD; Bernward Lauer, MD; Meinrad Gawaz, MD;
Tobias Geisler, MD; Oliver Gunkel, MD; Leonhard Bruch, MD;
Norbert Klein, MD; Dietrich Pfeiffer, MD;
Gerhard Schuler, MD; Uwe Zeymer, MD
on behalf of the TATORT-NSTEMI Investigators

50. Study Design, Flow, and Compliance
Methods
460 NSTEMI patients
20 not randomized
440 NSTEMI patients
221 assigned to thrombectomy
219 assigned to standard PCI
No CMR (n=40)
Claustrophobia (n=11)
PM/ICD (n=2)
Obesity (n=1)
Death (n=3)
Renal insuff. (n=0)
Other (n=23)
No CMR (n=27)
Claustrophobia (n=5)
PM/ICD (n=3)
Obesity (n=1)
Death (n=3)
Renal insuff. (n=1)
Others (n=14)
Primary endpoint analysis MO (n=181)
Secondary endpoint MBG (n=221)
Secondary endpoint TIMI-flow (n=221)
Clinical follow-up 6 months (n=218)
Primary endpoint analysis MO (n=192)
Secondary endpoint MBG (n=219)
Secondary endpoint TIMI-flow (n=219)
Clinical follow-up 6 months (n=216)

51. Primary Study Endpoint – MO in MRI
Results
Presence of MO
Extent of MO
Thrombectomy
Standard PCI
Median [IQR]
1.95% [0.80;4.10]
1.40%
[0.70;2.60]
Extent of MO, %LV
p=0.17 2 4 6 8 10
p=0.74
Presence MO, %
30.8%
29.2%
Thrombectomy
Standard PCI
Core lab assessed

52. Clinical Outcome 6 Months
Results
Clinical Outcome 6 Months
Thrombectomy
Standard PCI HR
95% CI P
Death/Reinfarction/TVR/new CHF
7.3%
10.1%
0.72
0.34
Death
3.0%
3.3%
0.83
0.74
Reinfarction
2.1%
2.7%
0.78
0.70
TVR
1.6%
1.30
0.73
New CHF
1.8%
4.4%
0.43
0.15
Evtl. weglassen und nur die Kaplan Meier Kurven zeigen

53. Which Intraprocedural Thrombotic Events Impact Clinical Outcomes After Percutaneous Coronary Intervention in Acute Coronary Syndromes? A Pooled Analysis of the HORIZONS-AMI and ACUITY Trials
Jeffrey D. Wessler, MD, MPH; Philippe Généreux, MD; Roxana Mehran, MD; Girma Minalu Ayele, PhD; Sorin J. Brener, MD; Margaret McEntegart, MD, PhD; Ori Ben-Yehuda, MD; Gregg W. Stone, MD; Ajay J. Kirtane, MD, SM
J Am Coll Cardiol Intv. 2016;9(4):

54. Results
6591 pts PCI for NSTEMI or STEMI
IPTE 7.7%
12/2% STE % NSTEMI

57. Use what works for you!

58. Should we stop thrombectomy?
Oculothrombotic reflex
Allows direct stenting
May reduce distal embolization but CVA
Techniques in trials poorly defined
J Blankenship JACC Int Jan 2016:
Why we will never stop aspirating coronary thrombi….selectively