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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
Disclosures
• Advisory Board: Abbott Vascular
Medtronic,Inc.
Boston Scientific
• Speaker: Medicure
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?
What PCI doc’s already know
• Is the size and amount of thrombus really
that important?
• YES!
• WE ALL WANT LESS DISTAL EMBOLI, NOREFLOW, AND STENT THROMBOSIS
Lots of papers in this area
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
Predictors of
mortality
Study design
Single center
Multicenter
Overall
(I2=0, P=0.51)
2
Predictors of
ST resolution
RR (95%)
0.58 (0.37, 0.90)
1.01 (0.67, 1.54)
0.81 (0.72, 0.91)
1
4
Study design
Single center
Multicenter
Overall (I2=84.8%, p<0.001)
0.3
RR (95%)
0.58 (0.37, 0.90)
1.01 (0.67, 1.54)
0.75 (0.72, 0.79)
1
Inaba Yet al. Eurointervention; 2009;5:375-83
2
Filters…no data for use
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!
What’s new in embolic protection?
MGuard Concept
STENT
+
EMBOLIC PROTECTION
STENT
+
EMBOLIC
PROTECTION
The MGuard and MGuard Prime
Embolic Protection Stent (EPS)
MGuard
Metallic frame
316L stainless steel
Strut width
100 µm
Crossing profile
1.1 – 1.3 mm
Shaft dimensions
0.65 – 0.86 mm
Mesh sleeve
PET**
- Fiber width
20 µm
- Net aperture size
150 - 180 µm
MGuard Prime
L605 cobalt chromium
80 µm
1.0 – 1.2 mm
0.65 – 0.86 mm
PET**
20 µm
150 - 180 µm
*InspireMD, Tel Aviv, Israel; **Polyethyleneterephthalate
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 60-90 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)
MASTER II Primary Endpoint
Complete ST-segment resolution
MGuard Prime (n=144)
10.4%
32.6%
Control (n=145)
11.0%
56.9%
29.7%
59.3%
Difference [95%CI] = -2.4% [-14.5,9.7]
P=0.68
AngioJet Rheolytic Thrombectomy
Why Angiojet Rarely Used?
• Set up more complex
• Heart Block, hypotension
• Deaths in AiMI often related to procedural
complications
• Manual Aspiration…must be better
Manual Thrombectomy
Tale of 4 Trials
• TAPAS
• INFUSE AMI
• TASTE
• TOTAL
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
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
Thrombus
aspiration
Conventional
PCI
P<0.001
Thrombus
aspiration
Svilaas T et al. NEJM 2008;358;-557-67
Conventional
PCI
TAPAS: 1,071 pts with STEMI undergoing
primary PCI randomized in the ER to manual
aspiration (Export) vs. control
12
30 days
4.0% vs. 2.1%
P=0.07
10
Mortality (%)
Conventional PCI
Thrombus-Aspiration
1 year
7.6% vs. 4.0%
P=0.04
8
6
4
2
0
0
100
200
300
Time (days)
Vlaar et al. Lancet 2008;371:1915-20
400
INFUSE-AMI Ant MI 452 pts
PCI <6 hrs after symptoms
Manual aspiration
vs.
no aspiration
Pooled across the abciximab randomization
ST-segment resolution (%)
INFUSE-AMI: STR 60 minutes post-PCI*
P=0.37
P=0.23
[55.8, 87.4]
[45.2, 87.2]
*Core laboratory assessed
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
TASTE and previous studies
TASTE
TASTE
TAPAS
JETSTENT
AIMI
INFUSE-AMI
VAMPIRE
PREPARE
Chevalier
Kaltoft
MUSTELA
X AMINE ST
PIHRATE
EXPIRA
DEAR-MI
Liistro
0
1000
2000
3000
4000
Number of patients
5000
6000
7000
8000
All-cause mortality at 30 days
HR 0.94 (0.72 - 1.22), P=0.63
Per protocol analysis based
on actual treatment:
HR 0.88 (0.66 - 1.17), P=0.38
Fröbert, O. et al. N Engl J Med 2013; 369:1587-97
Additional results
Not randomized in TASTE
Randomized in TASTE
PCI Only
Thrombus
Aspiration
Point Estimate
(95% confidence interval)
P Value
PCI Only
Thrombus
Aspiration
30 days
All cause death or myocardial infarction - no. (%)
140 (3.9)
121 (3.3)
HR 0.86 (0.67 - 1.10)
0.23
398 (11.6)
134 (11.8)
Stent thrombosis - no. (%)
19 (0.5)
9 (0.2)
HR 0.47 (0.20 - 1.02)
0.06
18 (0.5)
5 (0.4)
Target vessel revascularization - no. (%)
76 (2.2)
63 (1.8)
HR 0.83 (0.59 - 1.15)
0.27
80 (2.3)
30 (2.6)
Target lesion revascularization - no. (%)
57 (1.6)
43 (1.2)
HR 0.75 (0.51 - 1.12)
0.16
64 (1.8)
25 (2.2)
Stroke or neurological complication - no. (%)
18 (0.5)
19 (0.5)
OR 1.06 (0.55-2.02)
0.87
32 (0.9)
12 (1.0)
Perforation or tamponade - no.(%)
14 (0.4)
13 (0.4)
OR 0.93 (0.44-1.98)
0.85
13 (0.4)
7 (0.6)
Heart failure - no.(%)
234 (6.5)
245 (6.8)
OR 1.05 (0.87-1.27)
0.60
353 (10.0)
125 (10.8)
Index hospitalization
0.33
Left ventricular function - no. (%)
Moderately reduced, LVEF 30-39%
495 (13.7)
526 (14.5)
523 (14.8)
190 (16.4)
Severely reduced, LVEF <30%
157 (4.3)
137 (3.8)
255 (7.2)
102 (8.8)
TASTE vs. TAPAS
TASTE 12 mo: NO BENEFIT
TOTAL Trial Flow and Adherence
TOT
10,732 enrolled and randomized
AL
10,064 underwent PCI for STEMI
5035 Manual
Thrombectomy
Crossover to PCI
alone
in 231 (4.6%)
5035 included in analysis
TOT
AL
5029 PCI Alone
Cross-over to
Thrombectomy as
initial strategy in 70
(1.4%)
Bailout Thrombectomy
in 354 (7%)
5029 included in analysis
Primary Outcome (CV death, MI, Shock or
CHF) at 1 year
TOT
AL
Primary Outcome at 1 year
1 year
Thrombectom
y
(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
(0.82 -1.36)
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
TOT
AL
Safety Outcomes at 1 year
Stroke at 1 year
Stroke or TIA at 1
year
Landmark Analyses
Stroke 180 days to 1
year
TOT
AL
Thrombectomy
PCI alone
(N=5033) (%)
(N=5030) (%)
60 (1.2)
36 (0.7)
1.66
73 (1.4)
44 (0.9)
1.6
5
(1.10 –
2.51)
(1.14 –
2.40)
7 (0.1)
10 (0.2)
0.7
0
(0.27 –
1.83)
HR
95% CI
p
0.015
0.008
0.46
TOTAL one year: subgroups
Jolly et al. Lancet 2016; 387(10014): 127
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
2013 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
Aspiration Thrombectomy
COR
LOE
Recommendations
The usefulness of selective and bailout
aspiration thrombectomy in patients
IIb
C-LD undergoing primary PCI is not well
established.1
Routine aspiration thrombectomy before
III: No
A
primary PCI is not useful.2
Benefit
1. Modified recommendation from 2013 guideline (Class changed from IIa to IIb for selective and
bailout aspiration thrombectomy before PCI)
2. New recommendation
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
Background
Hypothesis
• 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
• Prospective, randomized, controlled, single-blind
• Single-center
Results
Microvascular obstruction, %LV
Primary Endpoint: Microvascular Obstruction
on MRI Day 1-4
p=0.47
5
3.1 ± 4.4
4
2.5 ± 4.0
3
2
1
0
Thrombus
aspiration
Standard PCI
only
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
Aim of DANAMI-3-DEFER study
To evaluate whether the prognosis of
STEMI patients treated with pPCI can be
improved by deferred stent implantation
Methods N=1207
DEFER:
•Minimal acute manipulation to restore stable flow in IRA
•Stent implantation 48 hours later
Conventional PCI:
•Immediate stent implantation
0.25
Primary
endpoint
Primary
endpoint
0.05
0.10
0.15
HR: 0.99 [0.75-1.29]; P=0.92
0.00
Event rate
0.20
Conventional
Deferred
0
1
2
3
Time (years)
4
5
159
156
0
0
Number at risk
Conventional 612
Deferred 603
568
543
533
526
360
359
Components of the primary endpoint
Conventional
Deferred
0.10
0.05
0.00
0.00
0
1
2
3
Time (years)
4
5
173
180
0
0
Number at risk
0
594
584
575
575
403
409
Conventional 612
Deferred 603
2
3
Time (years)
4
5
379
383
165
167
0
0
Conventional
Deferred
0.10
0.15
HR: 1.7 [1.04 - 2.92]; P=0.03
0.05
0.15
0.10
0.00
0.00
0.05
554
550
D
0.20
HR: 0.82 [0.47 - 1.43]; P=0.49
Cumulative incidence
0.20
0.25
C
Conventional
Deferred
586
564
Unplanned target vessel revascularisation
Hospitalisation for heart failure
0.25
1
Number at risk
Conventional 612
Deferred 603
Cumulative incidence
HR: 1.1 [0.69 - 1.64]; P=0.77
0.15
Cumulative incidence
0.15
0.10
B
0.20
HR: 0.83 [0.56 - 1.24]; P=0.37
0.05
Event rate
Recurrent myocardial reinfarction
0.25
Conventional
Deferred
0.20
0.25
All cause mortality
A
0
1
2
3
Time (years)
4
5
167
172
0
0
Number at risk
Conventional 612
Deferred 603
0
1
2
3
Time (years)
4
5
170
167
0
0
Number at risk
580
576
560
563
391
395
Conventional 612
Deferred 603
587
559
561
549
387
382
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)
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
Methods
Study Design, Flow, and Compliance
460 NSTEMI patients
20 not randomized
440 NSTEMI patients
221 assigned to thrombectomy
No CMR (n=40)
Claustrophobia (n=11)
PM/ICD (n=2)
Obesity (n=1)
Death (n=3)
Renal insuff. (n=0)
Other (n=23)
Primary endpoint analysis MO (n=181)
Secondary endpoint MBG (n=221)
Secondary endpoint TIMI-flow (n=221)
Clinical follow-up 6 months (n=218)
219 assigned to standard PCI
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=192)
Secondary endpoint MBG (n=219)
Secondary endpoint TIMI-flow (n=219)
Clinical follow-up 6 months (n=216)
Results
Primary Study Endpoint – MO in MRI
Presence of MO
Extent of MO
10
p=0.74
Median [IQR]
1.95%
[0.80;4.10]
Median [IQR]
1.40%
[0.70;2.60]
30.8%
29.2%
Extent of MO, %LV
Presence MO, %
8
p=0.17
6
4
2
Thrombectomy Standard PCI
Core lab assessed
0
Thrombectomy Standard PCI
Results
Clinical Outcome 6 Months
Thrombectom Standard PCI
y
HR
95% CI
P
Death/Reinfarction/TV
R/new CHF
7.3%
10.1%
0.72
0.371.41
0.34
Death
3.0%
3.3%
0.83
0.282.48
0.74
Reinfarction
2.1%
2.7%
0.78
0.212.89
0.70
TVR
2.1%
1.6%
1.30
0.295.80
0.73
New CHF
1.8%
4.4%
0.43
0.131.40
0.15
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 BenYehuda, MD; Gregg W. Stone, MD; Ajay J. Kirtane, MD,
SM
J Am Coll Cardiol Intv. 2016;9(4):331-337
Results
• 6591 pts PCI for NSTEMI or
STEMI
• IPTE 7.7%
• 12/2% STE
3.5% NSTEMI
Use what works for you!
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