Transcript slides

Strategies for Thrombus and No
Reflow Management in the Cath Lab
Gabriel Maluenda, MD
Clinica Alemana, Santiago, Chile
Gabriel Maluenda, MD
I/we have no real or apparent conflicts of interest to report.
IC thrombus and no-reflow
implications
The presence of thrombus and/or no-reflow
during PCI it are associated with poor outcomes,
including:
• reduced procedural success
• increased rates of abrupt vessel closure
• adverse ventricular remodeling
• major complications [death-MI-emergent
CABG]
MECHANISMS FOR NO REFLOW
Niccoli G et al, JACC 2009;54:281-92
Rezkalla SH, CCI 2008; 72:950–957
Aspiration
Thrombectomy and distal
protection devices
TAPAS: Primary Endpoint – MBG
100%
0 or 1
2
3
90%
80%
p < 0.001
70%
60%
46%
50%
40%
32%
26%
30%
20%
41%
37%
17%
10%
0%
Thrombus Aspiration
Conventional PCI
Reduction of Thrombus Burden &/or Facilitation of Direct Stenting?
Svilaas T et al. NEJM 2008;358:557
TAPAS: Mortality at 1 Year
12
Conventional PCI
Thrombus-Aspiration
Mortality (%)
10
8
Conventional PCI
Log-Rank p = 0.040
6
Thrombus Aspiration
4
2
0
0
100
200
300
400
Time (days)
Vlaar PJ et al, Lancet 2008; 371: 1915-20.
NON-MANUAL
THROMBECTOMY
MANUAL
ASPIRATION
ATTEMPT: 11 Included Trials
DIVER CE
REMEDIA
PRONTO
DEAR-MI
EXPORT
EXPORT
ANGIOJET
Antoniucci
X-SIZER
X-AMINE ST
RESCUE
Kaltoft
TVAC
De Luca
PIHRATE
EXPIRA
TAPAS
2,686 Patients
Median Follow-Up: 365 Days
(significantly extended compared to published FU of
included trials: 135 days)
VAMPIRE
Burzotta, ESC 2009; Eur Heart J 2009 30(18):2193-2203
ATTEMPT: Impact of Type of Thrombectomy
Device on Mortality
NON-MANUAL THROMBECTOMY TRIALS
Cumulative Survival
Cumulative Survival
100%
Thrombectomy
Standard PCI
95%
MANUAL ASPIRATION TRIALS
100%
Thrombectomy
95%
p = 0.482
Standard PCI
90%
90%
85%
85%
80%
80%
300
600
900
Time to Death (days)
1200
p = 0.011
Estimated NNT: 34
300
600
900
Time to Death (days)
1200
Burzotta, ESC 2009; Eur Heart J 2009 30(18):2193-2203
2009 ACC/AHA STEMI Guideline Update:
Aspiration for Rx of STEMI
• New Class IIa, Level of Evidence B recommendation
for the use of aspiration thrombectomy for STEMI
• IIA - Treatment benefits > Risk, “It is reasonable to perform.”
• B – Data from several non-randomized or a single randomized study.
• This recommendation does NOT apply to mechanical thrombectomy
(e.g., Angiojet)
• ACC/AHA guidelines cite:
• 2 randomized clinical trials: TAPAS & EXPIRA
• A meta-analysis by Bavry et al
• A large pooled analysis of randomized trials: ATTEMPT
To catch the thrombus – mesh
covered stent strategy
The MGuard and MGuard Prime
Embolic Protection Stent (EPS)
Metallic frame
Strut width
Crossing profile
Shaft dimensions
Mesh sleeve
- Fiber width
- Net aperture size
MGuard
316L stainless steel
100 µm
1.1 – 1.3 mm
0.65 – 0.86 mm
PET**
20 µm
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
The MASTER Trial
STEMI with symptom onset within 12 hours at
432 pts at 50 sites in 9 countries
R
Stratified by infarct vessel
and thrombus aspiration
PCI with BMS or DES
PCI with MGuard
Follow-up: 30 days, 6 months, 1 year
Primary endpoint: ST-segment resolution at 60-90 minutes
Substudies:
Cardiac MRI: 60 pts (30 pts in each arm) at 3-5 days
Angio FU: 50 pts in MGuard arm at 13 months
Stone GW et al. J Am Coll Cardiol 2012;60:1975–84
Primary Endpoint:
Complete ST-segment resolution
MGuard (n=204)
16.7%
25.5%
Control (n=206)
17.0%
44.7%
57.8%
38.3%
Difference [95%CI] = 13.2% [3.1, 23.3]
P=0.008
Conclusions and Implications
• Among pts with acute STEMI undergoing emergent
PCI, the MGuard micronet mesh covered stent
compared to conventional metallic stents resulted
in superior rates of epicardial coronary flow and
complete STR
• A larger randomized trial is warranted to verify
these findings, and determine whether these
benefits result in reduced infarct size and/or
improved clinical outcomes (MASTER II)
Stone GW et al. J Am Coll Cardiol 2012;60:1975–84
Intracoronary infusion of
IIb-IIIa inhibitors
Deibele AJ, et al. Circulation 2010;121:784-791.
Intracoronary Compared with
Intravenous Bolus Abciximab
Application During Primary PCI
Cardiac Magnetic Resonance Substudy of the
AIDA STEMI trial
Holger Thiele, MD; Jochen Wöhrle, MD;
Henning Suenkel, BSc; Josephine Meissner, MD; Sebastian Kerber, MD;
Bernward Lauer, MD; Matthias Pauschinger, MD; Ralf Birkemeyer, MD; Christoph Axthelm, MD;
Rainer Zimmermann, MD; Petra Neuhaus, PhD; Oana Brosteanu, PhD; Steffen Desch, MD;
Matthias Gutberlet, MD; Gerhard Schuler, MD; Ingo Eitel, MD
on behalf of the AIDA STEMI Investigators
Study Design, Flow, and Compliance
2065 patients enrolled and randomly assigned
No CMR (n=1270)
795 patients underwent CMR
394 assigned to intracoronary
abciximab
Incomplete CMR scan
- Scan terminated n=4
- T2 poor image quality n=39
- DE poor image quality n=7
401 assigned to intravenous
abciximab
Incomplete CMR scan
- Scan terminated n=3
- T2 poor image quality n=40
- DE poor image quality n=10
Analyzed CMR data
Analyzed CMR data
- LV function n=394
- T2-weighted imaging n=355
- DE imaging n=387
- MO n=384
- Hypointense core/Hemorrhage n=346
- LV function n=401
- T2-weighted imaging n=361
- DE imaging n=391
- MO n=390
- Hypointense core/Hemorrhage n=353
Area at Risk + Infarct Size
Area at risk
Infarct size
50
80
Median [IQR] Median [IQR]
35% [25, 48] 35% [26, 48]
Median [IQR] Median [IQR]
16% [9, 25]
17% [8, 25]
60
p=0.97
40
Infarct size, %LV
Area at risk, %LV
40
p=0.52
30
20
20
10
0
IC abciximab IV abciximab
N=344
N=354
0
IC abciximab IV abciximab
N=385
N=389
Reperfusion Injury
Hemorrhage
Microvascular obstruction
p=0.19
Presence MO, %
52%
47%
IC abciximab IV abciximab
N=384
N=390
Presence Hemorrhage, %
p=0.19
32%
37%
IC abciximab IV abciximab
N=346
N=353
AIDA STEMI Conclusions
• This largest multicenter CMR study in STEMI patients to
date demonstrates that IC as compared to IV abciximab
did not result in a difference in myocardial damage
and/or reperfusion injury.
• The results of the AIDA STEMI CMR substudy therefore
confirm the lack of difference in the combined endpoint
of death, reinfarction or congestive heart failure of the
AIDA STEMI trial.
IC infusion of Gp IIb-IIIa via dedicated
perfusion catheter?
• May reduce thrombus burden at site of lesion in a
most efficient manner
• May reduce no reflow phenomenon
• May address residual thrombus to prevent SAT
• May reduce cost with only bolus strategy
• Aim: to assess the feasibility and safety aspects of the
perfusion catheter and its claim to improve no-reflow
phenomena after PCI
• Population: 30 patients with ACS who developed noreflow during subsequent PCI
• Primary end-point: normal TIMI 3 flow with myocardial
blush grade (MBG) ≥2 or an increase in TIMI flow by ≥2
grades with a MBG ≥2 after intracoronary drug infusion
via the CW catheter
Maluenda G et al, J Interven Cardiol 2010;23:109–113
0.6
Percentage
0.5
0.4
Pre CW use
0.3
Post CW use
0.2
0.1
Post CW use
0
0
1
Pre CW use
2
3
Maluenda G et al, J Interven Cardiol 2010;23:109–113
INFUSE-AMI Conclusions
In patients presenting early within the course of
large anterior STEMI undergoing primary PCI with
bivalirudin:
1. Bolus IC abciximab delivered via ClearWay Rx
catheter resulted in significant but modest reduction
in infarct size at 30 days
2. Manual aspiracion with 6F Export catheter did not
reduce MI size
3. The utility of combined aspiration + local delivery of
IC abciximab deserves further studies
CONCLUSIONS
• IC thrombus and no reflow phenomenon could
be devastating and should be treated promptly
• The main approaches is removal of debris with
aspiration catheters – well supported in STEMI
• Mesh stent appears to be an attractive
alternative to reduce distal embolization
• The local IC infusion of Gp IIb-IIIa is an easy,
safe and attractive approach, but more data is
required to prove the concept in AMI
Thank you!