1. Strategies for Thrombus and No Reflow Management in the Cath Lab
Gabriel Maluenda, MD
Clinica Alemana, Santiago, Chile

2. I/we have no real or apparent conflicts of interest to report.
Gabriel Maluenda, MD
I/we have no real or apparent conflicts of interest to report.

3. 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]

4. MECHANISMS FOR NO REFLOW
Four interacting mechanisms (distal embolization, ischemia-related injury, reperfusion related injury, and individual susceptibility to microvascular injury) are responsible for no-reflow phenomenon. The individual contribution of these mechanisms to the pathogenesis of no-reflow is likely to vary in different patients.
Niccoli G et al, JACC 2009;54:281-92

5. Rezkalla SH, CCI 2008; 72:950–957

6. Aspiration Thrombectomy and distal protection devices8

7. TAPAS: Primary Endpoint – MBG
100%
0 or 1 2 3
90%
80%
p < 0.001
70%
60%
50%
46%
41%
37%
40%
32%
30%
26%
17%
20%
10% 0%
Thrombus Aspiration
Conventional PCI
Reduction of Thrombus Burden &/or Facilitation of Direct Stenting?
Svilaas T et al. NEJM 2008;358:557

8. TAPAS: Mortality at 1 Year12
Conventional PCI
Thrombus-Aspiration 10 8
Conventional PCI
Log-Rank p = 0.040 6
Mortality (%)
Thrombus Aspiration 4 2
100
200
300
400
Time (days)
Vlaar PJ et al, Lancet 2008; 371:

9. ATTEMPT: 11 Included Trials
REMEDIA
De Luca
PIHRATE
DIVER CE
MANUAL
ASPIRATION
DEAR-MI
PRONTO
EXPORT
EXPIRA
TAPAS
EXPORT
Antoniucci
ANGIOJET
2,686 Patients
X-SIZER
X-AMINE ST
NON-MANUAL
THROMBECTOMY
RESCUE
Kaltoft
Median Follow-Up: 365 Days
(significantly extended compared to published FU of included trials: 135 days)
TVAC
VAMPIRE
Burzotta, ESC 2009; Eur Heart J (18):

10. ATTEMPT: Impact of Type of Thrombectomy Device on Mortality
NON-MANUAL THROMBECTOMY TRIALS
MANUAL ASPIRATION TRIALS
Cumulative Survival
Cumulative Survival
100%
Thrombectomy
100%
Standard PCI
Thrombectomy
95%
p = 0.482
95%
Standard PCI
90%
90%
p = 0.011
85%
85%
Estimated NNT: 34
80%
80%
300
600
900
1200
300
600
900
1200
Time to Death (days)
Time to Death (days)
Burzotta, ESC 2009; Eur Heart J (18):

11. 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

12. To catch the thrombus – mesh covered stent strategy

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 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 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

15. Primary Endpoint: Complete ST-segment resolution
MGuard (n=204)
Control (n=206)
16.7%
17.0%
Difference [95%CI] = 13.2% [3.1, 23.3] P=0.008
44.7%
57.8%
25.5%
38.3%

16. 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

17. Intracoronary infusion of IIb-IIIa inhibitors19

18. Deibele AJ, et al. Circulation 2010;121:784-791.
Percent platelet GP IIb/IIIa RO during the bolus eptifibatide administration is demonstrated for the femoral vein and coronary sinus comparing the intravenous and intracoronary groups for bolus 1 and bolus 2
Deibele AJ, et al. Circulation 2010;121:

19. Cardiac Magnetic Resonance Substudy of the
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

20. Study Design, Flow, and Compliance
2065 patients enrolled and randomly assigned
No CMR (n=1270)
795 patients underwent CMR
394 assigned to intracoronary
abciximab
401 assigned to intravenous
abciximab
Incomplete CMR scan
- Scan terminated n=4
- T2 poor image quality n=39
- DE poor image quality n=7
Incomplete CMR scan
- Scan terminated n=3
- T2 poor image quality n=40
- DE poor image quality n=10
Analyzed CMR data
- LV function n=394
- T2-weighted imaging n=355
- DE imaging n=387
- MO n=384
- Hypointense core/Hemorrhage n=346
Analyzed CMR data
- LV function n=401
- T2-weighted imaging n=361
- DE imaging n=391
- MO n=390
- Hypointense core/Hemorrhage n=353

21. Area at Risk + Infarct Size50
Median [IQR]
35% [25, 48]
Median [IQR]
35% [26, 48]
Median [IQR]
16% [9, 25]
Median [IQR]
17% [8, 25] 40
p=0.97
p=0.52 30
Area at risk, %LV
Infarct size, %LV 20 10
IC abciximab
N=344
IV abciximab
N=354
IC abciximab
N=385
IV abciximab
N=389

22. Microvascular obstruction
Reperfusion Injury
Microvascular obstruction
Hemorrhage
IC abciximab
N=346
IV abciximab
N=353
32%
37%
Presence Hemorrhage, %
p=0.19
p=0.19
52%
47%
Presence MO, %
IC abciximab
N=384
IV abciximab
N=390

23. 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.

24. 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

25. 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 no-reflow 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

26. TIMI flow
Percentage
Maluenda G et al, J Interven Cardiol 2010;23:109–113

31. INFUSE-AMI Conclusions
In patients presenting early within the course of large anterior STEMI undergoing primary PCI with bivalirudin:
Bolus IC abciximab delivered via ClearWay Rx catheter resulted in significant but modest reduction in infarct size at 30 days
Manual aspiracion with 6F Export catheter did not reduce MI size
The utility of combined aspiration + local delivery of IC abciximab deserves further studies

32. 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

33. Thank you!