G.SARDELLA Dip.di SCIENZE CARDIOVASCOLARI POLICLINICO UMBERTO I GENNARO SARDELLA, MD, FACC ,FESC O.U. of Invasive Cardiology, Dept. of Cardiovascular Sciences Policlinico Umberto I “Sapienza “ University of ROME Impact of Thrombectomy with EXPort catheter in Infarct Related Artery during Primary PCI on Procedural Outcome in patients with AMI (EXPIRA Trial). 24 Months Clinical Outcome Gennaro Sardella, Massimo Mancone, Emanuele Canali, Rocco Stio, Luigi Lucisano, Angelo Di Roma, Giulia Benedetti, Luciano Agati, Francesco Fedele
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery during Primary PCI on Procedural Outcome in patients with AMI (EXPIRA Trial). 24 Months Clinical Outcome. - PowerPoint PPT Presentation
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G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
GENNARO SARDELLA, MD, FACC ,FESC
O.U. of Invasive Cardiology, Dept. of Cardiovascular SciencesPoliclinico Umberto I
“Sapienza “ University of ROME
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery during Primary PCI on Procedural Outcome in patients with AMI (EXPIRA Trial). 24 Months Clinical Outcome
Gennaro Sardella, Massimo Mancone, Emanuele Canali, Rocco Stio, Luigi Lucisano, Angelo Di Roma, Giulia Benedetti, Luciano Agati, Francesco Fedele
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
No relationship to disclose
GENNARO SARDELLA MD
FINANCIAL DISCLOSURE:
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery during Primary PCI on Procedural Outcome in patients with AMI (EXPIRA Trial). 24 Months Clinical Outcome
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
In STEMI the “ no-flow” phenomenon is caused by the distal embolization after the IRA reopening.
OOPS!!
Distal embolization during Primary PCI
No DE n = 167 (86.1%)
DE n = 27
(13.9%)
P Value
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
(Henriques JPS et al Eur H J 2002:23-1112-17)
No DEDE
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
Myocardial Perfusion After Primary PCI is the Strongest
Predictor of Mortality independently from IRA reopening
8080
8585
9090
9595
33
22
0/10/1
100100
Cu
mu
lati
ve S
urv
ival
(%
)
00 22 44 66 88 1010 12127575
Final Blush Score (patients Final Blush Score (patients with final TIMI 3 flow)with final TIMI 3 flow)
Blush 1-Year MortalityBlush 1-Year Mortality
3322
0/10/1
6.8%6.8%13.2%13.2%18.3%18.3%
PP=0.004=0.004
Stone GW, et al. Stone GW, et al. J Am Coll Cardiol.J Am Coll Cardiol. 2002;39:591-597. 2002;39:591-597.
Background
“ Open Artery ...but Closed Myocardium “!!
PPCI Hardest Goal
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
Role of Adjunctive Mechanical Device in STEMI A comprehensive meta-analysis 11 Randomized Clinical Trial
N= 2686 pts
MANUAL ASPIRATION TRIALS
300 days 600 days 900 days 1200 days
80%
85%
90%
95%
100%CUMULATIVE SURVIVAL
Estimated number of pts to treat to save 1
life: 34
P= 0.011
(Burzotta F.,De Vita M.,LeFevre T,Dudek D.,Sardella G. et al EHJ Sept.2 , 2009 )
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery during Primary PCI on Procedural Outcome in patients with
AMI (EXPIRA Trial). 24 Months Clinical Outcome
Relation between Final Myocardial Blush Grade and Cardiac Death and MACE at 2-years follow-up.
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
Cardiac death (%) 0.9 7.3 0.023MACE (%) 3.7 17.6 0.002
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery during Primary PCI on Procedural Outcome in patients with
AMI (EXPIRA Trial). 24 Months Clinical Outcome
Relation between % ST-segment resolution and Cardiac Death and MACE at 2-years follow-up.
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
In our experience Thrombectomy during Primary PCI has been demonstrated to be safe and effective improving myocardial perfusion and reducing infarct size .
In this study a very long term follow-up (>1 year) was assessed in the setting of primary PCI treated with adjunctive manual thrombectomy.
A pretreatment with manual thrombectomy results in a lower cardiac mortality and a lower incidence of other MACEs at 2-year follow-up than conventional therapy alone.
We observed that the occurrence of cardiac death and MACE is significantly related to final MBG and ST-segment resolution .
The major limitations of our study are the limited number of patients and that was not powered to investigate the magnitude of the effect of thrombus aspiration on hard MACE that requests more powered RCT’s.
Conclusion
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
Thank You !
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
In our experience Thrombectomy has been demonstrated to be safe and effective in AMI setting during Primary PCI.
Compared with conventional stenting, in patients with intracoronary visible and occlusive thrombus, pretreatment with manual aspiration thrombectomy during primary PCI improves acutely the parameters of myocardial tissue perfusion and ST resolution in a well selected population.
The difference observed in term of Systolic Strain between the two groups suggest a rapid and better segmental function recovery in pts treated with Thrombectomy.
These data also confirm that Systolic Strain after primary PCI could be useful to evaluate if primary percutaneus reperfusion has been effective in terms of function recovery.
Conclusion
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
Conclusion and Limits of the Study For the first time a very long term follow-up (>1 year) was assessed in the setting of primary PCI treated with adjunctive manual thrombectomy. The main finding of the present study is that a pre-treatment with manual thrombectomy during primary PCI results in a lower cardiac mortality and a lower incidence of other MACEs at 2-year follow-up than conventional therapy alone. Our findings are in agreement with the results of the recently published single-centre TAPAS trial and the ATTEMPT study, the benefit of improved myocardial reperfusion seen in the EM-PCI resulted in a significant improvement of long term clinical outcome. We observed that the occurrence of cardiac death and of MACE is significantly related to final MBG and ST-segment resolution as previously reported. Our Study represents a single-center experience with a limited number of patients. EXPIRA was designed to detect differences in myocardial reperfusion and it was not powered to investigate the magnitude of the effect of thrombus aspiration on clinical outcome. Nevertheless Kaplan Meier analysis showed a reduced mortality in patients randomized to manual thormbectomy with a mortality reduction of 88% (HR 0.12) at multivariate analysis.
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
Thank You !
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I
0
2
4
6 Adjunctive D.
PCI alone
2.7 2.8
4.4
5.3
3.13.4
p = 0.0018
p = 0.05
p = 0.69
30-d
ay m
orta
lity
(%)
Mechanical Thrombectomy
Manual Aspiration
Embolic Protection
Role of Adjunctive Mechanical Device in STEMI A comprehensive meta-analysis 9 Randomized Clinical Trial N= 2417 pts
G.SARDELLADip.di SCIENZE CARDIOVASCOLARI
POLICLINICO UMBERTO I (G.Sardella et al J. Am. Coll. Cardiol 2009;53;309-315 )
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI