Th b A i ti D i Pi P t C It ti J. Am. Coll. Cardiol. 2009;53;309-315 Thrombus Aspiration During Primary Percutaneous Coronary Intervention Improves Myocardial Reperfusion and Reduces Infarct Size: The EXPIRA (Thrombectomy With Export Catheter in Infarct-Related Artery During (Thrombectomy With Export Catheter in Infarct-Related Artery During Primary Percutaneous Coronary Intervention) Prospective, Randomized Trial Gennaro Sardella, Massimo Mancone, Chiara Bucciarelli-Ducci, Luciano Agati, Raffaele Scardala Iacopo Carbone Marco Francone Angelo Di Roma Raffaele Scardala, Iacopo Carbone, Marco Francone, Angelo Di Roma, Giulia Benedetti, Giulia Conti, and Francesco Fedele O.U. of Invasive Cardiology, Dept. of Cardiovascular Sciences *Dept.of Radiology Dip.di SCIENZE CARDIOVASCOLARI POLICLINICO UMBERTO I Policlinico Umberto I - University “La Sapienza ROME
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Th b A i ti D i P i P t C I t ti
J. Am. Coll. Cardiol. 2009;53;309-315
Thrombus Aspiration During Primary Percutaneous Coronary Intervention
Improves Myocardial Reperfusion and Reduces Infarct Size: The EXPIRA(Thrombectomy With Export Catheter in Infarct-Related Artery During(Thrombectomy With Export Catheter in Infarct-Related Artery During Primary Percutaneous Coronary Intervention) Prospective, Randomized Trial
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
BackgroundMicroembolization during Primary PCI
In the AMI setting the “ no-flow”gphenomenon is caused by the distal embolization after the IRAOOPS!!reopening.
This common complication is associated with poor perfusion
Embolism after IRA reopening
p pand high mortality.
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
Embolism after IRA reopening
M di l P f i Aft P i PCI i St t
BackgroundMyocardial Perfusion After Primary PCI is Strongest
Predictor of Mortality independently from IRA reopeningFinal Blush Score (patients withFinal Blush Score (patients with
PPCI Hardest point
100100
Final Blush Score (patients with Final Blush Score (patients with final TIMI 3 flow)final TIMI 3 flow)
9090
959533
viva
l(%
)
8585
9090
22
lativ
e S
urv
“ Open Artery ...but Closed M ocardi m !!
80800/10/1
Cum
u Blush 1Blush 1--Year MortalityYear Mortality3322
6.8%6.8%13.2%13.2% PP=0.004=0.004
Closed Myocardium !!
00 22 44 66 88 1010 12127575
0/10/1 18.3%18.3%
Stone GW et alStone GW et al J Am Coll CardiolJ Am Coll Cardiol 2002;39:5912002;39:591 597597
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
Stone GW, et al. Stone GW, et al. J Am Coll Cardiol.J Am Coll Cardiol. 2002;39:5912002;39:591--597.597.
( Courtesy of M.Gibson)
BackgroundAcute anterior MI post PCI
MicrovascularMicrovascular obstruction obstruction valued valued by by CeCe--MRI MRI predicts significantly increased rate of predicts significantly increased rate of
ii f Af A
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
cardiovascular cardiovascular adverse events adverse events after AMIafter AMI(Wu (Wu KC, et al. KC, et al. Circulation 1998;97:765)Circulation 1998;97:765)
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI
( EXPIRA Trial )
256 pts. (STEMI, at 6.8 ± 2.3 h from symptoms onset)
175 pts eligible for 1:1p , ,double-arm, mono-centric study.
Primary end-point :
p , ,double-arm, mono-centric study.
Primary end-point :
81 pts.excluded:Cardiogenic shock
3-vessel / Left Main
175 pts. eligible for 1:1 randomization
(Heparin 7.500 U/I, GPIIb/IIIa, A i i Cl id l 300 )Final MBG ≥ 2 ;
90’ ST resolution(> 70% decrease of ST segment after PCI)
Final MBG ≥ 2 ; 90’ ST resolution
(> 70% decrease of ST segment after PCI)
TIMI >0-1
TS < 3
Contra to GPIIb/IIIa
Aspirin, Clopidogrel 300 mg)
Secondary end-point :MACE at 9 month clinical f-u
Secondary end-point :MACE at 9 month clinical f-u
88 pts randomized to
87 pts randomized to
Principal investigatorG.Sardella MD
Principal investigatorG.Sardella MD
Thrombectomy + PCI
Standard PCI
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
9 months clinical f-u
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI
( EXPIRA Trial ).
Procedural Results MYOCARDIAL BLUSH GRADE
* <0 0001
( )
90100
*p=<0.0001
607080
MBG 3%
28.7*
70 3*
30405060 MBG 3
MBG 2MBG 0/1
% 70.3
102030
39.5*
11 8*0
Basal Final Basal Post-Thr. Final
CONVENTIONALPost- POBA
11.8*
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
EXPORT GROUPCONVENTIONALGROUP
(G.Sardella et al ,TCT 2007)
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI
( EXPIRA Trial ).
90’ ST resolution after PCI (%)( > 70% decrease of ST segment)( g )
p=<0.01100 OR 6.36
708090 (95% CI 3.23-12.50)
%4050600
80.0
203040
37.5
EXPORTCONVENTIONAL
010
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
EXPORTGROUP
CONVENTIONALGROUP
(G.Sardella et al ,TCT 2007)
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on procedural and clinical outcome in patients with AMI
( EXPIRA Trial )
9 months Composite Cardiac Event Rates
( EXPIRA Trial ).
10,312 p=ns
Event Rates
8
10
Pt %
p=0.059
4,6 4 56
8
CONTR.EXPORT
Pts %
4,6 4,5
4EXPORT
00
2
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
0DEATH MACE
(G.Sardella et al ,TCT 2007)
Aim of the Study
We sought to evaluate the impact of thromboaspiration onWe sought to evaluate the impact of thromboaspiration onprocedural and long term outcomes in terms of microasculardamage and infarct size by contrast enhanced-MRI (ce-MRI) as
E t® i ti th t (M dt i Mi li Mi t )
damage and infarct size by contrast enhanced MRI (ce MRI) ascompared to conventional primary PCI.
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
Left Ventricular Motion
ConclusionIn this study Thrombectomy has been demonstrated to be safe and effective
in AMI setting during Primary PCI.
Compared with conventional stenting, in patients with intracoronary visibleand occlusive thrombus, pretreatment with manual aspiration thrombectomyduring primary PCI improves acutely the parameters of myocardial tissueperfusion and ST resolution in a well selected population.
MRI long term evaluation showed a reduction of microvascular damage inthe Thrombectomy group compared with the Control groupthe Thrombectomy group compared with the Control group.
In the Thrombectomy group setting resulted a reduction of microvasculardamage and infarct size in long term compared with acute evaluationdamage and infarct size in long term compared with acute evaluation.
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I
Dip.di SCIENZE CARDIOVASCOLARIPOLICLINICO UMBERTO I