attempt study: pooled-analysis of trials on thrombectomy in acute myocardial infarction based on...
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ATTEMPT study: pooled-Analysis of Trials on ThrombEctomy in acute Myocardial infarction based on
individual PatienT data
CLINICAL TRIAL UPDATE IIIESC Congress 2009
September 2nd 2009, Barcelona
FRANCESCO BURZOTTAINSTITUTE OF CARDIOLOGY
CATHOLIC UNIVERSITY OF THE SACRED HEARTROME, ITALY
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ATTEMPT STUDY GROUP
Maria De VitaCo-Principal Investigator
Youlan GuTakaaki IsshikiThierry Lefèvre
Anne KaltoftDariusz Dudek
Gennaro SardellaPedro Silva Orrego
David AntoniucciLeonardo De Luca
Giuseppe GL Biondi-Zoccai
Filippo CreaFelix Zijlstra
Co-investigators
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BACKGROUND(
1)
Van’t Hof, Lancet 1997
No reflow occurs frequently during PCI in STEMI and is associated with reduced survival
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BACKGROUND(
2)Randomized trials showed that the adjunct of thrombectomy, but not distal protection, reduces the risk of no-reflow as compared to standard PCI in STEMI patients
Risk of failure to achieve ST-resolution
Burzotta et al, Int J Cardiol 2007
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AIM OF THE STUDY
TO ASSESS IF THROMBECTOMY IS ASSOCIATED WITH IMPROVED
CLINICAL OUTCOME COMPARED TO STANDARD PCI
BY POOLING THE INDIVIDUAL PATIENT DATA OF PROSPECTIVE RANDOMIZED
TRIALS
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SAMPLE SIZING
The rate of post-procedural MBG 3 was reported to be higher in the thrombectomy group with an OR estimate of 2.3 (Burzotta et al., Int J
Cardiol 2007).
Long-term total mortality rate has been reported to be 3% in patients with post-PCI myocardial blush grade (MBG) 3 and of 29% in patients
with post-PCI MBG < 3 (van ‘t Hof et al., Circulation 1998).
A sample size of 1350 patients (675 for each arm) was calculated to be needed to demonstrate, with an alpha risk of 5% and a beta risk of 20%, a survival advantage at one year using thrombectomy compared to standard
PCI
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STUDY DESIGN*
EuroPCR and TCT web-site search
MEDLINE search12 trials 5 trials
17 trials
Principal investigators (PIs) have been contacted to provide data regarding the patients included in their study
PIs of 11 trials agreed to participate the ATTEMPT DATABASE
(patients pre-PCI characterictics and longest available clinical FU)
* Published as full paper (De Vita et al, Vasc Health and Risk Management 2009)* Registered in clinicaltrials.org website NCT00766740
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INCLUDED TRIALS
X-AMINEST
X-SIZERX-SIZER
AntoniucciANGIOJETANGIOJET
NO
N-M
AN
UA
L
TH
RO
MB
EC
TO
MY
TVACTVAC VAMPIRE
RESCUERESCUE Kaltoft
MA
NU
AL
AS
PIR
ATIO
N REMEDIADIVER CEDIVER CE PIHRATEDe Luca
PRONTOPRONTO DEAR-MI
EXPORTEXPORT TAPASEXPORT EXPIRA
2686 ptsMedian FU available for
ATTEMPT study: 365 days (significantly extended compared to
published median FU of included trials: 135 days)
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300 days 600 days 900 days 1200 days
TIME TO DEATH
80%
85%
90%
95%
100%
CU
MU
LA
TIV
E
SU
RV
IVA
L
Standard PCI
Thrombectomy
PRIMARY END-POINT
P= 0.049
No previous report on outcome >1 year
Absolute Risk Reduction: 1.6%Relative Risk Reduction: 29%
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SECONDARY END-POINTS
Thrombectomy better Standard PCI better
0.50 21 3
MI OR 0.72 (0.47-1.10); P= 0.13
TVR OR 0.87 (0.67-1.13); P= 0.27
Death or MI OR 0.70 (0.52-0.93); P= 0.02
MACE OR 0.80 (0.65-0.98); P= 0.03
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TYPE OF THROMBECTOMY
MANUAL ASPIRATION TRIALS
NON- MANUAL THROMBECTOMY TRIALS
Estimated number of pts to treat to
save 1 life: 34
300 days
600 days
900 days
1200 days
80%
85%
90%
95%
100%CUMULATIVE SURVIVAL
300 days
600 days
900 days
1200 days
80%
85%
90%
95%
100%CUMULATIVE SURVIVAL
P= 0. 48 P= 0.011
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PRE-PCI SUBGROUPS
Thrombectomy betterStandard PCI better
Risk of death
DIABETES
IIb/IIIa INHIBITORS
TIME TO REPERFUSION
INFARCT RELATED ARTERY
TIMI FLOW
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Thrombectomy ± IIb/IIIa inhibitors
7.4%
5.0% 4.8%
3.3%
IIb/IIIa inhib -Thrombectomy -
IIb/IIIa inhib +Thrombectomy -
IIb/IIIa inhib –Thrombectomy +
IIb/IIIa inhib +Thrombectomy +
4%
2%
8%
6%
MORTALITY
P=0.02
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CONCLUSIONS
The present pooled analysis of individual patient data from 11 STEMI trials shows that:
- Thrombectomy (in particular when performed by manual thrombectomy catheters) improves survival
- Thrombectomy and IIb/IIIa inhibitors may synergistically improve the clinical outcome
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Available now online from European Heart Journal
http://eurheartj.oxfordjournals.org/cgi/content/full/ehp348
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For further slides on these topics please feel free to visit the metcardio.org website:
http://www.metcardio.org/slides.html