Transcript Diapositiva 1 - metcardio.org

ATTEMPT study: pooled-Analysis of Trials on
ThrombEctomy in acute Myocardial infarction
based on individual PatienT data
FRANCESCO BURZOTTA
INSTITUTE OF CARDIOLOGY
CATHOLIC UNIVERSITY OF THE SACRED HEART
ROME, ITALY
CLINICAL TRIAL UPDATE III
ESC Congress 2009
September 2nd 2009, Barcelona
ATTEMPT STUDY GROUP
Co-Principal Investigator
Co-investigators
Maria De Vita
Youlan Gu
Takaaki Isshiki
Thierry Lefèvre
Anne Kaltoft
Dariusz Dudek
Gennaro Sardella
Pedro Silva Orrego
David Antoniucci
Leonardo De Luca
Giuseppe GL Biondi-Zoccai
Filippo Crea
Felix Zijlstra
BACKGROUND(1)
No reflow occurs frequently during PCI in STEMI and is associated
with reduced survival
Van’t Hof, Lancet 1997
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
STresolution
Burzotta et al, Int J Cardiol 2007
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
SAMPLE SIZING
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 postPCI MBG < 3 (van ‘t Hof et al., Circulation 1998).
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).
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
STUDY DESIGN*
MEDLINE search
12 trials
17 trials
5 trials
EuroPCR and TCT
web-site search
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
NON-MANUAL
THROMBECTOMY
MANUAL
ASPIRATION
INCLUDED TRIALS
DIVER CE
REMEDIA
PRONTO
DEAR-MI
EXPORT
EXPORT
ANGIOJET
Antoniucci
X-SIZER
RESCUE
TVAC
X-AMINE
ST
Kaltoft
VAMPIRE
De Luca
PIHRATE
EXPIRA
TAPAS
2686 pts
Median FU available for
ATTEMPT study: 365 days
(significantly extended compared to published
median FU of included trials: 135 days)
PRIMARY END-POINT
CUMULATIVE SURVIVAL
100%
P= 0.049
Thrombectomy
95%
Standard PCI
90%
85%
Absolute Risk Reduction: 1.6%
Relative Risk Reduction: 29%
80%
No previous report on outcome >1 year
300 days
600 days
900 days
TIME TO DEATH
1200 days
SECONDARY END-POINTS
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
0
0.5
Thrombectomy better
1
2
3
Standard PCI better
TYPE OF THROMBECTOMY
NON- MANUAL THROMBECTOMY
TRIALS
MANUAL ASPIRATION
TRIALS
CUMULATIVE SURVIVAL
CUMULATIVE SURVIVAL
100%
100%
95%
95%
90%
90%
P= 0. 48
P= 0.011
85%
85%
80%
80%
300
days
600
days
900
days
1200
days
Estimated number of
pts to treat to save
1 life: 34
300
days
600
days
900
days
1200
days
PRE-PCI SUBGROUPS
Risk of death
DIABETES
IIb/IIIa
INHIBITORS
TIME TO
REPERFUSION
INFARCT RELATED
ARTERY
TIMI FLOW
Thrombectomy better Standard PCI better
Thrombectomy ± IIb/IIIa inhibitors
MORTALITY
8%
7.4%
P=0.02
6%
5.0%
4.8%
4%
3.3%
2%
IIb/IIIa inhib
Thrombectomy
-
IIb/IIIa inhib
Thrombectomy
+
-
IIb/IIIa inhib
Thrombectomy
–
+
IIb/IIIa inhib
Thrombectomy
+
+
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
Available now online from European Heart Journal
http://eurheartj.oxfordjournals.org/cgi/content/full/ehp348
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