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

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

BACKGROUND(

1)

Van’t Hof, Lancet 1997

No reflow occurs frequently during PCI in STEMI and is associated with reduced survival

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

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

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

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

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)

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%

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

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

PRE-PCI SUBGROUPS

Thrombectomy betterStandard PCI better

Risk of death

DIABETES

IIb/IIIa INHIBITORS

TIME TO REPERFUSION

INFARCT RELATED ARTERY

TIMI FLOW

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

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

For further slides on these topics please feel free to visit the metcardio.org website:

http://www.metcardio.org/slides.html