ATTEMPT study: pooled-Analysis of Trials on ThrombEctomy in acute Myocardial infarction based on individual PatienT data CLINICAL TRIAL UPDATE III ESC Congress 2009 September 2 nd 2009, Barcelona FRANCESCO BURZOTTA INSTITUTE OF CARDIOLOGY CATHOLIC UNIVERSITY OF THE SACRED HEART ROME, ITALY

ATTEMPT STUDY GROUP Maria De Vita Co-Principal Investigator 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 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 search 12 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 NCT

INCLUDED TRIALS X-AMINE ST X-SIZER Antoniucci ANGIOJET NON-MANUAL THROMBECTOMY TVAC VAMPIRE RESCUE Kaltoft MANUAL ASPIRATION REMEDIA DIVER CE PIHRATE De Luca PRONTO DEAR-MI EXPORT TAPAS EXPORT EXPIRA 2686 pts Median FU available for ATTEMPT study: 365 days (significantly extended compared to published median FU of included trials: 135 days)

300 days600 days900 days1200 days TIME TO DEATH 80% 85% 90% 95% 100% CUMULATIVE SURVIVAL Standard PCI Thrombectomy PRIMARY END-POINT P= No previous report on outcome >1 year Absolute Risk Reduction: 1.6% Relative Risk Reduction: 29%

SECONDARY END-POINTS Thrombectomy betterStandard PCI better MI OR 0.72 ( ); P= 0.13 TVR OR 0.87 ( ); P= 0.27 Death or MI OR 0.70 ( ); P= 0.02 MACE OR 0.80 ( ); P= 0.03

TYPE OF THROMBECTOMY MANUAL ASPIRATION TRIALS NON- MANUAL THROMBECTOMY TRIALS Estimated number of pts to treat to save 1 life: 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= 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

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