1. Francesco Burzotta HOTLINE III, ESC Congress 2007 September 4th 2007, Vienna OPTIMIST: the Outcome of Pci for stent-ThrombosIs MultIcentre STudy Institute of Cardiology, Policlinico A. Gemelli – Catholic University of the Sacred Heart (UCSC)

2. BACKGROUND AND RATIONALE FOR THE STUDY Stent thrombosis occurs in 1-2% of the pts treated by PCI with stent implantation Usage of drug-eluting stents (DES) in the real world practice might increase risk of stent thrombosis compared to bare metal stents (BMS) The most common management of pts with stent thrombosis is re-PCI There is lack of scientific data describing the angiographic and clinical outcome of PCI for stent thrombosis in the contemporary DES era

3. AIMS OF THE OPTIMIST STUDY TO COMPARE THE CLINICAL AND ANGIOGRAPHIC CHARACTERISTICS OF DES VS BMS THROMBOSIS TO EVALUATE THE EFFICACY OF THROMBECTOMY DEVICES DURING PCI FOR STENT THROMBOSIS TO ASSESS THE CLINICAL OUTCOME OF PCI FOR STENT THROMBOSIS

4. THE OPTIMIST STUDY DESIGN Non sponsored, multicentre registry S.Pietro FBF (Dr Belloni) S.Filippo Neri (Dr Pristipino) Pol. Gemelli (Prof. Crea, Dr Trani, Dr Romagnoli) S.Camillo (Dr Parma) S.Spirito (Dr Danesi) S.Eugenio (Dr Gioffrè) Pol. Umberto I (Dr Sardella) Pertini (Dr Rigattieri) Pol. Casilino (Dr Summaria) S.Carlo (Dr Mazzarotto) S.Giovanni (Dr. Manzoli)

5. Non sponsored, multicentre registry Burzotta et al, Am Heart J 2007 Enrolling during two years (2005-2006) all patients undergoing urgent PCI for angiographically-confirmed stent thrombosis The clinical outcome @ 30-day and @ 6-month (primary endpoints: death and MACCE) The angiographic outcome of PCI by an independent core-lab: Rome Heart Research, Dr Prati (primary end-points: TIMI 3+MBG 2-3 and MBG 3) TO ASSESS: THE OPTIMIST STUDY DESIGN

6. RESULTS PREVALENCE OF PCI FOR STENT THROMBOSIS

7. 12280* PCI with stenting 7318* PCI with DES (59.6%) OPTIMIST centres 4962* PCI with BMS (40.4%) *Official data of the Italian Society of Interventional Cardiology SICI-GISE 120 PCI for stent thrombosis in 110 patients 62 PCI for DES thrombosis 52 PCI for BMS thrombosis = = 0.85% 1.05% P=0.24 2484* urgent (primary or rescue) PCI for STEMI 89 (74%) STEMI NSTEMI UA = 3.6%

8. CHARACTERISTICS OF THE STUDY POPULATION Characteristics Males70% Age (yrs, mean+SD)66+12 Diabetes30% Renal Failure20% Anti-PTL therapy withdrawal <15 days10% Symptoms-to-PCI time (hrs, mean+SD)4+64+6 Cardiogenic Shock17% Type of thrombosed stent DES (SES, PES, other) BMS Unknown 50% (26%,14%,7%) 38% 12% Interval between PCI and stent thrombosis (days, mean+SD) 99+283 Left anterior descending artery (LAD)50% Pre-PCI TIMI 0-184%

9. DES vs BMS THROMBOSIS RESULTS

10. CharacteristicsDES (n=55) BMS (n=43) P Age (yrs+SD)63+1168+120.03 Diabetes40%19%0.02 Anti-PLT therapy withdrawal <15 days 15%2%0.04 LAD66%37%<0.001 Bifurcation27%7%0.01 Stent diameter2.8+0.43.0+0.50.04 DES VS BMS: BASELINE CHARACTERISTICS

11. CharacteristicsDES (n=55) BMS (n=43) P Age (yrs+SD)63+1168+120.03 Diabetes40%19%0.02 Anti-PLT therapy withdrawal <15 days 15%2%0.04 LAD66%37%<0.001 Bifurcation27%7%0.01 Stent diameter2.8+0.43.0+0.50.04 DES VS BMS: BASELINE CHARACTERISTICS

12. 1-30 days0-24 hrs> 1 year31-365 days ACUTESUBACUTELATEVERY LATE % DES BMS DES VS BMS: TYPES OF THROMBOSIS

13. DES BMS <30 days> 30 days LATE or VERY LATE % P=0.03 ACUTE or SUBACUTE DES VS BMS: TYPES OF THROMBOSIS

14. OUTCOME OF PCI FOR STENT THROMBOSIS RESULTS

15. PROCEDURAL CHARACTERISTICS PCI STRATEGY Balloon dilation95% Thrombectomy30% Stent implantation -DES -BMS 45% 20% 25% ANGIOGRAPHIC OUTCOME TIMI 3 TIMI 2 TIMI 0-1 73% 15% 12% Residual Stenosis (mean+SD)18+26% MBG 3 MBG 2 MBG 0-1 49% 27% 24%

16. PCI FOR STENT THROMBOSIS: CLINICAL OUTCOME 30-day6-month Death12%16% Non-fatal Mycardial infarction7%11% Target Lesion Revasc.13%17% Stroke1% MACCE21%29%

17. DES VS BMS: OUTCOME AFTER THROMBOSIS DES BMS no death no MACCE % 0 20 40 60 80 100 1 mo.6 mo.12 mo.

18. OR (95%CI) for 6-month mortality in MULTIVARIATE analysis PREDICTORS OF OUTCOME IN PCI FOR STENT THROMBOSIS VERY LATE THROMBOSIS 10.0 (1.2-85.7) OTHER IMPLANTED STENT DURING PCI 5.4 (1.3-22.8) POST-PCI MBG 2-3 0.3 (0.1-0.9) 21 0 43658791110 increased mortality

19. THROMBECTOMY DURING PCI FOR STENT THROMBOSIS RESULTS

20. BY INTENTION TO TREAT PCI FOR STENT THROMBOSIS: USE OF THROMBECTOMY Selection of devices according to the operator’s preference STANDARD PCI in 83 pts (75%) THROMBECTOMY in 27 PTS (25%) > Longer time-to-treatment > Females > STEMI > Inotropic drugs pre-PCI pre-PCI risk features > Large vessels Angiojet Angiojet (7,5%) Diver CE Diver CE (48.1%) Export Export (44.4%)

21. ANGIOGRAPHIC RESULTS OF THROMBECTOMY TIMI 3 + MBG 2/3MBG 3Thrombectomy Standard PCI % 76% 61% 52% 46% Pts without Shock (n=81) % 89% 61% 46% P=0.027P=0.18

22. CONCLUSIONS 1. Urgent PCI is needed for both DES and BMS thrombosis and represents 3.6% of the urgent PCI for STEMI 2. PCI for stent thrombosis is associated with a high rate of major adverse events, especially in pts with very late thrombosis 3. DES thrombosis, compared to BMS, shows different clinical features (late or very late presentation, association with anti-PLT therapy withdrawal) but similar long term outcome 4. During PCI for stent thrombosis, implantation of other stents should be avoided. Mechanical thrombectomy is feasible and should be reserved to pts without haemodynamic instability In the contemporary DES era…

23. Thank you for your attention