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OPTIMIST: the Outcome of Pci for stent-ThrombosIs MultIcentre STudy. Francesco Burzotta. Institute of Cardiology, Policlinico A. Gemelli – Catholic University of the Sacred Heart (UCSC). HOTLINE III, ESC Congress 2007 September 4th 2007, Vienna. BACKGROUND AND RATIONALE FOR THE STUDY.
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OPTIMIST: the Outcome of Pci for stent-ThrombosIs MultIcentre STudy Francesco Burzotta Institute of Cardiology, Policlinico A. Gemelli –Catholic University of the Sacred Heart (UCSC) HOTLINE III, ESC Congress 2007September 4th 2007, Vienna
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
AIMS OF THE OPTIMIST STUDY TO COMPARE THE CLINICAL AND ANGIOGRAPHIC CHARACTERISTICS OF DES VS BMS THROMBOSIS TO ASSESS THE CLINICAL OUTCOME OF PCI FOR STENT THROMBOSIS TO EVALUATE THE EFFICACY OF THROMBECTOMY DEVICES DURING PCI FOR STENT THROMBOSIS
Pol. Gemelli (Prof. Crea, Dr Trani, Dr Romagnoli) S.Pietro FBF (Dr Belloni) S.Filippo Neri (Dr Pristipino) S.Carlo (Dr Mazzarotto) S.Giovanni (Dr. Manzoli) S.Camillo (Dr Parma) S.Spirito (Dr Danesi) S.Eugenio (Dr Gioffrè) Pol. Umberto I (Dr Sardella) Pertini (Dr Rigattieri) Pol. Casilino (Dr Summaria) THE OPTIMIST STUDY DESIGN Non sponsored, multicentre registry
THE OPTIMIST STUDY DESIGN Non sponsored, multicentre registry Enrolling during two years (2005-2006) all patients undergoing urgent PCI for angiographically-confirmed stent thrombosis TO ASSESS: 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) Burzotta et al, Am Heart J 2007
RESULTS PREVALENCE OF PCI FOR STENT THROMBOSIS
2484* urgent (primary or rescue) PCI for STEMI 89 (74%) STEMI UA NSTEMI = = = 1.05% 0.85% 3.6% PREVALENCE OF PCI FOR STENT THROMBOSIS OPTIMIST centres 12280* PCI with stenting 4962* PCI with BMS (40.4%) 7318* PCI with DES (59.6%) 52 PCI for BMS thrombosis 62 PCI for DES thrombosis P=0.24 120 PCI for stent thrombosis in 110 patients *Official data of the Italian Society of Interventional Cardiology SICI-GISE
RESULTS DES vs BMS THROMBOSIS
% DES BMS 0-24 hrs 1-30 days 31-365 days > 1 year ACUTE SUBACUTE LATE VERY LATE DES VS BMS: TYPES OF THROMBOSIS
DES VS BMS: TYPES OF THROMBOSIS P=0.03 % DES BMS <30 days > 30 days ACUTE or SUBACUTE LATE or VERY LATE
RESULTS OUTCOME OF PCI FOR STENT THROMBOSIS
% 100 80 60 40 20 0 1 mo. 6 mo. 12 mo. DES VS BMS: OUTCOME AFTER THROMBOSIS DES BMS no death no MACCE
10.0 (1.2-85.7) VERY LATE THROMBOSIS 5.4 (1.3-22.8) OTHER IMPLANTED STENT DURING PCI 0.3 (0.1-0.9) POST-PCI MBG 2-3 1 2 3 4 5 6 7 8 9 10 11 0 increased mortality PREDICTORS OF OUTCOME IN PCI FOR STENT THROMBOSIS OR (95%CI) for 6-month mortality in MULTIVARIATE analysis
RESULTS THROMBECTOMY DURING PCI FOR STENT THROMBOSIS
BY INTENTION TO TREAT STANDARD PCI in 83 pts (75%) THROMBECTOMY in 27 PTS (25%) Angiojet(7,5%) pre-PCI risk features Export(44.4%) > STEMI > Longer time-to-treatment > Inotropic drugs pre-PCI > Females Diver CE(48.1%) > Large vessels PCI FOR STENT THROMBOSIS: USE OF THROMBECTOMY Selection of devices according to the operator’s preference
TIMI 3 + MBG 2/3 MBG 3 % 76% 61% 52% 46% % Pts without Shock (n=81) P=0.027 P=0.18 89% 61% 61% 46% ANGIOGRAPHIC RESULTS OF THROMBECTOMY Thrombectomy Standard PCI
CONCLUSIONS In the contemporary DES era… 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