Angioplastica coronarica nel paziente anziano ad alto rischio emorragico

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1 Attualità in Cardiologia Aprilia, Enea Hotel 22 ottobre 2011 Angioplastica coronarica nel paziente anziano ad alto rischio emorragico Fabrizio Tomai, MD, FACC, FESC Dept. of Cardiovascular Sciences - Interventional Cardiology Unit European Hospital-Aurelia Hospital-Roma

2 Società Italiana Cardiologia Invasiva Indication for PCI in Italy Year 2008: PCIs Stable CAD 61% PCIs 39% PCIs Acute Coronary Syndromes

3 High risk of bleeding in elderly patients undergoing PCI 1964 pts 10 CADILLAC Trial (30-d outcome) < 55 yrs yrs yrs 75 yrs % p < ,6 4,8 p <.005 3,6 4,1 6, ,8 1,7 1,2 0 p = ,2 0,2 0,4 Death Bleeding Stroke Guagliumi G. et al Circulation 2004

4 Impact of Major and Minor Bleeding on 1-Year Mortality after PCI 5,384 patients from 4 randomized trials (ISAR-REACT, SWEET, SMART-2 and REACT-2) on the value of abciximab after pretreatment with 600 mg of clopidogrel OR 4.75, 95% CI 3.34 to 6.76 p<0.001 Any bleeding Mortality (%) 10 5 No bleeding Months after randomization J Am Coll Cardiol 2008

5 Treatment of Elderly Pts With NSTEMI-ACS: Conservative or Invasive Therapy? Effect of Routine, Early Invasive Management on Outcome for Elderly pts with NSTE-ACS: 56% reduction of death/mi in 65 y with early invasive Cumulative Survival without MI * ** <65 y, early invasive <65 y, conservative 65 y, early invasive 65 y, conservative Time, d TACTICS TIMI 18 Inv. Ann Intern Med. 2004

6 The Italian Elderly ACS randomised trial: Results

7 PCI in elderly patients (high risk of bleeding) ü Anti-thrombotic therapy ü Vascular access ü Type of coronary stent ü Therapeutic strategy (co-morbidities)

8 TRITON TIMI 38: Bleeding Risk Subgroups Prior Stroke / TIA Yes No P int = Age 75 < 75 P int = 0.18 Wgt < 60 kg >=60 kg P int = 0.36 OVERALL Prasugrel Better Clopidogrel Better HR Wiviott SD et al. NEJM 2007

9 REPLACE 1: 1y mortality in high-risk subgroups p = p = p = p = ,9% $ 48% heparin + GPIIb/IIIa blocker Bivalirudin 7,1% $ 37% 3,6% 4,3% $ 33% 3,9% $ 41% 4,5% 2,9% 2,3% age >75 (N=795) age >65 (N=2489) Diabetes (N=1606) CrCl <60 (N=908) Lincoff AM et al JAMA 2004

10 ACUITY: Major Bleeding Endpoint (PCI Cohort) P= % 16% 14% 12% 10% 8% 6% 4% 2% 0% Hep + GPI Biv + GPI Biv alone P=0.010 P=0.033 P< P=0.007 P=0.001 P=NS P= < >=75 N=2052 N=2240 N=2121 Patient Age N=1376 Stone GW et al. NEJM 2006

11 ACUITY: Major Bleeding by Age Groups (PCI Cohort) Percentage (%) 80 Bleeding rate with Heparin + GPI Bleeding rate with Bivalirudin alone NNT ,6 4,3 5,6 6,3 1,7 2,9 4, Excluding patients with excess dose < With Bivaluridin alone Vs Heparin plus IIb/IIIa inhibitors to avoid 1 non- CABG Major Bleeding event among pts without excess dose Pts age (years) Lopes et al J Am Coll Cardiol 2009

12 ACUITY Major Bleeding: Radial vs Femoral Approch Endpoint Risk Ratio Radial (n=798) Femoral (n=11.988) OR (95%CI) Adjusted p value Net clinical outcome Ischemic composite 10.5% 11.1% 0.95( ) % 7.4% 1.10( ) 0.45 Major Bleeding 3.0% 4.8% 0.63( ) Radial better Femoral better

13 Type of stent and Duration of DAT THROMBOSIS BLEEDING ACC/AHA/SCAI Guidelines Pts be treated with DAT for 1 year after DES and at least 1 mo. after BMS, if not at high risk of bleeding (Class IB)

14 Premature Discontinuation of Antiplatelet Tx as Predictor of Stent Thrombosis 100 OR=89.8 ( ) HR=19.2 ( ) OR=4.8 ( ) HR=13.7 ( ) Odds/Hazard Ratio Iakovou et al. JAMA 2005 Park et al. Am J Card 2006 Kuchulakanti et al. Circulation 2006 Airoldi et al. Circulation 2007

15 Drug-Eluting Coronary Stents in Octogenarians 1-Year Analysis of the Worldwide e-select Registry (SES) 2.5% ST Octogenarian (675 pts) Stent Thrombosis and major bleeding risk (%) 2.0% 1.5% 1.0% 0.5% 0% MB Octogenarian ST Non-Octogenarian Time After Initial Procedure (days) MB: 2.0% vs 0.8% p=0.015 ST: 2.1% vs 0.9% p=0.002 At 1-y follow-up, a lower MB No-Octogenarian ( pts) proportion of octogenarians than nonoctogenarians were treated with DAT (73% vs 80% p= 0.001) Hong YJ et al JACC Intv 2011

16 New stent technology Bio-Engineered" Prohealing Stents Coronary Blood Flow Inflow EPC Enables Rapid Maturing and Endothelial Expressive Function Accelerated Differentiation Rolling Cell Surface Attachement and Uptake of Receptors Stent Surface

17 New stent technology. Biodegradable vs. durable polymer: effect of DAT discontinuation Overall Population Patient who d/c DAT 3,0 2,5 2,0 P = 0.73* 2,2 2,5 BES SES % 1,5 1,2 1,0 0,5 0,0 2 Y S T in LEADERS 0 0 ST after DAPT d/c < 12 M 0,6 N=0/154 N=2/163 N=0/484 N=3/479 ST after DAPT d/c > 12 M Klauss V et al. JACC Intv 2011

18 PCI in elderly patients at high risk of bleeding Conclusions ü Estimate bleeding vs. thrombotic risk ü Avoid new potent anti-platelet agents ü Select the appropriate coronary stent (taking in account the duration of DAT) ü Select the appropriate therapeutic strategy in the presence of co-morbidities and multilevel vascular disease