Quando rivascolarizzare il paziente anziano con stenosi coronariche paucisintomatiche

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1 Quando rivascolarizzare il paziente anziano con stenosi coronariche paucisintomatiche Fabrizio Tomai, MD, FCC, FESC Dept. Cardiovascular Sciences Interventional Cardiology Unit European Hospital - urelia Hospital Rome, Italy

2 Treatment of Elderly Pts with Stable Coronary rtery Disease: Conservative or Invasive Therapy? Elderly patients (>75 yrs) represent 9.3% of the italian population (5,4 millions) (ISTT 31/12/06) Elderly patients exhibit an higher risk profile with a TIMI risk score > 3-4 nel 92% of patients older than 65 yrs (TCTICS-TIMI 18 trial) 30% of patients with CS admitted to our CCUs had > 75 yrs (Blitz study) In the majority of randomized clinical trials comparing conservative and invasive strategies in patients with CD, age>75 years is an exclusion criteria

3 Società Italiana Cardiologia Invasiva Italian Society of Interventional Cardiology GISE Data Base Number of PCIs

4 Indication for PCI in Italy Year 2008: PCIs Stable CD 61% PCIs 39% PCIs cute Coronary Syndromes

5 Indication for PCI in Italy Year 2008: PCIs Stable CD 61% PCIs 39% 39% PCIs PCIs PCIs in >70yrs cute Coronary Syndromes

6 PCI vs Medical Therapy for Stable Coronary Disease Clinical Outcomes Utilizing Revascularization and ggressive Drug Evaluation (COURGE) trial Overall Survival 1 0,9 0,8 0,7 0,6 0,5 HR, 0.87; 95% CI ( ); p=0.38 PCI Medical Therapy N= Years Boden WE, et al. N Engl J Med 2007

7 PCI vs Medical Therapy for Stable Coronary Disease Clinical Outcomes Utilizing Revascularization and ggressive Drug Evaluation (COURGE) trial 30 % 25 Elderly (pre-specified subgroup analysis) OMT<65y (693) PCI<65y (688) OMT>65y (444) PCI>65y (460) p=0.51 p= p=0.11 * p=0.97 p=0.44 p=0.48 * p=0.93 p=0.86 p=0.83 p= Death MI Death/MI Death/MI/stroke CS * p<0.001 for incidence of death and MI in older pts compared with younger pts Teo K K et al. JCC 2009

8 PCI vs Medical Therapy for Stable Coronary Disease Clinical Outcomes Utilizing Revascularization and ggressive Drug Evaluation (COURGE) trial 30 Elderly (pre-specified subgroup analysis) OMT>65y (444) PCI>65y (460) p=0.51 p= p=0.97 p=0.48 p= Death MI Death/MI Death/MI/stroke CS Teo K K et al. JCC 2009

9 Co-existing Vascular Disease: a common finding in elderly patients

10 Co-existing Vascular Disease: a common finding in elderly patients Prevalence of CD (%) in PVD pts Prevalence of PVD (%) in CD pts Renal art. Carotid Infer. limbs ortic aneur. 0 Renal art. Carotid Infer. limbs Norgren et al, J Vasc Surg 2007

11 Therapeutic Strategies in Elderly Patients with Combined Coronary and Carotid rtery Disease Staged Strategy 1. CE > CBG (risk of MI 6.5%) * 2. CBG > CE (reversed) (risk of any stroke 6.3%) * 3. CE > PCI 4. CBG > CS Mixed Strategy 5. CS > CBG 6. PCI > CE 7. CS > PCI Percutaneous only 8. PCI > CS Simultaneous Strategy 9. CE & CBG (death and any stroke 8.7%) * 10. CS & PCI (or PCI & CS) 11. Hybrid pproach (CS & CBG) * Naylor et al, Eur J Vasc Endovasc Surg 2003 (Meta-analysis of 97 studies) F. Tomai, 6/2008

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

13 Duration of dual antiplatelet therapy in elderly pts undergoing PCI THROMBOSIS BLEEDING CC/H/SCI Guidelines Pts be treated with DT for 1 year after DES and at least 1 mo. after BMS, if not at high risk of bleeding (Class IB)

14 May Bio-Engineered" Prohealing Stents Be a Solution? Coronary Blood Flow Inflow EPC Enables Rapid Maturing and Endothelial Expressive Function ccelerated Differentiation Rolling Cell Surface ttachement and Uptake of Receptors Stent Surface

15 May a new polymer-free, carbofilm-coated, abluminal reservoir-based, tacrolimus-eluting stent, that requires only two months of DPT, be a solution? Stent cross section Initial strut cross section 1 st step Reservoir creation (external side) 2 nd step Integral Carbofilm coating bluminal reservoir

16 PCI vs Medical Therapy for Stable Coronary Disease Clinical Outcomes Utilizing Revascularization and ggressive Drug Evaluation (COURGE) trial Overall Survival 1 0,9 0,8 0,7 0,6 0,5 PCI Medical Therapy N=2287 HR, 0.87; 95% CI ( ); p= Years Enrolled/screened ratio: 6.4% Cross over to PCI: 33% Boden WE, et al. N Engl J Med 2007

17 PCI vs Medical Therapy for Stable Coronary Disease Clinical Outcomes Utilizing Revascularization and ggressive Drug Evaluation (COURGE) trial 60 High risk pts (pre-specified subgroup analysis) Cumulative propotion of cross-over revascularization High Risk (234 pts) Log-Rank Chi-Sq: < Non-High Risk (1837 pts) Years after enrollment Maron DJ m Heart J 2009

18 PCI vs Medical Therapy Survival Benefit by mount of Inducible Ischemia Retrospective study of pts without prior MI: treatment (PCI or MT) within 60 days after Myocardial Perfusion Tomography 1.0 Medical Therapy Survival free of Cardiac Death Time (days) Revascularization p= Cardiac Death Rate (%) % 1.0% Medical Therapy Revascularization 2.9% 3.7% 4.8% 3.3% > 20 % Total Myocardium Ischemic 6.7% P < % Unadjusted Kaplan-Meier Survival in pts undergoing revascularization vs medical therapy Observed cardiac death rates over follow-up period (2 years) in pts undergoing revascularization vs medical therapy as a function of inducible ischemia Hachamovitch R et al; Circulation 2003

19 Treatment of Elderly Pts With CS or CS: Conservative or Invasive Therapy? PPROCH Registry <70 y, N= y, N= y, N= 983 CS: 45% of pts 5-y survival in pts 80 y CBG: 77.4% PCI: 72% Medical: 60% ge < 70 (n=15395) ge > 80 (n=983) Proportion live Years Proportion live CBG PCI Medical Years Graham et al, Circulation 2002

20 Treatment of Elderly Pts With Stable Coronary Disease: Conservative or Invasive Therapy? 301 pts ge 75 y ngina CCS 2 on 2 antianginal drugs Invasive (PCI 52%, CBG 20%) *Death/MI/hospitalization for uncontrolled symptoms or CS Proportion with MCE* 0,08 0,06 0,04 0,02 0 Time trial Optimized Medical Tx Invasive Log rank P< Pfisterer M, et al. JM 2003

21 COURGE Trial Nuclear Substudy Cumulative Event-Free Survival Unadjusted p=0.001 Risk-djusted p= % (n= 23) % (n= 141) % (n= 88) 10 % (n= 62) Residual Ischemic Myocardium Time to Follow-up (years) Survival for patients by residual ischemia 314 pts: Myocardial Perfusion Tomography before treatment and after 1 year Leslee JS et al; Circulation 2008

22 CCF/SCI/STS/TS/H/SNC 2009 ppropriateness Criteria for Coronary Revascularization High-risk findings on STBLE CD on noninvasive imaging study and CCS class III or IV angina High-Risk Findings on Noninvasive Study CCS Class III or IV ngina Symptons Med. Rx Stress Test Med. Rx Class III or IV Max Rx Class I or II Max Rx symptomatic Max Rx U High Risk Max Rx High Risk No/min Rx Int. Risk Max Rx Class III or IV No/min Rx Int. Risk No/min Rx U U Class I or II No/min Rx U Low Risk Max Rx U symptomatic No/min Rx U U Low Risk No/min Rx I U Coronary natomy CTO of 1 vz; no other disease 1-2 vz. disease; no Prox. LD 1 vz. disease of Prox. LD 2 vz. disease with Prox. LD 3 vz. disease; no Left Main Coronary natomy CTO of 1 vz; no other disease 1-2 vz. disease; no Prox. LD 1 vz. disease of Prox. LD 2 vz. disease with Prox. LD 3 vz. disease; no Left Main

23 Treatment of Elderly Pts with Stable Coronary rtery Disease: Conservative or Invasive Therapy? Goal: Quality of life Risk Stratification (amount of inducible ischemia) Estimation of life expectancy Importance of PCI Strategy femoral, radial or brachial approach? which lesion in MVD? Simultaneous or staged procedure? chronic total occlusion & calcific lesions combined carotid and coronary artery disease contrast burden comorbidities associated medical treatment DES use (bleeding risk) Each patients requires a tailored treatment