Fabrizio Tomai, MD, FACC, FESC

Dept. Cardiovascular SciencesInterventional Cardiology Unit

European Hospital - Aurelia HospitalRome, Italy

Quandorivascolarizzare

il paziente anzianocon stenosicoronariche

paucisintomatiche

• Elderly patients (>75 yrs) represent 9.3% of theitalian population (5,4 millions) (ISTAT 31/12/06)

• Elderly patients exhibit an higher risk profile witha TIMI risk score > 3-4 nel 92% of patientsolder than 65 yrs (TACTICS-TIMI 18 trial)

• 30% of patients with ACS admitted to our CCUshad > 75 yrs (Blitz study)

• In the majority of randomized clinical trials comparingconservative and invasive strategies in patients with CAD,age>75 years is an exclusion criteria

• Elderly patients (>75 yrs) represent 9.3% of theitalian population (5,4 millions) (ISTAT 31/12/06)

• Elderly patients exhibit an higher risk profile witha TIMI risk score > 3-4 nel 92% of patientsolder than 65 yrs (TACTICS-TIMI 18 trial)

• 30% of patients with ACS admitted to our CCUshad > 75 yrs (Blitz study)

• In the majority of randomized clinical trials comparingconservative and invasive strategies in patients with CAD,age>75 years is an exclusion criteria

Treatment ofTreatment of ElderlyElderly PtsPts withwithStableStable CoronaryCoronary ArteryArtery DiseaseDisease::

Conservative or InvasiveConservative or Invasive TherapyTherapy ??

Number of PCIs

2003 2004 2005 2006 2007 2008

87.654

104.574

115.852124.091

128.428 127.946

Società ItalianaCardiologia Invasiva

Italian Society of Interventional CardiologyGISE Data Base

61%78.000 PCIs

39%50.000 PCIs

Acute Coronary Syndromes

Stable CAD

Indication for PCI in ItalyYear 2008: 128.000 PCIs

39%50.000 PCIs

Stable CAD

39%35.000 PCIs

15.000 PCIs

in >70yrs

61%78.000 PCIs

Acute Coronary Syndromes

Indication for PCI in ItalyYear 2008: 128.000 PCIs

PCI vs Medical Therapyfor Stable Coronary Disease

Boden WE, et al. N Engl J Med 2007

0,5

0,6

0,7

0,8

0,9

1

0 1 2 3 4 5 6 7Years

Ove

rall

Surv

ival

PCI

Medical Therapy

HR, 0.87; 95% CI (0.65-1.16); p=0.38

Clinical Outcomes Utilizing Revascularization andAggressive Drug Evaluation (COURAGE) trial

N=2287

PCI vs Medical Therapy for Stable Coronary DiseaseClinical Outcomes Utilizing Revascularization and

Aggressive Drug Evaluation (COURAGE) trial

Teo K K et al. JACC 2009

Elderly (pre-specified subgroup analysis)

0

5

10

15

20

25

30

Death MI Death/MI Death/MI/stroke ACS

p=0.11

p=0.97 p=0.44 p=0.48

p=0.93

p=0.51

p=0.86

p=0.58

p=0.83

p=0.41

OMT<65y (693) OMT>65y (444)PCI<65y (688) PCI>65y (460)

* *

* p<0.001 for incidence of death and MI in older pts compared with younger pts

%

PCI vs Medical Therapy for Stable Coronary DiseaseClinical Outcomes Utilizing Revascularization and

Aggressive Drug Evaluation (COURAGE) trial

Teo K K et al. JACC 2009

Elderly (pre-specified subgroup analysis)

0

10

20

30

Death MI Death/MI Death/MI/stroke ACS

p=0.97p=0.48

p=0.51p=0.58

p=0.41

OMT>65y (444) PCI>65y (460)

CoCo--existingexisting VascularVascular DiseaseDisease::a common finding in elderlya common finding in elderly patientspatients

0

10

20

30

40

50

Renalart.

Carotid Infer.limbs

Aorticaneur.

Prevalence of CAD (%) in PVD pts

0

10

20

30

40

Renal art. Carotid Infer. limbs

Prevalence of PVD (%) in CAD pts

Norgren et al, J Vasc Surg 2007

CoCo--existingexisting VascularVascular DiseaseDisease::a common finding in elderlya common finding in elderly patientspatients

• Staged Strategy1. CEA > CABG (risk of AMI 6.5%) *2. CABG > CEA (reversed) (risk of any stroke 6.3%) *3. CEA > PCI4. CABG > CAS5. CAS > CABG6. PCI > CEA7. CAS > PCI8. PCI > CAS

• Simultaneous Strategy9. CEA & CABG (death and any stroke 8.7%) *10. CAS & PCI (or PCI & CAS)11. Hybrid Approach (CAS & CABG)

* Naylor et al, Eur J Vasc Endovasc Surg 2003(Meta-analysis of 97 studies)

Mixed Strategy

Percutaneous only

F. Tomai, 6/2008

TherapeuticTherapeutic StrategiesStrategies inin ElderlyElderly PatientsPatients withwithCombinedCombined CoronaryCoronary andand CarotidCarotid ArteryArtery DiseaseDisease

CADILLAC Trial (30-d outcome)

< 55 yrs< 55 yrs 55-64 yrs55-64 yrs 65-74 yrs65-74 yrs 75 yrs 75 yrs

0,8

1,7

0

1,2

3,6

0,2

3,64,1

0,2

4,8

6,7

0,4

0

2

4

6

8

10

Death Bleeding Stroke

%%

p < .0001p < .0001

p = 0.02p = 0.02

Guagliumi G. et al Circulation 2004

p < .005p < .005

HighHigh riskrisk ofof bleedingbleeding inin elderlyelderly patientspatientsundergoingundergoing PCIPCI

Duration of dual antiplatelet therapyin elderly pts undergoing PCI

THROMBOSIS BLEEDING

ACC/AHA/SCAI GuidelinesACC/AHA/SCAI GuidelinesPts be treated with DAT for 1 year after DES and atPts be treated with DAT for 1 year after DES and atleast 1 mo. after BMS, if not at high risk of bleedingleast 1 mo. after BMS, if not at high risk of bleeding

(Class IB)(Class IB)

Stent Surface

Coronary Blood Flow Inflow EPC

Rolling Cell SurfaceAttachement andUptake of ReceptorsAccelerated

Differentiation

Enables RapidMaturing andEndothelialExpressiveFunction

Stent Surface

Coronary Blood Flow Inflow EPC

Rolling Cell SurfaceAttachement andUptake of ReceptorsAccelerated

Differentiation

Enables RapidMaturing andEndothelialExpressiveFunction

May “Bio-Engineered" Prohealing StentsBe a Solution?May “Bio-Engineered" Prohealing StentsBe a Solution?

May a new polymer-free, carbofilm-coated, abluminalreservoir-based, tacrolimus-eluting stent, that requires only

two months of DAPT, be a solution?

May a new polymer-free, carbofilm-coated, abluminalreservoir-based, tacrolimus-eluting stent, that requires only

two months of DAPT, be a solution?

Abluminal reservoir

Reservoir creation(external side)

Integral Carbofilm™coating

Initial strutcross section

1st step

2nd step

Stent crosssection

PCI vs Medical Therapyfor Stable Coronary Disease

Boden WE, et al. N Engl J Med 2007

0,5

0,6

0,7

0,8

0,9

1

0 1 2 3 4 5 6 7Years

Ove

rall

Sur

viva

l

PCI

Medical Therapy

HR, 0.87; 95% CI (0.65-1.16); p=0.38

Clinical Outcomes Utilizing Revascularization andAggressive Drug Evaluation (COURAGE) trial

N=2287

• Enrolled/screened ratio: 6.4%

• Cross over to PCI: 33%

Maron DJ Am Heart J 2009

PCI vs Medical Therapy for Stable Coronary DiseaseClinical Outcomes Utilizing Revascularization and

Aggressive Drug Evaluation (COURAGE) trial

High risk pts (pre-specified subgroup analysis)

Years after enrollment

Cum

ulat

ive

prop

otio

nof

cros

s-ov

erre

vasc

ular

izat

ion

High Risk(234 pts)

Non-High Risk(1837 pts)

Log-Rank Chi-Sq: <0.0001

0 1 2 3 4 5 6 70

10

20

30

40

50

60

PCI vs Medical TherapySurvival Benefit by Amount of Inducible Ischemia

Hachamovitch R et al; Circulation 2003

Su

rviv

alfr

eeo

fC

ard

iac

Dea

th

Time (days)

Retrospective study of 10.627 pts without prior MI: treatment (PCI or MT) within 60days after Myocardial Perfusion Tomography

0 200 400 600 8000.90

0.92

0.94

0.96

0.98

1.0 Medical Therapy

Revascularization

p=0.0004

0

2

4

6

8

10

Car

dia

cD

eath

Rat

e(%

)

1-5 5-10 11-20 > 20

% Total Myocardium Ischemic

Medical Therapy

Revascularization

1.0%1.8%

2.9%

3.7%

4.8%

3.3%

6.7%

2.0%

P < 0.02

Observed cardiac death rates over follow-up period(2 years) in pts undergoing revascularization vsmedical therapy as a function of inducible ischemia

Unadjusted Kaplan-Meier Survival in ptsundergoing revascularization vs medical therapy

APPROACH RegistryAPPROACH Registry

Graham et al, Circulation 2002

1.0

0.9

0.8

0.7

0.6

0.5

0 1 2 3 4 5

Years

Pro

po

rtio

nA

live

Age < 70 (n=15395)

CABG: 77.4%PCI: 72%Medical: 60%

1.0

0.9

0.8

0.7

0.6

0.5

0 1 2 3 4 5

Years

Age > 80 (n=983)

CABGPCIMedical

Pro

po

rtio

nA

live

• <70 y, N= 15.392• 70-79 y, N= 5.198• ≥ 80 y, N= 983

• CSA: 45% of pts

5-y survival in pts ≥ 80 y

Treatment ofTreatment of ElderlyElderly PtsPts WithWith ACS or CSA:ACS or CSA:Conservative or InvasiveConservative or Invasive TherapyTherapy ??

0

0,02

0,04

0,06

0,08

0 90 180 270 360

Optimized Medical Tx

Invasive

Log rank P<0.001

Pro

port

ion

with

MA

CE

**Death/MI/hospitalization foruncontrolled symptoms orACS

• 301 pts• Age 75 y• Angina CCS 2 on2 antianginal drugs• Invasive (PCI 52%,CABG 20%)

Pfisterer M, et al. JAMA 2003

Treatment ofTreatment of ElderlyElderly PtsPts WithWith Stable Coronary DiseaseStable Coronary Disease::Conservative or InvasiveConservative or Invasive TherapyTherapy ??

Time trialTime trial

COURAGE Trial Nuclear Substudy

Leslee JS et al; Circulation 2008

Survival forpatients by

residual ischemia

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

1.5 2.5 3.5 4.52 3 4 5

Cu

mu

lati

veE

ven

t-F

ree

Su

rviv

al

Time to Follow-up (years)

ResidualIschemicMyocardium

Unadjusted p=0.001

Risk-Adjusted p=0.09

≥ 10 % (n= 62)

5 – 9.9 % (n= 88)

1 – 4.9 % (n= 141)

0 % (n= 23)

314 pts: MyocardialPerfusion Tomographybefore treatment andafter 1 year

ACCF/SCAI/STS/AATS/AHA/ASNC 2009

Appropriateness Criteria for Coronary Revascularization

STABLE CADSTABLE CADHighHigh--riskrisk findingsfindings onon noninvasivenoninvasive imagingimaging studystudy and CCS class III or IV anginaand CCS class III or IV angina

3 vz.disease;no LeftMain

2 vz.disease

withProx.LAD

1 vz.diseaseof Prox.

LAD

1-2 vz.disease;no Prox.

LAD

CTO of1 vz; no

otherdisease

CoronaryAnatomy

3 vz.disease;no LeftMain

2 vz.disease

withProx.LAD

1 vz.diseaseof Prox.

LAD

1-2 vz.disease;no Prox.

LAD

CTO of1 vz; no

otherdisease

CoronaryAnatomy

Low RiskNo/min Rx

AsymptomaticNo/min Rx

Low RiskMax Rx

Class I or IINo/min Rx

Int. RiskNo/min Rx

Class III or IVNo/min Rx

Int. RiskMax Rx

AsymptomaticMax Rx

High RiskNo/min Rx

Class I or IIMax Rx

High RiskMax Rx

Class III or IVMax Rx

Stress TestMed. Rx

SymptonsMed. Rx

CCS Class III or IV AnginaHigh-Risk Findings on Noninvasive Study

AA A

AA

A

A A

A

A

A

AAU A

A

U A

UU

A AA

A A A

AAA

AAAA A

AA A

A A

A

A A

A A

A

U

U

I U

A

U

A A A AA A A

AA

Treatment ofTreatment of ElderlyElderly PtsPts withwithStableStable CoronaryCoronary ArteryArtery DiseaseDisease::

Conservative or InvasiveConservative or Invasive TherapyTherapy ??

• 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