quando rivascolarizzare il paziente anziano con stenosi ...€¦ · pci vs medical therapy for...
TRANSCRIPT
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