Upload
others
View
5
Download
0
Embed Size (px)
Citation preview
Management of cardiovascular disease
- coronary interventions -
Francesco Cosentino MD, PhD, FESC
Division of Cardiology
2nd Faculty of Medicine
University "Sapienza"
Rome, Italy
Master Classes in Preventive Cardiology I
Management of diabetes in patients with CVD
European Heart House
Revascularisation: which is better PCI
or CABG?
Coronary interventions
Patients with diabetes have:
– higher complication rate
– higher long-term mortality/morbidity following revascularization both after bypass surgery and PCI, even in the era of DES
– greater incidence of 3-vessel, more diffuse disease in proximal and distal segments (NHLBI PCI registry)
– Most outcome information is derived from registries and sub-group analyses (selection bias)
NEJM 1996; 335: 217
Comparison of CABG with PTCA in pts with CAD
Bypass Angioplasty Revascularisation Investigation (BARI)
Survival advantage in the
CABG compared to the
PCI cohort1289 pts with multivessel disease
of whom 353 had diabetes.
BARI Trial 10-Year Follow-Up Results
BARI Investigators, JACC 2007
Hlatky MA et al, Lancet 2009
• 1223 diabetic patients enrolled
in 10 PCI vs CABG trials
(6 PTCA and 4 BMS)
• median FU 5.9 years
• Long-term survival benefit
of CABG among 1223
diabetic patients
• Interaction between diabetes
status and treatment effect
2009 Collaborative meta-analysis of 10 RCT
PCI vs. CABG in multivessel CAD
Mo
rta
lity
%
PCI diabetes
CABG diabetes
PCI/CABG no diabetes
Years of follow-up
undertaken
Arterial Revascularization Therapy StudyA subgroup analysis of the ARTS-I trial
Abizaid et al Circulation 2001
BMS vs CABG in pts with multivessel CAD
Has the use of DES in diabetic patients
changed results first seen in
the pre-DES trials favouring CABG?
ARTS II TrialSES-PCI in Diabetes with multivessel CAD
(single-arm study)
3-year clinical outcomes for ARTS-I and -II diabetic patients
Daemen et al. JACC 2008
ARTS-I: PCI with BMS vs CABG
ARTS-II: PCI with SES
Incidence of MACCE (efficacy) Death/CVA/AMI (safety)
Collaborative Network Meta-analysis All Cause Mortality
• 35 studies
• 10947 non-diabetic and 3852 diabetic patients
Stettler C et al. BMJ 2008;337:a1331
Collaborative Network Meta-analysis Target Lesion Revascularization
DES seem same and effective
Stettler C et al. BMJ 2008;337:a1331
• Both DES were associated with a decrease in revascularization rates compared
with BMS in pts with and w/out diabetes
Massachussets Registry – DM - 3-Years Mortality
• Analysis including all patients undergoing PCI in non-federal hospital in
Massachussets between April 2003 and September 2004
• 5051 DM patients
• Unadjusted 3-year mortality 14.4% DES group and 22.2 BMS group (P<0.001)*
Propensity matched diabetic cohorts
Garg P et al. Circulation 2008;118:2277-85
Massachussets Registry – DM – 3-Years TVR
Propensity matched diabetic cohortsGarg P et al. Circulation 2008;118:2277-85
Risk-adjusted 3-year revasc rate 18.4% DES group and 23.7 BMS group (P<0.001)
Synergy between PCI with Taxus and Cardiac Surgery
(SYNTAX Trial)
1800 pts with LM or triple vessel CAD
the primary outcome occured more often in the PCI group
Serruys et al. NEJM 2009;360:961-72
Coronary Artery Revascularization in Diabetes (CARDia)DM and triple-vessel CAD
p =0.63
10.5%
13.0%
N=510
Primary endpoint: death, non fatal MI,
non fatal stroke
Preliminary results at 1 year
p=0.04
11.3 %
19.3 %
N=510
Coronary Artery Revascularization in Diabetes (CARDia)Higher rate of repeat revasc in the PCI group
Revascularization or Medical Management?
• Unstable CAD
• Stable CAD
Better
0 0.5 1.5 2.5
Adjusted Odds Ratio & 95% CI
p < 0.0001
Worse
21
Total, N = 29570Diabetes, N = 6458
Diabetic pts with non-ST ACS have higher 30-day mortality
Roffi et al.,Circulation 2001;104 2767-71
Diabetes
meta-analysis of the diabetic populations within IIb-IIIa inhibitor trials
Early Invasive or Conservative
Strategy in UA and NSTEMI 6 Months
p = 0.232
p = 0.028
ejt 0303–129
N=613 N=1607
DiabetesDiabetes No DiabetesNo Diabetes00
55
1010
1515
2020
2525
3030
27.727.7
20.120.1
16.416.414.214.2
Conservative
Invasive
Death, MI, Rehosp ACS, (%)Death, MI, Rehosp ACS, (%)
RRR 27%
ARR 7.6%
RRR 13%
ARR 2.2%
P=NSP<0.05
Cannon et al. NEJM 2001;344:1879-87
ESC Guidelines for the Management of NSTE-ACS
ESC ACS Guidelines 2007
Recommendations for Diabetes
Early invasive strategy is recommended for diabetic patients with NSTE-ACS (I – A).
Impact of revascularization vs med therapy alone
on mortality in stable CAD
• 28 trials, published 1977-2007
• 13121 pts (~470 patients/trial)
• Median FU 3 years
• No diabetes data
Jeremias A et al. Am J Med 2009;122:152-61
Meta-Analysis of Randomized Trials
Soares, P. R. et al. Circulation 2006;114:I-420-I-424
N=190 Diabetics
• 611 patients with stable multivessel CAD
• Randomized 1995-2000 to PCI, CABG or medical Tx
• 190 diabetic patients
• 5 yrs follow up
Coronary revascularization decreases mortality in
diabetics with stable multivessel disease
A retrospective analysis of MASS II study
Impact of Revascularization: Euro-Heart Survey
No DM, Revasc
No DM, No Revasc
DM, Revasc
DM, No Revasc
Freedom from MACE
Anselmino et al. Eur J Cardiovasc Prev Rehabil 2008;15:216-23
Impact of EBM: Euro-Heart Survey
Anselmino et al. Eur J Cardiovasc Prev Rehabil 2008;15:216-23
DM, No EBM
No DM
DM, EBM
Freedom from MACE
QuickTime™ e undecompressore
sono necessari per visualizzare quest'immagine.
Stable CAD and DiabetesPCI, CABG or medical management?
confront treatment decisions in practice
BARI 2D: study design
• 2368 diabetic pts with T2DM and stable CAD
• 2x2 design
– revascularization (CABG or PCI) + intensive medical tx vs. intensive medical tx alone
– insulin sensitization (metformin/TZD) vs. insulin provision (sulfonylureas/insulin)
• Randomization to PCI or CABG prespecified by the physician as the more appropriatetherapy for each patient
The BARI 2D study group NEJM 2009
2 parallel strategies for
death and CVE
2 parallel strategies for
long term death and CVE
The BARI study group NEJM 2009
1º endpoint: death
2º: death/MI/stroke
Follow-up 5 yrs
BARI 2Dlittle difference with respect to rates of survival and MACE
Outcomes in the CABG Subgroup of BARI 2D Trialprespecified analyses of secondary end point
Sobel BE, Coron Artery Dis 2010
The BARI study group NEJM 2009
reduction of death/nonfatal MI/stroke only among pts
who were selected to undergo CABG. Ins sens
associated with fewer CVE.
BARI 2D: Patients Characteristics
Low risk population for major CVE
on the basis of angina
symptoms, extent of CAD and VF
Conclusions (I)
• Diabetic patients at higher risk of CV events with both PCI and CABG
• Improvements in techniques for both PCI and CABG
• DES-PCI and CABG
– At 1 year similar death/MI/stroke rates
– PCI → more revascularization
– CABG → more stroke
• Choice of revascularization strategy based on diffuseness of atherosclerosis, clinical presentation, type of diabetes, comorbidities, pattern of coronary involvement, LV function.
• Interventional (Syntax) and surgical scores (Euroscore) should be taken into account
• Threshold for surgery should be lower in diabetic patients than in non-diabetic counterparts (especially in IDDM)
• Longer FU of the presented trials and results of ongoing controlled randomized trials in pts with diabetes (CARDia, FREEDOM) will further help in decision making
Conclusions (II)
• Optimal medical management is crucial, independently of revascularization strategy
• Initial conservative strategy is a valuable option
→ In the presence of optimal compliance to medical management
→ in low-risk diabetic patients (stable symptoms, moderate CAD on coronary angiogram, normal LV and renal function)
• Results of BARI 2 D cannot be extrapolated
→ to unstable or in other respect higher risk diabetic patients
→ to diabetic patients with unknown coronary anatomy
Diabetes with CAD
a moving target against which the effectiveness of evolving treatments must be repeatedly assessed
ESC/EASD Guidelines 2007
• Mechanical reperfusion by means of primary PCI is the revascularization mode of choice in diabetic patients with AMI (I – A)
• When PCI with stent implantation is performed in patients with diabetes, DES should be used (IIa - B)
• Glycoprotein IIb/IIIa inhibitors are indicated in elective PCI in patients with diabetes (I - B)