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2012 Top 10 Advances of InterventionalCardiology:
Prediction for the decade
Samin K Sharma, MD, FACC, FSCAIDirector Clinical & Interventional Cardiology
Zena and Michael a Weiner Professor of Medicine
Mount Sinai Hospital, NY
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Intervention 2012Andreas Gruentzig
1939 1985father of angioplasty
His dream was thecatheter-based
percutaneous treatment
of vascular disease inalert, awake patients
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NY State: Annual Revascularization Volume:
2003-2007-08-11PCI vs. CABG
N
5004651677
5817859976
53223
1469212988
11884 10324
11124
2003 2004 2005 2006 2007 2008 2009 2010 2011
70000
60000
50000
40000
30000
20000
10000
0
YEAR
PCICABG
11.3%
7.2%
54542
9985
55258
9812
54865
50124
8.9%
9742 9845
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2012 Top 10 Advances of Interventional Cardiology
Studies selected from the following journals
Journals 2012 # articles related to PCI
New Engl J Med 20
JAMA / (Lancet) 5 (3)
Circulation 68
J Am Coll Cardiol/JACC Intervention 72
ACCi2 meeting abstracts 112AHA meeting abstracts 45
TCT meeting abstracts 22
324
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2012 Top 10 Advances of Interventional Cardiology
Reasons for selection of the study
Revolutionary / significant observation
Widespread acceptance
Change in clinical practice
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2012 Top 10 Advances of Interventional Cardiology
1.
2.
3.
4.
5.6.
7.
8.9.
10. TRIOLOGY Trial: Prasugrel vs. Clopidogrel in ACS
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TRILOGY ACS STUDY DESIGNMedically Managed UA/NSTEMI Patients
1. All patients were on aspirin and low-dose aspirin (75 years, 5mg MD or prasugrel was given.
Primary Efficacy Endpoint: CV Death, MI, Stroke
Median Time toEnrollment = 4.5 Days
Randomization Stratified by:
Age, Country, Prior Clopidogrel Treatment
(Primary analysis cohort Age < 75 years)
Medical Management Decision < 10 days
(Clopidogrel started < 72 hrs. in hospital OR
on chronic clopidogrel) 96% of total
Medical Management Decision < 72 hrs.
(No prior clopidogrel given 4% of total)
Clopidogrel1
300 mg LD
+
75 mg MD
Minimum Rx Duration: 6 months; Maximum Rx Duration: 30 months
Prasugrel1
30 mg LD
+
5 or 10 mg MD
Clopidogrel1
75 mg MD
Prasugrel1
5 or 10 mg MD
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TRIOLOGY Trial: Efficacy Endpoint and
TIMI Major Bleeding Through 30 Months(Overall population)
End
point
Days
20.3% PrimaryEfficacyEndpoint
TIMIMajorBleeding
0
5
10
15
20
0 180 360 540 720 900
Clopidogrel Prasugrel
HR (95% CI):1.23 (0.84, 1.81)
P = 0.29
HR (95% CI):0.96 (0.86, 1.07)
P = 0.45
18.7%
1.8 %
2.5 %
Roe et al., NEJM 2012:367:1297
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Endpoint(%)
Days
16.0% PrimaryEfficacy
2.1%1.5%
13.9% Endpoint
TIMIMajorBleeding
HR (95% Cl):1.31 (0.81, 2.11)
p=0.27
HR (95% Cl):0.91 (0.79, 1.05)
p=0.21
Prasugrel Clopidogrel
Trilogy ACS: Primary Efficacy Endpoint and TIMI
Major Bleeding Through 30 Months(Age
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Trilogy ACS Trial: Incidence of Outcomes by
Angiography Status
Angio(n=3085)
Angio(n=3085)
%
p=0.031
p=0.042
p=0.626
p=0.074
No Angio(n=4158)No Angio(n=4158)
Prasugrel Clopidogrel
p=0.954
p=0.989p=0.569
p=0.851
%
Primary MI CV TIMI
Endpoint Death Major
Bleeding
Primary MI CV TIMI
Endpoint Death Major
Bleeding
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2012 Top 10 Advances of Interventional Cardiology
1.
2.
3.
4.
5.6.
7.
8.9. IABP Trials: CRISP-AMI, IABP-SHOCK II
10. TRIOLOGY Trial: Prasugrel vs. Clopidogrel in ACS
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Percutaneous LV Assist Devices
IABPPTVA:
TandemHeartIMPELLA:
Recovers 2.5
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PROTECT II Trial Design
Hemodynamic support during high-risk, non-emergent PCI, N=654Unprotected LM or last patent conduit & EF
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ONeill W et al. ACCi2 2011.
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LV Support During High Risk PCIRecent Trials Using IABP
BCIS-1
CRISP AMI
IABP-SHOCK II
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7.4% vs 4.6%, p = 0.32
Elective IABP(n=151)
No planned (n=150)
Kaplan Meier 6 month mortality
Balloon-pump Assisted Coronary
Intervention Study: BCIS-1
Perera D et al. JAMA 2010;304:867.
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IABP and infarct size in patients with acute anterior MI
infarction without shock: CRISP-AMI Randomized TrialInclusion Criteria Anterior STEMI
2 mm in 2 contiguous leads orat least 4 mm in the anterior leads
Planned Primary PCI within 6 hr
Anterior STEMI
Without Shock
IABP prior to PCI Standard of Care Primary PCI alone
At least 12 hours of IABP post PCI Routine Post PCI care
Cardiac MRI performed day 3-5 post PCI
Primary Endpoint: Infarct Size on CMR1. All Patients with CMR data2. Patients with Prox LAD occlusion TIMI 0/1 flow
Clinical Events 6 months
Randomize
Open Label
(n ~ 300 )
Patel et al. JAMA 2011;306:1329
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All IABP+PCI PCI Alone P
(N=337) (N=161) (N=176) Value
Primary endpoint
Infarct size (% LV), modified ITT all patients with CMR data 0.060
N 275 133 142
Mean 39.8 42.1 37.5
Median 38.8 42.8 36.2
Infarct size (%LV), modified ITT patients prox. LAD and TIMI flow 0/1 0.110
N 192 93 99Mean 44.4 46.7 42.3
Median 42.1 45.1 38.6
Patel et al. JAMA 2011;306:1329
IABP and infarct size in patients with acute anterior MI
infarction without shock: CRISP-AMI Randomized Trial
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IABP+PCI
(N=161)
PCI Alone
(N=176)
P
Value
Death (%) 1.9* 4.0* 0.26*
Stroke (%) 1.9 0.6 0.35
Major bleed per GUSTO 1 definition or transfusion (%) 3.1 1.7 0.49
Vascular complications (%) 4.3 1.1 0.09
Major limb ischemia requiring operative intervention (n) 0 0
Distal embolization (n) 0 0
Major dissection (n) 2 0
Pseudoaneurysm or AV fistula (n) 3 2
Hematoma > 5 cm (n) 3 0
30-day Clinical Events
* From KM curves and log-rank test. Patel et al. JAMA 2011;306:1329
IABP and infarct size in patients with acute anterior MI
infarction without shock: CRISP-AMI Randomized Trial
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IABP-Shock II Trial: Guidelines
IABP in AMI complicated by Cardiogenic Shock
Class IC
Class IB
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299 intended early revascularization
288 primary PCI
3 primary CABG 8 no revascularization
288 received IABP
13 did not receive IABP
10 died before IABP
3 protocol violation
301 intended early revascularization
287 primary PCI
3 primary CABG 11 no revascularization
298 with 30-day follow-up
- 1 withdrew informed consent
300 primary endpoint analysis
300 with 30-day follow
- 1 lost to follow up
298 primary endpoint analysis
269 received control therapy
30 cross-over to IABP (22 first day, 8 day 1-8 )
4 mechanical complications
25 protocol violation, 1 unclear reason
Allocation
Revascularization
Follow-Up
Primary endpoint
analysis Thiele H et al. Am Heart J 2012;163:938
IABP-SHOCK II Flow ChartPatient in cardiogenic shock complicating AMI
Check inclusion and exclusion criteria
Informed consent
IABP-SHOCK IIRegistry
Not suitable
Randomization
Group 1 (n = 301)IABP + Optimal medical therapy
Group 2 (n = 299)No IABP + Optimal medical therapy
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IABP-Shock II Trial: Results Primary Study Endpoint:
30-day Mortality
Mortality(%)
Time After Randomization (Days)
P=0.92 by log-rank testRelative risk 0.96; 95% CI 0.79-1.17; P=0.69 by Chi2-Test
Thiele H et al. NEJM 2012;367:1287.
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SafetyIABP (n=300) Control (n=298)
All-cause mortality 30-D; n (%) 119 (39.7) 123 (41.3)
Stroke in-hospital; n (%) 2 (0.7) 5 (1.7)Gusto bleeding: life-
threatening/severe; n (%) 10 (3.3) 13 (4.4)
Gusto bleeding: moderate; n (%) 52 (17.3) 49 (16.4)
Re-infarction in hospital; n (%) 9 (3.0) 4 (1.3)
Stent thrombosis in-hospital; n (%)
Peripheral ischemic complication
requiring intervention; n (%)
4 (1.3)
13 (4.3)
3 (1.0)
10 (3.4)
Sepsis; n (%) 47 (15.7) 61 (20.5)
P
0.15
0.71
0.77
0.51
0.69
IABP-Shock II Trial: Results
Thiele H et al. NEJM 2012;367:1287.
0.53
0.28
0.16
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2012 Top 10 Advances of Interventional Cardiology
1.
2.
3.
4.
5.6.
7.
8. Platelet Inhibition Studies: TRIGGER PCI, ARCTIC9. IABP Trials: CRISP-AMI, IABP-SHOCK II
10.TRIOLOGY Trial: Prasugrel vs. Clopidogrel in ACS
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Standard-Dose Clopidogrel
clopidogrel 75-mg daily X 6 months
High-Dose Clopidogrel
clopidogrel 600-mg, thenclopidogrel 150-mg daily X 6 months
Elective or Urgent PCI with DES*
VerifyNow P2Y12 Test 12-24 hours post-PCI by Accumetrics
PRU 230
RR
GRAVITAS Study Design
placebo-controlled
Primary Efficacy Endpoint: CV Death, Non-Fatal MI, Stent Thrombosis at 6 moKey Safety Endpoint: GUSTO Moderate or Severe Bleeding at 6 mo
Pharmacodynamics: Repeat VerifyNow P2Y12 at 1 and 6 months
All patients received aspirin (81-162mg daily)
*Peri-PCI clopidogrel per protocol-mandated criteria to ensure steady-state at 12-24 hrs
Price et al. JAMA 2011;305:1097.
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High-Dose Clopidogrel
Standard-Dose Clopidogrel
2.3% vs. 2.3%
HR 1.01 (95% CI 0.58 1.76)p=0.98
0 30 60 90 120 150 180 210
1
2
3
4
Cumu
lativeIncidenceof
CVdeath
,non-fatalMI,orST%
No. at RiskHigh Dose Clopidogrel
Standard Dose Clopidogrel1109 1056 1029 1017 1007 998 747 541105 1057 1028 1020 1015 1005 773 53
GRAVITAS Trial: Primary Endpoint: CV Death, MI, Stent
Thrombosis
Observed event rates are listed; P value by log rank test. Price et al. JAMA 2011;305:1097.
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Placebo LD,then Clopidogrel 75mgdaily X 6 months
PrasugrelLoading dose 60mg, then 10mg daily
X 6 months
Elective PCI with DES without GP IIb/IIIa use
VerifyNow P2Y12 Test 2-4hrs first clopidogrel MD (75mg)
PRU 206
RR
TRIGGER PCI Trial: Study Design
Primary Efficacy Endpoint: CV Death, Non-Fatal MI at 6 moKey Safety Endpoint: Moderate or Severe Bleeding at 6 mo
Pharmacodynamics: Repeat VerifyNow P2Y12 at 3 and 6 months
All patients received aspirin (81-162mg daily)
N= 2150
Trial was halted after 432 pts enrolled because of
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TRIGGER-PCI Study
Trenk et al., JACC 2012;59:2159
Cumulative Composite Incidence of Efficacy Bleeding Events
PAI Data
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ARCTIC Trial:Randomization before planned PCI with DES (n = 2500)
Monitoring Treatment Arm
1- Systematic assessment of PD response to clopidogrel+ aspirin pre-DES and between day
14 and day 30
2-Adjustment of DAPT dose regimen* if high on-treatment platelet reactivity pre-DES
3-Adjustment of DAPT dose regimen ifhyper/hyporesponder during the maintenance phase
Conventional Arm
1- No monitoring of PD response
2- DAPT strategy at physician discretion
according to routine practice
Assessment of the primary endpoint at 1 year (minimal follow-up of 6 months for the last patients)
All-cause mortality
MI
All urgent revascularization Stent thrombosis requiring revascularization or not
Ischemic stroke requiring a new hospitalization
*In the absence of high platelet reactivity (HPR), MD regimen is aspirin 75 mg + clopidogrel 75 mg.
DAPT =dual antiplatelet therapy
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ARCTIC Monitoring Arm
VerifyNow before PCI: aspirin and P2Y12 thienopyridine
Reload with 500 mg
of IV aspirin
GP IIb/IIIa + clopidogrel (re)-loading (> 600 mg) or prasugrel 60 mg and150-mg MD clopidogrel or prasugrel 10 mg+
VerifyNow DAY 14-30: aspirin and P2Y 12 thienopyridine for all patients
Double aspirin Clopidogrel dose by > 75 mg
or switch to prasugrel 10 mg+If clopidogrel 150 mg to
75 mg, or if prasugrerl switch to
clopidogrel 75 mg
ARU >550 > 90% inhibition< 15% inhibition/PRU > 235
ARU >550 < 15% inhibition/PRU > 235
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Proportion of Patients with Primary Outcome Events and with Main SecondaryOutcome Events at 1 Year Follow-up
Collett et al., NEJM 2012:367:2100.
ARCTIC Trial: Monitoring Antiplatelet Therapy for
Coronary Stenting
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ARCTIC Trial: Monitoring Antiplatelet Therapy for Coronary
StentingStudy End Points at 1 Year Follow-up*
Primary Secondary Death Death MI Stent Urgent Major or
End Point End Point recurrent ACS, thrombosis revasc Minor
stroke, TIA bleeding
p= 0.10
p= 0.77
p= 0.28
p= 0.24
p= 0.32
p= 0.51
Conventional Treatment (n=1227) Monitoring (n=1213)
p= 0.76 p= 0.08
* Patients could have more than one end point
%
Collett et al., NEJM 2012:367:2100.
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Routine Testing for Platelet Inhibition by
VerifyNow Assay Instrument (Accumetrics) Assessment of plateletaggregation inhibition (PI):
- Goal; Optimal response PRU230;- Make sure about compliance- PPI interaction- ? Genetic testing for2C19*2 allele polymorphism
- If on plavix, then eitherswitch to Prasugrel (30mg LD& 5-10mg MD or double
plavix dose to 150mg daily)
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GIFT Study: (Genotype Informationand Functional Testing) Study
GRAVITAS Trial
Price et al., JACC 2012;59:192
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GIFT Trial: Change in On-Treatment Reactivity
From Randomization to 30 Days by CYP2C19Genotype and Treatment Group
Price et al., JACC 2012;59:192
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Price et al., JACC 2012;59:1928
GIFT Trial: Adjusted Odds Ratios for High OTR at 30 Days
and 6 Months by CYP2C19 Genotype According to MDAssignment
High on treatment platelet reactivity ispredicted by genetic makeup but any
genetic phenotype did not correlate withthe 6M MACE
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2012 Top 10 Advances of Interventional Cardiology
1.
2.
3.4.
5.6.
7. YELLOW Trial: Change in plaque composition
8. Platelet Inhibition Studies: TRIGGER PCI, ARCTIC9. IABP Trials: CRISP-AMI, IABP-SHOCK II
10.TRIOLOGY Trial: Prasugrel vs. Clopidogrel in ACS
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()
, , , , , , , , ,
, ,
Presented at ACC 2012; Accepted for Publication in JACC 2013
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Chemogram
Landmark
WireDetection
BlockChemogram
Near Infrared Spectroscopy (NIRS)
NIRS provides lipid contents based onthe spectra processed by algorithm
and shown as lipid core burden index;
LCBI (range 1~1000) for each region of
interest.
Proximal
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High-Dose statin therapy will reduce lipid corecontent in severely obstructive coronary lesions inthe short term (6-8 weeks), as evaluated by Near-
infrared Spectroscopy
Hypothesis
Primary outcomeChange in coronary lipid core burden index (LCBI)after short-term high-dose statin therapy, as
determined by Near-infrared Spectroscopy (NIRS)
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Two/Three Vessel CAD
(n= 87)
After stenting the target vesselThe non-target lesion underwent FFR
FFR0.8IVUS, NIRS
RandomizedStandard Aggressive
n = 43 n = 44Continue statin the patient was taking Rosuvastatin 40 mg daily
Dual antiplatelet therapy for 1 year Dual antiplatelet therapy for 1 year
Follow up Cath (6-8 weeks)FFR, IVUS and NIRS repeated.
If FFR 0.8, lesion stented and imaging repeated.If FFR > 0.8 the patient was treated medically
Imaging data analyzed by CRF Core LabData analysis for primary outcome analyzed by MSH independent Core Lab
*Optimal medical therapy for all patients
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Paired Analysis Lesion LCBI
Baseline
Follow-up
LC
BI
400
200
0
Standard Aggressive
P= 0.47 P= 0.0008
33
Absolute LCBIReduction
Case Example
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Baseline
Lesion LCBI: 259
Follow-up
Max10mm LCBI: 511
Max4mm LCBI: 802
Lesion LCBI: 177
Max10mm LCBI: 289
Max4mm LCBI: 474
Case Example
Plaque Area5.6mm2
Plaque Area5.5mm2 FFR: 0.78
FFR: 0.74
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2012 Top 10 Advances of Interventional Cardiology
1.
2.
3.4.
5.
6. Transradial Intervention in STEMI: RIFLE-STEACS
7. YELLOW Trial: Change in plaque composition
8. Platelet Inhibition Studies: TRIGGER PCI, ARCTIC9. IABP Trials: CRISP-AMI, IABP-SHOCK II
10.TRIOLOGY Trial: Prasugrel vs. Clopidogrel in ACS
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Prior Meta-analysis of 23 RCTs of
Radial vs. Femoral PCI (N=7020)
Radial better Femoral better1.0
PCI Procedure Failure
Death
Death, MI or stroke
Major bleeding/Vascular Comp
1.31 (0.87-1.96)
0.74 (0.42-1.30)
0.71 (0.49-1.01)
0.27 (0.16-0.45)
Jolly S, et al. Am Heart J 2009;157:132
Access Site Crossover 3.82 (2.83-5.15)
RIVAL (RadIal Vs femorAL access for
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NSTE-ACS and STEMI
(n=7021)
Radial Access
(n=3507)
Femoral Access
(n=3514)
Primary Outcome: Death, MI, stroke
or non-CABG-related Major Bleeding at 30 days
Randomization
Key Inclusion: Intact dual circulation of hand required Interventionalist experienced with both (minimum 50 radial procedures in last year)
Jolly S et al. Lancet 2011;377:1409.
Blinded Adjudication of Outcomes
RIVAL (RadIal Vs femorAL access for
PCI) Study Design 3831 (45%) pts weresub-study
of OASIS-7 Trial
RIVAL TRIAL
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RIVAL TRIALSecondary Outcomes at 30 days
0
2
4
6
8
%
Radial (n=3507)Femoral (n=3514)
3.2
p=0.90
3.2
Death, MI, Stroke
1.7
p=0.47
p=0.65
1.31.5
0.60.4
1.9
MIDeath
p=0.23
%
StrokeNon-CABG MajorBleeding
p=0.30
0.7
0.9
Jolly S et al. Lancet 2011;377:1409.
RIVAL Study: Subgroups: Primary Outcome
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Death, MI, Stroke or non-CABG major BleedRIVAL Study: Subgroups: Primary Outcome
0.251.00 4.00
Radial better Femoral better
Hazard Ratio (95% CI)
142.5
Lowest Tertile
Middle TertileHighest Tertile
NSTE-ACSSTEMI
Age
Gender
BMI
Radial PCI Volume by Operator
Radial PCI Volume by Centre
Diagnosis at presentation
Overall
0.786
0.356
0.637
0.536
0.021
0.025
Interactionp-value
Jolly S et al. Lancet 2011;377:1409.
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RIFLE STEACS Flow Chart
Romagnoli E at al. JACC 2012
DESGN:
Prospective, randomized (1:1),
parallel group, multi-center trial
INCLUSION CRITERIA:
all ST Elevation Myocardial
Infarction (STEM) eligible for
primary percutaneous coronary
intervention.
ESCLUSION CRITERIA:contraindication to any of both
percutaneous arterial access,
INR > 2.0.
RIFLE STEACS T i l R lt NACE t
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RIFLE STEACS Trial: Results NACE rate
11.4 12.2
13.6
7.2 7.8
21.0
0
5
10
15
20
25
NACE MACCE Bleedings
Fermoral arm (N=501) Radial arm (N=500)
%
p = 0.003
p = 0.029 p = 0.026
Mortality: 9.2% 5.2% p=0.02
Romagnoli E at al. JACC 2012
Transradial PCI in AMI: REAL Multicenter Registry
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8.8
5.7
13.9
4.8
11.4
6.9
1.7
17.7
5.8
1.2
0
5
10
15
20
All Cause
Death
MI Stroke All Cause Death/MI/Stroke
Major Bleeding/Vascular Events
Transradial Group (n = 1501) Transfermoral Group (n= 1501)
Transradial PCI in AMI: REAL Multicenter RegistryClinical Outcomes in the Propensity Score-Matched at 2Y
%
Valgimigli et al., JACC Interv 2012;5:23.
P = 0.025
P = 0.27
P = 0.45
P = 0.013
P = 0.20
2012 T 10 Ad f I t ti l C di l
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2012 Top 10 Advances of Interventional Cardiology
1.
2.
3.4.
5. DAPT Duration Trials: PRODIGY, RESET
6. Transradial Intervention in STEMI: RIFLE-STEACS
7. YELLOW Trial: Change in plaque composition
8. Platelet Inhibition Studies: TRIGGER PCI, ARCTIC9. IABP Trials: CRISP-AMI, IABP-SHOCK II
10. TRIOLOGY Trial: Prasugrel vs. Clopidogrel in ACS
(Very) Late stent thrombosis
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(Very) Late stent thrombosisDES: Factors to consider
Discontinuation ofantiplatelet therapy
Delayedendothelialization
Late incompleteapposition
Polymer hypersensitivity/inflammation
Late StentThrombosis
Optimal Duration of ADP Receptor Blockers Post DES
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Optimal Duration of ADP Receptor Blockers Post DES
Still Remain Unclear (Aspirin 81-325 mg daily for life)
Cypher StentLaunch
5/2003
AHA/ACC PCIGuidelines 2001
(TAXUS stent 6 months post PCI)(Cypher stent 3 months post PCI)
AHA/ACC/SCAIUpdated Guidelines 2005
ESC 2005/ACC 2006PCI Updated Guidelines
(12 months post PCI)
CURE, PCI-CURE 2001CREDO 2002
TAXUS StentLaunch3/2004
(1-12 months post BMS)
9-12 months
BMS Era DES Era
(FDA recommendations)
Clopido/Prasugrel/Ticagshould be
continued for 1 yror even longer if nocontraindications
If not sure about DAPT compliance or has to be interrupted in
12M then BMS (Basket late) is safer & should be preferred
AHA/ACCUpdated Guidelines 2006
Stent Thrombosis Rates (ARC Definite)
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Stent Thrombosis Rates (ARC Definite)
XIENCEV
P=0.008
1.2
CYPHER
0.2
%
SORT-OUT IV
9 Months
XIENCEV
P=0.01
1.6
CYPHER
0.5
%
LESSON I
3 Years
XIENCEV
P
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REAL LATE/ZEST LATE Trials: 12M vs. 24M of Dual
Antiplatelet Therapy
0
1
2
3
4
5
MI, Strokeor death
%
12 Month Regimen (n=1357)24 Month Regimen (n=1344)
0.7 0.8
1.41.6
1.8
3.2
p=0.49
p=0.05
p=0.24
N Engl J med 2010;362:1374.
0.1 0.2p=0.35
2.4
3.1
p=0.22
0.40.4
p=0.76
Death MI TIMI MajorBleeding
Definite ST TLR
PRODIGY Trial: 6M vs 24M of Dual Antiplatelet Therapy
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0
5
10
15
PRODIGY Trial: 6M vs. 24M of Dual Antiplatelet Therapy
70 % second generation DES (Xience V/ Promus/ Endeavor)
Primary end point Death / MI TIMI Major Type 2, 3 or 5
Death/ MI/ Stroke Bleeding BARC bleeding
%
6M (N = 1012)
24M (N = 1001)
10.0 10.1
8.99.6
0.61.6
p= NS
p= NS
p= 0.0002
Valgimigli M et al. Circulation 2012;125:2015.
3.5
7.4
p= 0.041
ST1.0%0.9%
RESET Trial: Clinical Outcomes Through 1 Year
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Kim et al., JACC 2012:60:1340
4.7 4.7
0.5
1.0
0.2
0.4
3.93.7
0.2
0.30.5
1.0
0
1
2
3
4
5
Primary Death MI TVR Stent Major or minorEnd Point thrombosis bleeding
p= 0.84
p= 0.65
p= 0.39
p= 0.41
p= 0.70
p= 0.20
E-ZES + 3 Month DAPT (n=1059)
Standard Therapy (n=1058)
g
%
DAPT DURATION POST DES
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DAPT DURATION POST DES
Therefore DAPT duration of 6M is now
becoming the new 12M with newer
generation DES
What about DAPT discontinuation
POST DES?
Xience V USA Registry: Late ST Rates (30 D 1 Year)
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g y ( )
After DAPT Interruption
0
0.5
1
1.5
2
SubsequentLateST(ARCDef/Prob)(%)
No Interruption InterruptionAfter 30 Days
13/3500 2/1272 0/292 0/120
InterruptionAfter 180 Days
2/435 0/157
InterruptionAfter 90 Days
1/378 0/147
Overall
0.26
0
0.370.49
Standard (Low) Risk
0
0.16
0 0
Krucoff, Hermiller, Sharma et al. JACC Intervent 2011;4:1298.
Proposed Management of Patients Requiring
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p g q g
Temporary DAPT Cessation: MSH Protocol
Emergent need for surgery
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2012 Top 10 Advances of Interventional Cardiology
1.
2.
3.4. DES Comparison Trials: RESOLUTE, PLATINUM
5. DAPT Duration Trials: PRODIGY, RESET
6. Transradial Intervention in STEMI: RIFLE-STEACS
7. YELLOW Trial: Change in plaque composition
8. Platelet Inhibition Studies: TRIGGER PCI, ARCTIC9. IABP Trials: CRISP-AMI, IABP-SHOCK II
10.TRIOLOGY Trial: Prasugrel vs. Clopidogrel in ACS
Drug Eluting Stent System:
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Drug Eluting Stent System:
First vs. Second Generation New Stent DesignsXIENCE V
PROMUS
ENDEAVOR TAXUSEXPRESS
LIBERTE
CYPHER
Stent Material CobaltChromium
CobaltChromium
StainlessSteel
StainlessSteel
Bare StrutThickness
0.0032 0.0036 0.0052 0.0055
Bare StrutThickness
81m 91m 132m 140m
PolymerThickness
7m 6m 16m 14m
Total
Thickness
88m 97m 148m 154m
Drug Everolimus Zotarolimus Paclitaxel Sirolimus
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Endothelial Cell Recovery Between ComparatorPolymer-Based Drug-Eluting Stents
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Polymer-Based Drug-Eluting Stents
Joner et al. J Am Coll Cardiol 2008;52:333
Scanning Electron Micrographs of 14-DayComparator DES and BMS Controls
The upper panels show corresponding radiographic images ofeach stent. The lumens are clearly patent and struts are easilydiscerned underneath a thin neointimal surface. Among DES,there is less endothelial cell surface coverage in SES and PESstents compared with ZES and EES. The panel insets arerepresentative images at higher magnification (200) fromproximal and distal regions showing bare struts, surface thrombi,inflammatory cells, and endothelial cells.
Scanning Electron Micrographs of 28-DayComparator DES and BMS Controls
The upper panels show corresponding radiographic images of eachstent. The lumens are patent and struts are less discernable under athicker neointima relative to 14-day stents. Overall endothelialcoverage is near complete in all DES although it remains poor abovestruts in PES and SES compared with ZES and EES. The panelinsets are at higher magnification (200) from the proximal anddistal regions and show persistent uncovered struts, surface thrombi,inflammatory cells, and endothelial cells.
SPIRIT IV: Ischemia-Driven TLR Through
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Ische
mia-drivenTLR(%)
2 Years
Number at risk
XIENCE V 2458 2419 2392 2350 2318 2291 2269 2246 2226
TAXUS1229 1186 1159 1140 1124 1112 1104 1093 1073
Months
6.9%
4.5%
p=0.004
HR [95%CI] = 0.66 [0.50, 0.88]
2.4%4.6%
2.4%
p=0.0007
HR [95%CI] = 0.54 [0.38, 0.78]
2.2%
XIENCE V (n=2458)
TAXUS (n=1229)
Stone et al. JACC 2011;58:19.
Comparison of Everolimus-Eluting Vs. Paclitaxel-
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0
2
4
6
8
10
%
Paclitaxel-Eluting Stent (n=903)
Everolimus Stent (n=897)
p=0.007
p=0.58
p=0.0001
2.0
6.0
2.02.03.0
5.0
Death MI TVR MACE Stent Thrombosis
Eluting Stents in Real-life Practice: COMPARE TrialMajor Adverse Cardiac Events
p=0.002
p=0.029.0
6.0
3.0
0.7
Kedi E et al. Lancet 2010; 375:201.
Resolute All Comers Trial
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0
3
6
9
12
15
%
Zotarolimus-Eluting Stent (n=1119) Resolute DESEverolimus-Eluting Stent (n=1126) XienceV DES
p=0.57
p=0.36
Clinical Outcomes at 24 Months
p=0.52
p=0.75
p=0.073.2
1.01.9
12.912.5
9.110.0
4.0
5.55.0
Death MI TVR MACE Stent ThrombosisDefinite/Probable
Silber et al., thelancet. 2011;377:1241
PLATINUM Trial: 1-Year Clinical Outcomes
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Stone et al., JACC 2011;57:1700
P=0.97
P=0.85P=0.25
P=0.83
P=0.72
P=1.00
%
Overview of Bioresorbable Stents
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Company Picture Polymer/Drug Features
Igaki-Tamai
(2000)
PLLA
PLLA plus Tranilast
Zig-zag design
deployed with a
heated balloon
Biotronik
(2006)
Mg alloy Balloon expandable
design
Abbott (BVS)
(2006)
PLLA with everolimus Balloon expandable
Reva Medical
(2008)
Tyrosine poly carbonate
with iodine radio-opacity
Design has ratchet
links for deployment
BTI
(2008)
Salicylic acid blended into
polymer
Balloon expandable
Abbott Bioabsorbable Stent (BVS) ABSORBBioabsorbable Stent Technology
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bbott oabso bab e Ste t ( S) SO
Trial
At 2 yrs FU:
progressive polymer degradation normal histopathologic healing
restored vasoreactivity
late positive remodeling
Serruys et al. Lancet 200
ABSORB B Group 1 & 2
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30 days 6 months 1 Year 2 Years
Non-Hierarchical N=101 N= 101 N=101 N=100*
Cardiac Death% 0 0 0 0
Myocardial Infarction % (n) 2.0 (2) 3.0 (3) 3.0 (3) 3.0 (3)
Q-wave MI 0 0 0 0
Non Q-wave MI 2.0 (2) 3.0 (3) 3.0 (3) 3.0 (3)
Ischemia driven TLR % (n) 0 2.0 (2) 4.0 (4) 6.0 (6)
CABG 0 0 0 0
PCI 0 2.0 (2) 4.0 (4) 6.0 (6)
Hierarchical MACE % (n) 2.0 (2) 5.0 (5) 6.9 (7) 9.0 (9)*one patient missed the 2-year FUP
No scaffold thrombosis by ARC or Protocol out to 2-YearOnly 2 additional TLR events between 1 year and 2 years
Clinical Results - Intent to treat
SE2936417 Rev. A Absorb BVS is neither approved nor available for sale in the U.S.
Note: Absorb BVS is currently CE marked. Information provided for educational purposes only.
MACE: Cardiac death, MI, ischemia-driven TLRTVF: Cardiac death, MI, ischemia-driven TLR, ischemia-driven TVR
Drug Eluting Stents Comparison:RCT(Scale of 1+Bad to 4+Best)
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(Scale of 1+Bad to 4+Best)
Cypher Taxus Resolute/E Xience/Promus
Efficacy
TLR ++++ +++ + ++++
MI - - ++ ++
Death - - - -
Safety
Early stentthrombosis
- - -/+ ++
Late stent
thrombosis
- - ++ +++
Crossability/Trackability - + ++++ ++++
Market Share (%) -
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1.
2.
3. SYNTAX Trial: 5-Year follow-up4. DES Comparison Trials: RESOLUTE, PLATINUM
5. DAPT Duration Trials: PRODIGY, RESET
6. Transradial Intervention in STEMI: RIFLE-STEACS
7. YELLOW Trial: Change in plaque composition
8. Platelet Inhibition Studies: TRIGGER PCI, ARCTIC9. IABP Trials: CRISP-AMI, IABP-SHOCK II
10.TRIOLOGY Trial: Prasugrel vs. Clopidogrel in ACS
SYNTAX Trial
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Limited ExclusionCriteriaPrevious
interventions (PCI orCABG)Acute MI with CPK>2xConcomitant valve
surgery
De novo disease
Isolated left mainRevascularization inall 3 vascular territories
3-vessel diseaseleft main +1-vessel disease
left main +2-vessel disease
left main +3-vessel disease
Eligible PatientsSyntax Objective: To compare the MACCE rate at 12 months between patients
treated with TAXUSstents vs. patients undergoing CABG for de novo 3VDand/or LM disease. (*MACCE = major adverse cardiac and cerebrovascularevents; defined as death, stroke, MI, or repeat revascularization)
Serruys P et al. NEJM 2009;360:961.
SYNTAX Trial: All-Cause Death/CVA/MI to 5 Years
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ITT population
TAXUS (N=903)CABG (N=897)
Months Since Allocation
CumulativeEventRate(%)
Before 1 year*
7.7% vs 7.6%P=0.98
1-2 years*
2.2% vs 3.5%P=0.11
2-3 years*
2.5% vs 3.8%P=0.14
3-4 years*
2.7% vs 4.6%P=0.051
16.7%
0
25
50
20.8%
4-5 years*
3.1% vs 3.1%P=0.98
P=0.03
0 12 6024 36 48
P=0.03
SYNTAX Trial: Repeat Revascularization to 5 Years
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ITT population
TAXUS (N=903)CABG (N=897)
P
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TAXUS (N=903)CABG (N=897)
0000CumulativeEv
entRate(%)
Months Since AllocationITT population
Before 1 year*
12.4% vs 17.8%P=0.002
1-2 years*
5.7% vs 8.3%P=0.03
2-3 years*
4.8% vs 6.7%P=0.10
3-4 years*
4.2% vs 7.9%P=0.002
P
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Serruys P et al. NEJM 2009;360:961.
Syntax score is purelyan anatomic score of the
extent of CAD (>50%) in a pt
Each lesion is assigned anumerical number and then
sum of all lesions scorefor a patient is
calculated to come upwith the final numerical
Syntax score
Pt are divided in 3 groups:
Low 32
SYNTAX Trial: MACCE vs. SYNTAX Score
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0
5
10
15
20
25
22 23-32 33
MACCEat12M
onths(%)
14.7
13.6 12.0
16.7
10.9
23.4*
SYNTAX Score
*P= 0.03 vs PCI with SYNTAX score 22P= 0.002 vs PCI with SYNTAX score 23-32
Trend for PCI: P=0.006
P< 0.001
Serruys P et al. NEJM 2009;360:961.
CABG (n= 897)
TAXUS (n= 903)
SYNTAX Trial:MACCE to 5 Years by
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CABG PCIP
value
Death 10.1% 8.9% 0.64
CVA 4.0% 1.8% 0.11
MI 4.2% 7.8% 0.11
Death,
CVA orMI
14.9% 16.1% 0.81
Revasc 16.9% 23.0% 0.06
P=0.43
OverallTAXUS (N=299)CABG (N=275)SYNTAX Score Tercile Low Scores (0-22)
32.1%
28.6%
Cumulative KM Event Rate 1.5 SE; log-rank Pvalue
Months Since Allocation
CumulativeEve
ntRate(%)
0 12 24
50
0
25
4836 60
SYNTAX Trial:MACCE to 5 Years by SYNTAX
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CABG PCIP
value
Death 12.7% 13.8% 0.68
CVA 3.6% 2.0% 0.25
MI 3.6% 11.2%
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OverallTAXUS (N=290)CABG (N=315)
Score Tercile High Scores (33)
P
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RevascMethod
COR LOE
CABG I B
PCI IIaFor SIHD when low risk of PCI complications and high likelihood ofgood long-term outcome (e.g., SYNTAX score of 22, ostial or trunk left
main CAD), and a signficantly increased CABG risk (e.g., STS-predictedrisk of operative mortality 5%)
B
IIbFor SIHD when low to intermediate risk of PCI complications andintermediate to high likelihood of good long-term outcome (e.g., SYNTAXscore of 2%)
B
III: HarmFor SIHD in patients (versus performing CABG) withunfavorable anatomy for PCI and who are good candidates for CABG
B
IIaFor UA/NSTEMI if not a CABG candidate B
IIaFor STEMI when distal coronary flow is
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CABG PCI
Two-vessel CAD with proximal LAD stenosis A A
Three Vessel CAD with low CAD burden (i.e., threefocal stenosis, low SYNTAX score) A A
Three-vessel CAD with intermediate to high CAD burden (i.e., multiple
diffuse lesions, presence of CTO, or high SYNTAX score >32). A UIsolated left main stenosis A U
Left main stenosis and additional CAD with low CAD burden (i.e., one to twovessel additional involvement, low SYNTAX score 32)
A I
Patel et al., JACC 2012; 59:0000
and LM Coronary Artery disease
Update in the incorporation of SYNTAX Score (23) forrevascularization choices in patients with extensive CAD
As you all know, since Jan 2010, we have incorporated Syntax score in stratifying patients for revascularization choices
(PCI CABG) f d d CAD d t ith S t33 h t hi h i l i k b i f ti ll
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(PCI or CABG) for advanced CAD and pts with Syntax score 33 who are not high-surgical risk, being preferentiallyreferred for CABG. This practice is further endorsed by the recent presentation of 3-year data of Syntax Trial at TCT 2010,
showing CABG arm having significantly lower individual endpoint of death or MI or revascularization versus Taxus DES
PCI, in these high Syntax score pts. Hence as per evidence-based guidelines, optimal coronary revascularization to high
Syntax score pts should be CABG. Therefore, patients with SYNTAX Score 33 and not having absolute contraindications
to CABG (included below), should be taken out of the cath room for discussion regarding choices of revascularization. As
a rule, these patients (SYNTAX Score 23) should be categorically recommended for CABG because of survival & MI
advantage over PCI. An opinion of a cardiac surgeon will be required if PCI is contemplated in these pts. Only exception to
this rule (taking the pt out of the cath room for discussion) could be, if the referring cardiologist (who has to be different
then the Interventionalist) is physically present in the cath lab and expresses strong desire against CABG (because of
his/her own belief or known wishes of the patient).
Patients with SYNTAX Score >22 but following situations and co-morbidities could be excluded from routine CT
surgery consultations:
1) Acute MI (STEMI or Non-STEMI)
2) Age >80 years old
3) Prior CVA/recent TIA
4) Severe COPD (FEV1 50
6) Participation in IRB approved trial of PCI
Also patients firm refusal for CABG should be entertained only after the CT surgery consultation outside the cath
room in the holding area or the telemetry unit.
We will continue to monitor and report the data of this system process going forward by analyzing the triage of all
CAD pts with Syntax score of (23).
EXCEL Trial (Evaluation of Xience Prime vs. CABGfor Examination of LM Disease)
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LM disease (1, 2 or 3 vessel disease) and aSYNTAX score of 32
Randomize 2600 pts
ABBOTT Vascular
XIENCE Prime stent CABG
The primary endpoint is the composite incidence of death, large MI or stroke at a
median FU duration of 3 years, powered for sequential non-inferiority and
superiority testing.
The major secondary endpoint is the composite incidence of death, MI, stroke or
unplanned repeat revascularization. All patients will be followed for 5 years total.
2012 Top 10 Advances of Interventional Cardiology
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1.
2. FAME II Trial: PCI vs. MMT
3. SYNTAX Trial: 5-Year follow-up4. DES Comparison Trials: RESOLUTE, PLATINUM
5. DAPT Duration Trials: PRODIGY, RESET
6. Transradial Intervention in STEMI: RIFLE-STEACS
7. YELLOW Trial: Change in plaque composition
8. Platelet Inhibition Studies: TRIGGER PCI, ARCTIC9. IABP Trials: CRISP-AMI, IABP-SHOCK II
10.TRIOLOGY Trial: Prasugrel vs. Clopidogrel in ACS
FAME II Trial: Flow ChartStable patients scheduled for 1, 2 or 3 vessel DES stenting
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FFR in all targets lesions
Follow-up after 1 and 6 months and then 1, 2, 3, 4 and 5 years
Randomized TrialRegistry
At least 1 stenosiswith FFR < 0.80
When all FFR >0.80
OMT
OMTPCI + OMT
Randomization 1:1
50 % randomlyassigned to FU
FAME II Trial: Cumulative Incidence of Primary
E d P i t d It C t
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Bruyne et al., NEJM 2012:367:991
End Points and Its Components
FAME II Trial Results
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FFR-GuidedPCI
(n=447)MT
(n=441)p
value
Primary Endpoint 4.3% 12.7%
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(
%)
3.1
1.6 1.6
3.62.4
1.2
19.5
11.1
8.6
0
5
10
15
20
Any Revascularization Urgent
Revascurization
Non-Urgent
Revascurizaton
PCI+MT (n=447)
Registry (n=166)
P
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Conclusions
In patients with stable coronary artery disease and functionally significant stenosis, FFR-guided PCI plus the best available medical therapy, as compared with the best available
medical therapy alone, decreased the need for urgent revascularization. In patients
without ischemia, the outcome appeared to favorable with the best available medical
therapy alone. (Funded by St. Jude Medical; Clinic al trials. Gov. number. NCT 01132495)
Page 991
2012 Top 10 Advances of Interventional Cardiology
1 FREEDOM Trial CABG PCI i MV di b t
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1. FREEDOM Trial: CABG vs. PCI in MV diabetes
2. FAME II Trial: PCI vs. MMT
3. SYNTAX Trial: 5-Year follow-up4. DES Comparison Trials: RESOLUTE, PLATINUM
5. DAPT Duration Trials: PRODIGY, RESET
6. Transradial Intervention in STEMI: RIFLE-STEACS
7. YELLOW Trial: Change in plaque composition
8. Platelet Inhibition Studies: TRIGGER PCI, ARCTIC9. IABP Trials: CRISP-AMI, IABP-SHOCK II
10.TRIOLOGY Trial: Prasugrel vs. Clopidogrel in ACS
FREEDOM Trial: TRIAL SCREENING & ENROLLMENT
32 966 Patients were screened for eligibility
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16 withdrew post-procedure
43 were lost to follow-up
947 Randomized to CABG*18 underwent PCI/DES
26 withdrew prior to procedure3 died prior to procedure7 underwent neither PCI/DES or
CABG
953 Randomized to PCI/DES*5 underwent CABG
3 withdrew prior to procedure3 died prior to procedure3 underwent neither PCI/DES or
CABG
32,966 Patients were screened for eligibility
3,309 were eligible (10%)
1,409 did not consent 1,900 consented (57%)
36 withdrew post-procedure
51 were lost to follow-up
*953 and 947 included ITT analysis using all available follow-up time post-randomization
PCI/DES
FREEDOM Trial: PRIMARY OUTCOME DEATH / STROKE / MI
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30
20
10
0
Death/Stroke/MI%
PCI/DES
Logrank P=0.005
CABGPCI/DES
CABG
5-Year Event Rates: 26.6% vs. 18.7%
0 1 2 3 4 5 6
Years post-randomization
PCI/DES N 953 848 788 625 416 219 40
CABG N 947 814 758 613 422 221 44
FREEDOM Trial: ALL-CAUSE MORTALITY
PCI/DES
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Years post-randomization
0 1 2 3 4 5
0
10
20
30
All-Cause
Mor
tality% CABG
CABG
PCI/DES
953 897 845 685 466 243PCI/DES N
947 855 806 655 449 238CABG N
Logrank P=0.049
5-Year Event Rates: 16.3% vs. 10.9%
FREEDOM Trial: MYOCARDIAL INFARCTION
%PCI/DES
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Years post-randomization0 1 2 3 4 5
0
10
20
30
MyocardialInfar
ction%
C S
CABG
CABG
PCI/DES
953 853 798 636 422 220PCI/DES N
947 824 772 629 432 229
Logrank P
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Years post-randomization
0 1 2 3 4 5
0
10
20
30
Stroke%
PCI/DES
CABG
PCI/DES 2.4%
CABG
953 891 833 673 460 241PCI/DES N
947 844 791 640 439 230CABG N
Logrank P=0.034
5.2%
Severely DisablingScale CABG PCI/DES
NIH > 4 55% 27%
Rankin >1 70% 60%
30
,%
PCI/DES
CABG
FREEDOM Trial: REPEAT REVASCULARIZATION
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0
10
20
0 1 2 3 4 5 6 7 8 9 10 11 12
Months post-procedure
RepeatRevascularization
CABG
PCI/DES
944 887 856 818 792PCI/DES N911 858 836 825 806CABG N
Log rank P
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100
90
80
70
60
50
4030
20
10
0
0.0 1.0 2.0 3.0 4.0 5.0
SYNTAX Score 22 (N 669)
CABG
PCI/DES
5-Year Event Rates: 23.2%17.2%
FreedomfromEvent(%
Years post-randomization
100
90
80
70
60
50
4030
20
10
0
0.0 1.0 2.0 3.0 4.0 5.0
SYNTAX Score 23 32 (N 844)
CABG
PCI/DES
FreedomfromEvent(%
Years post-randomization
5-Year Event Rates: 27.2%17.7%
100
90
80
70
60
50
4030
20
10
0
0.0 1.0 2.0 3.0 4.0 5.0
SYNTAX Score 33 (N=374)
CABG
PCI/DES
Freedomf
romEvent(%)
Years post-randomization
5-Year Event Rates: 30.6%22.8%
Conclusions In patients with diabetes and advanced coronary
disease, CABG was of significant benefit as
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disease, CABG was of significant benefit ascompared to PCI. MI & all cause mortality wereindependently decreased, while stroke was
slightly increased
There was no significant interaction between the
treatment effect of CABG on the primaryendpoint according to SYNTAX score or anyother prespecified subgroup.
CABG surgery is the preferred method ofrevascularization for patients with diabetes &multi-vessel CAD.
2012 Top 10 Advances of Interventional Cardiology
1. FREEDOM Trial: CABG vs. PCI in MV diabetes
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1. FREEDOM Trial: CABG vs. PCI in MV diabetes
2. FAME II Trial: PCI vs. MMT
3. SYNTAX Trial: 5-Year follow-up4. DES Comparison Trials: RESOLUTE, PLATINUM
5. DAPT Duration Trials: PRODIGY, RESET
6. Transradial Intervention in STEMI: RIFLE-STEACS
7. YELLOW Trial: Change in plaque composition
8. Platelet Inhibition Studies: TRIGGER PCI, ARCTIC
9. IABP Trials: CRISP-AMI, IABP-SHOCK II
10.TRIOLOGY Trial: Prasugrel vs. Clopidogrel in ACS
2012 Top 10 Advances of Interventional Cardiology
R f l i f h i l
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Reasons for selection of the articles
Revolutionary / significant observation
Widespread acceptance
Change in clinical practiceIABP, PI Testing, Prasugrel in ACS:
Infraredex, Xience V:
DAPT 6M, TRI in STEMI:
FREEDOM, FAME II, Syntax Scoring:
Final result BETTER INTERVENTION/SURVIVAL
2007 (n= 4422)2008 (n= 4594)
MSH:Temporal Trends in Complications of PCIOver 5 years with
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0
0.2
0.4
0.6
0.8
%
2008 (n= 4594)
2009 (n= 5078)
2010 (n= 4799)
2011 (n= 4707)
In-hospital death Urgent CABG Q-wave/Large MI Major Complications(death, rCABG, MI, CVA)
0.06
0.0
0.21
0.270.24
0.16
0.23
0.040.0
0.080.09
0.110.09
0.08 0.08
0.490.520.53 0.51
0.58
...
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PCI Statistics 2008-10 # cases All casesNon-Emergency Emergencycases cases
1. Mount Sinai Hospital 14414 0.64** 0.41** 2.55
2. Saint Francis Hospital 9045 0.61** 0.35** 2.74
3. Columbia Presbyterians H 8750 0.87 0.59 2.36
4. Lenox Hill Hospital 8504 0.81 0.47 3.24
5. Saint Josephs Hospital 6510 0.83 0.58 2.576. North Shore Hospital 6112 0.70 0.56 1.72**
7. LIJ Medical Center 5896 0.63 0.36 2.45
8. Rochester General Hospital 5801 1.29* 0.77* 4.33
9. Stony Brook Hospital 5335 0.98 0.58 3.48
10. Beth Israel Medical Ctr 5073 0.65 0.30** 3.70
**RAMR significantly lower, *RAMR significantly higher than statewide rate
NYS Total 162918 0.90 0.55 3.17http://www.nyhealth.gov
Data on Top 10 Volume Centers in NY State 30-Day RAMR
PCI S i i f 20 0Non-Emergency Emergency
NYS-DOH Report of PCI 2010
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PCI Statistics for 2010 # cases All casesNon Emergency Emergencycases cases
1. Mount Sinai Hospital 4777 0.57 0.36 2.55
2. Saint Francis Hospital 2936 0.74 0.48 2.74
3. Columbia Presbyterians H 2856 0.81 0.55 2.36
4. Lenox Hill Hospital 2740 0.71 0.40 3.75
5. St Josephs Hospital 2314 0.86 0.61 2.886. LIJ Medical Center 2019 0.84 0.63 2.07
7. Stony Brook Hospital 1762 0.93 0.52 3.78
8. Beth Israel Medical Ctr 1762 0.75 0.40 3.89
9. Rochester General Hospital 1899 0.95 0.73 2.50
10. North Shore Hospital 1850 0.78 0.56 2.32
NYS Total 54035 0.84 0.51 3.09http://www.nyhealth.gov
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Conclusions
For patients with diabetes and advanced coronary artery disease, CABG was
superior to PCI in that it significantly reduced rates of death and myocardial
infraction, with a higher rate of stroke. (Funded by the National Heart, Lung, and
Blood Institute and others; FREEDOM ClinincalTrials.gov number, NCT00086450.)
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