hidden menace -stent thrombosis in drug eluting stent era
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Hidden Menace-Stent Thrombosis
in Drug Eluting Stent Era
Prof. Baogui SUNShanghai First People’s Hospital
What Are We Worrying About?
Stent Thrombosis
• Definite/Confirmed– Acute coronary syndrome AND– [Angiographic confirmation of thrombus
or occlusion OR– Pathologic confirmation of acute
thrombosis]
• Probable– Unexplained death within 30 days– Target vessel MI without angiographic
confirmation of thrombosis or other identified culprit lesion
• Possible– Unexplained death after 30 days
ARC Definition of Stent Thrombosis
Timing Classification of Stent Thrombosis
ST = stent thrombosis; SAT = subacute stent thrombosis;LST = late stent thrombosis; VLST = very late stent thrombosis.Adapted from Bhatt. J Invasive Cardiol. 2003;15(suppl B):3B.
DES definite ST incidence:Bern - Rotterdam Cohort Study
Daemen, Wenaweser et al. Lancet 2007;369:667-78
0.6% / yearEarly ST 91 pts(60%)
Late ST 61 pts (40%)
Incidence density:
1.3 / 100 patient years
N=8146
0.52% (95% CI=0.42-0.62)/ year
between 30 days and 5 years
DES Definite ST Incidence:Bern-Cohort Study @ 5 Years
Wenaweser P et al. ESC 2008
Overall Incidence of ST with DES
CYPHER
TAXUS ENDEAVOR XIENCE
BIOMATRIX
0.4 0.3
0.70.5
1.61.4
0.8
TAXUS II
TAXUS IV
TAXUS V
TAXUS VI
REALITY
SIRTAX
ISAR-D
M
1
0.5
0.8
1.9
Endea
vor I
Endea
vor I
I
Spirit I
II
Lead
ers
0.2
1.1
2
0.6
1.8
0.8
00
1
2
3
SIRIU
S
E-SIR
IUS
C-SIR
IUS
REALITY
SIRTAX
ARTS II
ISAR-D
M
%
Causes of Stent Thrombosis
STENT THROMBOSIS
StentDesign/Length
PolymerSurfaceDrugs
LesionVessel SizeThrombus
InterventionResidual Dissection
Incomplete Stent AppositionAntithromobotic Medication
PatientGenetic Polymorphism
Reduced LV-EFAcute Coronary Syndrome
Hematology Disorder
DrugsResistance
Drug-drug InteractionDuration of Antiplatelet
Treatement
Vessel ReactionVessel Remodelling
Hypersensitivity ReactionDelayed Healing
Procedure and Lesion- related Parameters
• Use of multiple stents • Small vessel diameter • Residual dissection • Geographic miss • Slow flow • Long and/or bifurcation
lesions • Mal-apposition and/or under-
expansion of the stent
Patient Characteristics
• Diabetes • Acute Coronary Syndromes
(especially STEMI) • Left ventricular dysfunction • Renal failure • Advanced age • High platelet reactivity
Anti-platelet therapy
• Inadequate intensity of therapy (i.e. non-dual platelet inhibition or insufficient dose)
• Non-compliance • Premature cessation of anti-
platelet therapy
Reasons of ST in pts with anti-platelet therapyReasons of ST in pts with anti-platelet therapy
Antiplatelet therapy at time of ST occurrence
Bern-Rotterdam Cohort Study @ 5 YearsWenaweser P et al. ESC 2008
Impact of Platelet Reactivity after Clopidogrel Administration on Drug-Eluting Stent Thrombosis
Buonamici P et al JACC 2007
2.3 1.70.6
1.4
8.6
3.84.8
8.6
0
5
10
Definite/Probable ST
Early ST Late ST Mortality
Responders (n=699)
Non-Responders (n=105)p<0.001 p<0.001
p<0.001p=ns
Stent Characteristics
• Stent design and structure
• Strut profile or thickness
• Polymer nature and type
• Drug which stent coated
Triton TIMI 38 – Prasugrel vs.
Clopidogrel in ACS Patients With Stents
Wiviott SD et al. Lancet 2008;371:1353-63
Overall Stent Thrombosis
Early Stent Thrombosis
Late Stent Thrombosis
Park et alAm J Card 2006
Airoldi et alCirculation 2007
Iakovou et alJAMA 2005
Machecourt et alJACC 2007
OR=1.03(1.00-1.05)
OR=1.01(1.00-1.03)
OR=2.75(1.55-4.88)
Od
ds
Rat
ioPredictor: Length of Stent
OR=1.02(1.00-1.04)
OR=1.08(1.06-1.1)
De la Torre et alJACC 2008
Roy et alJ Interv Card 2007
Kuchulakanti et alCirculation 2006
OR=4.4(2.0-10.0)
Odd
s R
atio
Predictor: Bifurcated Lesion
OR=2.4(1.1-5.6)
Iakovou et alJAMA 2005
OR=6.4(2.9-14.1)
Ong et alJACC 2005*
OR=12.9(4.7-35.8)
*in setting of AMIJoner et al JACC 2006
Park et alAm J Card 2006
Daemen et alLancet 2007
Urban et alCirculation 2006
OR=12.4(1.7-89.7)
OR=2.3(1.3-4.0)
OR=1.8(1.1-2.7)
Od
ds/
Haz
ard
Rat
ioPredictor: ACS
De la Torre et alJACC 2008
HR=2.6(1.3-4.9)
Impact of Thrombus Burden on Risk of ST With DES in Pts With STEMI
Sianos G et al. J Am Coll Cardiol 2007;50:573-83
Variable Hazard Ratio 95% CI
Age 0.6 0.4-0.8
Index ST 6.2 2.1-18.9
Bifurcation 4.1 1.6-10.0
Thrombectomy 0.1 0.01-0.8
Large thrombus 8.7 3.4-22.5
Independent Predictors of ST
Kuchulakanti Circ 2006
Urban Circ 2006
IakovouJAMA 2005
DaemenLancet 2007
Machecourt JACC 2007
OR=2.0(0.8-4.9)
OR=2.8(1.7-4.3)
HR=3.7(1.7-7.9)
HR=2.0(1.1-3.8)
OR=2.7(1.4-5.2)
Od
ds/
Haz
ard
Rat
ioPredictor: Diabetes
IijimaAm J Card 2007
HR=2.2(1.1-4.3)
HR=1.75(1.0-3.0)
De la TorreJACC 2008
Favours DES Favours BMS
>18
0 d
ays 3
1-1
80 d
ays0
-30
day
sT
ime
aft
er P
CI
.1 .2 .5 1 2 5 10 20 50 100
Odds Ratio
Favors DES Favors BMS
.1 .2 .5 1 2 5 10 20 50 100
Odds Ratio
Adjusted Resultswith interaction terms for time since PCI
Early period: 0-30 daysOR 0.59, 95% CI .35 - 1.01
Late period: 31-180 daysOR 0.52, 95% CI .16 – 1.75
Very late period: > 180 daysOR 9.4, 95% CI 2.56 – 34.70
Wenaweser et al. ACC 2007
DES vs BMSA cohort of 9,175 patients treated with either BMS or DES
(SES or PES), all patients with angiographically documented ST were identified as cases
Probable Causes of Late Stent Thrombosis
• Chronic inflammatory reaction to the polymer or drug
• Hypersensitivity to the polymer or drug
• Failure of stents to reendothelialize completely
• Late incomplete stent apposition• Disease progression
Late Incomplete Stent Apposition
Baseline 8 mo follow-up
SIRIUS Trial: 7/80 (8.7%) patients, no 12-month MACE
Ako J. et al. JACC 2005;46:1002-5
Cook et al. Circulation 2007Kotani et al. JACC 2006
Joner et al. JACC 2006Togni et al. JACC 2005
Abnormal Vasomotion Delayed Healing
Delayed Endothelialization Vessel Remodeling
Post-DES: Pathophysiologic Mechanism
Endothelialization
Clinical Outcomes of ST• Sudden Cardiac Death:
extremely dangerous• Non-fatal STEMI & NSTEMI:
most probably• Malignant Arrhythmias:
atypical• Chronic Total Occlusion:
gradually and asymptomatic
Treatment of Stent Thrombosis
Ⅰ. Repeated PCI:
most of pts
Ⅱ. Drug therapy:
all of pts
Ⅲ.Emergent CABG:
some of pts
Oral Medication
• Triple Antiplatelet Therapy: Clopidogrel & ASA & Cilostazol
• Double Dosage of Clopidogrel: 150mg per day.
• Prolonged Dual Antiplatelet Drug Therapy: >12 month ? longer is better?
• Dual Antiplatelet Drug Therapy & Oral Anticoagulation:
with warfarin ?
Prevention of Stent Thrombosis• Identification of High Risk Pts
modification of risks
• Avoidance of Abused Stent Deploymentlong stent, bifurcation stenting, stent overlapping
• Optimization of the Stent Deploymentno residual dissention,improve stent expansion
• Optimal anti-platelet therapyevaluate anti-platelet reactivity in high risk pts
• Prior to BMS in pts with low restenosis to the full extent possible
A Case of Very late ST
AMI for the First Time(22/Jun/2003)
• Female , 55 years old
• Chest Pain for 13 hrs , Medicine Treatment only in other Hospital, and to Our Hospital 1.5 Month later
• No History of Hypertension 、 DM 、 Dyslipidemia and Smoking
• ECG : V1~V2→QS , V3 → rS , V1~V3 → inversed T wave
• UCG : Slight Decreased Movement of Anterior Wall
CAG (7/Aug/2003) :Total Occlusion of LAD
The Result : Satisfied or Not ?
After PCI
• Clopidogrel was Stopped by the Pt 3-month after
PCI
• ASA 、 Statin 、 ACEI 、 Beta-blocker were kept
in using
• Symptom Free for 2 years, and Angina occurred 3
times in last 6 months before administration
AMI for the Second Time(11/Nov/2005)----27 Months Later
• Chest Pain for 4 hrs
• ECG: V2~V6→Elevated ST Segment for 0.1~0.6mV
• Markers of Myocardium : Normal for TNI 、 CK-
MB 、 MYO
• Primary PCI : 11/Nov/2005
CAG : Stent Thrombosis with TIMI II Flow, LCX Affected
What to do?
10 days laterIncomplete Stent Apposition
Tirofiban and IABP
AMI for the Third Time(11/Aug/2006)----36 Months Later
• Chest Pain for 3 hrs
• ECG: V2~V6→Elevated ST Segment for 0.1~0.5mV
• Markers of Myocardium : Normal for TNI、 CK-MB 、 MYO
• Primary PCI : 11/Aug/2006
CAG : LAD Occluded with In-stent Thrombosis, LCX AffectedWhat to do?
PTCA:Wire: ATW/BMWBallon: Sprinter 2.5*15mm
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