ivus findings in des thrombosis
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Cardiovascular Research FoundationCardiovascular Research FoundationNew York, NYNew York, NY
IVUS Findings in DES IVUS Findings in DES ThrombosisThrombosis
Gary S. Mintz, MDGary S. Mintz, MD
StentStent UnderexpansionUnderexpansion
Predictors of Predictors of CypherCypher Thrombosis @ CRFThrombosis @ CRF
00112233445566778899
1010
Minimum Minimum stentstentCSA (mmCSA (mm22))
StentStent expansionexpansion(%)(%)
Residual edgeResidual edgestenosisstenosis (%)*(%)*
SES Thrombosis (n=15)SES Thrombosis (n=15)
Matched controls (n=45)Matched controls (n=45)
00101020203030404050506060707080809090
100100
••2,575 patients were treated with 4,722 2,575 patients were treated with 4,722 CypherCypher stentsstents. . ••21 (0.8%) had 21 (0.8%) had stentstent thrombosis of whom 15 had IVUS thrombosis of whom 15 had IVUS ••12/15 SES thrombosis lesions has 12/15 SES thrombosis lesions has stentstent CSA <5.0mmCSA <5.0mm22 (vs 13/45 controls)(vs 13/45 controls)
**Residual edge Residual edge stenosisstenosis = edge lumen CSA <4.0mm= edge lumen CSA <4.0mm22 & plaque burden >70%.& plaque burden >70%.
((FujiiFujii et al. J Am et al. J Am CollColl CardiolCardiol 2005;45:9952005;45:995--8)8)
Predictors of DES Thrombosis @ WHCPredictors of DES Thrombosis @ WHC
30301414NN
0.140.144545±±14145353±±1515Largest plaque burden (%)Largest plaque burden (%)0.120.125.35.3±±2.12.14.34.3±±1.71.7Smallest lumen CSA (mmSmallest lumen CSA (mm22))
Distal referenceDistal reference0.0790.0796.86.8±±2.22.25.65.6±±1.61.6Distal edge CSA (mmDistal edge CSA (mm22))0.04890.04895.65.6±±1.71.74.64.6±±1.11.1MSA (mmMSA (mm22))0.170.177.07.0±±2.12.16.16.1±±1.71.7Proximal edge CSA (mmProximal edge CSA (mm22))
StentStent0.00180.00185656±±10106666±±88Largest plaque burden (%)Largest plaque burden (%)0.0670.0676.0 6.0 ±±2.32.34.74.7±±1.11.1Smallest lumen CSA (mmSmallest lumen CSA (mm22))
Proximal referenceProximal reference
PP--valuevalueMatched Matched ControlsControls
StentStentThrombosisThrombosis
(Okabe et al., Am J (Okabe et al., Am J CardiolCardiol. In press). In press)
0
1
2
3
4
5
6
7
3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0
ST (n=14)Controls (n=30)
Predictors of DES Thrombosis @ WHCPredictors of DES Thrombosis @ WHC
#
Minimum stent CSA (mm2)(Okabe et al., Am J (Okabe et al., Am J CardiolCardiol. In press). In press)
Comparison of IVUSComparison of IVUS--measured minimum measured minimum stentstent diameter diameter (MSD) and minimum (MSD) and minimum stentstent area (MSA) with the predicted area (MSA) with the predicted measurements from measurements from CordisCordis ((CypherCypher in yellow, n=133) and in yellow, n=133) and BSC (BSC (TaxusTaxus in red, n=67). DES achieve an average of only in red, n=67). DES achieve an average of only
75% of the predicted MSD (66% of MSA)75% of the predicted MSD (66% of MSA)
0
2
4
6
8
10
12
14
0 2 4 6 8 10 12 14
IVU
S M
easu
red
MS
A (m
m2 )
Predicted MSA (mm2)
0
1
2
3
4
5
0 1 2 3 4 5IV
US
Mea
sure
d M
SD
(mm
)Predicted MSD (mm)
(de (de RebamarRebamar Costa et al, Am Heart J 2007;153:297Costa et al, Am Heart J 2007;153:297--303)303)
Why do some Why do some underexpandedunderexpanded DES DES thrombosis and some thrombosis and some restenoserestenose??
36/936/912/312/3Cypher/TaxusCypher/Taxus
1.01.040%40%40%40%MalappositionMalapposition at F/Uat F/U0.010.0111/3411/349/69/6Site of MSA (Site of MSA (ProxProx/Dist)/Dist)
<0.0001<0.0001110110±±23237777±±2323Diffuse expansion (%)Diffuse expansion (%)0.0010.0017575±±20205555±±1616Focal expansion (%)Focal expansion (%)0.010.014.94.9±±1.81.83.73.7±±0.80.8MSA (mmMSA (mm22))
<0.0001<0.00017.27.2±±2.12.15.25.2±±0.80.8Mean Mean stentstent CSA (mmCSA (mm22))StentStent
0.120.126.66.6±±1.81.87.47.4±±2.62.6Lumen CSA (mmLumen CSA (mm22))0.120.1211.811.8±±4.14.113.713.7±±3.83.8EEM CSA (mmEEM CSA (mm22))
ReferenceReference
PP--valuevalueRS (n=45)RS (n=45)ST (n=15)ST (n=15)
Independent predictors of ST (Independent predictors of ST (vsvs RS) were diffuse RS) were diffuse stentstent expansion expansion (OR=1.5, p=0.03) and proximal location of MSA site (OR=12.7, p=0(OR=1.5, p=0.03) and proximal location of MSA site (OR=12.7, p=0.04) .04)
(Liu et al, unpublished)(Liu et al, unpublished)
““UncoveredUncovered”” (Residual) Edge (Residual) Edge StenosesStenoses
Predictors of Predictors of CypherCypher Thrombosis @ CRFThrombosis @ CRF
00112233445566778899
1010
Minimum Minimum stentstentCSA (mmCSA (mm22))
StentStent expansionexpansion(%)(%)
Residual edgeResidual edgestenosisstenosis (%)*(%)*
SES Thrombosis (n=15)SES Thrombosis (n=15)
Matched controls (n=45)Matched controls (n=45)
00101020203030404050506060707080809090
100100
••2,575 patients were treated with 4,722 2,575 patients were treated with 4,722 CypherCypher stentsstents. . ••21 (0.8%) had 21 (0.8%) had stentstent thrombosis of whom 15 had IVUS thrombosis of whom 15 had IVUS ••12/15 SES thrombosis lesions has 12/15 SES thrombosis lesions has stentstent CSA <5.0mmCSA <5.0mm22 (vs 13/45 controls)(vs 13/45 controls)
**Residual edge Residual edge stenosisstenosis = edge lumen CSA <4.0mm= edge lumen CSA <4.0mm22 & plaque burden >70%.& plaque burden >70%.
((FujiiFujii et al. J Am et al. J Am CollColl CardiolCardiol 2005;45:9952005;45:995--8)8)
CypherCypher ThrombosisThrombosis
Plaque Plaque ProlapseProlapse
IntraIntra--stentstent acute plaque acute plaque prolapseprolapse in the in the DIABETESDIABETES--I and DIABETESI and DIABETES--II TrialsII Trials
00000000StentStent thrombosisthrombosis7.3%7.3%6.3%6.3%3.3%3.3%00RestenosisRestenosis
1.49mm1.49mm221.71mm1.71mm220.77mm0.77mm220.55mm0.55mm22F/UF/U000.63mm0.63mm22000.72mm0.72mm22PostPost--PCIPCI
Mean intraMean intra--stentstenttissuetissue
65651515606099NN
No plaque No plaque prolapseprolapse
Plaque Plaque prolapseprolapse
No plaque No plaque prolapseprolapse
Plaque Plaque prolapseprolapse
TaxusTaxusCypherCypher
P<0.05P<0.05((FutamatsuFutamatsu et al. J Am et al. J Am CollColl CardiolCardiol 2006;48:11392006;48:1139--45)45)
Acute Acute StentStent MalappositionMalapposition
•• Most acute incomplete Most acute incomplete stentstent apposition apposition is modest in sizeis modest in size
•• There is little or no data linking isolated There is little or no data linking isolated acute acute incomplete incomplete stentstent apposition to apposition to adverse clinical events (thrombosis or adverse clinical events (thrombosis or restenosisrestenosis))
Late Late StentStent MalappositionMalapposition
IVUS Predictors of Late (>12 months) IVUS Predictors of Late (>12 months) DES Thrombosis DES Thrombosis
34.639
18.6
8
0
10
20
30
40
Stentlength(mm)
StentOverlap (%)
6.6 68
776.6
81
12
0123456789
MSA (mm2) Expansion (%) Stentmalapposition @ time of LST (%)
Late DES Thrombosis (n=13)Controls (n=175)
0123456789
(Cook et al. Circulation, in press)(Cook et al. Circulation, in press)
P<0.001P<0.001P=0.04P=0.04
012345678
3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 9.5 10.0
10.5
ST <1yr (n=14)ST >1yr (n=13)
StentStent UnderexpansionUnderexpansion in Early in Early vsvs Late Late DES Thrombosis (ST)DES Thrombosis (ST)
# with ST
Minimum stent CSA (mm2)(Okabe et al., Am J (Okabe et al., Am J CardiolCardiol. In press). In press) (Cook et al. Circulation, in press)(Cook et al. Circulation, in press)
Quantification of LSM in Patients Quantification of LSM in Patients with Late DES STwith Late DES ST
8.3
6.3
1.8
4
1.50.8
0123456789
Maximum LSM(mm2)
Maximum LSMlength (mm)
Maximum LSM depth(mm)
10 Late ST with LSM
21 Controls with LSM
P<0.001P<0.001
P=0.03P=0.03
P=0.03P=0.03
(Cook et al. Circulation, in press)(Cook et al. Circulation, in press)
Two Cases of Late Two Cases of Late StentStentThrombosis after DES ImplantationThrombosis after DES Implantation
•• LSM @ 6 months occurred in 10/195 (5.1%) lesions overallLSM @ 6 months occurred in 10/195 (5.1%) lesions overall•• 7/175 7/175 sirolimussirolimus--eluting eluting stentsstents•• 3/20 3/20 paclitaxelpaclitaxel--eluting eluting stentsstents
•• Subsequent followSubsequent follow--up of 19up of 19±±9 months9 months•• Two patients developed late Two patients developed late stentstent thrombosis (331 and thrombosis (331 and
1152 days). These patients had a 20% (50mm1152 days). These patients had a 20% (50mm33) and a 39% ) and a 39% (135mm(135mm33) increase in EEM volume and, presumably, ) increase in EEM volume and, presumably, severe LSMsevere LSM
((SiquieraSiquiera et al. J Am et al. J Am CollColl CardiolCardiol 2006;47:365A)2006;47:365A)((FeresFeres et al. et al. CathCath CardiovascCardiovasc InterventIntervent 2006;68:832006;68:83--8)8)
Late Late StentStent MalappositionMalapposition (LSM) and Events (LSM) and Events in IVUS in IVUS SubstudiesSubstudies
00--3.43.4±±2.6mm2.6mm2 2 (max area)(max area)
0% persistent0% persistent9.5% late acquired9.5% late acquired
116116IIII--MRMR
CYPHERCYPHER003mm3mm22 (mean area)(mean area)
0.75mm (max depth)0.75mm (max depth)21% @ follow21% @ follow--upup48 (40%)48 (40%)RAVELRAVEL
(85%)(85%)TAXUSTAXUS
002.5% persistent2.5% persistent5.3% late acquired5.3% late acquired
209209SRSR
0010.3% persistent10.3% persistent16.7% late acquired16.7% late acquired
7878MRMR(20%)(20%)IV,V, and VIIV,V, and VI
00--5.15.1±±1.8mm1.8mm2 2 (max area)(max area)
4.4% persistent4.4% persistent8.0% late acquired8.0% late acquired
113113IIII--SRSR
000.40.4±±0.1mm (max depth)0.1mm (max depth)0.70.7±±0.3mm (max depth)0.3mm (max depth)
7.5% persistent7.5% persistent8.7% late acquired8.7% late acquired
80 (15%)80 (15%)SIRIUSSIRIUS
EventsEventsLSMLSM% With LSM% With LSM# (%) in # (%) in
IVUS IVUS substudysubstudy
TrialTrial
Late Acquired Late Acquired StentStent MalappositionMalapposition & & Events from Events from AsanAsan Medical CenterMedical Center
•• [Persistent [Persistent malappositionmalapposition in 51/705 (7.2%)]in 51/705 (7.2%)]•• Late acquired Late acquired malappositionmalapposition in 85/705 (12.1%) in 85/705 (12.1%)
•• 71/538 (13.2%) 71/538 (13.2%) sirolimussirolimus--eluting eluting stentsstents•• 14/167 (8.4%) 14/167 (8.4%) paclitaxelpaclitaxel--eluting eluting stentsstents•• 25.0% (4/16) after DCA before 25.0% (4/16) after DCA before stentingstenting•• 27.5% (14/51) in CTO lesions27.5% (14/51) in CTO lesions•• 31.8% (7/22) after primary 31.8% (7/22) after primary stentingstenting in acute MIin acute MI
•• StentStent--vessel wall gapvessel wall gap•• 1.91.9±±1.2mm1.2mm22 (patients with persistent (patients with persistent malappositionmalapposition))•• 3.03.0±±1.9mm1.9mm22 (patients with acquired (patients with acquired malappositionmalapposition))
•• Except for only one death in the nonExcept for only one death in the non--LSM group, there were no LSM group, there were no MACE in either LSM or nonMACE in either LSM or non--LSM patients during a mean 10LSM patients during a mean 10--month month followfollow--up after detection of LSM.up after detection of LSM.
(Hong et al. Circulation 2006;113:414(Hong et al. Circulation 2006;113:414--9)9)
Strut Fracture and Inhomogeneous Strut Fracture and Inhomogeneous Strut DistributionStrut Distribution
DES after VBT failure DES after VBT failure for Rx of BMS for Rx of BMS
RestenosisRestenosis
ab
c
proximal2 years later2 years later
•• The most important IVUS findings in patients with The most important IVUS findings in patients with stent stent thrombosis (especially, within 1 year) continue thrombosis (especially, within 1 year) continue to be to be stent underexpansion stent underexpansion and inflow/outflow and inflow/outflow stenosesstenoses. But . But the effect of these mechanical the effect of these mechanical problems on problems on stent stent thrombosis decreases over time.thrombosis decreases over time.
•• Late Late stent stent thrombosis (beyond 1 year) may be linked thrombosis (beyond 1 year) may be linked to late to late stent malapposition stent malapposition with large with large stentstent--vessel vessel wall gaps, larger than have been reported routinely in wall gaps, larger than have been reported routinely in prospective single and prospective single and multicenter multicenter studies. However, studies. However, given the high frequency of late given the high frequency of late stent malapposition stent malapposition in these prospective single and in these prospective single and multicenter multicenter studies(studies(≈≈1010--20%), it is likely that other pathological 20%), it is likely that other pathological factors factors -- beyond the mere presence of late beyond the mere presence of late malappositon malappositon -- are involved.are involved.
ConclusionsConclusions