2. Prediction of restenosis after PCI with
contemporary drug-eluting stents
DR. ASHOK SETH
FRCP (LOND), FRCP (EDIN), FRCP (IREL), FACC, FSCAI, FCSI, DSc.
CHAIRMAN
CHIEF OF CARDIOLOGY
CHAIRMAN – CARDIOLOGY COUNCIL, FORTIS GROUP OF HOSPITALS
FORTIS ESCORTS HEART INSTITUTE
PRESIDENT – CARDIOLOGICAL SOCIETY OF INDIA
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3. Restenosis After BA and Stent
• Most significant problem for years
• DES have dramatically reduced instent
restenosis.
• Low rates of ISR in DES still a problem.
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5. Incidence of DES ISR
12% 11-12%
10%
8% 6-7%
6% 5-6%
4%
2%
0%
Native Denovo Real Life Patients Real Life Patients
Lesion 1st Gen DES 1st Gen DES 2nd Gen DES
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6. Delayed Restenosis
• Late ‘Catch Up’
Modest increase in NIH beyond 1-year on IVUS
study follow up.
– Delayed healing response
– Persistent biological reaction
– Hypersensitivity reaction to durable polymer
‘Therefore longer term follow up’
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7. Stent Thrombosis vs Restenosis
• ISR Presents as effort angina while stent
thrombosis usually presents MI.
• TVF within 30-days is usually stent thrombosis
while ISR is usually later.
• DES has delayed the time frame of ISR
• Both ISR and Stent thrombosis may co-exist.
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8. Definitions and Classification of Restenosis and
Stent Thrombosis
Dangas et al. J Am Coll Cardiol. 2010;56(23):1897-1907
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9. Possible Mechanisms of Restenosis After DES
Dangas et al. J Am Coll Cardiol. 2010;56(23):1897-1907
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10. Biologic Factors
• Drug Resistance
• Hyper sensitivity
– Allergy to Nickel / Molybdenum of 316 to stenosis
steel.
– RADAR STUDY (Research on Adverse Drug / Device
Adverse Reports) - Drug Hypersensitivity for DES.
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11. RADAR (Research on Adverse Drug Events
& Reports)
(Nebeker JR et al. J Am Coll Cardiol 2006;47:175-181)
• 5783 AE after DES
• 261 Hypersensitivity Reaction
• 17 DES cause of HS
• 4 Died of stent thrombosis between
4-18 months
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16. Technical Factors
• Stent Gap
• Gap between two overlapping stents
• Bends and Curves
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17. Predictors of ISR or TLR After DES Implantation
Dangas et al. J Am Coll Cardiol. 2010;56(23):1897-1907
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18. Risk Scoring to Predict TLR in DES
(Stolker et al. Circ Cardiovasc Interv. 2010;3:327-334)
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19. Predictors of DES Restenosis
(Corbett et al. Circulation. 2006;114:II_688)
• 2269 lesions 1283 patients (2003-2005)
• Angio FU 70% DES ISR : SES 16.9%
: PES 16.8%
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20. Morphologic Pattern of SES, PES, and BMS ISR
Dangas et al. J Am Coll Cardiol. 2010;56(23):1897-1907
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21. Clinical and Angiographic Outcomes After Percutaneous
Treatment of DES ISR
Dangas et al. J Am Coll Cardiol. 2010;56(23):1897-1907
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22. Morphological Pattern of Restenosis as a Predictor of Repeat
ISR after DES ISR Treatment
(Dangas et al. JACC 2010; 56: 1897-907)
Repeat ISR TLR
60% 57%
50%
40%
30%
23%
20% 18%
10%
10%
0%
Focal ISR Non Focal ISR
DES ISR
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23. Treatment of DES ISR
‘Difficult Disease Process’
• IVUS or other imaging essential to understand
the underlying mechanism.
• OPTIONS
– Balloon angioplasty
– DEB
– DES : Same DES
: Different DES
– VBT
– CABG
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24. Algorithm for the Treatment of DES Restenosis
Dangas et al. J Am Coll Cardiol. 2010;56(23):1897-1907
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25. Conclusion
• Though DES has lowered the restenosis rates of PCI, the
increased complexity of lesions being treated has resulted in
DES ISR being an important problem.
• The predictors of restenosis in DES era are similar to the BMS
era, but DES ISR can occur later and tends to be more focal and
this has a better prognosis than BMS ISR.
• Diffuse DES ISR is a very ‘difficult animal’ as the pathophysiology
and causative mechanism of DES ISR are in many cases unclear
and hence treatment options are ‘hit and trial’.
• Further studies new DES and Bioresorbable stents are on the
way to overcome this important problem.
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