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Dr Adrian Banning, The John Radcliffe, Oxford
Drug eluting stents for in-stent restenosis
Case Presentation (1)• 44-year old man
• August 2001 – presents with Unstable Angina,
– severe LAD stenosis. Direct stent - 3.5x15 NIR Elite
• October 2001: – recurrent angina,
– severe stenosis just proximal to the stent.
– 3.5x8 Express, partially overlapping the first
• April 2002: – recurrent angina - diffuse in-stent restenosis.
• CABG with LIMA->LAD
Case Presentation• August 2001 stent
• October 2001: stent
• April 2002: CABG with LIMA->LAD,
• June 2002– Recurrent angina
– Management?
–Exercise test on treadmill?
Case Presentation (2)
• August 2002: – cath - failed LIMA graft-
– enrolled in a multicenter registry (non-polymeric paclitaxel DES at concentration of 3.0 µg/mm2 DELIVER II )
– 2 “Achieve” stents 3.5x18 and 3.5x23 mm in the mid LAD Entire previously stented segment was covered
– Optimized with high-pressure 3.5 mm NC balloon, no IVUS
Case Presentation (2)• August 2002:
– cath - failed LIMA graft-
– enrolled in a multicenter registry (non-polymeric paclitaxel DES at concentration of 3.0 µg/mm2 DELIVER II )
– 2 “Achieve” stents 3.5x18 and 3.5x23 mm in the mid LAD Entire previously stented segment was covered
• September 2003 (13 months) recurrent angina– Further angiogram
– 5th in 22 months
September 2003
PRE-INTERVENTION
September 2003• Intervention number 4
– IVUS guidance Cypher 3.0x23 and 3.0x23 covering
all the previously stented segment with overlap.
3.5 NC balloon multiple inflations (up to 24 atm)
– IVUS used to check MLA>5 mm2
September 2003
POST-INTERVENTION
April 2004 (8 months post)
FOLLOW UP
April 2004 (8 months post)
FOLLOW UP
What is “in stent restenosis”
• Densely packed neointima
• mainly VSMC and matrix
• Like a keloid scar
• Not atheroma
The pre-DES era
Treatment modality does not matter
Vascular brachytherapy
good short term results
DES era: a bad start
Data from registries
Cypher stent: Brazilian and Dutch experience
Long term follow-up
QCA data: late catch up?
IVUS data: reassuring
SECURE registry
Recurrent ISR No Rec. ISR p
MLA <5mm2
9/11 5/19 0.003
MLA <4mm2
7/11 4/19 0.02
MLA <3mm2
4/11 1/19 0.03
Stent underexpansion is still important !!!
Sequential IVUS analysis of lumen and stent dimensions
Initial Cutting balloon DES High-pressure pre-dilatation (P vs baseline) (P vs Cutting) (P vs DES) MLD, mm 1.60.1 1.80.1* 2.10.1* 2.40.1† MLA, mm2 2.50.2 3.30.3† 4.30.3* 5.60.4† Original stent 7.60.7 8.10.6* 8.40.6NS 9.50.6 CSA, mm2 Stent-stent gap, mm2 3.20.3 3.10.3 NS Optimum DES 5 (30%) 10 (60%) deployment Symmetrical DES 13 (87%) 15(100%) deployment *P <0.01; †P <0.001; ‡P <0.0001;
Practical tips for treating ISR
• Prevent ISR using DES or properly expanded BMS!– much less diffuse ISR
• When treating ISR– Use preinflation/cutting balloon– Cover the whole stented segment with
generous margins– IVUS guidance (mandatory for DES failure)– Optimally expand both stents with NC
balloons
Conclusions
• DES can treat ISR as well (and probably better than) any other modality – including brachy and surgery!!
• Definitive trials will be published shortly
• Radiotherapy has a limited role in the future
TOO much radiation is bad for you
Even a little radiation can be bad for you!
• And who is that young man?
Don’t knowbut……
More pictures on SexyDrRobCrook.com.uk
Thank you
The end
Ongoing studies
Final result does