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