1MEET 2008 –

Drug eluting Drug eluting stents will solve stents will solve

the problem! the problem! AgainstAgainst

MEET 2008 – Session 5Below the knee arteries & limb salvage

M. BosiersK. Deloose P. Peeters

2MEET 2008 –

CLI with BTK-pathology

Focal lesion15%

Diffuse lesions85%

3MEET 2008 –

1/ Focal lesion

• Minority of cases

LL<20mm

DES effect ontotal treated area

PTA + DES

4MEET 2008 –

1/ Focal lesion

• QVA shows good patency with low late lumen loss

pre post 6M LLS = 0.4mm

Evolution of MLDas measured by QVA

Bosiers et al. J Cardiovasc Surg (Torino). 2006 Apr;47(2):171-6.

5MEET 2008 –

1/ Focal lesion

100 @ 7.7M97 @ 7.7M

Sirolimus DES6230

CommeauCardiovasc Interv Radiol 2006

96.0 @ 12M86.4 @ 12M6629SiablisJ Endovasc Ther 2007

-100 @ 6M3030ScheinertEuroIntervention 2006

88.5 @ 12M30.0 @ 12MPaclitaxel DES 5029SiablisJ Vasc Intervent Radiol 2007

95.0 @ 6M83.7 @ 6M

Non-elutingstents

4224RandCardiovasc Interv Radiol 2006

29

50

N

100 @12M40.5 @12M65SiablisJ Endovasc Ther 2007

89.3 @12M62.8 @12M62BosiersEuroIntervention 2007

LS % PP %Stent typen

N=patients, n=lesions

Sirolimus Sirolimus elutingeluting stents stents mightmight bebe beneficialbeneficial

Paclitaxel Paclitaxel elutingeluting stents stents mightmight bebe hazardoushazardous

• Stenting results : single center

6MEET 2008 –

1/ Focal lesion

ONGOING RANDOMIZED CONTROLLED TRIAL• BMS (Vision) vs DES (XIENCE V) – DESTINY

– 140 patients (70 Vision – 70 Xience V) – 5 European sites (Bosiers, Peeters, Scheinert, Zeller, Commeau)– 1° Endpoint = Angiographic patency (In-stent binary restenosis >50%) – First inclusion March ’07

ClinicalTrials.gov Identifier: NCT00510393

DESTINYDESTINY--trial can confirm trial can confirm whether DES for whether DES for focalfocal infrapopliteal lesionsinfrapopliteal lesions

really improves patency!!!really improves patency!!!

7MEET 2008 –

2/ Long diffuse lesions

• Majority of cases = daily practice

LL~200mm

Residual stenosis

PTA with long low-pressure balloon

Focal stenting with DES

8MEET 2008 –

2/ Long diffuse lesions

PrePre--opop PostPost--opop

PTA with long low-pressure balloons followed by focal stenting

9MEET 2008 –

• The problem of DES in long diffused lesions

• Long term vessel patency is limited bypatency rate of segment treated with PTA only

2/ Long diffuse lesions

PTA PTA onlyonlyDESDESPTA PTA onlyonly

Follow-up

Procedure

10MEET 2008 –

2/ Long diffuse lesions

• Coronary DES trials showed– Inadequate lesion coverage

may contribute to edge stenosisIncreased risk for restenosis if full index lesion is not completely covered by DES

Sakurai et al. Am J Cardiol 2005;96:1251–1253.

11MEET 2008 –

• DES only effective if full lesion coverage

PRICE ISSUE = does this excellent patency justifythe increased treatment cost???

2/ Long diffuse lesions

fullfull DES effectDES effect

Follow-up

Procedure

12MEET 2008 –

Is DES cost-beneficial?

NO!!!

2/ Long diffuse lesions

CLI treatment is all about

saving the limb

Limbsalvage

Primarypatency

30%

Romiti et al. J Vasc Surg 2008;47:975-81.

13MEET 2008 –

Conclusion

In the majority of cases, Drug eluting stents willNOT solve the problem

In long diffuse lesions, PTA + non-DES bail-out stenting

gives good limb salvageNO ECONOMICAL BENEFIT TO USE DES