Diapositiva 1

University of Modena and Reggio EmiliaVascular Surgery Director: prof. Coppi

Silingardi R. Veronesi J. Gennai S.

Where are we with drug eluting balloons and stents for SFA?Veronesi J. University of Modena and Reggio Emilia

chirvascmo@gmail.com

Good morning. As I was unable to attend the congress today, I have pre-registered the presentation for you. Im sorry you wont be able to ask me any questions today, but I have left an email address. I hope you enjoy the congress and thanks Ramesh for the kind invitation. Today I will present Where are we with drug eluting balloons and stents for SFA?

2PTA and BMS in SFA 12 Months Primary Patency

BMS provides improved patency, but data are limited for medium and long lesionsIn this slide are reported studies designed to compare the safety and effectiveness of PTA and bare metal stent (BMS). 12 Months primary patency is described. BMS provides improved patency, but data are limited for medium and long lesions. 3How can we keep SFA open?

The major problem regarding the treatment of SFA is the high incidence of restenosis in patients treated with stenting alone or with PTA/stenting 4DEB Drug eluting balloon

Local release of medication into the vessel wall during dilatation

The principle mechanism of DEB is related to the local release of medication into the vessel during dilation. It is necessary to perform a pre-dilation,then DEB has to be inflated for more than 3 minutes. It is necessary to put a stent only if there is a persistent flow limiting dissections. The post-dilation has to be performed with a post-dilation balloon staying within the DEB area. 5DEB

Same Drug - Different Excipients and Coating TechsIn this slide main DEBs commercially available are reported. They are covered by the same drug , but they have different excipients and coating techs. 65 DEB Trials with 6-month LLL Primary Endpoint

DEB vs Standard BalloonDe novo lesions, 6-months LLL in SFAThese are 5 trials that compared 4 different types of DEB with standard balloons in de novo lesions reporting 6-months LLL (late lumen loss) in SFA according to the length of the lesion. 7DEB vs PTA Meta-analysis4 Fem--pop trials: Thunder, FemPac, Levant I, Pacifier433 patientsDEB at 10.3 months --> reduced TLR, LLL, Restenosis All cause mortality unchangedCassese et al. 2012

In this meta-analysis a total of 433 patients enrolled in4trialswere included. The mean follow up period was 10.3 months. The authors concluded that DEB reduced TLR, LLL, and percent of restenosis. But all cause mortality was unchanged. 8DEB - Current issuesIntermittent claudicatioCostsCalcificationsAtherectomyLong Lesions

Fanelli et al

Regarding the DEB we have to consider current issues. First the problem related to the eventual treatment of intermittent claudicatio with DEB, the costs of the procedure, the calcifications, the eventual use of the atherectomy and the treatment of long lesions. 9DEB - Our indicationsIn-stent restenosis Femoro-popliteal segment diseaseLesions < 10 cmNo calcified lesionsYoung patients

University of Modena and Reggio Emilia

In our experience we suggest to use the DEBs in case of in-stent restenosis, femoro-popliteal segment disease, lesions less than 10 mm, in no calcified lesions and in young patients10Drug Eluting Stents (DES)Trials

SIROCCO I e II (Cordis)STRIDES (Abbott)Zilver PTX (Cook)

University of Modena and Reggio Emilia

In this slide the major trials are reported where DESs were compared with BMS11

Duda et al.

SIROCCO trialIn SIROCCO trial DES and bare nitinol stents were compared for the treatment of atherosclerotic lesions in the SFA. The results are reported below in terms of TVR, TLR, total occlusion and death. 12Sirolimus-Eluting versus Bare Nitinol Stent for Obstructive Superficial Femoral Artery Disease: The SIROCCO II Trial

Trend for greater efficacy in the sirolimus-eluting stent group

No statistically significant differences in any of the variablesIn Sirocco II Trial Sirolimus eluting stents were compared with Bare Nitinol Stent for obstructive superficial femoral artery disease. This trial revealed a trend for greater efficacy in the Sirolimus eluting stent group, even if no statistically significant differences in any of the variables were reported. 13STRIDES trial

Everolimus-eluting self-expanding nitinol stent can be successfully implanted in pts with severe PAD TLR after 6 and 12 months was 95% and 80%

Primary patency after 6 and 12 months was 94% and 68%In the STRIDES trial Everolimus eluting self expanding nitinol stent was successfully implanted in pts with severe PAD. TLR after 6 and 12 months was 95% and 80% , primary patency after 6 and 12 months was 94% and 68%. 143-Year EffectivenessPrimary Patency DES (Zilver PTX) vs. PTA

Finally in this slide you can see the results regarding the primary patency of DES, specifically Zilver PTX compared with PTA only. 15DES Current issuesStent fractureMid- and long-term results?Are costs justified?

Regarding the DEB we have to consider many current issues. First the problem of stent fracture, the mid and long term results and finally if its costs are justified. 16 DES - Our indicationsBailout after PTA Stent fractureRutherford scale categories IV, V, VI corresponded to resting pain, minor ulcerations and gangrenesYoung patientsUniversity of Modena and Reggio Emilia

In our clinical practice we suggest the use of DES for bailout after PTA, in case of stent fracture, in case of 4,5 e 6 categories of Rutherford Scale corresponding to resting pain, minor ulcerations and gangrenes, and also in case of young patients. 17DEB BTKDior(Eurocor)

DEB BTKIN.PACT Amphirion(Medtronic)DEB ATKIN-PACTAdmiral(Medtronic)DEB ATKFREEWAY (Eurocor)

Cases (n)2415105Mean Lesion Length (mm)281259272Primary Patency at 1 year 75707173Secondary Patencyat 1 year 80737880Follow up (months)45141410DEB : BTK and ATK From 2000 to 2012These are our results from 2000 to 2012 regarding the DEBs in these districts : BTK and ATK 18DES BTKDexamet (Biocompatible - Abbott Vascular)

DES BTKAmazonia Pax (Minvasys)DES ATKZilver PTX (Cook)

Cases (n)251016Primary Patency at 1 year 68%70%63%Secondary Patencyat 1 year 82%84%69%Follow up (months)533018DES : BTK and ATK From 2000 to 2012In this slide the results regarding DES are reported. You can see that in case of Zilver PTX the results were worse. 19For any questions

chirvascmo@gmail.com

www.chirurgiavascolare.unimore.it

. Thank you for your attention and please do not hesitate to write and ask any questions via email20CONCLUSIONS DEB & DES in SFADEB in SFA has demonstrated (in RCTs) clinical and morphologic benets in the mid-term compared with uncoated balloonDES promises improved patency compared with BMSResults from different DES trials are controversial Drug-eluting technology seems to reduce the need for reinterventions and compensation with costsPromising technology with long DEB and drug bioabsorbable stents is desirable In conclusion DEB in SFA ha demonstrated in RCTs clinical and morphological benefits in the mid-term compared with uncoated balloon. DES promises improved patency compared with BMS even if results from different DES trials are controversial. Drug eluting technology seems to reduce the need for reinterventions and compensations with costs. A promising technology with long DEBs and drug bioabsorbable stents is desiderable. 21