UpdateDEB Lesions Learned from the Trials and Daily Clinical Practice Ralf Langhoff, MD Center for Vascular Medicine Berlin-Wilmersdorf St. Gertrauden Hospital Charité, CC11 Academic Teaching Hospitals ― Charité Berlin Ralf Langhoff, MD Center for Vascular Medicine Berlin-Wilmersdorf St. Gertrauden Hospital Charité, CC11 Academic Teaching Hospitals ― Charité Berlin

Why SFA stenting isn’t always the answer Restenosis  Restenosis will occur in up to two thirds of patients undergoing endovascular treatment of SFA/popliteal disease  Vessel recoil  Neointimal hyperplasia  Vessel injury  Typical restenosis rates:  12mth post-stent 34%*  12mth post-PTA 61%* * Dick et al- ASTRON study CCI 74:

Why SFA stenting isn’t always the answer Flexion/Extension Areas of the SFA/popliteal remain ‘no-stent zones’ Mid-SFA Distal- SFAPopliteal Bending Rad/ang 70/20 (Shortening) 5%14%9% 90/90 (Shortening) 10%23%14% 13 mm 63 deg

Could Drug Eluting Balloons be the answer?  Early results for Drug Eluting Balloons in peripheral vessels show great promise.  Data is relatively limited (c. 10 studies 4000pts total  Patient and lesion selection is evolving, but encouraging results have been seen in: de novo and restenotic lesions, in-stent restenosis, AV Access  No-stent zones are a logical indication, plus segments prone to restenosis e.g. long BTK lesions

Walker JP, Owens CD, Curr Surg Rep 2013

Percentage freedom from binary restenosis at 6 – respectively 12 month Walker JP, Owens CD, Curr Surg Rep 2013

Certainly a good fit for DEB Long lesions Small vessels High restenosis rate ISR

DEB Treatment in the SFA: Are we Making Progress? ISET 2014

25 DEB (Safety and Efficacy - TLR Rates) 1. Incresing evidence that it is safe and effective in TASC A/B lesions

6mo Late Lumen Loss Comparison of Peripheral DEB RCTs  Late Lumen Loss seen in BIOLUX P-I was in line with published data using Paccocath  We based our regulatory claims on equivalence to Paccocath to support CE mark

6mo Binary Restenosis Comparison of Peripheral DEB RCTs  Binary Restenosis rates are encouraging, and suggest high clinical efficacy.  This result is promising due to the high dissection rate and relatively small vessel size (4.6mm in the DEB arm)

29 DEB Do They Also Work in More Challenging Lesions? Long vs. ShortDe-novo vs. RSOccl vs. Stenosis Pacifier Study, Werk et al. 2. It seems to work even better in challeging lesions!

29 DEB Do They Also Work in More Challenging Lesions? 3. Long lesions with good patency Leipzig Registry Mean lesion length: 24±10.1 cm

29 DEB Is the DEB as Effective as the DES? 4. No difference in long lesions in a retrospective study CX 2013, Zeller et al.

31 Procedure: DEB Does the DEB also work in in-stent RS? 5. DEBs seem to work in in-stent RS FAIR Trial (In.pact DEB)

DEB Does the DEB also work long-term? Thunder – Long-term results 6. Limited results in long lasting benefit in a retrospective study LINC 2012, Tepe et al.

DEB Is there an impact of calcium? 7. Heavy calcified arteries seem to reduce efficacy of DEBs ISET 2014, Tepe et al.

DEB Is there an impact of dissections? 8. Type C and D dissections need not be stented in case of DEB treatment JVET 2013, Tepe et al.

Take home message

The BTK story – brand new data from LINC a)Fair study (in.pact) b)Copa Cabana (Cotavance) c)Pacuba (Freeway) In.Pact Deep Medtonic Study failed: No efficacy More events in the DEB arm

Systematic Review and meta-analysis of additional Technologies to enhance angioplasty for infrainguinal peripheral arterial occlusive disease E.L. Simpson, J.A. Michaels, S.M. Thomas and A.J. Cantrel, Brit J Surg 2013

Preferred Reporting Items for Systematic Reviews and Meta-Analysis Simpson EL, Brit J Surg 2013

Restenosis at 6-month Simpson EL, Brit J Surg 2013

Revascularisation at 6- and 24 month Simpson EL, Brit J Surg 2013

Conclusion Simpson EL, Brit J Surg 2013

Ralf Langhoff, MD Center for Vascular Medicine Berlin-Wilmersdorf St. Gertrauden Hospital Charité, CC11 Academic Teaching Hospitals ― Charité Berlin Thank You For Your Attention!