DCB + BMS is not a DES

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DCB + BMS is not a DES Fabrizio Fanelli, MD, EBIR Professor of Radiology Director Vascular and Interventional Radiology Department "Careggi " University Hospital Florence - Italy

Disclosures Consultant / Speaker / Proctor / Advisory Board AstraZeneca Bayer Bolton Boston Scientific Cook Cordis CR Bard Medtronic Shockwave Medical Spectranetics Volcano W.L. Gore & Associates

Background DES Treatment of the whole lesion. Continuous mechanical effect on the arterial wall, increasing vessel scafolding + prolonged antiproliferative drug effect DCB + BMS DCB + provisional spot BMS Sub-optimal PTA. Selective stent implantation DCB + full BMS

Drug Eluting Stent Zilver PTX Cook Eluvia Boston Scientific

5-year Primary Patency (PSVR < 2.0) Zilver PTX vs. Standard Care 66.4% Zilver PTX p < 0.01 log-rank 43.4% Optimal PTA + BMS MD. Dake- Circulation 2016 At 5 years, Zilver PTX demonstrates a 41% reduction in restenosis compared to standard care

5-year Primary Patency (PSVR < 2.0) Provisional Zilver PTX vs. BMS Provisional 72.4% Zilver PTX p = 0.03 log-rank 53.0% Provisional BMS MD. Dake- Circulation 2016 At 5 years, Zilver PTX demonstrates a 41% reduction in restenosis compared to BMS

24-mos Primary Patency (PSVR < 2.5) Eluvia 83.5% S. Muller-Hulsbeck - Cardiovasc Intervent Radiol 2017

DES DCB + BMS

DES DCB + BMS Disadvantages Long metallic struts Fracture rate / metallic fatigue No-stent zone

DES DCB + BMS Advantages Prolonged drug release Limit stent coverage Stent only in more critical area

DCB + BMS Single center RCT 60 pts. (1:1) de novo fem-pop lesions 1. PTA vs. In.Pact Admiral DCB 2. Primary BMS + PTA vs. Primary BMS + In.Pact Admiral DCB

12-month Primary Patency analysis per lesion advantage of stent implantation more evident in small vessel diameter F. Fanelli J Cardiovasc Surg 2014

LINC 2017

Multi-center, Single-arm study 65 lesions Mean length 187.6 mm TASC C & D: 96% CTO: 80.4% Pulsar 18 (Biotronik) Paseo 18 Lux (Biotronik) 6 mos 12 mos 24 mos Freedom from Restenosis 98% 94.1% 88.2% Freedom from CD-TLR 96.1% 94.1% 88.2%

JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302 Journal of Endovascular Therapy 2017, Vol. 24(6) 783 792

Biolux 4EVER Physician-Initiated, prospective, multi-center, controlled trial 120 pts. Mean lesion length: 83.3 mm CTO: 33.3% Passeo 18 Lux (Biotronik) Pulsar 18 (Biotronik) M. Bosiers LINC 2017

12-mos Primary Patency 105 pts. 89.3% M. Bosiers LINC 2017

Conclusions Combination of DCB with a BMS shows a pretty good outcome Encouraging patency rate Few data available with limited follow-up No big difference between DCB + BMS and BMS + DCB. Still «open question»

EuroIntervention 2012;8:450-455 55 pts. From PEPCAD III randomized 26 pts: DES (Cypher) 29 pts: DCB + BMS 9-mos. F.U. angiographic and IVUS evaluation

9-mos. IVUS evaluation

9-mos. IVUS evaluation

9-mos. IVUS evaluation

D.G. 67-y. Male Heavy smoker, hypertension Right <50 mt claudication

Admiral (Medtronic) 4 mm In.Pact Admiral (Medtronic) 5 mm Inf. Time 3 min. Admiral (Medtronic) 5x60 mm Inf. Time 5 min

Zilver PTX 6x60 mm (Cook)

Zilver PTX 6x60 mm (Cook) 12-mos F.U.

Journal of Endovascular Therapy 2018, Vol. 25(1) 118 126 20 swine 1-3-6 mos Vessel integrity Hystological parameters In.Pact DCB 5x40mm Zilver PTX Advance 35 LP Zilver PTX

SMC Loss 3-mos Transmural SMC loss score: - DCB+DES: 3.3 - BA+DES: 2.5 p=0.04

Downstream effects and arteriolar changes of skeletal muscle due to paclitaxel Histological section based analysis of downstream non-target organs (skeletal muscle and coronary band) Fibrinoid necrosis and/or inflammation in small arteries and arterioles only in the DCB+DES group at 1 and 3 months. Thrombotic emboli were observed in 1 section of the DCB+DES group at 1 month and 1 section at 3 months but none in the BA+DES.

Journal of Endovascular Therapy 2018, Vol. 25(1) 118 126

Conclusions Combination of DCB with a BMS shows a pretty good outcome Encouraging patency rate Few data available with limited follow-up No big difference between DCB + BMS and BMS + DCB. Still «open question» Data are still supporting the use of DES especially in lorg-term Selection must take in consideration lesion characteristics Too many «open questions» (DCB before or after, spot vs. full stenting, etc) DCB + DES is a promising alternative

fanellif@aou-careggi.toscana.it

DCB + BMS is not a DES Fabrizio Fanelli, MD, EBIR Professor of Radiology Director Vascular and Interventional Radiology Department "Careggi " University Hospital Florence - Italy

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