DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of...
Transcript of DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of...
![Page 1: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/1.jpg)
Fabrizio Fanelli, MD, EBIR
Professor of Radiology
Director Vascular and Interventional Radiology Department
"Careggi " University Hospital
Florence - Italy
DCB + BMS is not a DES
![Page 2: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/2.jpg)
Disclosures
• Consultant / Speaker / Proctor / Advisory Board
– AstraZeneca
– Bayer
– Bolton
– Boston Scientific
– Cook
– Cordis
– CR Bard
– Medtronic
– Shockwave Medical
– Spectranetics
– Volcano
– W.L. Gore & Associates
![Page 3: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/3.jpg)
DES
DCB + BMS
DCB + provisional spot BMS
Sub-optimal PTA. Selective stent implantation
DCB + full BMS
Background
Treatment of the whole lesion.
Continuous mechanical effect on the arterial wall, increasing
vessel scafolding + prolonged antiproliferative drug effect
![Page 4: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/4.jpg)
Drug Eluting Stent
Zilver PTXCook
EluviaBoston Scientific
![Page 5: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/5.jpg)
5-year Primary Patency (PSVR < 2.0)
Zilver PTX vs. Standard Care
Zilver PTX
Optimal PTA+ BMS
66.4%
43.4%
p < 0.01log-rank
At 5 years, Zilver PTX demonstrates a 41% reduction in restenosis compared to standard care
MD. Dake- Circulation 2016
![Page 6: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/6.jpg)
Provisional BMS
Provisional Zilver PTX72.4%
53.0%
p = 0.03log-rank
At 5 years, Zilver PTX demonstrates a 41% reduction in restenosis compared to BMS
5-year Primary Patency (PSVR < 2.0)
Provisional Zilver PTX vs. BMS
MD. Dake- Circulation 2016
![Page 7: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/7.jpg)
24-mos Primary Patency (PSVR < 2.5)
Eluvia
S. Muller-Hulsbeck - Cardiovasc Intervent Radiol 2017
83.5%
![Page 8: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/8.jpg)
DCB + BMSDES
![Page 9: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/9.jpg)
Disadvantages
Long metallic struts
Fracture rate / metallic fatigue
No-stent zone
DES DCB + BMS
![Page 10: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/10.jpg)
Advantages
DES
Prolonged drug release
Limit stent coverage
Stent only in more critical area
DCB + BMS
![Page 11: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/11.jpg)
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
![Page 12: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/12.jpg)
12-month Primary Patency
analysis per lesion
F. Fanelli – J Cardiovasc Surg 2014
advantage of stent implantation more evident in small vessel diameter
![Page 13: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/13.jpg)
LINC 2017
![Page 14: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/14.jpg)
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%
![Page 15: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/15.jpg)
JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302
Journal of Endovascular Therapy 2017, Vol. 24(6) 783–792
![Page 16: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/16.jpg)
M. Bosiers – LINC 2017
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)
![Page 17: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/17.jpg)
12-mos Primary Patency
89.3%
105 pts.
M. Bosiers – LINC 2017
![Page 18: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/18.jpg)
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»
![Page 19: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/19.jpg)
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
![Page 20: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/20.jpg)
9-mos. IVUS evaluation
![Page 21: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/21.jpg)
9-mos. IVUS evaluation
![Page 22: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/22.jpg)
9-mos. IVUS evaluation
![Page 23: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/23.jpg)
![Page 24: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/24.jpg)
D.G. 67-y. Male
Heavy smoker, hypertension
Right <50 mt claudication
![Page 25: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/25.jpg)
Admiral
(Medtronic)
5x60 mm
Inf. Time 5 minAdmiral
(Medtronic)
4 mm
In.Pact Admiral
(Medtronic)
5 mm
Inf. Time 3 min.
![Page 26: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/26.jpg)
Zilver PTX
6x60 mm
(Cook)
![Page 27: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/27.jpg)
Zilver PTX
6x60 mm
(Cook)
12-mos F.U.
![Page 28: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/28.jpg)
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
![Page 29: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/29.jpg)
SMC Loss
3-mos Transmural SMC loss score:
- DCB+DES: 3.3
- BA+DES: 2.5 p=0.04
![Page 30: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/30.jpg)
Histological section–based analysis of downstream non-target organs (skeletal muscle and coronary band)
Downstream effects and arteriolar changes of skeletal
muscle due to paclitaxel
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.
![Page 31: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/31.jpg)
Journal of Endovascular Therapy 2018, Vol. 25(1) 118–126
![Page 32: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/32.jpg)
Conclusions
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
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»
![Page 34: DCB + BMS is not a DES · DCB + BMS is not a DES. ... Histological section–based analysis of downstream non-target organs ... Combination of DCB with a BMS shows a pretty good outcome](https://reader031.fdocuments.in/reader031/viewer/2022022008/5adf9bf27f8b9af05b8ca0fd/html5/thumbnails/34.jpg)
Fabrizio Fanelli, MD, EBIR
Professor of Radiology
Director Vascular and Interventional Radiology Department
"Careggi " University Hospital
Florence - Italy
DCB + BMS is not a DES