The clinical outcome camparison between covered

stent(CV) and drug-eluting balloon(DEB) for SFA lesions:

a single center result

Li Ming MD

Associated Professor in Vascular Surgery

2nd Xiangya Hospital, CSU

Provincial Center of Major Vessel Disease in Hunan

Vascular Surgery Center of CSU

Disclosure

Speaker name:

..Li Ming...............................................................................

I have the following potential conflicts of interest to report:

Consulting

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

R I do not have any potential conflict of interest

Background

Background

Viabahn for femoropopliteal in-stent restenosis. Al Shammeri O, Bitar F, Ghitelman J,

Soukas PA. Ann Saudi Med. 2012 Nov-Dec;32(6):572-82.

Background

Method

From 2015.6 to 2017.6, 53 patients’ data were reviewed

CS group: 32 pts, DEB group: 21pts

Inclusion criteria:

Rutherford 2-5

DE novo or ISR

SFA occlusive lesions >10cm

Post-op management: Clopidogrel 75mg +Aspirin 100mg

Baseline Characteristics

Characteristics CS group (n=32) DEB group(n=21) P Value

Age 65.66±12.35 64.05±12.81 1.000

Male 28(87.5%) 18(85.7%) 0.8510

Smoker 25(78.1%) 16(76.2%) 0.8693

Hypertension 13(40.6%) 10(47.6%) 0.6153

Hyperlipidemia 18(56.2%) 11(52.3%) 0.7820

CHD 12(37.5%) 8(38.1%) 0.9651

Diabetes 10(31.3%) 7(33.3%) 0.8737

Clinical Data

Characteristics CS group (n=32) DEB group(n=21) P Value

Rutherford 2 6(18.8%) 7(33.3%) 0.2275

Rutherford 3 13(40.6%) 6(28.6%) 0.3708

Rutherford 4 7(21.9%) 4(19.0%) 0.8039

Rutherford 5 6(18.8%) 4(19.0%) 0.9784

ISR 12(37.6%) 8(38.0%) 0.9651

Length of treated vessel(mm,Average)

285.9 233.3 P<0.01

Diameter of treatedvessel(mm,Average)

5.13 5.24 0.4796

Peri-operative Complications

Complications CS group (n=32) DEB group(n=21) P Value

MI 1 1 0.7597

Stroke 0 0

Renal failure 2 1 0.8187

Infection 0 0

Distal embolism 0 1 0.2127

Hematoma 0 0

Pseudoaneurysm 0 0

Overall death 1 0 0.4134

Procedure related death

0 0

Results

Complications CS group (n=32) DEB group(n=21) P Value

Amputation 0 0

Overall death 2(6.3%) 1(4.8%) 0.8187

Operation related death

0 0

Primary Patency@1 year

16(50%) 13(61.9%) 0.4673

Secondary Patency@1 year

26(81.2%) 18(85.7%) 0.6720

Results(ISR subgroup)

Complications CS group (n=12) DEB group(n=8) P Value

Mean length(mm) 254.8 184.0 P<0.01

Mean Diameter(mm) 5.17 5.19 0.9252

Amputation 0 0

Overall death 0 0

Operation related death

0 0

Patency rate(@6 months)

83.3% 87.5% 1.0

Patency rate(@12 months)

58.3% 75% 0.4439

Discussion

Author Year 1 2 3 4

Lammer 2000 Radiology, 217:95-104 80 13.8 NR 79

Jahnke 2003 J Vasc Interv Radiol, 14:41-51 52 8.5 83 78 74 62

Bleyn 2004 Edizioni Minerva Medica, 14:87-91 67 14.3 100 82 73 68 54

Panetta 2005 Endovasc Today, August 41 30.4 90 86 77

Chopra 2006 AIM Symposium, November 13-16 70 20 71 93 87 72

Coats 2006 Endovasc Today, September 83 NR 47 89

Fischer 2006 J Endovasc Ther, 12:281-16 59 10.7 87 67 58 57 52

Zander 2006 SIR Meeting, April 3 31 16.6 NR 86 78 78 78

Saxon 2007 J Vasc Interv Radiol, 18:1341-1350 87 14.2 42 76 65 60 55

Alimi 2008 Eur J Vasc Endovasc Surg, 35:346-352 102 11.7 NR 74 71 71

Djelmami-Hani 2008 SCAI Meeting, March 29 - April 1 132 21 39 80

Saxon 2008 J Vasc Interv Radiol, 18:823-832 97 7 21 65

VIBRANT 2009 VIVA, September 19-22 72 19 60 53

Kougias 2009 Am J Surgery, 198:645-649 31 23 100 75

Farraj 2009 J Invasive Cardiol, 21:278-281 32 15.4 100 80

Rabellino 2009 Cath Cardiovasc Interv, 73:701-705 32 NR NR 82 75 75 75

McQuade 2010 J Vasc Surg;in press 50 25.6 NR 72 63 63 59

Average / Total 1103 16.2 62 78 72 67 59

NR = Not Reported

Reported patency rates of GORE VIABAHN® Endoprosthesis / GORE HEMOBAHN

Endoprosthesis (5-8mm) treating the SFA in Studies of at least 30 limbs (updated 20-Jul-10)

Primary Patency

(years / %)No. of

Limbs

%

Occlusions

Lesion

Length

(cm)Journal Publication / Presentation

Discussion

Study name DEB name/manufacturer

Mean lesion length(mm)

POBA DEB

Patency rate(12 months)

DEB POBALEVANT 2 Lutonix 63.2 62.7 65.2% 52.6%

IN. Pact SFA IN.PACT 89.4 88.1 82.2% 52.4%

BIOLUX PI Passeo-Lux 51.4 68.5 84% 47.1%

Acocath AcoTec 152 147 76.1% 33.7%

ILLUMENATE Pivotal Study

Stellarex 80 89 82.3% 70.9%

Discussion

Our 12 months patency rate of CS andDEB are 50% and 61.9% respectively, bothare lower than literature

Probably due to longer lesion length andhigh percentage of CTO lesion

Discussion

Complications CS group (n=32) DEB group(n=21) P Value

Stop medicationrate

3(9.4%) 6(28.6%) 0.1315

Modified patency rate

55.2% 76.7% 0.066

Discussion-ISR subgroup

Complications CS group (n=12) DEB group(n=8) P Value

Mean length(mm) 254.8 184.0 P<0.01

Mean Diameter(mm) 5.17 5.19 0.9252

Patency rate(@6 months)

83.3% 87.5% 1.0

Patency rate(@12 months)

58.3% 75% 0.4439

Discussion-ISR subgroup

The Treatment of Superficial Femoral Artery In-Stent Restenosis:

The Jury Is Still Out. Gray BH et al. JACC Cardiovasc Interv. (2016)

Discussion-ISR subgroup

Conclusion

Real world experience comparing CS and DEB

DEB showed advantage over covered stent in treating SFA long lesion

Covered stent still plays a role in PAD treatment, especially for ISR

More data and longer follow-up time is needed

Thank you for your attention!

谢谢！

The clinical outcome camparison between covered

stent(CV) and drug-eluting balloon(DEB) for SFA lesions:

a single center result

Li Ming MD

Associated Professor in Vascular Surgery

2nd Xiangya Hospital, CSU

Provincial Center of Major Vessel Disease in Hunan

Vascular Surgery Center of CSU