The clinical outcome camparison between covered stent(cv) and drug-eluting balloon(deb) for SFA lesions: a single center result
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1 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
2 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
3 Background
4 Background Viabahn for femoropopliteal in-stent restenosis. Al Shammeri O, Bitar F, Ghitelman J, Soukas PA. Ann Saudi Med Nov-Dec;32(6):
5 Background
6 Method From to , 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
7 Baseline Characteristics Characteristics CS group (n=32) DEB group(n=21) P Value Age 65.66± ± Male 28(87.5%) 18(85.7%) Smoker 25(78.1%) 16(76.2%) Hypertension 13(40.6%) 10(47.6%) Hyperlipidemia 18(56.2%) 11(52.3%) CHD 12(37.5%) 8(38.1%) Diabetes 10(31.3%) 7(33.3%)
8 Clinical Data Characteristics CS group (n=32) DEB group(n=21) P Value Rutherford 2 6(18.8%) 7(33.3%) Rutherford 3 13(40.6%) 6(28.6%) Rutherford 4 7(21.9%) 4(19.0%) Rutherford 5 6(18.8%) 4(19.0%) ISR 12(37.6%) 8(38.0%) Length of treated vessel(mm,average) Diameter of treated vessel(mm,average) P<
9 Peri-operative Complications Complications CS group (n=32) DEB group(n=21) P Value MI Stroke 0 0 Renal failure Infection 0 0 Distal embolism Hematoma 0 0 Pseudoaneurysm 0 0 Overall death Procedure related death 0 0
10 Results Complications CS group (n=32) DEB group(n=21) P Value Amputation 0 0 Overall death 2(6.3%) 1(4.8%) Operation related death Primary Patency@1 year Secondary Patency@1 year (50%) 13(61.9%) (81.2%) 18(85.7%)
11 Results(ISR subgroup) Complications CS group (n=12) DEB group(n=8) P Value Mean length(mm) P<0.01 Mean Diameter(mm) Amputation 0 0 Overall death 0 0 Operation related death Patency rate(@6 months) Patency rate(@12 months) % 87.5% % 75%
12 Discussion 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) No. of Lesion Length % Primary Patency (years / %) Author Year Journal Publication / Presentation Limbs (cm) Occlusions Lammer 2000 Radiology, 217: NR 79 Jahnke 2003 J Vasc Interv Radiol, 14: Bleyn 2004 Edizioni Minerva Medica, 14: Panetta 2005 Endovasc Today, August Chopra 2006 AIM Symposium, November Coats 2006 Endovasc Today, September 83 NR Fischer 2006 J Endovasc Ther, 12: Zander 2006 SIR Meeting, April NR Saxon 2007 J Vasc Interv Radiol, 18: Alimi 2008 Eur J Vasc Endovasc Surg, 35: NR Djelmami-Hani 2008 SCAI Meeting, March 29 - April Saxon 2008 J Vasc Interv Radiol, 18: VIBRANT 2009 VIVA, September Kougias 2009 Am J Surgery, 198: Farraj 2009 J Invasive Cardiol, 21: Rabellino 2009 Cath Cardiovasc Interv, 73: NR NR McQuade 2010 J Vasc Surg;in press NR Average / Total NR = Not Reported
13 Discussion Study name DEB name /manufacturer Mean lesion length(mm) Patency rate(12 months) POBA DEB DEB POBA LEVANT 2 Lutonix % 52.6% IN. Pact SFA IN.PACT % 52.4% BIOLUX PI Passeo-Lux % 47.1% Acocath AcoTec % 33.7% ILLUMENATE Pivotal Study Stellarex % 70.9%
14 Discussion Our 12 months patency rate of CS and DEB are 50% and 61.9% respectively, both are lower than literature Probably due to longer lesion length and high percentage of CTO lesion
15 Discussion Complications CS group (n=32) DEB group(n=21) P Value Stop medication rate Modified patency rate 3(9.4%) 6(28.6%) % 76.7% 0.066
16 Discussion-ISR subgroup Complications CS group (n=12) DEB group(n=8) P Value Mean length(mm) P<0.01 Mean Diameter(mm) Patency rate(@6 months) Patency rate(@12 months) 83.3% 87.5% % 75%
17 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)
18 Discussion-ISR subgroup
19 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
20 Thank you for your attention! 谢谢!
21 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
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