DCB + stent in the SFA

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Denis Allison
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1 DCB + stent in the SFA 12-month results of the Biolux4ever trial Dr. Marc Bosiers LINC 2017, Leipzig

2 Conflict of interest 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) I do not have any potential conflict of interest 2

3 DCB + Stent : treatment rationale DCB 3

4 Single arm Proof of concepts DCB PASSEO 18 LUX PACCOCATH IN.PACT CVI PACCOCATH LUTONIX ADVANCE PTX 3µgr/mm² + BTHC P=0.033 PTX 3µgr/mm² + Ultravist P=0.031 PTX 3,5µgr/m m² + Urea P=0.001 PTX Excipient? PTX 3µgr/mm² + Ultravist P<0.001 PTX 2µgr/mm² + polysorbate & sorbitol P=0.016 PTX 3µgr/mm² No excipient P=0.12 4

5 Primary Patency at 12-months 5

6 stenting rate (%) Primary Patency at 12-months stenting rate N.A. N.A. N.A. 0 6

7 Example Case of our daily practice baseline Dilatation Passeo 18 Lux 6mm (Biotronik) Stenting Pulsar 18 6mm (Biotronik) 1 year result 7

8 a lot of remaining questions.?? First DCB then BMS???? First BMS then DCB???? Bail-out stenting???? Spot stenting???? Primary stenting???? Full lesion coverage?? 8

9 DCB & Stent : clinical evidence 9

10 DCB & Stent : clinical evidence DEBATE SFA Single center, randomized trial 110 lesions : 55 DCB (IN.Pact Admiral) + BMS (Maris SX) vs 55 POBA + BMS Primary endpoint : 12 m binary restenosis A.L.L. : (DCB + BMS) vs (POBA + BMS) Liistro et al. JACC 2013;6(12):

11 DCB & Stent : clinical evidence DEBATE SFA Liistro et al. JACC 2013;6(12):

12 DCB & Stent : clinical evidence DEBATE SFA Freedom yr Restenosis ~ lesion length yr Liistro et al. JACC 2013;6(12):

13 DCB & Stent : clinical evidence Single center, prospective, single arm trial 65 lesions : Pulsar 18 BMS + Passeo 18 LUX post-dil Primary endpoint : 12/24 m ppr (PSVR<2,5) A.L.L. : mm DEBAS 6m PP = 98.0 % time 1MFU 6MFU 12MFU 18MFU 24MFU at risk % Mwipatayi P. Veith 2015, NYC, US 13

14 DOES IT WORK ON THE LONG(ER) RUN??? Single center, prospective, single arm trial 65 lesions : Pulsar 18 BMS + Passeo 18 LUX post-dil Primary endpoint : 12/24 m ppr (PSVR<2,5) A.L.L. : mm DEBAS 12m PP = 94.1 % time 1MFU 6MFU 12MFU 18MFU 24MFU at risk % Mwipatayi P. Veith 2015, NYC, US 14

15 DOES IT WORK ON THE LONG(ER) RUN??? Single center, prospective, single arm trial 65 lesions : Pulsar 18 BMS + Passeo 18 LUX post-dil Primary endpoint : 12/24 m ppr (PSVR<2,5) A.L.L. : mm DEBAS 24m PP = 88.2 % time 1MFU 6MFU 12MFU 18MFU 24MFU at risk % Mwipatayi P. Veith 2015, NYC, US 15

of Fempop Arterial Stenotic Disease with

16 DCB & Stent : clinical evidence Physician-Initiated, prospective, multi-center (5), controled trial Investigating the Efficacy of EV Treatment of Fempop Arterial Stenotic Disease with BIOtronik Passeo-18 LUX Drug Releasing Balloon & Biotronik Pulsar-18 Stent (comparing with 4EVER trial results) 120 patients Target lesion < 19 cm Primary endpoint : 12 months DUS (PSVR < 2,5) PRELIMINARY 12 MONTH DATA 105 out of 120 patients 16

17 Participating centers Imelda Hospital, Bonheiden Dr. P. Peeters, Dr. J. Verbist, Dr. W. Van den Eynde AZ Sint-Blasius Hospital, Dendermonde Dr. K. Deloose, Dr. M. Bosiers, Dr. J. Callaert OLV Hospital, Aalst Dr. L. Maene, Dr. R. Beelen RZ Heilig Hart, Tienen Dr. K. Keirse, Dr. B. Joos University Hospital Antwerp Prof. J. Hendriks, Prof. P. Lauwers 17

18 Patient demographics N = 120 out of 120 Male (%) 79 (65.83%) Age (min max; ±SD) years ( ; ±10.52) Final data Rutherford Classification Nicotine abuse (%) 73 (60.83%) Hypertension (%) 76 (63.33%) Diabetes mellitus (%) 23 (19.17%) Renal insufficiency (%) 15 (12.50%) Hypercholesterolemia (%) 66 (55.00%) Obesity (%) 28 (23.33%) 17% 51% 32% Rutherford 2 Rutherford 3 Rutherford 4 *missing data for 1 patient 18

19 Indications & Procedural characteristics Lesion length (min max; ±SD) mm ( ; ±49.49) Reference Vessel Diameter 5.26 mm ( ; ±0.59) DCB STENT N = 151 N = 131 Mean DCB diameter (min max; ±SD) 5.15 mm ( ; ±0.57) Mean STENT diameter (min max; ±SD) 5.78 mm ( ; ±0.53) Occlusion (%) 40 (33.33%) Calcified lesion (%) 60 (50.00%) 19

20 12 Month Primary Patency (105 pts) 89.3 % time baseline 1MFU 6MFU 12MFU (D365) 12MFU (D395) %

21 12 Month freedom from TLR(105 pts) 93.7 % time baseline 1MFU 6MFU 12MFU (D365) 12MFU (D395) %

IS IT WORTHWILE TO ADD DCB??? 100 95 90 85 80 75 70 65 60 Primary patency 6 months 98.0 94.6 89.

22 IS IT WORTHWILE TO ADD DCB??? Primary patency 6 months DEBAS BIOLUX 4EVER - full cohort 4EVER 5-9% PPR 6m LL (cm) 18,8 8,3 7,2 PSVR (<) 2,5 2,5 2,5 22

23 IS IT WORTHWILE TO ADD DCB??? Primary Patency 12 months DEBAS BIOLUX 4EVER - 4EVER prelim pts 81,4 7-13% LL (cm) 18,8 8,3 7,2 PSVR (<) 2,5 2,5 2,5 23

24 IS IT WORTHWILE TO ADD DCB??? Primary Patency 24 months? DEBAS BIOLUX 4EVER 4EVER 16% LL (cm) PSVR (<)

25 IS IT COMPARABLE TO DES DATA? Benchmarking in the DES world MAJESTIC Zilver PTX RCT Zilver PTX Japanese PMS BIOLUX 4EVER (prelim 105 pts) DEBAS PPR 1yr f TLR LL (cm) PSVR (<)

26 Conclusion Combining Passeo Lux with Pulsar18 stent creates a win-win situation as shown in preliminary 12 months data of BIOLUX 4EVER and confirmed in DEBAS results Benchmarking with DES studies (although very difficult) shows comparable results with BIOTRONIK Combination Therapy 26

27 DCB + stent in the SFA 12-month results of the Biolux4ever trial Dr. Marc Bosiers LINC 2017, Leipzig

Combination therapy : treatment rationale and clinical evidence

LINC Asia Pacific 2016, Hong Kong A.Z. Sint-Blasius, Dendermonde Marc Bosiers Koen Deloose Joren Callaert Imelda Hospital, Bonheiden Patrick Peeters Jürgen Verbist Combination therapy : treatment rationale