Combination therapy : treatment rationale and clinical evidence

Transcription

1 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 and clinical evidence OLV Hospital, Aalst Lieven Maene Roel Beelen R.Z. Heilig Hart, Tienen Koen Deloose, MD Koen Keirse FMRP

2 DCB + Stent : treatment rationale DCB FMRP

3 Single arm Proof of concepts DCB POBA 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 3µgr/mm² + 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 3

4 Primary Patency at 12-months N.A. N.A. N.A. 4

5 stenting rate (%) Primary Patency at 12-months stenting rate N.A. N.A. N.A. 0 5

6 Freedom from TLR at 12-months 6

7 stenting rate (%) Freedom from TLR at 12-months stenting rate

8 Example Case of our daily practice baseline Dilatation Passeo 18 Lux 6mm (Biotronik ) Stenting Pulsar 18 6mm (Biotronik ) 1yr result 8

9 Stents with PACLITAXEL work ZILVER PTX versus ZILVER (COOK Medical ) ELUVIA versus INNOVA BMS (Boston Scientific ) 9

10 BUT PTX footprint with DCB + BMS is bigger than DES DES PTX contact DCB + BMS PTX contact 10

11 and DCB + BMS is more adaptable Longer lengths available (balloons stents) Spot stenting full coverage Economical advantage? DATA 11

12 DCB & Stent : clinical evidence 12

13 DCB & Stent : clinical evidence 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):

14 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 6 MONTH DATA 14

15 DCB & Stent : clinical evidence BIOLUX4EVER all patients enrolled Preliminary (85/120) 6 months data 15

16 Patient demographics N=85 out of 120 Male (%) 53 (62.4%) Age (min max; ±SD) ( ±10.26) Nicotine abuse (%) 32 (37.6%) Hypertension (%) 54 (63.5%) Diabetes mellitus (%) 30 (35.3%) Renal insufficiency (%) 9 (10.6%) Hypercholesterolemia (%) 47 (55.3%) Obesity (%) 19 (22.4%) 16

17 Indications + Procedural characteristics Rutherford 2 (%) 29 (34.1%) Rutherford 3 (%) 43 (40.6%) Rutherford 4 (%) 13 (15.3%) N= 85 out of 100 Duration (minutes) 49.05* ( ; ±18.77) Access side: - Left Common Femoral Artery (%) - Right Common Femoral Artery (%) 41 (48.2%) 44 (51.8%) Cross-over performed (%) 70 (82.4%) Fluoroscopy (minutes) 9.38** ( ; ±4.66) Contrast dose (ml) 91.65* ( ; ±91.65) *missing data for 2 patients, ** missing data for 7 patients 17

18 Lesion characteristics N = 85 out of 100 Left/Right limb (%) 41 (48.2%) / 44 (51.8%) Lesion length (min max; ±SD) mm ( ; ±49.12) Reference vessel diameter 5.27 mm Mean lumen diameter 0.58 mm Occlusion (%) 24 (28.2%) Calcified lesion (%) 35 (41.18%) 18

19 6 Month Primary Patency (interim) 96.1 % time baseline 1MFU 6MFU at risk %

20 6 Month Freedom from TLR (interim) 98.8 % time baseline 1MFU 6MFU at risk %

21 DCB & Stent : clinical evidence Single center, prospective, single arm trial 65 lesions : Pulsar 18 BMS + Passeo 18 LUX post-dil Strut width : the bigger, the lower direct PTX contact Strut thickness : the bigger, the lower direct PTX contact 85micro Pulsar Stent 140micro 21

22 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 6m PP = 98.0% 1 Month 6 Months 12 Months 18 Months 24 Months Mwipatayi P. Veith 2015, NYC, US Patients at risk (n) Patency (%)

23 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 12m PP = 94.1% 1 Month 6 Months 12 Months 18 Months 24 Months Mwipatayi P. Veith 2015, NYC, US Patients at risk (n) Patency (%)

24 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 24m PP = 88.2% 1 Month 6 Months 12 Months 18 Months 24 Months Mwipatayi P. Veith 2015, NYC, US Patients at risk (n) Patency (%)

25 IS IT WORTHWILE TO ADD DCB??? Primary patency 6 months , ,3 89,4 BIOLUX 4EVER DEBAS PEACE 4EVER LL (cm) 7,9 18,8 11,2 7,2 PSVR (<) 2,5 2,5 2,5 2,5 7% PPR 6m 25

26 IS IT WORTHWILE TO ADD DCB??? Primary Patency 12 months ,2 81,4 BIOLUX 4EVER DEBAS PEACE 4EVER LL (cm) 7,9 18,8 11,2 7,2 PSVR (<) 2,5 2,5 2,5 2,5 13% 26

27 IS IT WORTHWILE TO ADD DCB??? Primary Patency 24 months ,2 72,3 60 BIOLUX 4EVER DEBAS 4EVER LL (cm) 7,9 18,8 7,2 PSVR (<) 2,5 2,5 2,5 16% 27

28 IS IT COMPARABLE TO DES DATA? 100 Benchmarking in the DES world ,4 91,6 84,8 91,4 96,1 96, ,1 Zilver PTX RCT Zilver PTX Japanese PMS PPR 1yr MAJESTIC f TLR DEBAS LL (cm) 5,5 14,7 7,0 18,7 PSVR (<) 2,0 2,4 2,5 2,5 28

29 Conclusion DCB are effective (PPR & ftlr) & safe in treatment of SFA/pop lesions The longer the lesion, the more stents are used Combining DCB with low profile (!) modern BMS creates a win-win situation as shown in preliminary 6 months data of BIOLUX 4EVER and confirmed in DEBAS results, even up to 2 year Benchmarking with DES studies (although very difficult) shows comparable results with DCB + modern BMS LP Longer (and potentially cheaper) lesion length treatment with less metallic implants seems a reasonable advantage for DCB + BMS LP 29

30 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 and clinical evidence OLV Hospital, Aalst Lieven Maene Roel Beelen R.Z. Heilig Hart, Tienen Koen Deloose, MD Koen Keirse FMRP