Preliminary 6-month results of VMI-CFA trial

Transcription

1 Preliminary 6-month results of VMI-CFA trial Koen Deloose, MD Head Vascular Surgery, AZ Sint Blasius, Dendermonde, Belgium

2 Disclosure slide Speaker name: Koen Deloose, MD I have the following potential conflicts of interest to report: Consulting: Medtronic, Spectranetics, Biotronik, Abbott, Bard, ivascular, Bentley, Cook, GE Healthcare, Terumo, Boston Scientific, Contego Medical, Cardionovum 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 Among vascular surgeons, the common femoral artery remains one of the last areas of open reconstructive surgery NO ENDOVASCULAR THERAPY FOR THIS BABY And there are good arguments in support of such near-religion Criado F. Blog in Vascular Disease Management

4 there are good arguments in support of such near-religion Easy/Safe accessible for surgery High flexion zone Location prone to crush Bulky, eccentric, heavily calcified plaques Superb long-term (5-10yr) patencies (>90%) (surgical/endovascular) access area Frequently femoral bifurcation involvement 4

5 there are good arguments in support of such near-religion Easy/Safe accessible for surgery High flexion zone Superb long-term (5-10yr) patencies (>90%) 5

6 there are good arguments in support of such near-religion High flexion zone Easy/Safe accessible for surgery Ballotta et al. (Surgery 2010;147: ) 6,6% minor complication rate Mainly Superb lymphlong-term leaks (5-10yr) patencies (>90%) Kang et al. (J Vasc Surg 2008;48:872-7) 13,8% complication rate 5% required reintervention Kechagias et al. (World J Surg 2008;32:51-54) 17,1% wound infection rate 9% hematomas Derksen et al. (Vasc End Surg 2009;43:69-75) 14% wound infection rate 9% superficial infections, 5% deep infections Cardon et al. (Ann Chir 2001;126(8):777-82) 18% minor complication rate 3,6% major complication rate 6

7 there are good arguments in support of such near-religion Ballotta et al. (Surgery 2010;147: ) 8 yr single center, prospective study, 117 pts 1, 3, 5 & 7 yrs: 100%, 99%, 96%, 96% APP: 100% - LSR: 100% Kang et al. (J Vasc Surg 2008;48:872-7) 5 yr single center, prospective study, 58 pts 1 & 5 yrs: 93%, 91% High flexion zone APP: 100% Kechagias et al. (World J Surg 2008;32:51-54) 15 yr single center, prospective study, 111 pts PPR: 5, 10, 15 yrs: 93,7%, 93,7%, 85,2% 5, 10, 15 yrs: 68%, 50,6%, 42,5% Easy/Safe accessible for surgery Superb long-term (5-10yr) patencies (>90%) 7

8 there are good arguments in support of such near-religion Location prone to crush (surgical/endovascular) access area Bulky, eccentric, heavily calcified plaques 8

9 there are good arguments in support of such near-religion Frequently femoral bifurcation involvement 9

10 So the CFA-area is ripe for (tailored) endovascular penetration 10

11 So the CFA-area is ripe for (tailored) endovascular penetration Dpt Vascular Surgery, Leicester, UK. Davies R et al. Vasc EndoVasc Surg 2013 ; 47(8) ;

12 So the CFA-area is ripe for (tailored) endovascular penetration Bonvini R et al. JACC 2011, 58 (8) ;

13 So the CFA-area is ripe for (tailored) endovascular penetration Gouëffic Y et al. JACC Cardiovasc Interv 2017 Jul 10(13):

14 So the CFA-area is ripe for (tailored) endovascular penetration VMI-CFA Physician initiated, prospective, multicenter, single arm trial to evaluate the Supera Peripheral Vascular Mimetic Implant Device (Abbott Vascular) for symptomatic (RB 2-4) CFA disease treatment OLV Hospital, Aalst AZ Sint-Blasius, Dendermonde ZNA, Antwerp Imelda, Bonheiden CHU, Nantes Clinique Rhône-Durance, Avignon CHU, Clermont-Ferrand

15 VMI-CFA trial : Endpoints Primary endpoint Efficacy endpoint : Primary months (DUS PSVR < 2,5) (Core lab adjudicated) in CFA, SFA & DFA with no reintervention Safety endpoint : periprocedural adverse events up to 30 days post procedure Secondary endpoints Technical success rate (angiographical RS<30%) Primary 6 months (same definition) Freedom from 6 & 12 months Clinical success : defined as improvement in RB classification 15

16 VMI-CFA trial : In/Ex-clusion criteria Inclusion RB 2-4 classification De novo/post POBA lesions stenosis >50%/occlusions Patent DFA Good SFA run off Exclusion RB 5-6 classification In-stent lesions CFA Previous surgery CFA occluded DFA/SFA Non treatable inflow lesion thrombus Debulking, DE technologies Azéma L. et al. EJVEVS, 41, 6 : June 2011 ;

17 VMI-CFA trial : Timeline screen proc disch 1 M 6 M 12 M Patient informed consent In- / exclusion criteria check Medical / clinical history Medication Physical examination Rutherford ABI Regular Angiography Regular Duplex Ultrasound Core Lab Duplex Ultrasound Adverse Events 17

18 VMI-CFA trial : demographics N = 100 out of 100 Male (%) 81 (81%) Age (min-max ± SD) 72,72 (46,87-95,76 ± 8,59) Rutherford Classification * Nicotine (%) 29 (29%) Hypertension (%) 78 (78%) Diabetes (%) 35 (35%) Renal insufficiency (%) 14 (14%) Hypercholesterolemia (%) 62 (62%) Obesity (%) 25 (25%) Claudicant 79 (79%) CLI patient 21 (21%) * Protocol deviation 18

19 VMI-CFA trial : lesion characteristics N = 100 out of 100 Lesion length (min-max ± SD) 44,17mm (15mm 80mm ± 15,67) Ref vessel diameter (min-max ± SD) 7,29mm (5mm 9mm ± 0,93mm) Degree of stenosis (min-max ± SD) 82,6% (60% - 100% ± 10,65%) Occlusion (%) 11 (11%) Calcified lesion (%) 82 (82%) Azéma classification II (%) 52% Azéma classification III (%) 47% 19

20 VMI-CFA trial : Procedure Procedure time (min-max ± SD) Scopy time (min-max ± SD) Contrast (min-max ± SD) N = 100 out of ,68min (15min 150min ± 29,59min) 14,64min (4min 55min ± 9,93min) 82,54ml (10ml 353ml ± 75,08ml) Femoral access (%) 92 (92%) Cross-over performed (%) 82 (89,13%) Inflow lesion (%) 23 (23%) Outflow lesion (%) 62 (62%) 20

21 VMI-CFA trial : Procedure N = 100 out of 100 Predilatation performed (%) 100 (100%) Diameter predilatation balloon (min-max ± SD) 7,10mm (3mm 9mm ± 1,22mm) Length predilatation balloon (min-max ± SD) 7,29mm 50,53mm (20mm 200mm ± 31,65mm) # supera used stent received (%) 98 (98%) 2 stents received (%) 2 (2%) Diameter stent (min-max ± SD) Length stent (min-max ± SD) 6,48mm (5mm 8mm ± 0,79mm) 49,02mm (20mm 100mm ± 16,32mm) Postdilatation performed (%) 83 (83%) Diameter postdilatation balloon (min-max ± SD) Length postdilatation balloon (min-max ± SD) 7,43mm (5mm 10mm ± 1,06mm) 50mm (20mm 200mm ± 25,79mm) 21

22 VMI-CFA trial : primary patency 100% time baseline 1MFU (30 days) 6MFU* (180 days) 6MFU* (210 days) at risk % * Data from 1 patient missing 22

23 VMI-CFA trial : f-tlr 100% time baseline 1MFU (30 days) 6MFU* (180 days) 6MFU* (210 days) at risk % * Data from 1 patient missing 23

24 VMI-CFA trial : Survival Rate 96,9% 95,9% time baseline 1MFU (30 days) 6MFU* (180 days) 6MFU* (210 days) at risk % ,9% 95,9% * Data from 1 patient missing 24

25 VMI-CFA trial : clinical success Rutherford category Screening 1MFU 6MFU 5 * ** * Protocol deviation ** Data from 1 patient missing 25

26 VMI-CFA trial : Safety outcomes Primary safety endpoint 30 days Device or procedure related death (N) 0 CD-TVR (N) 0 Target limb major amputation (N) 0 MAEs 180 days 210 days Death (N) 3 4 CD-TVR (N) 0 0 Target limb major amputation (N) 0 0 Thrombosis (N)

27 Conclusion In 2018, although CFE still remains the golden standard, the historical no endovascular for this baby -statement is wrong. There are some indicative papers, the randomized TECCO trial included, that there is definitely a place for safer and as-efficient endovascular therapy in CFA Newer generation of devices, like the high crush resistant, repuncturable Supera stent, are facilitating this treatment With this particular device, the VMI-CFA trial shows excellent short term results (6m) with 100% PP- and f-tlr rates, clear clinical benefit & 100% safety profile 27

28 Preliminary 6-month results of VMI-CFA trial Koen Deloose, MD Head Vascular Surgery, AZ Sint Blasius, Dendermonde, Belgium