DCB level 1 evidence review
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1 DCB level 1 evidence review Raphaël COSCAS Vascular Surgery Department Ambroise Paré Hospital, AP-HP and Paris-Ouest University Boulogne-Billancourt, France
2 Disclosure Speaker name: Raphael COSCAS I have the following potential conflicts of interest to report: Consulting: Medtronic, Spectranetics, Terumo Employment in industry Shareholder in a healthcare company Owner of a healthcare company Other(s) I do not have any potential conflict of interest
3 Level 1: RCT with strong power Meta-analysis of RCTs Evidence Level 2: RCT with low power Non randomized controlled trials Grade A: Established proof Grade B: Presumed Grade of recommandation Level 3: Case-control studies Level 4: Comparative studies with major bias Retrospective studies, Case series Transversal or Longitudinal epidemiologic studies Grade C: Low level HAS, French Health Authorities Guidelines 2013
4 Where are the RCTs with DCBs?
5 3 DCBs with large RCTs IN.Pact Medtronic Lutonix Bard PTX concentration 3,5 2 2 Excipient Urea Polysorbate Sorbitol Stellarex Spectranetics Polyethylene glycol PTX type Crystalline Hybrid Hybrid Balloon state during PTX deposition Inflated Inflated Inflated
6 The Ideal RCT Large N / Multicenter Selected relevant population Adequate control therapy Double blind Blinded duplex and angio corelab Clinical event committee Independent data safety monitoring board External monitoring Optimal DCB use Relevant clinical endpoint
7 3 balloons are supported by high quality RCTs N > 300 Multicenter Similar exclusion criterias Rutherford 2, 3, 4 fem-pop Against standard PTA (POBA) Short lesions < 3-4cm Single blind Rutherford 5, 6 Blinded duplex and angio corelab In-stent restenosis Clinical event committee Failure to cross the lesion Independent data safety monitoring board Failed PTA External monitoring Severe calcification Relevant clinical endpoint (PP)
8 3 balloons are supported by high quality RCTs IN.Pact In.Pact SFA Lutonix Levant 2 Stellarex Illumenate EU RCT Stellarex Illumenate US Pivotal N (randomization) 331 (2:1) 476 (3:1) 294 (3:1) 300 (2:1) Age (y) 67.5 ± ± ± 9 68 ± 10 Claudicants (%) Lesion Length (cm) 8.9 ± ± ± ± 4.5 Occlusions (%) Data from DCB groups
9 In.Pact SFA trial IN.PACT SFA I 150 subjects enrolled at 13 EU sites Sep Apr 2011 IN.PACT SFA II 181 subjects enrolled at 44 US sites Apr Jan 2013 RC Pre-screening Screen Failure (treat per standard practice) Clinical and Anatomic Inclusion/Exclusion Criteria SUCCESSFUL PRE-DILATATION 2 Screening NO 331 Randomized 2:1 IN.PACT (220) PTA (111) Randomization Tepe et al. IN.PACT SFA Trial Investigators, Circulation 2015
10 In.Pact SFA at 1 year Tepe et al. IN.PACT SFA Trial Investigators, Circulation 2015
11 In.Pact SFA at 3 years Schneider et al. IN.PACT SFA Trial Investigators, Circ Cardiovasc Interv. 2018
12 In.Pact SFA at 3 years IN.PACT DCB (N=220) PTA (N=111) P-value Clinically-driven TLR [1] 15.2% (30/197) 31.1% (32/103) All TLR [2] 16.2% (32/197) 34.0% (35/103) < Time to First CD-TLR ± ± < Primary Sustained Clinical Improvement [3] 68.7% (114/166) 52.6% (51/97) ABI / TBI [4] ± ± Schneider et al. IN.PACT SFA Trial Investigators, Circ Cardiovasc Interv. 2018
13 Mean 6MWT Distance (m) In.Pact SFA at 3 years 6-Minute Walk Test* p=0.883 p=0.607 p=0.609 p=0.741 p=0.883 p=0.607 p=0.609 p=0.741 DCB patients achieved the same level of function with 48% fewer reinterventions *Data collected in IN.PACT SFA II phase only
14 Levant 2 trial LEVANT II Trial, N Eng J Med 2015
15 Levant 2 trial 73.5% 56.8% Primary Patency (KM) at 365 Days P= LEVANT II Trial, N Eng J Med 2015
16 Levant 2 trial
17 Levant 2 trial The role of the technique
18 Illumenate EU RCT Schroeder H et al. ILLUMENATE EU RCT, Circulation 2017
19 Illumenate EU RCT at 1 year Primary Patency Clinically-driven TLR Schroeder H et al. ILLUMENATE EU RCT, Circulation 2017
20 Illumenate EU RCT at 2 years Brodmann et al. ILLUMENATE EU RCT, Oral presentation, Viva 2017
21 Illumenate EU RCT Brodmann et al. ILLUMENATE EU RCT, Oral presentation, Viva 2017
22 Illumenate US Pivotal Krishnan P et al. ILLUMENATE US Pivotal, Circulation 2017
23 Illumenate US Pivotal Primary Patency Clinically-driven TLR Krishnan P et al. ILLUMENATE US Pivotal, Circulation 2017
24 Primary patency at 12 m in RCTs (Core lab) 70.9 p < 0.05 Inspired by slides from K. Keirse
25 Primary patency at 24 m in RCTs (Core lab) M.Brodmann - ILLUMENATE European Randomized Trial: 2-Year Results oral presentation, VIVA Sep 2017, Las Vegas 2 Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol Dec 1;66(21): Laurich C, oral presentation at SVS Annual Meeting June 2015, Chicago
26 Global view of primary patency of DCBs in RCT Inspired by slides from K. Keirse
27 Multiple meta-analysis of RCTs favor DCB over POBA Significant benefits in terms of TLR at 12 m and 24 m Primary patency at 6 and 12 m LLL at 6 m Katsanos K et al. J Endovasc Ther Jongsma H et al. J Vasc Surg Giacoppo D et al. JACC Cardiovasc Interv Kayssi A et al. Cochrane Database Syst Rev. 2016
28 DCB in ISR Cassese et al, Eurointervention 2017
29 DCB in ISR Cassese et al, Eurointervention 2017 Ott I et al, ISAR-PEBIS study, J Am Heart Assoc. 2017
30 No RCT comparing DCB with stents IN.PACT DCB 120% Bare Metal Stent Drug-Eluting Stent Stent-Graft 25,2 26,40 12m Primary Patency L length (cm) % 80% 60% 40% 87,5% 8,9 76,1% 19,4 89,3% 91,1% 90,9% 6,1 81,3% 81,1% 7,0 7,7 86,3% 8,3 73,7% 72,2% 9,3 9,6 77,2% 8,9 83,1% 5,4 96,4% 7,1 19,5 76,0% 22,6 77,6% 19,0 19,0 70,9% 53,0% % 4 0% IN.PACT SFA (IN.PACT DCB) [1] Zeller DCB vs. DES (DCB arm) [2] Micari DEB-LONG [3] IN.PACT Global Long Lesions [4] COMPLETE SE SFA (Complete SE) [5] RESILIENT (Lifestent) [6] STROLL (Smart Control) [7] SUPERB (Supera) [8] SuperNOVA (Innova) [9] DURABILITY I (EverFlex) [10] DURABILITY II (EverFlex) [11] ZILVER PTX RCT (Zilver PTX) [12] MAJESTIC (Eluvia) [13] Zeller DCB vs. DES (DES arm) [14] Zilver PTX Single- Arm TASC C&D (Zilver PTX) [15] VIASTAR (Viabahn) [16] VIBRANT (Viabahn) [17] 0 Primary patency rates and mean lesion lengths may be calculated differently, and therefore may not be directly comparable; chart is for illustration only. [1] Tepe G, et al. Circ 131: (2015). Laird JR, et al. J Am Coll Cardiol: 66: (2015). Note: 1 year results updated from interval to cumulative KM calculations. PSVR 2.4 and freedom from CD-TLR. [2] Zeller T, et al. JEVT. (3): (2014). [3] Micari A, et al. JACC Cardiovasc Interv. 9(9):950-6 (2016). [4] Scheinert D. EuroPCR [5] Complete SE Instructions for Use. [6] Laird J, et al. Circ Cardiovasc Interv 3: (2010). [7] Gray W, et al. J Vasc Interv Radiol 26:21-28 (2015). [8] Garcia L, et al. Circ Cardiovasc Interv 8(5): e (2015). [9] Innova Instructions for Use (Boston Scientific) [10] Bosiers M, et al. J Endovasc Ther 16:261-9 (2009). [11] Matsumura J, et al. J Vasc Surg 58:73-83 (2013). [12] Dake M, et al. Circ Cardiovasc Interv 4: (2011); Dake M, et al. JACC 61(24): (2013). [13] Müller-Hülsbeck S, et al. J Endovasc Ther. (2016). [14] Zeller T, et al. JEVT. (3): (2014).[15] Bosiers M, et a. J Cardiovasc Surg (Torino). 54(1): (2013). [16] Lammer J, et al. Cardiovasc Intervent Radiol 38:25-32 (2015). [17] G. Ansel. VIBRANT interim results presented at VIVA 2009.
31 Conclusions Large RCTs demonstrate the superiority of 3 DCBs over POBA in de novo SFA lesions regarding primary patency at 1 year 2 DCBs have sustained superiority at 2 years and 1 DCB remains superior at 3 years There is a lack of evidence for DCBs in other locations, in other indications and against other therapies (BMS, DES)
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