Is combination therapy with directional atherectomy followed by DCB the answer to challenges in treating SFA disease?

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Ilene Bradford
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1 Is combination therapy with directional atherectomy followed by DCB the answer to challenges in treating SFA disease? The REALITY trial G. Torsello Münster

2 Disclosure Speaker name: G. Torsello... 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) X I do not have any potential conflict of interest

Eur J Vas Endovasc Surg 33, S1-S75: 2007. 2. DeRubertis et al.

3 Factors associated with restenosis in peripheral interventions Lesion length 1 Diabetes 2 Occlusions 3 Calcification 4 1. Norgren et al. Eur J Vas Endovasc Surg 33, S1-S75: DeRubertis et al. J Vasc Surg 2008;47: Lida et al. Cath and Cardiovasc Interven 2011 Oct 1;78(4): Cioppa et al. CV Revasc. Med Jul-Aug:

4 DCB is a proven technology in TASC A & B lesions 3-year outcomes from the IN.PACT SFA RCT P. Krishnan. Drug-coated balloons show superior three-year outcomes vs. angioplasty: results from IN.PACT SFA randomized trial. Presented at VIVA 2016.

5 However, outstanding outcomes seen in global registries come at the cost of high bailout stenting rates The longer the lesion, the higher the bailout stent rate LUTONIX Global 1 ILLUMENATE Global 2 IN.PACT Global Full Clinical Cohort 3 IN.PACT Global Long Lesion 4 IN.PACT Global CTO 5 IN.PACT Global ISR 6 Follow-up 691 subjects Complete follow-up Site-reported Interim Core Labadjudicated 1406 subjects Complete followup Core Labadjudicated 157 subjects Complete followup Core Labadjudicated 126 subjects Complete followup Core Labadjudicated 131 subjects Complete followup Core Labadjudicated Key Lesion Characteristics 12M results Length (cm) CTO (%) Ca 2+ (%) 10.12cm 31.2% 50.2% 7.2cm 28.3% 62% 12.1cm 35.5% 68.7% 26.4cm 60.4% 71.8% 22.9 cm 100.0% 71.2% 17.2cm 34.0% 59.1% Primary Patency FF TLR/CD-TLR 85.4% 94.1% 86.5% 93.9% % 91.1% 94.0% 84.4% 88.2% 88.7% 92.9% Bail-out Stent (%) 25.2% 15.0% 25.3% 40.4% 46.8% 14.5% 1. Presented by Benenati, JF. VIVA 2016 BARD Symposium 2. Presented by Krishnan, P. NCVH Presented by Jaff M, VIVA Las Vegas Presented by Scheinert D, PCR Paris Presented by Tepe G, CX London 2016.] 6. Presented by Brodmann M, VIVA Las Vegas 2015.

Primary patency & late lumen loss negatively impacted by increasingly severe calcification Studies have shown Ca ++ represents a barrier to optimal drug absorption IN.

score + angiographic calcium score) Severity of lesion calcification is associated with LLL after treatment with DCB.

6 Primary patency & late lumen loss negatively impacted by increasingly severe calcification Studies have shown Ca ++ represents a barrier to optimal drug absorption IN.PACT DCB and Calcium Registry Study (n=60) 12 month Results 1 Retrospective analysis of 91 patients 2 Analysed at 6M post DEB Lesion calcification analysed by core labs (PACSS score + angiographic calcium score) Severity of lesion calcification is associated with LLL after treatment with DCB. Author conclusion: One possible approach to overcome this limitation might be plaque modification or removal prior to DEB usage. 1. Fanelli F, et al. Cardiovasc Intervent Radiol, 37: (2014). 2. Tepe G, et al. J Endovasc Ther Oct;22(5):

7 Why combination of atherectomy and Long-Severely Calcified Lesion drug elution? After Atherectomy After DCB 1. Sufficient luminal gain 2. Reduce calcium burden 3. Increase paclitaxel bioavailability 4. Bailout stenting reduction 5. Inflammation reduction after debulking

8 N=65 N=172 N=800 Which device? 12 Month Patency 78% Ability to remove calcified plaque 54% 62% Generate significant lumen gain Favourable complication profile CELLO (Laser) Pathway PVD (JetStream) DEFINITIVE LE (DA) 1. Dave J. Endovasc. Ther. 2009;13: Zeller et al. J Endovasc. Ther. 2009;16:

DEFINITIVE Ca++ demonstrated calcified disease can be treated with DA and embolic protection DEFINITIVE LE and Ca 2+ : Outcomes SilverHawk, TurboHawk (Medtronic) DEFINITIVE LE [1] DEFINITIVE Ca2+ [2]

9 DEFINITIVE Ca++ demonstrated calcified disease can be treated with DA and embolic protection DEFINITIVE LE and Ca 2+ : Outcomes SilverHawk, TurboHawk (Medtronic) DEFINITIVE LE [1] DEFINITIVE Ca2+ [2] Patient # 598 (RCC 1-3) 201 (RCC 4-6) 133 Lesion # Bail-out Stent 3.2% (33/1022) 4.1% (7/169) 1 MAE (30d) 1.0% (6/598) 3.5% (7/201) 6.9% (9/131) 1 o Patency (1y) 78.0% 71.0% NR 2 1 o Patency Def PSVR 2.4 by DUS NR 2 TLR NR NR NR NR = Not Reported. Boldfaced values indicate statistical significance (p < 0.05). 1. Site-reported lesions totaled 169 while Core Lab evaluated lesions totaled 168 (two site-reported lesions were considered one diffuse lesion by the Core Lab). Provisional stent rate was reported by Roberts, et al., with respect to the site-reported lesion number, i.e. 169 not Primary endpoint for DEFINITIVE Ca 2+ was safety; patency was not evaluated. 1. McKinsey J, et al. JACC Cardiovasc Interv 7(8):923-33: Roberts D, et al. Catheter Cardiovasc Interv 84(2):236-44:2014.

DEFINITIVE AR 1 Pilot study to detect trends in treatment differences between groups

DAART: Directional Atherectomy + Anti-Restenotic Therapy INCLUSION CRITERIA RCC 2-4

and 7mm EXCLUSION CRITERIA In-stent restenosis Aneurysmal target vessel Multiple

10 DEFINITIVE AR 1 Pilot study to detect trends in treatment differences between groups and designed to assess the effect of treating lesions with DA followed by DCB (DAART) DAART: Directional Atherectomy + Anti-Restenotic Therapy INCLUSION CRITERIA RCC % stenosis of SFA and/or popliteal artery Lesion Length 7-15cm Reference Vessel 4mm and 7mm EXCLUSION CRITERIA In-stent restenosis Aneurysmal target vessel Multiple lesions in target limb that require treatment 1. Zeller T, et al. Presentation at VIVA 2014

11 DEFINITIVE AR 1 Year Outcomes Emerging advantage in long & severely calcified lesions 1. Zeller T, et al. Presentation at VIVA 2014

12 Co-Principal Investigators Krishna Rocha-Singh, MD Chief Scientific Officer Prairie Heart Institute of Illinois Brian DeRubertis MD, FACS Associate Professor of Surgery UCLA Division of Vascular Surgery The REALITY Study evaluates patient outcomes with adjuctive use of Medtronic HawkOne or Medtronic TurboHawk and Medtronic IN.PACT Admiral drug-coated balloon. The multi-center, international, prospective, single-arm study will enroll up to 250 subject at up to 15 sites. The study includes angiographic and duplex ultrasound core lab adjudication. Primary patency is assessed by duplex ultrasound at 12-months. Patients are followed up to 24 months to determine clinically driven target lesion revascularization (CD-TLR). The study is sponsored and managed by VIVA physicians with support from Medtronic through an external research project grant. ClinicalTrials.gov Identifier: NCT

DeRubertis MD, FACS Associate Professor of Surgery UCLA Division

13 Co-Principal Investigators Krishna Rocha-Singh, MD Chief Scientific Officer Prairie Heart Institute of Illinois Brian DeRubertis MD, FACS Associate Professor of Surgery UCLA Division of Vascular Surgery Consent 250 subjects Goal Enrollment 150 subjects 10 U.S. Sites Lesion length 8-18cm Occlusion length 6-10cm 3 German Sites Lesion length up to 25cm ClinicalTrials.gov Identifier: NCT

14 I have a dream!

15 I have a dream as vascular specialist too Increase the applicability of endovascular techniques also in patients with complex lesions Including patients with limited number of runoff vessels, with severe lower limb ischemia and diabetes Improve long term patency also for long/calcified lesions

16 Conclusions Directional atherectomy and DCB perform well as standalone treatments Early data suggests that combined therapy may improve patient outcomes in more complex lesions REALITY will show whether DAART is the right answer to challenges in treating SFA disease

17 home page: Thank you! Universitätsklinik Münster St. Franziskushospital Münster

18 Is combination therapy with directional atherectomy followed by DCB the answer to challenges in treating SFA disease? The REALITY trial G. Torsello Münster

Vessel Preparation: What does it mean and what are the current tools? Lawrence Garcia, MD St. Elizabeth s Medical Center Boston, MA, USA

Vessel Preparation: What does it mean and what are the current tools? Lawrence Garcia, MD St. Elizabeth s Medical Center Boston, MA, USA Disclosure Statement of Financial Interest Within the past 12 months,