Lessons learnt from DES in the SFA is there any ideal concept so far?

Transcription

1 Wednesday, January 25, Time: 11:49-11:55 DEEP DIVE SESSION: Lower limb interventions (part II) Lessons learnt from DES in the SFA is there any ideal concept so far? S.Müller-Hülsbeck, MD, EBIR, FCIRSE, FICA ACADEMIC HOSPITALS Flensburg of Kiel University Faculty of Medicine Ev.-Luth. Diakonissenanstalt zu Flensburg Knuthstraße 1, FLENSBURG Dept. of Diagnostic and Interventional Radiology / Neuroradiology 1

2 Disclosure Speaker name: S.Müller-Hülsbeck... x x I have the following potential conflicts of interest to report: Consulting: Terumo, Boston Scientific, Abbott, GE, Cordis J&J 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 DES vs PTA prospective, multinational randomized controlled trial complementary single-arm study DES randomized PTA randomized DES provisional BMS provisional DES single-arm Primary 24month Freedom from 24month Dake MD et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol Jun 18;61(24):

4 DES vs PTA prospective, multinational randomized controlled trial complementary single-arm study DES randomized PTA randomized overall DES vs. Standard care Primary 5 years years 16.1 TLR 28.0 TLR 83.1 Freedom from TLRx 67.6 Freedom from TLRx Overall DES: primary and provisional DES Standard care: provisional BMS plus pt. optimal PTA Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Machan LS, Snyder SA, O'Leary EE, Ragheb AO, Zeller T; Zilver PTX Investigators. Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial. Circulation Apr 12;133(15):

5 Cumulative TLR-Free Rate Overall Efficacy & Safety 24-Month Freedom from TLR At risk: 91.3% Kaplan-Meier Estimate Month Safety Profile 7.5% (4/53) TLR rate No target limb major amputations 1 death at >365 days post-procedure, unrelated Stent Integrity No stent fractures Time Post-procedure (months) 12 Months 24 Months Primary Patency a 96.4% 78.2% Assisted Primary Patency b 98.2% 84.7% Note: Kaplan-Meier Estimates. a Duplex ultrasound peak systolic velocity ratio 2.5 and absence of TLR or bypass. b No TLR and those with TLR not for complete occlusion or bypass who were free of restenosis at 24 months. 5

6 TLR-free Mean Lesion Length (cm) 24-Month TLR-free Rate for SFA Endovascular Therapies 100% 10 80% 8 60% 6 40% 4 20% 2 0% MAJESTIC Zilver PTX RCT RESILIENT DURABILITY II SuperNOVA ILLUMENATE IN.PACT SFA 0 TLR-free Mean lesion length Drug-eluting Stent Nitinol Stent Drug-coated balloon Trial MAJESTIC Zilver PTX RCT RESILIENT DURABILITY II SuperNOVA ILLUMENATE IN.PACT SFA Lesion length (cm) TLR-free 91.3% 86.6% 77.8% 75.3% (CD-TLR) 77.0% 85.8% (CD-TLR) 91.0% (CD-TLR) 6

7 Lesion Characteristics Differ by Location Soft Plaque Above the Knee 1 Below the Knee 1 Thrombus Calcium Lesions more commonly calcified Dense calcium comprises a greater percentage of plaque (27% in tibial vs 12% in popliteal plaque) 2 Small vessels (2-3.5 mm) Tortuous anatomy ISR ISR Soft Plaque Thrombus Fibrotic CTOs Fibrotic CTOs Multiple plaque types (mixed morphology) Large plaque burden 2 Medium to large vessels (4-9 mm) Calcium 1. VIVA 2011 survey 100 physicians surveyed. 2. Bishop et al. Ann Vasc Surg. 2008;22:

8 SFA treatment algorithm 1. Lesion crossing 2. Lesion treatment Predilatation start with PTA Angioplasty 1st! Option 1 procede with DCB Option 2 procede with BMS /DES subintimal intraluminal 8

9 PTA DCB Option 1 TASC C PTA 5x200mm 9

10 Considerations for DCB vs DES in PAD Drug-coated Balloons Treat less-complex lesions Challenging stent zones Potential to cover long vascular territories Leave nothing behind (future options) Potential need for stent following DCB Drug-eluting Stents Treat more complex lesions Scaffold effect (higher lumen gain) Leaves permanent implant Sustained drug release Cost considerations if several stents are needed 10

11 Index Procedure PTA failure: Elastic Recoil! POBA DEB BMS/DES Option 2 11

12 Clinical Probability of Restenosis Following SFA Stenting: Peaks around 12 Months Timing of SFA restenosis is longer compared to coronary stenting, which predominantly occurs within 6 months after stenting Factors for restenosis in the SFA include the number of runoff vessels, severity of lower limb ischemia, and length of diseased segments Iida, O. et al. Cath and Cardiov Intv. 2011; 78: Kimura T, et al. N Engl J Med 1996;334:

13 Controlled Drug Release Drug release from the Eluvia system is sustained over time >90% of drug is released at 1 year Drug release coincides with the restenotic cascade Based on pre-clinical PK analysis. Data on file at Boston Scientific. Dake MD, et al. J Vasc Interv Radiol. 2011;22(5): The Eluvia Stent system is an investigational device, not available for sale in the European Economic Area (EEA). 13

14 Considerations for DES in PAD Severe calcium Consider adjunctive atherectomy? Predilate to assess vessel response Uncoated balloon angioplasty Option 1 Successful predilatation DCB Predilatation Residual stenosis, dissection, or recoil Scaffold (DES) If an implant is needed!!! Option 2 DCB, drug-coated balloon; DES drug-eluting stent. Ansel G, Phillips JA. Drug elution, data, and decisions. Supplement to Endovascular Today. Nov

15 Conclusion is there any ideal concept so far? DES have the power to become the new gold-standard for enhanced primary patency and reduced TLR, if a stent is required after failed PTA DES show promising results for PAD treatment At the moment two DES platforms are available: Zilver PTX for a fast and high-burst drug release ELUVIA for a sustained and low-burst drug release (dual layer Polymer) Primary patency at 24 months was 78,2%, accompanied by a freedom form TLR rate of 92.5%, and zero stent fractures observed through 24 months for ELUVIA Primary patency at 24 months was 74.8%, accompanied by a freedom from TLR rate of 86.6% for Zilver PTX are very encouraging! 15

16 Wednesday, January 25, Time: 11:49-11:55 DEEP DIVE SESSION: Lower limb interventions (part II) Lessons learnt from DES in the SFA is there any ideal concept so far? S.Müller-Hülsbeck, MD, EBIR, FCIRSE, FICA ACADEMIC HOSPITALS Flensburg of Kiel University Faculty of Medicine Ev.-Luth. Diakonissenanstalt zu Flensburg Knuthstraße 1, FLENSBURG Dept. of Diagnostic and Interventional Radiology / Neuroradiology 16