Drug Eluting Stents (DES) Below the Knee (BTK)

Transcription

1 Drug Eluting Stents (DES) Below the Knee (BTK) Osama A. Ibrahim, MD, FACC Director Peripheral Endovascular Therapies Director Limb Salvage and Amputation Prevention Program North Memorial Heart and Vascular Institute North Memorial Healthcare Minneapolis, MN

2 Disclosures Speaker s Bureau: None Stockholder: None Honorarium: None Grant/Research Support: None Consultant: None Medical/Scientific Boards: None

3 Background Critical Limb Ischemia (CLI) bears significant mortality, morbidity, and tissue loss. Majority of CLI patients present with Infrapopliteal/Below The Knee (BTK) arterial disease. Revascularization options for BTK disease include endovascular, surgical, and hybrid approaches. Surgical tibial bypass remains with significant morbidity, mortality, and graft failure.

4 Background Tremendous advancements have been made in endovascular approaches for BTK disease, however, patency rates remain suboptimal. The foundation of BTK endovascular revascularization remains Percutaneous Transluminal Angioplasty (PTA). Atherectomy is widely used but no robust data to support it s validity BTK. Stents are traditionally used for Bailout but restenosis rates are high with Bare Metal Stents (BMS).

5 Background Drug Eluting Stents (DES) have been the preferred choice of Coronary Artery revascularization since their introduction in Significant reduction in ISR have been noted with DES compared to BMS. Longer duration of Dual AntiPlatelet Therapy (DAPT) is needed with DES. The purpose of this presentation is to review usage of DES in BTK disease.

6 BTK Revascularization Challenges Long, complex, often calcified nature of lesions 1 Often associated with multilevel disease, thus success is inflow- and outflow-dependent 2 High restenosis rate 3 Limb salvage poorly correlated to primary patency 3 While literature landscape is dominated by small series and case studies, several examples of small RCTs do exist 1.Liistro F, et al. Circ 128: (2013). 2.Norgren L, et al. J Vasc Surg 45:S5-67 (2007). 3.Kudo T, et al. J Vasc Surg 41: (2005).

7 Overview The beginning DES vs PTA DES vs BMS DES vs DCB PTA (Drug Coated Balloon)

8 PaRADISE Prospective, non-randomized, single-center study of DES 1 DES (Cordis Cypher and BSX Taxus) Patient # 106 Limb # 118 Lesion Length (cm) Vessel diameter (mm) 2.9 Occlusion % Calcification % (severe) Restenosis 3 (256 ± 244 days)% 12.0 TLR 2 % 15.0 Limb salvage rate (3-year)% 94 [6/106] NR NR NR 1. Feiring AJ, et al. J Am Coll Cardiol Cardiovasc Interv 55: (2010). While 118 subjects were enrolled, 12 subjects experienced failed wire crossing; thus 106 subjects are reported here. 2. NR = not reported. Follow-up interval for TLR rate not provided.

9 Overview The beginning DES vs PTA DES vs BMS DES vs DCB PTA (Drug Coated Balloon)

10 ACHILLES Prospective, randomized, multicenter comparison of DES v PTA 1 DES (Cordis Cypher) PTA P-value Patient # Lesion # Lesion Length (cm) 2.69 ± ± Reference vessel diameter (mm) 2.6 ± ± Occlusion % [length 2 cm] 81.3% [0.67 ± 1.93] 75.4% [1.10 ± 2.24] Calcification % (moderate-severe) Post-procedure stenosis % 13.3 ± ± 15.2 <0.001 Device success 3 % <0.001 Bail-out Stent % (8/101) Patency 4 (12-mo) % Restenosis 5 (12-mo)% CD-TLR (12-mo) % Amputation rate (12-mo)% Scheinert D, et al. JACC 60: (2012). 2. Investigator reported. 3. Defined as achieving final residual diameter stenosis of <30% using assigned device only. 4. Defined as freedom from CD-TLR (clinically drive target lesion revascularization) and restenosis (diameter stenosis 50% via angiography or DUS). 5. Restenosis defined as diameter stenosis 50% via angiography or DUS.

11 Overview The beginning DES vs PTA DES vs BMS DES vs DCB PTA (Drug Coated Balloon)

12 DESTINY Prospective, randomized, multicenter comparison of DES v BMS 1 DES (Abbott Xience V) BMS (Abbott Vision) P-value 2 Patient # Lesion # Lesion Length (cm) 1.59 ± ± Reference vessel diameter (mm) 3.00 ± ± 0.72 NSS Occlusion % NSS Calcification % (significant) NSS Patency 3 (12-mo) % Freedom from TLR (12-mo) % Amputation rate (12-mo)% 1.4 [1/74] 3.0 [2/66] NR 1. Bosiers M, et al. J Vasc Surg 55:390-9 (2012). 2. NSS = not statistically significant; NR = not reported. 3. Defined as freedom from in-stent restenosis (diameter stenosis 50% via angiography or DUS) evaluated by Kaplan-Meier estimate.

13 Falkowski, et al. Prospective, randomized, multicenter comparison of DES v BMS 1 DES (Cordis Cypher) BMS (Cordis Sonic) P-value 2 Patient # Lesion Length (cm) 1.74 ± ± 0.35 NSS Reference vessel diameter (mm) 2.69 ± ± 1.6 NSS Occlusion % NR NR Calcification % NR NR Procedural success 3 % Restenosis 4 (12-mo)% <0.001 TLR (12-mo) % <0.05 Amputation rate (12-mo)% NR NR 1. Falkowski A, et al. Eur Radiol 19: (2009). 2. NSS = not statistically significant; NR = not reported. 3. Defined as achieving successful device implantation without serious complications. 4. Restenosis defined as diameter stenosis 50% via angiography or DUS.

14 YUKON-BTK Prospective, randomized, multicenter comparison of DES v BMS 1 DES (Translumina Yukon) BMS (uncoated Yukon) P-value 2 Patient # Lesion Length (cm) 3.0 ± ± 0.9 Reference vessel diameter (mm) 3.0 ± ± 0.4 Occlusion % Calcification % NR NR Post-procedure stenosis % 3 ± 5 3 ± 5 Procedural success 3 % Patency 4 (12-mo) % Restenosis 5 (12-mo) % TLR (12-mo) % Amputation rate (12-mo)% Rastan A, et al. Eur Heart J 32: (2011). 2. NSS = not statistically significant; NR = not reported. 3. Defined as successful implantation of study device with stenosis <20% of the vessel diameter. 4. Defined as freedom from in-stent restenosis 50% diameter determined via DUS or angiography. 5. Defined as in-stent restenosis 50% diameter determined via DUS or angiography.

15 Overview The beginning DES vs PTA DES vs BMS DES vs DCB PTA (Drug Coated Balloon)

16 IDEAS Prospective, randomized, multicenter comparison of DES v DCB 1 DES (Various Manufacturers) Patient # Lesion # DCB (Medtronic IN.PACT Amphirion) P-value 2 Lesion Length (cm) 12.7 ± ± Reference vessel diameter (mm) NR NR Occlusion % Calcification % (severe) Post-procedure stenosis % 9.6 ± ± 3.5 < Restenosis 3 (6-mo)% TLR (6-mo) % Amputation rate (major, 6-mo)% 7.4 [2/27] 4.0 [1/25] Siablis D, et al. J Am Coll Cardiol Cardiovasc Interv 7: (2014). 2. NR = not reported. 3. Restenosis defined as diameter stenosis >50% via angiography.

17 DES BTK Summary DES as a class exhibits consistent restenosis and revascularization rates. Falkowski 4 DESTINY 2 YUKON-BTK 3 ACHILLES 1 IDEAS 5 Comparator DES v BMS DES v BMS DES v BMS DES v PTA DES v DCB Subjects Patency NR 85% v 54%* 80.6% v 55.6%* 75.0% v 57.1%* NR Restenosis Rate 16% v 76%* 17% v 36% 19.4% v 44.4% 22.4% v 41.9%* TLR rate 12% v 56%* 8% v 35%* 9.7% v 17.5% 10.0% v 16.5% Amputation rate NR 1.4% v 3.0% 3.2% v 6.4% 13.8% v 20.0% 28.0% v 57.9%* (6mo) 7.7% v 13.6% (6mo) 7.4% v 4.0% (6mo) Primary patency (1 Patency), restenosis, and target lesion revascularization (TLR) may be defined differently among studies. * = Statistically significant; NR = Not reported. 1. Scheinert D, et al. JACC 60: (2012). 2. Bosiers M, et al. JVS 55:390-8 (2012). 3. Rastan A, et al. Eur Heart J 32: (2011). 4. Falkowski A, et al. Eur Radiol 19: (2009). 5. Siablis D, et al. J Am Coll Cardiol Cardiovasc Interv 7: (2014).

18 Pitfalls and Drawbacks Lesion length. Significant calcification. Residual stenosis -? Stent apposition. Adequate vessel debulking prior to stent deployment. Length and compliance of DAPT. Lesion location (proximal vs distal vessel). Sizing bias.

19 Future Ideas/Considerations Lesion selection Proximal 1/3 of the vessel. Short focal lesion(s). Combining with atherectomy optimal debulking prior to stent placement. Adequate stent apposition as verified by IVUS or OCT. Compliance with DAPT. Accurate vessel sizing.

20 Future Technologies Self expanding DES BTK. Smaller sizes. Longer lengths (although patency may be affected). Tapered stents. Bioabsorable scaffolds BTK.

21 Summary Small RCTs have demonstrated that DES exhibits superior patency and binary restenosis compared controls of PTA, DCB, and BMS In regard to limb salvage, however, all treatments appear to be associated with low amputation rates Multilateral approach with intervention, surveillance, and wound care necessary in providing optimal outcomes Focal, calcified lesions may be the desired targets for DES Capitalize on the scaffolding nature of the stent Establish reservoir of anti-proliferative drug

22 THANK YOU

23 Drug Eluting Stents (DES) Below the Knee (BTK) Osama A. Ibrahim, MD, FACC Director Peripheral Endovascular Therapies Director Limb Salvage and Amputation Prevention Program North Memorial Heart and Vascular Institute North Memorial Healthcare Minneapolis, MN