PES BTK 70 : 12 m results with a paclitaxelcoated self-expanding stent in BTK arteries
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1 LINC 2015, Leipzig A.Z. Sint-Blasius, Dendermonde Marc Bosiers Koen Deloose Joren Callaert Imelda Hospital, Bonheiden Patrick Peeters Jürgen Verbist OLV Hospital, Aalst Lieven Maene Roel Beelen R.Z. Heilig Hart, Tienen Koen Keirse Bart Joos PES BTK 70 : 12 m results with a paclitaxelcoated self-expanding stent in BTK arteries Marc Bosiers, MD FMRP
2 Disclosure slide 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) I do not have any potential conflict of interest FMRP
3 Randomized trials for DES-BTK Yukon Sirolimus eluting (Yukon/no polymer) stent vs. BMS Destiny Everolimus eluting stent (Xience) vs. BMS (Multilink Vision) Achilles Sirolimus eluting (Cypher) stent vs. POBA FMRP
4 Primary Patency % Randomized trials for DES-BTK year patency rates 80,6 82,5 55,6 54, BALLOON-EXPANDABLE & YUKON DESTINY ACHILLES SIRO/EVERO-LIMUS ELUTING Rastan A. et al (2011). European Heart Journal, 32, Bosiers M. et al (2012). Journal of Vascular Surgery, 55, Scheinert D. et al (2012). Journal of the American College of Cardiology, 60, P < 0.05 for all trials BMS/PTA SES FMRP
5 What about SELF-EXPANDABLE & PACLITAXEL ELUTING BALLOON-EXPANDABLE & SIRO/EVERO-LIMUS ELUTING FMRP
6 PES BTK-70 study Prospective, non-randomized, multi-center study To evaluate the immediate and long-term (up to 12 months) outcome of the Paclitaxel-Eluting Stentys Stent System (Stentys) in < 50 mm lesions FMRP
7 PES BTK-70 study Device description Stentys Stent System (Stentys) BTK self-expanding nitinol stent platform Biostable, hemocompatible, polysulfone polymer which elutes paclitaxel Stent for vessels smaller than 3mm was not available for the study paclitaxel FMRP
8 PES BTK-70 study Excellent vessel conformability Balloon-expandable stent (Driver) Proximal Proximal Stentys Distal Proximal FMRP 2015 Distal 8
9 PES BTK-70 study Perfect wall appositioning cfr. APPOSITION II trial; demonstrated on OCT imaging: balloon-expandable stent STENTYS stent Verheye S. (2010). TCT congress FMRP
10 PES BTK-70 study Participating centers BELGIUM M. Bosiers, K. Deloose, J. Callaert - AZ Sint-Blasius, Dendermonde P. Peeters, J. Verbist - Imelda Hospital, Bonheiden L. Maene, R. Beelen - OLV, Aalst K. Keirse - RZ Heilig Hart, Tienen J. Hendriks UZA, Edegem FMRP
11 PES BTK-70 study Study design Main inclusion criteria Rutherford classification 4 & 5 De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries Total target lesion length < 50mm Primary endpoint Primary patency at 6 and 12 months, defined as: absence of restenosis ( 50% stenosis) or occlusion within the originally treated lesion based on angiography, verified by Core Lab. FMRP
12 PES BTK-70 study Timeline proc disch 1 M 6 M 12 M Medication Physical examination Rutherford ABI Core Lab Angiography Core Lab Ultrasound Standard Ultrasound FMRP
13 PES BTK-70 study: Patient demographics N=70 Male (%) 45 (64.3%) Age (min max; ±SD) (45 92; ±9.44) Nicotine abuse (%) 10 (14.3%) Hypertension (%) 46 (65.7%) Diabetes mellitus (%) 28 (40.0%) Renal insufficiency (%) 7 (10.0%) Hypercholesterolemia (%) 30 (42.9%) Obesity (%) 11 (15.7%) Rutherford 4 (%) 37 (52.9%) Rutherford 5 (%) 33 (47.1%) FMRP
14 PES BTK-70 study: Lesion characteristics N=70 Left/Right limb (%) 39 (55.7%) / 31 (44.3%) Lesion length 19.7 mm Occlusion (%) 10 (14.3%) Calcified lesion (%) 43 (61.4%) Presence of thrombus (%) 2 (2.9%) Technical and procedural Success (%) 68 (97.14%) FMRP
15 PES BTK-70 study: 12-month Primary Patency 72.6% time baseline 6MFU 12MFU at risk % FMRP
16 PES BTK-70 study: 12-month Freedom from TLR 79.1 % time baseline 6MFU 12MFU at risk % FMRP
17 PES BTK-70 study: 12-month Survival 89.4 % time baseline 6MFU 12MFU at risk % FMRP
18 PES BTK-70 study: Rutherford improvement FMRP
19 Primary Patency % Comparison other trials: ,6 82,5 1 year patency rates 55,6 54, ,6 YUKON DESTINY ACHILLES PES BTK 70 BMS/PTA SES PES FMRP
20 Case Patent 12m post procedure Baseline pre-op Baseline post-op 12 MFU FMRP
21 Conclusion There is evidence for limus eluting, balloonexpandable stents in the CLI-BTK area The PES BTK-70 trial shows that the self-expanding paclitaxel-coated Stentys stent is a valid alternative in BTK-lesions FMRP
22 LINC 2015, Leipzig A.Z. Sint-Blasius, Dendermonde Marc Bosiers Koen Deloose Joren Callaert Imelda Hospital, Bonheiden Patrick Peeters Jürgen Verbist OLV Hospital, Aalst Lieven Maene Roel Beelen R.Z. Heilig Hart, Tienen Koen Keirse Bart Joos PES BTK 70 : 12 m results with a paclitaxelcoated self-expanding stent in BTK arteries Marc Bosiers, MD FMRP
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