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 2015 1
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 2015 2
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 2015 3
Primary Patency % Randomized trials for DES-BTK 100 80 60 40 20 0 1 year patency rates 80,6 82,5 55,6 54,4 57 75 BALLOON-EXPANDABLE & YUKON DESTINY ACHILLES SIRO/EVERO-LIMUS ELUTING Rastan A. et al (2011). European Heart Journal, 32, 2274-2281 Bosiers M. et al (2012). Journal of Vascular Surgery, 55, 390-398 Scheinert D. et al (2012). Journal of the American College of Cardiology, 60, 2290-2295 P < 0.05 for all trials BMS/PTA SES FMRP 2015 4
What about SELF-EXPANDABLE & PACLITAXEL ELUTING BALLOON-EXPANDABLE & SIRO/EVERO-LIMUS ELUTING FMRP 2015 5
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 2015 6
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 2015 7
PES BTK-70 study Excellent vessel conformability Balloon-expandable stent (Driver) Proximal Proximal Stentys Distal Proximal FMRP 2015 Distal 8
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 2015 9
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 2015 10
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 2015 11
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 2015 12
PES BTK-70 study: Patient demographics N=70 Male (%) 45 (64.3%) Age (min max; ±SD) 74.64 (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 2015 13
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 2015 14
PES BTK-70 study: 12-month Primary Patency 72.6% time baseline 6MFU 12MFU at risk 70 54 43 % 100 87.6 72.6 FMRP 2015 15
PES BTK-70 study: 12-month Freedom from TLR 79.1 % time baseline 6MFU 12MFU at risk 70 55 46 % 100 89.2 79.1 FMRP 2015 16
PES BTK-70 study: 12-month Survival 89.4 % time baseline 6MFU 12MFU at risk 70 62 55 % 100 92.6 89.4 FMRP 2015 17
PES BTK-70 study: Rutherford improvement FMRP 2015 18
Primary Patency % Comparison other trials: 100 80 60 40 20 0 80,6 82,5 1 year patency rates 55,6 54,4 57 75 72,6 YUKON DESTINY ACHILLES PES BTK 70 BMS/PTA SES PES FMRP 2015 19
Case Patent 12m post procedure Baseline pre-op Baseline post-op 12 MFU FMRP 2015 20
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 2015 21
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 2015 22