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TCT 2010: DES Below The Knee
1. DES-BTK: A Prospective, Double-Blind Randomized Trial of Polymer-Free Sirolimus-Eluting Stents (SES) Compared to Bare Metal Stents (BMS) in Patients with Infrapopliteal Disease A. Rastan, MD, G. Tepe, MD, H. Krankenberg, MD, R. Zahorsky, MD, U. Schwarzwälder, MD, E. Noory, MD, U. Beschorner, MD, S. Sixt, MD, T. Schwarz, MD, K. Bürgelin, MD, K. Brechtel, MD, T. Tübler, MD, F.-J. Neumann, MD, and T. Zeller, MD From the Herz-Zentrum Bad Krozingen, Bad Krozingen (A.R., U.S., E.N., U.B., S.S., T.S., K.B., F.J.N., T.Z.); Eberhard-Karls-Universität, Tübingen (G.T., K.B.); Universitäres Herz- und Gefäßzentrum Hamburg (H.K., T.T.); Cardiologicum Hamburg (R. Z.) ClinicalTrials.gov number, NCT00664963
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3. Study Endpoints Primary Endpoint: 1-year primary patency rate, defined as freedom from in-stent-restenosis (≥50%) detected with angiography or if appropriate with duplex ultrasound. Major secondary endpoints: 6-month primary patency rate secondary patency rates TLR rates Changes in Rutherford-Becker classification Ankle-brachial index MAE
4. A prospective, randomized, multi-centre, double blind trial (4/2006 to 4/2008) comparing a polymer-free sirolimus-eluting stent (SES) with a placebo coated bare-metal stent (BMS) in patients with either intermittent claudication or CLI who had a de-novo lesion up to 5cm length in an infrapopliteal artery. 161 patientsenrolled Study Profile 79 BMS 82 SES 12 died 8 died 3 patientswere lost tofu 4 patientswere lost tofu 1 patienttelephonecontact 2 patientstelephonecontact 67 patientsat 6 monthsfollow-up 64 patientsat 6 monthsfollow-up 2 died 3 died 1 patient was lost tofu 62 patientsat 12 monthsfollow-up 63 patientsat 12 monthsfollow-up
5. Primary & Secondary 1-Year PatencyABI at 1 Year P=0.004 (primary patency) P=0.005 (secondary patency) P = 0.1 each comparison Hazard ratio for restenosis for BMS vs. SES: 3.2 (95% CI 1.5 to 6.7; P = 0.003)
7. Event-free Survival at 12 months Survival free from target lesion revascularisation, major and minor amputation, myocardial infarction and death was compared by Kaplan-Meier analysis with the use of the Mantel-Cox log-rank test. 100 80 20
![Potential Conflicts of Interest Speaker’s name: Thomas Zeller My Disclosures: ,[object Object], Sanofi-Aventis, C.R. Bard, Cordis, ev3, Pathway Medical, Straub Medical, Invatec, Biotronik, Optimed, SquareOne ,[object Object], Cook, Krauth Medical, Pathway Medical, Abbott Vascular, Invatec, Angioslide, Novostent, IDEV, Biotronik, Atheromed, ev3, C.R. Bard, Cordis](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)