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Study Endpoints

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

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Study Endpoints

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  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 Aljoscha Rastan, MD, Gunnar Tepe, MD, Hans Krankenberg, MD, Rainer Zahorsky, MD, Uwe Schwarzwälder, MD, Elias Noory, MD, Ullrich Beschorner, MD, Sebastian Sixt, MD, Thomas Schwarz, MD, Karlheinz Bürgelin, MD, Klaus Brechtel, MD, Thilo Tübler, MD, Franz-Josef Neumann, MD, and Thomas 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

  2. Angiologie Herz-Zentrum Bad Krozingen 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

  3. 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. Angiologie Herz-Zentrum Bad Krozingen 161 patients enrolled Study Profile 82 SES 79 BMS 12 died 8 died 4 patients were lost to fu 3 patients were lost to fu 2 patients telephone contact 1 patient telephone contact 64 patients at 6 months follow-up 67 patients at 6 months follow-up 2 died 3 died 1 patient was lost to fu 62 patients at 12 months follow-up 63 patients at 12 months follow-up

  4. Angiologie Herz-Zentrum Bad Krozingen 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)

  5. Rutherford-Becker Classification at 6 Months & 1 Year *IQR = interquartile range

  6. Angiologie Herz-Zentrum Bad Krozingen 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

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