Study Endpoints

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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 - PowerPoint PPT Presentation

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  • 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 Schwarzwlder, MD, Elias Noory, MD, Ullrich Beschorner, MD, Sebastian Sixt, MD, Thomas Schwarz, MD, Karlheinz Brgelin, MD, Klaus Brechtel, MD, Thilo Tbler, 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-Universitt, Tbingen (G.T., K.B.); Universitres Herz- und Gefzentrum Hamburg (H.K., T.T.); Cardiologicum Hamburg (R. Z.)

    ClinicalTrials.gov number, NCT00664963

  • Study EndpointsPrimary 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 ratesecondary patency ratesTLR ratesChanges in Rutherford-Becker classificationAnkle-brachial index MAE

  • 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. Study Profile

  • P=0.004 (primary patency)P=0.005 (secondary patency)Hazard ratio for restenosis for BMS vs. SES: 3.2 (95% CI 1.5 to 6.7; P = 0.003) P = 0.1 each comparison

    Diagramm1

    55.671.4

    80.691.9

    primary patency

    secondary patency

    1-Year Patency Rates

    Tabelle1

    primary patencysecondary patency

    BMS55.671.4

    SES80.691.9

    Ziehen Sie zum ndern der Gre des Diagrammdatenbereichs die untere rechte Ecke des Bereichs.

    Tabelle2

    Tabelle3

    Diagramm1

    0.490.47

    0.690.75

    BMS

    SES

    Ankle Brachial Index

    Tabelle1

    BMSSES

    pre0.490.47

    1-year0.690.75

    Ziehen Sie zum ndern der Gre des Diagrammdatenbereichs die untere rechte Ecke des Bereichs.

    Tabelle2

    Tabelle3

  • *IQR = interquartile range

    6 monthsN=131N=64 (SES)N=67 (BMS) P-ValueMedian (IQR)*2 (1 to 3)1 (1 to 3)2 (1 to 3)0.3Improvement by 1 Class93 (70.9%)49 (76.5%)44 (65.7%)No Change35 (26.9%)14 (21.9%)21 (31.3%)Worse by 1 Class3 (2.3%)1 (1.6%)2 (3.0%)Median Change (IQR)* -1.5 (-3 to 0)-2 (-3 to-1)-1 (-2 to 0)0.0912 months N=125N=62 (SES) N=63 (BMS)Median (IQR)*2 (1 to 3)2 (0.75 to 3)2 (1 to 3)0.01Improvement by 1 Class91 (72.8%)52 (83.9%)39 (61.9%)No Change30 (24%)8 (12.9%)22 (34.9%)Worse by 1 Class4 (3.2%)2 (3.2%)2 (3.2%)Median Change (IQR)*-2 (-3 to 0)-2 (-3 to -1)-1 (-2 to 0)0.004

  • Event-free Survival at 12 monthsSurvival 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.1008020

    No. at riskSirolimus Stent8271646362Bare-metal Stent7972676463