TCT Asia Pacific 2009 ---Breakfast Symposium Transradial Intervention 2009-05-18¢  Transradial Intervention

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  • Transradial Intervention with Two Endeavor Stents for Patient

    Needing Elective Vascular Surgery------Discussion

    Chang-Gung Memorial Hospital and University, Second department of Cardiology

    I-Chang Hsieh, MD

    Apr.23,2009

    TCT Asia Pacific 2009 ---Breakfast Symposium

  • Discussion 1: 1. How to manage the symptomatic peripheral

    arterial occlusive disease (PAOD) in this patient? - PTA - Surgery

  • Atherothrombosis – symptomatic atherosclerosis in CAPRIE (overlap between PAD, CAD and CVD) Atherothrombosis – symptomatic atherosclerosis in CAPRIE (overlap between PAD, CAD and CVD)

    1CAPRIE Steering Committee. Lancet 1996;348:1329–1339.

    CAPRIE1 (n = 19185)

    Cerebrovascular disease (CVD)

    Peripheral Arterial Disease (PAD)

    Coronary artery disease (CAD)

    24.6% 29.9%

    19.2%

    3.3% 3.8%

    7.3%

    11.9%

  • Complete occlusion, right superficial femoral artery, both ATA and left peroneal artery.

    Multifocal stenosis, right deep femoral artery and left femoral artery and left PTA.

    Diffuse muscle atrophic change with decreased blood flow, left lower extremity.

    CT CT AngioAngio. for Low Extremity. for Low Extremity

  • Discussion 2: 1. How to manage the symptomatic peripheral

    arterial occlusive disease (PAOD) in this patient? - PTA - Surgery

    2. If surgery is indicated: Which stent is appropriate in PCI? - Bare metal stent (BMS) - Drug-eluting stent (DES)

  • If a patient will receive planned non- cardiac surgery but who needs PCI at first:

    Delay the surgery

    Yes No

    As usual PCI treatment PTCA without stent implantation or Bare metal stent implantation

  • Late thrombosis (> 6 months) in drug-eluting coronary stents after discontinuation antiplatelet therapy

    Stent occlusionColonoscopy and polypectomy335LAD

    CYPHER4

    Stent occlusionPoor compliance of patient375LCXCYPHER3

    Stent occlusionOp. for colon ca.442LADTAXUS2

    Stent occlusion

    Resection of bladder polyps343LADTAXUS1

    AngiographyReason to stop aspirin Days after stentingLocationDESCase

    ~Mc Fadden et al. Lancet 2004; 364:1519-21~

  • CAD with PAOD

    Risk of restenosis Safety

  • If a patient will receive planned non- cardiac surgery but who needs PCI at first:

    Delay the surgery

    Yes No

    As usual PCI treatment PTCA without stent implantation or Bare metal stent implantation

    New generation DES?

  • Discussion 3: 1. How to manage the symptomatic peripheral

    arterial occlusive disease (PAOD) in this patient? - PTA - Surgery

    2. If surgery is indicated: Which stent is appropriate in PCI? - Bare metal stent (BMS) - Drug-eluting stent (DES)

    3. If a drug-eluting stent was chosen: (a) Which DES is best? (b) How long should the dual anti-platelet therapy (Aspirin+ Clopidogrel) be used?

  • Endeavor Safety AnalysisEndeavor Safety Analysis ARC Definite/Probable ST to 1440 DaysARC Definite/Probable ST to 1440 Days

    Def/Def/ProbProb ThrombosisThrombosis 00 3030 270270 360360 720720 10801080 14401440 EndeavorEndeavor 21322132 21312131 21142114 20682068 20362036 16501650 10871087 # Events# Events 11 66 44 22 22 00 00

    % CI% CI 0.0%0.0% 0.3%0.3% 0.5%0.5% 0.6%0.6% 0.7%0.7% 0.7%0.7% 0.7%0.7% DriverDriver 596596 595595 587587 576576 570570 559559 543543

    # Events# Events 11 66 11 00 00 11 00 % CI% CI 0.2%0.2% 1.2%1.2% 1.3%1.3% 1.3%1.3% 1.3%1.3% 1.5%1.5% 1.5%1.5%

    0%

    2%

    4%

    6%

    8%

    10%

    0 9090 360 720 1440 Time After Initial Procedure (days)

    C um

    ul at

    iv e

    In ci

    de nc

    e of

    D ef

    /P ro

    b Th

    ro m

    bo si

    s (A

    R C

    )

    180180 270270 450 540 630 810 900 990 1080 1170 13501260

    Endeavor Driver

    1.5% 0.7%

    Before 1 year Endeavor: 0.6% Driver: 1.2%

    After 1 year Endeavor: 0.1% Driver: 0.3%

    Log rank p= 0.071

  • SENS Outcome of Non-cardiac Surgical Procedure and Brief Interruption of DAPT within 12 Months Following Endeavor Implantation

  • SENS Trial at ACC09

  • SENS Study Although current guidelines recommend DAPT for 12 months, the SENS study concluded that in the patients evaluated, Endeavor “appears to be safe and feasible in patients undergoing non-cardiac surgical procedure” after 3 months following stent implantation.

    Variables Early surgery group (0-3 months, n=34) Late surgery group (3-12 months, n=160) p-value

    Age(yrs)/Male(%) 62.2/63.5 63.1/50.9 NS

    Lesion type (B2/C) (%) 73.6 72.8 NS

    Stent number 1.4 1.5 NS

    Mean stent diameter (mm) 3.11±0.52 3.08±0.47 NS

    Total stent length (mm) 33.0±16.7 29.2±19.5 NS

    Major surgery (%) 20.5 22.8 NS

    Days from stenting to surgery 56.5 233.7

  • DATE Trial---unpublished data

    • Korean registry study • More than 800 patients • Discontinuation of dual anti-platelet

    therapy after 3 months of Endeavor implantation

    • Stent thrombosis rate is 0.35% after 12 months follow-up

  • HEALING DELIVERANCE For Internal Use; Do Not Copy or Distribute

    Clinical Events in patients with 6 month follow-up Interim results as of May 2, 2007, n=1039

    patients treated before May 22, 2006; 90.8% compliance all events adjudicated by CEC MACE=cardiac death, MI, CABG, and clinically driven TLR *There were 3 SATs, but one SAT occurred in a drug eluting stent and will be readjudicated

    1.74 %

    0 %

    0 %

    0 %

    1.06 %

    0.10 %

    1.16 %

    0.58 %

    30 days

    5.87 %MACE

    2.60 %PCI

    0.19 %Q-wave

    1.63 %MI

    0.29 %CABG

    2.89 %TLR (Clinically Driven)

    1.44 %Non Q-wave

    1.35 %Cardiac Death

    6 months

    0.48 %Late stent thrombosis

    0.29 %Sub-acute stent thrombosis*

    0.10 %Acute stent thrombosis

    e-HEALING Interim Analysis

  • Discussion 4:

    • Is it feasible and safe to use 5 Fr transradial guiding catheter in PCI?

  • UC200504205EEUC200504205aEEUC200504205aEE

  • Discussion 5:

    • Is it feasible and safe to use 5 Fr transradial guiding catheter in PCI?

    • If the diagonal branch was jailed and complex procedure (IVUS, kissing balloon technique) should be done, 5 Fr may be not the best choice