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 atherosclerosisin CAPRIE (overlap between PAD, CAD and CVD)Atherothrombosis – symptomatic atherosclerosisin CAPRIE (overlap between PAD, CAD and CVD)

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

CAPRIE1 (n = 19185)

Cerebrovasculardisease (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

polypectomy335LADCYPHER4

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 AnalysisARC Definite/Probable ST to 1440 DaysARC Definite/Probable ST to 1440 Days

Def/Def/ProbProb ThrombosisThrombosis 00 3030 270270 360360 720720 10801080 14401440EndeavorEndeavor 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 1440Time After Initial Procedure (days)

Cum

ulat

ive

Inci

denc

e of

Def

/Pro

bTh

rom

bosi

s (A

RC

)

180180 270270 450 540 630 810 900 990 1080 1170 13501260

Endeavor Driver

1.5%0.7%

Before 1 yearEndeavor: 0.6%Driver: 1.2%

After 1 yearEndeavor: 0.1%Driver: 0.3%

Log rank p= 0.071

SENSOutcome of Non-cardiac Surgical Procedure andBrief Interruption of DAPT within 12 Months Following Endeavor Implantation

SENS Trial at ACC09

SENS StudyAlthough 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 stentimplantation.

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 <0.001

DAP withdrawal (days) 13.4 14.8 NS

MACE (%) 8.9(2 Death, 1 MI)

0.6(1 MI) <0.001

SENS: Kim et al. ACC 2009.Note – ST data were not reported

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 DELIVERANCEFor Internal Use; Do Not Copy or Distribute

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

patients treated before May 22, 2006; 90.8% complianceall 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