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CILON-T Late Breaking Trial : Randomized prospective trial of dual vs. triple antiplatelet therapy after DES implantatio PowerPoint Presentation
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CILON-T Late Breaking Trial : Randomized prospective trial of dual vs. triple antiplatelet therapy after DES implantation . Presented at ACC & i2 summit, March 15th 2010, Atlanta, Georgia Published in Trials 2010, JACC 2011. Hyo-Soo Kim, MD, PhD

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CILON-T Late Breaking Trial :Randomized prospective trial of dual vs. triple antiplatelet therapy after DES implantation

Presented at ACC & i2 summit, March 15th 2010, Atlanta, Georgia

Published in Trials 2010, JACC 2011.

Hyo-Soo Kim, MD, PhD

Seoul National University Hospital, Seoul, Korea

cilon t trial
CILON-T trial
  • CILostazol-based triple anti-platelet therapy ON Ischemic Complication after drug-eluting stenT implantation
  • Multicenter, prospective, randomized trial
  • PROBE

(Prospective Randomized Open-label Blinded Evaluation)

  • Principal investigator
    • Hyo-Soo Kim, MD, PhD
  • Clinical trials identifier
    • NCT00776828
background of the cilon t trial
Backgroundof the CILON-T trial

Accumulating evidences suggest the relationship between clopidogrel resistance & clinical events.

Recent studies reported the value of using VerifyNow (PRU) in predicting clinical events.

Efficacy of adding cilostazol in reducing clinical events has been reported in the registry or small randomized controlled study of specific subpopulation.

background of the cilon t trial6
Backgroundof the CILON-T trial
  • Efficacy of adding cilostazol on DAT in reducing
  • clinical events or PRU valuehas not been tested
  • in the real-world all-comer patients with DES implantation
  • at the level of large randomized controlled study.
cilon t clinical trial design
CILON-T Clinical Trial Design
  • Comparison of two anti-platelet regimens

with random assignment of statin type (atorva-20 & rosuva-10)

  • 960 patients randomized (Sep 2006~June 2009)

TAT group (477) versus DAT group (483)

  • Five centers in Korea
  • Follow-up requirements
    • P2Y12 reaction unit (VerifyNow TM P2Y12) at discharge & 6 mo
    • Clinical F/U at 1, 3 and 6 mo
    • Angiographic F/U (recommended)

SP Lee, JW Suh,, HS Kim. Trials 2010

slide8

Assessed for eligibility (n=976)

Randomization (n=960)

DAT (n=483)

TAT (n=477)

Atorvastatin

(n=241)

Rosuvastatin

(n=236)

Atorvastatin

(n=242)

Rosuvastatin

(n=241)

3 Withdrawal at patient request

14 Withdrawal at clinician’s judgment

3 Failed PCI

2 Withdrawal at patient request

19 Withdrawal at clinician’s judgment

4 Failed PCI

TAT (n=457)

DAT (n=458)

915 patients with successful PCI & follow-up

  • ** Primary endpoint : at 6 month
  • Cardiovascular death, nonfatal MI, ischemic stroke, TLR
  • Platelet (P2Y12) reaction unit
cilon t trial endpoints
CILON-T Trial Endpoints
  • Primary Endpoint
    • Composite of clinical outcomes within six months

(cardiac death, MI, ischemic stroke & TLR)

  • Secondary endpoint
    • PRU level measured at discharge & 6 mo after the index procedure
    • All cause of death, stent thrombosis, and each component of primary endpoint at six months
  • Safety Endpoint
    • Bleeding complications according to TIMI criteria
    • The incidence of drug discontinuation
    • Heart rate

JW Suh,, HS Kim. JACC 2011

key participation criteria
Key participation criteria
  • Inclusion criteria
    • Age 18~80yrs
    • All-comers : patients with native coronary artery lesions for which DES implantation was feasible
  • Exclusion criteria
    • Hepatic dysfunction (GOT/GPT >*3 UNL)
    • Renal dysfunction (Scr>2.0mg/dl or on dialysis)
    • LV dysfunction (EF <30%)
    • Uncontrolled hematological disease
    • Patients taking warfarin or other antiplatelet agents
    • Allergy to study medications

JW Suh,, HS Kim. JACC 2011

profiles of medication at discharge
Profiles of Medication at Discharge

JW Suh,, HS Kim. JACC 2011

angiographic profiles of patients
Angiographic profiles of patients

JW Suh,, HS Kim. JACC 2011

results p2y12 reaction unit pru tat vs dat
Results: P2Y12 reaction unit (PRU): TAT vs DAT

JW Suh,, HS Kim. JACC 2011

PRU

p < 0.001

p < 0.001

results change of pru for 6 months tat vs dat
Results: Change of PRU for 6 months : TAT vs DAT

TAT

DAT

P2Y12 reaction unit (PRU)

p< 0.001

p =0.23

At discharge

6 mo

At discharge

6 mo

results clinical outcomes depending on pru value
Results: Clinical outcomes depending on PRU value

Composite of

CD, nonfatal MI,

ischemic stroke & TLR

Composite of

CD, nonfatal MI

& ischemic stroke

TLR

p=0.077

p=0.486

p=0.037

JW Suh,, HS Kim. JACC 2011

slide20

Results: Clinical outcomes depending on anti-plt regimen

Double anti-PLT regimen

Triple anti-PLT regimen

Composite of

CD, nonfatal MI,

ischemic stroke & TLR

Composite of

CD, nonfatal MI

& ischemic stroke

TLR

p=0.818 for log-rank test

p=0.701 for log-rank test

p=0.742 for log-rank test

9.2%

7.2%

8.5%

6.6%

2.0%

2.0%

pru value versus anti plt regimen to predict macce
PRU value versus Anti-PLT regimen to predict MACCE

Composite of

CD, nonfatal MI,

ischemic stroke & TLR

Composite of

CD, nonfatal MI

& ischemic stroke

TLR

JW Suh,, HS Kim. JACC 2011

subgroup analysis tat vs dat
Subgroup analysis : TAT vs DAT

Baseline characteristics

HR

95% CI

Diabetes

0.37-1.60

0.78

Yes

1.02

0.57-1.83

No

Age

≥ 65 yr

1.34

0.69-2.58

0.64

0.32-1.29

<65 yr

Sex

0.66

0.39-1.13

Male

3.41

1.12-10.4

Female

Lesion length

0.79

0.34-1.84

≥ 28mm

0.70

0.38-1.31

<28mm

Reference vessel diameter

<2.75mm

0.80

0.38-1.69

≥2.75mm

0.85

0.45-1.60

0

1

2

TAT better

DATbetter

results safety outcomes tat vs dat
Results: Safety outcomes : TAT vs DAT

JW Suh,, HS Kim. JACC 2011

study limitations
Study limitations
  • Open-label study, but blinded evaluation
  • Platelet reactivity measured by single method
  • Not powered to verify the effect of cilostazol on the hard endpoint, such as CD, nonfatal MI or stent thrombosis
summary of cilon t randomized controlled trial
Summary of CILON-T randomized controlled trial
  • TAT achieved lower PPR (post-treatment platelet reactivity) than DAT.
  • But it did not necessarily reduce MACCE within six months after DES implantation,
  • because there were substantial numbers of hypo-responders even to TAT.
  • The importance of PPR is reflected by the finding that the patients with low PPR (PRU < 210 unit) did not develop any thrombotic event (CD, MI, or ischemic stroke) irrespective of anti-platelet regimen.
conclusion of cilon t randomized controlled trial
Conclusion of CILON-T randomized controlled trial
  • Tailored decision on the adjunctive use of cilostazol according to PPR (post-treatment platelet reactivity) can be helpful to reduce adverse clinical outcomes in patients who undergo DES implantation.