Seoul National University Hospital CILON-T Late Breaking Trial : Randomized prospective trial of dual vs. triple antiplatelet therapy after DES implantation ACC & i2 summit, March 15th 2010, Atlanta, Georgia Hyo-Soo Kim, MD, PhD Seoul National University Hospital Seoul, Korea
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Seoul National University Hospital CILON-T Late Breaking Trial : Randomized prospective trial of dual vs. triple antiplatelet therapy after DES implantation.
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Seoul National University Hospital
CILON-T Late Breaking Trial :Randomized prospective trial of dual vs. triple antiplatelet therapy af-
ter DES implantation
ACC & i2 summit, March 15th 2010, Atlanta, Georgia
Hyo-Soo Kim, MD, PhD
Seoul National University Hospital
Seoul, Korea
Seoul National University Hospital
Nothing to disclose
Seoul National University Hospital
CILON-T trial
CILostazol-based triple anti-platelet therapy ON Ischemic Complica-tion 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
Seoul National University Hospital
CILON-T trial : participating centers
Centers Investigators
Seoul National University Hospital Hyo-Soo Kim, MD, PhD
Seoul National University Bundang Hospital In-Ho Chae, MD, PhD
Konyang University Hospital Jang-Ho Bae, MD, PhD
Korea University Guro Hospital Seung-Woon Rha, MD, PhD
Chungbuk University Hospital Myeong-Chan Cho, MD, PhD
Seoul National University Hospital
Background of the CILON-T trial
I. Accumulating evidences suggest the relationship between clopidogrel resistance & clinical events.
II. Recent studies reported the value of using VerifyNow (PRU) in predicting clinical events.
III. Efficacy of adding cilostazol in reducing clinical events has been reported in the registry or small randomized con-trolled study of specific subpopulation.
Seoul National University Hospital
Background of the CILON-T trial
Efficacy of adding cilostazol on DAT in reducing
clinical events or PRU value has not been tested
• in the real-world all-comer patients with DES implantation
• at the level of large randomized controlled study.
TAT (n=457)
Randomization (n=960)
TAT (n=477)
Rosuvastatin (n=236)
Atorvastatin (n=241)
Atorvastatin(n=242)
Rosuvastatin (n=241)
DAT (n=483)
Assessed for eligibility (n=976)
DAT (n=458)
3 Withdrawal at patient request14 Withdrawal at clinician’s judgment3 Failed PCI
2 Withdrawal at patient request19 Withdrawal at clinician’s judgment4 Failed PCI
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
Seoul National University Hospital
Key participation criteria Inclusion criteria
Age 18~80yrs All-comers : patients with native de-novo 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 anti-platelet agents Allergy to study medications
Seoul National University Hospital
RESULTS
Seoul National University Hospital
Clinical profiles of patients TAT (n=457) DAT (n=458) p
Age 1.02 (0.99~1.04) 1.01 (0.97~1.04)Diagnosis of AMI 0.62 (0.25~1.53) 1.01 (0.36~2.86)
Seoul National University Hospital
Study limitations
Open-label study, but with 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
Seoul National University Hospital
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 pa-tients with low PPR (PRU < 210 unit) did not develop any thrombotic event (CD, MI, or ischemic stroke) irrespective of anti-platelet regimen.
Seoul National University Hospital
Conclusion of CILON-T randomized controlled trial
Tailored decision on the adjunctive use of cilostazol ac-
cording to PPR (post-treatment platelet reactivity) may
be important to reduce clinical events in patients with